Pfizer Dodges Fraud Prosecution AGAIN By Paying Over $1 Billion Fine

Pfizer Dodges Fraud Prosecution AGAIN By Paying HUGE Government

Fine

If it were you or I or your neighbor down the street you can
bet that NO presecutor on the planet would “look the other way” to avoid
prosecution. But, when it involves the lergest drug company on the planet they
seem to be able to do just that and do it VERY WELL!!!
So, before going into the amazing facts in this most recent
case let me give you a reminder of the last big case involving a large fine for
off label marketing with Pfizer‘s Neurontin. After learning that Pfizer sales
reps had been drastically increasing profits by pushing Neurontin for off label
uses for several years felony charges were filed against the company for
doing so. (Keep in mind that this drug now carries warnings of increases in
suicide.) In 2004 they plead guilty to two felonies and agreed to pay $430
Million in fines as well. See the first article below as a quick
overview.
Now they have a whole new twist when it comes to approaching
similar charges with the off label prescribing of Bextra (Pfizer‘s version of
Vioxx) which was pulled from the market just the following year after pleading
guilty to the two felonies in the Neurontin case and paying the largest fine
ever for such a practice. Pfizer acquired a smaller drug company
called Pharmacia and they wanted to market Bextra for surgical pain.
When the FDA put their foot down and clearly said, “NO because of safety
issues,” Pfizer and Pharmacia went right ahead with their marketing campaign. So
when caught red handed in doing this, the prosecutor decides that Pharmacia can
plead guilty so that Pfizer is off the hook because it would have put them out
of business!!!!!

I quote from the article below: “So Pfizer and the feds cut a deal. Instead
of charging Pfizer with a crime, prosecutors would charge a Pfizer subsidiary,
Pharmacia & Upjohn Co. Inc.

“The CNN Special Investigation found that the subsidiary is nothing more than
a shell company whose only function is to plead guilty.”

As it turned out ONE HALF of their $1.7 Billion in profits on Bextra came
from off label prescribing and the government fine for that will be
the biggest ever once again. This time the figure is $1.2 Billion plus an
additional $1 Billion to settle a batch of civil suits (how many deaths those
involved is not mentioned) and denied wrongdoing in another dozen
similar charges involving illegal promotions!

“It paid nearly $1.2 billion in a criminal fine for Bextra, the largest fine
the federal government has ever collected.

“It paid a billion dollars more to settle a batch of civil suits — although
it denied wrongdoing — on allegations that it illegally promoted 12 other
drugs.”

This begins to make one wonder just how far we will get with changes in
government policy when they have learned how to extract such large sums of money
from these drug companies in the way of fines. Why are those fines not
distributed to those who were damaged by the off label prescribing?

Ann Blake-Tracy, Executive Director
International Coalition for Drug Awareness
Author: Prozac: Panacea or Pandora? – Our Serotonin
Nightmare & Help! I Can’t Get Off My
Antidepresant!

http://articles.sfgate.com/2004-05-14/business/17426572_1_neurontin-pfizer-fda

Huge penalty in drug fraud / Pfizer settles felony case in Neurontin
off-label promotion

May
14, 2004
|By Bernadette Tansey,
Chronicle Staff Writer

A division of Pfizer Inc., the world’s largest drugmaker, has agreed to plead
guilty to two felonies and pay $430 million in penalties to settle charges that
it fraudulently promoted the drug Neurontin for a string of unapproved uses.

In an agreement announced by government prosecutors Thursday, Pfizer unit
Warner-Lambert admitted that it aggressively marketed the epilepsy drug by

illicit means for unrelated conditions including bipolar disorder, pain,
migraine headaches, and drug and alcohol withdrawal.

A company whistle-blower, whose 1996 civil suit spurred
government investigations of Neurontin’s marketing campaign, will receive about
$26.6 million through the settlement under legal provisions that reward citizens
for helping to recover government money obtained by fraud.

