tag:blogger.com,1999:blog-13350079077156189662023-11-15T08:08:43.613-08:00MedTruthA Commentary on Truth in MedicineDr. Joseph Goldhttp://www.blogger.com/profile/00368001273179577986noreply@blogger.comBlogger29125tag:blogger.com,1999:blog-1335007907715618966.post-28088390920980730722012-07-18T13:52:00.000-07:002012-07-18T13:52:45.849-07:00What Is Cancer? Instead of the usual blog here on <em>MedTruth</em> I want to call your attention to a new paper (manuscript) I have recently published on a new, actually revolutionary, theory on cancer, <em>What Is Cancer?</em>, defining cancer as a <strong>normal body process</strong> which serves to "protect" the body from perhaps the most devastating environmental threat imposed on it during a person's lifetime. This environmental threat translates into tissue and organ damage--culminating in such disorders as heart attacks, diabetes and neurodegenerative diseases--aging (senescence) and cellular and whole-body mortallity (death). This fundamental threat from the environment is the development of oxidative stress--resulting from the oxygen environment in which we live and our oxygen-based metabolism.<br />
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In 1931 Otto Warburg received the Nobel Prize for his demonstration that cancer cells utilize a process known as glycolysis as their chief means of energy production, rather than the more energy-efficient oxidative respiration, as in normal cells. The present paper, <em>What Is Cancer?</em>, proposes that glycolysis serves a much more vital and deep-seated process to the overall integrity--and, paradoxically, downfall--of the body. In the present paper it is proposed that the basic "defect" of cancer is not glycolysis in <u>cancer cells</u> but a metabolic "shift" to enhanced glycolysis in <u>normal cells,</u> and that therapy of this "shift" in normal cells may constitute an effective treatment for cancer.<br />
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<em>What Is Cancer?</em> is published on the Internet by the author to secure wide dissemination in the professional and lay medical community and can be accessed at: <u><a href="http://www.thepathogenesisofcancer.com/">www.thepathogenesisofcancer.com</a></u>. Those with scientific or medical training and/or inclincation should find little difficulty in comprehending its contents.<br />
<br />Dr. Joseph Goldhttp://www.blogger.com/profile/00368001273179577986noreply@blogger.com25tag:blogger.com,1999:blog-1335007907715618966.post-51588109644134747682012-06-05T12:32:00.000-07:002012-06-07T09:05:55.022-07:00Cancer scammery (again!) <em>MedTruth is a commentary on truth in medicine and the current--May/June 2012--Newsletter of the Syracuse (NY) Cancer Research Institute lends itself well to illustrating the frequent lack of truth promulgated to the public especially in the field of cancer and especially as concerns hydrazine sulfate, which has been discussed previously. Accordingly, this Newletter is presented in toto.</em><br />
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<em> </em>May/June 2012<br />
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Dear Friend,<br />
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Syracuse has been one of the spots in the nation that has enjoyed unusually warm conditions this winter. Characteristically the snowiest major city in the United States, we have enjoyed sunny, spring-like weather throughout the winter with less than one-fifth the normal amount of snow. And with the approach of summer we all look forward with expectation to a continuation of those conditions that not only warm the body, but the soul.<br />
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Today I want to discuss with you an important question, one that frequently comes up and that can have great importance in our personal health and the health of the people we love.<br />
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The frequent question pertains to the work of the Syracuse Cancer Research Institute, the institute's development of the cancer drug hydrazine sulfate, which has been the subject of previous Newsletters and which controlled clinical trials performed in accordance with internationally accepted criteria have shown, without exception, to be efficacious and safe.<br />
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The question is: If hydrazine sulfate were such a good drug, why does the medical profession in general discourage its use? This is a most important question, especially since the incidence of cancer increases as we get older. That is, as we progress in life, the chances that we ourselves--our families, our friends and loved ones--acquire this disease become ever greater.<br />
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There are answers to this question. Direct answers. Challenging fallacious statements of the National Cancer Institute: "There are no randomized clinical trials demonstrating anticancer activity of hydrazine sulfate." Challenging the patient-confusing statements of trusted physicians: "If hydrazine sulfate were any good, don't you think we would be using it?" But minds cannot seem to override these fallacious statements, no matter how they are shown to be untrue.<br />
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I want to acquaint you with a "60 Minutes" broadcast several Sundays ago. The broadcast concerned the work of the Nevins laboratory of Duke University Cancer Center--and one of the most substantial advances in cancer medicine ever made. Considered one of the outstanding cancer laboratories in the world, the Nevins laboratory had recently reported breakthrough methodology whereby it became possible to "decode" the genetic makeup of each individual's cancerous tumor with the promise and hope of curing each patient of this disease. This advance excited a large segment of those engaged in cancer research and in particular received the endorsement of our country's National Cancer Institute, the largest cancer agency in the world. Many of the involved scientists, including some in the NCI itself, applied for patents regarding one aspect or another of this new discovery, with the understanding that not millions--but billions--of dollars could be individually forthcoming. The potential importance of the Duke University findings was repeated at every opportunity to the American people by scientists and administrators alike at all echelons in this cancer center as well as at leading cancer organizations around the United States. This "recitation" and "reiteration" was not the bottom of the cancer establishment talking--it was the very top. The most authoritative and valid. And therefore the most ethically credible.<br />
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The only trouble was that other cancer centers were having trouble reduplicating the Duke findings. No matter what their reputation, no matter the expertise of their individual scientists, word was beginning to get around that the Duke findings were "erroneous." The National Cancer Institute decided to finally settle the matter by launching a detailed investigation into the data. After careful study of these data, the NCI declared the Duke findings to be totally valid.<br />
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However, there was continued grumbling about these findings. Other laboratories were still not able to reduplicate them. Finally an article appeared in a small scientific monthly, giving words to the rumor that was beginning to circulate that the reason behind other laboratories having difficulties in redupicating the Duke findings was because, as some scientists were alleging, the input data were fraudulent. That is, not true. <em>Made up.</em> The NCI, which had just investigated the Duke findings, vigorously denied this.<br />
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But once the ice had been broken, other laboratories, other scientists joined the increasing chorus of those not only alleging fraud, but actually pointing out specific places where the data were falsified. Able to stand this increasing chorus no longer, the Duke University scientists responsible for these data admitted that the whole study was bogus. <em>Fiction.</em> That the data were totally false, that they were aware of the vast amounts of money to be gained by a positive study. The NCI was naturally embarrassed--for no one could be sure whether the institution was merely incompetent or it and its offficials were also in on the "take."<br />
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It is to be stressed that the Duke data were not merely a "mistake." They were fictitious. The Duke scientists and their NCI cohorts were engaged in a hoax--from the start--for reasons of money. And it was the very top, the most prestigious, the most honorable of the cancer establishment that was willing to trade lives for dollars. To allege progress in cancer treatment--when there was none--to lie at the expense of human life.<br />
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If these same people--the very leaders of our cancer programs--are willing to lie about a fictitious cancer drug/procedure that can make them a lot of money, when they know it is entirely fraudulent,would they not also be willing to lie about a genuine, inexpensive drug they know <em>is</em> effective--but cannot make them any money? Even though so doing would or could cost cancer patients their lives? That is the question you must decide.<br />
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But that's not all.<br />
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The deception by our government and trusted physicians extends yet deeper. There was another broadcast aired several weeks ago. This was an <em>NBC Dateline</em> expose about how drug companies test many of their drugs, including cancer drugs. And it's not here in the United States. It's in countries where the costs of human testing are much smaller. And it's not under FDA auspices. <em>Dateline</em> commissioned an Indian company to test a drug given a phony name, similar to one that had been recalled in the United States because of its great toxicity, including deaths--and was able to show that the Indian pharmaceutical company that elected to test it did in fact learn of the drug's toxicity but still assured the NBC "drug executives" that they could get it through the FDA and no one would be the wiser. The <em>Dateline</em> staff then revealed they were not a pharmaceutical company and that the drug under consideration was one already recalled in the U.S. because of its toxicity. Whereupon the NBC journalists were forcibly held prisoners (shown by <em>Dateline</em> hidden cameras) in company headquarters for five hours and subsequently released. Our FDA commented that too many drugs were tested in outside companies like this and many of them managed to navigate FDA hurdles and become successfully marketed in the United States.<br />
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I hope what I've written here might help save your life--if you or your family or friends or loved ones become ill with cancer. Upon making an inquiry of the possible merit of hydrazine sulfate in your loved one's case, should you learn that the medical profession actually discourages the use of this drug, know also there's another side of the mirror. The very same people who are doing the discouraging--because there's no money in it for them--are the ones doing the<em> en</em>couraging when it comes to expensive, relatively ineffective--even fraudulent--drugs and procedures they've developed, because there's a mountain of money in it for them. Know their intent--to dissuade you from a drug demonstrated by internationally accepted controlled clinical trials as effective and safe--emanates from the same sewer levels of the cancer establishment as--in the "60 Minutes" broadcast--the worst cases of cancer fraud.<br />
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And please realize also that the safety of all, especially new, drugs must be questioned, since the FDA does not have as tight control over drug safety and efficacy as generally considered.<br />
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If you think this Newsletter has been of help to you, we are hopeful you might respond in kind. This year we must ask a special favor of you. Not only your continued assistance--it has made the restoration of many lives possible. But a gift of special consideration. We must all provide for our families. For our health. For our children and their education. For our communities. For our special projects and undertakings that have loomed important to us. But short of those many of us find ourselves fortunate to be able to extend ourselves in unexpected directions. To our friends, to our loved ones. To strangers. To be part of the human condition. Today we ask your special consideration in extending the circle of your life to include the institute. We are greatly in need of funds to continue our important work. Your substantive gift at this time can make a great difference in our ability to deliver our life-sustaining programs and help enable us to extend the bridge of life to all who may be in need.<br />
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With best wishes for the upcoming summer season.<br />
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Sincerely<br />
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Joseph Gold, M,D.<br />
Director<br />
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<br />Dr. Joseph Goldhttp://www.blogger.com/profile/00368001273179577986noreply@blogger.com7tag:blogger.com,1999:blog-1335007907715618966.post-58246055604987853312011-02-22T08:38:00.000-08:002011-04-30T08:49:53.938-07:00OUTRAGEOUS CANCER INSTITUTE<div align="justify" style="line-height: 200%; text-indent: 0.5in;">“If people knew what we’re planning....”</div><div align="justify" style="line-height: 200%; text-indent: 0.5in;">“They’d think it outrageous!”</div><div align="justify" style="line-height: 200%; text-indent: 0.5in;">“By the way,” he said to his boss, “how’d this place get that funny name?”</div><div align="justify" style="line-height: 200%; text-indent: 0.5in;">“Because everything we do,” Marvin Dairywhimple replied, “our critics say is outrageous.” A crooked smile crossed his face. “So at first we replied, ‘You’re right, everything we do is outrageous.’ And just to lampoon them we further stated, ‘If you want to be treated for cancer, go to all those snake-oil salesmen with their roots and nostrums and see how far you get. If you want anything that’s effective—you’ll have to come to us: the “outrageous” ones.’ So we became known as the Outrageous Cancer Institute—the ‘OCI.’ Even Congress recognizes us. We’ve become the largest cancer institute in America, the most important in the world!”</div><div align="justify" style="line-height: 200%; text-indent: 0.5in;">Dexter Weinblut, deputy Director of Outrageous, regarded his boss. “But, Marv,” he said with a hint of rectitude, “we just can’t go through with this. This might be an effective drug!”</div><div align="justify" style="line-height: 200%; text-indent: 0.5in;">"And an inexpensive one! Remember, all our money comes from the fact that cancer drugs are expensive! The pharmaceutical companies that fund our programs! The people who stand up and volunteer hundreds of millions every year! The academic community that runs our protocols! Even the hick members of Congress who want to start giving us <i>public</i> funds!”</div><div align="justify" style="line-height: 200%; text-indent: 0.5in;">“But Marv, if they ever catch wind of—”</div><div align="justify" style="line-height: 200%; text-indent: 0.5in;">“They won’t! By the time we’re through with ‘blueberry lincture,’ they won’t want to hear those two words again!</div><div align="justify" style="line-height: 200%; text-indent: 0.5in;">“And that goes for the Boom-Bay Cancer Institute!” Dairywhimple asserted.</div><div align="justify" style="line-height: 200%; text-indent: 0.5in;">“But, Boss. They’re a legitimate cancer institute—even though they’re tiny. What’s wrong with them?”</div><div align="justify" style="line-height: 200%; text-indent: 0.5in;">“They’re the ones that developed ‘blueberry lincture,’ you idiot. Do you want the public to begin thinking that a small institute located on an obscure lagoon in Michigan has developed a cancer drug—from blueberries of all things—that is eclipsing our work, when Congress is getting ready to shell big bucks out of its pockets for us?”</div><div align="justify" style="line-height: 200%; text-indent: 0.5in;">“But, Marv. It’s a legitimate drug. A phtheric alcohol extract fraction of blueberry skin, I’m told.”</div><div align="justify" style="line-height: 200%; text-indent: 0.5in;">“Yes, and it works! We’ve already tested it in mice. But if the news gets out—a small institute on a small budget coming up with the first drug that’s useful against all cancers—it’ll wreck our cancer program. Our institute will really become ‘Outrageous.’ We won’t get any big money from Congress. We won’t be the national leader of cancer research anymore. And we won’t be the world’s clinical headquarters of cancer treatment.</div><div align="justify" style="line-height: 200%; text-indent: 0.5in;">“And besides,” Marvin Dairywhimple heaved his chest. “What if blueberry lincture achieves nationwide clinical testing—where does that leave us?”</div><div align="justify" style="line-height: 200%; text-indent: 0.5in;">Dexter Weinblut watched the expression of sudden revelation enter his boss’ face. “Yes…” Dairywhimple breathed. “What if blueberry lincture achieves nationwide testing—and fails?”</div><div align="justify" style="line-height: 200%; text-indent: 0.5in;">“Boss, we couldn’t....”</div><div align="justify" style="line-height: 200%; text-indent: 0.5in;">“We could!”</div><div align="justify" style="line-height: 200%; text-indent: 0.5in;">“We’d never get away with it!”</div><div align="justify" style="line-height: 200%; text-indent: 0.5in;">“Won’t we?” The misshapen smile returned to Dairywhimple’s face.</div><div align="justify" style="line-height: 200%; text-indent: 0.5in;">“Dexter. I want you to put out a bulletin on blueberry lincture. Say we recognize it is promising—say something nice about Boom-Bay in Michigan. Say we think the drug’s so promising, we’re going to sponsor nationwide testing of it—to confirm its effectiveness and safety. And say if it’s effective, we’ll be looking for a pharmaceutical partner to make it available to the world. And then get me Gardner Crookshank on the phone!”</div><div align="justify" style="line-height: 200%; text-indent: 0.5in;">“Crookshank!—But he’s head of the Creme-Cone Cancer Center. That’s where we send all our studies when we want them to come out negative!” The oblique smile became pronounced on Dairywhimple’s face.</div><div align="justify" style="line-height: 200%; text-indent: 0.5in;">“Yes, isn’t it, Dexter…. Sometimes I’m amazed at your lack of vision.”</div><div align="justify" style="line-height: 200%; text-indent: 0.5in;">“Boss…you’re a genius!”</div><br />
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<div align="justify" style="line-height: 200%; text-indent: 0.5in;">“So why did you want to meet me here?”</div><div align="justify" style="line-height: 200%; text-indent: 0.5in;">He watched the hundreds of people milling about the indoor promenade. “Because at the Fifth European Congress of Cancer Therapeutics, no one would think it unusual seeing us together.”</div><div align="justify" style="line-height: 200%; text-indent: 0.5in;">“All the way in London?”</div><div align="justify" style="line-height: 200%; text-indent: 0.5in;">“So much the better,” Dairywhimple replied. “There’s a pub nearby. Let’s go grab something.”</div><div align="justify" style="line-height: 200%; text-indent: 0.5in;">The two were seated at an old-fashioned wooden booth, a matching, highly varnished table between them. Two glasses of sparkling amber liquid occupied its shiny surface.</div><div align="left" style="line-height: 200%; text-indent: 0.5in;">“Mmm. This beer tastes good,” Crookshank said. “Different. You know you’re on the continent.”</div><div align="justify" style="line-height: 200%; text-indent: 0.5in;">“Have you thought over my proposition?”</div><div align="justify" style="line-height: 200%; text-indent: 0.5in;">“Yeah, Marv. I have. I don’t mind accommodating you, but it’s risky. Risky business. For me, that is. What’s in it for me? For Creme-Cone? We’re one of the most reputable cancer centers in the country. Cutting edge research, clinical programs unmatched by any other—”</div><div align="justify" style="line-height: 200%; text-indent: 0.5in;">“You know as well as I,” Dairywhimple interjected, “if blueberry lincture makes it, we’re all finished! Our country’s cancer leadership—the big fund raisers—Congress—will all think that all it takes is one organization—even a small one—with one idea—to come up with a drug that is effective against all kinds of cancer—and at every stage! What will they need us for? We’ll be scientific dinosaurs. We’ll go out of existence!”</div><div align="justify" style="line-height: 200%; text-indent: 0.5in;">Crookshank looked straight ahead, his eyes focused beyond the figure of his companion. “Yes,” he muttered. “I suppose you’re right.”</div><div align="justify" style="line-height: 200%; text-indent: 0.5in;">“Our cancer hospitals,” Dairywhimple pronounced. “Our cancer centers. Our cancer programs. The respect people accord us. All gone!”</div><div align="justify" style="line-height: 200%; text-indent: 0.5in;">“Don’t forget the funds.”</div><div align="justify" style="line-height: 200%; text-indent: 0.5in;">“Yes…the moneys.”</div><div align="justify" style="line-height: 200%; text-indent: 0.5in;">“Marvin, your face is too long. Remember, we’ve been there before. All those other alternative medications and treatments—”</div><div align="justify" style="line-height: 200%; text-indent: 0.5in;">“Yes, but this one’s different. The science behind it is impeccable!</div><div align="justify" style="line-height: 200%; text-indent: 0.5in;">“Even people like Dexter, they know it’s—”</div><div align="justify" style="line-height: 200%; text-indent: 0.5in;">“Effective?” Crookshank lifted his gaze directly to Dairywhimple’s face. “Some of the others had good science, too. Where are they now? But assure Dexter—and others of his ilk—our programs are always coming up with new, effective drugs….”</div><div align="justify" style="line-height: 200%; text-indent: 0.5in;">The two emptied their glasses. “Well,” Dairywhimple said, “what do you say we go back to the meetings?” A distorted smile occupied his face.</div><br />
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<div align="justify" style="line-height: 200%; text-indent: 0.5in;">“We can’t do that,” Dexter remarked, his voice approaching self-righteousness.</div><div align="justify" style="line-height: 200%; text-indent: 0.5in;">“Yes, we can and we will. Thiotonizone is our best anti-emetic. We use it in all our studies—prevents vomiting.”</div><div align="justify" style="line-height: 200%; text-indent: 0.5in;">“Yes, but blueberry lincture doesn’t produce vomiting.”</div><div align="justify" style="line-height: 200%; text-indent: 0.5in;">“Doesn’t matter. The disease itself produces vomiting. It’s so common, it’s known as ‘Tony.’ It’s used in the emergency rooms to treat food poisoning. People have it in their medicine cabinets....”</div><div align="justify" style="line-height: 200%; text-indent: 0.5in;">“Boss, blueberry lincture is a triethylamine reductase inhibitor—a TEAR inhibitor. And ‘Tony’ is incompatible with TEAR inhibitors. The pharmacology textbooks—over the last thirty years—all say that the two together are a ‘clinical hazard.’”</div><div align="justify" style="line-height: 200%; text-indent: 0.5in;">“Look, everybody knows that ‘Tony’ is the mildest of sedatives. And besides, we’ll challenge that blueberry lincture is a TEAR inhibitor—”</div><div align="justify" style="line-height: 200%; text-indent: 0.5in;">“But the pharmacology textbooks all say—”</div><div align="justify" style="line-height: 200%; text-indent: 0.5in;">“Damn the pharmacology textbooks! We’ll say they’re wrong! Who should know better, the writers of those stale chapters of the last century—or the most highly regarded contemporary experts of today—” The crafty smile returned to his face. “Who happen to be on our staff?”</div><div align="justify" style="line-height: 200%; text-indent: 0.5in;">“But, Boss. The Informed Consent Form that each patient is required to sign. We’ve got to put down somewhere in it that the use of blueberry lincture and 'Tony' together may cause sickness—even death.”</div><div align="justify" style="line-height: 200%; text-indent: 0.5in;">“What are you talking about?”</div><div align="justify" style="line-height: 200%; text-indent: 0.5in;">“That a TEAR inhibitor plus ‘Tony’—or any sedative—may result in morbidity or mortality!”</div><div align="justify" style="line-height: 200%; text-indent: 0.5in;">“A TEAR inhibitor? What TEAR inhibitor?”</div><div align="justify" style="line-height: 200%; text-indent: 0.5in;">“But, Boss, they’ll die….”</div><div align="justify" style="line-height: 200%; text-indent: 0.5in;">“They’ll die anyway.”</div><br />
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<div align="justify" style="line-height: 200%; text-indent: 0.5in;">She sat on the couch, across the way from him, the open sheet of paper dangling in his hand. The letterhead on the paper said, “Chicago Northwest Medical University,” the address block: “Adam Mohr, M.D., Ph.D., Distinguished Professor of Experimental Oncology.”</div><div align="justify" style="line-height: 200%; text-indent: 0.5in;">“I can’t understand it,” the woman was saying. “They actively campaigned—for over a year—to get you here. They just can’t fire you!”</div><div align="justify" style="line-height: 200%; text-indent: 0.5in;">“Oh yes they can!” His eyes scanned the computer-written page once again, as the woman had before him. “Dear Dr. Mohr,” the page had cryptically read, “the Division of Experimental Studies, which you chair, by action of the Trustees, has been abolished commencing immediately. We regretfully have to ask your departure from your post at your earliest convenience, in that the funding for the Division’s activities has terminated. The faculty joins me in wishing you <i>bonne chance</i> in your search for a new position.” It was signed by Jerry Bernard Henry, Dean.</div><div align="justify" style="line-height: 200%; text-indent: 0.5in;">“I don’t have tenure here,” he said to his wife. “I was hired ‘at the behest’ of the Chancellor, like so many of the main people here at the university. And I can be fired the same way…but why?</div><div align="justify" style="line-height: 200%; text-indent: 0.5in;">“I don’t know…” he answered his own question. A look of sudden introspection came over him. He let his mind go to about three weeks previously. It was on the blueberry lincture study. They were accruing 57 patients in the 400-patient nationwide study sponsored by Outrageous and under the protocols of Creme-Cone. They were non-small cell lung cancer—NSCLC—patients. He had reviewed all their charts and noticed that a sub-group of early patients—23 in all—were beginning to do well until they were placed on thiotonizone—‘Tony.’<i> Hey, wait a minute!</i> an inner voice reminded. <i>Wasn’t blueberry lincture a triethylamine reductase—TEAR—inhibitor and wasn’t ‘Tony’ incompatible with that?</i> He pulled those 23 patients off ‘Tony’ right away and they once again began to improve.</div><div align="justify" style="line-height: 200%; text-indent: 0.5in;">About three days later he was asked to see Dean Henry.</div><div align="justify" style="line-height: 200%; text-indent: 0.5in;">“Adam,” Jerry Henry had expressed, “do you have any idea why I’ve asked you to drop by?”</div><div align="justify" style="line-height: 200%; text-indent: 0.5in;">“No.”</div><div align="justify" style="line-height: 200%; text-indent: 0.5in;">“It’s that we’ve gone off protocol on part of the blueberry lincture study. By your doings. Creme-Cone and Outrageous have heard about it and they’re raising hell! To our Chancellor and Trustees. They know why you changed the protocol—you think blueberry lincture is a TEAR inhibitor and they want you to restore the protocol—to follow the original protocol as stated—with no changes!”</div><div align="justify" style="line-height: 200%; text-indent: 0.5in;">“But blueberry lincture <i>is</i> a TEAR inhibitor and adding ‘Tony’ to it will only make those patients die and make the study fail!”</div><div align="justify" style="line-height: 200%; text-indent: 0.5in;">“Not according to the experts they’ve assembled who all say to a person that the textbooks are wrong, blueberry lincture is <i>NOT</i> a TEAR inhibitor.”</div><div align="justify" style="line-height: 200%; text-indent: 0.5in;">“I don’t care what they say. The proof is in the pudding. Once I pulled these 23 off ‘Tony,’ they improved immediately. You don’t think I’m going to permit these patients to die and permit these studies to fail because blueberry lincture is cheap and a bunch of cocked-up, so-called academic scientists say that the lincture is not something that every book published on drug interactions in the world says that it is?”</div><div align="justify" style="line-height: 200%; text-indent: 0.5in;">“Adam, what we are threatened with is not only a loss of our major cancer grants but also a loss to our university’s largest bloc grants. I am going to have to insist that you adhere to the study’s original protocols.”</div><div align="justify" style="line-height: 200%; text-indent: 0.5in;">Adam Mohr sat facing his wife, no further word said between them. The page in his hand dropped to the floor, neither of the two figures bending to pick it up again.</div><br />
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<div align="justify" style="line-height: 200%; text-indent: 0.5in;">“’Boom-Bay is beginning to raise Cain!”</div><div align="justify" style="line-height: 200%; text-indent: 0.5in;">“About their studies?”</div><div align="justify" style="line-height: 200%; text-indent: 0.5in;">“Yes,” Dexter answered. “They’re all positive.”</div><div align="justify" style="line-height: 200%; text-indent: 0.5in;">“But small,” Marvin Dairywhimple responded. “Thirty-six patients, 65, 44—not enough in all these to establish statistical validity. Too few patients to achieve any semblance of statistical significance. The only thing these studies show is statistical deficiency.”</div><div align="justify" style="line-height: 200%; text-indent: 0.5in;">“But, Boss, that’s not so. The studies are smaller than ours but statistically accurate. Our own statisticians can’t find anything wrong with them....”</div><div align="justify" style="line-height: 200%; text-indent: 0.5in;">“Maybe privately so,” Dairywhimple answered. “But did you know, The Journal of Biostatistical Applications is coming out with a paper—in a few weeks actually—that will blast the Boom-Bay studies out of the water!” The slanted smile once again appeared on Dairywhimple’s face. “Yes, the Journal will claim—in the strongest language—I’ve seen the proof sheets myself—that each of the studies was ‘too small’ to achieve statistical validity, ‘that the power to detect the treatment effect was statistically low, leading to “false-positive” results,’ and—get this—‘the biological reasons for believing in a treatment effect due to blueberry lincture are not compelling.’ The article ends by recommending: ‘the scientific community must remain skeptical of Boom-Bay’s results.’</div><div align="justify" style="line-height: 200%; text-indent: 0.5in;">“No, Dexter, I don’t think we’ve got anything to worry about in Boom-Bay’s studies.”</div><div align="justify" style="line-height: 200%; text-indent: 0.5in;">Dexter Weinblut looked at his boss’ face a long moment before continuing. “That’s not all,” he advised. “Boom-Bay has put out the word that all our studies are in violation of the Nuremberg Declaration!” He watched the slanted smile and all other expression disappear from his boss’ face.</div><div align="justify" style="line-height: 200%; text-indent: 0.5in;">“They’ve pointed out,” Weinblut continued, “that our country is a major signatory to this international ratification—that governs the conduct of all human biomedical research. You’ll remember that it’s an outgrowth of the Nuremberg War Trials—against the Nazis’ horrific ‘experimentations’ on helpless people—adopted to guarantee that no patient in a new study is harmed by the conduct and procedures of the study. As you know, every new study published in the medical literature is required to carry the statement: ‘Performed in conformity with the Nuremberg Declaration.’” Weinblut paused, allowing his boss to digest the news. “Boom-Bay states that our studies have violated the ‘generally accepted standards’ rule—Principle 1—of the Nuremberg Declaration. They spell it out: ‘Biomedical research involving human subjects must conform to generally accepted scientific principles and be based on a thorough knowledge of the scientific literature.’ Boom-Bay goes on to say our studies are using an incompatible agent—‘Tony’—in the presence of a TEAR inhibitor—blueberry lincture—and that never in the history of drug testing has an incompatible agent been used with a test drug—since the two together can sicken or kill patients and bring down a study."</div><div align="justify" style="line-height: 200%; text-indent: 0.5in;">Marvin Dairywhimple screwed up his face and addressed Dexter without heightened emotion.</div><div align="justify" style="line-height: 200%; text-indent: 0.5in;">“Hrrumphh! Well, we were expecting that—and it all rests on whether blueberry lincture is a triethylamine reductase inhibitor. A TEAR inhibitor. Our experts all insist it’s not. Many—not all—of the textbooks say it is. But they offer no proof. So it’s our word against theirs. As long as our scientific advisors maintain there is no incompatibility here, we have not violated any Declarations nor are our studies flawed....”</div><div align="justify" style="line-height: 200%; text-indent: 0.5in;">“It’s not that simple,” Dexter interjected. “Boom-Bay’s caused an Office of Scientific Assessment investigation of our studies.”</div><div align="justify" style="line-height: 200%; text-indent: 0.5in;">“I know. They’re in their seventh month. The government’s watchdog agency.”</div><div align="justify" style="line-height: 200%; text-indent: 0.5in;">“The lead investigator is Bob Doyle,” Weinblut supplied. “He’s a thirty-year veteran investigator of the OSA and I’m told he’s put together a hard-hitting Final Draft Report against us that’s soon to be published. I’m told he’s of the opinion—but doesn’t know for sure—that blueberry lincture is a TEAR inhibitor.”</div><div align="justify" style="line-height: 200%; text-indent: 0.5in;">“I know,” Dairywhimple repeated. “A 28-page diatribe—with a bad title: ‘Outrageous Studies Spur Continued Controversy Over Blueberry Lincture Therapy.’ The report says the issue of incompatibility of blueberry lincture and thiotonizone is not ‘settled.’ It says our studies are flawed.”</div><div align="justify" style="line-height: 200%; text-indent: 0.5in;">Weinblut eyed his boss cautiously, unaware of Dairywhimple’s apparent, thorough intimacy with the OSA report. “Maybe we can send a delegation to speak to Doyle,” he offered.</div><div align="justify" style="line-height: 200%; text-indent: 0.5in;">“That smart-ass’ll be removed.”</div><div align="justify" style="line-height: 200%; text-indent: 0.5in;">“What about his report?”</div><div align="justify" style="line-height: 200%; text-indent: 0.5in;">“It’s already being rewritten,” Dairywhimple replied, a look of self-satisfaction overspreading his features. “Its title: ‘Outrageous Studies of Blueberry Lincture Not Flawed.’”</div><div align="justify" style="line-height: 200%; text-indent: 0.5in;">Weinblut again eyed his boss, this time for a long moment. “There’s a fly in the ointment,” he said at last.</div><div align="justify" style="line-height: 200%; text-indent: 0.5in;">“What’s that?”</div><div align="justify" style="line-height: 200%; text-indent: 0.5in;">“I was speaking to some of my contacts at Human Services the other day and they told me the government’s quarterly, Alternative Medicine, will soon feature a report on blueberry lincture. I’m told its first sentence will be: ‘Blueberry lincture is a triethylamine reductase—TEAR—inhibitor.’”</div><div align="justify" style="line-height: 200%; text-indent: 0.5in;">“Yes,” Dairywhimple replied, his eyebrows rising. “I’ve heard about it too. In fact, I went to see Philip Grun, Assistant Secretary of Health Affairs. I explained to him that because of the confusion surrounding blueberry lincture, bringing out the article in Alternative Medicine at this time may result in more injury to the public health than in anything positive. He agreed. We agreed that the article will be put off until four years from the time the newly rewritten OSA report is issued.” Dairywhimple paused, then continued.</div><div align="justify" style="line-height: 200%; text-indent: 0.5in;">“By then, I will assure you, Dexter, no one will care whether blueberry lincture is a TEAR inhibitor or not.”</div><div align="justify" style="line-height: 200%; text-indent: 0.5in;">Weinblut sat motionless, stunned by his boss’ words. At last he spoke: “But Boss, if patients keep calling us—like they have—what are we supposed to say to them?”</div><div align="justify" style="line-height: 200%; text-indent: 0.5in;">“We’ll simply tell them that doctors get cancer too, that doctors’ families get cancer—don’t you think if blueberry lincture were any good we’d use it for our own selves?”</div><div align="justify" style="line-height: 200%; text-indent: 0.5in;">“But Boss. Boom-Bay says it receives about twenty calls a day from doctors—for their own selves….”</div><div align="justify" style="line-height: 200%; text-indent: 0.5in;"><br />
