Over the past six
years, 10 Federal Drug Administration (FDA) approved drugs have been withdrawn
from the market due to deaths and injuries, leading lawmakers to accuse the FDA
of not doing its job in protecting the public from unsafe drugs and to call for
measures of improvement.
On June 20, The New
York Times reported that �two influential senators are expected within weeks to
introduce a legislative proposal that could drastically change how drugs are
tested and approved in the United States.�
The senators behind
the proposal are Michael Enzi (R-Wy), chairman of the Health, Education, Labor
and Pensions Committee, and Ted Kennedy (D-MA), the ranking Democrat on the
�In broad terms,�
the Times article by Gardner Harris explains, �the bill would require that drug
makers disclose the results of all large human tests of their drugs, known as
Phase 3 and Phase 4 trials; create a detailed risk management plan to uncover
and control any safety problems that arise after a drug is approved; and pay
penalties if they fail to follow through with this plan, according to four
experts who were briefed on the proposals.�
lawmakers search for ways to ensure that Big Pharma does not continue to
conceal adverse reactions that surface during drug trials and to sever the ties
between the nation�s public health officials and Big Pharma, the Bush
administration continues to promote their cozy relationships and help drug
companies escape accountability for misconduct.
The best example of
the administration's efforts to protect Big Pharma was revealed recently when
the FDA announced a preemption rule that would disallow lawsuits in state court
against drug makers if a drug has been approved by the FDA.
"We think that
if your company complies with the FDA processes, if you bring forward the
benefits and risks of your drug, and let your information be judged through a
process with highly trained scientists, you should not be second-guessed by
state courts that don't have the same scientific knowledge," said FDA
Deputy Commissioner on Medical and Scientific Affairs Scott Gottlieb.
But in all fairness,
the FDA is certainly not the only public health agency in bed with Big Pharma. Nobody
can deny the fact that Big Pharma is an equal opportunity corrupter. It's
obvious that drug companies have infiltrated every federal regulatory agency in
For instance, on
June 14, a National Institutes of Health (NIH) Alzheimer's researcher, Dr Trey
Sunderland, asserted his Fifth Amendment rights and refused to testify before
the House Energy and Commerce Committee about accusations that he has profited
from giving Pfizer access to spinal fluid and plasma samples collected by the
at the hearing revealed that between 1996 and 2004 Dr Sunderland accepted
consulting, speaking and advisory fees totaling about $612,000 and committee
staff members estimate that about $285,000, was related to 3,245 samples taken
from 538 patients who participated as volunteers at the NIH.
At a price of about
$12,000 per patient, the committee estimates the cost of collecting the samples
that Dr Sunderland handed to Pfizer is close to $6.5 million.
The committee also
noted that he did not seek prior approval to work for Pfizer and did not report
any of the income to the agency as required by NIH rules.
In fact, at one
point, when asked, Dr Sunderland said he had no outside deals. According to the
December 22, 2004, Los Angeles Times, while reviewing financial disclosure
reports from scientists at the NIH, in March 2000, ethics officer Olga Boikess
noticed that Dr Sunderland had not declared any jobs with the industry so she
sent him an e-mail that said: "You did not list any outside
To which, Dr
Sunderland replied: "I do not have any outside positions to note."
This case has been
dragging on for years but the doctor has probably not been too worried because
history shows that any time a Republican lawmaker get too pesky about the money
trails leading to the NIH, Big Pharma simply offers enough money to induce him
to jump ship.
A couple years ago,
two Republicans on powerful committees switched sides shortly after they
launched investigations into conflicts of interest between drug companies and
employees at the NIH.
Rep. WJ "Billy"
Tauzin (R-La.), was chairman of the House Energy and Commerce Committee, and
had cited "secret consulting fees and stock options from drug
companies" as reasons to request documentation of all payments from Big
Pharma to NIH scientists.
But next thing you
know, Tauzin announces that he is not running for reelection, and leaves
Congress to become president of the Pharmaceutical Research and Manufacturers
of America, the giant trade group that represents Big Pharma, with a reported
$2 million a year in salary, benefits and perks.
