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.

by Heidi Stevenson

30 July 2010

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?

The Authors of the Study

One can often tell how legitimate a study is by who authored it. This study's authors are all employees of the Tufts University School of Medicine. Tufts keeps popping up as a source of bad studies. Scott Reuben, the doctor who received only six months for inventing patients and data in several bogus studies, was a Tufts "researcher". As discussed here, Tufts' claim that they were unaware doesn't make sense.

Misreporting the Number of Trial Subjects

First, the report did not acknowledge that the trial started with 20 subjects, that 6 didn't make it through the first cut, and that a full 50% of those who made it through the cut were forced to drop out because of adverse effects. The article in The Journal of Clinical Pharmacology, "Ritonavir Has Minimal Impact on the Pharmacokinetic Disposition of a Single Dose of Bupropion Administered to Human Volunteers", reported only that the trial had been done on "7 healthy volunteers".

Nonreporting of Adverse Effects

The focus was not on what happened to the subjects. Instead, it was on the results of blood draws. The only significant effect reported was that Norvir reduces the bupropion-related metabolites.

Let that sink in. In a trial in which a full 50% of the subjects had to drop out because of adverse effects, and at least one of the remaining seven was in severely-damaged health because of it, the only negative that the trial's authors reported was a reduction in the effectiveness of Wellbutrin!

Dangerous Drugs Get on the Market

This is just one case of how drug studies are handled. As a result, the only adverse effect now reported by Medscape for the Norvir-Wellbutrin combination is "decreased effect" of Wellbutrin.

The fact that a full half of the subjects—healthy people, not ones suffering already—were unable to complete the study because of adverse effects was simply ignored. The remaining seven, which is the minimum number requred by the FDA, were treated as the entire study population, which is, at best, dishonest.

The fact that the side effects were so severe was evaded by simply not reporting on them, pointing out instead some of the blood serum results. One must wonder what blood serum results were also ignored.

The FDA, which could have investigated these problems, obviously did not do so. This is what happens when an agency is controlled by those it's supposed to regulate. The result is that the FDA protects Big Pharma—and Agribusiness—rather than the public.

Drugs that kill and offer questionable benefit are put on the market with complete disregard of the risks to real people. The FDA is then in the position of needing to cover up its lack of oversight, as happened recently with its panel's vote to leave the killer drug, Avandia, on the market.

How many other Ana Cantús are out there? She obviously isn't the only one, as the nonreporting of severe adverse reactions to Avandia, clearly demonstrates. It beggars belief to suggest that there was any innocence on Merck's part in the testing of Vioxx, or of Pfizer with Celebrex. All the Big Pharma companies seem to be guilty—along with a host of Big Pharma wanna-be's.

Most of modern medicine uses the nice-sounding concepts of "evidence-based medicine" and "double blind placebo controlled" trials for marketing. The reality is that little that's done in mainstream medicine is either concept in anything but image. Ana Cantú's experience is too obviously commonplace, not the exception.

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