Thursday, Nov 19th, 2009
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.
Fraud in the pharmaceutical industry
Pharmaceutical interests have long held the reins within the very agencies that were formed to protect the interests of the public. Whether controlling the outcome of clinical trials or falsely marketing approved products without consequence, Big Pharma corruption goes hand-in-hand with FDA corruption.
Drug manufacturers are responsible for sponsoring the clinical trials that must be undergone before a new drug can enter the market; the trial results are submitted to the FDA for review. Even if some of the trials reveal negative results, the FDA will typically approve the drug if there is at least one trial showing positive results.
The GAO report provides detailed analysis into the corruption that takes place within this model of drug approval, namely doctors tampering with the results in order to get the drugs to market. However the corruption goes even further once a drug is approved.
Drug companies are known for having a plenitude of financial ties with doctors whom they sponsor to promote their drugs far and wide. Doctors become hired pharmaceutical consultants who receive kickbacks for, often illegally, promoting drugs. Whether drugs are prescribed for people who don’t need them or they are prescribed for non-approved conditions, a clear conflict of interest exists between Big Pharma and doctors.
It is estimated that roughly half of all prescriptions are written for “off-label” purposes, meaning for conditions outside of the specified, approved use. After a drug is approved, the drugs companies usually continue to sponsor “seeding” studies designed to gain approval for a myriad of conditions outside of the original intended use. Often these studies are conducted by medical schools that get roped into the tangled web of the drug industry.
Annual reports from the top nine U.S. drug companies reveal that tens of billions of dollars a year are spent coaxing physicians into accepting, promoting, and prescribing various drugs. Gifts, expensive dinners, and exotic vacations are used to manipulate doctors into dealing drugs that, in an honest environment, would probably never have been approved in the first place.
Drugs are also being pushed on small children in order to increase drug company profits. Children as young as two, for example, are now being diagnosed with bipolar disorder for which they are prescribed scads of dangerously-powerful drugs never approved for children under ten. Thanks to medical experts who are scandalously financed by drug companies, such corruption is openly taking place right now.
Ending corruption at the FDA
If there is to be any hope of eliminating the corruption that plagues both the health care industry and the agencies that regulate it, massive reform must take place:
The revolving door between the FDA and drug companies that allows former pharmaceutical executives to hold positions of power in the FDA must be sealed shut. Criminal offenders within the FDA who break the law, lie about clinical trials, and in any way tamper with information must be prosecuted to the full extent of the law.
Pharmaceutical companies caught bribing doctors, marketing drugs illegally, or in any way sponsoring blatant deception must be prosecuted and forced to cease their operations. Enforcement of existing laws that deal with such offenses must be taken seriously in order to reinstate some degree of integrity into our system of governance.
Justice must be demanded from elected officials and lawmakers who have the authority to remedy the problem. Spreading the truth far and wide about deep-seated corruption in the current system will help put pressure on those appointed to end the corruption and restore the rule of law.
This article was posted: Thursday, November 19, 2009 at 5:40 am