Tuesday, December 9, 2008

Can 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?

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 expensive 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.

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.


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 per se? 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?

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?

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.

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.

As to the pricing of new drugs, especially those for treating cancer, the sky's the limit. For example, the drug Erbitux was initially priced at $12,000 per month and was subsequently raised to $18,000 per month (even though studies showed it to be only minimally useful). The drug Avastin was priced at $46,000 to $56,000 per-patient cost; Vectibix, $36,000; Lucentis, $48.000; Revlimid, $67,000; Sutent, $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.

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--
the financial wherewithal of individuals to bring up families and to otherwise enjoy life's many directions.

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.

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?

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.

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.

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.

Saturday, September 27, 2008

"Stand Up to Cancer"

About a year ago a blog was published on MedTruth, "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?

On Friday evening, September 5, 2008, all three major television networks--NBC, ABC, CBS--simultaneously telecast 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.

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?

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 $4.8 billion. 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 $5.0 billion annually, and the additional funds raised by this extraordinary gathering of dignitaries, celebrities, scientists, presidential nominees, news anchors, cancer advocates--$100 million--represents only 2 percent of available, annual cancer research funds. Will this make a significant inroad against cancer?

These additional funds raised by SU2C are to be relegated largely to translational 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.

The American Association for Cancer Research (AACR)--one of the large-scale cancer research organizations referred to in Is Bigger Better?--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.

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 individual 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.

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.

August Kekule 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 Fermi, 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 Banting, 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 the treatment regimen for millions of people all over the world with diabetes mellitus. Alexander Fleming, 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 Salk, 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 Heidelberger 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 Watson, Francis Krick, Rosalind Franklin and Maurice Wilkins, 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 Mullis, 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 Montagnier and Robert Gallo, 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 Einstein. A 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").

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.

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 who 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 inorganic 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 did 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.

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 heart 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 competition with one another, each turning out to make great, individual contributions, one an oral vaccine, the other an injectable. Watson, Krick, Franklin and Wilkins were all competitors, 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 truly the discoverer of HIV.

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 MedTruth 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?

"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.

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."

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.

The Stand Up 2 Cancer 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.

Friday, August 15, 2008

Cancer and obesity

This 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.

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 MedTruth has already indicated to be the case in cancer cachexia--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.

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.

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?

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?

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.

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.

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 know they're overweight.

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.

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.

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 likes 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.

Another aspect to this same question is, Do people get pleasure eating?

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.

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.

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.

Do people get pleasure eating? Yes they do.

At this juncture it is apparent that people who are overweight know they are overweight, know 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 reinforces 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 election of self-destruction 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.


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?

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?

What determines self-esteem? Self-esteem involves contemplation of the self--our overall raison d'etre--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?

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, The Voyage of Life (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.)

But we have given up living for our selves--living to express our individual purpose. Living to fulfill our "contract" with life.

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.

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.

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.

Can the loss of purpose be reversed? Yes, it can.

There are generally two ways to change our lives--redemption and reclamation.

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.

Reclamation, 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.

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.

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.

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.

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.

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.

Tuesday, June 17, 2008


Quackery 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, knowingly 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.

The term quackery 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.

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.

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 Charlatan (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.

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 (Racketeering in Medicine, J. Carter, 1993).

As detailed in a front page article from a recent Sunday edition of The New York Times, "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 a third of those patients [in the study] received chemotherapy in the last six months of their lives. even when their cancers were considered unresponsive to chemotherapy" (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 greater 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 Times article.

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.)

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.

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.

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.

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.

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.

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.

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.

Even books like Charlatan, 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.

Thursday, May 8, 2008

The 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."
--Michael DeBakey, M.D.

Webster defines euphemism as the "substitution of a mild, indirect or vague expression for one thought to be offensively harsh or blunt."

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.

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!"

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 imply that great progress has been made--and there is only a little way left to go. That only simple measures 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.

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 all 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."

Another type of ad illustrating the euphemistic opposite which appears with surprising frequency, is the all-female oncology team--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 team treatment, 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.

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 funding mechanisms 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.

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.

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?

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 brand new projects! Maybe ones you don't even agree with--that are unpopular with your scientists. We need new ideas!"

