Big pharma lied and the incompetent FDA did not catch it.
I would have never guessed.
What do you do if you’re trying to sell a product with few benefits over its competitors? You laud its lack of drawbacks. At least that’s what Pfizer did in the case of the arthritis medication Celebrex, advertising it as safer for the stomach than the equally effective ibuprofen.
Katie Thomas of The New York Times reports:
The truth was that Celebrex was no better at protecting the stomach from serious complications than other drugs. It appeared that way only because Pfizer and its partner, Pharmacia, presented the results from the first six months of a yearlong study rather than the whole thing.
A long-running securities fraud case against Pfizer recently opened up thousands of the company’s internal documents. The portfolio shows the company’s strategic distortion of research into Celebrex side effects. It includes a research chief’s email boast to a colleague, “They swallowed our story, hook, line and sinker,” after a research conference discussed Celebrex’s gentler effects on the stomach than comparable drugs.
Celebrex is one of Pfizer’s top selling drugs. It has brought them over $2.5 billion in sales, and 2.4 million patients in the U.S. in 2011 alone. It’s also the last COX-2 inhibitor pain drug still on the market, after the removal of Vioxx and Bextra in 2004 and 2005 due to evidence of heart risks.
Pfizer has yet to complete a now six-year-old study regarding Celebrex’s heart risks.
The company defends its choice to only release partial results from the drug’s safety studies by arguing that the high number of patients who have take it - 33 million Americans - proves its worth and safety.
The fact that Pfizer only partially revealed findings from the Celebrex stomach safety study was already known, the FDA revealed the full results of the study in 2001 and the unveiled discrepancies lead to a lawsuit in 2003. But these newly released documents are the first to show how calculatingly the company planned their data distortion.
Lawyers for Pfizer declined comments to the Times. A press release from the company retains confidence that it is in the right in regards to the way it presented Celebrex to consumers.
[via The New York Times]
[Image: discounteddrugsonline.net]
