Tuesday, February 22, 2011


“If people knew what we’re planning....”
“They’d think it outrageous!”
“By the way,” he said to his boss, “how’d this place get that funny name?”
“Because everything we do,” Marvin Dairywhimple replied, “our critics say is outrageous.” A crooked smile crossed his face. “So at first we replied, ‘You’re right, everything we do is outrageous.’ And just to lampoon them we further stated, ‘If you want to be treated for cancer, go to all those snake-oil salesmen with their roots and nostrums and see how far you get. If you want anything that’s effective—you’ll have to come to us: the “outrageous” ones.’ So we became known as the Outrageous Cancer Institute—the ‘OCI.’ Even Congress recognizes us. We’ve become the largest cancer institute in America, the most important in the world!”
Dexter Weinblut, deputy Director of Outrageous, regarded his boss. “But, Marv,” he said with a hint of rectitude, “we just can’t go through with this. This might be an effective drug!”
"And an inexpensive one! Remember, all our money comes from the fact that cancer drugs are expensive! The pharmaceutical companies that fund our programs! The people who stand up and volunteer hundreds of millions every year! The academic community that runs our protocols! Even the hick members of Congress who want to start giving us public funds!”
“But Marv, if they ever catch wind of—”
“They won’t! By the time we’re through with ‘blueberry lincture,’ they won’t want to hear those two words again!
“And that goes for the Boom-Bay Cancer Institute!” Dairywhimple asserted.
“But, Boss. They’re a legitimate cancer institute—even though they’re tiny. What’s wrong with them?”
“They’re the ones that developed ‘blueberry lincture,’ you idiot. Do you want the public to begin thinking that a small institute located on an obscure lagoon in Michigan has developed a cancer drug—from blueberries of all things—that is eclipsing our work, when Congress is getting ready to shell big bucks out of its pockets for us?”
“But, Marv. It’s a legitimate drug. A phtheric alcohol extract fraction of blueberry skin, I’m told.”
“Yes, and it works! We’ve already tested it in mice. But if the news gets out—a small institute on a small budget coming up with the first drug that’s useful against all cancers—it’ll wreck our cancer program. Our institute will really become ‘Outrageous.’ We won’t get any big money from Congress. We won’t be the national leader of cancer research anymore. And we won’t be the world’s clinical headquarters of cancer treatment.
“And besides,” Marvin Dairywhimple heaved his chest. “What if blueberry lincture achieves nationwide clinical testing—where does that leave us?”
Dexter Weinblut watched the expression of sudden revelation enter his boss’ face. “Yes…” Dairywhimple breathed. “What if blueberry lincture achieves nationwide testing—and fails?”
“Boss, we couldn’t....”
“We could!”
“We’d never get away with it!”
“Won’t we?” The misshapen smile returned to Dairywhimple’s face.
“Dexter. I want you to put out a bulletin on blueberry lincture. Say we recognize it is promising—say something nice about Boom-Bay in Michigan. Say we think the drug’s so promising, we’re going to sponsor nationwide testing of it—to confirm its effectiveness and safety. And say if it’s effective, we’ll be looking for a pharmaceutical partner to make it available to the world. And then get me Gardner Crookshank on the phone!”
“Crookshank!—But he’s head of the Creme-Cone Cancer Center. That’s where we send all our studies when we want them to come out negative!” The oblique smile became pronounced on Dairywhimple’s face.
“Yes, isn’t it, Dexter…. Sometimes I’m amazed at your lack of vision.”
“Boss…you’re a genius!”

“So why did you want to meet me here?”
He watched the hundreds of people milling about the indoor promenade. “Because at the Fifth European Congress of Cancer Therapeutics, no one would think it unusual seeing us together.”
“All the way in London?”
“So much the better,” Dairywhimple replied. “There’s a pub nearby. Let’s go grab something.”