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."

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 that team!"

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.]"

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...."

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.

Wednesday, March 26, 2008

The Jarvik affair

In July 2007 the blog "Ask Your Doctor" was published on MedTruth, 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.

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.

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.

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 New York Times--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, Lipitor.

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.

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 Lipitor." During the ad campaign Dr. Jarvik says: "I take Lipitor."

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 Lipitor.

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 Lipitor. 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?

$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 Lipitor. Pfizer then revealed it has spent more than $258 million advertising Lipitor, most of it on the Jarvik ad campaign!

During his ad campaign Dr. Jarvik additionally enthuses over Lipitor "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 Lipitor is thus open to question.

All advertising campaigns have a "director"--usually an advertising agency or public relations firm. But in the case of Lipitor, 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.

While we do understand that national spokespersons for ad campaigns such as for Lipitor 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.

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 billion dollar ad campaign designed to make Pfizer a fortune, would that erode your confidence in Dr. Jarvik's message?

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 Lipitor? 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?

If you knew that Dr. Jarvik let you believe he was on Lipitor while reciting its benefits--but actually was not--would the integrity of his message be altered for you?

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 clinical benefits of Lipitor?

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?

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 Lipitor is in some way associated with excellent physical health. Dr. Jarvik's setting for Lipitor's clinical benefits is by personal example--even though he is not taking it. Dr. Jarvik allows you to think his recommendations for Lipitor 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.

The Jarvik ad campaign illustrates the many untruths inherent in pharmaceutical ads. The New York Times 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.

Wednesday, February 20, 2008

A 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.

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.

How did this situation arise?

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?

In deciding whether a drug is active or not, one should never 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 studies 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.

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 claims..." 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. It is the studies. Dr. Gold is simply relating the results of studies--controlled clinical trials performed according to internationally established and accepted scientific criteria.

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.)

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 Cancer Research, Journal of Clinical Oncology, Cancer, The Lancet, Investigational New Drugs, and others, considered among the most respected, 'premiere' clinical cancer and scientific journals in the world.

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.

The Russian (Petrov Institute) and Harbor-UCLA studies of hydrazine sulfate were in full conformity to the Helsinki Declaration.

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 independent confirmation 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.

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?

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.

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 both 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, Megace, 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, Megace, 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.)

The three NCI-sponsored studies were published in the Journal of Clinical Oncology. 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 sequentially as lead articles in the same issue (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 dramatize 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].)

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 no incompatible agents (medications) be used in a drug trial. 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 suspected of incompatibility--is virtually unknown in human biomedical testing.

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--monoamine oxidase--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.)

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 presented (or accepted) for publication--no less "arranged" for sequential publication or appearance in the electronic media.

The NCI-sponsored studies of hydrazine sulfate were out of compliance with the Helsinki Declaration.

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 independent confirmation 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.

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 both 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 two of the studies)--there was no independent confirmation 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.

Who--which studies--would you stake your life on?

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:

"There is only limited evidence from animal studies [i.e., no human studies] that hydrazine sulfate has anticancer activity."

"Hydrazine sulfate has shown no anticancer activity in randomized clinical trials [the "gold-standard" of clinical trials]."

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?

Chlebowski RT, Heber D, Richardson B and Block JB. Influence of Hydrazine Sulfate on Abnormal Carbohydrate Metabolism on Cancer Patients with Weight Loss. Cancer Research 1984; 44:857-861.

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. The Lancet 1987; 2:241-243.

Chlebowski RT, Bulcavage L, Grosvenor M, et al. Hydrazine Sulfate in Cancer Patients with Weight Loss. Cancer 1987; 59:406-410.

Chlebowski RT, Bulcavage L, Grosvenor M, et al. Hydrazine Sulfate Influence on Nutritional Status and Survival in Non-Small-Cell Lung Cancer. Journal of Clinical Oncology 1990; 8:9-l5.

No human studies done? The above represent 4 of the 15 human studies done since 1975. No randomized clinical trials? All the above are randomized clinical trials. 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.")

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.

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.

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...."

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.

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.

But there is something else you can do.

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.

We must do something to elevate our chances of survival from a dread disease to those our cherished animals currently enjoy.