Next up to bat, was
Rep. James Greenwood (R-Pa.), who led three hearings on NIH conflicts of
interest and criticized the agency for allowing scientists to use "a
swivel chair" to make decisions while taking drug company money.
But lo and behold,
shortly thereafter, in July 2004, Rep Greenwood announced that he was giving up
his post as chairman of the Energy and Commerce subcommittee to retire, only to
become president of the Biotechnology Industry Organization, a group that in
the same year, urged lawmakers not to bar NIH scientists from entering into
paid consulting deals.
A report by the
Office of Government Ethics, released the same month that Rep Greenwood
announced his "retirement," said the NIH was beset by a "permissive
culture," and revealed that 40 percent of the 155 randomly selected sample
payments to agency employees reviewed had not been approved or accounted for
within the NIH.
The FDA remains at
the top of the list for corruption simply because the FDA evaluates the safety
and effectiveness of drugs and decides which drugs can be marketed in the US.
as a first step toward the approval process, a drug company will initiate
laboratory testing to assess the effectiveness and safety of a drug and if the laboratory
testing is successful, the company will begin testing the drug on animals. The
FDA does not become involved until the drug maker seeks permission to test the
drug on humans.
When the drug
reaches that point, the FDA's Center for Drug Evaluation and Research evaluates
the results of laboratory and animal testing prior to allowing any study on
Once a drug is
approved for testing on humans, an Institutional Review Board (IRB) is
appointed to review and monitor the research. An IRB is generally made up of
outside scientists, doctors and other medical professionals and has the
authority to approve or disapprove a study or to require modifications to
secure approval of the research.
The purpose of an
IRB is to assure that appropriate steps are taken to protect the rights and
welfare of human subjects. To that end, an IRB uses a group process to review
research protocols and materials, such as informed consent documents and
investigator brochures related to the research.
In recent years,
serious questions have been raised regarding the impartiality of the review
process, due to the fact that many of the FDA advisors recommending approval of
a product are at the same time either employed by the drug company that
developed the drug or hold some other financial interest link to the company.
to these conflicts of interests, critics say dangerous drugs are winning
approval. For instance, nearly a third of the members of the advisory panel
that reviewed the data on Vioxx, Celebrex and Bextra, and voted to allow the
drugs to remain on the market, even after Bextra and Vioxx had been pulled off
the market, had financial ties to the makers of the drugs and had their votes
not been counted, they would never have received a vote of approval.
problems continue to surface in the private research industry. Contract research
organizations (CROs), are now hired by the industry to perform research.
Critics says the
competing CROs are skewing research in favor of approval in order to win more
contracts. The funding up for grabs is enormous. According to a March 24, MSNBC
commentary by Arthur Caplan, director of the Center for Bioethics at the
University of Pennsylvania, "Private companies running studies for
pharmaceutical and device companies are now a $14 billion industry in the
United States alone."
According to John
Abramson, a clinical instructor at Harvard Medical School, and author of,
�Overdosed America,� �When the institutional review boards were created, most
medical research was conducted by universities and nonprofit institutions.�
Abramson says, �oversight of the safety of human volunteers in most U.S.
studies is no longer done by nonprofit IRBs, but by for-profit review
companies, hired directly by the for-profit research companies.�
In his opinion, he
says the system lacks the appropriate checks and balances to protect human
In the April 6 LA
Times, Mr Abramson made a shocking revelation when he said, �the FDA recently
approved 'phase 0 studies' in which human beings can be given minuscule doses
of experimental drugs even before animal studies are completed.�
A recent case in the
UK demonstrates the dangers that could occur in such a study. In March, six
otherwise healthy men ended up in a London hospital in critical condition after
participating in the trial of a new an anti-inflammatory drug, called TGN1412,
to treat conditions involving the immune system, such as leukemia, multiple
sclerosis and rheumatoid arthritis, conducted by the US based company, Parexel
International Corp, on behalf of the German drug maker TeGenero.
The worst affected
of the six men, Mohamed 'Nino' Abdelhady, called the Elephant Man because of
the extreme swelling of his head, on April 5, told the Daily Mail that he is
plagued by nightmares.
