Saturday, September 19, 2009

Lend Me Your Name

Journalism regarding the horrors of ghostwritten papers in medical journals is all the rage these days (1, 2, 3). Here's my very small contribution. The document shown below from a medical writing company has been described elsewhere. But it is worth seeing in its glory firsthand. The document is from Wyeth's ghostwriting firm, DesignWrite. It was part of the Premarin/hormone replacement therapy disaster (see below). Perhaps you remember the era when hormone replacement therapy was being prescribed for all sorts of people because it was supposedly a wonder treatment. So what if it increased risk for breast cancer and perhaps other conditions as well? Not to worry, DesignWrite could get around that...

In layman's terms, it goes like this... Wyeth -- you give us some hints about the marketing spin you'd like us to put on your studies. We'll then write up the studies accordingly and have big-name academics sign off as if they had something to do with our oh-so-objective "research". And don't worry, Wyeth, you get to review all papers we write up to make sure we market your drug appropriately.

We now know that several academics participated in this program. To quote one ethicist, regarding the academics who lent their names as authors: "They sold their credentials for false credit and money." DesignWrite's current slogan is: "Where we put clinical data to work." Hmmm. DesignWrite gets paid, Wyeth gets paid, and the academics who lend their names get paid and/or get another publication to boost their stock in the academic world.

Oh, and patients, what did they get out this... breast cancer. But who cares about them anyway -- patients are just little buckets of money; it's not like they're real human beings.

A summary of the results that led to the downfall of hormone replacement therapy

Three years after stopping hormone therapy, women who had taken study pills with active estrogen plus progestin no longer had an increased risk of cardiovascular disease (heart disease, stroke, and blood clots) compared with women on placebo. The lower risk of colorectal cancer seen in women who had taken active E+P disappeared after stopping the intervention. The benefit for fractures (broken bones) in women who had taken active E+P also disappeared after stopping hormone therapy. On the other hand, the risk of all cancers combined in women who had used E+P increased after stopping the intervention compared to those on placebo. This was due to increases in a variety of cancers, including lung cancer. After stopping the intervention, mortality from all causes was somewhat higher in women who had taken active E+P pills compared with the placebo.

Based on the findings mentioned above, the study’s global index that summarized risk and benefits was unchanged, showing that the health risks exceeded the health benefits from the beginning of the study through the end of this three year follow-up. The follow-up after stopping estrogen plus progestin confirms the study’s main conclusion that combination hormone therapy (E+P) should not be used to prevent disease in healthy, postmenopausal women. The most important message to women who have stopped this hormone therapy is to continue seeing their physicians for rigorous prevention and screening activities for all important preventable health conditions.

I'm glad to see that ghostwriting is now the topic du jour in health journalism. But in a few weeks, the attention will vanish as the drug industry and its associated writing firms will agree to allegedly stringent guidelines that ensure this never happens again. And nothing will actually change. I mean, seriously, do you think academic researchers are going to write their own papers? Do you think drug companies are going to stop hiring writers to expertly spin the data? The current system works too well for it to simply go away.

Thanks to an alert reader for sending this document along. You can search for more documents at the Drug Industry Document Archive, including those from Wyeth and DesignWrite. Happy digging!

Wednesday, September 09, 2009

Wanted: Drug Pimp/Key Opinion Leader

Daniel Carlat from the Carlat Psychiatry Blog received an invitation to the key opinion leader club from the good people at Schering-Plough. The company wanted him to read their slides to other physicians in order to promote their brand spanikn' new antipsychotic/mood stabilizer Saphris (asenapine). Because, of course, if he reads the slides, they are more credible than if read by one of those sleazy drug reps; it's so much more classy and believable if an "independent" psychiatrist reads the company's marketing copy.

Carlat posted the documents used in the attempt to recruit him (cover letter, speaker bureau arrangement, pimp, er, speaker fees) Everyone should read them. Speakers are only allowed to rake in $170,000 of dirty money through this program. I suppose anything more would make them look like shameless drug pimps. But if you were to take, say, $50k for your "educational" services, that would be totally acceptable, right? I hereby nominate anyone who accepts Schering-Plough's generous offer for the much coveted Golden Goblet Award.

What's the deal with this Saphris drug, anyway? One neuropsychologist reviewed the data and found that it promises to be yet another also-ran atypical antipsychotic, at best. Some have also raised questions of whether the drug deserved FDA approval at all. Get ready for some ghostwritten articles that present the evidence surrounding Saphris in a ridiculously biased manner, for key opinion leaders to travel to conferences extolling its virtues, and for the rest of the usual marketing tricks.