Would You Believe Drug Trials Do Not Look At Safety?

It’s a bit hard to swallow but manufacturers are so busy scrambling to get their product approved, they carry out the fastest and shakiest tests that could possibly be considered “legal” (but not scientific). Trials are so short that safety issues never show.

Well, hardly ever. When they do, the drug manufacturers just suppress it. Yet again Merck is in the frame for lying and covering up the fact that Vioxx (rofecoxib) kills. Why are the directors of this organization still walking the streets instead of being in jail for manslaughter, at least?

It has emerged through independent investigation that the fact that Vioxx increased risk for heart attack, stroke and death, were known for years before the drug’s voluntary withdrawal from the market in 2004.

The researchers found 30 trials with a total of 20,152 patients, comparing the anti-inflammatory medication with placebo.

Twenty-one of those trials had been completed by the end of December 2000, and a risk of heart attack, stroke and death among patients taking Vioxx was clear and should have led to a safety warning, Ross said.

The risk for those cardiovascular events was 35% higher among patients taking Vioxx compared with those taking placebo. The association grew as more trials were completed, increasing to 39% in April 2002, when newer data was analyzed, and to 43% in September 2004, according to the study.

Merck’s excuse? (you won’t believe this one!) “Merck believes the article published in The Archives of Internal Medicine in today’s issue related to Vioxx used unreliable methods and reached incorrect conclusions.”

What a cheek! They can use unreliable and incorrect conclusions to push their stuff. But if somebody criticizes them, it’s bad…

“Merck acted responsibly — from researching Vioxx prior to approval in studies with approximately 10,000 patients to monitoring the medicine while it was on the market — to voluntarily withdrawing the medicine when it did,” their statement said. “Our decisions were based on the data from well-controlled clinical trials.”

Usual doublespeak: they relied on well-controlled clinical trials (maybe), BUT THEY IGNORED LOTS OF OTHER TRIALS THAT THEY DIDN’T LIKE, WHICH SAID THEIR DRUG WAS DANGEROUS.

This new finding showed that Merck’s chief executive officer lied before a U.S. Senate committee in November 2004, by stating that earlier clinical trials showed no difference in the risk of heart events between patients taking Vioxx and those taking a placebo.

So much for the US Constitution, never mind medical science and the public good. Big Pharma is contemptible.

[Sources: Nov. 23, 2009, Archives of Internal Medicine; Nov. 23, 2009, statement, Merck & Co.]

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