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Your Depression and Bipolar Disorder Source Knowledge is Necessity Is the drug industry corrupting psychiatry? "What he omits to mention, however, is a study that failed." Main articles page. Go here. More Issues and Advocacy Articles What is right/What is wrong One Flew Into the Cuckoo's Nest The Drug Industry The Media Public Policy |
Side Effects A strategically-located TV monitor in the Philadelphia Convention Center is showing what looks like a scene from the movie, Rocky, with a man in a hooded sweat suit running up the steps to the Philadelphia Museum of Art. He reaches the summit, raises his arms in the air in triumph, and turns around to reveal on the back of his sweatshirt: Effexor XR. The audience this message is intended for constitute the more than 19,000 psychiatrists and mental health professionals who attended the American Psychiatric Association’s annual meeting held in Philadelphia at the end of May 2002. Upstairs, in the exhibit hall, where the pharmaceutical companies have set up shop, Eli Lilly is displaying a cheesy virtual reality video of a man experiencing a manic episode. Everywhere are marketing people and scientists, anxious to ply you with pens, souvenirs, promotional handouts, as well as studies that look good if you don't ask too many hard questions about drop-out rates, the placebo response, side effects, and apparent lack of efficacy over other drugs of the same type. Most of the seminars I attend are sponsored by the drug companies, virtually all the speakers have drug company associations which they are required to disclose, and every calorie I consume is the result of industry largesse. At least one company can’t wait for attendees to get to the Convention Center - Janssen Pharmaceutica has an ad at the airport inviting new arrivals to visit their exhibit for a virtual bus ride inside the mind of a person with schizophrenia. On Tuesday, I scramble aboard an industry-provided shuttle bus on my way to a hotel where Tipper Gore will be giving a talk hosted by AstraZeneca. I’m seated with a friendly group of Asian psychiatrists toting pharmaceutical company shopping bags and sipping bottled water with drug brand names. I joke that should there be security in the place, we’re bound to get turned away - how else would you react to people brandishing liquid Prozac and liquid Zyprexa? Call it the reverse Cuckoo’s Nest phenomenon, where the doctors get mistaken as patients. Earlier that day, I have occasion to experience a more disquieting side to drug company presence. This is at a Bristol-Myers Squibb press conference to inform the media of the company’s soon-to-be-released antipsychotic, Abilify, which has an excellent side effects profile and looks very promising for the treatment of mania. Rather than use their own scientists, Bristol-Myers Squibb calls on outside academic researchers to make the presentation. The person presenting the mania data, a very well-known authority, duly outlines the one pivotal study that the drug has passed with flying colors. What he omits to mention, however, is a study that failed. Note, it was the study that failed rather than the drug that failed. Unfortunately, the silence speaks volumes. Almost in defiance of the drug companies, on the last day of the APA meeting - the graveyard shift - a surprisingly large number of psychiatrists turn out to attend a seminar on lithium. Frederick Goodwin MD, co-author with Kay Jamison PhD of the definitive work on bipolar, minces few words. Lithium, he says, is now an orphan drug getting driven off the map by industry-sponsored CMEs and marketing. Young psychiatrists are simply not taught lithium, he asserts. Yearly sales are $44 million for lithium, 1/25 of Depakote figures. The next casualty, he predicts, will be Tegretol, which has recently gone off-patent. At the same seminar, Jeffrey Jefferson MD, of the Lithium Information Center at the Madison Institute of Medicine in Wisconsin, observes that it is very rare to find an industry-supported symposium where new drug side effects are discussed. When he raises the topic at these symposia, he reports, "the invitations go down." Meanwhile ... Picture a psychiatric seminar and a sign by the lectern reading: "For this talk, Dr Smith is being paid $3,500, business-class airfare, and four-star hotel accommodations by Eli Lilly and Company." We have E Fuller Torrey MD, Executive Director of the Stanley Medical Research Institute, to thank for that striking piece of fiction. Never one to duck a controversy, Dr Torrey in an article in the July 2000 The American Prospect zeroed in on the intended targets of drug industry largesse, those in the audience, whose air fares, hotel accommodations, registration fees, and other perks tend to be on the house. And the pay-off? Dr Torrey cites a study of the prescribing patterns of 10 physicians before and after their attendance at all-expenses paid symposia at popular sun belt sites. Despite their predictions to the contrary, following their junkets the physicians' prescriptions for one drug increased 87 percent and another 272 percent. In an article in the May 2003 British Journal of Psychiatry, David Healy MD, Director of the North Wales Psychiatric Service, who has gained notoriety