The two were seated at an old-fashioned wooden booth, a matching, highly varnished table between them. Two glasses of sparkling amber liquid occupied its shiny surface.
“Mmm. This beer tastes good,” Crookshank said. “Different. You know you’re on the continent.”
“Have you thought over my proposition?”
“Yeah, Marv. I have. I don’t mind accommodating you, but it’s risky. Risky business. For me, that is. What’s in it for me? For Creme-Cone? We’re one of the most reputable cancer centers in the country. Cutting edge research, clinical programs unmatched by any other—”
“You know as well as I,” Dairywhimple interjected, “if blueberry lincture makes it, we’re all finished! Our country’s cancer leadership—the big fund raisers—Congress—will all think that all it takes is one organization—even a small one—with one idea—to come up with a drug that is effective against all kinds of cancer—and at every stage! What will they need us for? We’ll be scientific dinosaurs. We’ll go out of existence!”
Crookshank looked straight ahead, his eyes focused beyond the figure of his companion. “Yes,” he muttered. “I suppose you’re right.”
“Our cancer hospitals,” Dairywhimple pronounced. “Our cancer centers. Our cancer programs. The respect people accord us. All gone!”
“Don’t forget the funds.”
“Yes…the moneys.”
“Marvin, your face is too long. Remember, we’ve been there before. All those other alternative medications and treatments—”
“Yes, but this one’s different. The science behind it is impeccable!
“Even people like Dexter, they know it’s—”
“Effective?” Crookshank lifted his gaze directly to Dairywhimple’s face. “Some of the others had good science, too. Where are they now? But assure Dexter—and others of his ilk—our programs are always coming up with new, effective drugs….”
The two emptied their glasses. “Well,” Dairywhimple said, “what do you say we go back to the meetings?” A distorted smile occupied his face.

“We can’t do that,” Dexter remarked, his voice approaching self-righteousness.
“Yes, we can and we will. Thiotonizone is our best anti-emetic. We use it in all our studies—prevents vomiting.”
“Yes, but blueberry lincture doesn’t produce vomiting.”
“Doesn’t matter. The disease itself produces vomiting. It’s so common, it’s known as ‘Tony.’ It’s used in the emergency rooms to treat food poisoning. People have it in their medicine cabinets....”
“Boss, blueberry lincture is a triethylamine reductase inhibitor—a TEAR inhibitor. And ‘Tony’ is incompatible with TEAR inhibitors. The pharmacology textbooks—over the last thirty years—all say that the two together are a ‘clinical hazard.’”
“Look, everybody knows that ‘Tony’ is the mildest of sedatives. And besides, we’ll challenge that blueberry lincture is a TEAR inhibitor—”
“But the pharmacology textbooks all say—”
“Damn the pharmacology textbooks! We’ll say they’re wrong! Who should know better, the writers of those stale chapters of the last century—or the most highly regarded contemporary experts of today—” The crafty smile returned to his face. “Who happen to be on our staff?”
“But, Boss. The Informed Consent Form that each patient is required to sign. We’ve got to put down somewhere in it that the use of blueberry lincture and 'Tony' together may cause sickness—even death.”
“What are you talking about?”
“That a TEAR inhibitor plus ‘Tony’—or any sedative—may result in morbidity or mortality!”
“A TEAR inhibitor? What TEAR inhibitor?”
“But, Boss, they’ll die….”
“They’ll die anyway.”

She sat on the couch, across the way from him, the open sheet of paper dangling in his hand. The letterhead on the paper said, “Chicago Northwest Medical University,” the address block: “Adam Mohr, M.D., Ph.D., Distinguished Professor of Experimental Oncology.”
“I can’t understand it,” the woman was saying. “They actively campaigned—for over a year—to get you here. They just can’t fire you!”
