SAN DIEGO - As the 160th annual meeting of the American Psychiatric Association convened last week, it seemed all the Prozac and Zoloft in the world might not be able to cure San Diego's case of the "May Grays," which shrouded the convention center in gloomy clouds.
Inside, pharmaceutical and biotechnology company exhibits filled the convention center with towering displays, fiber optic lights, coffee stands, and smiling sales reps . . . proving that mental illness is big business.
That topic took center stage at a lively panel called "Uneasy Partners: The Pharmaceutical Industry and the Psychiatric Profession." The standing-room-only crowd erupted into cheers as panelists made suggestions for repairing a system of evidence-based medicine that some claim has been "compromised" by industry. But surprisingly, the physicians laid much of the responsibility for fixing the problem at their own feet.
"The pharmaceutical industry is not pure evil, and the psychiatric profession is not all good," said Nassir Ghaemi, associate professor of psychiatry at Emory University.
Panelists voiced concerns about how industry ties can create conflicts of interest, potentially biasing the randomized clinical trials on which evidence-based medicine depends. Specifically, speakers complained about academia becoming distanced from clinical trials as industry increasingly relies on contract research organizations; trials that are designed to be easy rather than compare the drug to the best available care; and supposedly double-blind studies in which patients know they are on drug.
David Osser, associate professor of psychiatry at Harvard Medical School, presented an examination of 162 clinical studies published between 2001 and 2003. The 46 percent of the trials sponsored by drug companies were five time more likely to achieve a positive outcome.
To address that problem, Ghaemi recommended more investigator-initiated and National Institutes of Health-sponsored trials to tackle designs that the drug industry would not want to pay for. He also urged doctors who sit on advisory boards to push for "real-world" trial designs, reminding them that their role is not to help companies make profits.
Another sore spot among panelists was the publication of data resulting from clinical trials. David Healy, a psychiatrist affiliated with Cardiff University College of Medicine, said drug companies repeatedly have denied him access to full data sets from clinical trials. Osser, too, complained that negative clinical trials often disappear, citing examples such as Lamictal (lamotrigine, GlaxoSmithKline plc), for which one positive bipolar study was published while three negative studies were not.
Yet Fred Goodwin, professor of psychiatry at George Washington University Medical Center and former director of the National Institute of Mental Health, argued that negative studies often are ignored because "statisticians realize it's very hard to get a positive study and very easy to get a negative study." He added that many negative trials are not informative and have more to do with faulty trial designs than faulty drugs.
Congress is debating bills that would require the disclosure of all clinical trial results on a public web site, and the panelists debated the logistics of making full datasets - which may contain several gigabytes of information - available, or how to narrow that down without introducing bias.
If there was one point all panelists agreed upon, it was that the practice of ghost-authoring scientific papers containing clinical trial results should be stopped. Healy noted that such papers often are used to promote drugs off-label, and Osser added that the remarks in the abstract and conclusion often are far more positive than the actual data.
Goodwin suggested using the good old-fashioned "shame factor" to discourage that practice. Several other speakers discussed creating an algorithm that could detect ghost-authorship, as many of those papers are written by vendors that use a similar style.
Industry-sponsored continuing medical education, which ballooned from a $302 million to a $1.1 billion enterprise in the last decade, also came under fire. Physicians are often paid to speak at CME-accredited lectures and to serve as consultants to the industry, but opinions among the panelists varied as to how much of a conflict of interest that really presents.
Goodwin proposed that the term "conflict of interest" should be replaced with "confluence of interest," since the interests involved do not necessarily have to be opposed. "The reason top experts have so many confluences is that everyone wants their opinion," he said. Trying to remove those with a perceived conflict from government positions would leave "third-rate people the industry doesn't care about" in charge, he added.
Goodwin also suggested a "level playing field" regarding disclosures. If physicians have to disclose drug company funding, why not disclose funding from government, managed care, trial lawyers or their own book sales? He then took a jab at one of his fellow panelists, pointing out that Healy is "one of the best-known witnesses against the pharmaceutical industry."
"I think that was missing from your disclosure slide," Goodwin joked.
Healy is known for voicing his opinions about the influence of the drug industry on academia and authored the book, "Let Them Eat Prozac: The Unhealthy Relationship Between the Pharmaceutical Industry and Depression."
During the panel, Healy took issue with the practice of disease mongering, or turning personality traits into illnesses. He also argued that while drugs for schizophrenia or mood disorders work differently, the drug industry does not try to discern what subsectors of the disease each drug would work best in. Instead, they "mine us" for information about where there is an unmet medical need and then "market the drug back to us" in that niche, he said.
Yet overall, the physicians did not point the finger at pharma, instead urging each other to step up to the plate. "We must be sophisticated consumers of the evidence," Osser said. "Those academicians and educators that are part of the problem must abandon their roles as co-promoters of drugs."