Experts Conclude Pfizer Manipulated Studies

[CAL/AAEM News Service]

Experts Conclude Pfizer Manipulated Studies 

By STEPHANIE SAUL

 

Source: The New York Times ( http://www.nytimes.com )

Date: October 8, 2008 

 

 

The drug maker Pfizer earlier this decade manipulated the
publication of scientific studies to bolster the use of its epilepsy drug
Neurontin for other disorders, while suppressing research that did not support
those uses, according to experts who reviewed thousands of company documents
for plaintiffs in a lawsuit against the company. 

 

Pfizer’s tactics included delaying the publication of
studies that had found no evidence the drug worked for some other disorders, “spinning”
negative data to place it in a more positive light, and bundling negative
findings with positive studies to neutralize the results, according to written
reports by the experts, who analyzed the documents at the request of the
plaintiffs’ lawyers. 

 

One of the experts who reviewed the documents, Dr. Kay
Dickersin of the Johns Hopkins Bloomberg School of Public Health, concluded
that the Pfizer documents spell out “a publication strategy meant to convince
physicians of Neurontin’s effectiveness and misrepresent or suppress negative
findings.” 

 

Pfizer issued a statement Tuesday denying that it had
manipulated Neurontin data, saying “study results are reported by Pfizer in an
objective, accurate, balanced and complete manner, with a discussion of the
strengths and limitations of the study, and are reported regardless of the
outcome of the study or the country in which the study was conducted.” 

 

The expert reports, unsealed Monday in a federal court in Boston, add to
accusations that the pharmaceutical industry has controlled the flow of clinical
research data, blurring the lines between science and marketing. 

 

In April, for example, a group of academic doctors
questioned the validity of drug industry research after finding that Merck had
hired ghostwriters to produce scientific articles about Vioxx, then recruited
prestigious doctors to serve as their official authors. Vioxx, a painkiller, was
withdrawn from the market in 2004 after research indicated it could cause
strokes and heart attacks.

 

Last winter, Merck and Schering-Plough were criticized for
delaying the release of a study on their best-selling cholesterol medication
Vytorin that showed the drug did not slow the growth of plaque in arteries. In
the case of Pfizer’s Neurontin, the negative studies would have increased
doubts about the drug’s value for several unapproved uses — treating bipolar
disorder, controlling certain types of pain and preventing migraine headaches, according
to the expert opinions. 

 

So-called off-label use of Neurontin for those conditions
helped propel its sales to nearly $3 billion a year before it lost patent
protection in 2004. 

 

In one example, the experts concluded that Pfizer had
deliberately delayed release of a study that showed the drug had little effect
against pain that is a complication of long-term diabetes, even as the outside
researcher who was a lead investigator for the study, Dr. John Reckless of Bath, England,
pushed to publish the unflattering findings on his own. Dr. Reckless’s office
said Tuesday that he could not be reached for comment. 

 

According to one September 2000 e-mail message by a
Neurontin team leader at Pfizer, “The main investigator in the U.K. (Dr. Reckless)
is keen to publish but this will have several ramifications.” The team leader
later wrote, “I think we can limit the potential downside of the 224 study by
delaying publication for as long as possible.” 

 

Pfizer said Tuesday that it had submitted the Reckless study
to two journals which declined to publish it. The results were not published
until 2003 and, according to plaintiffs’ experts, when they did appear they
were combined with two other studies and together the findings concluded
Neurontin was effective for treating neuropathic pain. 

 

Another series of e-mail messages had the subject line
“Spinning Serpell,” a reference to an investigator on the study, Dr. Michael
Serpell of Glasgow, Scotland. In the e-mail exchange a
senior marketing manager for Pfizer and a professional medical writer discussed
how to cast the results in a more favorable light for a poster presentation at
a medical conference, the experts concluded. 

 

“If Pfizer wants to use, present and publish this
comparative data analysis in which two of the five studies compared make the
overall picture look bad, how do we make it sound better than it looks on the
graphs?” the medical writer asked.

 

Pfizer discontinued its marketing program for Neurontin in 2004
after the drug became available as a generic. That same year, the company paid $430
million to settle federal criminal and civil claims that Warner-Lambert, which
Pfizer acquired in 2000, promoted Neurontin for unapproved uses during the 1990s.


 

At the time, Pfizer said the illegal marketing had occurred
before Pfizer acquired the company or drug. On Tuesday, Pfizer repeated that it
had instituted procedures when it acquired Warner-Lambert to make sure there
was no off-label promotion of Neurontin. 

 

Despite that settlement, separate legal action involving the
drug is still pending in Boston,
where consumers and third-party payers including insurance companies and trade
unions want Pfizer to repay them billions of dollars for Neurontin
prescriptions. The plaintiffs accuse Pfizer of fraudulently misrepresenting the
drug’s benefits.

 

Thomas Greene, a lawyer for the plaintiffs, said the
documents in the case revealed that even after the Neurontin settlement.

 

“Pfizer continued with the medical marketing firms and
planted marketing messages in journal articles that Neurontin was effective
while they knew that their own clinical trials had failed to demonstrate it was
effective,” Mr. Greene said. 

 

Dr. Dickersin, the Johns Hopkins expert, said that of 21
studies she reviewed, five were positive and 16 negative, meaning they did not
prove the drug was effective. Of the five positive studies, four were published
in full journal articles, yet only six of the negative studies were published
and, of those, two were published in abbreviated form. 

 



Abid Mogannam &
Brian Potts MD, MBA
Managing Editors, CAL/AAEM News Service
University of California, Irvine

The CAL/AAEM Archives are available at: http://maillists.uci.edu/mailman/public/calaaem/

CAL/AAEM, a nonprofit professional organization for emergency physicians, operates the CAL/AAEM News Service solely as an educational resource for physicians. Dissemination of an article by CAL/AAEM News Service does not imply endorsement, agreement, or recommendation by CAL/AAEM News Service, CAL/AAEM, or AAEM.  


      
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