as an expert witness in wrongful death lawsuits involving Prozac and Paxil, reports that drug companies spend approximately £10,000 ($US 16,000) per annum per physician. Drug studies ("infomercials," he calls them) appearing in medical journals are typically ghost-written by pharmaceutical company employees using academic authors as window dressing (in Sept 2001, 13 journals began cracking down on this practice). It gets worse. Because the pharmaceutical companies regard data from their drug trials as proprietary, Dr Healy writes, only selected findings are made public and the rest kept under wraps, without exposure to the kind of scientific scrutiny that is taken for granted in other branches of science. Instead, we find academic researchers on the payroll, endorsing products. According to Dr Torrey, industry-sponsored speakers are paid an honorarium of $2,000 to $3,000 per presentation, more if the speaker organized the symposium, and more still if the expert presents data very favorable to the company's drug. In Dr Torrey’s words: "Psychiatrists trying to evaluate schizophrenia drugs are not told that the expert who minimizes the side effects of Zyprexa receives a $10,000 retainer from Eli Lilly and also owns substantial company stock." Perhaps the most egregious case of a company over-hyping its product concerns Warner-Lambert (as it then was) and its anticonvulsant medication, Neurontin. In July, 2003, Dateline NBC aired a story which came to light in 2002 when a corporate whistleblower exposed how Warner-Lambert, now part of Pfizer, "deliberately distorted information," about Neurontin, "possibly putting lives at risk ... in what may be one of the biggest medical deceptions in history." Former Warner-Lambert employee David Franklin PhD told correspondent John Hockenberry how he "was trained to deceive doctors" into prescribing Neurontin for a variety of off-label uses, including bipolar. Dr Franklin was part of a marketing blitz that included recruiting doctors to hear "scientific presentations" in places like Jupiter Beach, Florida and at venues like Yankee Stadium. The drug is FDA-approved as an adjunct for treating epilepsy. Off-label use is common for psychiatric meds, and is often best practice. But Gary Sachs MD of Harvard and head of the NIMH STEP-BD clinical trials, told Dateline that "Neurontin’s a drug that has been studied under double-blind conditions twice. And in neither case did it prove to have any efficacy at all." Which led to the following exchange: Hockenberry: "So, based on the science, someone with bipolar who’s only taking Neurontin is essentially untreated." Sachs: "I think that’s a fair assumption." Dateline interviewed one such untreated patient, Regina Adams, 54, who gained 100 pounds on Depakote and was prescribed Neurontin as a replacement. As her mania escalated out of control, her doctor kept increasing the Neurontin, to no avail. She is back on Depakote A 1995 company memo made public in a whistleblower lawsuit indicates Warner-Lambert was aware that there was "no pre-clinical evidence of efficacy in bipolar disorders." In 2004, Pfizer, which since acquired Warner-Lambert, pleaded guilty to criminal fraud and agreed to pay $430 million in fines and civil damages. The settlement pales in light of the $2.9 billion in sales Neurontin generated in 2003, up from $97.5 million in 1995. Lest we convey a wrong impression, it is worth quoting Howard Solomon, chair of Forest Laboratories which markets Celexa and Lexapro in the US. Howard Solomon has a unique perspective as the father of Andrew Solomon, whose struggles with depression were so eloquently recounted in "The Noonday Demon: An Atlas of Depression". In a letter to shareholders, reported in a cover story in Business Week in 2002, Howard Solomon wrote: "The pharmaceutical industry contributes more to human well-being - to health and longevity, to the relief of pain and misery and ultimately to human happiness - than any other industry ... It is absurd to suggest that there is some villainy in pharmaceutical companies developing and marketing new products." Well maybe if you forget about the Neurontin case. For three free online issues of McMan's Depression and Bipolar Weekly, email me and put "Sample" in the heading and your email address in the body. Updated July16, 2003 Issues and Advocacy articles All articles
Anonymous (May 25, 2004): I have a neurological disorder, and have been severely ill. Passed out, horrible dreams. Had even became suicidal. Too long to mention. One med I was given was Neurontin. Doing research of my increased symptoms, saw Neurontin was sometimes prescribed for Bipolar disorders. Am aware of all of the so called antipsychotic drugs and side effects. Makes me sick! Richard (Jan 6, 2005): I agree with you; we need the anti- psychiatry movement to keep things honest and open I am very concern about the psychiatric medication causing suicides in people among other things and the psychiatric? mental health profession with their advocacy groups are trying to cover up this issue.Thanks. Post your opinion here. |
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Above: What you might see at an APA meeting - Pfizer, makers of Zoloft, getting the word out.
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