1 Boring Old Man

Data Transparency

Independent of the outcome of the Baum Hedlund suit [Laura A. Plumlee et. al. v. Pfizer] in the courts, I think their complaint was illuminating, at least to me. I didn’t know that Zoloft was the best seller in the antidepressant market, or the story of its approval and its rise to those heights. I didn’t know about the extent of the ghost-writing campaign mounted by Pfizer to get it up there. I sure didn’t know how marginal the F.D.A. approval had been. All I really knew was that I’d tried it with a depressed patient shortly after it came out. It didn’t help – actually it made things worse. She said it made her feel "like a tree." So I put it aside and waited for further information. I’m still waiting. That’s actually how things work with doctors. A bad early experience with a new drug sets the course – particularly in this era when you can’t really count on the medical literature to do what it’s supposed to do – inform doctors. So Zoloft was off my personal radar.

I think what  this Zoloft story brings home loud and clear is that data transparency [meaning the publication of the raw data for all Clinical Trials] is the only real solution. Anything else just gives honest people more hoops to jump through, and dishonest people something else to navigate around. Making the trial data available means that an independent party can reanalyze the data without having a potential $30 B carrot clouding their vision and tell us what the drug really does. In the case of Zoloft, those very first studies are still in question in my mind.

But the real problem was with what followed – the Current Medical Direction [CMD] campaign. And there was no way to vet those distortions. As I’ve said repeatedly, "The only reason for Clinical Trial data to be secret is to maintain the ability to distort it." The drug companies might argue that if everything were public, they’d never get any drugs approved, or maybe it wouldn’t be profitable developing drugs altogether. So I reckon we’d just limp along and learn how and when to use the drugs we’ve got effectively, or talk to people, or hibernate and wait for some scientist to come up with something that works for real. But there is no valid argument for allowing a system that relies on illusion and secrecy to continue.

Depression

^{Plaintiff Laura A. Plumlee ["Plaintiff’], like many Zoloft consumers within the United States and the State of California, purchased and ingested Zoloft for the treatment of depression. She believed, relying on Zoloft’s drug label and Pfizer’s extensive marketing and promotion, that Zoloft would help her manage the symptoms related to her life-long struggle with depression. Over the course of three years, however, Zoloft was not effective at treating her depression, even after increasing her dosage from fifty [50] mg to two-hundred [200] mg per day. Plaintiff, like many consumers within the United States and in California, was misled into purchasing an expensive and side-effect-ridden antidepressant that, according to most clinical studies, was no better than a sugar pill in treating depression…}



^{On or about March 18, 2005, Plaintiff Laura A. Plumlee was prescribed a fifty [50] mg daily dose of Zoloft by her psychiatrist to treat ongoing depression. In later years, because Zoloft was not effective at treating her depression, her dosage was increased to one hundred [100] mg, then two hundred [200] mg, and then to four-hundred [400] mg per day. Upon information and belief, Plaintiff’s physician was misled into prescribing Zoloft because he had been led to believe it was more effective in treating depression that it actually is. This deception occurred as a result of the same misleading conduct that was directed toward the Plaintiff – a misleading drug label and deceptive advertising. Plaintiff continued to purchase and ingest Zoloft until shortly after Pfizer’s patent over Zoloft expired in June 2006. Plaintiff last purchased brand name Zoloft on or about August 11, 2006. Thereafter, Plaintiff purchased the generic version of Zoloft, sertraline until on or about June 2008.}

^{In total, between March 18, 2005 and August 11, 2006, Plaintiff spent approximately $162 of her own money to purchase Zoloft and, with insurance payments, Pfizer received approximately $3,315. Prior to ingesting Zoloft, Plaintiff read over Zoloft’s drug label. In addition, prior to purchasing the drug, Plaintiff had seen several commercials which indicated that Zoloft was effective for treating depression. Relying on the representations about Zoloft’ s efficacy on both the drug label and through Pfizer’s direct-to-consumer advertisements, Plaintiff was induced into purchasing and ingesting Zoloft. During the period in which Plaintiff was purchasing and ingesting Zoloft, Plaintiff did not know that Zoloft’s drug label and advertising were deceptive or that they lacked material information about the drug’s efficacy. In early 2012, Plaintiff discovered that Pfizer had misrepresented Zoloft’s efficacy, stating that it was more effective that it actually was. Plaintiff learned that the majority of clinical trials related to Zoloft’s efficacy had shown it is no better than placebo. Given the risk of the serious and well-documented side effects associated with Zoloft, Plaintiff would never have purchased or ingested Zoloft if this information had been made known to her. In other words, Plaintiff had relied on the sufficiency and accuracy of Pfizer’s advertisements and Zoloft’s drug label in making her decision to purchase and ingest Zoloft to treat her depression…}

Laura’s story tells us more than just something about Zoloft or the rampant and capricious overuse of medications. Her story is an indictment of a psychiatry that would continue a patient on Zoloft for three years in escalating doses when she had no response [even if it were the most efficacious medication in the pharmacopoeia]. It’s an indictment of psychiatry if her story of lifelong depression was taken at face value [if that were indeed the case] without a thorough exploration of her biography and her history. It’s an indictment of our government that it allows direct-to-consumer ads trolling for gullible patients for potentially dangerous drugs, essentially telling lies. It’s an indictment of Pfizer for using the term "chemical imbalance" in its Zoloft commercials as if it meant something. It’s an indictment of an insurance company that will pay for her medication that isn’t working but not the kind of thorough evaluation that might lead her in a productive direction. And it’s an indictment of us all when we talk about depression as if it is a unitary thing in a case like this, a disease, and imply that there’s a cure. There are depressions that are disease-like, but this doesn’t sound like one of them.