Friday, February 27, 2009

"Buried Data," a "Smoke-and-Mirrors Job" and a "Positive Spin" on a "Cursed Study"

Documents produced on discovery and recently unsealed during litigation suggested how AstraZeneca handled clinical research data in the marketing of its atypical anti-psychotic drug Seroquel (quetiapine). As reported by Bloomberg,

AstraZeneca Plc 'buried' unfavorable studies on its antipsychotic drug Seroquel, 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 London-based company faces about 9,000 lawsuits claiming it failed to properly warn users that Seroquel can cause diabetes and other health problems.

'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.

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 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.

'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.

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.'

So here we have more evidence about a big pharmaceutical company suppressing and manipulating data from the clinical research when its results proved unfavorable to its product. The unsealed evidence, when added to many other cases we have discussed, suggest that manipulation and suppression of clinical research data to support companies' vested interests is a common practice by commercial health care firms, including but not restricted to pharmaceutical, biotechnology, and device companies.

As we have said before, suppression and manipulation of research amounts to post-hoc abuse of research subjects who volunteered their participation believing that it would advance science and health care.

Furthermore, suppression and manipulation of research can deceive physicians into prescribing tests and treatments that will fail to help, or even harm patients, and deceive patients into thinking that they are getting the best possible tests and treatments, when, again what they are getting is ineffective or even harmful.

In my humble opinion, there is an increasingly strong argument that clinical research should not be controlled, and probably should not be done at all by organizations with vested interests in the research producing results favorable to their products.

See additional comments about the Seroquel litigation on the Clinical Psychology and Psychiatry blog here, and the Carlat Psychiatry Blog here.

ADDENDUM (2 March, 2009) - See detailed comments on the apparent manipulation of a meta-analysis of Seroquel versus a "typical" anti-psychotic, haloperidol, on the Clinical Psychology and Psychiatry Blog.


Anonymous said...

Also discussed on the following blogs: (Pharmalittle) (BNET Pharma) (Hooked)

Anonymous said...

Forgot to mention multiple posts on Pharmagossip and Furious Seasons.