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Dr. Healy (Courtesy of David Healy)
In his new book, Pharmageddon, international expert David Healy, M.D. paints a bleak picture of doctored data, skewed drug trials, and rigged treatment guidelines that he asserts characterize today’s pharmaceutical industry.
Dr. Healy, in a recent interview, elaborated on his findings that are sure to be a wake up call for some and to further expose others to the questionable practices taking place, not just in the United States, but the world over.
Ms. Rosenberg: Many people will be shocked to learn the abuses are not only limited to the United States, where direct-to-consumer advertising is legal, but also found in Europe.
Dr. Healy: The situation is identical. Pharma actually finds socialized health care systems easier to exploit. Despite direct-to-consumer advertising, more money is spent on marketing to doctors who are the real consumers. They are also pressured by the treatment guidelines process, which is based on “evidence” that Pharma makes sure to keep secret so they [consumers] are really in the dark, though they may not realize it.
Ms. Rosenberg: Many would think the United Kingdom wouldn’t have the problems of Pharma influence of the United States because of the socialized medicine model. But the Texas Medication Algorithm Project (TMAP), conceptualized and funded by U.S. Pharma, and Britain’s government program, National Institute for Health and Clinical Excellence (NICE), sound almost identical.
Dr. Healy: Despite their public/private differences, both organizations recommend the use of branded antipsychotics like Risperdal, Zyprexa, and Seroquel before the use of older, affordable antipsychotics, which of course enriches Pharma. Both America and Europe are also keen to keep their companies happy and have turned a blind eye to the outsourcing of clinical trials to Asia and Eastern Europe.
Ms. Rosenberg: In Pharmageddon, you chronicle how clinical trial oversight has gone from a hospital and university-based system to a for-profit system run by clinical research organizations or CROs.
Dr. Healy: The drug companies have outsourced all their operations from drug development and testing to clinical trials to scientific and academic writing so that they have become nothing but marketing organizations at their core. At each juncture where they have spun off a traditional responsibility, no one has objected and so it continues.
Ms. Rosenberg: There have been reports of risks to human subjects in overseas trials as well as bribes and protocol irregularities. Who oversees the ethics of outsourced trials and the quality of their data?
Dr. Healy: Clinical trials are overseen by private Institutional Review Boards, which are funded by the organizations they regulate.
A recent large trial for the antipsychotic Abilify demonstrates the danger with outsourced clinical trials. On the basis of about 28 trials in the United States, Abilify did not prophylactically stabilize mood as the manufacturer wants to claim. But when data from just two trials from Mexico were mixed in, it did.
Ms. Rosenberg: In your book you charge that most of Pharma’s power to mislead and harm comes from such opaque and distorted data.
Dr. Healy: Without access to the raw drug data, medical professionals cannot practice responsible medicine and guidelines cannot be written. Yet Pharma, with very few exceptions, refuses to publish the data and share them with practitioners. This results in guidelines that are fictions and doctors who lack critical information they need, to prescribe and treat.
The stonewalling of data and use of ghostwriters has resulted in articles in major medical journals that made anti-inflammatory drug Vioxx; hormone therapy; and Neurontin, used to treat epilepsy, look safe when they weren’t, Pharmageddon argues.
Ms. Rosenberg: Another example you give is a paper in the Journal of the American Academy of Child and Adolescent Psychiatry in which GlaxoSmithKline (GSK) has made the antidepressant Paxil look safe by hiding raw data. Then editor, Mina Dulcan, says about the missing data, which hid Paxil’s side effect of potential suicide in children, “I can’t control the authors. No, I don’t have regrets.”
Dr. Healy: If we were getting our drug information from The New York Times instead of medical journals, we would all be a lot safer. When the Times reporter Jayson Blair was found to have fabricated stories, he was history. But the editors and writers involved with journal fraud still have their jobs and the articles are not even retracted. In fact, Liz Wager, the chair of the Committee on Publication Ethics (COPE) is herself Pharma linked.
Ms. Rosenberg: Many conflicts of interest outlined in your book, including COPE’s leadership, are structural and create a closed loop of misinformation, especially because of the money that Pharma wields. How can sunlight and transparency ever break through?
Dr. Healy: Some colleagues and I are in the process of fine-tuning a free website that offers FDA MedWatch data with other crucial drug information but gets people [negatively] affected by treatment to report in detail for perhaps the first time. The site, called RxISK.org, also helps patients file an adverse event report to U.S. and Canadian authorities, with other countries to follow.
For too long, patients, doctors, and pharmacists have been isolated from each other when they encounter adverse drug events and only Pharma’s messages get out. This will help them communicate directly.
David Healy’s Pharmageddon has been published by University of California Press and is available now.
David Healy is a Professor of Psychiatry at Bangor University. He is a former Secretary of the British Association for Psychopharmacology, and author of over 150 peer reviewed articles, 200 other pieces, and 20 books, including “The Antidepressant Era,” and “The Creation of Psychopharmacology” from Harvard University Press, “The Psychopharmacologists,” Volumes 1-3, “Let Them Eat Prozac,” “Mania,” and “Pharmageddon.” He has been involved as an expert witness in homicide, suicide, and birth defect legal actions involving psychotropic drugs, and in bringing problems with these drugs to the attention of American and British regulators, as well raising awareness of how pharmaceutical companies sell drugs by marketing diseases and co-opting academic opinion leaders, ghostwriting their articles.
Martha Rosenberg is a health reporter and author who lives in Chicago.
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