“Oh yes they can!” His eyes scanned the computer-written page once again, as the woman had before him. “Dear Dr. Mohr,” the page had cryptically read, “the Division of Experimental Studies, which you chair, by action of the Trustees, has been abolished commencing immediately. We regretfully have to ask your departure from your post at your earliest convenience, in that the funding for the Division’s activities has terminated. The faculty joins me in wishing you bonne chance in your search for a new position.” It was signed by Jerry Bernard Henry, Dean.
“I don’t have tenure here,” he said to his wife. “I was hired ‘at the behest’ of the Chancellor, like so many of the main people here at the university. And I can be fired the same way…but why?
“I don’t know…” he answered his own question. A look of sudden introspection came over him. He let his mind go to about three weeks previously. It was on the blueberry lincture study. They were accruing 57 patients in the 400-patient nationwide study sponsored by Outrageous and under the protocols of Creme-Cone. They were non-small cell lung cancer—NSCLC—patients. He had reviewed all their charts and noticed that a sub-group of early patients—23 in all—were beginning to do well until they were placed on thiotonizone—‘Tony.’ Hey, wait a minute! an inner voice reminded. Wasn’t blueberry lincture a triethylamine reductase—TEAR—inhibitor and wasn’t ‘Tony’ incompatible with that? He pulled those 23 patients off ‘Tony’ right away and they once again began to improve.
About three days later he was asked to see Dean Henry.
“Adam,” Jerry Henry had expressed, “do you have any idea why I’ve asked you to drop by?”
“It’s that we’ve gone off protocol on part of the blueberry lincture study. By your doings. Creme-Cone and Outrageous have heard about it and they’re raising hell! To our Chancellor and Trustees. They know why you changed the protocol—you think blueberry lincture is a TEAR inhibitor and they want you to restore the protocol—to follow the original protocol as stated—with no changes!”
“But blueberry lincture is a TEAR inhibitor and adding ‘Tony’ to it will only make those patients die and make the study fail!”
“Not according to the experts they’ve assembled who all say to a person that the textbooks are wrong, blueberry lincture is NOT a TEAR inhibitor.”
“I don’t care what they say. The proof is in the pudding. Once I pulled these 23 off ‘Tony,’ they improved immediately. You don’t think I’m going to permit these patients to die and permit these studies to fail because blueberry lincture is cheap and a bunch of cocked-up, so-called academic scientists say that the lincture is not something that every book published on drug interactions in the world says that it is?”
“Adam, what we are threatened with is not only a loss of our major cancer grants but also a loss to our university’s largest bloc grants. I am going to have to insist that you adhere to the study’s original protocols.”
Adam Mohr sat facing his wife, no further word said between them. The page in his hand dropped to the floor, neither of the two figures bending to pick it up again.

“’Boom-Bay is beginning to raise Cain!”
“About their studies?”
“Yes,” Dexter answered. “They’re all positive.”
“But small,” Marvin Dairywhimple responded. “Thirty-six patients, 65, 44—not enough in all these to establish statistical validity. Too few patients to achieve any semblance of statistical significance. The only thing these studies show is statistical deficiency.”
“But, Boss, that’s not so. The studies are smaller than ours but statistically accurate. Our own statisticians can’t find anything wrong with them....”
“Maybe privately so,” Dairywhimple answered. “But did you know, The Journal of Biostatistical Applications is coming out with a paper—in a few weeks actually—that will blast the Boom-Bay studies out of the water!” The slanted smile once again appeared on Dairywhimple’s face. “Yes, the Journal will claim—in the strongest language—I’ve seen the proof sheets myself—that each of the studies was ‘too small’ to achieve statistical validity, ‘that the power to detect the treatment effect was statistically low, leading to “false-positive” results,’ and—get this—‘the biological reasons for believing in a treatment effect due to blueberry lincture are not compelling.’ The article ends by recommending: ‘the scientific community must remain skeptical of Boom-Bay’s results.’
“No, Dexter, I don’t think we’ve got anything to worry about in Boom-Bay’s studies.”