The settlement includes $152 million to pay back amounts spent on Neurontin
by the federal Medicare program and 50 state Medicaid programs for the poor. In
addition, Pfizer will pay a $240 million criminal fine, the second-largest such

fine ever imposed in a health care fraud prosecution, the Department of Justice
said.

Prosecutors said Warner-Lambert turned Neurontin into a blockbuster drug with
tactics like paying doctors to listen to pitches for unapproved uses and
treating them to luxury trips to Hawaii, Florida or the 1996 Olympics in
Atlanta. One doctor received almost $308,000 to tout Neurontin at conferences.

“This illegal and fraudulent promotion scheme corrupted the information
process relied on by doctors in their medical decision making, thereby putting
patients at risk,” said U.S. Attorney Michael Sullivan, chief prosecutor for the
federal district based in Boston.

Doctors are free to prescribe drugs for uses not specified on their FDA-
approved labels, but the FDA forbids drug companies from promoting them for
those off-label uses. Prosecutors said Neurontin’s manufacturers decided not to
seek an expanded FDA label for the drug, an expensive process requiring solid
proof from clinical trials. Instead, the company boosted sales through
aggressive promotional strategies, even when scientific studies had demonstrated
that it was not effective, the Justice Department said.

The tactics included planting company operatives in the audience at medical
education events to contradict unfavorable comments about Neurontin, and paying
doctors to allow sales representatives to sit in on patient visits, prosecutors
said.

Feds found Pfizer too big to nail

Submitted by Drew Kaplan on April 22, 2010 – 11:39 amOne Comment

Imagine being charged with a crime, but an imaginary friend takes the rap for
you. That is essentially what happened when Pfizer, the world’s largest
pharmaceutical company, was caught illegally marketing Bextra, a painkiller that
was taken off the market in 2005 because of safety concerns. When the criminal case was announced last fall, federal
officials touted their prosecution as a model for tough, effective enforcement.
“It sends a clear message” to the pharmaceutical industry, said Kevin Perkins,
assistant director of the FBI’s Criminal Investigative Division.

But beyond the fanfare, a CNN Special Investigation found another story, one
that officials downplayed when they declared victory. It’s a story about the
power major pharmaceutical companies have even when they break the laws intended
to protect patients.

Big plans for Bextra

The story begins in 2001, when Bextra was about to hit the market. The drug
was part of a revolutionary class of painkillers known as Cox-2 inhibitors that
were supposed to be safer than generic drugs, but at 20 times the price of
ibuprofen.

Pfizer and its marketing partner, Pharmacia, planned to sell Bextra as a
treatment for acute pain, the kind you have after surgery.

But in November 2001, the U.S. Food and Drug Administration said Bextra was
not safe for patients at high risk of heart attacks and strokes.

The FDA approved Bextra only for arthritis and menstrual cramps. It rejected
the drug in higher doses for acute, surgical pain.

Promoting drugs for unapproved uses can put patients at risk by circumventing
the FDA’s judgment over which products are safe and effective. For that reason,
“off-label” promotion is against the law.

If we prosecute Pfizer … a lot of the people who work for the company who
haven’t engaged in criminal activity would get hurt.

–Mike Loucks, federal prosecutor But with billions of dollars of profits at
stake, marketing and sales managers across the country nonetheless targeted
anesthesiologists, foot surgeons, orthopedic surgeons and oral surgeons. “Anyone
that use[d] a scalpel for a living,” one district manager advised in a document
prosecutors would later cite.

A manager in Florida e-mailed his sales reps a scripted sales pitch that
claimed — falsely — that the FDA had given Bextra “a clean bill of health” all
the way up to a 40 mg dose, which is twice what the FDA actually said was
safe.

Doctors as pitchmen

Internal company documents show that Pfizer and Pharmacia (which Pfizer later
bought) used a multimillion-dollar medical education budget to pay hundreds of
doctors as speakers and consultants to tout Bextra.

Pfizer said in court that “the company’s intent was pure”: to foster a legal
exchange of scientific information among doctors.

