1 Boring Old Man

The availability of the story of Seroquel‘s trip to market is fortuitous in that it came in the early days of the Internet and widespread use of email. The html driven WorldWideWeb was introduced in 1994, and by the period in question [1996-1997] was quite the rage in corporate life. I doubt Zeneca‘s staff realized how much of their communication would end up in the public domain [I’d bet that today’s wheelings and dealings are done in evaporative media like phone calls or face-to-face]. There are several archives of  unsealed court documents that open the windows into the dark side of the Pharmaceutical industry and the Physicians who play on that playground – heavily populated with Psychiatrists:

Most of the really outrageous stuff comes after the period I’ve been investigating, after Seroquel is on the market. So many threads! Damage control, spinning [or denying] weight gain and diabetes, extending their targeted population to mania, then bipolar disorders, then depression, etc. It’s a story of a corporate culture that has no connection with the impact of their decisions on their  patients  customers, dealing with a large segment of a medical specialty that has equally lost its way. This email from around the time Seroquel was approved exemplifies the depth of the plunge. It was a response to an investigator’s request for funding:

I’ve already posted the famous email congratulating Dr. Lisa Arvanitis’ "’smoke and Mirrors’ job" in obfuscating the weight gain data in the Trial 0015 report to the F.D.A. [and as the author of the published reports]. And there was Dr. Arvanitis’ own email musing about how to spin and muddle data so the Sales Reps could downplay weight gain. Unposted is this thread where they’re debating about burying Trial 0015 altogether [which they did]. I’ll just post one more. It’s Dr. Arvanitis again, a memo explaining how she’s going to spin Trial 0015 to the investigators who actually did the study to explain its disappearance. It’s a conscious lie:

I think the reason I keep picking Dr. Lisa Arvanitis’ communications is that though they’re nowhere near the most devious or the diciest, she was the Physician in charge of the Seroquel project at Zeneca. She shepherded the drug all the way through, wrote [?] the papers, wrote-up the "cursed" Trial 0015, buried it. And I can find no place where it seemed to dawn on her that they had a dog of a drug – a weak antipsychotic that makes patients gain a lot of weight and sometimes develop Diabetes, something dangerous. In this Memo, she doesn’t seem to register that she’s becoming a part of what’s wrong in the world. Even though she was the physician in charge, she was as much a part of the Sales and Marketing department as anyone else – even before they made it official. I doubt this was what the little girl Lisa thought about when she dreamed of being a doctor as a child, but she took to it like a duck takes to water.

Seroquel was approved on September 26, 1997. I consider that to be the "end of the beginning," but I’m taking a break for a while from the Seroquel story [It’s not good for my mental health]. I expect I’ll be back on it sooner than I think. There are several points I’d like to pursue: How did a weak, moderately toxic, Atypical Antipsychotic get to be a drug used in Depression? What does this story say about the Clinical Trials world and evidence-based medicine? But most of all, "Why do people take it?" They wouldn’t stay on an older antipsychotic no matter what the ad said. What is it that Seroquel [and Abilify or Zyprexa] do for people that makes them want to keep taking the drugs? I know it’s not its effectiveness in Schizophrenia, and I doubt that it has anything to do with it being an Antidepressant. And other than apparently being a really good sleeping pill, I don’t know the answer to that last question…