In Vanity Fair, Donald Barlett and James Steele have devoted more than 6,000 words to chronicling the gaping holes in the global pharmaceutical industry, particularly as pertains to the globalization of clinical trials. Even if you’re familiar with many of the specific incidents covered, their cumulative effect, driven home with forceful and authoritative prose, is brutal. Each paragraph holds another tale of trials gone wrong, children killed and bad results that somehow never came to the attention of American regulators.
It used to be that clinical trials were done mostly by academic researchers in universities and teaching hospitals, a system that, however imperfect, generally entailed certain minimum standards. The free market has changed all that. Today it is mainly independent contractors who recruit potential patients both in the U.S. and—increasingly—overseas.
They devise the rules for the clinical trials, conduct the trials themselves, prepare reports on the results, ghostwrite technical articles for medical journals, and create promotional campaigns. The people doing the work on the front lines are not independent scientists. They are wage-earning technicians who are paid to gather a certain number of human beings; sometimes sequester and feed them; administer certain chemical inputs; and collect samples of urine and blood at regular intervals. The work looks like agribusiness, not research.
After neatly setting up each pin with demonstrations of how international the pharmaceutical industry has become, then proceed to knock them all down with examples of industry impunity and FDA weakness.
The F.D.A., the federal agency charged with oversight of the food and drugs that Americans consume, is rife with conflicts of interest. Doctors who insist the drug you take is perfectly safe may be collecting hundreds of thousands of dollars from the company selling the drug. … Quite often, the F.D.A. never bothers to check for interlocking financial interests. In one study, the agency failed to document the financial interests of applicants in 31 percent of applications for new-drug approval. Even when the agency or the company knew of a potential conflict of interest, neither acted to guard against bias in the test results.