But an internal marketing plan called for training physicians “to serve as
public relations spokespeople.”

According to Lewis Morris, chief counsel to the inspector general at the U.S.
Department of Health and Human Services, “They pushed the envelope so far past
any reasonable interpretation of the law that it’s simply outrageous.”

Pfizer’s chief compliance officer, Doug Lanker, said that “in a large sales
force, successful sales techniques spread quickly,” but that top Pfizer
executives were not aware of the “significant mis-promotion issue with Bextra”
until federal prosecutors began to show them the evidence.

By April 2005, when Bextra was taken off the market, more than half of its

$1.7 billion in profits had come from prescriptions written for uses the FDA had
rejected.

Too big to nail

But when it came to prosecuting Pfizer for its fraudulent marketing, the
pharmaceutical giant had a trump card: Just as the giant banks on Wall Street
were deemed too big to fail, Pfizer was considered too big to nail.

Why? Because any company convicted of a major health care fraud is
automatically excluded from Medicare and Medicaid. Convicting Pfizer on Bextra
would prevent the company from billing federal health programs for any of its
products. It would be a corporate death sentence.

Prosecutors said that excluding Pfizer would most likely lead to Pfizer’s
collapse, with collateral consequences: disrupting the flow of Pfizer products
to Medicare and Medicaid recipients, causing the loss of jobs including those of
Pfizer employees who were not involved in the fraud, and causing significant
losses for Pfizer shareholders.

“We have to ask whether by excluding the company [from Medicare and
Medicaid], are we harming our patients,” said Lewis Morris of the Department of
Health and Human Services.

So Pfizer and the feds cut a deal. Instead of charging Pfizer with a crime,
prosecutors would charge a Pfizer subsidiary, Pharmacia & Upjohn Co.
Inc.

The CNN Special Investigation found that the subsidiary is nothing more than
a shell company whose only function is to plead guilty.

According to court documents, Pfizer Inc. owns (a) Pharmacia Corp., which
owns (b) Pharmacia & Upjohn LLC, which owns (c) Pharmacia & Upjohn Co.
LLC, which in turn owns (d) Pharmacia & Upjohn Co. Inc. It is the
great-great-grandson of the parent company.

Public records show that the subsidiary was incorporated in Delaware on March
27, 2007, the same day Pfizer lawyers and federal prosecutors agreed that the
company would plead guilty in a kickback case against a company Pfizer had
acquired a few years earlier.

As a result, Pharmacia & Upjohn Co. Inc., the subsidiary, was excluded
from Medicare without ever having sold so much as a single pill. And Pfizer was
free to sell its products to federally funded health programs.

An imaginary friend

I can tell you, unequivocally, that Pfizer perceived the Bextra matter as an
incredibly serious one.

Two years later, with Bextra, the shell company once again pleaded guilty. It
was, in effect, Pfizer’s imaginary friend stepping up to take the rap.

“It is true that if a company is created to take a criminal plea, but it’s
just a shell, the impact of an exclusion is minimal or nonexistent,” Morris
said.

Prosecutors say there was no viable alternative.

“If we prosecute Pfizer, they get excluded,” said Mike Loucks, the federal
prosecutor who oversaw the investigation. “A lot of the people who work for the
company who haven’t engaged in criminal activity would get hurt.”

Did the punishment fit the crime? Pfizer says yes.

It paid nearly $1.2 billion in a criminal fine for Bextra, the largest fine

the federal government has ever collected.

It paid a billion dollars more to settle a batch of civil suits — although it
denied wrongdoing — on allegations that it illegally promoted 12 other
drugs.

In all, Pfizer lost the equivalent of three months’ profit.

It maintained its ability to do business with the federal government.

Pfizer says it takes responsibility for the illegal promotion of Bextra. “I
can tell you, unequivocally, that Pfizer perceived the Bextra matter as an
incredibly serious one,” said Doug Lankler, Pfizer’s chief compliance
officer.