Still recovering in
the hospital at the time, he explained what he remembered. "I started to
feel ill," he said, "almost as soon as they had finished injecting
"I felt as if I
had rocks on my head," he recalled, "and I must have started
he told the newspaper, then he screamed, "I'm dying."
Ryan Wilson, the
most critically ill man, begged doctors to put him to sleep because he was in
such agony. His family was warned that his heart, lungs and kidneys failed.
His sister-in-law Jo
Brown, recalled the horrific moment when they saw Mr Wilson in intensive care.
She told reporters that his head had swollen to nearly three times its normal
size, and that his neck was the same or wider than his head and that his skin
had turned a dark purple.
Mr Wilson remained
in a coma for three weeks, and upon awakening, learned that he may lose parts
of his fingers and toes, which had turned black because of his reaction to the
"I'm told it's
like frostbite and my fingers will just fall off," he told the UK's News
of the World recently.
In addition, Mr
Wilson also suffered from heart, liver and kidney failure, septicemia,
pneumonia and dry gangrene and is considered very luck to be alive, according
to the May 20 News Target.
The Parexel research
was at the Phase I stage, where a drug is tested for safety with a small number
of people who are given a tiny dose under careful supervision, not to determine
whether the drug works, but to check for side effects, according to Q&A
Drug trials by BBC News on March 16, 2006.
Experts say the
recruitment of subjects for the Parexel trial left much to be desired. The
web site that announced the recruitment hardly mentioned the potential risks,
but elaborated at great length about the good pay, free food and "plenty
of time to read or study or just relax, with digital TV, pool table, video
games, DVD player and free Internet access.''
recruits by placing ads online or in local papers, where critics say they draw
the attention of the young and poor. Once on the books, recruits often get
automatic offers. �The offers keep rolling in via text message,� Tom de
Castella, a former Parexel volunteer told the March 19Times Online. ��650 for
three days here, �1,000 for a week there,� he said.
Ethicists shown the
Parexel consent form, which is supposed to describe the experiment and its
risks, told Bloomberg News, �the document didn't sufficiently inform
participants of the therapy's possible dangers or properly depict the treatment
as a novel drug that can disrupt the body's immune system.�
The 13-page form
also exploited the subjects' need for money, they said, by threatening to
withhold the �2,000 ($3,500) payment if the men left the test early.
questionable research recruitment techniques are also occurring in the US. On
November 29, 2005, in Austin, Texas, CBS News Channel 42 reporter, Nanci
Wilson, revealed records showing that staff at state mental hospitals in Texas
help recruit patients into studies of experimental drugs not approved by the
At a state hospital
in San Antonio, Channel 42 News found 16 beds set aside to allow drug companies
to conduct studies on mental patients under the state's care. Channel 42 asked
Austin psychiatrist Deborah Peel to review some of the records they obtained.
Dr Peel said the
situation raised serious questions as to whether this is moral and ethical
treatment. "They are essentially turning the state hospital population
into research subjects," she noted.
officials claim the mentally ill patients give informed consent by signing a
detailed form describing the risks and benefits of participating in the study.
But Dr Peel says, "I think there are real questions how informed their
consent would be under those situations, because these are not people who have
the means to choose to go elsewhere for treatment, and so, there's a powerful
element of pressure, of coercion that they have to feel."
Dr Peel points out, "we have people who have no means, who are dependent
on the state system, and the state system is working hand-in-glove with private
In many studies, Channel
42 news investigators determined that patients had been taken off drugs that
were working and, in the new study, some patients were given the experimental
drug while others received a placebo.
Critics point out
that for patients taking a new drug, there is no guarantee it will work, and
the risks and long-term effects are not known. �To take people off medication
when they have just been admitted for an inability to function and might have
even been a harm to themselves or others, that raises real questions for me,�
Dr Peel told Channel 42 News.
What's worse, she
says, is that patients are not told whether they are taking a placebo or a drug
even when they are discharged from the hospital during the study. They could
get suicidal, she said, or could harm others.