</div><div align="justify" style="line-height: 200%; text-indent: 0.5in;">Dolores Jaynes sat before the expansive desk, awaiting word from the grey-haired, middle-aged gentleman seated behind, having met him for the first time a few weeks prior.</div><div align="justify" style="line-height: 200%; text-indent: 0.5in;">“I am afraid I have no good news for you, Mrs. Jaynes,” the middle-aged man spoke. “Your tests show the cancer has spread. To the bones and liver. There’s no curative treatment I can recommend, but we’ll use chemotherapy and radiation to try to slow it down.”</div><div align="justify" style="line-height: 200%; text-indent: 0.5in;">“Doctor,” she responded, “you know I’m a schoolteacher. I teach computer science. I’ve been on the Internet and reading a lot about something called blueberry lincture.”</div><div align="justify" style="line-height: 200%; text-indent: 0.5in;">She saw a frown immediately displace his previously pleasant expression.</div><div align="justify" style="line-height: 200%; text-indent: 0.5in;">“There are reports it could be very helpful in my condition. Without exerting serious side effects.”</div><div align="justify" style="line-height: 200%; text-indent: 0.5in;">“Yes, we’ve been hearing a lot about blueberry lincture lately,” the doctor agreed. “But I’m afraid I can’t recommend it to you.</div><div align="justify" style="line-height: 200%; text-indent: 0.5in;">“It’s been shown to be ineffective in nationwide tests sponsored by Outrageous Cancer Institute and under the direct conduct of Creme-Cone Cancer Center protocols. I suppose you know they’re the two leading cancer authorities in the world. I’d have to pay strict attention to their recommendations.”</div><div align="justify" style="line-height: 200%; text-indent: 0.5in;">“But there’s a controversy to those studies. There’re smaller studies showing the drug to be effective and safe.”</div><div align="justify" style="line-height: 200%; text-indent: 0.5in;">“I know, I know. Something about Outrageous using incompatible medications in a drug study. You don’t believe that, do you? The largest cancer institute in the world making such a basic mistake? Outrageous convened a panel of experts—who affirmed there were no irregularities whatsoever in its studies. I’d have to go with that.</div><div align="justify" style="line-height: 200%; text-indent: 0.5in;">“And those smaller studies,” he continued “—done by Boom-Bay Cancer Center in Michigan—a tiny cancer institute, really. Yes they were positive, but they were also too small to be conclusive. They did not achieve what is called statistical significance.” His face showed no emotion as he said, “I’m sorry, they’re clinically meaningless.”</div><div align="justify" style="line-height: 200%; text-indent: 0.5in;">“Did you read them, doctor?”</div><div align="justify" style="line-height: 200%; text-indent: 0.5in;">“Read them?” He looked toward the door leading to his office. “Take a look at the waiting room. All the patients. Waiting to see me. Think I have time—a morning or afternoon—to spend before a computer or in a medical library every week reading studies? No, I haven’t read them. In fact, I haven’t read a medical journal from cover to cover in years.”</div><div align="justify" style="line-height: 200%; text-indent: 0.5in;">“Then you don’t know the Outrageous/Creme-Cone studies are said to be in violation of the Nuremberg Declaration?”</div><div align="justify" style="line-height: 200%; text-indent: 0.5in;">“The <i>what</i>?”</div><div align="justify" style="line-height: 200%; text-indent: 0.5in;">“Nuremberg Declaration.”</div><div align="justify" style="line-height: 200%; text-indent: 0.5in;">“Look, Mrs. Jaynes. I never heard of the ‘Nuremberg Declaration!’ I don’t know what it is.” His expression was filled with genuine empathy. “I know what you’re going through. I see it with many of my patients. I’d like to recommend blueberry lincture to you, but we doctors—we can’t read all the studies. We’ve got to take the word of somebody. And the best authorities we know are Outrageous and Creme-Cone. They’re the very best in cancer. We’ve got to take their word for it. Even the government—the Office of Scientific Assessment—has done a months-long investigation of the Outrageous studies and found them not to be lacking and unflawed.”</div><div align="justify" style="line-height: 200%; text-indent: 0.5in;">“I still don’t believe that blueberry lincture can’t be helpful. Those smaller studies—that are not in violation of the Nuremberg Declaration—show it to be therapeutic for a number of cancers.”</div><div align="justify" style="line-height: 200%; text-indent: 0.5in;">The doctor leaned over to the patient and saw the tears welling up in her eyes as she prepared to leave. His heart went out to her, wondering what words he might express to erase any further thoughts of the medication on which she placed so much hope.<br />
“Mrs. Jaynes,” his voice was kind. “We doctors get cancer, too. Our families get cancer. Don’t you think if blueberry lincture were any good, we’d use it for ourselves…?”</div><br />
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<div align="center"><i>DON’T THINK THIS COULDN’T HAPPEN</i></div>Dr. Joseph Goldhttp://www.blogger.com/profile/00368001273179577986noreply@blogger.com124tag:blogger.com,1999:blog-1335007907715618966.post-58451799657541570352010-08-05T12:52:00.000-07:002010-08-13T07:10:26.646-07:00Are we winning the war against cancer?Numerous bulletins to the public from time to time have announced our progress in the fight against cancer, advising of breakthroughs or significant inroads against this disease, in the form of new drugs and treatments, preventive measures, dietary updates, major discoveries and advances and financing. And much of the population has become involved in this fight. Such activities as the <em>Race for the Cure</em> and similar events have attracted hundreds of thousands nationwide to become personally involved in the ongoing endeavor to defeat this disease.<br /><br />As a result it is felt by many that these activities, in combination with the frequent communiques that the incidence of one form or another of cancer was decreasing--was being trimmed--by major advances, that the "cure" was just around the corner, that we are on the verge of significantly silencing this ruthless killer.<br /><br />But is this the case?<br /><br />Unfortunately, it is not. In an investigative report to the public in the April 24, 2009, issue of <em>The New York Times</em>, respected science writer Gina Kolata reports that 'As Other Death Rates Fall, Cancer's Scarcely Moves.' In this article the author indicates that in the last 60 years, for example, the death rate--the number of deaths adjusted for population age and size--has plummeted for heart disease, stroke and other disease modalities. But for cancer it has hadly budged.<br /><br />Kolata indicates the decrease in death rate for cancer in those 60 years is only 5 percent, compared to a decrease of 67 percent for heart disease in that same time.<br /><br />But is death rate a credible measure of progress in cancer? Yes, researchers say. While death rates are not perfect, they are considered the most valid measure, used by the American Cancer Society and the National Cancer Institute to assess progress in this disease.<br /><br />But why?-- Why has there been virtually no progress in cancer death rates in the last half-century or more? Because of the lack of "transforming discoveries" in prevention and treatment, according to scientists quoted in this <em>New York Times</em> article. What is a "transforming discovery?" It is a major discovery capable of interdicting a disease or disease process. An example of a 'transforming discovery' in treatment would be the advent of <em>insulin</em>, whose discovery virtually normalized the lives of millions of diabetics the world over. A 'transforming discovery' in prevention would be the <em>Salk polio vaccine</em>, the first medical treatment which prevented the contraction of poliomyelitis in millions of people worldwide and brought this disease to a virtual standstill in every nation on earth. Transforming discoveries have the capacity to beneficially affect great portions of the population.<br /><br />Have there been any 'transforming discoveries' in cancer? In order to have a transforming discovery, one has to first undertand the disease. In the case of cancer, we don't even know what cancer is. Is it a disease? Is it more than one disease? Is it caused by heredity? By diet? By viruses? Bacteria? DNA mutations? Environmental pollution? We don't know. And until we know--and can understand--we are not likely to come up with a 'transforming discovery.'<br /><br />So which is correct? The constant barrage of promising new advances that are causing cancer mortality and incidence to decrease in the general population, that we are on the verge of curing major cancers? --Or that the death rate in cancer has virtually not improved in the last 50 years--i.e., since the advent of modern cancer treatment?<br /><br />Have the messages meted out to the public by the cancer establishment--the cancer organizations, the pharmaceutical industry, the academic institutions, the medical news media--been misleading, evasive?<br /><br />We must decide this. If we decide that the decades-long death rates in this disease have remained stationary, we must send a message to our cancer leadership: and that message must be that we will no longer be duped into believing significant progress is being made, when statistics show it is not. That we will no longer contribute our energies, our resouces or acceptance to another decade of pursuing the same tired, old methods in defeating this disease.<br /><br />We must send a message to our cancer leadership that the reason the death rate in this disease has remained the same--is that obviously there is something wrong with the way we understand cancer. Something wrong in what our comprehension of this disease is. Something wrong perhaps with our equation of the <em>tumor</em> with cancer.<br /><br />For the past half-century or more our attention has been focused on the <em>tumor</em>. But all attempts to treat the tumor--to kill the tumor and therefore wipe out the disease--have in general been futile. Cytotoxic chemotheray, the major weapon to defeat cancer in the last 50 years, has succeeded in killing cancer cells, but in killing normal cells, too, and has been itself a cause of cancer mortality. Even the newer methods of treating this disease, genetic, monoclonal (antibodies) and other recombinant therapies, are posing limitations due to drug resistance and major drug toxicity. Every "push" we have made against the cancer, the cancer has seemed to "push back" harder.<br /><br />In the case of diabetes we have made a basic understanding that the clinical symptoms of this disease--which kill patients--are due to a basic lack of insulin. A lack of a hormonal agent that facilitates the entry of glucose into a cell. We did not make the mistake of thinking that in diabetes it was the cells themselves that were "resistant" to the entry of glucose. That there was some pathologic process inherent in the body's cellular makeup that caused the cells to resist the passage of glucose. We did not spend our nation's entire bankroll or direct our country's almost total research programs to "fixing" the cell so that it would admit glucose. The discovery of insulin was indeed a "transforming discovery."<br /><br />We must now do the same with cancer. It is obvious that treatment of the"tumor" will bring us more of the same, as in the last 50 years. It is obvious that the "tumor" is but the endpoint of the cancerous process, that the "tumor" is not the same as "the cancer." It is obvious that what have 'led up' to the tumor--the biochemical processes that have "caused" the tumor--are the vulnerable aspects of cancer where drug therapy may indeed be effective in stopping or reversing the cancerous process. Until we can understand cancer on a more 'intimate' basis--its biochemical or metabolic underpinnings--a "transforming discovery" in this disease is not likely to occur.<br /><br />When we can finally turn our attention to the reality that even though it is the "tumor" that kills, it is in an understanding of those processes that lead up to tumor formation--its metabolic and biochemical fundamentals--that the war on cancer will truly be won.Dr. Joseph Goldhttp://www.blogger.com/profile/00368001273179577986noreply@blogger.com68tag:blogger.com,1999:blog-1335007907715618966.post-20343460993922311422010-06-16T08:31:00.001-07:002010-06-16T09:15:02.457-07:00SCRI Newsletter<p><em>Dear Readers,</em></p><p><em>It has been some time since a new entry has been placed on </em>MedTruth<em>, and this has been due to a new paper I have been writing for publication, "What Is Cancer?" This paper details a new causation for cancer and, based on this, new treatment options. More details will be forthcoming upon publication of this paper.</em></p><p><em>Meantime I thought it might be of interest to enter on </em>MedTruth<em> the Syracuse Cancer Research Intitute's latest semi-annual Newsletter.</em></p><p align="center"><strong>Syracuse Cancer Research Institute</strong></p><p align="center"><strong>600 East Genesee Street</strong></p><p align="center"><strong>Syracuse, NY 13202</strong></p><p align="left">June 2010</p><p align="left">Dear Friend,</p><p align="justify">Summer of 2010 is upon us and I am happy to inform you that the use of hydrazine sulfate for general cancer is beginning to spread rapidly worldwide. That is because more and more doctors are becoming acquainted with the controlled clinical trials of hydrazine sulfate in the medical literature, performed in accordance with international standards, and their specific results of efficacy and safety. And the reason this has happened is that the Internet has called special attention of the medical profession that these studies exist and should be consulted as part of any treatment-making decision.</p><p align="justify"> </p><p align="justify">I want to emphasize to each and every one of you that if you or a friend or loved one has cancer, the doctor should consider a course of hydrazine sulfate--whether or not other treatments are used, such as chemotherapy, radiation or some of the newer recombinant pharmaceuticals. Consider the statistics: those controlled clinical trials, done in conformity with the "generally accepted standards" rule (the Helsinki Declaration) demonstrate that for every million <em>late-stage</em>, <em>unresponsive</em> cancer patients given hydrazine sulfate, 500,000 will show measurable symptomatic improvements, 400,000 will have their tumors stop growing or regress and some will go on to long term (>10 years) survival. These are "factually terminal" patients. No studies have yet assessed earlier patients, who are known to respond more favorably to almost all drugs.</p><p align="justify"> </p><p align="justify">These hard-to-believe results are becoming known to many physicians, since they are now reportedly seeing these results in their own initial patients. And this is a worldwide phenomenon. Overseas <em>Pharmsynthez</em>, a pharmaceutical company, has been registering and marketing hydrazine sulfate as an approved drug in European countries and also in Canada, under the trade name <em>Sehydrin</em>. And in the United States the drug remains obtainable by a doctor's prescription.</p><p align="justify"> </p><p align="justify">It is really regretful that progress on this drug has moved so slowly. But for those who are regular readers of this Newsletter, the reasons for this are well known. Nevertheless, no matter what the past bottlenecks, hydrazine sulfate is now beginning to emerge globally as a drug capable of helping patients with common and recently diagnosed cancers, those who are advanced and those who literally have no further treatment options available.</p><p align="justify"> </p><p align="justify">I urge that if you or a loved one are diagnosed with cancer, that you consult your doctor about the advisability of including hydrazine sulfate in whatever treatment option may be considered. The actual statistics of permissibly performed studies indicate that doing so may well tip the scale of clinical response in your favor.</p><p align="justify"> </p><p align="justify">If we can be of help in providing you or your doctor with information or with clinical studies, please let us know. In the meantime we would appreciate your remembering us with a mid-year gift, as these gifts are the fuel that makes possible our continuing work.</p><p align="justify">With every best wish.</p><p align="justify">Sincerly,</p><p align="justify">Joseph Gold, M.D.</p><p align="justify">Director</p><p align="justify"> </p><p align="justify"><em>P.S. Your gifts are tax-deductible to the extent allowed by law.</em></p><p align="center">Visit us at: scri.ngen.com</p>Dr. Joseph Goldhttp://www.blogger.com/profile/00368001273179577986noreply@blogger.com2tag:blogger.com,1999:blog-1335007907715618966.post-16877915036411120102010-01-05T07:38:00.000-08:002010-01-07T12:42:04.867-08:00If you have cancer, you may have an added adversary: the National Cancer InstitutePreposterous? Think it couldn't happen? Yes, the National Cancer Institute has historically been involved in multiple scandals. Scientific. Financial. Administrative. But <em>treatment-wise</em>? --The NCI, part of the federal government, established to <em>battle</em> cancer? To <em>aid</em> the cancer patient? To work tirelessly to devise new treatments, drugs, vaccines? To fund research efforts nationwide devoted to new--what the NCI has deemed <em>effective</em>--cancer treatments? What it has decreed <em>acceptable</em> to the nation's welfare? Acceptable to the nation's--i.e., NCI's--national cancer program? And preserve its stringent control over all cancer funds and its central position in the constellation of all cancer efforts?<br /><br />Could NCI be exerting its resources--its dominance over all cancer undertakings--<em>against</em> the cancer patient?<br /><br />Sometimes--actually not infrequently--organizations set up for one purpose go 'over the line' to its opposite purpose, because of a 'confusion of power.'<br /><br />Is it possible that the NCI--set up to safeguard this nation's cancer program and the development of adequate treatments that might ameliorate this disease--has grown so powerful as to exclude any therapy which it might perceive threatening to its existence?<br /><br />The answer to this vexing question is 'yes.' The NCI has been an adversary to a cancer drug--hydrazine sulfate--which controlled clinical trials performed in accordance with internationally accepted standards of biomedical research have demonstrated to be safe and effective in most types, and stages, of cancer. This drug is inexpensive, active by itself or in combination with chemotherapy or radiation therapy and is free from serious clinical side effects.<br /><br />Our NCI? Against this drug? The agency that is supposed to be acting to <em>help</em> cancer patients?<br /><br />This adversarial relationship to hydrazine sulfate--and therefore to cancer patients--is long-standing, beginning in the mid 1970s.<br /><br />On March 8, 1976, because of concerns regarding controversy and irregularities by cancer authorities in the early stages of clinical testing of the drug hydrazine sulfate, developed by the Syracuse (New York) Cancer Research Institute, veteran Syracuse Congressman James M. Hanley (Chair of the House Post Office and Civil Service Committee and a member of many important subcommittees) requested a "status report" on hydrazine sulfate from the director of the National Cancer Institute. Within two weeks he received a reply that stated: "Hydrazine sulfate has been tested in the Soviet Union at the Petrov Institute in Leningrad [St. Petersburg]. In a clinical study directed by Dr. Michael Gershanovich, no evidence of meaningful anticancer activity was reported. This information was communicated to the NCI under the Joint U.S.-U.S.S.R. Health Agreement of 1972." Congressman Hanley forwarded the reply to the Syracuse Cancer Research Institute.<br /><br />Shortly after receiving the reply, the SCRI received--from Leningrad--an unexpected, unsealed, registered manilla envelope in the mail. Inside of this was a reprint of a scientific study--all in Russian, except for the English abstract (summary) at the end of the article. The principal investigator was indicated as Dr. Michael L. Gershanovich and the study site as the N.N. Petrov Research Institute of Oncology. The title of the paper was "Experimental and Clinical Data on Antitumor Action of Hydrazine Sulfate."<br /><br />It was the same Russian study to which the NCI reply to Congressman Hanley referred--only it said exactly the opposite of what was communicated to Congressman Hanley. The English summary read: "Clinical observations enabled us to state a definite therapeutic effect of hydrazine sulfate in patients with lymphogranulomatosis [Hodgkin's and non-Hodgkin's lymphoma] and malignant tumors of various localizations in far-advanced stages, where other measures of specific therapy failed." The summary added that because of the favorable outcome, the study was being enlarged immediately.<br /><br />Translation of the entire study of 48 "factually terminal" (stage 4) patients--with different types of cancer--revealed the following therapeutic effects. "Diminution or disappearance of pleural effusions and ascites [fluid accumulation in the chest cavity and abdomen, containing individual cancer cells], lowering of fever, normalization of laboratory indices, diminution or disappearance of pain, increase in strength, disappearance of hemoptysis [spitting of blood in patients with lung cancer], increased overall performance status [ability to ambulate and perform work], tumor stabilization [no further increase in tumor size], tumor regression [tumor shrinkage]." Therapeutic benefits were registered without significant clinical side effects. "Pharmacological characteristics of this compound demonstrate that the antitumor effect is observed in doses which do not produce toxicity."<br /><br />No meaningful anticancer activity? A drug that took away much of the patients' harsh symptomatology, improving them greatly and--with some patients--took away the disease itself?<br /><br />As to the question of whether the NCI's response to Congressman Hanley represented an innocent error on the part of the NCI or a deliberate fabrication, a further letter from the NCI, dated June 22, 1976, stated: "An abstract [summary] of the Gershanovich study appeared in <em>Cancer Therapy Abstracts</em> (Vol. 16: No. 4 [19]75-2046), a journal published under contract to the NCI." This published abstract<em> </em>antedated the NCI's response to Congressman Hanley by more than six months. Thus, at the time the NCI was writing to Congressman Hanley that the Soviet data were negative, the NCI had already known for months these data were positive.<br /><br />What was the meaning of the misinformative response by the NCI?<br /><br />Hydrazine sulfate was the first drug for generalized--any type of--cancer. It was developed by the Syracuse Cancer Research Institute, a small, private cancer research organization with an annual budget not exceeding $200,000. If you were a member of the House or Senate Appropriations Committees of Congress, would you authorize billions of dollars annually, as a result of the National Cancer Act of 1971, <em>directly</em> to the NCI-- in the face of a small private laboratory which had just come up with the first useful drug for all cancers, on a budget of less than $200,000? You'd have to say "Whoa--let's reevaluate this whole situation."<br /><br />Thus, in framing a deliberate lie to Congressman Hanley--in turning its guns against hydrazine sulfate--the NCI was fighting for its life. In perceiving hydrazine sulfate as a threat to its existence, the NCI was fighting to preserve its dominance, centrality--and preeminence--over all cancer endeavors and cancer funding. <em>In its opposition to hydrazine sulfate, NCI gave little</em> <em>thought it could be jeopardizing the lives of millions of cancer patients the world over.</em><br /><br />Over the ensuing years the NCI hardened its resistance to hydrazine sulfate, referring in cancer textbooks to the ever-enlarging and positive Russian controlled clinical trials--demonstrating statistically significant antitumor and anti-cachexia effects in otherwise unresponse cancer patients--as showing only "hints of subjective activity," while at the same time totally ignoring the published Phase III randomized, double-blind Harbor-UCLA studies demonstrating, again statistically significantly, that hydrazine sulfate normalizes the abnormal metabolism associated with cancer cachexia--i.e., associated with more than 70 percent of all cancer deaths.<br /><br />But not until 1989 did it occur to NCI that it would have to undertake controlled clinical trials of its own which might counter the Russian and Harbor-UCLA studies before its adversarial position on hydrazine sulfate might be believed by the scientific and medical communities. Accordingly, in 1989 the NCI took over all clinical testing of hydrazine sulfate in the U.S., prohibiting (by grant denial) Harbor-UCLA (which up to that time had performed and published almost 10 years of increasingly positive studies on hydrazine sulfate)--and by association any other U.S. cancer center--from any further clinical study of hydrazine sulfate. Thus, in 1989 the NCI became the only player in the clinical testing of hydrazine sulfate within the borders of the United States of America.<br /><br />Before proceeding further--and in order to have a more complete understanding of clinical studies--it is necessary to become acquainted with the Helsinki Declaration.<br /><br />The Helsinki Declaration--an outgrowth of the Nuremberg Trials (Doctors Trial) following World War II which uncovered the heinous human medical "experiments" inflicted on helpless human beings by the Nazis--is a multinational ratification of principles governing human biomedical research studies, to which the U.S. is a major signatory, put in place to guarantee that no harmful procedures be used in patients undergoing experimental medical treatment. This document lies at the very heart of all clinical studies and informed consent--and as such represents the international "law of the land," requiring all human biomedical research to conform to its stated principles, and to so acknowledge in all written experimental protocols and published studies.<br /><br />Controlled clinical trials performed in accordance with the Helsinki Declaration have--<em>without exception</em>--demonstrated the efficacy and safety of hydrazine sulfate. These include the 17 years of multicentric Phase II Russian (Petrov) studies (with participation of the Herzen Institute of Oncology, Moscow; Oncological Institute of Lithuania, Vilnius; Institute of Oncology of the Ukrainian Academy of Sciences, Kiev; and Rostov Institute of Oncology and Radiology, Rostov an Donau) and the 10 years of Harbor-UCLA randomized Phase III studies--performed by scientists considered among the most outstanding and experienced clinical cancer investigators in the world and published chiefly in leading U.S. peer-reviewed cancer and medical journals.<br /><br />The only controlled clinical trials to indicate non-efficacy of this drug--were three nationwide studies sponsored by the National Cancer Institute, parts of which were performed at various cancer centers and hospitals throughout the U.S. However, these were in violation of the Helsinki Declaration (the "generally accepted standards" rule) by virtue of their use of incompatible agents (medication) with the test drug and therefore declared by this Declaration to have no scientific standing. (Use of incompatible agents in a drug study is virtually unknown in human biomedical testing, since such use can result in the grave illness--or death--of a patient, as well as cause a negative drug study.) No written statement appears affirming that the protocols or published studies of NCI's sponsored trials were designed or carried out in conformity with the Helsinki Declaration.<br /><br />The combined Russian and Harbor-UCLA studies, the only controlled clinical trials performed in accordance with the Helsinki Declaration, state that of every million late-stage, unresponsive cancer patients treated with hydrazine sulfate, more than 500,000 would receive measurable symptomatic improvement, 400,000 would demonstrate a halt or regression of tumor growth, and some would go on to long term (>10 years) "complete response," i.e., survival.<br /><br />But the NCI continues its practice of knowingly misleading the worldwide lay and medical community. On the Internet it states there are no <em>human</em> studies of hydrazine sulfate that show anticancer activity: "There is only limited evidence from <em>animal studies</em> that hydrazine sulfate has anticancer activity." (Factually, there are 15 published human studies of hydrazine suflate that show anticancer activity, dating from 1975.) NCI states there are no <em>randomized clinical trials</em> (the "gold-standard" of clinical trials) of hydrazine sulfate that show anticancer activity: "Hydrazine sulfate has shown no anticancer activity in <em>randomized clinical trials." </em>(In reality, four of the five Harbor-UCLA studies are randomized clinical trials. All show clinical anticancer activity.)<br /><br />The NCI has shown clearly and repeatedly it intends to defeat hydrazine sulfate as a valid anticancer drug by whatever means possible. Whether by lying to representatives of Congress, whether by placing distorted and untrue information on the Internet, whether by omission to the lay and medical public that its sponsored studies of hydrazine sulfate--the ones it uses in citing this drug's "ineffectiveness"--were all <em>in violation</em> of the Helsinki Declaration, using medical procedures well known to cause a negative drug study (and gravely ill patients), whether by failing to call attention of the medical profession and lay public to the 17 years of controlled clinical trials by the Petrov Group and the 10 years of controlled clinical trials by Harbor-UCLA Medical Center, all performed in conformity to the internationally accepted Helsinki Declaration's principles of medical research conduct--and all showing the efficacy and safety of hydrazine sulfate in cancer.<br /><br />Regarding this drug, which may be life-restorative to you, no matter how advanced your cancer, the NCI--our own federal government--has been dealing you low. In this special instance the National Cancer Institute, the agency charged to safeguard your health, has been your long time adversary, acting to dissuade you from a drug which it has discredited for years, but one which competently performed clinical trials have explicitly demonstrated may help save your life.Dr. Joseph Goldhttp://www.blogger.com/profile/00368001273179577986noreply@blogger.com96tag:blogger.com,1999:blog-1335007907715618966.post-45312770237395928312009-10-28T08:02:00.000-07:002009-11-02T07:43:05.891-08:00Would the government lie about the existence of an effective treatment for cancer?Would the government deny that competent, controlled clinical trials have demonstrated there is a drug that is effective against most types--and stages--of cancer, that is safe, inexpensive and free from serious clinical side effects?<br /><br />The answer is 'yes.' The drug's name is hydrazine sulfate. If you're a reader of the blog <em>MedTruth</em>, you've already seen several articles on this drug. But perhaps you'd like to witness the actual commencement of this official lying and opposition to this drug.<br /><br />The year was 1976, the date, March 8. Because of my concern regarding controversy and irregularities by cancer authorities in the early stages of clinical testing of the drug hydrazine sulfate, developed by the Syracuse (New York) Cancer Research Institute, veteran Syracuse Congressman James M. Hanley (Chair of the House Post Office and Civil Service Committee and a member of several important subcommittees, including Manpower and Civil Service, Housing and Community Development, Institutions and Finance, Small Business Oversight and Minority Enterprise, Small Business Administration Legislation), requested a "status report" on hydrazine sulfate from the director of the National Cancer Institute (NCI)--part of the federal government and this country's, and the world's, most influential cancer agency. Within two weeks he received a reply that stated: "Hydrazine sulfate has been tested in the Soviet Union at the Petrov Institute in Leningrad [St Petersburg]. In a clinical study directed by Dr. Michael Gershanovich, no evidence of meaningful anticancer activity was reported. This information was communicated to the NCI under the Joint U.S.-U.S.S.R. Health Agreement of 1972." Congresman Hanley forwarded me the reply.<br /><br />The letter was devastating to me personally. Although I had known that cancer scientists in the Soviet Union were performing mouse and rat studies with hydrazine sulfate (they had picked up from our original work published in the medical literature), I had no idea they had already performed human studies--and that these studies were negative. Reading this letter--and what it said--constituted the lowest point in my professional career. I was dejected the entire day, unable to believe the contents of the letter.<br /><br />The very next day a scenario occurred that could only have been fashioned in Hollywood. The mailman came to the large plate-glass front doors of our reception suite (where I was at the time) and I could see he was holding a five-by-seven inch shiny manilla envelope in his hand, the kind one used to see in the Depression days of the 1930s, and to boot it was totally unsealed. He entered the suite and handed the receptionist the envelope, for which she had to sign. It was registered and postmarked "Leningrad." We did not know anybody in Leningrad, nor were we expecting mail from Leningrad. The receptionist handed me the unsealed envelope and we all--several of our laboratory staff had gathered in the reception area--looked at each other puzzled. I removed the contents of the envelope. It was a reprint of a scientific study--all in Russian, except for the English abstract (summary) at the end of the article. The principal investigator was indicated as Dr. Michael L. Gershanovich and the study site as the N. N. Petrov Research Institute of Oncology. The title of the paper was "Experimental and Clinical Data on Antitumor Action of Hydrazine Sulfate," and the English summary read:<br /><br />"Clinical observations enabled us to state a definite<br />therapeutic effect of hydrazine sulfate in patients<br />with lymphogranulomatosis [Hodgkin's and non-<br />Hodgkin's lymphoma] and malignant tumors of<br />various localizations in far-advanced stages, where<br />other measures of specific therapy failed." [The<br />summary added that because of the favorable<br />outcome, the study was being enlarged immediately.]