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Report paints grim picture of drug trial safety

A new federal report paints a very grim picture as to how well the Food and Drug Administration protects Americans who are subjects in human experimentation. The FDA is called on the carpet for not knowing how many experiments are actually being done in the U.S.  But who is really to blame for the lack of oversight?

When a bridge collapses in an American city or a mine implodes, it does not take long before government gets in motion to figure out what to do about the problem. We see the carnage and demand action. 

When a federal agency charged with protecting your health and safety is found grossly deficient, the response, sadly, is mainly talk. 

That is because it is hard to see where the victims are and, without them, it is hard to get the problem fixed. But when it comes to the Food and Drug Administration, we had better demand repairs.

A new report from the inspector general of the Department of Health and Human Services paints a very grim picture as to how well the FDA protects Americans who are subjects in human experimentation. The FDA is called on the carpet for not knowing how many experiments are actually being done in the United States. The report also faults the FDA for inadequate audits of research sites and a failure to ensure compliance with its orders when FDA inspectors find something amiss at a research site.

The problems discussed in the report are not new. They have been festering for years. Who is to blame? 

It falls on Congress, which continues to underfund the FDA while at the same time being first in line to chime in when the undermanned and overwhelmed agency fails to rein in a renegade researcher, or does not act quickly to recall a drug or device that may be responsible for killing dozens or hundreds of people.

The FDA has no way to keep track of the number of clinical trials being done every year, who does them, who pays for them or even how many people are involved as subjects. This is beyond belief since the government agencies responsible for monitoring research with animals collect exactly that data every year. How can it be that we know how many pigs, frogs, rats and monkeys are used in research and who uses them without knowing what is going on with respect to human beings?

Are too many poor people disproportionately recruited for research? Who knows? Are the elderly in nursing homes underrepresented in clinical trials? Who can tell? Should more children be involved in studies of new drugs? Cannot say.

Is it more likely that people get injured in for-profit test centers than in academic research settings? No data is available to answer that question.

Despite tens of billions of dollars being spent every year on research, the FDA is flying blind when it comes to really knowing what is going on with that money.

Worse still, the FDA relies almost exclusively on paperwork compliance to ensure subject safety. It is as if the Internal Revenue Service relied just on the forms sent in by taxpayers each year without doing any audits. The FDA barely has enough people to keep tabs on the data submitted by companies seeking approval of new drugs, vaccines and devices. 

Wouldn’t you feel better if you were involved in a clinical trial and you knew that the FDA had the personnel to conduct random audits and unannounced inspections of research sites?

The amount of research done annually in the U.S. has increased exponentially from what was going on 40 years ago. Yet the FDA still is asked to police this research with a budget and staff more suited to the 1960s than the 21st century.

The criticisms leveled at the FDA are right on target. 

We need sound data on research, tough oversight of trials, vigorous on-site auditing and tough enforcement when the few bad apples in research go off the rails. Congress undoubtedly will applaud the report and many elected officials will express shock and dismay at the failings and loopholes found at the FDA. Outrage is fine, but it is long past time that Congress and the Bush administration did something to fix the problem. 

The infrastructure supporting the safety of American research is in trouble. It is long past time to allot the funds to fix it.

Arthur Caplan, Ph.D., is director of the Center for Bioethics at the University of Pennsylvania.