Post resurrects “buried” Seroquel study (FiercePharma)
March 18, 2009 — 11:43am ET |
By Tracy Staton
Stories about “buried” drug data have become shockingly common–or, we should say, so common that they’re no longer shocking. Take today’s Washington Post article about “Study 15,” a trial of the AstraZeneca psychotic Seroquel back in 1997. On the heels of study-burying allegations against many of AstraZeneca’s rivals–Eli Lilly (Zyprexa), Pfizer (Neurontin), GlaxoSmithKline (Paxil), among others–the never-publicized, filed-away Study 15 seems like just one of a crowd.
That fact says more about jaded attitudes than it does about Study 15 itself, presuming the Post‘s article is accurate (which we do). Study 15 found that Seroquel patients gained 11 pounds a year on the drug. After analyzing the data, the Post concluded that four out of five patients stopped taking the drug. But that information never got to the public until eight years later, when a taxpayer-funded study “rediscovered” the drug’s unwelcome side effects.
The study did get to the FDA. But the agency never released the data, and it continues to maintain that it doesn’t have the authority to do so. Moreover, as AstraZeneca points out, the FDA had Study 15 in hand when it approved Seroquel, saying it was safe and effective. Presumably, the agency could have said “no.” But it didn’t. Instead, the FDA required AstraZeneca to include the risk of weight gain and metabolic disorders on Seroquel’s label.
Meanwhile, AstraZeneca folks were worried about Study 15. As you know, internal emails released as court documents show that higher-ups praised a company doctor’s efforts to put a “positive spin” on “this cursed study.” Company officials discussed their “cherry-picking” of data; one said, “Thus far, we have buried Trials 15, 31, 56 and are now considering COSTAR” (which also produced unfavorable results). In public, however, AstraZeneca publicized a less-rigorous study showing that patients lost weight on Seroquel.
Defending AstraZeneca’s research, spokesman Tony Jewell told the Post that Seroquel’s weight-gain risks have been on the label since 1997. Plus, he pointed out the fact that few patients remained at Study 15’s conclusion. “A large proportion of patients dropped out in both groups, which the company felt made the results difficult to interpret.”
– Read the article in the Post
Legal eagles eye AZ’s battle over Seroquel – FiercePharma
Seroquel user wants FDA to see sealed papers – FiercePharma
Unsealed documents raise Seroquel questions – FiercePharma
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