Cantú: Anatomy of a drug trial

Ever wonder what it would be like to be in a drug trial? Doubtless the experience varies. But the account offered by Austin-American Statesman commentary editor Ana Cantu is unsettling. If nothing else,  it suggests that the very experience of some of these trials is far from normal reality. That’s aside from questions of the integrity of trial design — or what sort of pressures the participants are under to either drop out (if the drug doesn’t seem to be working) or stay in, if it is.

Exactly five years ago, in exchange for the most miserable month of my life, I got paid $4,800 to test the effects of a drug made by GlaxoSmithKline.

You know where you’ve heard the name GlaxoSmithKline recently, right? That’s the company on the verge of losing the approval of the Food and Drug Administration for the diabetes medication Avandia after regulators discovered omissions in a key clinical trial report. On Wednesday, the FDA ordered Glaxo to stop enrolling people in another Avandia trial.

According to a review reassessing the drug’s safety by the FDA’s Dr. Thomas Marciniak, a number of patients taking Avandia appeared to have serious heart problems that were not counted in the study’s tally of adverse events, otherwise known as side effects.

Such repeated mistakes “should not be found even as single occurrences” and “suggest serious flaws with trial conduct,” he wrote.

via Cantú: Anatomy of a drug trial.

Later you get to this part:

July 25: I was pretty excited that I didn’t get sick after my dosings. … I think the secret is to not drink the milk.

A short but riveting read.

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