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Sunday, June 26, 2011

Glaxo Warned in 1994 About their "False & Misleading" Information on Paxil/Seroxat



Another gem of a file from the Project on Government Oversight (POGO), who recently uploaded a total of 296 documents to the DIDA Library.

This particular document shows how, in 1994, GlaxoSmithKline were warned by The Department of Health & Human Sciences [DOHHS] about their promotion of Paxil [known in the UK as Seroxat]

The complete 12 page letter, which can be downloaded here, shows how the DOHHS sent Glaxo a warning letter pointing out that their promotion of Paxil carried many false and misleading claims.

Here's a few tasters:

7. "A low discontinuation rate" chart. (PX1004, pg. 16)
This chart presents the two most common reasons for discontinuation in the clinical trials, suggesting that the sum of these rates, 5-7%, provide an estimate of the overall rate of discontinuation. Because the actual overall rate of discontinuation due to adverse events is much higher, 21%, this suggestion is false and/or misleading.


8. Failure to provide fair balance.
Pages 16 and 17 of PX1004 are incorporated into a fold-out page layout design. These pages discuss the warnings and adverse events associated with Paxil therapy. However, unless the viewer is actively searching for this important risk information, it is unlikely that SKB's sales representatives will call attention to this disclosure. Moreover, since the brochure is a detail aid for sales representatives use and is not left behind for the healthcare provider, this likelihood is further diminished. The presentation of risk information is completely inadequate and is false and/or misleading.


11. "Proven safe and effective in long-term treatment and relapse prevention." (PX1634, pg. 16)
This claim and accompanying graph are derived from the study by Duboff et al. entitled, "Long Term Treatment of major depressive disorder with paroxetine." This study consists of a one year, multicenter, open-label study involving 433 patients with ma^or depressive disorder followed by a long-term extension study including 110 of the patients. As discussed in Comment 1, the lack of a placebo control arm renders the efficacy resultsuninterpretable. Therefore, this study is inadequate to support this claim, and this claim is false and/or misleading.


14. "'Like many other antidepressants, common side effects..." (PX1604)
The phrase, "like many other," minimizes the importance of the side effects associated with Paxil therapy. Therefore, this statement is false and/or misleading.


There are 18 in all, all of which can be viewed HERE


ARE YOU STRUGGLING TO WITHDRAW FROM SEROXAT/PAXIL?

Email Glaxo and tell them. Chances are, you will be referred back to your doctor, if so, email me.

Email GSK Customer Relations HERE

Related articles:

How Glaxo Wanted to Turn the Issue of Withdrawal in Their Favour

Previously Unseen Paxil GlaxoSmithKline Court Documents Part I


Fid


ORDER THE PAPERBACK
'THE EVIDENCE, HOWEVER, IS CLEAR...THE SEROXAT SCANDAL' By Bob Fiddaman
US & CANADA HERE OR UK FROM CHIPMUNKA PUBLISHING

AUSTRALIAN ORDERS HERE