| PAXIL DOCUMENTS
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| Paxil Advisory Board Meeting | |
| 1993 | A proposal from Scientific Therapeutics Information Inc. for the Paxil Advisory Board Meeting in Palm Beach Florida in November 1993 [the year after the drug was introduced]. Dr. Charles Nemeroff had been chosen to moderate the meeting with the objectives of "Strengthening the Paxil Profile"; "Identifying competitors deficits/strengths"; "Evaluate clinical research/promotional programs"; "Generate information for use in promotion/education"; "Strategize to reach Primary Care Physicians". Dr. Nemeroff moderated most sessions and in the cost breakout, there was money set aside for "preparation of moderator for meeting." |
| Proposal for Journal Article [Study 329] | |
| 1998 | A proposal from Scientific Therapeutics Information Inc. to write a Journal article on Study 329, a study of Paxil in Adolescents, for Dr. Martin Keller, the principle Investigator. There are clear references to the review of drafts by SmithKline Beecham. The final article [2001] became the paradigm of "ghost written" articles from STI [a complete roster of documents from that case is here]. This GlaxoSmithKline funded study has been famously discredited on any number of grounds [here]. |
| Ghostbusting in Paxil Birth Defect Litigation | |
| 2009 | This is an article by Evelyn Pringle detailing the case of Kilker vs Glaxo, a successful litigation against GlaxoSmithKline concerning Paxil related birth defects. It documents the Ghost-writing program run by STI in the employ of GSK, and Dr. Nemeroff’s involvement in promoting Paxil in pregnancy [the raw tesitimony in the case is here]. |
| POGO Letter to NIH on Ghostwriting Academics | |
| 2010 | The most recent allegation of Ghostwriting was in a letter from the Project on Government Oversight to the National Institute of Health. In the specific case of Drs. Nemeroff and Schatzberg’s 1999 book, Recognition and Treatment of Psychiatric Disorders: A Psychopharmacology Handbook for Primary Care, POGO displays three documents to support the claim: a first draft from STI, an STI timeline for completion with copies to GSK, and the preface acknowledging only editorial assistance. |
| Nemeroff and Schatzberg’s “Textbook” Pushed Paxil | |
| 2010 | Dr. Danny Carlat, author of this blog post, is a respected watchdog of the Pharmaceutical influences on Academic Psychiatry. He read Drs. Nemeroff’s and Schatzberg’s book, Recognition and Treatment of Psychiatric Disorders: A Psychopharmacology Handbook for Primary Care, not so much focusing on whether it was ghost-written or not, but looking to see if it was inappropriately weighted towards Paxil, the drug promoted by the financiers of the book and its number one customer. He argues convincingly that the suspected influences are there. My own read was the same. |
| PRACTICAL SSRI PSYCHOPHARMACOLOGY with an n of 1 [1boringoldman]
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| The makers of Paxil embarked on a fairly vigorous marketing campaign shortly after Paxil came on the Market as an antidepressant in the SSRI class of drugs. That’s hardly surprising. Prozac had been a dramatic success, and Paxil was in the group of latter day saints fighting for a place. Prozac wasn’t the easiest drug to use with its long half-life, slow onset, sexual side effects, tendency to agitate some patients, etc. It was, however, a godsend to certain patients because when it worked, it really worked. My first experience with it was in a clinical psychologist who was the first AIDS patient I ever saw. He had developed a lymphoma, and in the course of his work-up had an HIV test which was still experimental at the time. As his illness progressed, he became depressed and having heard about Prozac, wanted to try it. We read up on the new drug, and he took it with rather dramatic results. My second case was the president of a national organization for manic depressive patients and had been in and out of the hospital for years. She was another dramatic responder. It changed her life. They were, however, exceptions to the usual patients who were bothered by side effects. Since I primarily saw people for long term therapy, I didn’t do a whole lot of prescribing. So I wasn’t on the front row as the SSRI wave wafted across the country. |
