Another page is written these days in the scandal around
pharmaceutical companies paying good money in order to hide eventual bad
results of their drug trials and promote the drugs although they proved inefficient.
This time the scandal builds around world’s largest pharmaceutical company,
Pfizer Inc., and its anti-seizure drug Neurontin.
The company appears to have suppressed a large European
study suggesting that Neurontin was ineffective for chronic nerve pain, and it
privately strategized about how to silence a British researcher who wanted to
bring everything out in the open, according to internal Pfizer documents
submitted in a lawsuit against the company. The documents were submitted to the
US District Court in Boston
and were made available on its website.
During the same time, the company launched in a public
campaign promoting positive findings of a smaller Neurontin study it had
published in a major medical journal. The campaign turned the drug into one of
the fastest-growing blockbuster drugs worldwide. Overall, it generated more
than $2 billion a year in US
sales before a generic competitor entered the market in 2004. The same year,
Pfizer agreed to pay $430 million and plead guilty to criminal charges for
illegally marketing Neurontin for unapproved uses such as migraines and pain.
In response to these accusations, Pfizer released a
statement denying the charges. “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
statement read.
On the other hand, Dr. Kay Dickersin of the Johns Hopkins Bllomberg
School of Public Health, one of the experts reviewing the documents, concluded
that the Pfizer documents spell out “a publication strategy meant to convince physicians
of Neurontin’s effectiveness and misrepresent or suppress negative findings.”
This is not the first time a drug company does questionable
things in order to promote their drugs even though they are ineffective and
pose patients’ lives in danger. A report appeared in the August 19 issue of the
Annals of Internal Medicine revealed that a 1999 clinical trial (called
ADVANTAGE or Assessment of Differences between Vioxx And Naproxen To Ascertain
Gastrointestinal tolerability and Effectiveness) of Merck & Co.’s Vioxx,
was done in fact to support a marketing campaign before the drug’s launch.
Many researchers believe that such behavior, which raises
ethical and scientific questions, is not singular when it comes to drug
companies and their way of promoting their new recipes. An editorial in the
Journal of the American Medical Association suggested the ENHANCE study of
Vytorin was also done for marketing purposes, but the authors cited only
circumstantial evidence for the allegation.
Merck reported in the first place that Vioxx was “well
tolerated,” but internal company documents revealed that patients given the
drug in one trial had been more than four times as likely to die as those given
a placebo, and 2.5 times as likely to die in a second trial. The two trials
resulted in 34 deaths among about 1,000 patients given Vioxx and 12 deaths
among a similar number given a placebo.
Vioxx generated sales of $2.5 billion a year before the
arthritis and chronic pain pill was withdrawn from US drugstores almost four
years ago, when a Merck study showed that long-term users had twice the risk of
heart attack and stroke.