<br /><br />I was stunned to read this summary. It was from the same Russian study to which the NCI reply to Congressman Hanley referred--only it was exactly opposite of what was communicated to Congressman Hanley. Upon translation of the entire study, the following therapeutic effects of hydrazine sulfate in 48 "factually terminal" [stage 4] patients--with different types of cancer--were detailed: "diminution or disappearance of pleural effusions and ascites [fluid accumulation in the chest cavity and abdomen, containing individual cancer cells], lowering of fever, normalization of laboratory indices, diminution or disappeance of pain, increased appetite with cessation of weight loss or weight gain, increase in strength, disappeance of hemoptysis [spitting of blood in patients with lung cancer], increased overall performance status [ability to ambulate and perform work], tumor stabilization [no increase in tumor size], tumor regression." Therapeutic benefits were registered without significant clinical side effects: "Pharmacological characteristics of this compound demonstrate that the antitumor effect is observed in doses which do not produce toxicity."<br /><br />No meaningful anticancer activity?<br /><br />As to the important question whether the NCI response to Congressman Hanley represented an innocent error on the part of the NCI or a deliberate fabrication, a further letter from the NCI, dated June 22, 1976, stated: "An abstract [summary] of the Gershanovich study appeared in <em>Cancer Therapy Abstracts</em> (Vol. 16: No. 4 [19]75-2046), a journal published under contract to the NCI." This published abstract antedated the NCI's response to Congressman Hanley by more than six months. Thus, at the time the NCI was writing to Congressman Hanley that the Soviet data were negative, the NCI already knew these data were positive.<br /><br />Why the deception?<br /><br />What was the meaning of this misinformative response by the NCI?<br /><br />Hydrazine sulfate was the first drug for generalized--any type of--cancer. It was developed by the Syracuse Cancer Research Institute, a small, private cancer research organization with an annual budget not exceeding $200,000. If you were a member of the House or Senate Appropriations Committees, would you authorize billions of dollars annually, as a result of the National Cancer Act of 1971, <em>directly </em>to the NCI--in the face of a small private laboratory which had just come up with the first useful drug for all cancers, on a budget of less than $200,000? You'd have to say "Whoa--let's reevaluate this whole situation."<br /><br />Thus, in framing a deliberate lie to Congressman Hanley--in turning its guns against hydrazine sulfate--the NCI was fighting for its life. In perceiving hydrazine sulfate as a threat to its existence, the NCI was fighting to preserve its hegemony over the network of all cancer funds and its central position in the constellation of all cancer efforts.<br /><br />As many readers of <em>MedTruth</em> know, over the ensuing years the NCI maintained its resistance to hydrazine sulfate, referring in cancer textbooks to the ever-enlarging Russian controlled clinical trials demonstrating statistically significant antitumor and anti-cachexia effects (see above) in otherwise unresponsive patients--as showing only "hints of subjective activity," while at the same time not even acknowledging the published Phase III randomized, double-blind Harbor-UCLA studies demonstrating, again statistically significantly, that hydrazine sulfate normalizes the abnormal metabolism associated with cancer cachexia--(i.e., associated with over 70 percent of all cancer deaths).<br /><br />But not until 1989 did it occur to NCI that it would have to undertake controlled clinical trials of its own which might counter the Russian and Harbor-UCLA studies before the scientific and medical communities might believe its adversarial position on hydrazine sulfate. Accordingly, in 1989 NCI took over all clinical testing of hydrazine sulfate in the U.S., prohibiting (by grant denial) Harbor-UCLA--which up to that time had performed and published almost 10 years of increasingly positive studies on hydrazine sulfate--and by association any other U.S. cancer center from any further clinical study of hydrazine sulfate. Thus, in 1989 the NCI became the only player in the clinical testing of hydrazine sulfate within the United States.<br /><br />The NCI sponsored three studies of hydrazine sulfate, parts of which were performed at various cancer centers and hospitals throughout the U.S. But before going further, it is necessary for you to become acquainted with the Helsinki Declaration.<br /><br />The Helsinki Declaration--a multinational ratification of principles governing human biomedical research studies, to which the U.S. is a major signatory-- is an outgrowth of the Nuremberg Trials (Doctors Trial) following World War II which uncovered the heinous human medical "experiments" inflicted on helpless human beings by the Nazis, put in place to guarantee that no harmful procedures be used in patients undergoing experimental medical treatment. This document lies at the very heart of all clinical studies and informed consent--and as such represents the international "law of the land," requiring all human biomedical research to conform to its stated principles, and to so acknowledge in all experimental protocols and published studies.<br /><br />All controlled clinical trials performed in accordance with the Helsinki Declaration indicate--without exception--the efficacy and safety of hydrazine sulfate. These include the 17 years of multicentric Phase II Russian studies and the 10 years of Harbor-UCLA randomized Phase III studies--performed by scientists considered among the most outstanding and experienced clinical cancer investigators in the world and published chiefly in leading U.S. peer-reviewed cancer and medical journals.<br /><br />The only controlled clinical trials to indicate the non-efficacy of this drug were those sponsored by the National Cancer Institute. However, these were in violation of the Helsinki Declaration (the "generally accepted standards" rule) by virtue of their use of incompatible agents (medications) with the test drug and therefore declared by this Declaration to have no scientific standing. (Use of incompatible medication in the presence of a test drug can result in the grave illness--or death--of a patient, as well as cause a negative drug study. Use of incompatible agents in a drug study is virtually unknown in human biomedical testing.)<br /><br />Most major media science writers and personnel are reluctant--even fearful--to touch this story. The idea that there could be an existent, effective cancer treatment--which the government refuses to acknowledge--is almost preposterous. But in those instances where reporters and other media representatives have made inquiries to the National Cancer Institute, stating their plans for a possible story on hydrazine sulfate, they receive the following type of reply:<br /><br />"How could you perpetrate such a cruel hoax on the American people? You would be giving hundreds of thousands of people false hope."<br /><br />Here is the 'cruel hoax': The combined Russian and Harbor-UCLA studies, the only controlled clinical trials performed in conformity with the Helsinki Declaration, state that of every million late-stage, unresponsive cancer patients treated with hydrazine sulfate, more than half a million would receive measurable symptomatic improvement, 400,000 would demonstrate a halt or regression in tumor growth, and some would go on to long term (> 10 years) "complete response," i.e., survival.<br /><br />This 'cruel hoax' must out. NCI's well-kept 'secret' must out. The major media must have the courage to take on this difficult story and inform the American people that there <em>is</em> an effective cancer treatment out there, one that competently performed clinical trials have identified as capable of extending benefits to even very advanced cancer patients.<br /><br />I am asking each of you who reads this communication to send a copy to anyone you know who has cancer, to anyone you know who may be in a position to majorly publicize--to "break"--this story. To your doctor. Your health care provider. To the earnest people in hospice who care for human beings in their last weeks and months of life. To your Congressmen and Congresswomen. Ask them to do something about this tragic situation which keeps really ill people from a drug which competently performed clinical studies say might help them and only incompetently performed studies say otherwise....Dr. Joseph Goldhttp://www.blogger.com/profile/00368001273179577986noreply@blogger.com31tag:blogger.com,1999:blog-1335007907715618966.post-70906575618777969732009-06-25T11:50:00.000-07:002009-06-26T12:44:16.899-07:00Meditated manslaughterToday I want to inform you of a recent occurrence, one of the most diabolical happenings in medicine I have ever been aware of, that has the capacity to negatively affect the life of anyone who has cancer and indirectly negatively impact the life of every man, woman and child in this nation, even abroad.<br /><br />In the June 1, 2009 issue of <em>Newsweek</em> magazine there was an insert of the Syracuse (NY) Cancer Research Institute in the cancer care section, calling attention to the last blog on <em>MedTruth</em>, "If you have cancer, even advanced, studies show this drug may help save your life...." The drug referred to was hydrazine sulfate, developed by the SCRI, though the insert did not name the drug. The blog reviewed in detail the advantages of especially late stage cancer patients having a trial on the drug, based on controlled clinical trials performed in accordance with internatiionally authorized biomedical procedures, as well as the National Cancer Institute's (NCI's) historical opposition to it. This insert appeared in <em>Newsweek's</em> New York state, Northern New Jersey and Washington, D.C's editions.<br /><br />Those of us responsible for this insert thought that the potential for many cancer patients and their families to read this blog was high, and therefore we undertook to place comprehensive information on hydrazine sulfate on-line. To that end we published on Wikipedia--the Internet's encyclopedia--a full informational statement on hydrazine sulfate, inclusive of scientific background, clinical indications, clinical trials, side effects, drug incompatibilities, costs and a Reference list from the medical literature. We strived and hopefully succeeded in providing non-biased, 'even-handed' information, so that readers of this important statement might have a well-balanced idea of this drug and its expectations.<br /><br />This statement lasted on Wikipedia only 24 hours. Approximately one day later, it was replaced by a totally new statement--not of our doing--which retained only vestiges of our original statement. The new statement was seemingly the work of National Cancer Institute (NCI)-oriented forces arrayed against hydrazine sulfate for many years and aroused by the <em>Newsweek's</em> insert appearance in the Washington, D.C. area, home of the NCI (Bethesda, MD).<br /><br />But these NCI-oriented forces did not want readers to see the non-prejudicial and medically and scientifically correct material we originally published on Wikipedia. Rather they wished to publish their own statement, and to that end they convinced the editors of Wikipedia to remove our statement totally and substitute one of their own.<br /><br />The new statement was startling in its content of misinformation, in its wholesale substitution of fiction for fact, as well as presentation of slanted innuendos, aspersions and outright fabrications.<br /><br />The "new" Wikipedia piece states: "The California [Harbor-UCLA Phase III randomized, placebo-controlled clinical] trials saw no statistically significant effect on survival from the treatment." But what the California studies actually <em>reported</em> in their published, peer-reviewed paper was exactly the opposite: "For the PS [Performance Status] 0-1 patients [earlier patients] survival was [statistically] significantly prolonged with hydrazine sulfate compared with placebo (P = .05) [measure of positive statistical significance]. The survival at 1 year was also significantly increased (P = .05) for hydrazine sulfate compared with placebo (42% alive <em>v</em> 18%, respectively)" (<em>Journal of Clinical Oncology</em> 8:9-15, 1990). We e-mailed this direct quote of the California studies to Wikipedia <em>twice</em>. The result? Wikipedia continued to publish its statement that the California studies showed no statistically significant survival increase from hydrazine sulfate treatment.<br /><br />In another example, the new, substituted Wikipedia piece stated:<br /><br />"Later randomized controlled trials failed to find any improvement in survival, with some trials finding...poorer quality of life." These "later" trials are the NCI-sponsored studies of hydrazine sulfate. Those of you who read our previous blog referred to above will remember that these are the same studies found to be in<em> violation </em>of the "generally accepted standards" rule, Principle 1, of the Helsinki Declaration, by virtue of their use of incompatible medications (alcohol, tranquilizers, sleeping pills) in the presence of a test drug (hydrazine sulfate, an irreversible MAO inhibitor).<br /><br />The Helsinki Declaration--an outgrowth of the Nuremberg Trials (Doctors Trial) following World War II which uncovered the heinous human medical "experiments" inflicted on helpless human beings by the Nazis--is a multinational ratification of principles governing human biomedical research, to which the United States is a major signatory, put in place to guarantee that no harmful procedures be used in patients undergoing experimental medical treatment. This document lies at the heart of all clinical studies and informed consent--and as such represents the international "law of the land"--and requires all human biomedical research to conform to its stated principles and to so state in all published studies and research protocols.<br /><br />Principle 1, the paramount principle, of the Helsinki Declaration states: "Biomedical research involving human subjects must conform to generally accepted scientific principles...and be based on a thorough knowledge of the scientific literature." Most important of generally accepted scientific principles in the conduct of human biomedical research is that no incompatible agents (medications) be used in a drug trial, since such use can result in the grave illness--or death--of a patient, as well as cause a negative drug study. Use of incompatible agents in a drug study is virtually unknown in human biomedical testing.<br /><br />By virtue of NCI's use of incompatible medications in its sponsored, "later" studies of hydrazine sulfate, the Helsinki Declaration declares that these "later" studies have no scientific standing and that the results of these trials are null and void. The Helsinki Declaration further states, regarding these studies (Principle 8): "Reports of experimenation not in accordance with the principles laid down in this Declaration should not be accepted for publication."<br /><br />The new, substituted Wikipedia statement omits entirely any mention of the Helsinki Declaration, or of these "later" trials being in violation of this Declaration, or of the fact that in none of these "later," published studies or research protocols (#'s 8931, 89-24-51, 89-49-51) is there any statement that these studies were carried out, or to be carried out, in accordance with the Helsinki Declaration. Yet by allowing these NCI-oriented forces' assertion that these "later" trials failed to find any survival benefit and knowing that this assertion was incorrect, and in making no mention of the Helsinki Declaration, Wikipedia did not seemingly care that a startlingly erroneous impression was being made on the American public, with potentially very serious consequences.<br /><br />The effect of misrepresentations such as the above is two-fold. Foremost, it promotes increased physical and psychological distress and ill-health in cancer patients by sending an incorrect signal to the lay and medical public. To doctors and patients alike it says that hydrazine sulfate is not effective and may even be harmful. Whereas the peer-reviewed medical literature in fact documents that controlled clinical studies, performed in conformity with the Helsinki Declaration, indicate--without exception--the efficacy and safety of hydrazine sulfate in cancer patients of all kinds and at all stages. These properly controlled clinical trials demonstrate that of every million late stage, unresponsive cancer patients given hydrazine sulfate, more than 500,000 would receive measurable symptomatic improvement, 400,000 would demonstrate a halt or regression in tumor growth, and some would go on to long term (>10 years) "complete response," i.e., survival.<br /><br />The effect of the Wikipedia misrepresentations--by dissuading cancer patients (and their doctors) from a trial on hydrazine sulfate and thus a 50 percent chance of improvement in their status--is to promote increased suffering and death. As such--by acquiescing to NCI-oriented pressures (e.g., change of the actual medical literature from reading "statistically significant increase in survival" to non-efficacy)--Wikipedia makes itself a direct participant in the 'meditated manslaughter' of cancer patients all over the world.<br /><br />Of perhaps equal consequence, misrepresentations such as the above send a message to the public that its institutions promoting and safeguarding First Amendment rights, such as Wikipedia, are susceptible and vulnerable to government-sponsored pressure to change truth to fiction, without an investigation of the merits of these changes. The presentation of false and/or misleading information as truth not only acts to dupe the public but, more importantly, to dilute the integrity and reliability of our public institutions.<br /><br />What can be done to rectify this unfortunate situation? Undue, if not improper, government-sponsored pressure must be corrected at government levels. We can each contact our representatives and senators in Congress, calling attention to the sponsorship of governmental forces threatening to destroy what have become our free institutions, such as Wikipedia, and their dissemination of factual information to the American people, especially in regard to the public health. You will find that many of our Congressmen and Congresswomen will be responsive to this concern.Dr. Joseph Goldhttp://www.blogger.com/profile/00368001273179577986noreply@blogger.com71tag:blogger.com,1999:blog-1335007907715618966.post-45180803867296486422009-02-27T09:20:00.000-08:002009-03-02T13:10:13.844-08:00If you have cancer, even advanced, studies show this drug may help save your life....A year ago, on February 21, 2008, I placed a blog on <em>MedTruth</em>, "A Dog Has a Better Chance of Recovering from Cancer Than You Do," in which I attempted to show, in dramatic fashion, that the public is being "hoodwinked" from using hydrazine sulfate for human cancer, principally by the U.S. National Cancer Institute--part of the federal government--whereas the veterinary industry is largely immune from this constraint, using hydrazine sulfate on animals sick with cancer, many of whom, as a result of this treatment, are being reported to have staged significant or complete recovery. I went on in this blog to show that it was our National Cancer Institute (NCI) which was knowingly spreading misinformation on this drug to the public and to the medical profession, in an attempt to keep it from becoming adopted for routine use in human malignancy.<br /><br />The reason for the present blog is to emphasize the great possibilities for improvement and curative effect by this drug for individuals with cancers of almost all types--and at all stages--whether hydrazine sulfate is used by itself, with chemotherapy or radiation therapy, or with other modalities of cancer treatment, and eliminate, to the extent possible, the "contest" imposed on this drug by the NCI.<br /><br />Controlled clinical trials, done in conformity with the Helsinki Declaration, show that of every million late-stage, unresponsive cancer patients treated with hydrazine sulfate, more than half a million would receive measurable symptomatic improvement, 400,000 would demonstrate a halt or regression in tumor growth, and some would go on to long term (>10 years) "complete response," i.e., survival.<br /><br />These are truly late-stage patients--i.e., those who have become refractory to their treatments or were never responsive to them in the first place. (It would be expected that in "earlier" patients the foregoing very favorable results would be even improved.)<br /><br />These clinical results emanate from 17 years of Phase II multicentric clinical trials headquartered at the Petrov Research Institue of Oncology in St. Petersburg (with participation of the Herzen Institute of Oncology, Moscow; Oncological Institute of Lithuania, Vilnius; Institute of Oncology of the Ukranian Academy of Sciences, Kiev; and Rostov Institute of Oncology and Radiology, Rostov-an Danou)--and 10 years of randomized, double-blind Phase III clinical trials at Harbor-UCLA Medical Center in California, performed by scientists considered among the most outstanding and experienced clinical cancer investigators in the world and published chiefly in leading U.S. peer-reviewed cancer and scientific journals.<br /><br />The Helsinki Declaration--an outgrowth of the Nuremberg Trials (Doctors Trial) following World War II which uncovered the hideous human medical "experiments" inflicted on helpless human beings by the Nazis--is a multinational ratification of principles governing human biomedical research studies, to which the U.S. is a major signatory, put in place to guarantee that no harmful procedures be used in patients undergoing experimental medical treatment. This document lies at the very heart of all clinical studies and informed consent--and as such represents the international "law of the land" and requires all human biomedical research to conform to its stated principles.<br /><br />The only controlled clinical trials to find this drug non-effective were those sponsored by the U.S. National Cancer Institute--which were in violoation of the Helsinki Declaration by their use of incompatible agents in the presence of a test drug. The paramount principle--Principle 1--of the Helsinki Declaration states: "Biomedical research involving human subjects must conform to generally accepted scientific principles...and be based on a thorough knowledge of the scientific literature." Most important of generally accepted scientific principles in the conduct of human biomedical research is that no incompatible agents (medications) be used in a drug trial, since such use can result in the grave illness--or death--of a patient, as well as cause a negative drug study. Use of incompatible agents in a drug study is virtually unknown in human biomedical testing.<br /><br />In the blog, "A Dog Has a Better Chance...." it was shown that the NCI-sponsored studies, out of conformity with the Helsinki Declaration by violation of the "generally accepted standards" rule (Principle 1), were also under the leadership of inexperienced or ethically compromised investigators, were not "juried" in the usual manner (it was not clear whether they were subject to outside, independent peer-review prior to publication), were "interconnected"--i.e., not independent of one another (thus no independent conformation was possible), and were subject to an accompanying NCI editorial containing blatant, unscientific language, referring to hydrazine sulfate as a "vampire," thus impairing their "legitimacy" as impartial, objective scientific investigations.<br /><br />In contrast, the Petrov and Harbor-UCLA studies were in full compliance with the Helsinki Declaration, were carried out by experienced, world-class investigators not involved in any irregularities or conflicts of interest, were subject to outside, independent peer-review before winning publication, were not "interconnected" and thus constituted <em>independent confirmation</em> of one another (reinforcing the validity of their individual data). These studies were carried out in strict accordance with internationally established and recognized principles and contained no additions or modifications which might act to dilute or question their scientific, impartial, objective integrity.<br /><br />It is important to note that while the NCI is the largest cancer agency in the world and its scientific opinions considered most authoritative and regarded by the medical profession in the highest repute, once a study is incompetently performed--in this case in violation of "generally accepted scientific principles," in violation of an international Agreement of principles governing allowable human biomedical research procedures, to which the United States is a signatory--it doesn't matter what the "credentials" of the sponsoring organization are or in what esteem it is held, its studies are invalid. Period. Science declares they are null and void and must be excluded from any treatment options.<br /><br />There are only two sets of valid, controlled clinical trials--those which are in full compliance with the Helsinki Declaration--on hydrazine sulfate: the Russian (Petrov) and the Harbor-UCLA data. Both sets of studies show the same results: In late-stage patients who are or have become refractory to all treaments, hydrazine sulfate produces an approximate 50 percent response rate. 50 percent of these "factually terminal" patients respond with "moderate-to-marked" symptomatic improvements (decrease in weakness, pain and other cancer-specific symptoms, return of appetite, well-being), tumor stabilization (no tumor progression), tumor regression, or a combination of these effects. These benefits will persist from months to years, and in some cases will endure long term (>10 years), accompanied by complete response (total remission of disease).<br /><br />These results are not a bad "scorecard" for those who have only "30 to 60" days to live, who are in the throes of weakness, pain and organ failure. The point is, there are no valid, controlled clinical data to disagree with these results.<br /><br />Then why wouldn't--shouldn't--all patients with cancer want an immediate try on hydrazine sulfate? The results suggest that all unresponsive patients--or those growing weaker on their present therapy--who have no further treatment options available, should. Even earlier patients whose disease is stable or in remission, should consult their physicians regarding the advisability of adding hydrazine sulfate to their present regimens.<br /><br />This move could be life-sparing or life-saving to you if you have a malignant disease. Regarding this drug's toxicity, since hydrazine sulfate is not a cytotoxic agent (cell-killer), side effects have been characterized as "mild" and frequently transient. Controlled clinical trials have demonstrated no incidence of carcinogenicity or documentation of organ failure as a result of hydrazine sulfate therapy: "There were no significant differences between the protocol arms with regard to myelodepression, gastrointestinal toxicity, renal toxicity, cardiopulmonary toxicity, or neurotoxicity."<br /><br />Many of you know me as the developer of hydrazine sulfate as an anticancer agent and therefore it would be expected to be in my--"Dr. Gold's"--interest to promote this drug. But it is not Dr. Gold talking. Not Dr. Gold making these recommendations. It is the studies. The contr0lled clinical trials performed within the confines of the Helsinki Declaration. The controlled clinical trials performed in accordance with internationally accepted scientific principles of experimental biomedical study conduct. Dr. Gold is merely quoting the results of these studies.<br /><br />These studies in essence suggest that<strong> it would be sheer insanity for a cancer patient failing current therapy, not to try hydrazine sulfate</strong>. To wait until his/her disease becomes truly terminal, from which there is no return.<br /><br />But when consulting your doctor, you may hear remarks in good faith such as: "The National Cancer Institute has tested this drug and found it to be ineffective." "This drug's been around a long time. If it were any good, we'd know about it." "This drug is very toxic." "There is no credible evidence that this drug has anticancer activity." Remarks such as these from a trusted medical advisor can serve only to discourage and dissuade you from a try on this drug.<br /><br />Know, however, there is but one judgment--the controlled clinical trials--that can advise whether a drug trial may be beneficial. The controlled clinical trials properly done--i.e., the Petrov and Harbor-UCLA studies. Your doctor may be unaware of these. Your doctor may be aware of only the incompetently performed National Cancer Institute-sponsored studies, those in violation of the Helsinki Declaration.<br /><br />You can present your health care provider with copies of the actual Petrov and Harbor-UCLA studies, performed in compliance with the Helsinki Declaration, by visiting the Web site <strong>scri.ngen.com</strong> and clicking onto "Articles." To the left of each listed article is an icon. By clicking onto the icon, a one-paragraph summary ("abstract") of the published study will appear. By clicking onto the title of the study to the right of the icon, the entire published study will appear. Either the summary or the entire article, as they appear in the medical literature, can be downloaded and then presented to your physician.<br /><br />Your physician will then have the opportunity to review the pertinent data--the results of properly controlled clinical trials--he/she may not have been previously aware of, and then discuss with you any recommendations as to the appropriateness of hydrazine sulfate as a treatment option for you.<br /><br />Hydrazine sulfate is presently available by a doctor's prescription filled in a compounding pharmacy. A listing of compounding pharmacies nearest you may be obtained from The International Academy of Compounding Pharmacists, Houston, Texas, 800-927-4227.<br /><br />As a last word, I know it sounds almost absurd to have a cancer drug that can induce significant anticancer response, largely ignored by the medical establishment and by specific cancer organizations and agencies, such as the National Cancer Institute. But the reality is that the only controlled clinical trials of this drug not in conflict with the internationally ratified Helsinki Declaration--the Petrov and Harbor-UCLA data--say this is the case: That upwards of 50 percent of all cancer patients, even those who are late-stage, can expect an improvement in their cancer status as a result of this treatment.Dr. Joseph Goldhttp://www.blogger.com/profile/00368001273179577986noreply@blogger.com3tag:blogger.com,1999:blog-1335007907715618966.post-75274218136721454162008-12-09T11:32:00.000-08:002008-12-12T08:35:40.263-08:00Can the pharmaceutical profit motive be subdued?Are pharmaceutical companies today uncontrolled in their lust for profits--at the expense of drug utility and safety? In our nightly television news broadcasts the frequent pharmaceutical ads must portray, by FDA rule, the side effects of each drug. In many instances the side effects are horrific--but in practically each instance the drug advertised is very expensive and this, not its "therapeutic" effect, is the reason it is being promoted. Do pharmaceutical companies really care about the welfare of patients, or is patient welfare merely the excuse to amass large profits?<br /><br />A few weeks ago there was an Internet report that one of our largst pharmaceutical companies, Pfizer, Inc.. was "shifting its research focus to diseases that have high potential for high profits," such as in "oncology [cancer], pain and Alzheimers disease." What happens to lesser illnesses that affect major portions of the populations--illnesses that may not perhaps require <em>expensive</em> medications? Do they go by the boards? Suppose a drug company or companies developed a drug that could adequately treat a common illness--but there was no or little profit in it? Would they go ahead with it? Would they place expensive ads on television dramatizing its curative effects? Full-page ads in the medical journals, in consumer-read national magazines? Not according to the pharmaceutical news reports appearing in the media. Not according to the constantly escalating prices of commonly used and expensive drugs--heartburn medications, hormones, anti-arrhythmia medications--which have been on the market for years, some of which force especially older people to choose between paying for these expensive medications and buying food.<br /><br />Years ago the drug manufacturing profession used to be known as the "ethical pharmaceutical industry," in contradistinction to patented or other preparations hawked to the public by commercial promoters ("Carters Little Liver Pills"). Ethical pharmaceuticals included companies primarily engaged, under federal regulation and supervision of law, in manufacturing and fabricating drugs--in the form of pills, ampules, ointments, powders and suspensions--to the medical, dental and veterinary professions, which have been shown to be medically useful to the public and to veterinary patients. The word "ethical" embraced this industry's image for product honesty and portrayal of sincere helpfulness to humanity as the primary purpose of its business undertakings.<br /><br />Today?<br /><br />Is there anyone in the drug industry that cares about the public? Is there any CEO, CFO, COO or company chairman or president that knows anything about the drug trade? About drugs <em>per se</em>? Who is not primarily a business person? Who is not primarily concerned--obsessed--with profits? Who does not think the term "ethical" laughable--an appellation that belongs in the last century?<br /><br />The announcement by Pfizer, Inc., that it will now concentrate on drugs only with a high profit potential--is now industry-wide. Only with few exceptions all pharmaceutical companies are adopting this financial strategy. What effect will it have on you? What effect on the population? On businesses and industry? On our national welfare?<br /><br />There are two aspects of drug pricing that need to be addressed and--in my estimation-- immediately corrected. Runaway drug 'caps.' And, in many cases, initial--obscene--drug pricing.<br /><br />As part of current, federal health laws, there are no 'caps'--upper limits--on prescription drug prices. Thus while those enrolled in various health plans may pay only a fraction of retail drug prices for their prescriptions, there is no cap on the drugs' retail pricing. The drug companies are free to charge whatever they want. People, for example, in a drug plan paying only a modest amount for a prescription item, may find their out-of-pocket expense for it double by the next year. And people who are in no prescription plan--or those who have reached the 'doughnut hole' of their plans--might no longer be able to afford the same prescribed drug one year later. From a pricing point of view the pharmaceutical companies are not primarily concerned whether people are in a drug plan, they--the companies--are free to raise the price of their drugs as often and to the exent they see fit.<br /><br />As to the pricing of new drugs, especially those for treating cancer, the sky's the limit. For example, the drug <em>Erbitux</em> was initially priced at $12,000 <em>per month</em> and was subsequently raised to $18,000 per month (even though studies showed it to be only minimally useful). The drug <em>Avastin</em> was priced at $46,000 to $56,000 per-patient cost; <em>Vectibix</em>, $36,000<em>; Lucentis, $48.000; Revlimid</em>, $67,000<em>; Sutent</em>, $46,000; even single injections of simple colony-stimulating agents, for example those to increase a patient's production of red or white blood cells, $2,000 to $7,000 per injection. Do you mean to say most individuals can afford these obscene and unneeded payments? No, they can't. But the health insurance plans all authorize them. So the payments are spread among the entire membership of these plans, among the businesses and industries that underwrite these plans for their employees and among the federal and state governments.