HealthWatch

NEW YORK (CBS News) ―  An inspector general's report of the Food and Drug Administration's oversight of clinical drug trials says such tests - which involve millions of patients using experimental drugs and medical devices - are inadequately monitored by the government for patient safety, according to a report released Friday.

Over a six-year period, the FDA inspected just one of every 100 trial sites, or one percent, raising questions about the agency's ability to ensure the safety of study participants, according to the report by Health and Human Services Department inspector general Daniel Levinson.

Hampered by the lack of a comprehensive catalog of clinical trials, the FDA is unable to even identify all trials, the estimated 350,000 study sites, and the institutional review boards that oversee each study to ensure they meet scientific, ethical and legal obligations, the report says.

Those limitations hinder the FDA's ability to ensure participants are protected from unreasonable risks, Levinson said.

The FDA relies on just 200 inspectors to police human studies of drugs and devices. The inspections they perform focus more on ensuring the accuracy of trial data than on verifying the measures put in place to protect the study participants, the investigation found.

CBS News correspondent Steve Kathan says while drug companies push hard for people to take part in expensive drug trials, this report says government oversight is disorganized and underfinanced - and that even when serious problems are uncovered, the findings are often watered down, downgraded by senior officials and rarely treated with follow-up inspections to see whether issues have been resolved.

In the case of the FDA's drug office, 68 percent of inspector recommendations that the agency take regulatory action (typically in the form of a warning letter) were downgraded.

Between 2000 and 2005, the FDA found serious problems at test sites 348 times. But only 26 investigators were disqualified from conducting further clinical trials, and data were disqualified just twice, according to the report.

Among the findings:

     •The FDA does not maintain a clinical trial registry, so it cannot even identify all ongoing clinical trials and their associated trial sites.
    •FDA relies on voluntary compliance to correct violations of regulatory significance.
    •The majority of inspections conducted verify clinical trial data rather than human subject protections. Seventy-five percent of bioresearch monitoring inspections were of completed trials focusing on the verification of a clinical trial data's quality.

"The report makes clear without a tough cop on the beat to enforce the rules, unscrupulous researchers can take advantage of trial participants and potentially expose them to harm," said Rep. Edward Markey, D-Mass., co-author of a provision in an FDA bill signed into law this week that creates a mandatory clinical trial registry.

"Right now I think there is better protection, in some ways, afforded to animals that are involved in research than humans," University of Pennsylvania medical ethicist Dr. Arthur Caplan told CBS Radio.

The FDA told the inspector general that inspections make up only one part of its efforts to ensure human subject are protected. The agency sees its review of study protocols before they get under way as the most important step in protecting participants.

The FDA oversees the safety of companies' drug or medical device trials, while the Office for Human Research Protections does the same for federally financed tests.

There is no federal monitoring of privately financed, noncommercial trials.

The study was first reported in The New York Times' Friday editions.

The report made recommendations to the FDA, including developing comprehensive registries of drug trials and databases of inspections, and to seek the legal authority to provide oversight of all stakeholders in clinical trials.

(© 2009 CBS Broadcasting Inc. All Rights Reserved. This material may not be published, broadcast, rewritten, or redistributed. The Associated Press contributed to this report.)