Dexter Weinblut looked at his boss’ face a long moment before continuing. “That’s not all,” he advised. “Boom-Bay has put out the word that all our studies are in violation of the Nuremberg Declaration!” He watched the slanted smile and all other expression disappear from his boss’ face.
“They’ve pointed out,” Weinblut continued, “that our country is a major signatory to this international ratification—that governs the conduct of all human biomedical research. You’ll remember that it’s an outgrowth of the Nuremberg War Trials—against the Nazis’ horrific ‘experimentations’ on helpless people—adopted to guarantee that no patient in a new study is harmed by the conduct and procedures of the study. As you know, every new study published in the medical literature is required to carry the statement: ‘Performed in conformity with the Nuremberg Declaration.’” Weinblut paused, allowing his boss to digest the news. “Boom-Bay states that our studies have violated the ‘generally accepted standards’ rule—Principle 1—of the Nuremberg Declaration. They spell it out: ‘Biomedical research involving human subjects must conform to generally accepted scientific principles and be based on a thorough knowledge of the scientific literature.’ Boom-Bay goes on to say our studies are using an incompatible agent—‘Tony’—in the presence of a TEAR inhibitor—blueberry lincture—and that never in the history of drug testing has an incompatible agent been used with a test drug—since the two together can sicken or kill patients and bring down a study."
Marvin Dairywhimple screwed up his face and addressed Dexter without heightened emotion.
“Hrrumphh! Well, we were expecting that—and it all rests on whether blueberry lincture is a triethylamine reductase inhibitor. A TEAR inhibitor. Our experts all insist it’s not. Many—not all—of the textbooks say it is. But they offer no proof. So it’s our word against theirs. As long as our scientific advisors maintain there is no incompatibility here, we have not violated any Declarations nor are our studies flawed....”
“It’s not that simple,” Dexter interjected. “Boom-Bay’s caused an Office of Scientific Assessment investigation of our studies.”
“I know. They’re in their seventh month. The government’s watchdog agency.”
“The lead investigator is Bob Doyle,” Weinblut supplied. “He’s a thirty-year veteran investigator of the OSA and I’m told he’s put together a hard-hitting Final Draft Report against us that’s soon to be published. I’m told he’s of the opinion—but doesn’t know for sure—that blueberry lincture is a TEAR inhibitor.”
“I know,” Dairywhimple repeated. “A 28-page diatribe—with a bad title: ‘Outrageous Studies Spur Continued Controversy Over Blueberry Lincture Therapy.’ The report says the issue of incompatibility of blueberry lincture and thiotonizone is not ‘settled.’ It says our studies are flawed.”
Weinblut eyed his boss cautiously, unaware of Dairywhimple’s apparent, thorough intimacy with the OSA report. “Maybe we can send a delegation to speak to Doyle,” he offered.
“That smart-ass’ll be removed.”
“What about his report?”
“It’s already being rewritten,” Dairywhimple replied, a look of self-satisfaction overspreading his features. “Its title: ‘Outrageous Studies of Blueberry Lincture Not Flawed.’”
Weinblut again eyed his boss, this time for a long moment. “There’s a fly in the ointment,” he said at last.
“What’s that?”
“I was speaking to some of my contacts at Human Services the other day and they told me the government’s quarterly, Alternative Medicine, will soon feature a report on blueberry lincture. I’m told its first sentence will be: ‘Blueberry lincture is a triethylamine reductase—TEAR—inhibitor.’”
“Yes,” Dairywhimple replied, his eyebrows rising. “I’ve heard about it too. In fact, I went to see Philip Grun, Assistant Secretary of Health Affairs. I explained to him that because of the confusion surrounding blueberry lincture, bringing out the article in Alternative Medicine at this time may result in more injury to the public health than in anything positive. He agreed. We agreed that the article will be put off until four years from the time the newly rewritten OSA report is issued.” Dairywhimple paused, then continued.
