Seroquel Documents: AZ "Buried" Seroquel Studies

This came to me too late at night for me to do much poking around. From Bloomberg:

"Feb. 27 (Bloomberg) -- Unfavorable studies about the antipsychotic drug Seroquel were 'buried' by AstraZeneca Plc, according to an internal e-mail unsealed as part of litigation over the medicine.

"The drugmaker failed to publicize results of at least three clinical trials of Seroquel and engaged in 'cherry picking' of data from one of those studies for use in a presentation, an AstraZeneca official said in a December 1999 e-mail unsealed yesterday under an agreement between the company and lawyers for patients...."

"'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."

More on Trial 15 which the Wall Street Journal also picked up on:

"One unsealed document showed AstraZeneca officials considered Trial 15, one of the studies Tumas described as 'buried,' to be a problem because it didn’t produce favorable results on the issue of weight gain for patients taking the drug. Gaining weight can be a factor in the development of diabetes.

"Richard Lawrence, an Astra Zeneca 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.

"'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 pointed out that AstraZeneca had 'buried trials 15, 31, 56,' and was considering a study listed as COSTAR. The focuses of the trials weren’t specified in the e-mail.

"He also noted '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," he said. The data was used in 'the recent Velligan presentations,' he noted. 'Thus far, I am not aware of any repercussions regarding interest in the unreported data.'"

I cannot find any references to a published COSTAR study online.

Velligan is likely a reference to University of Texas (San Antonio) psychiatry professor Dawn Velligan. She's done some Seroquel studies in schizophrenia. For example, this.

More:

"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,' he 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.'

"Among the unsealed documents was a March 2000 e-mail from Tumas in which he noted a study comparing Seroquel to Risperdal, Johnson & Johnson’s rival antipsychotic drug, produced data 'that don’t look good.'

"The results showed that Seroquel failed to best Risperdal in at least five different categories and only out-performed the placebo used in the study, according to study data made public yesterday. Those categories included mood, anxiety and hostility, the documents showed."

Wow is all I can say.

"AstraZeneca officials have criticized lawyers for former Seroquel users for pushing to have documents in the case unsealed.

"'It is not surprising that plaintiffs’ lawyers have resorted to these tactics to distract attention from their lack of success on the merits of the claims,' Jewell said in his statement."

Separately, Tony Jewell, an AZ spokesman, said in a statement to Bloomberg, "None of the documents can obscure the fact that AstraZeneca acted responsibly and appropriately as it developed and marketed Seroquel."

With a first trial set for Delaware in April, it'll be interesting to see if AZ settles or goes to trial. AZ has settled none of the approximately 9,000 lawsuits it faces over Seroquel.