Part 3 of 3 parts; Off-label prescribing of prescription drugs: Pfizer embroiled in massive lawsuit over off-label use of Neurontin
By Evelyn Pringle
Online Journal Contributing Writer
Jun 1, 2006, 00:55
Pfizer is currently
engaged in multi-district litigation (MDL). On October 26, 2004, the Judicial
Panel on Multidistrict Litigation consolidated nearly all Neurontin off-label
cases in the US District Court for the District of Massachusetts.
The JPML is a panel
of seven federal judges chosen by the Chief Justice of the US Supreme Court
that decides on the appropriateness of establishing an MDL, and where the MDL
should reside. The MDL brings together lawsuits with common claims to determine
The MDL primarily
involves cases of consumers who purchased Neurontin for off-label uses that
Pfizer knew showed no efficacy but more lawsuits have been filed on behalf of
persons who suffered adverse effects when Neurontin was prescribed for
off-label uses. The first Neurontin trial is expected to take place later this
year or early 2007.
In 2004, the New
York law firm of Finkelstein & Partners filed several lawsuits and
announced plans to file many more. At the time, the firm�s senior partner,
Andrew Finkelstein, said he had gathered the names of 160 people who committed
suicide and 2,000 more who attempted suicide while taking Neurontin.
addition to handling lawsuits, for more than two years Mr Finkelstein's law
firm has been warning the FDA about patients committing suicide while taking
Neurontin and asked the FDA numerous times to add a black box warning to
Neurontin's label about the risk of suicide in patients taking the drug. As of October 2005, Mr Finkelstein has been
contacted by the relatives of 425 people who committed suicide while on
After a year of
inaction by the FDA, on March 21, 2005, Mr Finkelstein wrote a letter to the
FDA's Dr Russell Katz and said in part: "Enclosed you will find two
hundred fifty eight MedWatch forms . . . Each represents a suicide of an
American who was on Neurontin when he or she took his or her own life."
Mr Franelstein told
Dr Katz the "complete inaction by the FDA to warn an unknowing population
that was relying upon the FDA to require warnings for potential adverse events
from off-label usage is deplorable."
conversation of March 31, 2004," he wrote, "my firm has learned of
seventy four additional suicides that occurred after that date."
"Many of these
suicides likely could have been prevented," he said, "had both the
treating physician and unsuspecting families been armed with full knowledge of
the risks of suicide that was known to both the FDA and the manufacturer."
recommended for approval by the Neuropharmacolgical Drug Products Division of
the FDA in 1992, and according to Mr Finkelstein, at that time, Mr Katz oversaw
the FDA�s analysis of the clinical data supplied by the sponsor seeking
approval to sell Neurontin.
obtained the FDA�s 1992 analysis of the New Drug Application for Neurontin, and
in reviewing the data, he told Dr Katz he found "shocking
evaluation of serious adverse events that occurred during original clinical
trials," he advised Dr Katz in the letter, "the risk of Neurontin
causing suicide was both known and a major concern."
reviewer from your Division," Mr Finkelstein pointed out,
"specifically stated in December, 1992: Serious adverse events may limit
the drug�s widespread usefulness. Depression, while it
may not be an
infrequent occurrence in the epileptic population, may become worse and
or lead to suicide, as it has resulted in some suicidal attempts during
during the clinical trials . . . Neurontin was attributable to four people
actually attempting suicide, two more having depression with suicidal ideations
and twenty two participants reporting depression so severe it required
he said, "nineteen of the seventy eight participants who reported
depression during the clinical trials had no prior history of depression."
Mr Finkelstein wrote, "the FDA did not approve this drug with any
expectation of use beyond the approved indication."
the FDA knew Neurontin caused depression that may lead to suicide and that
Neurontin�s effects were never fully tested on people who suffered from chronic
pain, bipolar disorder or other psychiatric conditions," he told Dr Katz,
"the FDA acted with no urgency."
reminded Dr Katz of the company's 2004 conviction for fraud in the DOJ case and
said: "The complicity by the FDA in Parke-Davis�s scheme to defraud
physicians and consumers is more egregious than the underlying fraud
governmental body charged with the responsibility of protecting the health and
safety of Americans has done absolutely nothing to prevent entirely preventable
deaths," he continued. "Such complicity borders on criminality,"
October 14, 2005, Mr Finkelstein wrote another letter to Dr Katz and summarized
the efforts by his law firm to get the FDA to warn people about the risk of
suicide. He began by saying: "Due to the continued public danger facing a
substantial class of prescription drug users, I am compelled to write to you
regarding the FDA�s ineffective oversight related to appropriate warnings for
March 31, 2004," he reminded Mr Katz, "you were advised of thousands
of serious psychiatric adverse events that occurred while Americans were taking
that time," he said, "the FDA recognized a potential imminent health crisis
existed, yet nothing was done to require enhanced warning labels."
to the FDA�s inaction," Mr Finkelstein continued, "my firm filed a
citizen�s petition on May 17, 2004, with the hope that the FDA would
investigate the potential for Neurontin contributing to self-injurious
In addition to the
black box warning, the petition asked that a Dear Doctor letter be sent to
health care providers cautioning them to be on alert for increased depression
in patients taking Neurontin.
FDA took six (6) months to respond," Mr Finkelstein told Dr Katz,
"and stated no decision had been reached and more time was needed to
investigations, if any," he wrote, "have been couched in secrecy and
not open to public scrutiny while the same serious health crisis
the letter concluded, "this is an example of why the American people have
lost faith in the FDA's ability to protect them from unsafe drugs."
real motivations are not known at this time," he advised, "it is
clear your interest is not in discovering the truth or protecting the health
and safety of the American people."
