A Growing Awareness of a Problem: Focusing Our Microscopes on the Elephant in the Lab

By Bruce W. McNulty, MD
This article is part of our MedRIB project and was published April 24, 2008.

It would appear that public awareness of the issues we are discussing concerning the credibility of medical research data is increasing. It is not hard to find frequent references to this in the popular press. Two recent examples, one in The Chicago Tribune and another in The New York Times, provide examples of the problem of research integrity and how some doctors are taking measures to safeguard their reputations.

Let’s look first at the troubling story in the April 6, 2008 edition of the Chicago Tribune, which can be found at the following link:

http://www.chicagotribune.com/news/chi-birth-control1apr06,0,7409040.story

The article entitled “Drugmaker hid contraceptive data,” by Gardiner Harris and Alex Berenson, reports that according to internal company documents, for years, Johnson and Johnson “obscured evidence that its popular Ortho Evra birth control patch delivered much more estrogen than standard birth control pills, potentially increasing the risk of blood clots and strokes.” According to the article, this has resulted in more than 3000 lawsuits against the company in which it has been claimed that “use of the Ortho Evra patch caused heart attacks, strokes and, in some cases, death.” Documents made public due to the lawsuit show that even before FDA approval, the company’s own research revealed that the patch delivered far more estrogen than that which was reported to the FDA. The FDA then received multiple reports of problems with the patch from 2002-2006, but did not warn the public until 2005. What is not clear from the article is what data the FDA relied on to approve the medication and from where it originated. The company now hopes to avoid being successfully sued, based on the fact that the medication was FDA approved, despite the inaccuracies of its estrogen dosing. The legal argument is called pre-emption and will be ruled by the Supreme Court in the fall. Stay tuned.

Indicative of just how damaged the credibility of industry funded research has become, take a look at this article from The New York Times, found at the following link: http://www.nytimes.com/2008/04/15/health/15conf.html?pagewanted=1&_r=3&ref=health&adxnnlx=1208279239-xqTqRAQmrU5NBWie7VgYhQ
Entitled, “Citing Ethics, some Doctors are Rejecting Industry Pay,” the article notes that due to increasing public awareness of conflict of interest issues, some prominent physicians have made the decision to stop taking payments from food, drug and medical device companies. If they do work for these companies, they do it pro bono. The article describes the striking story of three physicians, among them, Dr Peter Libby, chief of cardiovascular medicine at Brigham and Woman’s hospital in Boston. As a highly respected scientist, his views were often solicited and and like many well known researchers, for many years he served as a speaker and consultant paid by the pharmaceutical industry. Recently, after spending four years working for free with PBS to create the TV series “The Mysterious Human Heart,” his work was accused of bias by ‘bloggers’ and others. Although there is nothing to suggest that his work was compromised by the monetary relations he had with the pharmaceutical companies, he came to the decision that he could no longer continue “under suspicion,” and for this reason, he decided to sever his ties to industry as a paid speaker and consultant. Two other prominent doctors who made similar decisions to avoid ‘the asterisk’ next to their names associated with physicians who choose to accept these payments are profiled in this article. As always, these are complicated issues. Dr. Libby indicated that he would continue to speak at forums sponsored by the pharmaceutical industry and consult for companies, but he would no longer accept payments. “It is not worth it to be under suspicion,” he said. So we see here the dilemma: some good scientists have been sensitized to the conflict of interest risks and they are taking a stance to safeguard their reputation and personal integrity. The question remains, how can we safeguard the reputation and integrity of the industry after it has been seriously damaged? Certainly, much work is needed.

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