| I never started anyone on Paxil and rarely refilled a prescription for someone already on the drug. That stems from a friend’s wife, a Social Worker who had been put on it very early on. When she tried to stop it, she had a really terrible time with the withdrawal symptoms, and it took her months to taper off of the drug ["miserable" months]. That kind of experience has a powerful impact on an individual physician – seeing a "miserable" side effect up close. I don’t know how often it occurs, but seeing it once was enough to wave me off. So when it was up to me to pick a drug, I gravitated to the later drugs which had fewer side effects and nothing like that withdrawal syndrome. |
| Since I saw patients frequently, I knew what was happening when they were started on these medications. My own prescribing was primarily informed by my own experience after initially reading about and hearing about the drugs as they came and went. I tended to stay with drugs I knew well until the new arrivals had been around for a while and had a track record of safety and effectiveness. But that was a luxury not available to everyone, more a function of my kind of practice. I was lucky in that regard. |
| Now in retirement, I volunteer in several charity clinics where I can’t follow people that closely, and where medications are a more regular part of practice than they were in my former life. Choices are limited by either the formulary restrictions of the Clinic or the prices for generics in the local pharmacies. Frankly, I’m glad about that. I don’t have to worry about the profiles of the newer "ask your doctor if … is right for you" designer drugs. I’m restricted to the world of the tried and true. In one clinic, I see adolescents. I’ve tried SSRIs in a few really depressed kids with occasional success. One 17 year old got agitated, though he thankfully wasn’t suicidal. I’ve pretty much limited my use of SSRIs in adolescents to kids with OCD [where they seem pretty effective, at least here in the woods]. I still practice in luxury because all of the kids I see are being followed by counselors who see them frequently, and in the adult clinic I can see people often enough to check on how things are going. |
| All of this is to say that I can see how hard it is for Primary Care Physicians in private practice to know how to use these drugs. Most of the ones around here are pretty decent docs, but they see a huge number of patients. I expect they have to rely on sources other than their own experience to keep up with our medications – and their practices are filled with patients with psychiatric symptoms. The literature, CME courses, drug reps, meetings – that’s all they’ve got. That’s why there’s so much focus on ghostwritten literature, industry infiltrated CME courses, advice in many forms without a declaration of conflict of interest. Physicians have to live with the conflict between effectiveness and the side effects or dangers of a treatment every day, many times in a day. Those decisions are hard enough when the available data is solid. When it’s not, one can’t be confident of anything. |
The narrative of my own experience has a point. The allegations in those documents at the beginning of this post are an open affront to the practical practice of medicine. GSK has every right to market Paxil in its best light, but there’s ample evidence that they went beyond that. They intruded into the process that doctors rely on – the scientific literature – in a secretive way, and they seem to have been joined in that endeavor by expert physicians, actively a part of the deceit. I don’t know enough about the law to know how such a thing might play out in a courtroom, but when I read that an academic psychiatrist moderates a private pharmaceutical marketing meeting on how to "Strategize to reach Primary Care Physicians", a physician paid by that company for a variety of services [examples], and then he later authors a book, Recognition and Treatment of Psychiatric Disorders: A Psychopharmacology Handbook for Primary Care, a book that leans into that company’s drug by omitting widely reported side effects, a book financed and distributed by that same company, that’s more than enough for me to cry foul. As Dr. Carlat said, the ghostwriting allegation just adds insult to injury.
This post is obviously my response to the threatening letters written to POGO by Drs. Nemeroff and Schatzberg mentioned in a recent post [enter the lawyers…]. The damage to their reputations is hardly the central issue here. They’ve already done that on their own. The point is more about the Doctors and the Patients who count on that information system we call "the medical literature" to be as free from bias as possible…
For a laugh http://bipolar-stanscroniclesandnarritive.blogspot.com/2010/12/pogos-silent-night-fever-starring-ghost.html
Silent Night Fever – Starring the Ghost Writer Dancers
Staphany,
Very cute! I love the hair…