Pharmaceutical Consultants Come Across Law Breaking Doctors Working With The FDA
Sunday, March 14th, 2010The US Government Accountability Office GAO has used pharmaceutical consultants to look into people working for the FDA and the results are a damning criticism that the Food and Drug Administration hires criminally convicted doctors to work for it in clinical trials. This is a damning indictment of the FDA who has even been found to be breaking their own rules when they fail to debar these personnel when they are discovered to hold a criminal record.
GAO officials have publicised their records which show that it takes the FDA an average of four years to debar convicted medical practitioners from working with them. This is despite the fact that the administration is required by law to disqualify doctors who have been found guilty of fraud or other crimes. In one case it took the FDA 11 years to disqualify a doctor who had been convicted of 53 charges including covering up a patient’s suicide during a clinical trial.
Other cases involve medical professionals who have committed fraud or prescribed medicines without a license. There are also major concerns over the fact that three doctors continue to work with the FDA even though they are known convicted criminals.
presenting false data at clinical trials was the dominant charge amongst the doctors. They made up statistics for non-existent participants, did not follow the research plan of the trial or failed to gain the informed consent of trial participants. And medical devices are one of the most contentious issues in this whole affair. Under present FDA rules, a doctor who has been convicted of a criminal offence is not prohibited from practicing in the medical device industry, which could be putting the lives of millions of people at risk, especially since inhalers used to treat asthma are thought of as a medical device.
Because the FDA is already breaking its own rules and laws governing it, there seems little reason to implement new regulations. Instead, they propose a wide reform of the whole health care system in America. There should be no room for a company executive to move into a senior role at the FDA, drug companies and the FDA should not think of each other as friends but the FDA needs to be seen as a regulatory body with the power to punish the companies; On top of this, doctors who have been found to break the law should be prosecuted and excluded from the health profession entirely.