Last Updated Feb 17, 2009 2:19 PM EST
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.Unsurprisingly, not everyone buys that argument. Here's David Egilman, clinical associate professor at Brown University's Department of Community Health:
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 ... Saying they're protecting the patient is a self-serving, fraudulent argument.(It was Eligman's leaks to the NY Times that eventually led to investigations in which Eli Lilly ended up paying just over $3 billion in settlements over Zyprexa side effects.)
The AZ/Seroquel suit promises to be entertaining:
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."(This MacFadden must be some sort of superstud if he can get what he wants by propositioning women. Usually it's the other way around ... ) Regardless, it was MacFadden who wrote this "dear doctor" letter regarding Seroquel and weight gain back in 2004.
The plaintiffs say the affairs "can create bias which can affect the integrity of the science.''
Some of AZ's own people have given unfortunate evidence against the company:
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.AZ has spent $500 million on this litigation so far, the St. Pete Times reported.
"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.
UPDATE: The company has written a letter to the St. Pete Times, complaining about bias in the coverage. You can read it here. A sample:
... the company has shared millions of pages of documents with the court and with plaintiffs' lawyers and allowed many documents to be filed publicly. The company does oppose efforts to release documents that are irrelevant to the cases or those that deal with confidential or proprietary information.
Efforts to publicize non-final, preliminary, and tentative views on the risks and benefits of Seroquel jeopardize the FDA's deliberative process and could disrupt critical patient treatment for serious mental illnesses by allowing incomplete or potentially inaccurate risk information to be released to the public before scientific regulatory decisions are made.
... The court in the first two product liability cases in Orlando granted summary judgment and dismissed those cases in January, concluding that plaintiffs did not have sufficient evidence to establish that Seroquel was responsible for the plaintiff's alleged injuries.
- BNET's previous coverage of Lilly and Zyprexa:
- FDA Asks AZ to Tighten Seroquel Label; 9,000 Lawsuits Start Trials Next Week
- The History of AstraZeneca's Mismarketing of Seroquel
- FDA: J&J's Risperdal and Lilly's Zyprexa Are Over-Used in Kids
- AstraZeneca Allegedly Recruits Tigger and Eeyore to Sell Seroquel