lawsuit filed against Pfizer Inc. two years ago and just unsealed last
month calls into question the safety of the company's popular
antipsychotic drug Geodon as well as the reputation of some of the
researchers who worked on its clinical trials.
The lawsuit, filed by Dr. Stefan Kruszewski of Harrisburg, Pa., alleges
that three of the researchers who helped conduct Geodon clinical trials
- Dr. Richard Borison, Dr. Bruce Diamond and Dr. Louis Fabre - have
been sanctioned by regulatory authorities. Borison and Diamond were
debarred by the U.S. Food and Drug Administration and received prison
time, according to the suit, and Fabre earned sanctions in Texas for
”Pfizer's reliance on clinical researchers with a known history of
professional misconduct” - which news reports indicate go back at least
as far as a 1997 indictment of Borison and Diamond and included the
FDA's 2005 shutdown of Fabre's clinical-testing facility -
“demonstrates the lengths to which the company is willing to go to
facilitate its 'positive' clinical trials' reporting,” according to the
Pfizer isn't the only company that used Borison and Diamond to do
clinical studies of schizophrenia patients. A 1998 Boston Globe article
cited the pair as a “favorite” of such other drug firms as Eli Lilly
& Co., Janssen Pharmaceutica, AstraZeneca Pharmaceuticals and
Questions about drug-research procedures have been a long-standing bone
of contention, with some critics charging that statistics can be
manipulated, especially now that much of the research trials are funded
and controlled by pharmaceutical companies with an inherent interest in
having their compounds brought to market.
Pfizer, in a statement, broadly denied allegations in the Kruszewski
lawsuit. A Pfizer spokeswoman added that “a rigorous internal system is
used for monitoring the safety of patients in clinical trials. In
addition, independent data monitoring boards are often used during
later stages of development.”
The FDA would not address whether the agency is reviewing Geodon data
based on allegations contained in the lawsuit. It also said it could
not comment on whether the FDA would be investigating any of the
clinical researchers associated with Geodon's approval, some of whose
names are redacted in official documents supplied by the agency.
But in a statement, the FDA said it “does go back and relook at data if we become aware of possibly fraudulent data.”
”Regarding Geodon specifically, the FDA feels that we have accurate
information and we feel the drug label accurately reflects the risks
and benefits of this drug,” said agency spokeswoman Sandy Walsh in a
The FDA branded as false an allegation in the lawsuit that the agency
approved Geodon's marketing over strong objection from its staff.
The FDA said it has no control over the practice of medicine and how
doctors prescribe drugs. All it can do, the agency said, is regulate
off-label promotion of drugs by pharmaceutical companies.
Kruszewski's suit questioning Geodon's approval was unsealed at about
the same time as another legal action in which former Pfizer sales
representative Mark R. Westlock accused the company of using the
National Alliance on Mental Illness as a “Trojan horse” to push
off-label use of the drug.
Doctors are allowed to prescribe drugs off-label for conditions not
specifically approved by the FDA with the understanding that
individuals may be helped by a drug that doesn't prove particularly
effective in a large population. But companies are not allowed to
promote off-label uses as if they were clinically proven treatments.
The Kruszewski lawsuit is part of a series of whistleblower actions
that led to an announced $2.3 billion in penalties against Pfizer this
month for illegal marketing tactics related to several of its
The suit was initially sealed, but became a public document when the
U.S. District Court for the Eastern District of Pennsylvania released
it after Pfizer agreed last month to settle various illegal-marketing
cases throughout the country. The cases included a $1 billion civil
penalty as well as $1.2 billion for what turned out to be the largest
criminal fine in U.S. history.
But while money seemed to be at the heart of many of the
illegal-marketing schemes that Pfizer allegedly engaged in,
Kruszewski's suit extends concerns about the company into the critical
area of clinical science - the process by which authorities determine
the safety and effectiveness of a new drug. The suit claims that Pfizer
presented misleading data to the FDA before receiving approval for
Geodon and indicates that the antipsychotic medication may be riskier
than the company has been willing to admit.
To bolster his points, Kruszewski, identified as a board-certified
expert in psychopharmacology, alleges in the suit that Pfizer misled an
FDA advisory committee about the frequency of adverse reactions to
Geodon and gave incorrect information to authorities about possible
“favorable effects” of the drug on heart-disease risk factors such as
In fact, Kruszewski said in the suit, Geodon has been tied to prolonged
heartbeats. The lawsuit also cites what he calls “undisclosed side
effects” of Geodon for some people, including substantial weight gain,
restlessness and increased risk of infection.
This wouldn't be the first time that research associated with Pfizer
has been tied to skewed data. Earlier this year, Dr. Scott Reuben, a
Baystate Medical Center researcher in Springfield, Mass., and a former
member of Pfizer's speakers' bureau, was accused of perpetrating one of
the largest research frauds in U.S. medical history for apparently
making up data to support the preconceived notion that a combination of
two of the company's drugs, Lyrica and Celebrex, helps with
Geodon, known generically as ziprasidone hydrochloride, was discovered
and developed at Pfizer's campuses in Groton and New London. The FDA
approved its use in 2001 after denying an application to market the
drug under a different name three years previously.
The so-called non-approvable letter cited concerns over safety data,
particularly a “potentially fatal” heart problem tied to Geodon. Later
studies submitted by Pfizer, however, showed serious side-effects from
using the medicine fell in a range similar to other atypical
But an analysis of statistics on deaths of patients exposed to
experimental doses of Geodon showed a “mortality rate ... higher than
the rates observed for other recently reviewed antipsychotic
medications,” and that “cardiovascular related deaths were more
commonly observed in ziprasidone treated individuals compared to
patients receiving placebo or active (similar) medications,” according
to an FDA report. But the death rate, which tends to be higher for
schizophrenics than for other populations, was an improvement over
those given a placebo, the report stated.
Though the FDA eventually approved the use of Geodon, it did so under
the condition that labeling identify only three relatively uncommon
conditions for which it should be prescribed.
According to the suit, Pfizer's sales team immediately went to work in
an effort to expand Geodon's market by promoting off-label uses of the
drug, including for pediatric patients with autism-spectrum disorders
and elderly patients with dementia and depression.
In fact, the suit states that Pfizer's promotion of off-label uses for
its drug convinced at least one psychiatric unit in Pennsylvania to
issue a standing order to administer Geodon if a dose of the
antipsychotic drug Depakote was refused. A nursing home, according to
the suit, routinely administered Geodon off-label to treat nighttime
disruptiveness and agitation.
Kruszewski, who calls himself “an eyewitness to Geodon off-label
promotional marketing,” said in the suit that Pfizer hired pediatric
psychiatrists to give lectures promoting the drug.
”Pfizer had a large number of child psychiatrists routinely paid
substantial honorariums to give purportedly 'educational' lectures
about Geodon,” the suit states.
Kruszewski received $29 million as his share of more than $100 million
received by Pfizer whistleblowers in the settlement announced earlier