A report by the inspector general of the Department of Health and Human Services, Daniel R. Levinson, assails the FDA for failing to ensure the health of patients in clinical trials. According to the report, the FDA could not accurately determine how many trials were being conducted, audited less than 1% of all testing sites and, when an audit found problems, supervisors downgraded the findings 68% of the time.
“In many ways, rats and mice get greater protection as research subjects in the United States than do humans,” said Arthur L. Caplan, chairman of the department of medical ethics at the University of Pennsylvania.
Animal research centers have to register with the federal government, keep track of subject numbers, have unannounced spot inspections and address problems speedily or risk closing, none of which is true in human research, Mr. Caplan said.
It logically follows that allowing trials to not follow federal guidelines and to report incorrect data could result in the mistreatment of patients participating in trials and perhaps later product liability lawsuits against drug manufacturers if ineffective or dangerous medications are approved for general prescription.
For more information on this subject, please refer to our section on Drugs, Medical Devices, and Implants.