Trials and Tribulations: How the FDA Fails to Adequately Oversee Human Experiments

In the past several decades, modern medicine has moved from basing therapy on the anecdotal experience of respected individual physicians to the systematic collection of data in experiments called clinical trials. In general, this is a trend to be welcomed. Personal observations can be warped by one’s biases, and small benefits or rare side effects can easily be missed.

But what if there was inadequate oversight of these trials, to the possible detriment of the patients in these studies? A September 2007 report by the Inspector General (IG) of the Department of Health and Human Services (available online at http://www.oig.hhs.gov/oei/reports/oei-01-06-00160.pdf) suggests that this is no mere rhetorical question; it is the current reality, even as tens of thousands of Americans annually lay their bodies down for science. Just recently, The Washington Post reported on a 36-year-old generally healthy woman who died in an early-stage test of a genetically engineered virus for her arthritis.

The IG’s report focuses only on a limited sliver of human experiments: clinical trials falling under the purview of the Food and Drug Administration (FDA). The FDA has jurisdiction over any trial that could support an application to the agency for product approval.

The important questions here are, “what does the FDA know and when do they know it?” The answers are all too clear: not much and too late. 

Here’s what the report says the FDA doesn’t know: “it is unable to identify all ongoing clinical trials,” “it is unable to identify all [ethics committees]” and its databases “do not consistently track inspection information.” 

Much of what little the agency does know is based on on-site inspections. But the IG report estimated that the FDA inspected only 1 percent of clinical trial sites in fiscal years 2000 to 2005. And even these were not primarily dedicated to human subjects’ protection. As might be expected from an agency whose primary mission is product evaluation, the emphasis of the inspections is on data quality, not ethics. To make matters worse, most of the inspections that do take place occur after the study is complete – too late to make any changes that might enhance protections for volunteers.

And what if these inspections actually find infractions? Turns out that violations detected by inspectors in the field are systematically downgraded by more senior officials in Washington. In the FDA’s drug center, for example, an astounding 68 percent of the most severe infractions were downgraded, while only 26 percent of the least severe findings were upgraded.

Even then, the FDA does little to enforce compliance. Its primary enforcement instrument is called a Warning Letter, but compliance is voluntary. Of course, the FDA cannot consistently determine whether the infraction was corrected, because the agency cannot track inspections properly. It’s a Catch-22.

People who are willing to take risks to benefit science and society deserve respect, even honor and certainly protection. They are entitled to a system that can monitor clinical trials and that can correct deficiencies before it is too late. What they have instead is a system that is more interested in the data they generate than their well-being.