Black People : Phizer Experimenting on Blacks????

Kemetstry

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Feb 19, 2001
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In a stunning whistleblower lawsuit, the world's largest
pharmaceutical company is being sued over the dangerous practice of illegally
promoting a kidney transplant drug for unapproved uses -- and targeting
African-Americans, even though they are at higher risk of complications.

Two former hospital sales representatives, Marlene Sandler
and Scott Paris, originally filed their suit in 2005 but the case was recently
unsealed. The amended complaint against Pfizer and Wyeth was filed this week,
as reported by the Pharmalot blog .

Sandler and Paris claim that Wyeth, which is now owned by
Pfizer, promoted the "off-label" use of Rapamune, a kidney transplant
drug, encouraging its sales force to promote the drug for heart, lung, liver,
and pancreas transplants even though Rapamune was never approved for those
procedures. The Food and Drug Administration warned against such off-label use
of Rapamune in 2004 and 2007.

The suit claims:

"Wyeth trained and encouraged its sales representatives
to market Rapamune for uses outside those listed on the FDA-approved label and
to misrepresent and withhold clinical information regarding the safety and
efficacy of Rapamune. As a result of Wyeth's wrongdoing, patients were put at
risk of serious physical and financial harm, including: the disruption or
discontinuation of stable treatment regimens; increased costs associated with
treating side effects caused or exacerbated by Rapamune; life-threatening side
effects such as anemia, bone marrow suppression, inhibited wound-healing,
proteinuria, blood clots, leukopenia, thrombocytopenia, liver failure,
pulmonary dehiscence; and death."



Off-label promotion of drugs has become one of the most controversial issues in
the pharmaceutical industry, and has lead to host of federal indictments and
massive settlements. Just last September, Pfizer agreed to plead guilty to criminal charges and to pay more
than $2 billion in fines to settle allegations regarding its market practices,
which included the off-label promotion of the antipsychotic Geodon and the
antibiotic Zyvox.

One of the most stunning allegations in the Sandler-Paris
suit, is that Wyeth targeted African-American patients for unapproved use of
the drug "even though they didn't have data supporting its use in that
population," reports BNet.com . "Blacks are considered
"high-risk" patients for kidney transplants because of their more
vigorous immune response to new organs. Rapamune reduces immune response so patients
don't reject their new kidneys."

Yet the suit claims that Wyeth targeted two hospitals with
predominantly African-American patient populations -- Philadelphia's
Einstein Medical
Center and New
York's SUNY
Downstate Medical
Center.

Some hospitals, including the famed Mayo Clinic, raised
concerns with Wyeth Global Medical Affairs that patients given the drug were
experiencing "very serious side effects," but "nothing was
done," according to the complaint.

The suit alleges that several prominent doctors, including
the clinical research director of the prestigious Cleveland Clinic, were
involved in helping promote the use of Rapamune.

The suit describes a speakers list of 18 physicians who
could talk about off-label use of drugs. One of those cited was the Cleveland
Clinic's Dr. Stuart Flechner, who was available to speak about the use of
Rapamune "for an honorarium of $2,000 or "prorated $15,000."
Flechner, a fellow of the American College of Surgeons, was named one of the Top Doctors
in America,
according to the clinic's Website.

When doctors at Mt.
Sinai Medical
Center expressed concerns
about using Rapamune as part of a specific regimen, Wyeth brought in Flechner
to talk to them:

"Wyeth paid Dr. Flechner to assist in the marketing of
the unapproved combination of Cellcept, an IL-2 receptor antagonist and
Rapamune in order to overcome these objections and secure Rapamune sales."

Pfizer issued the following statement to HuffPost:

"Pfizer is committed to patient safety and to ensuring
that information provided to physicians for Rapamune is consistent with its
FDA-approved indications. We are very confident that the current promotional
practices surrounding this product are fully compliant with all legal
requirements.



"Rapamune was first approved by the FDA in 1999 for the prophylaxis of
organ rejection in patients 13 years or older receiving kidney transplants. As
the science has evolved, so, too, has our labeling information for Rapamune,
which includes the appropriate caveats about treatment areas where safety and
efficacy have not been established."

A spokesman for Wyeth's then National Director of Transplant
Sales Joe McCafferty, who selected Philadelphia's
Einstein Medical Center
as the focus of the firm's sales plan for Rapamune, did not return calls to
HuffPost. A spokesman for the Cleveland Clinic did not return calls for comment.











:em0200:

 
This type of foolishness should never happen. This is what makes Blacks afraid to trust the medical community, and righteously so.

We do need studies done on Black people, just not like this. We have different kidney functions, immune systems, and are at risk of different diseases. All of these things should be studied, but this is not proper protocol.

I am sure all they will get is a slap on the hand and a fine paid to some government agency that will not benefit the victims or even Black people at large.
 

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