Friday, May 1, 2009

Let Me Go Back . . .

The trigger for this writing is the first sentence that appears in Paul Krugman's op-ed column in today New York Times. "The 2008 election ended the reign of junk science in our nation’s capital, and the chances of meaningful action on climate change, probably through a cap-and-trade system on emissions, have risen sharply."
I know about junk science. It has been more than twenty years and I am still licking my wounds. At the time, I represented more than 400 children who had been born with a variety of limb deformations. Approximately eighty of these children had both arms missing above the level of the elbow. The remainder had single amputations. All of these children had one thing in common; Their mothers took the drug Bendectin between days 28 and 56 of their respective pregnancies. When trying to prove that a drug can cause birth defects, it is necessary to look at a great deal of indirect evidence. Testing at the microscopic level revealed that Bendectin was capable of damaging the integrity of cells in a manner necessary to implicate the drug in causing birth defects. A substance that causes such cellular damage is labeled a mutagen. Bendectin was labeled a mutagen by the federal government in 1988 and the mutagenic effect was confirmed by a variety of subsequent research projects. In addition, a wide variety of animal research in which Bendectin, or its various components, were administered to pregnant animals and the offspring of these animals were examined in detail. Damage to the cells that ultimately become limbs was observed in multiple animal studies involving multiple animal species and was dose-related, a cardinal sign of a potential effect in the human. Then there were the human studies. One of the drug company's defense expert witnesses characterized the dilemma of human studies in his scientific writings. "Epidemiology is like a brief bikini bathing suit. What it reveals is interesting, but what it covers up is critical." Most of the epidemiology studies conducted on Bendectin defined exposure to the drug as women having taken the drug through 120 days of pregnancy. This group was then compared to a control group of women who had not taken the drug and the presence or absence of children born with various birth defects in both groups was compared. In these studies, it was a mistake to include women as being exposed to the drug when they started receiving the drug only after the critical period of limb development had been completed, i.e. after 56 days of pregnancy. For example, a woman who began Bendectin on the 85th day of pregnancy had done so at a time when the limbs of her baby were not in jeopardy of being damaged. Nevertheless, she would be included in the group of Bendectin exposures. The net result of this mistake was, of course, the conclusion that Bendectin was safe. I hired an eminent epidemiologist who reanalyzed all of the various epidemiology studies by eliminating this time discrepancy. Only cases in which the mothers actually took the drug during critical periods of limb development were considered as being exposed. The result of this reanalysis showed clearly that the likelihood of Bendectin causing limb defects was more than three times greater in a mother receiving Bendectin than those who did not. The reanalysis was labeled as junk science by the defendant drug corporation (because a plaintiffs' lawyer had paid to have it done) and that tag stuck with the federal judges who heard the same evidence in case after case and threw out successful verdicts in cases across America. Bendectin litigation became the poster child of junk science for the right wing's campaign against lawsuits to hold corporate America accountable for the harm its products caused.

The point of this diatribe is to illustrate how the machinations of the drug company and the federal judiciary in this particular very important piece of litigation served as the forerunner of the current status of science involved in larger questions today. Global warming? Junk science. Throw it out. Harmful effects of carbon dioxide? Same. Throw it out. What a breath of fresh air, literally and figuratively, to finally have politicians in place who seem to understand that the country needs to get back to a system of thought where a decision is made after information is presented. Only demagogues decide what an answer is first and then cherry pick evidence to support the ill-founded conclusion. Let me go back . . .

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