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Poor FDA Oversight of Clinical Trials Puts Patients in Danger

Report Says FDA too Slow to Take Action When Violations are Found

Sep 28, 2007 | Parker Waichman LLP

Lax oversight of clinical trials for drugs and medical devices by the Food & Drug Administration (FDA) is endangering the lives of millions of people who participate in such studies.   A new report says that the FDA has too few inspectors, does not audit clinical trials often enough, and takes few corrective measurers on the rare occasions inspectors do spot problems with clinical trials. And more often than not, inspectors focus less on the safety of human trial subjects, and worry more about whether data is being collected accurately.

According to the New York Times, the report which was conducted by the inspector general of the Department of Health and Human Services, found that the FDA does not even known how many clinical trials are going on.   The agency has only 200 inspectors, many of whom have other duties, to oversee an estimated 350,000 clinical studies.  As a result, less than 1 percent of all clinical trials are audited, and the few audits that do take place can come months after a clinical trial has ended.  

Even when audits are performed, little is done to insure that problems in a particular trial have been corrected. The report says that between 2000 and 2005, the FDA barred investigators from conducting clinical trials 26 times, but disqualified the data they collected just twice even though inspectors found serious deficiencies at clinical trial sites on more than 300 occasions.

This lax oversight has real consequences for the patients enrolled in clinical trials, as is evidence by one disturbing case reported in The New York Times.   According to the newspaper, a patient with bipolar disorder had agreed to take part in a clinical trial for a new medication meant to treat mania.  She signed a consent form that said she could change her mind at any time.   For the study, the patient was required to check into a psychiatric hospital owned by the doctor conducting the clinical trial.  A few days later, the patient did change her mind but the doctor refused to let her leave and she was forced to take the experimental medicine.   It took a lawyer with a court order to get the woman out of the psychiatric facility.  But an FDA inspector did not look into the incident until 9 months later, when the inspection turned up dozens of other problems with the clinical trial.  But it took two years before the agency sent the doctor involved a warning letter. The New York Times wrote that such time lags are not unusual at the FDA.

The inspector general also found that the FDA is not nearly as aggressive as it should be when dealing with troubled clinical sites.  For instance, The New York Times details a case where an FDA inspector wrote a warning letter to another doctor conducting a clinical trial.  In the letter, the inspector actually hinted that if the doctor promised to reform, the FDA was unlikely to conduct further inspections to see if he had taken corrective measures.

Critics of the FDA say that these problems have long been known.  They say that the FDA’s program to oversee clinical trials has been under funded and disorganized for years.  And, as the number of clinical trials under FDA jurisdiction has exploded in the past several years, the number of FDA inspectors assigned to audit trials keeps dropping. 

The inspector general’s report made a number of recommendations to improve the current situation.  Those recommendations included creating a computerized registry to keep track of clinical trials, something that was part of a comprehensive FDA reform law signed by President Bush this week.  The report also recommended that the FDA use such a database to track research inspections and create a registry of research ethics boards.  But what the FDA can and should do immediately is take a more aggressive attitude toward its oversight.  Taking years to issue warning letters to clinical trial sites is unacceptable, and puts the millions of people who volunteer for these studies at unnecessary risk.


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