<br /><br />Thus, in their pricing--and in their unbridled avarice--the pharmaceutical companies are succeeding in bringing down the average individual, in reducing--to unncecessary lengths--<br />the financial wherewithal of individuals to bring up families and to otherwise enjoy life's many directions.<br /><br />But obscene pharmaceutical prices are not only bringing down individuals and their families, they are also contributing to the demise and "foreclosure" of business and industry. Many of the country's businesses--large and small--have either collapsed or left these shores because costs in underwriting the health and prescription plans of their employess have constituted the "straw that broke the camel's back.' And, in like manner, ever-increasing health and prescription costs are eroding the national welfare, helping to create a negative impact on the country's gross domestic product and services.<br /><br />How can we "rescind" the excess profit motive of this industry? How can we restore the "ethical" to pharmaceuticals? How can we damp the greed of our health insurers--whose executives, often controlling the medical decisions of physicians, frequently walk away with millions of dollars they have managed to squeeze from their hapless memberships annually?<br /><br />There is a way. And that is that this runaway "health machine" must be regarded in the same way as a war. If our nation can contribute billions to an actual war, it can contribute these kind of funds to what is actually an ongoing war--health costs eating up the wherewithal of people and the industrial backbone of this nation. We must bring into being a type of universal health care whereby people no longer have to worry about having sufficient money to cover their families' health and prescription costs, whereby businesses and industry are freed from the constraint of underwriting health costs for their employees in order to stay in business.<br /><br />And at the same time, we must tame these costs. We must rescind them to levels that are commensurate with reasonable profits. We must regulate them and not allow the genie of greed to run rampant in today's health sector of society.<br /><br />Health care is one of the most important issues that will confront the new administration. There is every hope that this new administration and its determined president will devote its considerable resources to finding a way of adequately resolving this demanding question.Dr. Joseph Goldhttp://www.blogger.com/profile/00368001273179577986noreply@blogger.com22tag:blogger.com,1999:blog-1335007907715618966.post-8335811636343124292008-09-27T08:19:00.000-07:002008-09-30T09:46:21.818-07:00"Stand Up to Cancer"About a year ago a blog was published on <em>MedTruth</em>, "Is Bigger Better?" describing the evolution of large-scale cancer research organizations, i.e., in excess of 20,000 members, whose growth was associated with a considerable slowing of important advances in cancer, with a "gobbling up" of cancer research funds appropriated by Congress to the annual budgets of the National Cancer Institute (NCI) and from other sources, and with a possible, paradoxical lessening of opportunity for the truly gifted, for young investigators whose ideas may be "outside" current cancer concepts--whose scientific thinking may harbor the truly great discoveries to come. The blog asks: Is bigger better? Or is big brother somehow, invisibly, paradoxically acting to smother--to exclude from opportunity--the most gifted of its ranks?<br /><br />On Friday evening, September 5, 2008, all three major television networks--NBC, ABC, CBS--<em>simultaneously</em> telecast<em> </em>a live, star-studded, hour-long, commercial-free telethon, "Stand Up to Cancer," in Los Angeles, attended by thousands of people and dignitaries, aimed at raising large amounts of money for cancer research. Present were celebrities from the entertainment world, such as Jennifer Aniston, Halle Berry, Keanu Reeves, Jack Black, Patrick Swayze, Billy Crystal and others, presidential nominees John McCain and Barack Obama, and network news anchors Katie Couric, Charles Gibson and Brian Williams, who acted as emcees. People and business organizations were urged by these celebrities to call in their donations, while other stars from the entertainment industry--America Ferrera, Christine Ricci, Neil Patrick Harris, Kirsten Dunst--answered phones. Other stars, Jennifer Garner, Forest Whitaker, and again Halle Berry, read personal accounts from patients battling cancer, while cancer "survivors" Elizabeth Edwards (wife of former presidential candidate John Edwards, now battling recurrent breast cancer) and Lance Armstrong recited U.S. and global cancer statistics. This was an unprecedented effort to raise funds for cancer research in order to break the existing bottleneck to effective cancer treatments.<br /><br />According to an ABC News update on Thursday, September 11, 2008, the "Stand Up to Cancer" telethon raised "one-hundred million plus" dollars. This seems like an enormous amount of money raised by this most significant and monumental effort. Will it increase the amount of cancer research funds by 100 percent? By 50 percent? By 10 percent? How significant was this fund raising effort by this distinguished, if not spectacular, gathering of celebrities, cancer research advocates, scientists, news anchors, even the two 2008 major presidential nominees--speaking for the necessity to raise more funds for cancer research, exhorting the nation's private resources, individuals and industry, to come together in a convincing demonstration of the need and willingness of the public to sponsor more effective cancer therapy. "100 million+" is a lot of money. But is it?<br /><br />The cancer research budget for the National Cancer Institute (NCI)--part of the federal government--as allocated by Congress for fiscal 2008, i.e., currently, is <em>$4.8 billion</em>. This is 48X the funds raised by Stand Up to Cancer (SU2C). But there are other sources of federal cancer research dollars, as well as sources from the private-sector, such as the American Cancer Society (ACS); according to its Annual Report the ACS allocated $146 million to cancer research in 2007 (about the same for 2008). Thus the total available federal and private-sector cancer research funds are at least <em>$5.0 billion</em> annually, and the additional funds raised by this extraordinary gathering of dignitaries, celebrities, scientists, presidential nominees, news anchors, cancer advocates--$100 million--represents only <em>2 percent</em> of available, annual cancer research funds. Will this make a significant inroad against cancer?<br /><br />These additional funds raised by SU2C are to be relegated largely to <em>translational</em> cancer research. Translational cancer research seeks to convert ("translate") scientific "discoveries" that have been accumulating at the laboratory level--which have to date not resulted in any clear-cut clinical advances--to actual, new, near-term therapies that will significantly benefit cancer patients. However, it must be borne in mind that critics of this type of cancer research have alleged that many of these discoveries--made by the armies of members (20,000+) in large-scale cancer research organizations are artifactual--i.e., not real--in nature, and the reason they cannot be "translated" into effective cancer treatments is because they are intrinsically faulty.<br /><br />The American Association for Cancer Research (AACR)--one of the large-scale cancer research organizations referred to in <em>Is Bigger Better?</em>--has been selected by the Scientific Advisory Committee of SU2C to administer these new funds. The AACR is a private organization made up of scientists, clinicians, educators and administrators. Many in its membership (currently 24,000) are at the heart of all--and the leadership of many--cancer research organizations, cancer programs and cancer centers in this country and the world over. This organization over the years sponsors annual scientific symposia, has raised funds for myriad cancer colloquia and causes, maintains official liaison and interacts with the NCI, ACS and other important cancer groups, is the sponsor and publisher of well known cancer journals, has inaugurated its own charitable foundation--but has never been the actual controller of the type of funds raised by SU2C. If all $100 million go to the AACR, it will represent a windfall for this organization, the magnitude of which it has historically never known.<br /><br />On September 9, 2008, the AACR issued an Internet advisory stating it will participate in "selecting the most promising research projects" for funding (from the new SU2C funds), that the new funds would enable the "best and brightest" investigators from leading institutions around the world--usually senior investigators--"to work together." What follows is a series of words and phrases--"collaborative efforts," "Dream Teams...of top investigators who have never worked together," "team-approach, rather than competition"--ominously reminiscent of a Communist manifesto, such as would send author and philosopher Ayn Rand (who championed the <em>individual</em> as the "supreme" value of society) spinning in her grave (her portrait graces the 1999 U.S. first-class postage stamp). I am reminded of the get-together of pianist Arthur Rubenstein, cellist Gregor Piatigorsky and violinist Jascha Heifetz, regarded as among the greatest living musicians of their time or of any time--for a recording session. The trios to be recorded by these outstanding musicians--because of their brilliance--would be so great as to be "transcendental." But they weren't transcendental. They were a flop. Because each artist was a "virtuoso" in his own right, each had different "takes"--which did not mesh--on the trios recorded.<br /><br />In its advisory the AACR emphasized the value of a "team-oriented" apporach, implying that true achievement is more likely to be the results of "collective," i.e., "collaborative," efforts. Nothing could be further from the truth. Historically true achievement--especially in science and medicine--was/is the result of one person. One mind. One brain.<br /><br />August<strong> Kekule</strong> in 1865 (rumored the result of a reverie, based on his 25 years of prior work) discovered the ring structure of benzene--which was responsible for the phenomenal growth of organic chemistry, biochemistry, the pharmaceutical industry, medicine, modern chemistry-dependent industry, the production of many commercial household and industrial products, etc. Enrico <strong>Fermi</strong>, capitalizing on the work of Meitner and Hahn before him, was the developer of the first atomic reactor, which led to both nuclear weapons and the modern nuclear industry--yielding electric power in countries all over the globe, nuclear medicine, and other fissionable-based industrial and medical products. Frederick <strong>Banting, </strong>working at first in his garage and then at the University of Toronto, isolated and purified--and was thus the discoverer of--insulin, which revolutionized modern medicine (and medical theory) and remains <em>the</em> treatment regimen for millions of people all over the world with diabetes mellitus. Alexander <strong>Fleming</strong>, working alone and publishing a paper in 1929 showing the killing effect of a strange substance leaching from a penicillium mold in an agar plate--inaugurated the antibiotic era which has saved the lives of millions of people the world over annually. Jonas <strong>Salk</strong>, publishing the results of his work in the Pittsburgh (Pennsylvania) newspapers because of his distrust for the medical journals and their medical sponsors, was the innovator of the first polio vaccine, which was administered to the children all over the cities and rural areas of America--with the exception of Boston (Massachusetts)--in early 1955. (The doctors of Boston--then considered the "mecca of U. S. medicine"--refused to have the children of Boston immunized with a vaccine they deemed "dangerous.") Later that same year, 1955, Boston suffered the worst polio epidemic ever recorded in the U.S.) The Salk vaccine, followed by the subsequently developed and competitive Sabin vaccine, virtually eliminated poliomyelitis from the face of the earth. In 1957 Dr. Charles <strong>Heidelberger</strong> developed the anticancer drug 5-FU (5-fluorouracil). Working alone, Heidelberger, a medical biochemist, conceived the idea of substituting a fluorine atom for a hydrogen atom on the nucleic acid base uracil--important to rapidly dividing cancer tissue--with the thought that this new molecule would inhibit cancer cells' ability to multiply and would thus result in a true anticancer effect. Dr. Heidelberger synthesized the molecule 5-FU himself, tested it on cancer-bearing animals himself, then tested it on humans himself. Such was Heidelberger's erudition and creativity, that this work not only advanced chemotherapy signficantly but that 5-FU has remained a mainstay in cancer therapy for over 50 years, used today--by itself and in conjunction with other chemotherapy agents--in a spectrum of human cancer. James <strong>Watson</strong>, Francis <strong>Krick</strong>, Rosalind <strong>Franklin</strong> and Maurice <strong>Wilkins</strong>, working alone and on both sides of the Atlantic in the 1950s, unlocked the mystery of the double-helix structure of DNA, making possible the first scientific inquiries into the genetic code--and genomes--of various species, including humans, and thus figuring significantly in the important scientific and medical gains to result from this signal discovery. Watson, Krick and Wilkins all received the 1962 Nobel Prize for this work. Franklin unfortunately died (of ovarian cancer) in 1958 and was thus ineligible to be included in this prize, since Nobel Prizes are not awarded posthumously. Biochemist Kary <strong>Mullis</strong>, working by himself, conceived and developed the polymerase chain reaction (PCR), allowing the amplification of specific DNA sequences, literally opening the door of the entire field of genetics to researchers, scientists, clinicians, pathologists, forensic investigators and others the world over--for which Mullis received the Nobel Prize in 1993. The PCR made possible entry of the science of genetics--and the science of medicine itsef--into the modern era. Luc <strong>Montagnier</strong> and Robert <strong>Gallo</strong>, working alone and again on each side of the Atlantic--Montagnier at the Pasteur Institute in Paris, France, and Gallo at the National Cancer Institute in Bethesda, Maryland--were the co-discoverers in 1983 and 1984 of HIV, the presumptive viral cause of AIDS. While Montagnier is generally credited with priority in this discovery, Gallo is regarded as establishing the science which led to this virus' identification and scientific 'portrait.' The discovery and identification of HIV continues to have far-reaching effects on the treatment of millions of AIDS patients worldwide and research on the development of retroviral vaccines in general. Albert <strong>Einstein. </strong>A<span></span> German-born theoretical physicist, Einstein is perhaps the ultimate example of an individual working by himself to achieve an extraordinary scientific discovery. Employed as an examiner in a Swiss patent office, personally out of touch with the physics community, in 1905 he published a paper in the German journal, Annals of Physics (Annals der Physik) on the "Special Theory of Relativity," in which he speculated that small amounts of matter could release vast amounts of energy, according to his accompanying equation, E = mc2 . Einstein's monumental discovery changed not only the world of physics and mathematics but has had lasting and unabating ramifications on the worlds of social, scientific, political, ethical--and even religious--thinking and institutions, and continues to have effects on the current world of particle physics (cf. CERN's "Large Hadron Collider").<br /><br />As many of you know, I , myself, may have reason to understand the contribution that single investigators, working alone, have made to the march of science, because of my discovery of the biochemical (i.e., thermodynamic) mechanism of cancer cachexia, the weight loss and debilitation seen in late-stage cancer, which accounts for 73 percent of all cancer deaths. But I would like to relate an incident which occurred long before then, which was to acquaint me with the importance of but a single individual to the progress of medicine.<br /><br />Just having received my M.D. degree as a 26-year-old in May 1956, I found myself, two months later, as a post-doctoral research fellow in the Department of Physiological Chemistry at the University of California School of Medicine at Berkeley, as a result of winning a U.S. Public Health Service Post-Doctoral Research Fellowship. In this department where I spent half-time (the other half was spent across the bay in San Francisco, in clinical medicine) my immediate milieu was a sea of Ph.D.s and graduate students who did not exactly appreciate an M.D. in their bailiwick. M.D.s are in general considered a waste of time--and sometimes not too bright--in a basic science department, since most would go on to practice clinical medicine. My boss, and department chairman, renowned biochemist David M. Greenberg, however, was very kindly and encouraged me in scientific directions he thought would be most helpful. In my experimental work I needed a key biochemical, essential to energy metabolism in cancer and normal cells, glyceraldehyde-3-phosphate, G3P for short. The only trouble was none was commercially available. Fine biochemical companies advertised they would custom synthesize it in gram quantities at $800 per gram (a very large sum at that time), but would not guarantee its biological activity. Frustrated, I apprenticed myself to a famed sugar-phosphate biochemist (professor) on the Berkeley campus, who himself had synthesized G3P by a complicated multi-step organic synthesis, including a hydrogenation over palladium, which (if done wrong) might "blow up" the wing of the building in which the hydrogenation apparatus was located. I tried this 10-step organic synthesis, each step starting out with large amounts of material and ending with much smaller amounts. The "synthesis" took me over a month, and when I was finished I ended up with gram quantities of useless "crud." I was sure I could not obtain G3P by this method--no matter<em> who</em> synthesized it. But I thought about the situation. And suddenly it occurred to me that I could start out with a chemical "skeleton" of G3P and in a single, one-step <em>in</em>organic synthesis--if it worked--I could open up an epoxy bond with common sodium dihydrogen phosphate (NaH2PO4) and obtain more, 100 percent pure, 100 percent biologically active G3P overnight than had ever been seen before. And that's the way it turned out. The sugar-phosphate chemist (full professor) under whom I apprenticed myself for a short time, was not happy to hear of this achievement. But my department chairman, Dr. Greenberg, was and encouraged me to make application for a U.S. patent on it after obtaining the University of California's consent for me to do so and the concurrence of the Surgeon General of the United States. In a short time the price of G3P tumbled from $800 per gram with no guarantee of biological stability or activity to under $20 per gram with full guarantee of biological stability and activity. (And in a few years I <em>did</em> receive a U.S. patent on this process.) In the intervening 50 years since then and now this very same material has sponsored countless research projects, opening a door to the investigation of energy metabolism that had been previously shut tight. And teaching me--even at a young age--about those who would control the politics and purse-strings of biomedical research.<br /><br />Returning to the AACR advisory on its plans for the SU2C funds, not only is this advisory inaccurate and incorrect, implying that true scientific achievement would be more likely the result of "collaborative" efforts of scientists "working together," rather than the individual efforts of scientists working by themselves, but the advisory stresses the team-approach to be of potentially greater value "than competition." But competition is the <em>heart</em> of creativity. And scientists in competiton with one another have frequently cracked the code of discovery. In the above list of those who were innovators of great discoveries, Salk and Sabin were in <em>competition</em> with one another, each turning out to make great, <em>individual</em> contributions, one an oral vaccine, the other an injectable. Watson, Krick, Franklin and Wilkins were all <em>competitors</em>, racing to see who would be first to decode the mysterious structure of DNA. Gallo and Montagnier contended vigorously with one another, even instituting lawsuits to determine who was <em>truly </em>the discoverer of HIV.<br /><br />After extolling the "collaborative" approach of the "best and brightest" scientists from "leading institutions" around the world "working together," the AACR advisory also states the following: "A portion of the [SU2C] funds raised will also support innovative, high-risk, high-impact, research grants, many of which will fund talented young investigators who are driving cutting-edge research"--i.e., individual investigators. Are these the truly gifted, young investigators that the <em>MedTruth</em> blog, "Is Bigger Better?" spoke of, those "whose ideas may be 'outside' current cancer concepts--whose scientific thinking may harbor the truly great discoveries to come?" Who magically cannot seem to have their grant applications approved or funded?<br /><br />"A portion" of the funds going to these "talented young investigators" reminds me of an incident that occurred in the early 1990s. My wife and I were at the annual scientific meetings of the AACR, at which I was to give a paper on the second day of the 4-day meeting. Usually, on the first evening of the conference the AACR holds a "Mixer," open to all registrants of the meetings, the purpose of which is to have the newly elected members--and the newer members in general, including its younger attendees--meet the senior members of the AACR. That was the case in 1957--when I was young attendee at my first AACR conference; at the Mixer I personally met such well known and accomplished scientists as Charles Heidelberger, Sidney Weinhouse, Dean Burk, George Weber and others. But--strangely--at the Mixer in the early 1990s, there were no senior scientists to be seen. The Mixer took place in a very spacious hall, in which there were hundreds of young and unfamiliar-looking individuals milling about--but none of the AACR officers or its more prominent members I had come to know. And in contrast to earlier years when the hall contained all types of refreshment and drinks, at the present Mixer there were only a few stations containing potato chips, and a corner cash-bar where one could purchase cold drinks. But my wife is a "coffee-holic," and she expressed to me, "There's not even a hot cup of coffee here." After saying hello to some old friends we left for the hotel lobby. But our elevator "inadvertently" left us off in a sub-basement. We were about to re-enter the elevator when my wife said, "Wait. I smell coffee!" We found ourselves walking down a corridor full of overhead pipes in the direction from which the smell of coffee was coming. And suddenly trays of hot food appeared from kitchens to the right side of the corridor being wheeled across the hallway to a very large banquet room to the left side of the corridor. Echelons of waiters, all carrying hot foods on enormous trays above their heads were entering this banquet room. And it was obvious the smell of coffee was emanating from this room. My wife and I peeked into this room---filled with large white linen-covered tables, around each of which were ten people, many of whom were in formal attire. About 200 people were seated around these tables. But--suddenly--I recognized one of the faces--then another--then another--and then many! It was a banquet for the "senior" members of the AACR. The mystery was solved. While the younger and newer members of this organization were milling about upstairs at the Mixer, imbibing potato chips and cold beer, my wife and I had stumbled onto an exclusive gathering (unlisted in the Program) for the AACR's senior membership. Later I learned that the AACR itself had paid (from its general funds) for this gastronomic feast.<br /><br />As alluded to previously, even at a young age my research projects had placed me in a position of an early understanding of the politics and funding of biomedical research. And as illustrated by the above incident of the AACR banquet for its senior membership, the AACR knows how to take care of its own. Over the years I have become acquainted with the words and language--with the catch-phrases and code-expressions--large-scale cancer research organizations use in communications with each other and in their dispatches and communiques to the public. The AACR states "a portion" of the SU2C funds will go to "young investigators"--the very people who find it so difficult to get grants for their ideas. But the advisory doesn't specify how much--how much of the $100 million will go to these frequently gifted individuals. But let us now look at the initial emphasis and predominant verbiage of this advisory. The phrases "most promising research projects," "collaborative efforts," "best and brightest," "leading institutions," "working together," "interdisciplinary and multi-institutional Dream Teams" do not speak of "young investigators" working alone, but of the 'ol' boys' (and girls') network, the senior makeup of large-scale cancer research projects, institutions and organizations who have always received the lion's share of cancer research funds. One can be sure that the predominant (SU2C) funds will go to these well connected, in this case "inter-connected," scientists--as they always have--the very ones who have sponsored the scores of discoveries at the laboratory level waiting to be "translated" to new treatments. The words "a portion" appear in this advisory almost as an afterthought, and clearly imply a minority of the SU2C funds. Even so, the language used indicates that this slim "portion" will support high-risk, high-impact research grants, "many of which"--but not all--"will fund young investigators."<br /><br />I have an alternative proposal for the AACR. One that holds real hope for progress in the cancer research world--for new discoveries. For new treatments. For new benefits for cancer patients urgently waiting. Let's use these funds--exclusively--for our "talented young investigators." Let's get young investigators--not the older, more "established" scientists, some of whom may in reality be hard-pressed to recognize new ideas--to sit on the peer-review committees. Let's use the $100 million to take all those grant applications from our younger people--that have not been approved, or approved but not funded--and take a second look.<br /><br />The <em>Stand Up 2 Cancer</em> funds raised could indeed have high impact, not funding collaborative-type research--where the whole is hoped greater than the sum of its parts--but going exclusively to those who are willing to work alone and test the new ideas which have germinated in their young minds.Dr. Joseph Goldhttp://www.blogger.com/profile/00368001273179577986noreply@blogger.com5tag:blogger.com,1999:blog-1335007907715618966.post-59220665760383230342008-08-15T11:17:00.000-07:002008-09-05T08:49:28.165-07:00Cancer and obesityThis blog is a commentary on truth in medicine and thus it would not seem apropos to discuss truth or its lack in terms of cancer and obesity--both exist, both are "true." But perhaps a deeper truth can be found in both topics--one that is not readily apparent: Is there a similarity between the two? Cancer is overtaking heart disease as the number one cause of death in this country. And obesity is rampant, spreading as the number one health hazard both in this country and around the world.<br /><br />Cancer is said to be more than one disease--to result from many different causes. There is the genetic cause--cancer results from mutated or damaged genes, which can then be transmitted to (inherited in) succeeding generations. Cancer results from abnormal metabolic processes--which <em>MedTruth</em> has already indicated to be the case in cancer <em>cachexia</em>--the weight loss and bodily debilitation seen frequently in advanced disease, which is the major cause of death in cancer (73 percent of all cancer deaths) and treatable by the drug hydrazine sulfate. Cancer results from chronic, poor nutrition. Cancer results from inflammatory tissue reaction. Cancer results from physical trauma (bodily injury). Cancer results from (excess) radiation exposure--medical and 'background.' Cancer results from psychological trauma--following an unexpected breakup in relationships, the loss of a business partner, the death of a loved one. Because cancer has been indicated to result from so many different causes, it has been said to be many different diseases, not one--and thus not prone to a single solution. This consideration has prompted some cancer scientists to express, "There is no silver bullet for cancer," meaning there is no single treatment that will be curative for all types of cancer.<br /><br />But this doesn't reflect current activity. All cancer centers, all cancer research efforts, all cancer research investigators--are trying to discover a single remedy that will treat all kinds of cancer. Cancer researchers recognize that while many different 'stimuli' will produce cancer, that the disease in various organ systems--no matter what the immediate cause--has certain characteristic similarities and just because we do not know its basic underlying cause does not mean that we will not one day find it and thus come up with a single treatment that will be effective in all cases.<br /><br />The same may also be the case for obesity. Obesity has many different causes: 'glandular,' metabolic, genetic, calorie balance, nutrition, lifestyle and others. Thus while many people attribute obesity to caloric intake alone, this is clearly not the case. While increased caloric intake must necessarily--from a thermodynamic point of view--accompany most cases of obesity, obesity can result in the face of "normal" or sometimes even "subnormal" caloric intake. Like cancer, obesity seems to be many 'diseases'--to have many causes. But like cancer, can it also have a common, underlying cause--one that is pertinent to all cases--but one which we have simply not yet discovered?<br /><br />In geometry there is a theorem: things equal to the same thing are equal to each other. If cancer, which is said to result from many causes, has in reality a single, underlying cause--which we have not yet identified--can obesity, which is said also to result from many causes--in reality also have a single, underlying cause--which, again, we have simply failed to identify?<br /><br />Much effort is now being expended to find a single cause for cancer. Hardly any effort is being expended to see whether indeed this "twin" condition under discussion may also have a unifying theme. Therefore this blog will examine obesity--to see whether a deeper truth in medicine may exist to account for this growing world problem.<br /><br />It is expected that the 'soluton' to cancer will involve physical--biochemical, biological--mechanisms that will account for tumor growth, for abnormal tissue formation and invasion into normal bodily tissues and glandular elements, especially in view of this disease's multiple manifestations. Obesity, too, has multiple manifestations--'causes'--but because obesity also must necessarily involve 'choice'--the excess intake of calories in most cases--a 'solution' to this problem may well reside in, and therefore yield to an examination of--the psychological realm.<br /><br />A first question to arise is, Do people who are overweight know they're overweight? By "people" is meant the majority of people. We cannot ever achieve 100 percent when we talk of people who may carry excessive weight--but we can speak of at least 70 percent to 95 percent. Do people who are overweight actually know they're overweight? The answer must be a resounding 'yes!' The mirror tells them they're overweight. Social situations tell them they're overweight. Their own eyes tell them they're overweight. This question in no way addresses whether they care they're overweight--merely the knowledge that they <em>know</em> they're overweight.<br /><br />Do people know that being overweight is associated with a multitude of health problems--high blood pressure, diabetes, heart disease, among many others--which can result in severe illness and/or severely shorten life expectancy? Television broadcasts, frequent articles in the print media, visits to their doctors' offices emphasize these life-limiting complications at every turn. Therefore the answer to this question is that people who are overweight know--are frequently informed--that being overweight is not good for them.<br /><br />Thus people who are overweight know they are overweight and that being overweight is destructive of their health. That is, being overweight is a self-destrutive election on their part.<br /><br />Do people who are overweight like being overweight? This is not a simple question, for some maintain that people basically do what they like to do--that a person who is overweight <em>likes</em> to be overweight. But with the large numbers of dieters striving to lose weight, the nationwide diet support groups, the diet foods on grocery and specialty-shop shelves, even the in-hospital diet programs, there is no doubt that the vast majority, even those who may "like" being overweight--do NOT like being overweight. Thus whether a 'psychological ambivalence' to this queston seems to exist is immaterial, in the face of the vast numbers of dieters seeking to lose weight.<br /><br />Another aspect to this same question is, Do people get pleasure eating?<br /><br />People must get pleasure in life. In their activities. In their strivings. In sexual expression. In their interpersonal relations. Even in masochistic outlets--in physical and psychological harm done to them by others. No matter what the orientation or circumstance--the hermit immersed in the psychological cave of darkness, the child trapped in the vise of familial poverty, the socially advantaged whose overindulgence of appetites has led to spiritual dissolution--the inner urge for pleasure remains as a rock-bottom part of the human condition.<br /><br />I often have lunch at a cavernous restaurant--dozens of substantial tables and chairs, many booths--that serves good food in quantity and at fair prices. From a table in the middle of the restaurant one can view the front glass doors--which at that time of day hardly ever have time to close completely, due to the plethora of diners entering and exiting. Making their way into this restaurant at meal times is a cross-section of humanity--the old (some in wheelchairs), the young, those in-between--in business suits and jackets, in dresses and skirts, in leisure clothes, many in shorts and flimsy tops or sweatshirts, weather permitting. But what is outstanding about the mass of humanity entering or exiting is their weight. Many are carrying an extra twenty-five to fifty pounds. Some, more than a few, are frankly--frighteningly--obese. The men are sheltering up to 100 pounds or more above their belt lines, some with their abdomens hanging below their waists. The women are storing excess weight in all parts of their bodies, their legs, arms and other parts of their anatomy stretched by layers of 'cellulite.' Children, whose outlines appear to be puffed up like balloons, follow in their family's footsteps. In many instances the adults are so obese that they tip while walking or actually use assistive devices--canes--to walk. Observations inform us immediately that this overweight is not 'gender-specific'--men, women (unfortunately many children) are caught up equally in this 'epidemic.' If one bothers to do an informal 'count' on those entering the restaurant, it seems that two out of three are carrying excessive amounts of weight--and half of those (one out of three) are frankly obese.