Migramatic Shock:Alan Milstein on the Stanford Prison Experiments

Alan sounds off on the Jon Stewart oddity of the year:

What a Milgramatic shock to see Phillip Zimbardo on Jon Stewart the other night to promote his new book. Zimbardo, of course, was the Principal Investigator of the Stanford Prison Experiment in 1971, in which healthy volunteers were recruited to participate in a psychology experiment to explore, allegedly, how good people turn evil. (The subtitle of his new book.) He has made a career and, apparently, a nice living on a human research project regarded by most bioethicists today as patently unethical because it offered all risk and no benefit to the student subjects.

One of the main disincentives to even considering an unethical experiment, in addition to the threat of being sued by an enterprising plaintiff’s lawyer, is supposed to be the prohibition against publishing or promoting the results of such a study, even if scientifically sound. That has never stopped Zimbardo or his handlers. The Professor was even brought in to testify on behalf of one of the Abu Ghraib prison guards, opining that his experiment yielded scientific proof that human beings could not help themselves in such situations from turning cruel. The testimony, according to Zimbardo himself, was ignored by the tribunal.

What Zimbardo has never understood is that human beings simply should not be treated as a means to an end, as mere guinea pigs or, to use the terms from another horrible era, logs or material. When an experiment crosses that line, the only evil it finds is in the researcher.

Alan Milstein on Pfizer and Torcetrapib

The media coverage of the recent termination of the Pfizer torcetrapib clinical trial has been nothing short of startling in this age of aggressive investigative journalism. In short, the stories have been about Money, Money, Money. In announcing the halt of this experiment after a finding that human subjects had died because of their participation, the New York Times announced, “End of Drug Trial is a Big Loss for Pfizer.” Bloomberg broke the story by observing: “Pfizer Shares Drop After Company Abandons Cholesterol Drug.” The Toronto Star had a different take: ‘Drug Failure Cost Pfizer 23 Billion.”

In its front page story, the New York Times further added this remarkable conclusion: “Pfizer will not face the product liability lawsuits that have dogged Merck over its painkiller, Vioxx . . . Patients in clinical trials must sign waivers confirming that they understand the risks they face when they take unapproved medicines in clinical trials.” Do they?.

Why am I skeptical? Money. Money. Money. Pfizer had long touted this drug in meetings with shareholders, actual and potential, as the Mother of all Blockbusters. Could this potential have delayed the end of this experiment, even though some researchers had long warned that such drugs might actually pose more risks than benefits.

Two aspects of this trial, what surprisingly little we know about it, trouble me. First, the experiment took place largely in the offices of thousands of cardiologists across the country. What this means is that the subjects may have been induced to participate by their long trusted physician and signed on not to better mankind (or “Pfizer”) but because they believed their physician thought it was in their best therapeutic interest to do so. This might make the informed consent document neither voluntary nor informed.

Second, Pfizer says the delay in halting the trial was because this was a double blinded experiment with one arm taking Lipitor only and the other adding torcetrpib. Only when the data managing subcontractor removed the blinds were the devastating results revealed.

Call me naïve (I’ve been called worse), but why double blind a study where the data is comprised of good and bad cholesterol numbers? Does anyone believe there could be a placebo response that would raise good cholesterol? I have long advocated that the industry’s reliance on this “gold standard” is not always to eliminate researcher bias or that dreaded placebo response. Sometimes it is to keep subjects and physicians in the game. And if this had not been a double blinded study, could the ongoing results have been known to the physicians and disclosed to their patients earlier?
Alan Milstein