Firms tied to MDs who set policy

Virtually all the psychiatrists who wrote the latest clinical guidelines for how to treat depression, bipolar disorder, and schizophrenia had financial ties to drug companies, according to preliminary findings by Boston-based researchers. Their study is the first to examine potential conflicts of interest in the American Psychiatric Association panels that write the treatment guidelines widely used by practitioners, the paper's authors said. The guidelines focus heavily on medications and give relatively little attention to nondrug treatments and how and when to phase out drugs prescribed for mentally ill patients, the authors wrote. They said three common diagnoses generate some $25 billion in drug sales per year. "Most patients assume that when they're prescribed a drug, the decision is made on the basis of an objective review of the scientific evidence," said the paper's lead author, Lisa Cosgrove of the University of Massachusetts at Boston. "However, our study raises the question: Is that decision based in science, or is there a financial incentive behind it? This is an important question because the lack of biological tests for mental disorders renders psychiatry especially vulnerable to industry influence." The psychiatric association responded that its guidelines, which sum up research and real-world experiences with treatments, go through a long and elaborate vetting process and that people who get significant portions of their income from drug companies are excluded from the guideline panels. "We work very hard to ensure that the guidelines that we develop and publish are free of bias to the greatest possible extent," said Dr. John S. McIntyre, chairman of the guideline steering committee. The study, scheduled to be published online this month in the journal Psychotherapy and Psychosomatics, found that among 20 authors of the guidelines, 18 had at least one financial tie to drug companies. It did not name names or specify sums, but found that 12 guideline authors had ties in at least three categories, such as consulting, research grants, speaking fees, or stock ownership. To find financial ties, Cosgrove and her colleagues, who included Sheldon Krimsky of Tufts University and Dr. Harold Bursztajn of Harvard Medical School, searched publicly accessible databases such as Medline and the records of the federal patent office. Dr. Roy Perlis, listed as a consultant on the bipolar guidelines, works in psychiatric genetics at Massachusetts General Hospital. In published papers - including one that examined financial conflicts of interest in clinical trials of psychiatric medications - he disclosed having received consultant or speaker's fees from five major drug companies: AstraZeneca, Bristol-Myers Squibb, Eli Lilly, GlaxoSmith Kline, and Pfizer. But Perlis noted that the guidelines for bipolar disorder make two main points, neither of which benefit drug companies: that lithium, which has long been available as an inexpensive generic drug, is still the "gold-standard treatment" and "that certain kinds of talk therapy are a very important part of treatment." "My job is to find better treatments for my patients. These are awful illnesses. People really suffer," he said. "And the people who are most responsible for developing new treatments right now are the pharmaceutical companies. What is being lost in all this is that if I didn't work with them, I couldn't do my job as a scientist - the part of my job that says we have people who are suffering that need new treatments." The pharmaceutical industry defends its practice of paying "thought leaders" in various specialties to lend their expertise to drug development and marketing, saying that their input benefits both colleagues and patients and that they must be paid for their work. But there is a growing backlash against conflicts of interest in medicine. A posse of those pushing for change in the medical culture is centered in Boston and includes Drs. Marcia Angell and Jerome Kassirer, former editors of the New England Journal of Medicine, and researchers such as Cosgrove and Krimsky. These critics contend that financial ties introduce the potential for bias, and at the very least, all such ties must be disclosed. "What we're saying," said Krimsky, is that guideline writers "should be totally transparent about their relationships with the drug companies so people reading a guideline might ratchet up the skepticism they might have about the use of drugs as the first line of therapy." This week in the Journal of the American Medical Association, a group of influential medical leaders went further, calling on medical specialty groups to adopt tough policies against industry influence, including appointing "only individuals who have no ties to industry" to committees writing treatment guidelines. Among the leaders, who specified they were not acting as representatives of their organizations, was the medical director and CEO of the psychiatric association. The psychiatric association now requires guideline writers to publish any financial ties along with the guidelines they work on, but at the time the current guidelines for depression, bipolar disorder, and schizophrenia were published in 2004 and 2005, no such disclosures were required. McIntyre, of the psychiatric association, said the steering committee that oversees the guideline-creation process has always screened proposed members of the groups that work on each set of guidelines for potentially troubling ties, including spouses who work for drug companies. The idea, he said, is to avoid people who get more than roughly 5 percent to 15 percent of their income from pharmaceutical firms, especially when from one particular company. It would be a mistake to disqualify everyone with drug-company ties, he said, because it would mean losing valuable expertise in research that must be evaluated, but the association is considering whether to set a limit on committee members' industry income and research support. The guidelines - the psychiatric association has produced 16 - also go out to hundreds of psychiatrists and others for comment and review, McIntyre said. "When you subject a document to that kind of review, by a large number of people, a single voice that might unwittingly be biased gets diluted," he said. The new paper found that all of the authors of the schizophrenia and bipolar guidelines had relationships with the drug industry, and 60 percent of the authors on depression did. More than three-quarters received research funding from drug companies, and more than one-third served on the speakers' bureaus of drug companies. In an editorial, this month's American Journal of Psychiatry singles out speakers' bureaus as the clearest example of conflict of interest, noting that they supply prominent psychiatrists "to deliver company-approved presentations that market their drugs to their clinical colleagues in the guise of medical education."