JANUARY 9, 2008

PIMPING FOR NEURONTIN

This has been quite a year for disturbing revelations about the corruption of the medical literature by pharmaceutical company interests. I wrote previously about ghost writing by Merck and others, and how papers were produced by drug companies that said "insert author here" and then they went out and shopped around for an author at an academic institution. Academics are always worried about damage to their reputations, but in these cases, what can your say...?

I previously wrote about a study showing that the overwhelming majority of negative trials never get published while the positrive ones always do, which leads to a false sense of the efficacy of the drug. The worst extreme of course is the sorry example of trials of SSRIs in kids where multiple studies of paxil were "shoved in the desk drawer" as we say here in the industry, and a bs campaign to get kids on paxil was launched.

In the study I previously wrote about on suppression of the literature on antidepressants if you only looked at the medical literature, you would think that 94% of the studies show that antidepressants work, when in fact only 51% were positive.

I remember a couple of years ago standing at a poster with a glass of wine in my hand at the American College of Neuropsychopharmacology (ACNP) which presented similar data (maybe it was the same study). Someone from pharma commented that you can't get negative data published. Well that is a lot of hooey. You can get data published somewhere. For instance, Psychopharmacology Bulletin, where I am an Associate Editor (at least for now), and that publishes its stuff online, makes a policy of taking in negative clinical trials.

Btw someone at the ACNP got miffed I think about my post on the ACNP and called and left a message asking what I "meant" by my post. My research coordinator I'm not sure if he was asking about my dissent from the ACNP's opinion that antidepressants can't make you suicidal (which they have faithfully affirmed for the past decade) or that the whores in Puerto Rico are cheaper that in the States. Or that someone drew their poster title with a crayon. All statements I think are fairly straightforward and equally true (or at least in the case of #2 used to be, who knows with this volatile market place). Anyhoo I will keep you updated on whether they cancel my membership in the ACNP.

In this week's NEJM there is an editorial about the promotion of Neurontin (gabapentin) for off label uses ranging from bipolar disorder to neuropathic pain. This editorial includes references to online documentation of how data was suppressed and manipulated, marketing tactics were used to illegally promote off label use, and academics, government, and the FDA either colluded or did nothing. Other news comes from an article by Ray Moynihan in bmj showing that the pharmaceutical industry has used a strategy of "grooming" the Key Opinion Leaders (KOLs) (their terms, not mine) to promote their "message", and how they measure prescribing practices before and after a "KOL" gives a talk to check their impact on local prescribing practices, and then reward "good" KOLs with more talks with lucrative speaking fees and "drop" under performers. Of course this unconsciously drives speakers to push their product. I for one went through this mill back in 2001 and was probably dropped for not performing and arguing with them about using their slides. I gave a talk last year for grand rounds at a med school and a friend of mine told me I was not "approved" by the drug company sponsors and therefore they had to scramble to find funds to pay for talk. More news from the bmj article is that there are organizations that offer to "manage" your "KOLs", like kolonline.com. You can read for yourself, but they basically offer their services to drug companies to manipulate or control KOLs to deliver the "right" message to the other docs who will follow their lead about how to prescribe. They offer to "validate and manage" the KOLs and "identify rising stars" (sounds like grooming young girls to participate in prostitution and/or incest to me). Disgusting. Can you say...?

Pimping for KOLs

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COMMENTS

Doug, You may want to look up the settled qui tam false case act: David Franklin v. Parke Davis (Pfizer). Franklin was with Parke Davis while selling Neurontin, and he filed this case in 1996. It settled in 2004. He was a Harvard PhD, and working as a medical laison for them for maybe 3 or 4 months, and was being coerced to do things you illustrated in your post, Dan

Yes, there was a whistle blower cited in the article I linked to, I think it was the same one. His boss told him to sell Neurontin for everything. Put today (look here there is an article in the NYT that the FDA approved companies to promote off label use. Dreadful. Why is the FDA even there? -Doug Bremner

I wrote a blog post about Neurontin being no better than a placebo for bipolar treatment. Sounds like this drug is a junker--and used for pain far too often and then it can cause psychosis and weird stuff in medical patients. Stephany

http://bipolarsoupkitchen-stephany.blogspot.com/2008/04/neurontin-vsplacebo-for-bipolar.html