Don’t Turn Your Back on Industry, but Keep It Honest
by Jeffrey A. Lieberman, MD
Dec 19, 2012
My comments are prompted by an article that was published on November 24 in the Washington Post, which was highly critical of GlaxoSmithKline and the pharmaceutical industry because of studies that were done with the hyperglycemic agent Avandia (rosiglitazone), which was subsequently recalled. The last thing I want to be known as is an apologist for the pharmaceutical industry in terms of defending any unscrupulous or mercenary behavior. However, I think we need to be aware of the fact that the pharmaceutical and biotechnology industry is the private sector, which is involved in the drug development enterprise. It is an essential industry in our society and vital to the medical field in terms of being able to further progress in developing treatments for medical illnesses and disease. In other words, we cannot tolerate what would be unprofessional and inappropriate, dishonest, or harmful behavior, but at the same time, we have to resist the temptation to throw the baby out with the bathwater.The article that was published in the Washington Post was entitled "As Drug Industry’s Influence Over Research Grows, So Does the Potential for Bias." The article was referring to a study that was published in the New England Journal of Medicine on December 7, 2006. The lead author was Dr. Kahn for the ADOPT Study Group, and the study was on the glycemic durability of rosiglitazone, metformin, or glyburide monotherapy. This study was a comparison of oral hyperglycemic agents, and it found that rosiglitazone was superior for glycemic control compared with the other agents. Subsequently, after the drug was released and marketed successfully, concerns about cardiac toxicity emerged. The drug was ultimately recalled, and there have been some medicolegal actions that have occurred in the aftermath.
The Washington Post article reviewed the history of this, calling into question relationships between the investigators from the academic community and the pharmaceutical company, who did not report or failed to detect the signs of safety risks. Therefore, the article pointed the finger at the investigators as having an unhealthy relationship with the pharmaceutical industry. This is extremely worrisome, but the fact of the matter is that this does not mean that the academic medical community and physician investigators should not or cannot be actively involved collaboratively in the drug discovery and development process. Indeed, this type of interaction and collaboration is not just helpful but is essential if we are going to sustain medical progress in developing treatments for human disease. We need to understand that although there have been wrongdoings in some instances by both industry and academic physicians collaborating with industry, we should not throw the baby out with the bathwater. The pharmaceutical and biotech industries are not the tobacco industry. If the tobacco industry went away tomorrow, no one in our society would be necessarily the worse off for it. If the pharmaceutical industry disappeared, we would be in big, big trouble…
APA Answers Criticism of Pharma-Influenced Bias in DSM-5
by Deborah Brauser
Jan 04, 2013
The American Psychiatric Association [APA] has fired back a strong response to a recent article by the Washington Post questioning the possibility of pharmaceutical industry influence on decisions regarding the upcoming fifth edition of the Diagnostic and Statistical Manual of Mental Disorders (DSM-5). The Post article specifically examined relationships with industry sources, including receiving partial income, for members of the DSM-5 Mood Disorders Work Group and the APA’s Clinical Practice Guidelines Work Group on major depressive disorders. They also discussed the manual’s dropping of the bereavement exclusion, calling that decision a potential "bonanza for the drug companies" and "opening the way for more…to be diagnosed with major depression — and thus, treated with antidepressants."
"While speculation is bound to occur, we think it is important to stay focused on the fact that APA has gone to great lengths to ensure that DSM-5 and APA’s clinical practice guidelines are free from bias," said David Kupfer, MD, chair of the DSM-5 Task Force, in a release. "Throughout the development of each product, APA established, upheld, and enforced its disclosure policies and relationship limits," said Dr. Kupfer. He noted that no DSM-5 task force or work group member is allowed to have more than $10,000 of his or her annual income to be derived from industry sources, nor are members allowed to hold stock or shares valued at more than $50,000 in a pharmaceutical or device company.With the Post article questioning whether these amounts are still too high, Medscape Medical News asked Dr. Kupfer if the limits should be lowered even more. "When we established the limits on income from industry sources, we looked to make them more stringent than requirements for staff at the National Institutes of Health, members of advisory committees for the Food and Drug Administration, and most academic departments," he answered. Dr. Kupfer added that each member agreed to follow these limits at the start of their work on DSM-5 — and to continue following them as long as they are involved in the development of the manual. "APA has looked to strengthen these policies even further for new clinical practice guidelines in development"…