<br /><br />When those overweight people are seated at tables and their meals delivered, in many instances their plates are laden with food, and are cleaned totally--even the children's.<br /><br />Do people get pleasure eating? Yes they do.<br /><br />At this juncture it is apparent that people who are overweight <em>know</em> they are overweight, <em>know</em> that being overweight is destructive of their health--will make then ill, prevent them from full participation in life, shorten their lives--that being overweight is a self-destructive choice on their part. And that people gain pleasure in eating. While at first glance it may be thought that pleasure gained in eating offsets the destructive elements of overweight, it actually <em>reinforces</em> them, acting as the 'mortar' that helps keep the edifice of self-destructiveness in place. One can see at a glance that despite diet programs and diet foods and diet support groups and media promotion of dietary success stories, these measures are doomed to failure, for they do not address the fundamental <em>election of self-destruction</em> inherent in overweight. That is, despite knowing they're overweight and knowing that overweight will substantially cripple their physical and psychological lives, despite the existence of self-help groups to reverse and rectify this condition, people still choose to maintain this mode of destroying the self.<br /><br />Why?<br /><br />Is there a relation between overweight and self-esteem? A connection? Can people with self-esteem be overweight? How can people who 'admire' the self carry excess weight to the point of bodily distortion? How can people who 'admire' the self engage in a 'process' that leads to destruction of the self?<br /><br />But that is too easy. Because 'self-esteem' can be based on both physical and psychological considerations. Can people who are 'pleased' with their psychological development, intellectual and artistic, ignore the destructive process they are imposing on their bodies by overweight, processes that will shorten their life spans--and still remain 'pleased' with themselves?<br /><br />What determines self-esteem? Self-esteem involves contemplation of the self--our overall <em>raison d'etre</em>--our 'reason' for being in this world. We all think about this--both consciously and unconsciously--continuously. From childhood into adulthood. Why have we come into life? Is there a purpose in life? Do we have an individual purpose in life? Are people endowed with purpose?<br /><br />It is commonplace to see the smiles and the expression of joy on even the smallest of infants--as they contemplate their surroundings, their parents and/or caregivers. This joy expressed by children--is the joy to be alive. The realization--amorphous at first, more finite with the passing years--that life is the greatest gift of all. That to each of us is given a "sense" that our individual life--self--is "special." That individual life is special. That this sense of "specialness" makes us what we are. That as long as we retain it, it will act as our internal gyroscope and will "validate" the life we have been given. The early nineteenth century landscape painter (especially of the Hudson River Valley), Thomas Cole, in his four-part masterpiece, <em>The Voyage of Life</em> (Munson-Williams Proctor Museum, Utica, New York), allegorizes that each life has 'magic' and in the second panel of his four-part painting he depicts "youth" reaching out to attain the 'magic' of life. This magic is none other than our "purpose" in life. Our individual purpose. That as long as we continue to develop the self within us--our hopes, dreams, aspirations--the individual magic with which we are endowed will be retained. (This development of the self is to be distinguished from "selfishness"--the aggrandizement of the individual over other individuals for the purpose of harnessing their power and wealth.)<br /><br />But we have given up living for our selves--living to express our individual purpose. Living to fulfill our "contract" with life.<br /><br />Instead we are increasingly being told that our "purpose" is to live for someone else. The purpose of the self--is to serve other people's selves. Whether the Communistic theme or the altruistic theme, we have been duped into giving up our integrity, our "specialness," our individual "purpose" in life.<br /><br />Once we have done that, anything goes--our inner 'gyroscope' is gone. We have closed the door to preservation of the self. Self-destruction, in all its forms, sets in. And we are powerless to overcome it, for it is, in more instances than not, "frozen" in our unconscious.<br /><br />We become adrift. We are afloat with the tide. We are in search of "finding ourselves." But the 'self'--our inner "essence"--is missing. It is gone. We have given it away. We know that overweight is destructive to our health, but we seem powerless to do anything about it. And the more we seem to try, the greater the problem becomes.<br /><br />Can the loss of purpose be reversed? Yes, it can.<br /><br />There are generally two ways to change our lives--redemption and reclamation.<br /><br />When we perceive we have been on a wrong track, many times we try to do things that will "make up" for our wrong moves. We try to "redeem" our shortcomings, or what we perceive "must be" a defect in our make-up. Very often we do "volunteer" work, something we hope will result in the public, or private, good--as it usually does. Or church work, or temple work--the promotion of religious values. Join organizations for the disadvantaged, for the promotion of world peace, etc. But these redemptive measures--while serving potentially very constructive aims in society--cannot restore the 'magic' or "specialness" to the personality that loss of purpose has exacted.<br /><br /><em>Reclamation</em>, however, can. We can "reclaim" at least part of our lost sense of purpose by revisiting old hopes and dreams and aspirations long ago abandoned (because of their anxiety content), long ago given up. But still beckoning to us. Still "open." Still sometimes flitting into our consciousness.<br /><br />We can revisit one of these "open" longings--"scary" as it might be to do so. We can pursue a direction long ago cast aside but promising soul-deep satisfaction. Not for "mom and dad." Not for "hubby or wife." Not for the sake of our children--or of society. Not for the "greater good." But for ourselves.<br /><br />We can confront those privately cherished, long given up goals one at a time, and if we work hard enough, then we will find we are successful in the 'reconstruction of the self,' and our need for self-destruction will diminish. And if we are overweight, chances are our overweight will diminish, too, without any specific measures taken.<br /><br />Once we have been successful in "reclaiming" a single 'tableau' in our life that we had let slip by, it will be easier turning to another, then another. If we are successful in our efforts to face up to the poor decisions we have made in life--the ones that have markedly abridged what we have always known to be our inborn potential--the door to preservation of the self will once again open, and self-destruction, in all its manifestations--including overweight--will be chased away.<br /><br />Regarding cancer, it will not be easy finding its single underlying molecular cause or causes, but once we do, we have a real hope of conquering the disease.<br /><br />Regarding obesity, if indeed a loss of 'self' or 'purpose' is the basic 'cause' underlying this growing, worldwide illness, it, too, can be conquered. It will require courage, discipline and determination.Dr. Joseph Goldhttp://www.blogger.com/profile/00368001273179577986noreply@blogger.com0tag:blogger.com,1999:blog-1335007907715618966.post-32032794728686341042008-06-17T08:21:00.000-07:002008-06-20T07:14:05.139-07:00QuackeryQuackery is defined as the fraudulent pretension to medical skill, in which the practitioner of quackery, often referred to as a charlatan or imposter or quack, <em>knowingly </em>gives or prescribes inaccurate or inappropriate or false or deceptive medical information or treatment, for the purpose of making money. The quack often takes advantage of the medical ignorance of his "patients" and of the confidence they have come to build up in him.<br /><br />The term <em>quackery</em> can apply to a host of different situations, but there is an overall definition which applies to all: namely, that quackery is the practice of intentionally dispensing false medical information to those seriously ill, or not ill at all, for the purpose of acquring wealth.<br /><br />There is no doubt that the practitioner of quackery must be regarded as a reprehensible human being in today's society--despicable, loathsome, odious, repugnant--a vampire, eager to squeeze the last dollar from a patient's illness or his/her yearnings for better health.<br /><br />However, there are two types of quackery: authorized and unauthorized. It is the unauthorized kind that we commonly talk about when we speak of quackery: the snake-oil salesman, the purveyor of fake nostrums that purportedly cure all ailments from "dementia" to sexual inadequacies. Illustrating this kind of quackery is Pope Brock's new book <em>Charlatan</em> (Crown Books, 2008), detailing the case of John Brinkley who during the first half of the 20th century established clinics across America for surgically implanting goat's testicles in men to restore "sexual vigor." Brinkley, who received a medical degree, became enormously wealthy, dying in 1942, before he could be brought to trial on charges of mail-fraud.<br /><br />Today there are legitimate, well-credentialed doctors who act as "quackbusters." These doctors attempt to alert society to the dangers of what they perceive as "quackery" and who they perceive as "quacks." However, the targets of these "quackbusters" often turn out to be legitimate, well-credentialed physicians or scientists themselves who have come up with unconventional or unpopular (to the medical establishment) treatments. Illustrative of these quackbusters was the late, well-known physician (and attorney) Victor Herbert, M.D., J.D. Herbert, often declaiming against the use of vitamin treaments as part of conventional medical therapy--he called this "quackery"--was himself the target of lawsuits alleging incompetence, malfeasance and professional misconduct (<em>Racketeering in Medicine</em>, J. Carter, 1993).<br /><br />As detailed in a front page article from a recent Sunday edition of <em>The New York Times</em>, "Cancer doctors are pocketing hundreds of millions of dollars--often the majority of their practice revenue...by selling drugs to patients--a practice that almost no other doctors follow....Typically oncologists [cancer doctors] buy chemotherapy drugs themselves, often at prices discounted by the drug manufacturers trying to sell more of their products, and then administer them intravenously to patients in their offices. They can make huge sums...from the difference between what they pay for the drugs and what they charge for them, a practice known as the 'chemotherapy concession'....The practice creates a conflict of interest for these doctors, who must help patients decide whether to undergo or continue chemotherapy if it is not proving to be effective....The [chemotherapy] concession [i.e., the profit motive] may lead some doctors to recommend chemotherapy when patients may not benefit. In a 2001 study of cancer patients in Massachusetts a team of [National Institutes of Health] researchers found that <em>a third of those patients [in the study] </em><em>received chemotherapy in the last six months of their lives. even when their cancers were considered unresponsive to chemotherapy</em>" (emphasis added). Some doctors argue that their motivations for this practice are not money, but solely "to provide patients a chance, no matter how slim, of living longer or suffering less." But use of chemotherapy in unresponsive patients is known to frequently result not in longer life or suffering less, but in shorter life and <em>greater</em> suffering and sometimes abrupt death. " 'All the evidence suggests that doctors do respond to money,' " Dr. Susan D. Goold, a professor at the University of Michigan School of Medicine states in the <em>Times</em> article.<br /><br />But treating hapless (late stage, unresponsive) patients with known, useless therapy--and gaining wealth therefrom (the chemotherapy concession)--isn't that the exact definition of quackery? To the extent that cancer doctors recommend that advanced, refractory patients with only a short time to live undergo or continue ineffective chemotherapy (one-third of even study patients)--with the profit motive in mind--these doctors cannot be told from their more aggressive and obvious "brethren" selling ineffective nostrums in order to gain wealth. Nor is this practice, filling the exact definition of quackery, without harm. Frequently enough cytotoxic chemotherapy given to patients with but a short time to live results in their untimely deaths. In the United States alone there are thousands of authenticated chemotherapy deaths annually. (One of these was Jackie Kennedy, wife of the late president John F. Kennedy, who reportedly received chemotherapy in the very advanced states of lymphoma, dying shortly--within days--thereafter.)<br /><br />Thus there is a second type of quackery--one that I term 'authorized' quackery. Less recognizable and more socially accepted than the 'flim-flammery' of the nostrum peddler, it is every bit as diabolical. And that is the practice by physicians--many upstanding and well-credentialed--of recommending and instituting treatments known to be useless and ineffective in certain cases, but for which the physician knows he will be well compensated. He imparts 'confidence' to the patient, 'hope' to the family when he knows that the only certain outcome--his true motivation for recommending the treatment--will be a gain in his own wealth. We don't call that quackery. We call it 'courage.' We call it 'heroic.' But it is quackery.<br /><br />Are there other types of physician-induced medical treatments--where the treatment is useless, ineffective or not necessary, and not without harm--that are done with only a fee in mind? To name a few: hysterectomies, physician-run vitamin mills ("every patient who comes through my door gets a B-12 shot"), tonsillectomies, mastectomies ("they took my breast--but thank God it wasn't cancer"), breast augmentations, lobectomies, prostatectomy "factories" ("I'm moving my urology practice to Florida--where there are lots of old men with money"). The list is endless. For there is hardly a medical or surgical procedure that is not infrequently recommended and performed with only a fee in mind.<br /><br />The question is: Which is quantitatively greater in our society? The occasional hawker of fake nostrums? Or the purveyor of unnecessary, useless, ineffective, sometimes harmful medical or surgical procedures? Which causes more economic chaos, more disappointment, more personal heartache? The easily identifiable snake-oil salesman? Or the pharmaceutical or medical pitchman invading the cavities of our minds and our pocketbooks? The 'unauthorized,' unlicensed quack? Or the licensed 'pillar of society' knowingly recommending and performing useless, unnecessary procedures for the sake of accumulating wealth? I think you will find that the John Brinkleys of today's society are a drop in the bucket compared to the 'authorized' medical fraud perpetrated by elements of our medical establishment.<br /><br />For the above reason it is almost preposterous for a doctor to hang a sign on himself as an "expert" exposing the "quackery" of "others" without calling attention to the medical fakery of fellow physicians.<br /><br />And it is almost obscene for the professional "quackbuster" to single out as "quacks" those who are the innovators of new treatments--new directions in medical research and management--almost anything that changes/upsets the medical status quo. Historically scientists and physicians who are the heroes of tomorrow's medicine are routinely labeled as "quacks" in the early part of their careers.<br /><br />Those who don the garb of professional "quackbusters" are in reality dangerous elements to our society who, under the 'window dressing' of protectors of society are in actuality more frequently the agents of unspeakable harm to medical progress, managing in their usually long careers to clip the wings of many birds before they can fly.<br /><br />My advice is to run from these beastly individuals. From those who have taken their careers in medicine--their many long years of arduous study and training--to become little more than beacons exposing fraud from without the medical profession without beaming their lights on the medical profession itself.<br /><br />Even books like <em>Charlatan</em>, interesting and historic as they are, serve to divert attention away from the quantitaively greater "quackery" that confronts society today--not the outlandish implantation of goat testicles in human beings to restore their sexual vigor, but that accomplished every day in the recommendation and performance of thousands of useless, unnecessary, ineffective medical procedures by avaricious, money-obsessed individuals within the medical profession itself.Dr. Joseph Goldhttp://www.blogger.com/profile/00368001273179577986noreply@blogger.com4tag:blogger.com,1999:blog-1335007907715618966.post-78391591273035071372008-05-08T07:16:00.000-07:002008-05-09T11:46:14.523-07:00The euphemistic opposite"People often use words in a loose way that covers over what they're talking about. I like to choose words that get to the basics."<br />--<em>Michael DeBakey, M.D.</em><br /><br />Webster defines <em>euphemism</em> as the "substitution of a mild, indirect or vague expression for one thought to be offensively harsh or blunt."<br /><br />Today we have in the field of medicine many expressions and slogans I have dubbed "the euphemistic opposite"--which detail a rosy picture so far as actual or anticipated progress and advances are concerned, but which in reality hide just the opposite. The public image is for the hoped for advances. The reality is often the hidden--"offensively harsh"--opposite.<br /><br />This subject brings to mind the well-born, clueless son who approaches his father wearing a new naval officer's hat and a navy blazer decorated with gold-threaded anchors and other seafaring insignia. He points to his cap and says to his father with sincerity: "Look, dad. I've bought a boat. I'm a captain now!" The father looks over his son, his new naval blazer, his gold-trimmed officer's cap. "By your friends," he answers his son with equal sincerity, "you're a captain. By your family, you're a captain. By your business associates, you're a captain. But by a captain, you ain't no captain!"<br /><br />So it is in the field of medicine. We are bombarded by ads, slogans, sayings, expressions, catch words which are geared to make us think that inherently desperate--"offensively harsh"--situations are about to yield their secrets, to give (or are well on their) way to solution. These catch phrases work by implication. The phrases <em>imply</em> that great progress has been made--and there is only a <em>little way left</em> to go. That only <em>simple</em> <em>measures</em> are now needed to result in the complete solution of a complex, mind-shattering problem. That it is within the reach of human beings to at last draw the curtain on devastating disease. "Race for the Cure," the registered trademark of the Susan G. Komen Breast Cancer Foundation, is one of these phrases. This phrase has many implications. It states that much progress has already been made in breast cancer. That humans can pay money and enter a race--that can result in the complete eradication ("cure") of this disease. That it is the "money" that individuals contribute in entering the race that can make a difference in whether this disease gets cured. That the cure to cancer in general may be imminent. But the reality is that this year 200,000 American women will be diagnosed with breast cancer--and over 40,000 will die from this disease, the same as in previous years. As in previous decades. The reality is that the moneys raised in these "races" and "relays" and "walkathons" and "marathons" and "bike-athons" are but a drop in the bucket compared to the overall funding annually earmarked and available for breast cancer in this country--and guess what?--the reality is that much of these moneys find themselves in the hands of the same old scientists and researchers, who sit on the same old federal and large private-sector granting (peer-review) committees of our cancer agencies, frequently for the same old projects or variations thereof. These events--and their slogans--thus occlude with rosy expectations the grim reality of what prevails--the lack of significant progress, despite available funding. However, the moneys raised by these events--by the hundreds of thousands of people who enter these races countrywide--do serve a purpose, in some instances converting their sponsoring organizations to financial powerhouses.<br /><br />Another example of the euphemistic opposite are the ubiquitous ads--calling attention in all cities to the advantages of one hospital over another for one purported medical reason or another. In Syracuse, New York, for example, the State University Hospital frequently advertises, in newspapers, on buses, on radio and television that it makes the "academic difference"--that it is part of a state medical center, with a medical school, that its departments are peopled by "professors" and an academic house staff--and therefore its medical services are "superior." But the reality is that this hospital was recently cited by the state Health Department as having the highest death rate rate for angioplasty--a common operation that clears out blocked heart arteries--between the years 2003-2005 of any hospital in New York state. And this hospital was cited as having the highest risk-adjusted death rate following <em>all</em> cardiac surgery again in 2005--double the average--of any hospital in New York state. The "academic difference?" Superior services? Again, it is the euphemistic opposite that prevails. It is not that these hospitals want to extend to you in these ads and slogans a better level of treatment. It is simply that they want your money and are willing to lure you in by any means. It is the moneys that this--and similarly inclined hospitals around the country--are trolling for by putting out slogans such as "A Winner of the Conusmer#1 Award."<br /><br />Another type of ad illustrating the euphemistic opposite which appears with surprising frequency, is the all-female <em>oncology team</em>--surgeons, oncolgists and others--specializing in the treatment of breast cancer. Frequently this ad emanates from moderate-to-large size hospitals which may or may not have a separate oncology unit, and contains the pictures of the various individual--usually young and attractive--doctors making up this all-female team. Their expressions are uniformly hopeful, cheerful, smiling and competent. The ad implies that female doctors better understand and better treat women with breast cancer and extend to them more compassion, as a result of which patients with this disease will have a better chance of cure. The ads also frequently state that "no better care and treatment" are available elsewhere in the country. The primary euphemistic opposite of the ads is the premise that because of gender, female doctors can better treat women with predominantly female cancers. Nowhere is mentioned skill and experience of individual surgeons, oncologists and other cancer specialists. It is implied that treatment benefit will accrue as a result of <em>team treatment</em>, rather than individual expertise which is not a function of gender but of training and experience. And it is stated--falsely--that no better treatment for any type of breast cancer can be obtained anywhere, even in the nation's primary cancer centers, than in these small enclaves. The purpose of these implications and assurances--of these outstanding examples of the euphemistic opposite--is not to offer women with breast cancer better treatment options--but money. To attract as many female patients as possible with this high-incidence cancerous disease--and the expected large sums relating to breast cancer treatment and testing--to these hospitals, for the purpose of contributing to the financial vigor of these medical institutions and their successful fiscal operations.<br /><br />Another type of euphemstic opposite--frequently seen and heard on radio broadcasts, in headlines, on nightly network news telecasts--is the 'medical breakthrough.' Commonly in the field of cancer, these news stories detail exciting developments that will herald promising new treatments for those seriously afflicted with disease. But where are they? Where are these new medical treatments that will markedly indent cancer and other diseases? How do these 'breakthroughs' get on television? And in our newspapers? The answer is that they are put there--by hired medical publicists or skilled public relations people. But, then, if not to herald new treatments, why the publicity? What is their purpose? The answer is 'money.' If one looks carefully enough, the publicity for many of these 'breakthroughs' occurs at the very time the medical groups responsible for them are being considered for a major grant from the federal government (National Science Foundation, National Institutes of Health, etc.)--or a branch of the federal health establishment (National Cancer Institute, for example) is petitioning Congress for increased budgetary allocations. Thus, while the 'hope' generated by these broadcasts and attention-getting news stories so often vanishes, their underlying 'dynamics' succeed. For the reasons behind these broadcasts and headlines frequently have nothing to do with real innovative advances, but with exerting public pressure on <em>funding mechanisms</em> to increase the 'business' of medical research. Again--as in all medical euphemistic opposites--it is money that is the reason for these frequently dramatic and promising public disclosures. Although the 'big breakthroughs' fade, their 'big business' underpinnings remain.<br /><br />The euphemistic opposite tends to misinform the American people. To program the minds of countless individuals that all is rosy when it is not. To wrongly influence the judgment of well-meaning segments of our populations who contribute their time, energies and money in behalf of the slogans and ads--"there's only a little way left to go," "we're almost there..."--which daily explode around them, in the hope that their efforts will tip the balance "the rest of the way" toward effective medical treatments.<br /><br />If people were to understand that the exact opposite of their beliefs pertained--that regarding cancer and other serious disease we are not yet "almost there," we have more than just "a little way to go"--would they behave differently? Would their seeming complacency give way to constructive activism? Would they be capable of influencing our organizations, our government in a truly constructive manner--to use their concern and efforts and money and energies to really bring about change and effective treatments?<br /><br />Would they send a message to "Race for the Cure" and the "relays" and "walkathons" and "marathons" and "bike-athons"--and others--"Don't numb my mind with your slogans that a cure is just around the corner--then give my money to the same useless projects, to the same individuals who dole it out to the same scientists and researchers. And don't tell me how much progress you've been making. The only progress that's really been made is in early diagnosis, practically none in treatment advances. For God's sake my next door neighbor, 38 years old, just died of breast cancer--left three young kids. No different from ten years ago. I want my money and sponsorship to go to <em>brand new projects! </em>Maybe ones you don't even agree with--that are unpopular with your scientists. <em>We need new ideas!"</em><br /><br /><em></em>And to the medical centers 'trolling' for patients: "Don't try to lure me in to your hospital by telling me how 'good' you are, how you'll take 'better care' of me, how 'superior' your treatment services are to the other area hospitals--because you are part of a medical center, because your 'academic difference' increases the likelihood of my obtaining a good result, or for one reason or another, when there is nothing that distinguishes the quality of your medical services--when in fact during a segment of recent years you are the worst hospital in the community in simple cardiac procedures, when in fact during that same period you have the very worst risk-adjusted death rate in the state, double the average, for all cardiac procedures. And then you have the gall to advertize your hospital as the winner of 'Consumer Awards?' You'll have to do better than that. You'll have to get rid of your 'professors' and your mediocre house staff and others who slide along on your 'academic difference.' You'll have to hire and train real educators and real healers, those whose 'track records' are truly distinguished in their respective fields of medicine, who genuinely make a 'treatment difference.' Who truly make a medical institution great. That's what it'll take for me to be a patient in your hospital."<br /><br />And to the pictures (hospital ads) of the young female faces shining out: "Do you think I'm stupid enough to believe that because a doctor is a woman, she's able to treat my breast cancer any better? That because my case of breast cancer will be entrusted to a team of exclusively women doctors I will get a better result? More compassion? Are you kidding? That I shouldn't be concerned over who has the best reputation, widest experience, most expertise--surgeon, chemotherapist, radiation oncologist? Are you telling me that in this community there are no male physicians who qualify? Whose 'track record' in the treatment of breast cancer is outstanding, at least the equivalent of, perhaps far superior to any of his colleagues--male or female? I want the best surgeon I can find--the best chemotherapist, the best radiation oncologist. And I know they come in two sexes. There are no gender exclusives. When you can show me a picture of your breast cancer oncology team composed of doctors of both sexes--saying they are the best, the most qualified--then maybe I'll believe you. Maybe I'll really want to be treated by <em>that </em>team!"<br /><br />To the evening telecast news networks: "I know your science editors are experienced in the medical field, in some cases they are actually medical doctors. So how come they fail to do in-depth investigations of the stories they put forward almost every night? The 'advances' they talk about--turn out not to be advances at all. The 'promising new treatments' disappear. You never hear about them again. They talk about these new studies--in reputable medical journals. Do they actually read the studies and make scientific or medical jusdgments about them? Or do they just take the 'canned PR' that comes with the stories? When they recite a story sent to them by an important medical center or institute, do they first investigate these stories in detail before going on the air with them? To see if they're legit? [But the audiences of these newscasts do not understand the constraints these science editors are frequently under. They do not know that if a science editor refuses to accept a news story, say from XYZ university or cancer center, he may never get another one from them. And if it is an important university or cancer center--and the story has enough "juice" behind it--the editor who refuses to run it, no matter how competent or well known, might suddenly find himself out of a job.]"<br /><br />There is every reason to believe if these targeted populations--i.e., everyone--rebelled against these 'euphemistic opposites,' i.e., sent e-mails and letters to their sponsoring organizations, to the hospitals, to the medical centers, to the governement medical institutions, to the television and radio networks, to the newspaper and magazine conglomerates, saying "Enought is enough! No more slogans! No more telling it like it isn't!"--there could be a great change in the emergence and development of true advances and new treatments. If our granting organizations--pushed by the demand of countless citizens to reverse the dearth of signifcantly beneficial medical treatments--said, "Let's look over the grant applications of well-qualified scientists and doctors who were refused. Let's see if there were something in these applications we've overlooked. Ever hear of Jane Doaks? I haven't, but look at her credentials--she's well-qualified. The idea she's put forward really outraged the peer-review committee. But you know, she's got a point. Maybe we should see how far she can run....And look at this one from Jack Smith. He doesn't even have his Ph.D. yet. That's why he was turned down. But look at his background. Entered university when he was 16. Bachelors at 19. Masters at 20. He'll only be 22 by the time he gets his doctorate. Maybe the committee shouldn't have acted so hastily. Maybe we should let him run with his idea. It's really way out! But, heck, he couldn't do much worse than we've been doing...."<br /><br />An educated electorate, an educated population, an educated citizenry who refused to listen to untruths, who demanded that those in charge of our medical research and programs turn their attention and energies and time and concern to new ideas, who demanded the reversal and dissolution of the euphemistic opposite in the field of all medical operations will get, as a result of their effort, new and effective treatments for all kinds of serious disease, and surprisingly swiftly.Dr. Joseph Goldhttp://www.blogger.com/profile/00368001273179577986noreply@blogger.com11tag:blogger.com,1999:blog-1335007907715618966.post-49757237790352452872008-03-26T08:03:00.000-07:002008-03-27T09:24:50.980-07:00The Jarvik affairIn July 2007 the blog "Ask Your Doctor" was published on <em>MedTruth</em>, a commentary on truth in medicine, describing direct-to-the-consumer pharmaceutical ads, in which a frequently well known pitchman (or pitchwoman) "beams" the benefits of the advertised pharmaceutical to a national audience, in a quest to snag as many of them as possible on the drug. The companies justify these ads by saying they are performing a service--giving information to the viewing public that may be of great benefit to their health. But, if you and the viewing audience do as told, i.e., "ask your doctor"--and many of them do--you might find yourself taking an expensive and unnecessary medication, incurring the risks of serious side effects or corrupting your relationship with your doctor who may be actually quite reluctant to put you on any more medications.<br /><br />However, other than the foregoing, there are many mistruths to these ads. The pharmaceutical advertised may not actually be as effective as portrayed. It may be more hazardous. The celebrity pitchperson, who usually says he or she is also a patient taking the drug--"and the reason I'm taking it is because I know the difference--you wouldn't think a person like me would take a dud--or recommend one to you--do you?" Even the background of the ads--country clubs, dances, social environments that only people in good health--and experiencing high-quality times--can partake of. But these ads can also deceive. Despite the celebrity spokesperson being a well known--even respected--individual, all of what may be said or inferred to the viewing or listening audience may be untrue.<br /><br />Just how much this deceit may be involved in these kind of ads was recently brought home by the televised and print ad campaign of Dr. Robert Jarvik.<br /><br />Dr. Jarvik, highly respected pioneer in medicine, was the inventor of the first working artificial heart to be used in human patients. In March 2006--as described in the February 8, 2008 and February 27, 2008 <em>New York Times</em>--he began serving as the celebrity spokesperson for an ad campaign by the pharmaceutical company Pfizer, in behalf of its top-selling, cholesterol-lowering drug, <em>Lipitor</em>.