Federal Headache for Brown Psychiatrist

By: Lissa Jean

Remember the good ol’ days? When a crooked doctor could pocket thousands of dollars from a sleazy drug company, and not worry about attracting the attention of Congress?

Well, according to several pharma blogs those innocent times are coming to and end. The Senate Finance Committee is preparing to investigate Dr. Martin Keller, Brown’s head of psychiatry, for plump payoffs he received while researching the antidepressant Paxil. This is just the latest piece of bad news for Keller, whose reputation was recently shredded in “Side Effects,” Alison Bass’s new book about the dirty business of mood elevators.

After such a downer month, I imagine Keller might be tempted to pop a few happy pills. There’s kind of a sweet irony in that, don’t you think?

More info about the investigation after the jump
In order to fully understand why Alison Bass thinks Martin Keller is the pharmaceutical anti-Christ, let’s take a look at how this sordid saga began.

The trouble started in July 2001, when Keller published a paper in the American Academy of Adolescent Psychiatry touting Paxil’s benefits. According to the study, the drug was a cure-all with minimal side effects. Keller and his fellow researchers reported nothing more extreme than a few headaches in their patients, and confidently declared Paxil to be an “effective [treatment] for major depression in adolescents.”

Paxil’s manufacturer, GlaxoSmithKline, was predictably thrilled this study (sponsoring it was the best move they’d ever made!), and the UK-based company wasted no time in marketing their product to every bluesy kid in America. Family physicians were reassured by Keller’s public endorsement, and by 2002, Paxil sales had jumped to $55 million.

For a couple of years, all was well in Paxil Land. Profits rolled in and no one bothered to second-guess the wonder drug’s negative consequences. These happy times came to a screeching halt, however, when the U.K.’s Dept. of Health decided to review the company’s studies. After combing through nine different Glaxo cases, which had surveyed over 1,000 children, the British health agency found that kids on Paxil had a “risk of suicidal thoughts and self harm two to three times greater…compared to those on a placebo drug.” Well, shit.

Officials at the UK Health Department rubbernecked. On June 10 2003, they banned doctors from prescribing the drug to children and prompted the FDA to conduct their own Paxil review. Unsurprisingly, the studies’ results turned out to be just as bogus stateside. According to the FDA, not only did Paxil fail to outperform its placebo – it caused suicidal thoughts in 6.5% of its patients. This being America, land of the free, the agency chose not to ban the drug as the Brits had done, but simply recommended that Paxil not be prescribed to people under 18. I mean, who were they to keep our nation’s youth from contemplating their own graphic deaths?

Of all the studies reviewed, Keller’s was perhaps the most infamous since it was actually published. Typically, if a study shows your drug to have horrifying side effects, decorum stipulates you bury it deep in a filing cabinet and pretend it never happened. Keller, renegade badass that he is, decided to buck tradition and put his results in ink for all the world to see.

As a fun fact, it should also be noted Keller might not have written his study. In 2007, the BBC show Panorama claimed that Glaxo had ghostwritten the study for Keller, allowing them to shape how his data was presented. As evidence, Panorama quoted letters exchanged between Keller and the ghostwriter. In one particularly incriminating passage, the ghostwriter tells Keller to “please re-type the letterhead” before he submits the study for publication. Nothing says “this study’s legit!” like an official-looking letterhead.

So what was the fallout of this shitstorm? Well, about a year after the FDA released its findings, Gov. Elliot Spitzer filed a lawsuit against Glaxo for suppressing Paxil’s negative results. Still beloved as the Anti-Corruption Crusader, Spitzer won praise from academics and watchdog groups for having the courage to spit in Big Pharma’s face. Unfortunately, Glaxo never had to weather a public shaming. Only two months after the case was filed, the company settled quietly out of court. Activists had to console themselves with a minor victory in 2004, when the FDA forced Glaxo to slap a suicide warning label on Paxil’s packaging.

The current investigation, then, has been a long time coming. Nearly two decades after Glaxo first discovered that Paxil increases suicidal thoughts, Keller and his fellow study authors still haven’t been reprimanded for their actions. Thankfully, Senator Charles E. Grassley (R-IA) seems hell-bent on bitchslapping psychiatrists who’ve allowed drug companies to shower them with money and gifts. As a senior member of the Senate Finance Committee, Grassley is demanding that the American Psychiatric Association open its financing records to Congress. He plans to use this data to investigate potentially corrupt researchers from schools such as Stanford, Harvard, the University of Cincinnati, and of course, Brown.

Looks like you’ve got a bumpy road ahead of you, Martin Keller. Just remember – suicide is never the answer.