“By then, I will assure you, Dexter, no one will care whether blueberry lincture is a TEAR inhibitor or not.”
Weinblut sat motionless, stunned by his boss’ words. At last he spoke: “But Boss, if patients keep calling us—like they have—what are we supposed to say to them?”
“We’ll simply tell them that doctors get cancer too, that doctors’ families get cancer—don’t you think if blueberry lincture were any good we’d use it for our own selves?”
“But Boss. Boom-Bay says it receives about twenty calls a day from doctors—for their own selves….”

Dolores Jaynes sat before the expansive desk, awaiting word from the grey-haired, middle-aged gentleman seated behind, having met him for the first time a few weeks prior.
“I am afraid I have no good news for you, Mrs. Jaynes,” the middle-aged man spoke. “Your tests show the cancer has spread. To the bones and liver. There’s no curative treatment I can recommend, but we’ll use chemotherapy and radiation to try to slow it down.”
“Doctor,” she responded, “you know I’m a schoolteacher. I teach computer science. I’ve been on the Internet and reading a lot about something called blueberry lincture.”
She saw a frown immediately displace his previously pleasant expression.
“There are reports it could be very helpful in my condition. Without exerting serious side effects.”
“Yes, we’ve been hearing a lot about blueberry lincture lately,” the doctor agreed. “But I’m afraid I can’t recommend it to you.
“It’s been shown to be ineffective in nationwide tests sponsored by Outrageous Cancer Institute and under the direct conduct of Creme-Cone Cancer Center protocols. I suppose you know they’re the two leading cancer authorities in the world. I’d have to pay strict attention to their recommendations.”
“But there’s a controversy to those studies. There’re smaller studies showing the drug to be effective and safe.”
“I know, I know. Something about Outrageous using incompatible medications in a drug study. You don’t believe that, do you? The largest cancer institute in the world making such a basic mistake? Outrageous convened a panel of experts—who affirmed there were no irregularities whatsoever in its studies. I’d have to go with that.
“And those smaller studies,” he continued “—done by Boom-Bay Cancer Center in Michigan—a tiny cancer institute, really. Yes they were positive, but they were also too small to be conclusive. They did not achieve what is called statistical significance.” His face showed no emotion as he said, “I’m sorry, they’re clinically meaningless.”
“Did you read them, doctor?”
“Read them?” He looked toward the door leading to his office. “Take a look at the waiting room. All the patients. Waiting to see me. Think I have time—a morning or afternoon—to spend before a computer or in a medical library every week reading studies? No, I haven’t read them. In fact, I haven’t read a medical journal from cover to cover in years.”
“Then you don’t know the Outrageous/Creme-Cone studies are said to be in violation of the Nuremberg Declaration?”
“The what?”
“Nuremberg Declaration.”
“Look, Mrs. Jaynes. I never heard of the ‘Nuremberg Declaration!’ I don’t know what it is.” His expression was filled with genuine empathy. “I know what you’re going through. I see it with many of my patients. I’d like to recommend blueberry lincture to you, but we doctors—we can’t read all the studies. We’ve got to take the word of somebody. And the best authorities we know are Outrageous and Creme-Cone. They’re the very best in cancer. We’ve got to take their word for it. Even the government—the Office of Scientific Assessment—has done a months-long investigation of the Outrageous studies and found them not to be lacking and unflawed.”
“I still don’t believe that blueberry lincture can’t be helpful. Those smaller studies—that are not in violation of the Nuremberg Declaration—show it to be therapeutic for a number of cancers.”
The doctor leaned over to the patient and saw the tears welling up in her eyes as she prepared to leave. His heart went out to her, wondering what words he might express to erase any further thoughts of the medication on which she placed so much hope.
“Mrs. Jaynes,” his voice was kind. “We doctors get cancer, too. Our families get cancer. Don’t you think if blueberry lincture were any good, we’d use it for ourselves…?”