On the heels of Eli Lilly’s $1.4 Billion settlement for illegally marketing Zyprexa for use by
the elderly and even children earlier this month – an amount identified by the media as the
largest settlement ever paid by a drug company to date, Pfizer attempted to bury their own
bad news – a $2.3 Billion settlement for marketing their recalled painkiller Bextra.

In a disclosure nearly drowned out by the news of its $68 billion acquisition of
Wyeth, Pfizer Inc. said it agreed to pay $2.3 billion to settle a federal investigation into its alleged off-label marketing of
the now-withdrawn painkiller Bextra.

Pfizer reached the $2.3 billion agreement with the Massachusetts U.S. Attorney to, it said, “resolve previously disclosed
investigations” regarding Bextra and “other open investigations.”  

And, while Pfizer disclosed no other details, its fourth-quarter earnings dropped a massive 90 percent over the charges
and investigation. The Wall Street Journal blog (WSJ) noted that Pfizer’s fourth-quarter earnings dropped to $266
million from $2.72 billion the prior year.

According to Bloomberg News, the Pfizer settlement is the largest for allegations of off-label marketing practices, a topic
of significant concern to consumers, the medical community, and patient advocates.  The prior record had occurred
earlier this month when Eli Lilly & Company paid out $1.42 billion over its antipsychotic Zyprexa, said Patrick Burns of
Washington advocacy group Taxpayers Against Fraud, reported Bloomberg.  Pfizer spokesman, Christopher Loder,
explained that the $2.3 billion settlement represents an “agreement in principle to resolve government allegations of
past off-label practices,” said Bloomberg, noting that Loder refused to say what other investigations were covered.

Right behind this article, here's the next in the world of big Pharma:

The "Business" of Drugs: A New Blow to Pfizer's Future - Nigerian Illegal Drug Testing
on Children to be Tried in U.S. Courts

Last week it was a $2.4 Billion settlement for illegal marketing of drugs not approved for children and the elderly, this
week the U.S. Court of Appeals overturned a lower court dismissal of a lawsuit brought by Nigerian families for illegally
testing a deadly experimental antibiotic drug on Nigerian children back in 1996. A ruling that could set a precedent
affecting other American drug companies accused of wrongdoing overseas.

The Washington Post reported that the lawsuits sought unspecified damages on behalf of the families, who say Pfizer
violated international law by testing the drug, known as Trovan, on perilously ill children without their knowledge.
Eleven children died during the 1996 clinical trial, carried out during a record meningitis epidemic. Other children
developed brain damage and crippling arthritis. (
See the full Washington Post article).

Pfizer also is the target of criminal and civil legal actions in Nigeria, where authorities are seeking damages of more
than $8 billion. While the ruling in New York has no direct effect on the Nigerian actions, lawyers in the case said it
could complicate long-running settlement negotiations there.

Of course, in their inimitable talent for spinning their actual position regarding their criminal and legal issues – and their
underwhelming level of responsibility for their actions, Pfizer issued a statement dismissing the court action as "only a
procedural ruling."

The experiment came to light in December 2000, when The Washington Post published a lengthy examination of the
trial. It found that Pfizer carried out the experiment on 200 children at a makeshift epidemic camp in the Nigerian town of
Kano. The articles reported that Pfizer had no signed consent forms for the children and relied on a falsified ethics
approval letter to defend the design of the experiment.

Trovan was never approved for use by American children. In fact, while the Food and Drug Administration approved it
for adults in 1998 it later severely restricted its use after reports of liver failure. The European Union banned the drug in
1999.

Suggested Action

This particular case involves a U.S. drug corporation seeking to conduct very shoddy “clinical” studies and do so under
the radar of strict government regulations and scientific standards, let alone ethical codes. It was an effort to come back
to the U.S. and put forth yet another fictitious piece of documentation in order to obtain approvals from the FDA to
remarket a highly dangerous drug. Standard practice for this and many other drug companies unfortunately – but one
which has no place in the health industry.

You can help to ensure this is not tolerated and that not only are the companies held accountable, but the people
themselves are as well. While the money awarded in such cases may well help the families of the victims involved, the
11 children who died and the others who suffered brain damage and other ailments, the people who orchestrated this
catastrophe should spend their remaining years behind bars – not merely, reprimanded, fired or reassigned to other
departments.

Contact your State and Federal government representatives and ask them to ensure justice is brought to bear and the
PEOPLE involved are held accountable. (
See: Contact Your Government Representatives) on the WINHS.ORG web
site to locate and email your representatives.

Thank you,

Rudi C. Loehwing
Managing Director
World Institute of Natural Health Sciences
www.winhs.org
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The "Business" of Drugs: Not to be outdone by Eli Lilly,
Pfizer raises the Settlement Bar on
Criminal Off Label Marketing of Drugs to $2.3 Billion
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