Astrazeneca Denied Drugs Diabetes Link Years After Alarm
Nancy White, the saleswoman, and a colleague met with an unidentified doctor in July 2006 who reported “getting a lot of flak” from patients about Seroquels 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.
More than 15,000 patients have sued London-based AstraZeneca, claiming the company withheld information about links between diabetes and Seroquel. Many of the suits also claim AstraZeneca promoted Seroquel, approved by the U.S. Food and Drug Administration for schizophrenia and bipolar disorder, for unapproved uses.
Seroquel, which generated sales of $4.45 billion in 2008, is the companys second-biggest seller after the ulcer treatment Nexium.
Unproven Claims
“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.”
A federal judge in Orlando, Florida, ordered AstraZeneca to unseal the sales-call notes by Sept. 11 after Bloomberg News filed a motion to gain access to company files turned over in Seroquel litigation. The judge allowed AstraZeneca to withhold physicians names on privacy grounds.
All federal-court cases over Seroquel, a so-called atypical or second-generation anti-psychotic medicine, have been consolidated in Orlando for pre-trial proceedings.
In his e-mail, Jewell said AstraZeneca “has always provided adequate warnings” about Seroquels health risks and has complied with varying regulatory standards around the world in connection with the drug.
Adequate Warnings
“When Seroquel was first approved in 1997, U.S. labeling alerted physicians” that diabetes and weight gain had been observed in some clinical trials, said Jewell, who is based in the companys U.S. headquarters in Wilmington, Delaware.
In the 2002 letter, AstraZeneca officials warned Japanese doctors not to prescribe the drug for diabetic patients and to push users to monitor their blood-sugar levels. Jewell acknowledged earlier this year AstraZeneca didnt start warning U.S. doctors to monitor blood-glucose levels until January 2004.
“Its 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 dont think its ethical to warn doctors in Japan about this drug and then downplay or ignore the risk in the U.S.”
Weight Gain
In another note recently unsealed by the company, salesman Eric Payne alerted his supervisors in January 2005 that he had “discussed weight gain associated with atypicals” with another unidentified doctor.
Payne assured the physician there was a low incidence of Seroquel users gaining weight and encouraged the doctor to make the drug his “first line choice,” according to a copy of the note.
Documents unsealed earlier in the Seroquel litigation show AstraZeneca trained its sales force to deflect questions about links between weight gain and the drug.
In a 2005 voice-mail, for example, AstraZeneca manager Christine Ney offered the companys U.S. salespeople information they could use to “neutralize customer objections to Seroquels weight and diabetes profile.”