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Medical Forum / General / Cardiology / June 2006

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Personal Injury Lawsuits filed Against Pfizer over Undisclosed Risks of Lipitor

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Sharon Hope - 26 Jun 2006 06:06 GMT
http://www.pharmalive.com/News/index.cfm?articleid=348135&categoryid=27#

Personal Injury Lawsuits filed Against Pfizer over Undisclosed Risks of
Blockbuster Cholesterol Drug Lipitor

Suits allege Pfizer's deceptive marketing practices and failure to warn
physicians and patients about serious health problems tied to Lipitor use;
mother of a teenage suicide points to statin usage; patients and family
members to meet with U.S. Senate Finance Committee to ask for more stringent
warnings on statins

NEW YORK, June 8, 2006--A pair of personal injury lawsuits has been filed
against Pfizer Inc. charging the giant drug company with concealing serious
health risks associated with its blockbuster anti-cholesterol medication
Lipitor.

The suits accuse Pfizer of deceptive marketing practices and allege that the
company promoted Lipitor as a safe drug with minimal health risks while
knowingly failing to warn physicians and patients of Lipitor's more
dangerous side effects, including nerve damage, memory loss and other
cognitive impairment.

Aggressive marketing of Lipitor - supported by physician "education" groups
funded by Pfizer - has helped secure its status as the best-selling drug in
the world, with sales exceeding $12 billion in 2005.

The two new lawsuits were filed in New York State Supreme Court on behalf of
Charles M. Wilson, a 60-year-old former insurance executive from Atlanta and
Michael Mazzariello, a 47-year old attorney from New York.

Mr. Wilson has suffered a series of irreversible health problems, which he
asserts were caused by taking Lipitor during a 17 month period in 2002 and
2003. Among the damages he alleges were provoked by Lipitor are peripheral
nervous system damage (peripheral neuropathy), inflammatory demyelinating
polyneuropathy, and memory loss. Nearly three years after discontinuing the
medication, he continues to suffer from loss of balance, burning in the
hands and feet, and bouts of fatigue. He was forced to leave his job as a
result of his injuries.

Mr. Mazzariello, who practiced criminal trial law throughout New York State,
suffered debilitating injuries to various muscles forcing him to walk with a
cane and endure repeated hospitalizations. He also suffered extensive memory
loss, which he attributes to his statin usage.

The two men announced their lawsuit at a news conference in New York City,
during which they were joined by individuals from other parts of the country
describing their own personal health problems associated with Lipitor.
Included in the group was Susan Nelson of Bainbridge Island, Washington.
Mrs. Nelson claims that her teenage son Jacob, a gifted gymnast, began
experiencing severe bouts of depression and violent nightmares after he
began a course of Lipitor to reduce his cholesterol in 2001. He committed
suicide in 2003.

"It is very clear to me that the culprit of the depressions...and suicide of
my son is due to the side effects of the cholesterol-lowering drugs Mevacor
and Lipitor," Mrs. Nelson wrote in a letter. "Had I known that the
nightmares, lack of concentration, and depression...could have been warning
signs for side effects of these medications, the doctors, my husband, son
and I could have taken another course and gotten (him) off these supposed
wonder drugs! There is no doubt my son Jake would be alive today had I been
warned..."

"Pfizer has aggressively promoted Lipitor to consumers as a safe drug with
manageable and limited side effects despite apparently knowing and
fraudulently concealing the serious health risks associated with statins,"
said attorney Mark Jay Krum, who represents Mr. Wilson and Mr. Mazzariello.
"The complaints allege that the company has negligently misled both
physicians and patients and is apparently more concerned with driving sales
of Lipitor than with the safety of its users."

The complaints note that despite receiving two letters since 2001 from the
Food & Drug Administration expressing concerns that Lipitor's marketing
material did not reflect the heath risks the drug poses, Pfizer promoted the
drug as virtually symptom free, stating on its Web site: "In fact, in some
clinical studies, Lipitor has been proven to be as safe as taking a sugar
pill."

Statins work by blocking certain cholesterol-producing enzymes, but a number
of physicians have warned that the process to curtail cholesterol inhibits
other metabolic functions that can lead to a host of medical issues. One
doctor who has written extensively on the risks of statin usage declared
recently, "The inevitability of significant, serious and even lethal side
effects has been knowingly accepted by the manufacturer."

That Pfizer was well aware of the cognitive risks associated with its statin
drug is evident in a letter by a Pfizer physician dated October 2003. "A
search of our postmarketing safety surveillance datatbase for Lipitor
revealed that we have received spontaneous reports of amnesia and thinking
abnormal since the market introduction of Lipitor," the doctor wrote. Pfizer
conducted its own controlled studies of cognitive function and found a .3%
incidence of amnesia from Lipitor and a .2% rate of what the company called
"abnormal thinking." Together, those two outcomes would translate into more
than 100,000 cases of mental impairment given the current population of
Lipitor users.

This past March, Pfizer was sued by a group of union and employee insurance
plans who charged the company with fraudulently marketing Lipitor for
off-label uses not approved by FDA protocols for cholesterol treatment. The
employee and third-party health plans allege that Pfizer's off-label
promotion of Lipitor has resulted in billions of dollars in unnecessary
prescriptions for the drug. The health plans challenged Pfizer's creation
and funding of "educational" organizations offering physicians continuing
medical education courses and publication of articles extolling the
off-label usage. There is also a class action pending against Pfizer for its
marketing of Lipitor to women.

The latest personal injury suits contend that Lipitor is defectively
designed and inadequately tested, and lacks the proper patient warnings as
to its dangers. At the news conference, Mr. Wilson and Mr. Mazzariello were
joined by several other patients who described experiencing similar serious
health problems from Lipitor use, including a former airline pilot from
Washington, D.C. who believes his loss of motor function and severe chronic
pain were caused by statin usage; and a former Army helicopter from Corpus
Christi, Texas, who believes that his memory loss and disorientation are the
result of taking Lipitor.

Also participating to discuss the effects of statin drugs was Dr. Paul
Rosch, president of the American Institute of Stress and a clinical
professor of Medicine and Psychiatry at New York Medical College.

"Statin drugs make enormous amounts of money for the pharmaceutical
industry, the power and influence of which should not be underestimated,"
said Dr. Peter Langsjoen, a noted cardiologist from Texas who attended the
news conference. "By lowering cholesterol they give doctors and their
patients a false sense of security by treating 'cholesterol neurosis,' but
statin adverse effects are insidious and are often delayed for several
years."

The group will meet with members of the Senate Finance Committee in
Washington, D.C. on Friday to discuss their concerns over potential harmful
effects of Lipitor and to call for stricter federal health warnings on
statin usage.

Please let us know if you'd like a copy of the complaints or would like to
speak with Mr. Krum.

###

Contact: Robin Brassner, 212-262-7472, rbrassner@aol.com
Sara Wolosky, 212-262-7470, swolosky@hotmail.com
trumpetfish@comcast.net - 26 Jun 2006 15:36 GMT
> http://www.pharmalive.com/News/index.cfm?articleid=348135&categoryid=27#
>
[quoted text clipped - 138 lines]
> Contact: Robin Brassner, 212-262-7472, rbrassner@aol.com
> Sara Wolosky, 212-262-7470, swolosky@hotmail.com
 
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