Author, Dr Marcia
Angell, also recognizes the massive influence that drug companies exert over
the FDA, Congress and doctors, and how this influence is harming Americans.
After she resigned
as interim editor-in-chief of the New England Journal of Medicine in 2000, Dr
Angell decided to write a book about the biases in clinical trials but in doing
her research, says she discovered that "all roads led back to drug
Her book, "The
Truth about Drug Companies: How They Deceive Us and What to Do About It,"
provides an in depth account of the entanglements between Big Pharma and every
area of the health care field including government agencies, doctors, medical
journals, Congress, and universities, as well as how these relationships harm
During an August 18,
2004, interview with Business Week Online, Dr Angell told reporter Amy Tsao,
that she saves her harshest criticism for her fellow physicians and the medical
profession as a whole. "After all," she said, "the industry is
in business to make money, but that isn't what doctors and medical schools
should be doing."
have to be in bed with the drug companies," she said. "But they
Dr Angell explained
how drug companies finance most of the continuing education seminars for
doctors, as well as meetings of professional societies, and how they lavish all
kinds of gifts on doctors including dinners in fancy restaurants and trips to
provide speakers and meals for interns and residents in teaching
hospitals," she told Business Week.
All of which, she
says, adds to the high cost of prescription drugs. "The profession should
acknowledge that this is all a form of marketing," she said, "which
adds to the prices of prescription drugs."
take responsibility for their own education and buy their own meals," Dr
The most perverse
examples of off-label marketing involve drugging children. In 2001, Dr Stefan
Kruszewski, a Harvard-trained psychiatrist working for the Pennsylvania
Department of Public Welfare, began investigating the widespread off-label use
of psychotropic drugs and found cases of what he calls "horrendous
The first disturbing
pattern he noticed was that an overwhelming number of patients were being
prescribed Neurontin to treat conditions like anxiety, depression, psychosis
and impotence. "The FDA had not approved using that drug for mental
illnesses," he noted.
Dr Kruszewski found
patients on as many as five medications at the same time, something he says is
"hard to justify."
One of the most
disturbing cases he found was a mentally retarded 15-year-old girl who was
supposedly being treated for defiance and sexual promiscuity.
discovered that the girl was on 11 different drugs, including five
anti-psychotics, even though she had no diagnosis of a psychiatric disorder.
"She was so overmedicated," he said, "that she had trouble
getting out of bed or standing up by herself."
physicians can choose to prescribe virtually any medication for any
condition," he explains, "the promotion of Neurontin remains the
subject of intense scrutiny since Pfizer�s off-label promotion was previously
the subject of civil and criminal penalties by the US Department of
"In my opinion
as a clinical and academic psychiatrist," Dr Kruszewski says,
"Neurontin's link to severe emotional and cognitive disturbances,
including mania, depression, suicide and memory loss, continues to be the most
egregious aspect of Neurontin's promotion."
suffering, morbidity and death," he noted, "problems that Pfizer and
the current generic makers of Neurontin have failed to make known to consumers
and potential victims,� he said.
Crenshaw, Executive Director for National Judicial Conduct and Disability Law
Project, agrees that off-label prescribing is a major problem and says any drug
manufacturer even suspected of such "market expansion" should be
called on the carpet.
"The idea of
salesmen hyping drugs to doctors," she says, "for conditions beyond
those for which the products were approved is unnerving."
that even dire prescription drug warnings probably reflect a minimum level of
adequate care," she warns, "prescribing drugs off-label should seem
When Dr Kruszewski
warned his superiors that off-label use of the drugs was not only harmful to
patients but could also expose the state to liability from lawsuits
by injured patients, he was told "it's none of your business."
When Dr Kruszewski
continued to voice his concerns he was told to quit digging up dirt and when he
refused to let go he was fired. He has since filed a whistleblower lawsuit
against state officials and six drug companies, including Pfizer, alleging
among other things, that the defendants: "through the use of political
friendships, money and other emoluments, effectively achieved a level of
influence with Pennsylvania's state government that allowed them to abuse state
finances and state citizens with impunity."
Accountability Project (GAP) is a nonprofit public interest group that promotes
government and corporate accountability by advancing occupational free speech,
defending whistleblowers, and empowering citizen activists.
The GAP is assisting
Dr Kruszewski with his lawsuit against the drug giants. Mark Cohen, an attorney
with the GAP, describes whistleblowers like Dr Kruszewski as "regular
people who have been pushed beyond the limits their consciences can bear."
"They feel a
moral duty to set the situation right," he says.
"They can no
longer 'go along to get along' in the face of wrongdoing," he explains.
"And they can't simply opt out -- take another job and keep their lips
sealed -- and ignore the wrongdoing," he says.
"But if 'right'
and 'wrong' mean anything," Mr Cohen says, "they feel they don't
really have a choice but to blow the whistle."
they do so at great personal risk," he says. He recognizes, "Speaking
up puts their current job in jeopardy and it threatens to brand them as troublemakers
with other employers."
In fact, people who
do expose the highly profitable Medicaid fraud or off-label practices often find
themselves fired like Dr Kruszewski. However, the False Claims Act now provides
a cause of action for whistleblowers with remedies that include reinstatement
to their job, three times the wages lost, compensatory damages, and attorney�s
For more information
for injured parties go to Lawyers and
Evelyn Pringle is a
columnist for OpEd News and an investigative journalist focusing on exposing corruption in government.
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