To prevent it from happening again, Pfizer has set up what it calls
“leading-edge” systems to spot signs of illegal promotion by closely monitoring
sales reps and tracking prescription sales.

It’s not entirely voluntary. Pfizer had to sign a corporate integrity
agreement with the Department of Health and Human Services. For the next five
years, it requires Pfizer to disclose future payments to doctors and top
executives to sign off personally that the company is obeying the law.

Pfizer says the company has learned its lesson.

But after years of overseeing similar cases against other major drug
companies, even Loucks, isn’t sure $2 billion in penalties is a deterrent when
the profits from illegal promotion can be so large.

“I worry that the money is so great,” he said, that dealing with the
Department of Justice may be “just of a cost of doing business.”

http://www.cnn.com/2010/HEALTH/04/02/pfizer.bextra/index.html?hpt=T2

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3/30/2001 – LSD to Prozac and back to LSD?!

In the last half century we have witnessed Eli Lilly bring America LSD and
then Prozac. Now that the public has been brainwashed about the “benefits” of
Prozac and its clones, it is time to once again attempt to sell us on LSD.
After admitting in this article the truth of the argument I have made for ten
years against the SSRI antidepressants – they work like LSD in the brain (”
Nichols says there is some indication these drugs work on the serotonin
pathway in the brain, the same target of the selective serotonin reuptake
inhibitor drugs Prozac, Paxil and Zoloft, used to treat depression, anxiety
and obsessive compulsive disorder.”) they now work to sell us on the
“benefits” of LSD. After all, if we can as a society have given similar drugs
– the SSRIs – such a warm welcome, we must now be ready to accept LSD, the
CIA’s drug of choice for a mind control experimentation, with welcome arms as
well.

Has the world gone completely mad?! Obviously! We now have the National
Institute on Drug Abuse encouraging us to use a drug, already declared
dangerous and of no medical use, when they are suppose to educate us on the
dangers of it. Perhaps the name of the institute should be changed to the
National Institute for Production of Drug Abuse. At this point it would
certainly be more appropriate. Clearly they are counting on their lack of
educating the public about drugs to have produced enough public ignorance of
drugs and their effects so as to allow them to get away with this one. As I
have said repeatedly, the drug companies count on our memory loss. They
expect us to forget within a generation our experience with a drug and then
pull the same drug on us again. They generally give it a new name, or a new
twist, but the more you learn about drugs, the more you realize that the
drugs remain the same.

Obviously on this one they are counting on mass stupidity among the general
population for its acceptance. I would hope that everyone of you is working
as hard as you can to educate all around you to the dangers of these drugs.
Time is of the essence! If you have not yet figured out that we are in a
battle for our lives, you have missed something. Our society as we have known
it and our future is at stake. The Brave New World is here. And with them
feeling so confident as to take such a bold and blatant step as this all that
can be said at this point is, “God help us all!”

Ann Blake-Tracy, Executive Director,
International Coalition For Drug Awareness
www.drugawareness.org

http://abcnews.go.com/sections/living/DailyNews/hallucinogen010322.html

A computer-generated model of the LSD molecule. (Heffter Institute)

MedicalHallucinogens?

Researchers Studying Possible Medical Use of LSD, Peyote, Psilocybin

By Robin Eisner

N E W Y O R K, March 22 Could shrooms or LSD help the mentally ill?

STORY HIGHLIGHTS
Hallucinogens Among Oldest Drugs
Trials Must Be Rigorously Designed
Critics: Risks Outweigh Benefits

At Harvard, a psychiatrist is studying whether the hallucinogenic cactus
peyote creates any long-term memory or attention problems in the American
Indians who take the drug as part of religious rituals.

A University of Arizona psychiatrist is poised to begin researching whether
taking the hallucinogen psilocybin under controlled circumstances may help
people suffering with obsessive compulsive disorder.

And another Harvard psychiatrist is in the beginning phases of designing a
protocol that may employ LSD or another hallucinogen to see if it helps
terminally ill people suffering from depression and pain.