<br /><br />Now you would think Dr. Jarvik knows a lot about heart and cholesterol-lowering medications and would not lend his name to anything that is not absolutely true.<br /><br />During the first three months of the televised ad campaign--from March 2006 through June 2006--the ad depicts Dr. Jarvik rowing a racing shell--sculling--across Lake Crescent, near Port Angeles, Washington. In this ad Dr. Jarvik looks in his early 60s (he is actually 61) and the viewer has got to think: "He's in pretty good shape to be sculling in a big boat like that by himself at his age," and secondarily, "he knows what he's doing taking <em>Lipitor</em>." During the ad campaign Dr. Jarvik says: "I take <em>Lipitor</em>."<br /><br />But it turns out Dr. Jarvik was not sculling at all. It was a stand-in double. Seattle rowing enthusiast Dennis Williams. (His role as stunt-double for Dr. Jarvik was described in a newsletter published by the Lake Washington Rowing Club, of which he is a member.) Williams was used to confuse the television audience into thinking it was Dr. Jarvik whose apparent excellent physical health was somehow linked with his good judgment in taking <em>Lipitor</em>.<br /><br />But turns out also that during the first part of the ad campaign--at least during the first month--Dr. Jarvik wasn't even taking <em>Lipitor</em>. That when he was initially reciting the drug's benefits, he wasn't the recipient of them. Then what would propel him to be this drug's spokesman?<br /><br />$1,350,000. That's what Pfizer said it agreed to pay Dr. Jarvik as a minimum over two years for serving as celebrity spokesperson for <em>Lipitor</em>. Pfizer then revealed it has spent more than<em> $258 million</em> advertising<em> Lipitor</em>, most of it on the Jarvik ad campaign!<br /><br />During his ad campaign Dr. Jarvik additionally enthuses over <em>Lipitor</em> "as a doctor and a dad." This statement is true, however, only in the most general sense. While he is actually an M.D.--and actually a "dad"--he did not go through residency training and is not licensed to practice medicine or prescribe drugs. The inference ("as a doctor") that it is as a clinically experienced physician that he is recommending <em>Lipitor</em> is thus open to question.<br /><br />All advertising campaigns have a "director"--usually an advertising agency or public relations firm. But in the case of <em>Lipitor</em>, Pfizer did not hire one--but nine--high-powered advertising agencies or PR firms to make sure you, the public, do not escape Dr. Jarvik's message. The average John Q. Public of a national television audience is no match for nine advertising agencies, who have on their staffs some of the keenest psychologists, sociologists and swayers of public and personal opinion in the nation. In hiring these firms Pfizer is doing everything it can to compel you to act quickly and positively on its message.<br /><br />While we do understand that national spokespersons for ad campaigns such as for <em>Lipitor </em>are paid money for their services, we are loath to accept that a person such as Dr. Jarvik would use his considerable celebrity status simply to make money--and not necessarily believe the message he was disseminating to the public.<br /><br />If Dr. Jarvik had begun his campaign by stating, "The reason I'm saying this is that Pfizer gave me a lot of money to do so, not that I believe it--heck, I'm not even taking it!" would you believe his pitch? Would you rush out to get the drug? Would you besiege your doctor for it? If you knew Dr. Jarvik was the centerpiece of what would shortly become a quarter of a <em>billion</em> dollar ad campaign designed to make Pfizer a fortune, would that erode your confidence in Dr. Jarvik's message?<br /><br />If you knew it was not Dr. Jarvik sculling across Lake Crescent in that racing shell, but someone else made up to look like him, made up to look like someone in peak physical condition, would you think that good physical health was associated with <em>Lipitor</em>? If you knew that Dr. Jarvik knew that it wasn't he sculling across Lake Crescent--but let the public think otherwise--would you pay heed to Dr. Jarvik's message?<br /><br />If you knew that Dr. Jarvik let you believe he was on <em>Lipitor</em> while reciting its benefits--but actually was not--would the integrity of his message be altered for you?<br /><br />If you knew that although Dr. Jarvik holds a medical degree he is primarily an inventor, not a clinician--who is not licensed to practice medicine or prescribe drugs, who did not undergo clinical residency training--would you have confidence in his recitation of the <em>clinical</em> benefits of <em>Lipitor</em>?<br /><br />If you knew that nine experienced ad agencies or PR firms were conspiring against you in order to tip the balance of your thinking in favor of Dr. Jarvik's message, would you be more inclined to follow its advice?<br /><br />These questions reveal that the entire wording and visual depictions of this ad--as in many direct-to-the-consumer pharmaceutical ads--is composed of untruths. In this ad Dr. Jarvik is not sharing his knowledge of a drug with you out of the goodness of his heart or because it may be helpful to you--but because he is being paid to do so. Substantially so. Dr. Jarvik is not rowing a boat across a lake--and he knows he isn't--but is allowing you to think he is in order to program your mind that taking <em>Lipitor</em> is in some way associated with excellent physical health. Dr. Jarvik's setting for <em>Lipitor's</em> clinical benefits is by personal example--even though he is not taking it. Dr. Jarvik allows you to think his recommendations for <em>Lipitor</em> is based on his clinical experience ("as a doctor"), even though he has not undergone formal clinical training nor does he practice medicine or prescribe drugs.<br /><br />The Jarvik ad campaign illustrates the many untruths inherent in pharmaceutical ads. <em>The New York Times</em> cautions that these ads must be taken with a "very large grain of skepticism." But it is more than that. For these ads, utilizing celebrity personages as their central focus, are structured in deceit and function to spread misinformation over a largely medically uninformed public. For me the totally demoralizing aspect of this particular ad campaign is that Dr. Jarvik, who is genuinely a medical innovator, should choose to use his well deserved celebrity as the centerpiece of a web of untrue words and images--merely for the sake of money.<br /><em></em>Dr. Joseph Goldhttp://www.blogger.com/profile/00368001273179577986noreply@blogger.com5tag:blogger.com,1999:blog-1335007907715618966.post-44843926034165847562008-02-20T07:42:00.000-08:002008-02-25T07:24:46.136-08:00A dog has a better chance of recovering from cancer than you do...You're being hoodwinked on hydrazine sulfate. As many of you already know from our previous blogs (published and accessible on this Web site), hydrazine sulfate is an inexpensive cancer drug that acts to reverse weight loss and halt tumor growth. The National Cancer Institute (NCI)--part of our federal government--says that hydrazine sulfate is worthless. But the facts are that a dog has a better chance of recovering from cancer than you do.<br /><br />Previous studies--done properly--show that hydrazine sulfate is effective and safe in large numbers of cancer patients with all types of cancer and at all stages, interacts well with other types of cancer therapies and is free of harmful clinical side effects. Previous studies--done improperly--i.e., the NCI's sponsored studies of this drug--show that hydrazine sulfate is ineffective. NCI's "good word" is out to physicians (in cancer journals) and lay people (on the Internet) that hydrazine sulfate is no good. But NCI's message has not yet reached veterinarians and animal caregivers. Consequently many animal health care professinals are now using hydrazine sulfate on small animals--pets--with cancer. And the reported results are that many dogs and cats with advanced solid cancers are recovering, frequently fully, from their disease. A dog stands a better chance of getting this drug and thus recovering from cancer than you do.<br /><br />How did this situation arise?<br /><br />The underlying question here is, Is the anticancer action of this drug real? Does it really work? Or is it a figment of its developer's--Dr. Gold's--imagination? His wishful thinking?<br /><br />In deciding whether a drug is active or not, one should <em>never </em>take the word of an individual--the drug's developer or its critics--no matter how authoritative that individual/those individuals might be. It is only the <em>studies</em> that will answer this very basic question. And there are only two aspects to all studies that must be considered: their quality and whether they are properly--in accordance with established and accepted scientific priniciples of study conduct--done.<br /><br />As indicated, you must be very careful not to take the word of any individual--no matter how prestigious or authoritative--that hydrazine sulfate is effective or not effective. Specifically, the adversaries of hydrazine sulfate--many of them respected, authoritative cancer officials--like to say, "Dr. Gold <em>claims</em>..." and then recite a litany of benefits, or the like--and thus diminish the situation by "personalizing" it. It is as though there is no scientific backing to Dr. Gold's remarks. Actually, Dr. Gold doesn't "claim" anything--and never has. <em>It is the studies</em>. Dr. Gold is simply relating the results of studies--controlled clinical trials performed according to internationally established and accepted scientific criteria.<br /><br />What are these studies? There are two sets of studies demonstrating the efficacy and safety of hydrazine sulfate. The first were seventeen years of Phase-II controlled, multi-institutional clinical trials headquartered at the Petrov Research Institute of Oncology, St. Petersburg (with participation by the Herzen Institute of Oncology, Moscow; Oncological Institute of Lithuania, Vilnius; Institute of Oncology of the Ukranian Academy of Sciences, Kiev; and Rostov Institute of Oncology and Radiology, Rostov-an-Donou). The second were ten years of randomized, controlled clinical trials--'RCT's (the "gold-standard" of clinical trials)--performed at Harbor-UCLA Cancer Center in Los Angeles. These studies showed that of every million late-stage, refractory cancer patients treated with hydrazine sulfate, more than half a million would obtain measurable symptomatic improvement, 400,000 would demonstrate a halt or regression in tumor growth, and some would go on to long term (>10 years) survival. (More than 500,000 Americans die each year from cancer, and more than one million new cases are reported annually in the U.S. alone.)<br /><br />Who are the authors of these studies? Where were they published? The authors of these studies were among the leading and most experienced cancer investigators the world over. Among the Harbor-UCLA investigators were a former senior official at the NCI, with specific expertise in the implementation and evaluation of new clinical trials and a cancer scientist renowned in the field of intermediary cancer metabolism, entrusted by the U.S. government to help establish a cancer teaching center in Taipei, Taiwan, the Republic of China. Among the Petrov Institute investigators , Dr. M. L. Gershanovich, chief of studies and deputy director of the Russian equivalent of the U.S. Food and Drug Administration, was regarded by our NCI as one of the principal chemotherapists of the world. These studies were published in such peer-reviewed American journals as <em>Cancer Research, Journal of Clinical Oncology, Cancer, The Lancet, Investigational New Drugs</em>, and others, considered among the most respected, 'premiere' clinical cancer and scientific journals in the world.<br /><br />Did these studies conform to the Helsinki Declaration? The Helsinki Declaration is a multinational ratification of principles governing human biomedical research studies, first adopted by the World Medical Assembly in Helsinki, Finland, June 1964, and thereupon amended by this organization in 1975, 1983 and 1989. An outgrowth of the Nuremberg Trials (Doctors Trial) following World War II which uncovered in detail the hideous human medical "experiments" inflicted on helpless human beings by the Nazis, the Declaration, to which the United States is a principal signatory, was put in place to guarantee that no harmful procedures be used in patients undergoing experimental medical treatment. This document lies at the very heart of internationally accepted standards for biomedical research and is at the very core of all clinical trials and informed consent. As such, the Helsinki Declaration represents the international "law of the land" and requires all human biomedical research to conform to its stated principles.<br /><br />The Russian (Petrov Institute) and Harbor-UCLA studies of hydrazine sulfate were in full conformity to the Helsinki Declaration.<br /><br />Are the two sets of studies--the Russian and Harbor-UCLA--connected? There is no link, no connection whatsoever between the two sets of studies. As such they constitute <em>independent confirmation</em> of one-another. This is the strongest kind of confirmation known to science and acts to confirm and strengthen the validity of each other's conclusions.<br /><br />You must decide: What is the likelihood of these studies being authentic? That the results demonstrated--that hydrazine sulfate is effective and safe in a broad spectrum of cancers--are real, credible?<br /><br />Now let us look at the NCI-sponsored studies--the ones which indicate hydrazine sulfate to be worthless. There were three such studies, all lasting less than two years. One of these--the largest--was conducted under the auspices of the Scripps Clinic in La Jolla, California, the other two by the Mayo Clinic in Rochester, Minnesota. All three were randomized, controlled clinical trials.<br /><br />Who were the authors of these studies? Where were they published? The lead investigator of the largest of the three studies--the Scripps Clinic study--was still concluding his two-year military obligation in the U.S. Navy when designated by the NCI as principal investigator of this study. He was totally inexperienced in conducting a clinical study of any kind, and by his own words in a published interview he was quoted as stating he had "never held the reins of a major study before." The NCI was aware that the conduct and outcome of this study had the potential of impacting the lives of millions of cancer patients around the world. The lead investigator for <em>both</em> the second and third studies, although young, was not inexperienced in the conduct of clinical trials. Appointed as principal investigator of these studies by the NCI, he found himself in an instant, ethically compromizing situation. For as principal investigator of the two NCI-sponsored studies of hydrazine sulfatge, he was also--at the same time--the principal investigator of a study of a competing, private-sector drug, <em>Megace</em>, from Bristol-Myers Squibb Company, of which he was an outspoken advocate and in which Bristol-Myers Squibb had large proprietary interests. Entrusting two pivotal studies of competing drugs to the same principal investigator at the same time--one in which a large pharmaceutical company had sizable financial interests--inevitably raises the spectre of conflict of interest. Health policy analyst Lynn H. Ehrle writes: "Dr. [L....] was the principal investigator of the anti-cachexia drug, <em>Megace</em>, and his selection by the NCI to conduct two trials of hydrazine sulfate is a clear conflict of interest." Referencing the principal investigator's experience in the conduct of clinical trials, Ehrle states: "He should have recused himself." (Letter to Randy P. Juhl, Chair, FDA Pharmacy Compounding Advisory Committee, November 3, 1999.)<br /><br />The three NCI-sponsored studies were published in <em>the Journal of Clinical Oncology</em>. But these studies were not the usual types of publication, submitted for outside, independent (external) peer-review and then individually published as these studies were completed. These studies were "arranged" for publication. Although they were completed at far different intervals of time, they were published<em> sequentially </em>as lead articles <em>in the same issue</em> (June 1994) of this journal. This could not have happened without prior collaboration between the authors and the journal, leaving open the question as to whether these studies were "juried" in the usual manner. The effect of sequential publication is to emphasize their findings. The NCI was not satisfied to emphasize their findngs. They sought also to <em>dramatize </em>them. A fourth "study" was also published in this same journal issue--a lead editorial, in which hydrazine sulfate was identified as a "vampire" and the three NCI studies as "three stakes" in the heart of the vampire ("Three Stakes in Hydrazine Sulfates' Heart..."). Thus the publication of these studies is not entirely normal, is irregular by virtue of prior "arrangement"--i.e., lack of separation--between authors and journal and use of improper and biased language. (Study results were also published by the NCI electronically [on the Internet].)<br /><br />Did the NCI studies conform to the Helsinki Declaration? The paramount principle--Principle 1--of the Helsinki Declaration states: "Biomedical research involving human subjects must conform to generally accepted scientific principles... and [be] based on a thorough knowledge of the scientific literature." Perhaps most important of generally accepted scientific principles in the conduct of human biomedical research is that <em>no incompatible agents </em>(<em>medications</em>) <em>be used in a drug trial</em>. Why? Because such use can result in the grave illness--or death--of a patient, as well as cause a negative drug study. For this reason use of an incompatible agent--or one even<em> suspected</em> of incompatibility--is virtually unknown in human biomedical testing.<br /><br />But the NCI used incompatible agents in all its sponsored studies of hydrazine sulfate. Hydrazine sulfate belongs to a class of drugs known as MAO--<strong>m</strong>ono<strong>a</strong>mine <strong>o</strong>xidase--inhibitors and was indicated in pharmacology textbooks for three decades prior to the NCI-sponsored studies as an "irreversible," i.e., powerful, MAO inhibitor, and throughout the scientific literature as a mitochondrial MAO inhibitor. Also indicated throughout the scientific literature were multiple warnings that use of tranquilizers, barbiturates and/or alcohol with an MAO inhibitor constituted a "clinical hazard." But these were the very substances NCI elected to use in its hydrazine sulfate trials. (One of NCI's studies was terminated early because of unexpected illnesses and death.)<br /><br />Principle 8 of the Helsinki Declaration states: "Reports of experimentation not in accordance with the principles laid down in this Declaration should not be accepted for publication." This principle essentailly states that the NCI-sponsored studies of hydrazine sulfate, out of compliance with the major principle of this document (Principle 1), should never have been <em>presented</em> (or accepted) for publication--no less "arranged" for sequential publication or appearance in the electronic media.<br /><br />The NCI-sponsored studies of hydrazine sulfate were out of compliance with the Helsinki Declaration.<br /><br />Thus, the Petrov Institute and Harbor-UCLA studies were carried out by experienced investigators, acknowledged by their peers to be among the foremost cancer investigators and chemotherapists in the world and entrusted by their respective governments to high positions of responsibility in their cancer programs. These studies were individually subject to outside, independent peer-review before winning publication in journals considered among the most leading and respected internationally. The Petrov Institute and Harbor-UCLA studies were not "connected" in any way and as such constituted <em>independent confirmation</em> of one-another, reinforcing the validity of their individual data. These studies were in full compliance with the Helsinki Declaration. There were no "irregularities" or conflicts of interest in either set of studies. These studies represent straightforward investigations--impartial, objective, unbiased--carried out in strict accordance with internationally established and recognized principles and criteria.<br /><br />In contrast, the largest of the NCI studies was carried out by an individual totally inexperienced in the conduct of clinical trials, still serving his required military obligtion in the U.S. Navy when appointed by the NCI as principal investigator of this study. By his own words, he had "never held the reins of a major study before." The principal investigator of <em>both</em> the second and third NCI studies, in assuming leadership of these clinical trials, immersed himself and the studies in an immediate--and major--conflict of interest. For as principal investigator of the NCI-sponsored studies of hydrazine sulfate, he was also--at the same time--the principal investigator of a study of a competing drug from the private sector, of which he was an outspoken advocate and in which a large pharmaceutical company had very sizable financial interests. These studies were "arranged" publications--it is not clear whether they were subject to outside, independent peer-review--and appeared sequentially in the same journal issue, denoting prior interaction--collaboration--between authors and journal. All three NCI studies were "interconnected" and not independent of each other (one author was principal investigator of <em>two of the</em> studies)--there was <em>no independent confirmation</em> of any of these studies. The studies did not conform to the Helsinki Declaration. The drug under study was referred to as a "vampire" ("Three Stakes in Hydrazine Sulfate's Heart...") by an accompanying NCI editorial in the same journal issue as the three NCI-sponsored studies, leaving open the question as to their 'legitimacy' as impartial, objective scientific investigations.<br /><br />Who--which studies--would you stake your life on?<br /><br />If you or a family member or a loved one or a friend or neighbor had cancer--and you wished to have a trial on hydrazine sulfate--you may have to answer this question. The chances are your doctor has never heard of the Petrov Institute or Harbor-UCLA studies. He/she has only heard of the widely publicized NCI studies and will tell you, in good faith, that hydrazine sulfate is ineffective. Your doctor has heard countless times the following NCI advice regarding hydrazine sulfate, which NCI has posted annually for the medical profession and the public alike. and appears currently, on the Internet:<br /><br />"There is only limited evidence from <em>animal studies</em> [i.e., no human studies] that hydrazine sulfate has anticancer activity."<br /><br />"Hydrazine sulfate has shown no anticancer activity in <em>randomized clinical trials</em> [the "gold-standard" of clinical trials]."<br /><br />How can your doctor fail to believe these statements from the NCI, perhaps the most respected cancer authority in the world, that only animal--no human--studies, certainly no randomized clinical trials, have shown any anticancer activity of hydrazine sulfate?<br /><br /><em>Chlebowski RT, Heber D, Richardson B and Block JB. Influence of Hydrazine Sulfate on Abnormal Carbohydrate Metabolism on Cancer Patients with Weight Loss.</em> <em><strong>Cancer Research</strong> 1984; 44:857-861.</em><br /><em></em><br /><em>Tayek JA, Heber D and Chlebowski RT. Effect of Hydrazine Sulphate on Whole-Body Protein Breakdown Measured by 14C-Lysine Metabolism in Lung Cancer Patients. <strong>The Lancet</strong> 1987; 2:241-243.</em><br /><em></em><br /><em>Chlebowski RT, Bulcavage L, Grosvenor M, et al. Hydrazine Sulfate in Cancer Patients with Weight Loss. <strong>Cancer</strong> 1987; 59:406-410.</em><br /><br /><em>Chlebowski RT, Bulcavage L, Grosvenor M, et al. Hydrazine Sulfate Influence on Nutritional Status and Survival in Non-Small-Cell Lung Cancer<strong>. Journal of Clinical Oncology</strong> 1990; 8:9-l5.</em><br /><br />No human studies done? The above represent 4 of the 15 human studies done since 1975. No randomized clinical trials? All the above are <em>randomized clinical trials</em>. No anticancer activity? All the above, all human studies, demonstrate anticancer activity. ("Hydrazine sulfate resulted in tumor stabilization and regression in 71% of 38 patients with [brain cancer]....Hydrazine sulfate prolongs patient survival and improves quality of life in this category of cancer patients." "Treatment with hydrazine sulfate resulted in complete tumor regression in 6 of 740 (0.8%) of patients, partial tumor regression in 25 (3.4%) of patients, up to 25% tumor regression in 47 (6.4%) of patients, tumor stabilization in an additional 263 (35.5%) patients and accompanying symptomatic improvements in 344 (46.5%) of the patients." "Using a randomized, placebo-controlled study design...hydrazine sulfate treatment resulted in significant improvement in the abnormal glucose metabolism seen in patients with weight loss and cancer." "The proposal that cancer patient survival may be increased by improving host metabolism represents a fundamentally new direction in cancer management.")<br /><br />Your doctor, however, has no reason to doubt the veracity of the NCI statements regarding hydrazine sulfate--and that's the problem. The medical profession is largely uninformed that a substantial medical and scientific literature exists--including the above--which demonstrates the efficacy and safety of hydrazine sulfate in cancer.<br /><br />If you want a trial on hydrazine sulfate--and it is perfectly legal for your doctor to write you a prescription for this drug--you will have to inform him/her of the Petrov/Harbor-UCLA studies. Your doctor will simply have to learn that the NCI studies were intrinsically flawed, not performed in conformity to the Helsinki Declaration, and that NCI advice regarding hydrazine sulfate--is simply wrong.<br /><br />Most professional animal caregivers--veterinarians and others--are not in the mainstream of NCI disseminations and thus are 'immune' to NCI advice regarding hydrazine sulfate. Moreover, these individuals seem to be willing to go the extra mile for their patients--the dogs and cats who are unable to speak for themselves and thus have no other advocate for them. So these dogs and cats more easily have a try on hydrazine sulfate, when their owners present these caregivers with authentic medical evidence showing efficacy and safety of hydrazine sulfate in cancer. Thus "a dog has a better chance of recovering from cancer than you do...."<br /><br />But this need not be the case. You can have the same chance as these cherished animals. But you must first present your doctor with the same evidence that pet owners present to their animal caregivers. You must present them with evidence that controlled clinical trials, properly done, including randomized clinical trials, have demonstrated the effectiveness and lack of serious side effects of hydrazine sulfate in various types and at all stages of cancer. You must also present them with evidence that the NCI-sponsored studies were performed out of conformity to the Helsinki Declaration and that NCI advice regarding hydrazine sulfate is misleading and misrepresents the medical literature.<br /><br />I suggest you bring a copy of this blog to your doctor, if you are interested in obtaining a trial on hydrazine sulfate for yourself or family member or friend and informing the doctor of an Internet Web site on which the actual Petrov/Harbor-UCLA published studies are available as published--i.e., without added commentary (scri.ngen.com). Your doctor can then judge the quality of these studies and make an informed judgment as to whether a trial on hydrazine sulfate may be warranted and/or useful.<br /><br />But there is something else you can do.<br /><br />Send a copy of this blog to any friend, any acquaintance, you might have who has cancer--or whose friend or acquaintance or family member has cancer. Send a copy of this blog to your doctor. To your health care provider. To the earnest people in hospice who care for human beings in their last weeks and months of life. Send a copy to your congressman or congresswoman. Ask them to do something about this tragic situation which keeps really ill people from a drug which competently performed clinical studies say might help them and only incompetently performed clinical studies say otherwise.<br /><br />We must do something to elevate our chances of survival from a dread disease to those our cherished animals currently enjoy.Dr. Joseph Goldhttp://www.blogger.com/profile/00368001273179577986noreply@blogger.com7tag:blogger.com,1999:blog-1335007907715618966.post-690880115485826472008-01-16T08:01:00.000-08:002008-01-17T12:13:44.639-08:00The Food and Drug AdministrationThe federal Food and Drug Administration--the FDA--is the principal federal agency charged with overseeing the safety of our food supply and effectiveness of pharmaceuticals (drugs) and medical devices and procedures. Many people assume that this oversight is complete--that whatever the FDA says has been well-investigated and is true. That one can have 100 percent confidence in FDA's pronouncements. But is that true? Does the label 'approved by the FDA' literally mean there is no room for error--innocent or other? To understand how FDA's pronouncements can affect the health and safety of each one of us, it is perhaps best to first review the history of this federal agency.<br /><br />Prior to 1962 the FDA was a pussycat. Its role, according to the Food and Drug Act of 1906 and the Food, Drug and Cosmetic Act of 1938, was to assure the purity of foods and safety of drugs. Although the 1938 Act required drug companies to submit safety data to the FDA prior to drug clearance and licensing, the potential for FDA conflicts of interest, chicanery and other devious practices was low, since certain safety tests were put in place for drugs as were standards for purity of foods: a drug either passed the safety tests or didn't; a food either met the purity standards or didn't. There was very little room for 'politics' and therefore reason for widespread oversight and/or enforcement powers by the FDA. But all that was to change abruptly.<br /><br />In 1962 an antihistamine-type sedative, thalidomide, used by pregnant women particularly in Great Britain and Germany but throughout Europe, caused congenital deformities of all types in considerable numbers of babies--infants who were born without hands, arms, legs, feet, digits, and other very significant malformations. This did not happen in the United States, because thalidomide had not yet cleared the--largely administrative--safety hurdles of the FDA. This serendipitous 'escape' by the United States forever changed the course of the FDA and, with it, all aspects of modern medicine.<br /><br />In 1962, recognizing it was only the 'safety' oversight exercised by the FDA which prevented a similar situation happening in America as happened in Europe, Congress passed the Kefauver-Harris Amendment to the 1938 Food, Drug and Cosmetic Act, granting enormously increased powers to the FDA, not only in terms of assuring drug safety, but more importantly in granting FDA<em> efficacy oversight</em> over drugs, as well as safety. <em>It was now only FDA who could decide whether a drug was effective</em>, whereas previously FDA would only decide whether a drug was safe and individual physicians would decide efficacy. With this new jurisdiction over efficacy, FDA became a powerhouse: it could make new rules, enforce them, even send armed personnel against any entity or individual it wished, by virtue of the extensive police power granted to it by the Amendment. With this Amendment the FDA became the most powerful government agency in the face of the medical establishment, making virtually every decision as to what drug--or device--or procedure could or couldn't be used in the treatment of human, even veterinary, patients, thereby dominating clinical practice and research of all kinds. With such power, however, also comes abuse of power. FDA has been accused of intimidating drug companies, individuals, even employee scientists and physicians who came to disagree with official FDA policies and practices, as well as those who sought to reform its approaches to alternative medicine and new research.<br /><br />Perhaps most important, with the requirement of efficacy oversight thrust upon it by Congress, FDA was suddenly understaffed and overburdened. One of the ways FDA solved this problem was to create 'advisory committees.' These committees were composed of experts in their respective fields--who were not FDA employees, but were nevertheless frequently well known to the FDA to be sympathetic to FDA concerns. These advisory committees would meet to discuss--and recommend--whether any drug or device or procedure should be approved or disapproved. For example, the Oncology Drug Advisory Committee (ODAC) would meet to discuss cancer drugs and recommend to FDA what action should be taken. Almost without exception the FDA would adopt its advisory committee recommendations.<br /><br />The only trouble was that after a period of time certain 'excesses' were being taken at the meetings of the advisory committees, some of which began resembling 'kangaroo courts.' Such meetings would frequently not present balanced viewpoints but only those sanctioned by the FDA. As a result Congress passed the Federal Advisory Committee Act of 1998, which specifically prohibited 'undue influence' from operating in the advisory committee meetings. This legislation, however, was not enough to halt the approval of drugs which later were shown to be dangerous, causing them to be "black-boxed" or pulled off the market entirely. Drugs such as Zelnorm, Baycol, Permex, Mellaril, Vioxx, Celebrex, Ketek and a host of others prescribed in good faith by doctors and taken in good faith and in high expectations by patients, were shown, <em>after</em> FDA approval, to produce heart attacks and heart damage, stroke, dissolution of muscles, liver toxicity, kidney damage, severe metabolic abnormalities, suicide and death.<br /><br />These problems besetting FDA--approval of drugs which upon post-marketing experience are found to be dangerous, even lethal, essentially a failure of FDA's 'safety' oversight--follow in the wake of the 1962 Kefauver-Harris Amendment which conferred upon FDA <em>efficacy</em> oversight of drugs. As indicated previously, with the <em>efficacy</em> requirement thrust upon it by Congress, FDA was suddenly understaffed and overburdened.<br /><br />While many in the FDA labor ceaselessly in good faith, this agency cannot hope to keep up with the burdensome requirements imposed upon it. In particular the requirement of efficacy oversight has necessarily shifted FDA resources away from its other responsibilities, depriving the FDA of adquate personnel and means to guarantee the integrity of its 'safety' operations--with the result that many dangerous drugs are needlessly being presented to the American people.<br /><br />FDA's efficacy oversight also operates in other ways to impede its safety functions. FDA-approved pharmaceuticals have become a big business. Much money is made by drug companies by the sale of these pharmaceuticals. Thus, much attention is occupied by FDA in overseeing its efficacy function. Unfortunately, politics, moral decay, instances of criminal behavior have infiltrated FDA's efficacy deliberations--have entered into its equations of drug approval--with the result that drugs with 'marginal' or insufficient safety records being accorded 'approval.' (In October 2006 FDA Commissioner Lester Crawford was charged by the Justice Department with failing to disclose his income from exercise of stock options in the very companies he [FDA] regulated.)