Criminal Doctors and Researchers Still Allowed by FDA to Work on
November 19, 2009
Natural News
By E. Huff
(NaturalNews) The U.S. Government Accountability Office (GAO) recently released a report indicting the U.S. Food and Drug Administration (FDA) for allowing health professionals convicted of crimes to perform research for the agency and to supervise patients’ safety during clinical trials.
The FDA is required by law to disqualify from positions within its organization doctors that have been convicted of fraud or other crimes. Yet the GAO is publicizing that it takes an average of four years for criminals to be disbarred from their positions.
In one case, a doctor who was convicted of 53 counts of criminal offense was allowed to remain at the FDA for 11 years before action was taken. The doctor’s offenses included bribing an employee to cover up a patient suicide that occurred during a clinical trial and prescribing drugs without a license.
Another doctor was convicted of defrauding his employer of more than $10 million in clinical research funds. Rather than using the money to conduct the trial, he diverted it to entities owned or controlled by the clinical trial investigators.
One of the more notorious cases is the debarment of Anne Kirkman-Campbell, an Alabama physician who pled guilty to mail fraud in a clinical trial for Sanofi-Aventis SA’s antibiotic, Ketek. Though sentenced to more than four years in prison, it took the FDA nearly five years to actually debar the felon.
According to the report, three doctors who broke FDA regulatory rules or who have been convicted of crimes have yet to be debarred and continue to work for the agency. One of the doctors is involved in fraud that dates back to 2005; the doctor has yet to be debarred.
Falsified clinical trial data
In the majority of cases, doctors are convicted of falsifying clinical trial study data. Everything from submitting data for fictitious study participants to lying about study results has been tolerated by the FDA. The consequences of such deception are ultimately costing people their lives.
Other examples of common misconduct include failing to obtain informed consent from clinical trial participants, failure to properly maintain case histories and records, failure to comply with requirements to obtain initial and continuing approval from an institutional review board, and failure to follow the clinical trial’s research plan.
All such misconduct warrants debarment from the FDA, yet the GAO study has concluded that it takes the FDA an average of four years to remove criminal doctors from its ranks. While required to debar all doctors who violate federal guidelines as well as openly convicted criminals, the FDA habitually drags its feet in dealing with offenders.
One of the biggest problems with the FDA’s debarment policy is a loophole that allows convicted criminals to continue working in another area outside of the one in which they were convicted. For instance, a doctor convicted of drug trial fraud can still work in trials in other areas such as medical devices.
Another major problem is the fact that the FDA holds no actual authority to debar convicted criminals from engaging in medical-device industry activity, a growing segment of the health care industry. A doctor convicted of lying about the purported benefits of a new device to treat asthma, for instance, cannot be debarred under current FDA policy.
Proposed solutions to the problem
Representative Joe Barton of Texas has proposed a bill that would mandate removal of convicted criminals from the FDA within one year of either being found committing fraud or of being formally convicted of committing one.
One year is more than enough time to execute proper removal procedures. Yet the FDA’s track record of handling the crooks in its midst is far from satisfactory and many are demanding some type of reform within the agency.
The GAO has proposed that the FDA be given debarment authority over medical devices in order to curb the transfer from one area of research to another in cases of criminal activity. Regulatory revisions to eliminate any further participation by criminal offenders within the organization is necessary to maintain any sort of organizational integrity.
The foundational problem is that, even with guidelines, the FDA continues to break its own rules and perpetually fails to act in accordance with its mission statement. More rules would potentially do very little to remedy the corruption that continues to plague the agency.
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