The FDA has ignored
atrocities in research involving mentally ill subjects for years. Back in 1998,
a review of the data on atypical antipsychotic drugs submitted to the FDA,
obtained with FOIA requests by Robert Whitaker, revealed numerous safety
problems for subjects who participated in the trials.
Mr Whitaker found
that among 12,176 patients from the US and abroad at the time the data was
submitted, there were 88 deaths, including 38 suicides, meaning there was an
overall death rate of 1 out of every 138 patients, according to his article in
the November 17, 1998, Boston Globe.
The suicide rate in
trials was found to be two to five times higher than the normal. In the medical
literature, Mr Whitaker reported, suicide rates for schizophrenics ranged from
two to five deaths per 1,000 per year, while the rate in trials was close to 10
In addition, he
found that for the three approved drugs in the study -- Zyprexa, Risperdal, and
Seroquel -- 60 percent of the 7,269 patients who received the drugs dropped out
before the end of the study, which typically lasted six to eight weeks.
In the 1990s, the
prospect of antipsychotic drugs gaining FDA approval, promised a major market
for Big Pharma and, therefore, drug companies needed to recruit trial subjects
quickly. And drug companies were willing to pay top dollars to researchers for
each patient recruited.
In the Boston Globe
article, Mr Whitaker discusses a criminal case in Georgia that reveals just how
far researcher are willing to go to meet recruitment goals.
Dr Richard Borison,
chairman of the Psychiatry Department at the Medical College of Georgia, and
Bruce Diamond, a pharmacologist on the school's faculty, demonstrated a knack
for rounding up psychotic patients quickly for trials funded by Eli Lilly,
Janssen, Zeneca, and Novartis.
As faculty members,
Borison and Diamond were supposed to get approval for research and payments for
trials were supposed to go the school. But according to Georgia authorities,
who indicted the duo in early 1997, in 1989, they started having the drug
makers send payments directly to them.
They simply opened
an office across from the school, hired a commercial service to do ethical
reviews of their studies and placed their staff on the school's payroll, but
kept all the money for themselves.
As unbelievable as
it may seem, the scheme worked for about seven years. From 1989 to 1996,
Borison and Diamond made over $10 million, including more than $4 million from
schizophrenia drugs, according to the indictment and testimony during an
investigation by the Augusta Veterans Affairs Hospital, where Borison was chief
And these guys were
slick. To recruit the mostly male patients, they hired good-looking young
women, who testified that they were paid bonuses that ran into the thousands,
and one staffer was even given a Honda Accord.
To find their recruits,
workers looked for mentally ill patients who were stable and living in the
community and offered them $150 to check into the VA so they could be in a
study. Patients already in locked wards were offered cigarettes to participate.
many with no medical training, determined whether a patient belonged in a
study. According to an FDA investigation, untrained staff drew blood samples
and adjusted doses of the drugs, and Borison and Diamond hardly ever saw the
patients at all.
But the two
researchers lived high on the hog, according to Georgia authorities. They
socked away more than $5 million in cash and securities, spent nearly a half a
million on antiques and drove Mercedes-Benz vehicles.
But as the old
saying goes, all good things must end. In December 1997, Diamond pleaded guilty
to theft and bribery charges and was fined $125,000, sentenced to five years in
prison, and ordered to pay $1.1 million to the college.
guilty to theft and racketeering charges, was sentenced to 15 years in prison,
fined $125,000, and ordered to pay $4.26 million to the college.
all bases, over the years, Big Pharma has also become adept at corrupting the
For instance, Dr Bruce Levine, PhD, clinical psychologist and
author of World Gone Crazy, tells a story
about Eli Lilly corrupting the judicial process in a case that began in 1989
when Joseph Wesbecker opened fire at his former place of employment, killing eight
people and wounding 12 before committing suicide, a month after he began taking
Prozac. The victims of the shooting sued Eli Lilly, claiming that Prozac had
pushed the guy over the edge.
long been known that Prozac induces violence in some patients, but the FDA
never required Lilly to list violence on the drug�s label. But as it turns out,
five of the nine members on the 1991 FDA advisory panel investigating the
association between Prozac and violence, who voted against requiring a warning
label for violence, had ties to Big Pharma and two of the members had served as
lead investigators for Lilly-funded Prozac studies.
