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 175 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, & 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.
Rosenberg: Your new book, Pharmageddon, gives a bleak picture of the doctored data, skewed drug trials and rigged treatment guidelines that characterize today’s pharmaceutical industry. Many people will be shocked to learn the abuses are not limited to the US, where direct-to-consumer advertising is legal, but found in Europe.
Healy: The situation is identical. Pharma actually finds socialized health care systems easier to exploit. And 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 are really in the dark, though they may not realize it.
Rosenberg: One example you give of Pharma’s reach and power is the eerie symmetry between the Texas Medication Algorithm Project (TMAP), conceptualized and funded by US Pharma, and Britain’s National Institute for Health and Clinical Excellence (NICE).
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. One of the other issues is this–there is a new bill aimed at speeding up the FDA approval process yet again–and also getting regulators to take into account the jobs that come with a strong pharmaceutical sector. Both America and Europe have been keen to keep their companies happy and have turned a blind eye to the outsourcing of clinical trials to Asia and Eastern Europe.
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.
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.
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?
Healy: Clinical trials are overseen by private Institutional Review Boards, which are funded by the organizations they regulate–
Rosenberg: Like Moody’s and Standard & Poor’s are funded by their clients?
Healy: Yes. A recent large trial for the antipsychotic Abilify demonstrates the danger with outsourced clinical trials. On the basis of about 28 trials in the US, 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.
Rosenberg: Most of Pharma’s power to mislead and harm comes from such opaque and distorted data, you charge in Pharmageddon.
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 result is guidelines that are fictions and doctors who lack critical information they need to prescribe and treat.
Rosenberg: Pharma’s stonewalling of data and use of ghostwriters has resulted in articles in major medical journals that made Vioxx, hormone therapy and Neurontin look safe when they weren’t. Another example you give is a paper in the Journal of the American Association 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 suicidal side effect in children, “I can’t control the authors. No, I don’t have regrets.”
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.
[Ed note. The COPE site says, “Liz provides writing, editing, training and consultancy services for various pharmaceutical companies (most recently Astra Zeneca, Cephalon, Cordis, GlaxoSmithKline, Eli Lilly, Janssen-Cilag, Merck Serono, Mundipharma, Norgine, Novo Nordisk, Sanofi Pasteur and Vifor). ]
Rosenberg: Many conflicts of interest 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?
Healy: Some colleagues and I are in the process of fine-tuning a free web site that offers FDA MedWatch data with other crucial dug information but gets people 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 US 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.
Martha Rosenberg’s is an investigative health reporter. Her first book, Born With A Junk Food Deficiency: How Flaks, Quacks and Hacks Pimp The Public Health, has just been released by Prometheus books.