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Suppress to impress

What shall we do with the drug companies?  The year is only a few weeks old but already they've been caught out on two occasions suppressing vital data that revealed their drugs weren't working anywhere near as well as they have claimed. 

In the first case - involving the cholesterol-lowerting drug Zetia (ezetimibe) - the truth about its inneffectiveness was revealed only when a Congressional hearing in the USA forced the manufacturer to release the data from its Enhance trial.

In the second, independent researchers discovered that selective reporting of data from trials into a range of antidepressants had made them seem at least 30 per cent more effective than in fact they were.

America's drug regulator, the Food and Drug Administration (FDA), has one answer.  From next September, every drug trial must be registered with the agency, and ongoing reearch and findings must be revealed other than during the first, preliminary stages.

The worry is that the ruling has no teeth.  Drug companies that fail to comply can be fined a whopping $10,000 (UK£5,100), which will certainly make them think twice before suppressing data on drugs that generate billions of dollars of sales every year.

Still, it's an attempt of sorts, we suppose, and we don't expect the UK's drug regulators - who pride themselves on being the fastest in the world - to come up with anything similar any time soon.

 

 

Published 25 January 2008 15:06 by Bryan Hubbard

Comments

 

Victim said:

As a Vioxx victim and now a Zetia victim, I am very upset with the FDA and big Pharma.  I was a healthy 55 year old with a sore back and ended up with a heart attack from vioxx.  Then I was treated for heart problems with zetia and now I find out it didn't help me.  Who are we the American public to believe?  Surely not big Pharma, they hide all the study information until they make billions and then Settle for less then half of what they made.  VIOXX SETTLEMENT is a sham, only dictated by Merck and accepted by greedy lawyers.

January 25, 2008 18:01
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