Wesbecker Prozac lawsuit did not take place until 1994, but in the meantime,
according to Dr Lavine, �Eli Lilly had been settling many Prozac violence cases
behind closed doors.�
he says, more than 150 Prozac lawsuits had been filed by the end of 1994, so
�it was looking for a showcase trial that it could win.�
A crucial component of the victims� legal strategy in the
Wesbecker suit was for the jury to hear about Lilly�s history of reckless
disregard toward consumers, especially about the drug Oraflex, introduced in
1982 but taken off the market three months later.
Justice Department investigation linked Oraflex to the deaths of more than 100
patients,� Dr Lavine notes, �and concluded that Lilly had misled the FDA.�
end, Lilly was charged with 25 counts related to mislabeling side effects and
Wesbecker case, Lilly attorneys argued that the Oraflex information would be
too prejudicial for the jury to hear and the judge initially agreed. However,
when Lilly attorneys used witnesses to testify about it�s superb system of
collecting and analyzing side effects, the judge said that Lilly had opened the
door to evidence to the contrary and so the Oraflex information would also be
to the judge�s amazement,� Dr Lavine says, �victims� attorneys never presented
the Oraflex evidence and Eli Lilly won the case. �
later learned that Lilly was successful in corrupting the judicial process in
the case by cutting a secret deal with victims� attorneys to pay them and their
clients not to introduce the damaging Oraflex evidence.
Dr Lavine says, the judge �smelled a rat" and fought for an investigation,
and in 1997, Lilly quietly agreed to the verdict being changed from a victory
to �dismissed as settled.�
Legal experts are
finding ways to expose and punish Big Pharma for conducting fraudulent research
that requires no involvement by the nation's compromised regulatory agencies.
Barry Turner, Lecturer in Law at Leeds Law School in the UK, is a great fan of
the False Claims Act legislation in the US.
As an academic
lawyer, he has for a number of years been involved in litigation regarding the
activities of the pharmaceutical industry and for the past two years, he has
been involved in qui tam litigation preparation.
"Tying qui tam
into human rights and civil liberties issues is easy," Mr Turner says.
"When President Lincoln initiated this law in 1863 it was because Union
soldiers were going into battle in shoddy boots and uniforms equipped with guns
and ammunition that were third rate," he explains. "All because
'businessmen' saw the war as a gravy train."
Mr Turner explains, "protects taxpayers and since tax revenue is the
lifeblood of any state, any evasion of liability or deliberate defrauding of a
taxpayer is an attack on all taxpayers and consequently all citizens."
Qui tam in its long
history, he says, has brought to book many crooks who stole from the US taxpayer
and is based on the individual citizen being able to blow the whistle for the
benefit of fellow citizens and the country.
The more recent
Sarbanes-Oxley Act of 2002 (SOX), was enacted in the wake of the Enron and
WorldCom scandals, and was designed to restore investor confidence in the
nation�s financial markets by improving corporate responsibility through
changes in corporate governance and accounting practices, and by providing
whistleblower protection to employees of publicly traded companies who report
SOX contains a civil
and a criminal whistleblower provision. Section 806 creates a civil cause of
action for employees who have been subject to retaliation for whistleblowing,
and Section 1107 makes it a felony for anyone to knowingly retaliate against or
take any action harmful to any person, including interfering with employment,
for providing truthful information relating to the commission or possible
commission of a federal offense.
According to Mr
Turner, SOX is not limited to shareholders of a company. "What needs to be
understood," he says, "is that many millions of people who own no
stock at all get defrauded in scams all the time."
"Those who pay
into pension funds are vulnerable to the financial shenanigans not only of fund
managers but of boards of companies," he explains, "and CEOs that
fail to police the companies' activities or in some cases actively encourage
fraud and reckless business practices."
SOX came into being
to prevent those financial shenanigans, he says. "The fat cats may lose a
small amount of their stake in any scam," he points out, "but the
little man as ever stands to lose all."
