Wednesday, January 11, 2006

The best clinical data money can buy?


John Abramson is a clinical instructor at Harvard Medical School. He is also the author of Overdosed America (HarperCollins, 2004) and a consultant to attorneys of patients who took Vioxx and are suing Merck.

He writes in the LA Times:

"Several of our most venerated scientific journals have recently been besmirched by allegations of scientific misconduct. Shocking? We should be just as shocked as Inspector Renault (pic) when he discovered gambling at Rick's Cafe in Casablanca."

He notes: "Why shouldn't we be surprised? Because over the last 25 years, clinical research has been largely privatized. Three-quarters of the clinical studies published in the three most respected medical journals (the New England Journal of Medicine, the Journal of the American Medical Assn. and the Lancet) are now commercially funded. As a result, our medical knowledge grows not in the direction that best improves our health but toward corporate profits, the way that plants grow toward sunlight."

His observations on Vioxx and the NEJM are interesting:

"The Journal's editors are now accusing Merck of withholding critical data. Shame on Merck. But shame on the Journal too for not insisting that the article include a discussion of the most important complications. Doctors were left with the impression that Vioxx was safer than naproxen when exactly the opposite was true.

The Journal again misled its readers in 2001, when one of its influential review articles dismissed the dangers of Vioxx as perhaps reflecting "the play of chance." This article was published seven months after FDA reviewers' concerns and Merck's own research data, which documented the dangers, had been posted on the FDA's website. Worse, the Journal violated its own policy prohibiting scientists with conflicts of interest from writing review articles. (Both authors had financial ties to Merck.) That the Journal disclosed those ties mitigates neither its ethical breach nor the consequences of its repeated understatement of the risks of Vioxx."

Read this thought provoking piece in full here:
LA Times

3 comments:

Anonymous said...

I've seen this first hand. Pfizer's data supporting their inhaled Insulin product Exubera had entire sections pertaining to patients who smoked, had colds and or allergies removed.

Why? Pfizer decided the FDA didn't need to know that some patients got doses as low as zero (any upper or lower respiratory condition, even those not yet "symptomatic" to the patient can prevent dosage) if they were smokers or had a cold or allergies...

Five years from now, you read about the Exubera deaths and know they knew.

insider said...

This is HUGE, if it is true.

How do you know?

Protect yourself: create a hotmail account and email me at:
pharmagossip@hotmail.co.uk

Do the right thing.

Regards

Insider

Anonymous said...

I'd never work again. You know that.