Does the world have the right to know about negative studies on AstraZeneca's potent antipsychotic drug Seroquel?
Or whether company representatives promoted the drug for unapproved uses?
And what about details of sexual relationships between Wayne Macfadden, AstraZeneca's former U.S. medical director for Seroquel, and two women who researched and wrote papers supporting the drug's safety and efficacy?
A federal judge in Orlando may answer those questions as soon as tomorrow in a case stemming from personal-injury claims by 15,000 people that Seroquel triggered weight gain, diabetes, and other health problems.
Plaintiffs' attorneys and Bloomberg News, the news organization, have sued to force London-based AstraZeneca P.L.C. to make public documents discovered in the litigation. AstraZeneca's U.S. headquarters are in Wilmington.
"This is, first and foremost, a public-safety issue," said Howard Nations, chairman of the Seroquel litigation group of the American Association for Justice (formerly the Association of Trial Lawyers of America).
Patients, Nations said, have the right to know about safety concerns raised in discussions between AstraZeneca and the U.S. Food and Drug Administration or in unpublished research on the drug.
Seroquel belongs to a class of drugs known as atypical antipsychotics. The drug is approved to treat bipolar disorder and schizophrenia, but doctors have been prescribing it and similar drugs for conditions including attention-deficit disorder and sleeplessness.
Seroquel is now one of AstraZeneca's best-selling drugs, with $4.5 billion in sales last year.
AstraZeneca has asked the FDA to approve an extended-release version of the drug, Seroquel XR, to treat major depression and generalized anxiety disorder.
In December, the FDA asked for more information on that application. AstraZeneca said today that the FDA had scheduled a meeting in April to review the safety and efficacy of Seroquel XR for depression and anxiety.
Last month, the Philadelphia U.S. Attorney's Office completed a $1.4 billion settlement with Eli Lilly & Co., the maker of Zyprexa, also an atypical antipsychotic, over allegations that the Indianapolis drug company illegally promoted Zyprexa to treat dementia in the elderly. AstraZeneca has said the U.S. attorney was looking into its marketing of Seroquel.
Lilly also paid $1.2 billion to settle several thousand personal-injury suits over allegations that Zyprexa caused weight gain and led to diabetes.
Last month, U.S. District Judge Anne Conway threw out the first two Seroquel personal-injury cases for lack of evidence.
Nations and other lawyers, along with Bloomberg, have asked Conway to unseal documents discovered in the dismissed cases.
They want to unseal correspondence and other documents stemming from AstraZeneca's initial application for FDA approval of Seroquel.
They are also asking that Conway make public so-called call notes from Seroquel representatives that may reveal whether AstraZeneca sales pitches focused on prescribing the drug for uses not approved by the FDA. If that happened, it would be illegal. Plaintiffs' attorneys and Bloomberg have also requested that correspondence between Macfadden and people who researched or wrote about Seroquel be made public.
AstraZeneca spokesman Tony Jewell said the hearing tomorrow is about the confidentiality of 111 documents, and of those documents, AstraZeneca is arguing that only 65 documents should remain confidential. The company also is worried that documents released in litigation may cause undue concern among patients.
"AstraZeneca believes the best way for physicians and patients to understand benefits and risks of medicines is through communications from the FDA, not in discovery as part of litigation or through the media," Jewell said.
The company also said that while it did not condone Macfadden's behavior, details of his relationships are irrelevant. He no longer works for AstraZeneca and could not be reached for comment.