With some support from the private New Mexico-based Heffter Institute, these
researchers, along with others in the United States and abroad, represent a
small movement of scientists looking at the possible medical benefits of
hallucinogens for some psychiatric conditions.

Hallucinogens Among Oldest Drugs

Hallucinogens are among the oldest known group of drugs that have been used
for their ability to alter human perception and mood, according to the Drug
Enforcement Agency. They have been used for medical, social and religious
practices.

More recently, synthetic hallucinogens have been used recreationally, with
hippies from the ’60s, such as the now deceased ex-Harvard psychology
professor Timothy Leary, first promoting their use with the famous slogan,
Turn on, Tune in, Drop Out.

Today, hallucinogens are deemed drugs of abuse by the DEA, with no known
medical benefit. Approximately 8 percent to 10 percent of high school
seniors tried a hallucinogen in the past year according to a University of
Michigan study of drug use.

It remains unclear how these drugs exert their action in the brain, but
anecdotal evidence and some earlier studies indicate they may help a variety
of psychiatric conditions, says David E. Nichols, founder of the Heffter
Institute, in Santa Fe, and professor of medical chemistry and molecular
pharmacology at Purdue School of Pharmacy in West Lafayette, Ind.

Nichols says there is some indication these drugs work on the serotonin
pathway in the brain, the same target of the selective serotonin reuptake
inhibitor drugs Prozac, Paxil and Zoloft, used to treat depression, anxiety
and obsessive compulsive disorder.

He founded the institute in 1993 to help give scientific credibility to
medical research on hallucinogens. After years of fund-raising, the
institute now has enough money to help scientists do serious research.

Trials Must Be Rigorously Designed

Since opinions are so strongly held about hallucinogens, it is essential
that any studies in this area be performed with the most rigorous modern
methods and great care to have an impartial approach, says Dr. Harrison
Pope, professor of psychiatry at Harvard Medical School, who is leading the
four-year peyote study in American Indians.

Funded largely by the National Institute of Drug Abuse and Heffter, Popes
group will be comparing three populations of American Indians peyote users
in religious ceremonies, alcoholics, and local tribespeople to see if
peyote use is associated with cognitive problems.

Pope is also developing a trial to follow up on studies from the ’60s and
’70s suggesting that hallucinogens helped ease anxiety and depression in the
terminally ill and also reduced their need for pain medication.

The challenge is to design the study in such a way that if the drug shows
benefits, skeptics are convinced, and if it doesnt help, proponents of
hallucinogenic use dont challenge the research as inadequate, Pope says.

Psilocybin mushroom

These studies take time to develop to get that scientific imprimatur. They
also need to get review, by local medical institutions and governmental
regulatory authorities. The DEA and the FDA is still reviewing a protocol by
Dr. Francisco Moreno, an assistant professor of psychiatry at the University
of Arizona in Tucson, hoping to study a chemically synthesized psilocybin
for obsessive-compulsives. His hospital gave him permission to start the
study.

A protocol of psilocybin and depression in Switzerland also is undergoing
revision before it is submitted to the government authorities there, Nichols
says.

Critics: Risks Outweigh Benefits

Some scientists, however, question the potential risks of these studies.

The problem with this kind of research is that when average people hear or
read about them in this preliminary stage they might think these drugs could
be good for them now, says Una McCann, associate professor of psychiatry at
Johns Hopkins School of Medicine. But it remains unknown until the studies
are finished, McCann says.

Dr. Gregory Collins the director of the Alcohol and Drug Recovery program at
the Cleveland Clinic, in Cleveland, Ohio, believes the risks outweigh any
benefits.

Some of these drugs have been shown to have long-term consequences in
healthy people, Collins says. I would be reluctant to try them in the
mentally ill.

Nichols, however, defends the research. I think we will find some medical
benefit of these drugs, Nichols says. There is no other drug class that
doesnt have some medical utility.

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