Mental Health Blogs

Bloomberg is reporting today on documents recently unsealed in federal court in Florida in the ongoing case against AstraZeneca concerning claims that the company did not properly notify the public of risks (principally, diabetes and weight gain) associated with its antipsychotic Seroquel, now one of the top selling drugs in the world

“Nancy White, the saleswoman, and a colleague met in July 2006 with an unidentified doctor who reported ‘getting a lot of flak’ from patients about Seroquel’s diabetes links, according to a note unsealed as part of a lawsuit. AstraZeneca wrote in November 2002 to Japanese doctors that it received a dozen reports of diabetes-related cases tied to Seroquel ‘where causality with the drug could not be ruled out.’

“White said in the 2006 note that she told the physician that ‘there has been no causative effect’ found between Seroquel and diabetes. The doctor ‘said he would not quit writing’ prescriptions for Seroquel ‘due to this at this time,’ White reported.”

Issuing a warning in Japan while not issuing one in the US probably won’t play out really well for AZ at trial. The behavior is reminiscent of Lilly warning Japanese doctors of similar diabetes problems with Zyprexa in 2002 while months later in the US claiming the drug was perfectly safe as it rolled out a huge sales campaign aimed at PCPs.

Tufts psychiatrist Danny Carlat echoes what I wrote in 2007 about Zyprexa:

“‘It’s pretty clear that if a drug poses a diabetes risk in one country, it poses that risk in others,’ Dan Carlat, a psychiatrist at Tufts University in Boston who writes a blog about the health-care industry, said in an interview. ‘I don’t think it’s ethical to warn doctors in Japan about this drug and then downplay or ignore the risk in the U.S.’”

Unethical? I’d say it should be illegal and the FDA ought to look into how it can reconcile US labeling to conform to warnings on the same drugs in other countries.

In other documents, AZ sales reps are reportedly working to downplay docs concerns about weight gain in Seroquel users, in effect flat out lying about the issue when Seroquel was known to be producing rapid weight gain in some patients, a potential precursor to diabetes.

An AZ spokesman told Bloomberg:

“‘The heart of these cases are unproven claims that Seroquel caused diabetes,’ Tony Jewell, an AstraZeneca spokesman in Wilmington, Delaware, said in an e-mailed statement. ‘The evidence does not back up the allegations that Seroquel was responsible for the plaintiffs’ alleged injuries.’”

That remains to be seen.

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Related posts:

1. AstraZeneca Can’t Exclude Diabetes Expert Witness From Seroquel Trials
2. AstraZeneca Defends Seroquel Weight Gain Warnings
3. AstraZeneca Exec Was Pressed To Lie About Seroquel Weight Gain
4. Seroquel Promoted As Weight Neutral When Company Knew It Produced Large Weight Gain
5. AstraZeneca Whines About Chicago Tribune’s Seroquel Coverage