Blackouts Don't Stop Drug Trial—Or Let Subject Out of It

What Ana Cantú went through as a GSK guinea pig is shocking enough, but worse is how a major medical journal published the study as having innocuous results.

Ana Cantú’s description of her participation in a GlaxoSmithKline (GSK) drug trial is a riveting read. By the end, you know that the entire system that allows Big Pharma to conduct its own trials is corrupt at the core, and that, by extension, the FDA’s willingness to approve drugs based on such trials must also be utterly corrupt.

Following is a brief review of the study and how it was misreported in The Journal of Clinical Pharmacology. While the events of the trial itself are horrifying, even worse is how they were hidden and whitewashed through a peer-reviewed medical journal.

Trial Subject’s Suffering

Ana was well-paid to be a subject in a GSK trial for combining Norvir (generic name ritonavir), an HIV drug, and Wellbutrin (generic name bupropion), an SNRI antidepressant. She received $4,800 five years ago to participate as a healthy patient.

Originally, there were 20 subjects. Six of them were eliminated immediately, one for drinking a caffeinated beverage within 24 hours of the check-in. (It should be noted that there are no warnings to avoid caffeine when taking either of these drugs separately, let alone together. What does GSK know that they aren’t telling us?)

That left 14 subjects. They all lasted through the first week, but then began dropping like flies. The first to go suffered from severe jaw and tooth pain. Severe nausea and vomiting took out the next subject. 2½ weeks into the trial, there were only 7 subjects left—the minimum required to file a trial report with the FDA.

Over the month-long course of the trial, near-constant nausea caused Ana to lose 10% of her weight. Insomnia allowed her to sleep only 3 hours a night.

Ana wanted out of the trial, but if she dropped out without approval, she’d lose the $4,800 payment. The trial sponsor did not want to lose more subjects, because that would invalidate the entire thing.

A little over 3 weeks into the trial, Ana nearly blacked out. She stated:

…we were standing around in the cafeteria waiting to dose. All of a sudden, I couldn’t see and lost the ability to balance. If I hadn’t been standing between two of my fellow subjects, who grabbed me and held me up, I would’ve slammed into the floor.

Since she didn’t black out if she stayed on her feet only briefly, the examining doctor approved continued dosing.

At her exit screening, Ana’s blood pressure was so low that it had to be checked three times.

The trial ended with 7 subjects, and was submitted to the FDA, which now accepts the combination of Norvir and Wellbutrin.

How the Trial Was Reported in a Peer-Reviewed Journal

As frightening as the trial itself was, even worse is how extremely it was misrepresented in a major peer-reviewed medical journal. It reported only minimal problems. How did it accomplish that?

Rest of story…