<br /><br />Efficacy oversight corrupts safety standards in still another way. Many high officials in the FDA, upon leaving FDA, go on to become high officials in pharmaceutical companies, their efficacy experience in the FDA often being utilized in their new employ to guide new pharmaceutical products into quick and economical approval. For example, Michael A. Friedman, M.D., a former high NCI (National Cancer Institute) official, became acting commissioner of the FDA upon the resignation of Dr. David A. Kessler, assuming full control of FDA's operations. Dr. Friedman left the FDA to become Senior Vice-President for Clinical Affairs at G. D. Searle & Company, a division of the giant Monsanto Chemicals. In that capacity Dr. Friedman was responsible for the implementation and development of new drugs and products by Monsanto's Life Sciences Program and their successful navigation through FDA's regulatory processes, which as acting FDA commissioner he oversaw for one and a half years. Dr. Friedman's example is legion. Many former commissioners and deputy-commissioners of FDA become important pharmaceutical executives because of their ability to 'traverse' the often-difficult efficacy requirements imposed by the FDA on new drug products. Out of necessity the successful conclusion of their efforts--especially as concerns the efficacy of new drug products--is at the expense of safety concerns.<br /><br />Thus the efficacy requirements imposed upon FDA by the Kefauver-Harris Amendment has come in time to undermine FDA's safety operations--by virtue of displacing limited FDA resources and personnel away from its safety oversight, by virtue of engaging FDA and pharmaceutical company officials in illegal collusion, by virtue of former FDA officials using their expertise and experience, as high pharmaceutical company neo-executives, in guiding new drugs to approval. In fact it is this efficacy aspect of FDA operations which has most occupied FDA procedures and consciousness since the Kefauver-Harris Amendment.<br /><br /><em>Some years ago I was on the telephone with a deputy commissioner of the FDA, discussing various aspects of FDA oversight of drug efficacy. We discussed FDA's issuance of INDs (Investigational New Drug Exemptions), its requirements for pharmaceutical </em>drug<em> development, its evaluation of clinical trials, its constant reminders to the medical profession concerning drug use. I happened to innocently remark that a certain drug had been 'proven' by large-scale controlled clinical trials. He disputed me, saying: "No drug is proven until <strong>we</strong> say it's proven."</em><br /><br />What can be done to restore safety to FDA operations, so that drug products which are dangerous, even deadly, have the <em>least</em> likely chance to enter the marketplace?<br /><br />The most immediate measure is to return FDA to its original, pre-Kefauver Amendment function to assure the safety and purity of foods and drugs--and <em>rescind the efficacy oversight requirement</em>. Relinquishment of FDA's virtual stranglehold on drug efficacy could have multiple--and far-reaching--benefits on the public health: Judgment of the effectiveness of drugs would be returned to individual practitioners; doctors would be free to choose drugs based on their medical expertise, experience, interpretations of studies in the medical literature, attendance at scientific conferences, interaction with colleagues, etc., knowing full well FDA has certified these drugs as safe. Smaller pharmaceutical companies would be free to engage in true competition with larger companies--it now costs $300 million for any drug to undergo FDA-mandated testing and evaluation, largely to satisfy efficacy requirements, assuring that only large companies 'need apply'--ushering in an era in which the pent-up pressures of innovation and new ideas in smaller companies would be free to emerge in the form of new products. Most importantly, FDA would now be free to concentrate its entire resources on drug and food safety, a not inconsiderable function in view of the many drugs approved by the FDA which have been shown in Phase IV--post-marketing--experience to be dangerous, even fatal, and have been recalled. With exclusive concentration on food and drug safety, FDA could play a more crucial and enhanced role in the nation's effort to exclude harmful substances from our drug supply--to provide increasingly safe, decreasingly toxic and progressively more effective agents in the conquest of disease.<br /><br /><em></em><em></em><em></em><em></em><em></em><em></em>Dr. Joseph Goldhttp://www.blogger.com/profile/00368001273179577986noreply@blogger.com1tag:blogger.com,1999:blog-1335007907715618966.post-28093597090322032442007-12-13T08:16:00.000-08:002007-12-14T09:11:49.279-08:00The Helsinki Declaration<em>To some the story of the inexpensive, effective and safe anticancer drug hydrazine sulfate and its suppression by the National Cancer Institute (NCI)--this country's top federal cancer agency--presented in this blog-series, may remind one of the "legendary carburetor" of the 1940s and 1950s, which reportedly got 100 miles to the gallon but which the Detroit automobile manufacturers were burying because of the interests of the oil companies. Is hydrazine sulfate in the same boat as the magic carburetor--that it is as ineffective as the carburetor is non-existent, as the NCI and the auto makers affirm? Or is hydrazine sulfate different--that it is a remarkably effective, safe and extremely inexpensive drug, which is being put down by the NCI only in the interest of the pharmaceutical companies? "Yeah...sure." The Helsinki Declaration presents continuing evidence that in the case of hydrazine sulfate, the drug is real, the controlled clinical trials that have demonstrated its safety and effectiveness are real, and the NCI's power to suppress or approve any medication it wishes--over and above the authority of the Helsinki Declaration--is real.</em><br /><br />How many of you have heard of the Helsinki Declaration? Sounds like an international treaty, you might think. Well it is...something like the Geneva Convention. But unlike the Geneva Convention, which is largely ineffective, the Helsinki Declaration, pertaining to the safe and allowable conduct of medical studies involving human beings, is extremely effective and underlies all experimental human research. The Declaration in fact requires all published human studies to state: "This study was conducted in conformity to the Helsinki Declaration."<br /><br />The Helsinki Declaration is a multinational ratification of principles governing human biomedical research studies, first adopted by the World Medical Assembly, in Helsinki, Finland, June 1964, and thereupon amended by this organization in 1975, 1983 and 1989. This document, to which the United States is a principal signatory, lies at the very heart of internationally accepted standards for biomedical research.<br /><br />The Declaration, an outgrowth of the Nuremberg Trials (Doctors Trial) following World War II which uncovered in detail the hideous human medical "experiments" inflicted on helpless human beings by the Nazis, was put in place to guarantee that no harmful procedures be used in patients undergoing experimental medical treatment--and is at the very core of all clinical trials and informed consent.<br /><br />Principle 1 of this Declaration affirms: "Biomedical research involving human subjects must conform to generally accepted scientific principles and...[be] based on a thorough knowledge of the scientific literature." Perhaps most important of generally accepted scientific principles in the conduct of human biomedical research is that<em> no incompatible agents </em>(<em>medications</em>) <em>be used in a drug trial</em>. Why? Because such use can result in the grave illness--or death--of a patient, as well as can cause a negative drug study. For this reason use of an incompatible agent--or one even <em>suspected </em>of incompatibility--is virtually unknown in human biomedical testing.<br /><br />Principle 1 of the Helsinki Declaration also requires experimental studies to be based on a "thorough knowledge of the scientific literature." In the case of NCI's sponsoring of the hydrazine sulfate studies, is it possible that the NCI did not know hydrazine sulfate was an MAO inhibitor, as so described throughout the medical literature? Is it possible that the scientists responsible for the hydrazine sulfate sponsored studies were not conversant with even the most basic pharmacology textbooks, which for three decades prior to these studies had indicated hydrazine sulfate to be an "irreversible"--powerful--MAO inhibitor? Is it possible that the sponsors of these studies--administrators and scientists--were unfamiliar with the multiple warnings throughout the scientific literature that use of tranquilizers, barbiturates and alcohol was incompatible with MAO inhibitors such as hydrazine sulfate and would result in "sicker patients" and negative studies? The NCI's <em>PDQ </em>publication of October 25, 1999, suggests that NCI was well aware hydrazine sulfate was an MAO inhibitor.<br /><br />In view of the Helsinki Declaration's prohibition of biomedical studies not in conformity with internationally accepted standards, why did NCI use incompatible agents with a test drug in the sponsored trials of hydrazine sulfate? As indicated in our previous blog, only two reasons underlie such usage: incompetence and deliberateness.<br /><br />Given the level of scientific expertise available to the NCI, it is hardly likely that NCI did not know hydrazine sulfate was an MAO inhibitor and therefore that incompetence was the reason for NCI's going ahead with its sponsored studies. Was it deliberateness? Knowing full well an incompatible agent in the presence of a test drug acts to produce a negative study, did NCI have reason to deliberately go ahead with its sponsored studies? NCI's twenty-five-year-long adversarial orientation--if not antipathy--to hydrazine sulfate ("We throw away better drugs than hydrazine sulfate"), may well speak to this question.<br /><br />But NCI's violation of the Helsinki Declaration was not limited solely to Principle 1. Principle 8 of the Declaration states: "Reports of experimentation not in accordance with the principles laid down in this Declaration should not be accepted for publication." Principle 8 specifies that the NCI-sponsored studies--in their failure to conform to Principle 1 (accepted scientific standards)--should never have been <em>presented</em> for publication in the first place, no less arranged by NCI for sequential publication in the same journal issue (<em>Journal of Clinical Oncology</em>, June 1994). NCI further violated Principle 8 by publishing the results of its studies on the Internet for the public --while at the same time juxtaposing to them false statements on hydrazine sulfate: "There is only limited evidence from <em>animal studies </em>[i.e., no human studies] that hydrazine sulfate has anticancer activity....Hydrazine sulfate has shown no anticancer activity in <em>randomized clinical trials</em> [the "gold-standard" of clinical trials]." (Whereas the truth was that up to the time of the NCI Internet publication, there were ten controlled <em>human</em> studies published in the peer-reviewed medical literature, all known to the NCI since 1975, all showing anticancer activity; and of five Harbor-UCLA studies published in the peer-reviewed medical literature, four were <em>randomized clinical trials</em>, all showing anticancer activity and all known to the NCI.)<br /><br />The Helsinki Declaration is the international standard for the performance and acceptance of human experimental biomedical research. It has been ratified literally by all nations which participate in human clinical testing, including the United States.<br /><br />However, in its sponsored studies of hydrazine sulfate the NCI seems to have lost sight of the Helsinki Declaration, of the fact that the United States was a sponsoring signatory to this Declaration, and that this Declaration in regard to human biomedical experimental research is the international "law of the land." This Declaration in fact requires <em>all published human biomedical research to contain a statement of compliance with principles enunciated in the Declaration</em>. But nowhere in the research protocols or in the published NCI-sponsored trials of hydrazine sulfate is there such a statement.<br /><br />The Helsinki Declaration asserts that by virtue of use of an incompatible medication in the presence of a test drug, a study is in violation of internationally accepted standards of medical conduct. The Helsinki Declaration states that the NCI studies, in violation of Principle 1 and Principle 8, thus have no ethical, scientific or legal standing among the international medical community, that in effect the NCI had no ethical or scientific right to engage in its sponsored studies of hydrazine sulfate as performed, or be a party to their publication.<br /><br />By NCI's ongoing Internet publication and publicity of the results of its non-conformant hydrazine sulfate studies, by its lack of compliance with Helsinki Declaration directives in these studies, NCI on its part indicates that it can defy any international agreement which this country endorses--to which the United States has given its name--that when it is in its interests, NCI alone is the 'law of the land.'Dr. Joseph Goldhttp://www.blogger.com/profile/00368001273179577986noreply@blogger.com0tag:blogger.com,1999:blog-1335007907715618966.post-61805877075568943752007-11-26T09:36:00.001-08:002007-11-27T12:47:14.720-08:00"Do not use with MAO inhibitors." The NCI acts criminally in its investigation of hydrazine sulfate.How many times have you heard--usually recited quickly--at the end of a pharmaceutical ad on television, "Do not use this medication with an MAO inhibitor." What's an MAO inhibitor? And why shouldn't the advertised medication be used with it? Because the two together can harm you. Because the two together can even kill you.<br /><br />An MAO inhibitor is an inhibitor of the enzyme <em><strong>M</strong>ono<strong>A</strong>mine<strong>O</strong>xidase</em>. Monoamines, such as <em>dopa</em>, play key roles in neurotransmission, and the enzyme MAO keeps these neurotransmitters from accumulating in the brain. MAO inhibitors (MAOIs), on the other hand, can <em>cause</em> an accumulation of these substances in the brain, which accounts for their therapeutic--i.e., anti-depressive--action. But MAOIs can also amplify the side effects of some medications and cause these medications to become a clinical hazard, in some instances resulting in severe illness and even death.<br /><br />Thus the effect of mixing an <em>incompatible</em> medication with an MAOI can be very dangerous to a patient, and if the MAOI in question also has a <em>therapeutic</em> function, mixture of an incompatible agent (medication) can also <em>destroy the therapeutic action</em> of the MAOI; if the MAOI is being used as a test medication in a drug study, mixture of an incompatible agent can result in a <em>negative</em> study.<br /><br />Pharmaceutical companies therefore do not wish you to use any of their products in the presence of an MAOI--just in case their products happen to be incompatible with MAOIs--or just in case you happen to be in a drug study, or on a drug protocol, with one of their products. These companies simply don't want you to end up incapacitated or a sure death.<br /><br />Many of you know I--and the Syracuse Cancer Research Institute--am the developer of the anticancer drug hydrazine sulfate. The drug that competently performed controlled clinical trials have shown to be safe and effective in many different types and in all stages of cancer. And that the National Cancer Institute (NCI)--this country's top federal cancer treatment, investigative and funding agency--has found to be ineffective in its sponsored studies. But did you also know hydrazine sulfate is an MAO inhibitor? A powerful--i.e., irreversible--MAOI?<br /><br />More importantly, did the NCI know that hydrazine sulfate was an MAO inhibitor--a powerful one? In an investigation of the NCI-sponsored studies of hydrazine sulfate ordered by Congress, the NCI claimed--over and over again--that hydrazine sulfate was<em> not</em> an MAOI (inhibitor). Even though pharmacology textbooks over the last three decades indicated it <em>was</em> a potent MAO inhibitor. Even though author of the prominent textbook on drug interactions, <em>A Primer of Drug Action</em>, Robert M. Julien, M.D., Ph.D., an acknowledged expert in the field of drug interactions, indicated hydrazine sulfate was "an <em>irreversible</em> MAO inhibitor" (Dr. Julien's emphasis). Even though NCI received a faxed letter from its Russian counterparts, in response to a specific NCI inquiry, "Hydrazine sulfate is a modulator of biologic reaction and functions as an inhibitor of monoamine oxidase [MAO]." Even though studies throughout the medical literature identified hydrazine sulfate as a specific "mitochondrial MAO" inhibitor.<br /><br />What was the reason the NCI denied to Congressional investigators that hydrazine sulfate was an MAO inhibitor--despite overwhelming evidence that it was? Because in its sponsored studies of hydrazine sulfate--the only controlled trials to ever show hydrazine sulfate was ineffective--the NCI used tranquilizers, sleeping pills (barbiturates), alcohol--<em>all of which are known to be incompatible with MAO inhibitors</em>. Acknowledgment by the NCI of MAO inhibition by hydrazine sulfate would be tantamount to an admission by NCI that NCI wittingly or unwittingly used known incompatible agents--negative bias factors--in its hydrazine sulfate studies, and thus by definition its studies were intrinsically flawed.<br /><br />While NCI officials were vigorously denying that hydrazine sulfate could be an MAO inhibitor--challenging established scientific fact--did they really know all along that it was? Was NCI's use of incompatible agents witting or unwitting?<br /><br />It must be considered that the NCI--as the world's leading cancer agency--had the top expertise available to it and that experts in the field could hardly not advise NCI that hydrazine sulfate was a known and acknowledged MAO inhibitor and that tranquilizers, barbiturates and alcohol could not be used with it. Thus,<em> incompetence could not have been the reason</em> for NCI's use of incompatible agents. But there are only two reasons that investigators would use a test drug in the presence of an incompatible agent: incompetence or <em>deliberateness.</em><br /><br /><em>Deliberateness</em>? Did NCI know all along that hydrazine sulfate was an MAO inhibitor? Four years after the Congressionally-mandated investigation of NCI's sponsored studies of hydrazine sulfate had safely passed, NCI issued a multipage newsletter on complementary and alternative medicine, (<em>PDQ Complementary/Alternative Medicine, Hydrazine Sulfate, National Cancer Institute, November 25, 1999</em>), discussing hydrazine sulfate. Its opening line was: "Hydrazine sulfate is an MAO inhibitor..."<br /><br />Did NCI know all along that hydrazine sulfate was an MAO inhibitor? NCI's level of expertise available to it and its <em>PDQ</em> publication would indicate--beyond the shadow of a doubt--that it knew from the beginning that hydrazine sulfate was an MAO inhibitor. Yet it went ahead and used tranquilizers, barbiturates and alcohol freely with it, knowing full well that the medical literature identified these substances as constituting a "clinical hazard" with MAO inhibitors--capable of making test patients ill or worse, capable of bringing down a (causing a negative) study. In violation of a multinational agreement on the conduct of experimental medical studies. And nowhere mentioned in the informed consent forms patients were required to understand and sign prior to being enrolled in the studies.<br /><br />Deliberately causing a negative study? Deliberately causing illness and mortality in test patients? Is it possible the NCI would use known incompatible agents with an MAO inhbitor? Is it possible that the NCI did not know hydrazine sulfate was an MAO inhibitor?<br /><br />Is it possible that the federal government--the NCI--would act to defeat a cancer drug it knows--or suspects--to be safe and effective?<br /><br />To the extent that the captains of our cancer leadership knew and understood that hydrazine sulfate was an MAO inhibitor--knew and understood that use of tranquilizers, barbiturates and alcohol with it would bring down patients and the study--yet went ahead anyway with this study design-- it seems to me that rather than "disinform" the American people that hydrazine sulfate is useless and thus engage in the worst type of medical untruth imaginable-- they must criminally answer for the pain, suffering and premature deaths they have knowingly and needlessly inflicted, and continue to inflict, on spouses, children, grandparents, uncles and aunts, friends, loved ones, your neighbors--and mine--the world over.Dr. Joseph Goldhttp://www.blogger.com/profile/00368001273179577986noreply@blogger.com76tag:blogger.com,1999:blog-1335007907715618966.post-63599451500654456032007-10-17T11:40:00.000-07:002007-10-19T07:20:33.901-07:00Annual report to the nation on the status of cancer"Cancer Death Rates Plunge." This encouraging news appeared as a front-page, four-column headline in a recent edition of the Syracuse, New York daily newspaper. This headline was repeated in newspapers around the country, in newswire services, in nationwide network television newscasts and on the Internet. Many media emphasized that it was screening tests, public health and preventive measures, not necessarily advances in curative treatments, that resulted in a decrease of both cancer incidence rates and cancer death rates.<br /><br />This was an annual report to the nation, compiled by the Center for Disease Control and the American Cancer Society. It was not a study published in a journal, subject to peer-review in the usual sense. It is described as a "U.S. government work" put together by 15 authors, one of whom is listed as being "under contract with the Indian Health Service for a portion of her work on this manuscript."<br /><br />Through cancer registry programs and associations, SEER (Surveillance, Epidemiology, End Results) compilations, NCI (National Cancer Institute) and ACS (American Cancer Society) programs it was estimated that cancer incidence data for this report was available for "up to 82% of the U.S. population."<br /><br />The report specifies that overall cancer death rates declined 1% from 2002 through 2004, compared to 1993 through 2002 (i.e., 2.1% compared to 1.1%). Breast cancer incidence (therefore death rate) decreased 3.5% a year in 2002-2004, but this drop was indicated to be chiefly due to a discontinuance by women of hormonal replacement therapy (HRT)--which was found to actually <em>cause</em> breast camcer--not to any treatment advance, as discussed in a previous blog.<br /><br />A decrease in colorectal cancer for both men and women was largely attributed to screening tests, such as colonoscopy and stool guaiac examinations. At colonoscopy benign polyps--which can later become cancer--are easily excised and thus cancer incidence from this disease is<br />decreased; frank cancer found at colonscopy is usually found at an earlier--and therefore more treatable--stage than would normally be the case, and thus this examination can also lead to a decrease in death rate. Stool guaiac tests are also simple tests to detect occult blood in the stool, which could be coming from a cancerous tumor in the colon; these tests, too, lead to earlier diagnosis which in turn promotes a decrease in the death rate.<br /><br />Favorable trends in the incidence and mortality from lung cancer in men were largely attributed to "enhanced tobacco control" (i.e., men giving up smoking). In women the death rate from lung cancer has overtaken that of breast cancer in recent years. Incidence and death rates from this cancer in women, unlike men, did not decrease during the 2002-2004 period; the incidence remained flat and death rates actually<em> increased</em> but at a slower rate than in previous years.<br /><br />This report constitutes truly encouraging news. It means that cancer incidence and death rates can be controlled--by preventive measures, such as women's discontinuance of HRT and avoidance of the use of tobacco products, both of which are <em>causative</em> or contributive agents for breast, lung and other cancers. Also, use of screening tests, such as those employed for colorectal cancer, can result in a marked decrease in cancer incidence/mortality in various organ systems.<br /><br />The negative side of this report, however--what this report also states--is that very little, if any, of the improvements in cancer incidence/death rates during this period is due to the advancement of cancer therapy per se. Once established in the body, major organ cancers--colorectal, pancreatic, lung, brain, breast and others--are extremely difficult to cure. The report, by omission, calls attenion to this deficit in innovative therapies which may significantly and beneficially alter the course of established cancers. What in fact this report silently screams is the need for new ideas, the need to implement old ideas that have not been adequately explored and the need to move away from the centralization of power and money as the determinants of cancer thought and therapy.Dr. Joseph Goldhttp://www.blogger.com/profile/00368001273179577986noreply@blogger.com2tag:blogger.com,1999:blog-1335007907715618966.post-58607629203433615792007-10-02T11:58:00.000-07:002007-10-03T12:39:56.081-07:00Don't bet on this cancer communiqueIn our initial commentary it was stated that this blog will be devoted to truth in medicine and exposing misrepresentations wherever they exist.<br /><br />Some months ago almost every cancer doctor in the Syracuse, New York area--11 oncologists in a group private practice and others in an academic setting--jointly published a letter-to-the-editor in <em>The </em>(Syracuse) <em>Post-Standard </em>calling attention to the pending cancellation by the National Cancer Institute--the federal government--of a nationwide study of drugs "that could reduce breast cancer incidence by more than 50 to 70 percent."<br /><br />What? Prevent up to 70% of all breast cancer? But this is astonishing! If there were any drug or drugs or treatment that could prevent even one-tenth that amount of breast cancer--5% to 7%--that would be considered a major victory!! But 50% to 70%? And the National Cancer Institute (NCI) itself--this country's and the world's bastion of defense against cancer--cancelling a study that could virtually wipe out breast cancer? That doesn't even make sense.<br /><br />Lest you think this was an isolated letter in a single newspaper, similar letters appeared in newpapers throughout the country, submitted by oncologists in all locales. These were spurred by chairman and principal investigator Norman Wolmark, M.D., of the National Surgical Adjuvant Breast and Bowel Project (NSABP), which had charge of this proposed study. Dr. Wolmark stated, "We believe [this study] has the potential to prevent the incidence of breast cancer by up to 70%," and any decision not to go ahead with this study could wreak havoc with the nation's ability to test new drugs.<br /><br />The name of the drug study was "P4-STELLAR"--"P-4" for short--which sought to test two drugs, letrozole and<em> </em>raloxifene. The letter detailed that although the proposed study, which "could ultimately prevent thousands of cases of breast cancer," underwent a "rigorous review process" at the NCI, including "seven different approvals" by various NCI committees, "the NCI's director abruptly halted activation of the [P-4] trial and now continues to delay trial commencement."<br /><br />The doctors stress that "200,000 American women will be diagnosed" with breast cancer this year and "more than 40,000 will lose their lives to this disease." It urges women to contact the NCI, to demand that this study be activated. "Time is of the essence," the letter urges. "We must persuade the NCI to release funding for this critically important [drug] trial...or risk losing...this opportunity to dramatically reduce the toll of breast cancer....forever." Thousands of women, taking heed of the oncologists' letters, responded by writing letters of their own to the NCI urging that the study be activated.<br /><br />But the NCI--apparently not in agrement with the letter writers' exhortation that the P-4 study could "dramatically reduce the toll of breast cancer"--did indeed cancel this $130 million clinical study, citing its exessive cost ("there are other priorities that are very [more] important," an advisory panelist stated), as well as "troubling complications."<br /><br />The study would have entered 12,000 women who would have received either letrozole or raloxifene, but not both together. Each drug acts to target--to reduce--the production of estrogen, which promotes the growth of cancer cells. However, each of these drugs had <em>already</em> been tested individually and many of their effects were already known. For example, raloxifene had already been tested in 37,000 postmenopausal women in the STAR (Study of Tamoxifen and Raloxifene), RUTH (Raloxifene Use for the Heart), MORE (Multiple Outcome of Raloxifene Evaluation) and CORE (Continuing Outcome Relevant to Evista [Raloxifene]) trials. Tamoxifen, an anticancer drug used for many years in breast cancer, and raloxifene were compared in a large trial and found to have about the same level of effectiveness in preventing cancer. Letrozole, also, had undergone clinical testing in thousands of women--in comparison to the anticancer effectiveness of tamoxifen (BIG 1-98 Trial) and by itself. It was found in one study that letrozole was only slightly more effective than tamoxifen.<br /><br />In its cancellation letter of June 19, 2007 to the study's principal investigators at the University of Pittsburgh (as reported one day later in <em>The Washington Post</em>), the NCI cited the "relatively small number of women--3 or 4 out of 100--who benefit from [the proposed two test drugs]."<br /><br />Only 3 or 4 out of 100? That's nowhere near "50% to 70%." That's nowhere even near 5%. What about the potential "virtual obliteration" of breast cancer, as indicated in the NSABP chairman's statement and as set forth in the doctors' letters?<br /><br />The NCI letter of June 19 also cited the "troubling complications of the two cancer prevention drugs [letrozole and raloxifene] in its cancellation decision. "The danger of introducing these drugs," the letter stated, "with their many side effects [sudden chest pain, coughing up of blood, sudden change or loss of vision, vomiting, diarrhea, breast and stomach pain, headache, vaginal bleeding and irritation, dizziness, etc.] outweighs their potential until we are better able to determine who will benefit from [them]."<br /><br />Could it be that the chairman of the NSABP and the letter writers did not know that the P-4 trial's two drugs, raloxifene and letrozole, had no hope of preventing--could not possibly prevent--"50 to 70 percent" of breast cancer? Could it be that these individuals did not know that these two drugs had many and significant side effects and their introduction into the general population constituted a potential hazard until it could be determined who might benefit from them?<br /><br />But the chairman of the NSABP and the letter writers were privy to the same information--the same prior study results--as the director of the NCI and his panel of advisors. They well knew that there wasn't a chance that the two test drugs could prevent '50 to 70 percent' of breast cancer--or anywhere near these figures. Then what was their motivation in stirring up the hopes of the American people that so great a proportion of breast cancer could be prevented? What was their motivation in mobilizing the women of America to contact the NCI and <em>demand</em> that the P-4 trial be activated?<br /><br />Dr. Wolmark, the NSABP's chairman, provides an answer. "Due to the cancellation of this trial," he writes, "the infrastructure of more than 500 trial centers we have built up over the last 15 years will cease to exist."<br /><br />500 trial centers? These are the test sites where oncologists, members of the NSABP, test drugs on cancer patients. Dr. Wolmark's remarks in essence state that activation of the $130 million P-4 study guarantees that the NSABP nationwide network of trial centers--established over the last 15 years and characterized as of "importance" to the "advancement of science"--will be maintained. "The National Surgical Adjuvant Breast and Bowel Project has been successfully conducting multi-center breast cancer prevention trials since 1992, advancing the knowledge base and testing new prevention options through its clinical trials," the doctors' letter in <em>The Post-Standard </em>reiterates. "We must persuade the NCI to release funding for this critically important P-4 trial."<br /><br />Critically important? It can't be critically important to the prevention of 50% to 70% of breast cancer--both the NSABP chairman and the doctors know that's an impossibility. Clearly, it is critically important to the maintenance of the NSABP's trial centers. That they don't melt away. That these testing mills--processing millions of dollars annually--remain functioning. That these money machines keep on rolling.<br /><br />And this is the real reason for the doctors' letters. The real reason for mobilizing the public to pressure the NCI into "activating" the P-4 study. The crass motivation for making shabby use of millions of American women, raising their hopes and medical aspirations that the disease of breast cancer might be largely silenced forever by this P-4 study, only to guarantee the maintenance of the NSABP's trial centers--its "centers of excellence"--that have produced no treatments that have significantly altered the course of breast or bowel cancer since their inception.<br /><br />This commentary, as stated previously, is devoted to truth in medicine and exposing misrepresntations wherever they exist. The shameful orchestration of power by the NSABP and its affiliates, presented here, illustrates perhaps most indelibly the degree to which the medical profession is capable of a <em>lack of truth</em>. How--falsely portraying the therapeutic potentials of a study--elements of the cancer establishment literally wipe their behinds with the public.Dr. Joseph Goldhttp://www.blogger.com/profile/00368001273179577986noreply@blogger.com1tag:blogger.com,1999:blog-1335007907715618966.post-25944649588466001242007-09-04T07:30:00.000-07:002007-09-05T13:07:51.143-07:00Is bigger better? The evolution of large-scale cancer research organizationsIn the early summer of 1956, a newly graduated M.D. from the State University of New York Upstate College of Medicine at Syracuse, I found myself on the campus of Berkeley, California, as a post-doctoral fellow in the Department of Physiological Chemistry at the University of California School of Medicine. My two-year fellowship, which I was just beginning, shared my time between basic science on the Berkeley campus and medicine across the bay in San Francisco.<br /><br />Shortly after my arrival my boss, Dr. David M. Greenberg, a celebrated biochemist and head of the department, informed me that he had arranged for me to attend the annual scientific meetings of the American Association for Cancer Research (AACR), to take place in Chicago.<br /><br />That first meeting of the AACR to which I was exposed made an indelible impression on me. At the time, there were only several hundred members of the AACR worldwide, and it was difficult to gain elected membership.<br /><br />At that meeting I was to hear the first presentation of Dr. Charles Heidelberger, who as a medical biochemist had had the brilliant idea of substituting a fluorine atom for a hydrogen atom on the 5-position of the nucleic acid base uracil--important to rapidly dividing cancer tissue--with the thought that this new molecule (drug) would 'gum up' cancer cells' ability to multiply, with the result of a true chemotherapeutic--anticancer--effect.<br /><br />The new molecule was called 5-fluorouracil or 5-FU for short. Dr. Heidelberger synthesized this molecule himself, tested it on cancer-bearing animals himself and then tested it on humans himself. Of course, he had assistants and helpers in these endeavors, but it was his concepts alone that led to this scientific and medical breakthrough. Such was Dr. Heidelberger's erudition and creativity, that 5-FU has remained a mainstay in cancer chemotherapy--for colon cancer, ovarian cancer, breast cancer and many other cancers--for the last 50 years.