Neurontin was originally approved by the FDA a decade ago for treating seizures and later for pain caused by shingles, but not for other conditions.
The Associated Press reported today that a thorough analysis of a dozen published studies testing possible new uses for a
Pfizer Inc. epilepsy drug found that reporting of the test results was often misleading. According to the report, when the
company-funded study's primary finding wasn't favorable, that result was usually buried and something else positive was
highlighted, without disclosing the switch.
The documents used in the review were obtained by insurer and consumer attorneys suing Pfizer for refunds on prescriptions.
The attorneys, who are seeking class action status for the cases, claim that Pfizer concealed evidence that the epilepsy drug
Neurontin actually didn't work for those unapproved uses, including nerve pain, migraines and bipolar disorder.
Pfizer disputes the report's conclusions, saying the company never attempted to mislead the medical community about the
effectiveness of the drug for certain uses.
The report, by researchers at the University of California at San Francisco and the Johns Hopkins Bloomberg School of Public
Health, comes two months after Pfizer was fined a record $2.3 billion -- including an unprecedented $1.2 billion criminal fine --
for illegally marketing other blockbuster drugs.
The analysis report appears in this Thursday's New England Journal of Medicine.
Dr. Sidney Wolfe, head of health research at consumer group Public Citizen, called the report the first comprehensive look "at
studies in which a company and people working for it so maliciously manipulated the data to make a drug look more effective
than it actually was." Wolfe pointed out that in every instance, the published article made the drug look better than it would have.
Wolfe, a member of the Food and Drug Administration's drug safety advisory committee, said that this type of misinformation
tactic, “...results in harm."
And it is very important to note, no matter what it was originally approved for, its potential side effects have always included suicidal tendencies and
While doctors may get away with prescribing drugs for off-label and unapproved uses, certainly a dangerous practice, drug companies are legally
barred from promoting their products for such uses. Drugmakers often test drugs for additional conditions and then publicize the results, but they don't
always seek approval for those new uses, particularly if the new findings aren't convincing.
Experts believe that most Neurontin sales were for off-label uses - the ones in the reviewed studies. Sales peaked at $2.7 billion in 2004, when Pfizer
paid $430 million in government fines to settle allegations it improperly marketed the epilepsy drug for unapproved uses. By last year, Neurontin sales
fell to $387 million due to cheaper generic versions sold as Gabapentin.
For the analysis, the researchers examined 20 patient studies funded by New York-based Pfizer and its Parke-Davis unit on use of Neurontin for
preventing migraines or treating nerve pain or bipolar disorder. The studies were published in medical journals or presented at conferences over the
FALSIFICATION OF DRUG RESEARCH CONTINUES
In eight of the 12 published studies, the main outcomes listed in actual internal documents completely differ from the ones later given in the drug
company published reports. In half the cases, a new primary outcome was wholly substituted and in others, the original main outcome was instead
reported as a secondary measure or wasn't even disclosed at all.
Arthur Caplan, director of the University of Pennsylvania's Center for Bioethics, called the report "one of the most ethically disturbing papers I've read
in some time" and "an indication that people have been playing fast and loose with studies," particularly industry ones. Caplan said the FDA should
have the power to audit industry drug studies. Wolfe said there should be bigger fines and jail terms for manipulating study data, plus tougher rules for
studies being published in journals.
Medical journals in recent years have required that studies be listed on a federal Web site, http://www.clinicaltrials.gov, to be eligible for publication.
That move was made partly to make it harder for industry to hide studies on products that don't pan out and only publish those with good results. The
study descriptions also list their primary and secondary outcomes.
What You Can Do?
1. Pass this email on to any and everyone you know who should be interested or would be effected by this information. (Forward the link to this page)
2. Let your government representatives know – this is a illegal practice that must be stopped. Contact your government representatives and let them
know that this is an illegal practice that must be stopped – the health of consumers are at stake when the efficacy or potential side effects of
pharmaceutical drugs are allowed to be misrepresented or wholly fabricated. Drug company executives must be personally held accountable when
authorizing such illegal practices and people’s lives are impacted.
Please go to https://www.winhs.org/contribute.htm and let your personal government representative know your views.
All the best,
Rudi C. Loehwing
World Institute of Natural Health Sciences
The "Business" of Drugs: Peer Review Analysis of Pfizer Drug
Studies Reveal Intentional Falsifications
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