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The corruption of the drug regulatory bodies
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helen delaney
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Joined: 30 Jan 2006
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PostPosted: Mon Jun 26, 2006 2:54 pm    Post subject: The corruption of the drug regulatory bodies Reply with quote

One of two of the best articles ever on this topic today

http://www.sierratimes.com/06/06/24/75_7_241_211_29304.htm

Big Pharma Research Racket Is Killing People
Evelyn Pringle

Over the past six years, ten FDA approved drugs have been withdrawn from the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, 2006, 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 committee.

“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.”

However, while 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. Its obvious that drug companies have infiltrated
every Federal regulatory agency in the US.

For instance, on June 14, 2006, a National Institute of Health 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 NIH.

Documents presented at the hearing revealed that between 1996 an 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 LA 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 positions."

To which, Dr Sunderland replied: "I do not have any outside positions to
note."

This case had 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.

Representative, 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 Representative James Greenwood (R-Pa), who led 3
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 low 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% 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.

Typically, 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 humans.

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 employed by
the drug company that developed the drug or hold some other financial
interest link to the company.

Due 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 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.

In addition, problems continue to surface in the private research industry.
Contract Research Organizations (CRO), 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, 2006, 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.”

“Similarly,” Mr 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 volunteers.

In the April 6, 2006 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 2006, 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 5th, 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 me."

"I felt as if I had rocks on my head," he recalled, "and I must have started
hallucinating."

"Help me," he told the newspaper that 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 drug.

"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 News Target on May 20, 2006.

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.''

Parexel also 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 said in the March
19, 2006 Times 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 pound ($3,500) payment if the men left the
test early.

Highly questionable research recruitment techniques are also occurring in
the US. On November 29, 2005, in 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 FDA.

At a state hospital in San Antonio, CBS News found 16 beds set aside to
allow drug companies to conduct studies on mental patients under the state's
care. CBS 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.

Texas hospital 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."

“Once again," 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 corporations."

In many studies, CBS 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 CBC 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 2 to five times higher than the
norm. 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 per 1,000.

In addition, he found that for the three approved drugs in the study -
Zyprexa, Risperdal, and Seroquel - 60% of the 7,269 patients who received
the drugs dropped out before the end of the study, which typically lasted
six to 8 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, were favorites for schizophrenia drugs and demonstrated a knack for
rounding up psychotic patients quickly for trials funded 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 7 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 of psychiatry.

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.

Study coordinators, 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 off 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 5 years in prison, and ordered to pay $1.1 million to the
college.

Borison pleaded 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.

To cover all bases, over the years, Big Pharma has also become adept at
corrupting the judicial process.

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 8 people and wounding 12 more,
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.

It has 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 9 members on the 1991 FDA advisory panel
investigating the association between Prozac and violence that 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.

The Wesbecker trial 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.”

In fact, 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 case 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 3 months later.

“A US Justice Department investigation linked Oraflex to the deaths of more
than 100 patients,” Dr Lavine notes, “and concluded that Lilly had misled
the FDA.“

In the end, Lilly was charged with 25 counts related to mislabeling side
effects and pled guilty.

At the Wesbecker trial, 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 allowed in.

However, to Judge’s amazement,” Dr Lavine says, “victims’ attorneys never
presented the Oraflex evidence and Eli Lilly won the case. “

It was 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.

However, 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."

"Qui tam," Mr Turner explains, "protects taxpayers and since tax revenue is
the lifeblood of any state, any evasion of liability or deliberate
defrauding of a taxpayers 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 fraud.

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 CEO's 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 interest.

"SSRI 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.

"Even where 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."

Every unnecessary 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 information.

Therefore, according to Mr Turner, "inducing people to invest in companies
that engage in illegal and reckless activity is a violation of SOX."

"Inducing 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 Merck.

"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
marketed."

"Those who today peddle drugs for fictitious illnesses and push dangerous
and useless medications on the children," he warns, "in our societies are
doing just this."

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 ideation

While suppressing 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

In 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.

"Since 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."

Because charities receive tax breaks, he says, fraudulent charities defraud
US taxpayers.

"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.

Information for injured parties can be found at Lawyers and Settlements.com

http://www.lawyersandsettlements.com/articles/Pharma.html

Evelyn Pringle
evelyn.pringle@sbcglobal.net

(Evelyn Pringle is a columnist for OpEd News and an investigative journalist
focused on exposing corruption in government and corporate America)

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