Last Updated Feb 27, 2009 11:52 AM EST
Back story: AstraZeneca is accused of marketing its antipsychotic without warning patients about the dangers of weight gain and diabetes. (See "AstraZeneca's Sex-for-Studies Seroquel Scandal: Did Research Chief Bias the Science?")
Richard Lawrence, an AstraZeneca official, said in a February 1997 e-mail that the company had engaged in a "great smoke-and-mirrors job" in dealing with U.S. and Canadian investigators on the trial's results.Enter Tumas:
"Adopting the approach Don has outlined should minimize (and dare I venture to suggest) could put a positive spin (in terms of safety) on this cursed study," Lawrence said in the e-mail. It isn't clear from the e-mail which person Lawrence is referring to.
In his December 1999 e-mail, Tumas said that AstraZeneca had "buried trials 15, 31, 56," and was considering a study listed as COSTAR. Details of the trials weren't specified in the e-mail.That, right there, is everything you need to know about PR and marketing when it comes to drugs that have serious risks and side effects. Print it out and stick it to the wall of your cubicle, drug marketers.
"The larger issue is how we face the outside world when they begin to criticize us for suppressing data," John Tumas, an AstraZeneca publications manager, told colleagues in the e-mail.
He also noted that "there is growing pressure from outside the industry to provide access to all data from clinical trials conducted by industry."
Tumas chastised colleagues for using favorable data produced by Trial 15 without disclosing the full study results, according to his unsealed e-mail.
"There has been a precedent set regarding 'cherry picking' of data," which was used in "the recent Velligan presentations," he said. "Thus far, I am not aware of any repercussions regarding interest in the unreported data."
The publications manager indicated that AstraZeneca had a favorable reputation for engaging in "ethical behavior" when it came to disclosing study results on its drugs.
"We must decide if we wish to continue to enjoy this distinction," Tumas wrote.
"The reporting of the COSTAR results will not be easy," he added. "We must find a way to diminish the negative findings. But, in my opinion, we cannot hide them."
The damage being done to AZ's reputation (the FDA just frowned upon extending Seroquel's indications), to sales of Seroquel, and ultimately to the company when it adds up the costs of all this litigation, could have been largely avoided if anyone in charge at AZ had looked at Tumas's messages and concluded, "Um, he's probably right. Better to take our lumps now than in the headlines later."
For form's sake, here's the current line from AZ PR, per Bloomberg:
None of the documents can obscure the fact that AstraZeneca acted responsibly and appropriately as it developed and marketed SeroquelSupplementary stuff for latecomers: The plaintiffs in the case allege:
- By July 2001, AZ had received at least 46 reports of diabetes in patients taking Seroquel, 21 cases of ketoacidosis or acidosis, and 11 deaths. By the end of 2003 AZ had received at least 23 more. "Most cases appeared within 6 months of initiating therapy."
- The FDA asked AZ to send out a dear doctor letter about diabetes and Seroquel on Sept. 11, 2003. AZ did not send out the letter until January 2004.
- "On April 24, 2004, AZ was forced to send out a revised "Dear Doctor" letter due to the fact that the first one was misleading, as it potentially downplayed the need to continually monitor a patient's blood sugar levels."
- BNET's previous coverage of Lilly and Seroquel:
- AstraZeneca's Sex-for-Studies Seroquel Scandal: Did Research Chief Bias the Science?
- Seroquel Trial: Allegations of Sex-for-Secrets; AZ Wants Papers Sealed
- 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