<br /><br />Dr. Heidelberger's published papers bore his name exclusively as the innovator of his therapy. At the time it was common in medical science to see published papers (studies) with one author alone--or perhaps two or three. Papers with single--or few--authors signified original research. They were the product usually of one person's brain. One person's creativity. Years later, in 1969, when I was elected to membership in the AACR, it was still part of the membership requirements that an applicant show original work by at least two different single-authored papers published in the peer-reviewed scientific literature relating to cancer, as well as have the written endorsements of several well-established senior investigators, known for their own original research. At that time single-authored papers--and scientific innovation in general--proceeded at a brisk pace, were actually common, especially in the cancer field.<br /><br />Today, in the cancer journals--in the peer-reviewed medical literature as a whole--it is rare to see a single-authored paper. Or a paper with two authors, even three. Instead, in the most prestigious, leading journals it is common to see a paper with 20--25--even 30 authors! What? So many brains 'collaborating' on a single project? Is there a new idea here? Whose? Is there a Charles Heidelberger buried in these lists of investigators?<br /><br />Concomitant with the multiple-authorship of published papers is the slowdown in cancer treatment innovation. No more brilliant innovations. No more wrenching from nature its deeply buried secrets. No more new directions. No more products of a single brain. One that has apprehended something no other brain has thought of.<br /><br />Today we have the team effort. The team project. Perhaps not with the payoff that a briliant new idea can bring, but with an improvement--hopefully. A bettering of an understanding of science--and perhaps a more modest payoff therein.<br /><br />And a lot of different authors get their names on a paper. You know--publish or perish? And a lot of different 'important' investigators get their names on many papers. How do you think department heads or their equivalents get their names on--publish--'100 papers' in a single year (yes, that happens--one investigator, reputedly, on 300 papers in one year)? If I were engaged in original research involving six different projects, I would find it a chore writing 6 different, adequate and complete papers for publication in one year--maybe 2 years. But some department heads and senior investigators simply tack their names on every paper sent out in their department for publication or by their junior investigators, justifying their doing so by reading through and commenting on their manuscripts before publication. In some departments a junior investigator would not dare send out a paper for publication without listing his/her boss as a co-author. (Guess who gets the money?)<br /><br />But there is a reason for all this. A 'structure' which makes multiple-authored publications both possible and necessary.<br /><br />In the mid-1950s, when I first attended the meetings of the AACR and heard the Heidelberger paper, as previously stated there were some 300-to-400 members of that organization. Today the membership is 24,000! No longer are the requirements for active membership proof of <em>original </em>research, but only 2 years' experience doing scientific work resulting in articles published in the peer-reviewed medical literature. Instead of the multiple, written letters of recommendation of several well-established, senior investigators, what is needed now are merely the signatures of "two nominators" on the membership application itself. And rather than scientists and clinicians only, active membership is now also open to 'administrators' and 'educators' in the cancer field. Also the application for membership must be accompanied by a fee, currently $255.<br /><br />24,000. That's quite a bunch! With the diluted membership requirements one wonders whether all one has to do is appear in an open doorway of a basic research laboratory, and poof!--you're in--as long as you pay the fee. Of course, this is a simplification, but one wonders exactly how dilute the qualifications are today for becoming 1 of 24,000 cancer "experts."<br /><br />And it is not the AACR alone whose ranks have swelled from earlier, more modest--but creatively vibrant--beginnings. It is the AACR's sister organization, the American Society of Clinical Oncology (ASCO), charged with investigating questions in <em>clinical</em> cancer medicine, whose ranks have become similarly enlarged (25,000 members at present).<br /><br />The AACR and ASCO, as well as like research/clinical organizations worldwide, have become businesses. One look at their structure--their arms of research, clinical medicine, journal sponsorship, even foundations (to which members and readers of their journals are invited and exhorted to contribute monies, trusts, legacies, etc.)--and this aspect of their operations is readily apparent.<br /><br />Have these hordes of researchers, these armies of researchers--the 20,000+ membership of these organizations--acted to dilute the 'brilliance quotient' when membership was in the several hundreds, composed of provably outstanding scientific minds whose 'track records' for original scientific thought--even as young investigators--was abundantly apparent?<br /><br />When organizations numbered in the hundreds in membership, there were in general adequate funds available from cancer funding sources. If a "Manhattan Project" developed, requiring markedly additional funds, these materialized easily. But with research organizations numbering 20,000 or more in membership, a wholly different complexion developed.<br /><br />Research salaries are paid by faculty or institution salaries or research grants, but whether grants or salaries, by far most of these funds derive from the U.S. National Cancer Institute, as appropriated directly from Congress in each budget year. This annual appropriation of the NCI budget by Congress in general limits the amount of cancer funds available each year.<br /><br />Consider the funding dynamics of a cancer research organization of 20,000 members. Each member--researcher, administrator, educator--receives a salary, research project grant funds, travel allowances, in some cases institutional overhead, totaling well over $100,000 on average (in some instances of senior investigators, hundreds of thousands). That's a minimum of $2.4 billion annually. That doesn't even include the billions spent each year on institutional grants and contracts, cancer centers, large-scale studies and special multicentric (sometimes multinational) epidemiologic projects, NCI operations, and the like. The NCI budget as appropriated by Congress for 2007 only totals $4.75 billion--which is more than oversubscribed. Thus large-scale cancer research organizations contribute significantly to exhausting the reservoir of available cancer funds.<br /><br />Organizations such as the AACR, in order to support a membership of 24,000, have had to grow from a small, mainly professional group to an immense, complex and powerful business enterprise--its business interests at times seemingly eclipsing its research operations. Frequently this organization importunes its membership--all 24,000 of them--to contact Congress in favor of more cancer appropriations--or for passage of certain legislation favorable to increased cancer funding. The leadership of these organizations stresses to Congress that they and their membership--all 24,000--speak with one voice: that the more cancer monies, the more new ideas to be explored. But many in these organizations do not believe as the "one voice" of its leadership. Because with each increase in the annual cancer (NCI) budget mandated by Congress, the reality is that a smaller percentage of approved research grants has been funded.<br /><br />Is more better? Are cancer research organizations with membership in excess of 20,000 better equipped to deal with the complex problems in medicine today than in earlier times when membership was much smaller? On the positive side of this question, team efforts are definitely needed to solve the problem, for example, of the human genome and the genetic basis of disease, which can lead to many treatment advances and a new understanding of disease processes. On the other side, before the advent of large-scale research organizations, it was, for example, a few individual, brilliant, competing investigators--Watson, Krick, Franklin--who unraveled the double-helix structure of DNA and thus figured significantly in the important scientific and clinical benefits to result from this discovery. And working by himself, a lone researcher--Nobel prize winner Kary Mullis-- conceived of the polymerase chain reaction, which literally opened the door of the entire field of genetics to researchers, scientists, clinicians, pathologists and others the world over.<br /><br />One cannot ignore the fact that in cancer medicine particularly, with the advent of large-scale organizations, important treatment advances have slowed considerably. One wonders: Are the armies of researchers in these organizations--who do not have to show proof of capacity for original research--creating funding or other shortages for the truly gifted, for young investigators whose ideas may be "outside" current cancer concepts--whose scientific thinking may harbor the truly great discoveries to come?<br /><br />Is bigger better? Or is big brother somehow, invisibly, paradoxically, acting to smother--to exclude from opportunity--the most gifted of its ranks?<br /><br /><br /><br /><br /><br /><br /><br /><em></em><em></em><em></em>Dr. Joseph Goldhttp://www.blogger.com/profile/00368001273179577986noreply@blogger.com3tag:blogger.com,1999:blog-1335007907715618966.post-55434908196141690902007-08-09T11:54:00.000-07:002007-10-19T10:37:08.443-07:00Hydrazine sulfate, does it work--or not?Many of you know me as the developer--the "inventor"--of the anticancer drug hydrazine sulftate, a drug that combats cancer cachexia, the weight loss and debilitation seen in advancing cancer, induces tumor stabilization and regression and promotes increased survival time and quality of life. There has been much pro and con talk on the internet about this drug. The question is--does it work or not?<br /><br />On one side of the line is the NCI--the U.S. National Cancer Institute. The NCI says its studies--published in a well regarded, peer-reviewed cancer journal--show hydrazine sulfate is ineffective. On the other side, Harbor-UCLA Medical Center and the N. N. Petrov Research Institute of Oncology (St. Petersburg) say their studies--published in equally prestigious, peer-reviewed cancer journals--show that this drug is safe and effective in many different types of cancer and at all stages.<br /><br />What else does the NCI say about hydrazine sulfate?<br /><br />NCI has not seen fit to confine its point of view about hydrazine sulfate to cancer journals, but has gone directly to the American (and world) public. It currently states on the internet:<br /><br />"There is only limited evidence from <em>animal studies</em> that hydrazine sulfate has anticancer activity."<br /><br />The clear meaning of this statement is there have been no human studies that have documented the anticancer activity of this drug, and its proponents are hanging on to slim evidence generated solely from animal studies--and who should know better than this nation's top cancer agency?<br /><br />But in actual fact there have been <strong>ten</strong> (10)<em> controlled</em> <em>human studies</em> of hydrazine sulfate, all showing anticancer activity, all known to the NCI since 1975. A sampling of these studies follows:<br /><br />"A definite stabilizing effect exerted against tumor growth was noted in 21% of patients. Antitumor effects were observed in a total of 19 of 95 (20%) of patients. The symptomatic [anti-cachexia] action of the drug...was expressed in appreciable improvement of general status and appetite, reduction of severe weakness characteristic of the pretreatment period, reduction or complete elimination of pain." (Gershanovich, et al., <em>Cancer Treatment Reports </em>60:933-936, 1976.)<br /><br />"This experience with hydrazine sulfate in an advanced cancer population points to a...role for this drug in maintaining weight in patients with cancer cachexia." (Chlebowski, et al., <em>Cancer</em> 59:406-410, 1987.)<br /><br />"Our results suggest that hydrazine sulfate can favorably influence the abnormal metabolism associated with weight loss in patients with cancer." "The proposal that cancer patient survival may be increased by improving host metabolism represents a fundamentally new direction in cancer management." (Chlebowski, et al., <em>Cancer Research</em> 44:857-861, 1984; Chlebowski, et al., <em>Journal of Clinical Oncology</em> 8:9-15, 1990.)<br /><br />"Hydrazine sulfate resulted in tumor stabilization and regression in 71% of 38 patients with glioblastoma [brain cancer]....Hydrazine sulfate prolongs patient survival and improves quality of life in this category of cancer patients." (Filov, et al., <em>Voprosy Onkologii </em>40:332-336, 1994.)<br /><br />"Treatment with hydrazine sulfate resulted in complete tumor regression in 6 of 740 patients (0.8%), partial [>50%] tumor regression in 25 patients (3.4%), up to 25% tumor regression in 47 of the patients (6.4%), tumor stabilization in an additional 263 patients (35.5%) and accompanying symptomatic [anti-cachexia] improvements in 344 (46.5%) of the patients." (Filov, et al., <em>Investigational New Drugs</em> 13:89-97, 1995.)<br /><br />No human studies? No anticancer activity?<br /><br />But the NCI wanted to <em>make sure</em> <em>doctors<strong> </strong></em><strong></strong>got the message of no valid anticancer activity in human studies, so they added:<br /><br />"Hydrazine sulfate has shown no anticancer activity in <em>randomized clinical trials</em>."<br /><br />Randomized clinical trials--better known as RCTs--are the "gold-standard" of clinical trials. In actual fact, 4 out of the 5 Harbor-UCLA trials, published in the peer-reviewed medical literature, were <em>randomized clinical trials, all</em> of which showed anticancer activity, and all of which were known to the NCI. A sampling illustrates:<br /><br />"Using a randomized, placebo-controlled, double-blind [study] design...hydrazine sulfate treatment resulted in significant improvement in the abnormal glucose metabolism [i.e., cancer cachexia] seen in patients with weight loss and cancer." (Chlebowski, et al., <em>Cancer Research</em> 44:857-861, 1984.)<br /><br />"These data demonstrate an association between...hydrazine sulfate administration and body weight maintenance [i.e., anti-cachexia effect] in patients with cancer." (Chlebowski, et al., <em>Cancer</em> 59:406-410, 1987.)<br /><br />"Hydrazine sulfate [combats] subnormal protein synthesis in skeletal muscle, believed to be the primary cause of loss of muscle mass and weight loss [i.e., cachexia] in lung cancer patients." (Tayek, et al., <em>The Lancet</em> 2:241-244, 1987.)<br /><br />"In a randomized clinical trial...a statistically significant increase in median survival time was associated with hydrazine sulfate addition to chemotherapy." (Chlebowski, et al., <em>Journal of</em><br /><em>Clinical Oncology </em>8:9-15, 1990.)<br /><br />Thus, NCI's internet message to the public--that only animal studies (no human studies) have hinted at the anticancer activity of hydrazine sulfate--is misleading, incorrect and false.<br /><br />Why would the NCI misrepresent this easisly verifiable information to the public? Because it knows the public will take its 'authoritative' word and won't go to the medical libraries--or do an internet search--to look up the studies themselves. Because it wants the public to believe the curative effect of hydrazine sulfate is a "myth."<br /><br />An unsolicited letter-to-the-editor in an upstate New York newspaper reads: "The cure of hydrazine sulfate for cancer is not a myth, but a fact. I was given a death sentence in 1994 by three top doctors and three top hospitals in Syracuse and Rochester. I had a cancerous tumor that was squeezing my bile duct and was inoperable because of its location. All the doctors told me I had two months to live and to prepare myself for my funeral.<br /><br />"Shortly after starting on the hydrazine sulfate, my appetite returned. The weakness lessened and I regained my strength slowly but surely. That was 10 years ago. The tumor has completely disappeared and I'm feeling marvelous." (Syracuse <em>Post-Standard</em>, April 7, 2004).<br /><br />Is it possible that the federal government would thwart a cancer drug that it knows--or suspects--to be effective and safe? Would go on the internet with misrepresentations at every turn to the public?<br /><br />It would appear to be medical schizophrenia to answer "yes" to the above question. For the federal government--in this instance the National Cancer Institute--was put in place to help guarantee effective treatments for the disease which torments people the world over. Why would the NCI want deliberately to squelch a drug which competent studies indicate shows promise as a safe and effective treatment for all kinds of cancer?<br /><br />Consider the scenario: It was learned by a small number of doctors that certain fruits, eaten in sequential order, possessed anticancer qualities that none of the fruits had separately. This was discovered from the dietary habits of an isolated Tibetan community located at an elevation of eleven thousand feet in the Himalayas that had no cancer. The doctors--environmental oncologists--had visited the community as a result of an international medical exchange program.<br /><br />When the doctors returned to their home base in the U.S., they determined to--quietly--test a small number of patients with the diet. Twenty patients--with different types of progressive cancer--were administered oranges, bananas, strawberries, kiwi, kumquats and mangoes sequentially, and instructed to repeat this every three days.<br /><br />At the end of one month the doctors looked at each other warily. Their patients, still with cancer, displayed none of the progressive features of their disease apparent one month ago. At the end of two months, none of the 20 patients had any findings of clinical cancer. The doctors sent their 20 patients to 5 different scanning facilities, so as not to arouse suspicion. All C-T scans, MRI scans and PET scans showed no signs of cancer in any of the 20 patients.<br /><br />The environmental oncologists became very excited and highly enthusiastic. They realized they had hit on a cure for the most vicious disease the world had ever known. And consisting of common and plentiful foods, to boot! No more dangerous, harmful and ever-more expensive cancer drugs! No more big regional cancer centers! No more need for cancer education and fund-rasing organizations. No more need for ever-greater cancer appropriations from Congress. No more seats of individual cancer power and authority to dictate treatments that are largely ineffective. No more need for cancer specialists, cancer administrators, cancer czars.<br /><br />The environmental oncologists were aware, however, that they had tested their treatment in only 20 patients. What they needed was a test in thousands of study patients. A double-blind, placebo-controlled, prospectively randomized multicentric epidemiologic clinical test. A test that could only be funded by the National Cancer Institute--involving large numbers of cancer clinicians and scientists and administrators--in what could possibly be their last job. Of course, the justification by the small group of environmental oncologists for this large study was that if the clinical results obtained in the first 20 patients held up in the thousands of patients, cancer could be erased from the face of the earth.<br /><br />Do you think the NCI would approve a grant application for such a study? That the large private-sector cancer centers, the cancer hospitals and clinics, the national cancer education and fund-raising organizations, the pharmaceutical industry, the cancer research and treatment organizations, the leadership of cancer doctors, cancer nurses and cancer administrators--a $200 billion conglomerate in the U.S. each year, which maintain close liaison with the NCI--would give their concurrence?<br /><br />This is the first blog on hydrazine sulfate. There will be many more. For the antipathy of the NCI to this drug extends over 30 years. And its message to the public has always been--from the very beginning--that of an adversary.<br /><br /><br /><br /><br /><br /><br /><em></em><br /><em></em><br /><br /><br /><br /><br /><br /><br /><br /><em></em>Dr. Joseph Goldhttp://www.blogger.com/profile/00368001273179577986noreply@blogger.com5tag:blogger.com,1999:blog-1335007907715618966.post-32649189428710822822007-07-30T10:59:00.000-07:002007-08-16T12:05:42.802-07:00What's wrong with cancer medicine? (Cont.)A front-page story from The New York Times, "Drug Sales Bring Huge Profits, and Scrutiny, to Cancer Doctors," published in its Sunday, January 26, 2003 edition, details how cancer doctors--oncologists--make most of their money. "At a time when overall spending on prescription drugs is soaring," the article begins, "cancer specialists are pocketing hundreds of millions of dollars each year by selling drugs to patients." The article goes on to describe the "cancer concession," the practice by cancer doctors of obtaining cancer drugs at low prices from multiple sources and administering--selling--them to their office patients at exceedingly high "mark-ups." The article states that cancer doctors "can make huge sums--often the majority of their practice revenue" from the difference between what they pay "wholesalers, discounters and pharmaceutical companies" and what they charge "patients, insurers and government programs." It has been estimated, the article states, that "oncologists in private practice typically make two-thirds of their practice revenue" from the "cancer concession."<br /><br />That's a lot of money, considering that cancer doctors often just out of residency can generate upwards of $500,000 for their practice annually. Naturally, the more expensive cancer drugs that are administered, the more income generated. Administration of cancer drugs such as Avastin, Lucentis, Revlimid, Sutent, Vectibix and Erbitux--at average per-patient costs of $51,000, $48,000, $67,000,$46,500, $36,000 and $18,000 (per month), respectively--can generate large sums of money.<br /><br />The New York Times article equally points out that this practice by cancer doctors "creates a potential conflict of interest for oncologists, who must help patients decide whether to undergo or continue chemotherapy if it is not proving effective"; that the "inappropriate" sales of chemotherapy to patients in the last stages of cancer was rife within oncology practice (for example, it was found in an audit of a Massachusetts study that "a third of the patients received chemotherapy in the last six months of their lives, even when their cancers were considered unresponsive to chemotherapy"); that the reason for this widespread practice was possibly related to the profit motive. "All evidence suggests that doctors do respond to money," a clinical faculty member at the University of Michigan Medical Center was quoted.<br /><br />Today the treatment of human malignancy has become big business. It has been estimated that the conglomerate of cancer therapy, cancer research, cancer care, cancer administration and cancer pharmaceuticals totals $200 billion per year in the United States alone. The treatment of patients, in a real sense, has become business-driven. Gone are the days when cancer doctors would tailor individual treatments to patients as they deemed necessary or desirable; today instead, patients are placed on what are called 'protocols'--single or combinations of anticancer drugs that are usually experimental in nature. The 'protocols' very frequently emanate from the National Cancer Institute (NCI), which in turn subsidizes oncology group practices throughout the United States--to the tune of hundreds of millions of dollars each year. This puts great pressure of individual oncologists to put away their own treatment initiatives in favor of one or another protocol. Typically the cancer drugs used in a protocol--commonly newly developed from pharmaceutical companies or from the NCI--are very expensive.<br /><br />Oncologists who are confronted with a choice of treating a patient individually, perhaps with an inexpensive new agent, or placing the patient on a protocol, frequently opt for the latter. Not wishing to risk the disfavor of their colleagues, they may be reluctant to place the patient on any new agent--inexpensive or not--that may threaten the lucrative incomes their practices have come to generate and thus kill the goose that lays the golden egg.<br /><br />It is precisely with the advent of 'big business' as cancer practice that loss of innovation--and diversity of effective cancer treatment--has occurred. In this regard the public is regularly deceived. Every week news broadcasts, and headlines, trumpet new cancer breakthroughs. But where are they? How do these stories get on television? The answer is--that they are put there. By hired medical publicists or skilled public relations people. And if one looks carefully enough, many of these 'breakthroughs' are being publicized at the very time the medical groups responsible for them are being considered for major grants from the federal government--the NCI or National Science Foundation. Or a branch of the federal health establishment is petitioning Congress for increased budgetary appropriations. And while the 'hope' generated by these news stories so often vanishes, their underlying fundamentals usually succeed. For the reasons behind these broadcasts and headlines frequently have nothing to do with innovative advances, but with exerting public pressure on funding mechanisms to increase the 'business' of cancer research and treatment. The 'big breakthroughs' fade. But 'big business' prevails.<br /><br />Today we have experienced a "shift" from high scientific achievement to big money achievement in cancer. Individual cancer practice is corrupted by money, and cancer science has become corrupted by money. It is this factor--big money--that is one of the two chief reasons underlying the woeful lack of progress and significant treatment advances in cancer medicine.<br /><br />The other chief factor for the lack of innovation in cancer treatment is the NCI--the National Cancer Institute, part of the federal government.<br /><br />The National Cancer Institute is the single, largest, most powerful cancer institution on the face of the earth. Its budget--received directly from Congress since the National Cancer Act of 1971--currently exceeds $4.75 billion annually, dwarfing by far the annual budgets of all cancer research, cancer treatment, cancer education and cancer fund-raising agencies in the private sector combined. While twenty-five years ago organizations with smaller budgets but with prestigious scientific staff in the private sector were, to an extent, the 'tail that wags the dog' (the NCI), this is no longer the case. With its almost exponential growth in budget, program and funding, the NCI has emerged as the dominant force in all phases of cancer investigation and treatment.<br /><br />The NCI directly funds all officially-designated cancer centers in the United States--and the personnel and projects ongoing in these centers; without the NCI these centers--and their programs--wouldn't exist. The NCI makes institutional grants available to medical centers, universities and academic institutions nationwide; without the NCI much of the faculties of these institutons--and their projects--would dry up. The NCI is the major granting agency for young scientists with innovative ideas as well as for established scientists with many ongoing projects; without the NCI these projects--and scientists--would disappear. NCI officials sit on the editorial boards of virtually every important cancer journal in the nation--and thus exercise strong influence as to what appears in the mainstream cancer literature. NCI has become a virtual tsunami, whose waves crash against the shores of all cancer research and treatment projects worldwide.<br /><br />But the NCI is also a monopoly. And it does what all monopolies do--acts in restraint of trade. Acts in restraint of true innovation. For who on NCI's dole would dare challenge current scientific thinking and directives of those who occupy NCi's highest echelons and formulate policy? Where is the <em>incentive</em> for individual scientists to excel and what if their endeavors lead them in directions that are not <em>welcome</em> at these top levels of power?<br /><br />Monopolies usually tend to quash incentive. That is because incentive is a function of <em>competition</em>. There is no competition in NCI operations--except for monies and position advancement. But monetary and position improvement have nothing to do with true scientific innovation.<br /><br />True innovation is a function of competition of thought. There must be no single monolith. No single source of power so great as to intimidate scientists from submitting grant proposals that are 'unpopular,' proposals outside current mainstream scientific thought--frequently brilliant, unrestricted, challenging traditional scientific concepts--and often the source of large steps forward.<br /><br />There must be several 'NCI's--each independent of the others--that would be in <em>competition</em> with one another and would be rewarded according to their discoveries. The most immediate--and fundamental--advantage of such a structure would be that no one person--or group of cronies--would have absolute control over what research gets funded, what drugs get tested, what papers get published.<br /><br />Naturally, there would be drawbacks to such an arrangement. It could be argued, for example, that there would be much duplication of work--and thus waste of tax dollars. But duplication of work is not necessarily a bad thing. For different scientists working on similar projects can come up with far different results, depending on the mind-set of the scientist, serendipitous occurrences, etc. On more than one occasion individual scientists or a group in competition with others--working on the same project--have 'cracked the code' of discovery and cure, such as the isolation and purification of insulin, the development of the polio vaccine, the identification of human immunodeficiency virus (HIV) and more.<br /><br />The brilliance of scientific discovery bringing large public benefits has always been based on a milieu of competition and incentive--the competition of ideas and the incentive and freedom to carry them out. Until the NCI's concentration of power is lost--and with it the inhibition of these aspects of human inquiry in which great discoveries reside--there will be little and few signifcant steps made in the defeat of cancer.<br /><br />Thus big money and the NCI, our best hope for protection against cancer, are largely responsible for the treatment abyss surrounding this disease of the last 30 years. Big money has corrupted--and acted to dethrone--the primacy of high clinical and scientific achievement in favor of high money achievement. The NCI, and its centralization of power, paradoxically has acted to stifle new ideas, new advances and true innovation.<br /><br />In my opinion, it is these two factors which have contributed majorly to the lack of progress in cancer medicine.Dr. Joseph Goldhttp://www.blogger.com/profile/00368001273179577986noreply@blogger.com3tag:blogger.com,1999:blog-1335007907715618966.post-20614145010450435692007-07-19T08:49:00.000-07:002007-08-16T11:30:01.574-07:00What's wrong with cancer medicine?In recent decades there has been a plethora of clinical advances--in heart medicine, in stroke, in diabetes and other endocrine diseases, in respiratory illnesses, in infectious disease, in orthopedics--but very little progress in the treatment of cancer. One only has to look around--at his neighbor, at his family member, at his workplace acquaintance, at his friend or loved one afflicted with such major cancers as lung, brain, gastrointestinal, even breast cancer--to know that those major killers have hardly been indented by modern medicine.<br /><br />To be sure there have been scientific and clinical advances--duly reported by the medical media--made in the field of cancer research, but most of these advances have not resulted in any "transitional" gains that have really advanced clinical cancer treatment.<br /><br />Yet the public has been made to think we are making great strides in the treatment of cancer. Night after night, week after week, our electronic media announce new scientific discoveries that "promise" to advance cancer treatment. And every so often we are reminded of the large "victories" being made in cancer survival. But one of these victories in overall survival is in "skin" cancer. What we are not told is that included in this category of cancers are "basal cell tumors," comprising by far the great majority of this group of cancers. The survival rate of basal cell cancers is almost 100%, no matter what medical action--if any--is taken. If one subtracts basal cell tumors from overall cancer survival, the overall survival rate dramatically decreases.<br /><br />Several months ago it was announced that a major advance had been made in breast cancer, decreasing the incidence of this disease in postmenopausal women. But it turned out that this decrease was not due to any new advance but to tens of thousands of women giving up their monthly hormonal replacement therapy (HRT) which was being shown--contrary to their physicians' prior belief--to actually cause breast cancer. Thus this scientific "advance" was not a treatment advance at all but merely a deletion from therapy of a medication causing breast cancer.<br /><br />Closely related to advances in the treatment of breast cancer are mammograms. Women, especially over 40, are recommended to have yearly mammograms. Mammograms are radiation and this form of radiation is well known for its life-saving benefits, in the form of early diagnosis. What is not so well known--and is at the heart of the continuing heated debate in the medical profession as to whether especially younger women should receive mammograms--is that radiation can also <em>cause</em> breast cancer. Even in the low doses in mammograms. Thus, while mammography's usefulness in the field of early diagnosis is not in dispute, it has been estimated by some epidemiologists and cancer statisticians that a single mammogram actually <em>increases</em> the cumulative likelihood of breast cancer in a woman by 0.3%.<br /><br />Regional and national cancer fund-raising events--"walkathons," "marathons," "bike-athons," "races," "relays"--and the publicity given them also act to give the impression that the cure to cancer can be imminent. These events attract thousands of participants who contribute funds to the sponsoring organizations, believing sincerely that their efforts may help to bring about the "cure." But the tired truth is that the funds these events raise--reinforcing and strengthening the sponsoring organizations--frequently find themselves in the hands of the same old scientists and researchers, who sit on the same old federal and large private-sector granting (peer-review) committees of our cancer agencies, frequently for the same old projects or variations thereof.<br /><br />In contrast to the rosy picture painted by our periodic promising communiques in the medical literature and medical media, qualified cancer experts have in fact affirmed that overall cancer survival has not significantly changed in the last 30 years.<br /><br />What accounts for this woeful lack of progress?<br /><br />There are two major causes of this tragic situation. One is money, the other is the way cancer funds are distributed. These will be discussed in detail in our next blog.Dr. Joseph Goldhttp://www.blogger.com/profile/00368001273179577986noreply@blogger.com2