AstraZeneca, maker of the blockbuster antipsychotic Seroquel, is battling to keep information about the drug out of the public's view … for the public's own good.
This month in Orlando, lawyers for the drugmaker will argue that unsealing company documents, including unpublished clinical trial data and letters from the FDA, could harm "a vulnerable patient population."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.
Seroquel is approved only for schizophrenia and bipolar disorder, but its use for everything from depression to insomnia to ADHD in kids is so widespread that the drug has been prescribed for more than 22 million patients. Its $4.5 billion in sales last year put it among the top-selling drugs in the world.
In light of Seroquel's popularity, the argument that hiding information protects patients has public health advocates throwing up their hands.
"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."
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Though Egilman is merely an observer of the Seroquel proceedings, he knows the power of sealed documents in drug liability cases. He played a key role when similar lawsuits were lodged against another mega-selling antipsychotic, Eli Lilly's drug Zyprexa. As in the Seroquel cases, thousands upon thousands of patients claimed Zyprexa caused weight gain and diabetes.
Hired as an expert witness for the plaintiffs in Zyprexa cases, Egilman was given access to reams of internal Lilly documents that had been sealed by the court. The documents showed that the drugmaker had ignored evidence of diabetes among patients while pushing Zyprexa's off-label use for anxiety and dementia.
Egilman defied the judge's orders and helped leak thousands of damaging Lilly documents to the New York Times. Egilman ended up paying a $100,000 fine to Lilly for releasing the sealed documents.
The leaked documents, meanwhile, helped the U.S. Department of Justice build a criminal case against Lilly. The company pleaded guilty to marketing Zyprexa illegally and last month paid a record $1.4 billion fine. Though a landmark amount, Lilly's fine amounts to about 3.5 percent of the $39 billion in revenues Zyprexa has posted since the FDA approved it 1996.
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Seroquel's parent, AstraZeneca, has a similarly valuable franchise to protect. The antipsychotic accounted for 14 percent of AstraZeneca's sales of $31.6 billion last year. Avoiding negative publicity — one of the reasons the company wants to seal documents in the Orlando cases — is critical as it seeks to maximize sales before Seroquel loses patent protection in about three years.
The skirmish over document disclosure in Orlando is part of a hornet's nest of litigation against AstraZeneca, a British company with U.S. headquarters in Wilmington, Del. More than 15,000 patients have filed over 9,000 personal injury lawsuits. About 40 percent of these claims have been consolidated for pretrial motions in U.S. District Court for the Middle District of Florida.
Plaintiffs say the company knew as early as 2000 that Seroquel caused diabetes, weight gain and other health problems, but failed to adequately warn patients and doctors.
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.
AstraZeneca denies the allegations and has spent more than $500 million defending itself against Seroquel claims. Key to the company's strategy has been its insistence that millions of pages of documents produced in discovery should remain under seal, out of the public eye.
To Egilman, such blanket agreements in drug liability cases are outrageous. "Confidentiality agreements that prohibit disclosure of important information that may impact public health to state and federal authorities should be illegal,'' he said. "The court should at least send all discovery in drug cases to the FDA and DOJ (Department of Justice) for review if they intend to seal them."
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."
AstraZeneca's lawyers say the information to be discussed at the hearing scheduled Feb. 26 is so sensitive that the court should be closed to the public. "The potential harm of dissemination of documents at this stage in the litigation far outweighs the public's right of access, particularly when trials in these cases are on the near horizon,'' company lawyers said in a filing Feb. 6. "The whole picture will be presented to the public at once."
The judge has not ruled on the request.
There's a good chance that many of these cases will never come to trial, and the underlying documents will never become public. In a victory for AstraZeneca, the judge dismissed the first two cases in late January, saying plaintiffs had not sufficiently established that their health problems were caused by Seroquel. Up to nine trials are slated for 2009.
In the Zyprexa litigation, Lilly paid $1.2 billion to settle injury claims involving 31,000 patients. Damaging company documents were never released by the court, though they were available on the Internet after Egilman leaked them and excerpts appeared in the New York Times.
Egilman is well aware of the big money in liability lawsuits, having made $2.3 million as an expert witness in Vioxx cases. He contends that patients' lawyers are motivated by maximizing their share of any settlement, which can be 30 percent or more. He says attorneys should be required to get their client's approval before agreeing to seal documents.
"The client may be more interested in making sure that health information gets to their doctor than money," he said. "They have a real interest and it's called their health."
Gary Farmer, a Fort Lauderdale lawyer who represents more than 100 Seroquel patients, said Egilman has a point.
"If we can get the documents to win the case and get compensation, you have to ask yourself, 'Is it necessary to make that information public?' " he said.
Whether the mountains of Seroquel material now sealed in Orlando's federal court ever see the light of day may depend on the progress of related cases. Four states — Pennsylvania, Montana, Arkansas and South Carolina — are suing AstraZeneca for off-label marketing of Seroquel.
The company said it is aware that the U.S. Attorney's Office in Philadelphia is investigating Seroquel's marketing practices, most likely based on whistle blower complaints.
Regulators also seem to be taking note. In December, the FDA sent AstraZeneca a warning letter after learning a sales rep had pitched Seroquel to a doctor as a treatment for depression. Though doctors can prescribe a drug for any use, it is illegal for pharmaceutical companies to promote such uses.
The FDA also reportedly sent AstraZeneca two letters in late December, telling the company to strengthen Seroquel's warnings about diabetes. The drugmaker declined to comment, saying its communications with the FDA are confidential. The letters remain sealed in Orlando's federal court.
Kris Hundley can be reached at email@example.com or (727) 892-2996.