AstraZeneca Wants To Hide Evidence Of Seroquel Problems From Patients, World

UPDATE, 2/17/09, 9:28 a.m. PST: Apparently, AstraZeneca reads this website as, this morning, Tony Jewell, a company spokesman, passed along a letter to editor of the St. Petersburg Times, which was published earlier today. Basically, the company claims that the paper relied on selective quotes from AZ's court filings and that AZ feels that information about the side effect profile of Seroquel should come from the FDA and not from a court proceeding. The letter is here.

A great article appeared in the St. Petersburg Times over the weekend, revealing that lawyers for AstraZeneca will argue in court later this month that the company wants documents introduced into a federal court hearing in a case over various allegations around Seroquel sealed and hidden from public view. They want an upcoming hearing in the federal class action lawsuit against AZ closed to the public as well. Lawyers argue that they are protecting patients and, oddly, the public at-large.

"This month in Orlando, lawyers for the drugmaker will argue that unsealing company documents, including unpublished clinical trial data and letters from the FDA, could harm 'a vulnerable patient population.'

"'This (disclosure) could jeopardize public safety by causing confusion and alarm in patients, who may then discontinue their medication without seeking the guidance of a medical professional,' lawyers for the drugmaker said in a recent filing in federal court."

This statement is bizarre and offensive. How would court documents even conceivably affect public safety? Are company lawyers arguing that everyone who takes its drug would go off the drug were the documents released and then patients would turn violent and run in the streets? That's what they appear to be implying and that's sickening. What's more, AZ is essentially advancing the same types of arguments that Lilly did when the infamous Zyprexa documents were leaked to the New York Times in late 2006 and were, later, made public by yours truly in early 2007--that is that the documents were distortions and served to confuse vulnerable people. AZ's argument is similarly lame.

But since I know some of AZ's outside lawyers read this site, let me offer you a thought: if you really believe that patients and the public would be harmed by unsealed documents, then you need to file a motion with the court to have the press banned from not just the Feb. 26 hearing, but from the proceedings at trial because reporters will be able to quote from documents introduced at trial, publish articles on the same and people will read those articles, and that could imperil a vulnerable population and threaten the public. Good luck with that argument.

In all seriousness, AZ doesn't give a rat's ass about patients. It wants as little publicity as possible for details of what it knew when about injuries caused by Seroquel and of how it may have marketed the drug for unapproved uses. This is about protecting AZ, no one else and one hopes the court will reject AZ's request. One hopes as well that the St. Petersburg paper--the trial is in Tampa--and the Bloomberg wire service, which has been covering the trial, will get their lawyers to file some kind of motion with the court on this matter.

"'They don't want anybody to know about the side effects of their drug, and they're keeping secret the results of studies from patients, their doctors and the FDA,' said Dr. David Egilman, clinical associate professor at Brown University's Department of Community Health.

"'Saying they're protecting the patient is a self-serving, fraudulent argument.'"

I agree with Egilman, who was the original leaker of the Zyprexa documents. AZ is embarrassing itself. The drug is so widely used (its 2008 sales were $4.5 billion) for conditions other than schizophrenia and acute mania--such as ADHD, sleep problems, depression and anxiety--that to keep documents from the public would actually work to keep doctors and many patients in the dark who have a legitimate right to know about the company and its drug.

Some interesting detail from the article:

"Dr. William C. Wirshing, a California psychiatrist, has lectured doctors on AstraZeneca's behalf and has prescribed Seroquel to as many as 5,000 patients. Though he has been a paid consultant for the drugmaker, in a pretrial deposition he left no question about the links he sees between the drug, weight gain and diabetes.

"'You literally just got to watch them get bigger...it was riveting to me,' said Wirshing who estimated that several hundred of his patients developed diabetes."

Several hundred of one doctor's patients? No wonder AZ wants those documents under wraps.

More details of what AZ wants to keep secret:

"The upcoming hearing is expected to focus on specific items that the plaintiffs' lawyers say have no legal right to secrecy. Among them: unpublished results of several drug studies, sales reps' notes on Seroquel's marketing strategies and letters from the FDA.

"The drugmaker also hopes to keep under seal information about sexual relationships that Dr. Wayne MacFadden, AstraZeneca's former U.S. medical director for Seroquel, had with an independent researcher as well as with a woman who wrote papers supporting the drug's safety and efficacy. Correspondence shows that MacFadden, who was also director of clinical research for neuroscience drugs, "promised sexual favors in exchange for intelligence on AstraZeneca's competitors."

"The plaintiffs say the affairs 'can create bias which can affect the integrity of the science.'

"Lawyers for the drugmaker counter that the affairs are not relevant to the lawsuits. Other disputed documents, they say, contain trade secrets, could taint the jury pool and could 'harm public health.'"

One of AZ's officials was having sex with a researcher studying the drug? Oh, wow. I wonder who it was.

It'll be interesting to see how this all turns out.

Keep in mind that even the FDA has lost its patience with AZ. Last December, the agency busted the company for off-label marketing of Seroquel for depression. The agency has still not answered my repeated inquiries about what possible sanctions AZ could face for the transgression. In January, the FDA ordered AZ to update its warnings on the drug to reflect risks of rapid weight gain.