Healthy Skepticism Library item: 1093

Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.

Publication type: news

FDA inquiry needed
2003 Apr 2

Full text:

STUDENTS at West Virginia University are being paid large sums to beguinea pigs in pharmaceutical tests – and a bit of suspicion has beenraised about the honesty of the test results.

Journalism student Andrew Joseph Arthur joined a test and wrote a report in the Sunday Gazette-Mail. His account was an eye-opener. He found: As the U.S. government reduces medical research, more testing of new drugs is being funded by the manufacturers themselves. Presumably, the makers don’t want to discover ugly side-effects caused by their products.

Kendle International operates an independent testing clinic in Morgantown. It places ads in the WVU campus newspaper offering good pay to students – usually $400 to $600 each – to take drugs, wait in the clinic a few days, and have blood samples drawn dozens of times. Since most students are young and healthy, and usually need cash, they’re ideal volunteers.

But there’s a catch: If a student suffers a side-effect, he or she gets medical treatment but no money. Obviously, this tempts students to conceal any ill-effects, and thus casts doubt over the reliability of the test results.

Arthur was chosen for a lucrative test. He was offered $1,475 to spend three weekends in the clinic, taking a colitis medication on the first weekend and having 70 blood samples drawn thereafter. He described boredom and sleeplessness during the waiting periods.

On the final night, he suffered pain in his chest and arms so severe that, “I really thought I was having a heart attack. The pain was intense and was akin to having a raging ice-cream headache in my chest and arms.”

He woke a watchman, who called a nurse, who gave him Tylenol. She said a doctor could be called, “but it would affect my paycheck.” Arthur declined the physician. Next morning, he felt fine and dismissed the pain as flu symptoms.

Then the nurse offered to delete the pain complaint from his record, so there would be “less complications, should I decide to do another study.

I obliged.”

Perhaps the pain had nothing to do with the colitis medication – but there’s a nagging doubt about the integrity of the test. As long as students lose money for reporting side-effects, some will hide ailments.

We think the U.S. Food and Drug Administration should inquire into this dubious arrangement revealed by a student journalist.