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FDA openly allows criminally-convicted doctors, researchers
to keep working on pharmaceuticals and clinical trials
E. Huff
Natural
News
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.
"When the people find they can vote themselves money,
that will herald the end of the republic." - Fall
Of The Republic - Buy
the DVD here
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