One of the features
of SOX, he says, is the ability to bring an action against those who recklessly
and fraudulently deal with stockholders money. Big Pharma, and its handmaiden
psychiatry, he notes, is built on fraud.
For example, Mr
Turner explains, Ritalin fraud consists of labeling millions of children as
basket cases based on fraudulent research and a consensus of the vested
fraud," he advises, "extends depression into the world of normal
human experience to ever-extend the peddling of the often useless and
frequently dangerous treatments."
In other instances,
he says, many poor and elderly people are starved of life saving drugs because
the budgets of Medicare and Medicaid are bled dry by claims from drug companies
for 'me too' drugs that in many cases are superfluous.
there is some justification for the use of these drugs," he explains,
"there is a drive to constantly increase the dose above the minimum
effective one because a 'minimum effective dose' to the drug company means
minimum effective profit."
"Where money is
diverted from real healthcare provisions, to a profit greedy industry that
manufactures an illness to fit the drug," he notes, "rather than
provide drugs for real illnesses, then the most fundamental of constitutional
rights 'Life, Liberty and the Pursuit of Happiness' is most at risk."
dose of Ritalin, Prozac, Paxil, and other psychiatric drugs prescribed and paid
for with US tax dollars, he says, deprives patients dependant on state
healthcare programs of drugs they need for cancer, diabetes, heart disease and
other serious conditions.
In addition, Mr
Turner points out that, "the marketing of these drugs and the ever
expanding definition of psychiatric disorder that is part of this marketing
strategy labels, discriminates against, and stigmatizes hundreds of thousands
of American citizens."
"It is indeed a
dramatic irony," he says, "that in very many of these cases the US
taxpayer gets to fund an industry that acts in a manner so alien to the
American constitutional ideals."
For purposes of the
litigation, �knowingly� is defined as: (1) Actual knowledge of the false
information; (2) Acts in deliberate ignorance of the truth or falsity of the
information; or (3) Acts in reckless disregard of the truth or falsity of the
to Mr Turner, "inducing people to invest in companies that engage in
illegal and reckless activity is a violation of SOX."
people to take vast amounts of drugs that are known to be harmful and
deliberately hiding the known dangers is a violation of SOX," he contends.
"One day this
edifice will come tumbling down," he says, "and what will the
investors in Big Pharma say then?"
In light of the
Vioxx disaster, Mr Turner says, we should perhaps ask people who invested in
"Those at the
top of this company," he notes, "gambled with the lives of patients
and the money of stockholders in equal bad faith when they engaged in
fraudulent and dishonest behavior that allowed a dangerous drug to be
today peddle drugs for fictitious illnesses and push dangerous and useless
medications on the children in our societies are doing just this," he
Merck acted with
reckless disregard for the truth because it had prior knowledge of the adverse
effects of Vioxx. The same goes for Eli Lilly and its prior knowledge of the
lack of efficacy of Prozac and GlaxoSmithKline's knowledge of Paxil's suicide potential.
negative studies, these companies placed drugs on the market that were known to
be faulty in one way or another. All of these drugs have cost taxpayers dearly,
not to mention the personal suffering they have inflicted in other ways
considering other acts of fraud, Mr Turner looked at the pharma backed
charities that are based on fraudulent research to see what federal laws they
may be violating.
a number of imaginative illnesses are based on this fabricated research and
since a number of charities are based on the 'imaginative illnesses' that arose
out of the imaginative research," he says, "its just a matter of
connecting the dots."
charities receive tax breaks, he says, fraudulent charities defraud US
"The fraud in
this industry is not divided into that which injures by over drugging and that
which cheats taxpayers and stockholders out of their money," he explains.
"They are two sides of the same counterfeit coin."
Mr Turner says we
must tackle them together, and that lawyers in the US should be actively
seeking clients who have lost money by these frauds and getting the matter
before the Security and Exchange Commission now.
for injured parties can be found at Lawyers and
Evelyn Pringle is a
columnist for OpEd News and an investigative journalist focusing on exposing corruption in government.