Navigation Links
Trial Data on Anti-Seizure Drug Might Have Been Manipulated: Report
Date:11/11/2009

Study found outcome measures differed between company documents, published reports

WEDNESDAY, Nov. 11 (HealthDay News) -- An unusual look at internal documents from a pharmaceutical company suggests that clinical data was manipulated to make a popular anti-seizure drug, gabapentin (Neurontin), look more effective than it actually was, thereby increasing possibilities for its off-label usage, according to a new report.

"This means we're not seeing the full picture, and the picture we are seeing is suspect because perhaps there was selective reporting of outcomes so that only the positive outcomes were reported," said Kay Dickersin, senior author of a paper reporting the alleged deception in the Nov. 12 issue of the New England Journal of Medicine.

But this revelation may just be the tip of the iceberg, especially given that internal company research protocols are rarely available to outsiders, stated another expert.

"The reality is that a deliberate fraud is extremely difficult to unearth. If scientists and companies agree to report results in a way that wasn't initially intended, unless you have access to original documents, it is extremely difficult to actually figure out what happened and how it happened," said Dr. Steven Nissen, chairman of cardiovascular medicine at the Cleveland Clinic Foundation in Ohio. "How many other examples like this are there out there that we simply don't know about? That's what's frightening."

Dickersin, a professor of epidemiology at the Johns Hopkins Bloomberg School of Public Health in Baltimore, gained access to internal company documents when she was asked to testify for the plaintiff in a lawsuit alleging that Pfizer and Parke-Davis (now a division of Pfizer as a result of its Warner-Lambert acquisition) illegally tried to market the drug for off-label uses.

Neurontin is approved by the U.S. Food and Drug Administration to treat seizures and shingles, but is also widely used off-label to fight migraines, bipolar disorder and pain.

Dickersin compared internal company documents to 20 trials funded by Pfizer and Parke-Davis, 12 of which were published.

Typically, clinical trials are set up to track both primary and secondary outcomes. These initial decisions then dictate other aspects of the trial, such as how many participants will be included. And that feeds back into how valid the final results are for that specific trial design and that specific primary outcome.

But here, Dickersin and her colleagues discovered that the primary outcomes specified in the early company protocols were not always the same as those appearing in later reports.

"What appears to be happening is that outcomes are changing between what was planned and what was published," Dickersin said.

Sometimes researchers changed what the primary outcome was (if a different outcome cast the drug in a more positive light), neglected to report the primary outcome at all, turned a secondary outcome into the primary outcome or simply added new outcomes, the report said.

"This distorts the scientific evidence that's available on the benefits and risks of therapies," Nissen said.

On Tuesday, Pfizer issued a statement in response to the study, part of which read: "The suggestion that Pfizer attempted to mislead the medical community about the effectiveness of gabapentin [Neurontin] for certain off-label conditions is untrue. The review recently published in the New England Journal of Medicine, regarding the reporting of industry-sponsored trials for gabapentin for off-label use, was derived from a report created for litigation and coauthored by plaintiffs' expert witness, who was hired to produce opinions to support plaintiffs' arguments. We believe the review suffers from significant bias, insufficient data, poor methodology, and cannot pass the threshold of credible scientific research."

"The safety and efficacy of gabapentin has been widely published, both by Warner-Lambert/Pfizer as well as independent researchers, and Pfizer has supported the dissemination of the results of these studies, regardless of outcome. At Pfizer, science and medical integrity come first and foremost," the statement concluded.

Although regulations require that all clinical trials be registered at some point, the study authors feel that's not enough.

"We need to actually have the protocol itself available for people to look at so there aren't opportunities for people to fiddle around with what they submit," Dickersin said.

One possibility would be to register the protocol itself. "This doesn't necessarily fix it, but it does mean that it's transparent, that the public has access to what people say they're going to do before they do it," she added.

"The peer-reviewed scientific literature is how we write our guidelines and how we make decisions about what therapies to give patients," Nissen said. "If the material available to us is severely distorted by commercial influences, then the evidence we use to take care of patients is flawed. That is too high a price to pay."

More information

The U.S. National Institutes of Health has a registry of current clinical trials.



SOURCES; Kay Dickersin, Ph.D., professor, epidemiology, Johns Hopkins Bloomberg School of Public Health, Baltimore, director, Center for Clinical Trials, Johns Hopkins; Steven E. Nissen, chairman, department of cardiovascular medicine, Cleveland Clinic Foundation, Ohio; Nov. 10, 2009, statement, Pfizer Inc.; Nov. 12, 2009, New England Journal of Medicine


'/>"/>
Copyright©2009 ScoutNews,LLC.
All rights reserved

Related medicine news :

1. St. Jude and UF Proton Therapy Institute to begin proton therapy clinical trial
2. St. Jude Childrens Research Hospital and UF Proton Therapy Institute to Begin Proton Therapy Clinical Trial
3. Tyco International to Present at the Citi Industrial Manufacturing & Transportation Conference
4. Robbins & Myers to Present at Bairds 2009 Industrial Conference November 11, 2009
5. Cardiome And Astellas Announce Initiation Of Patient Enrolment In ACT 5 Trial
6. Winner Medicals Subsidiary Won Contribution in Chinese Nonwovens and Industrial Textiles Industry Award
7. Positive Data from Arena Pharmaceuticals Pivotal BLOOM Trial Demonstrate that Lorcaserin Significantly Improved Markers of Cardiovascular Risk and Glycemic Parameters and was not Associated with Depression or Suicidal Ideation
8. Full Results of AIDS Vaccine Trial Confirm Modest Benefit
9. Detailed Results from RV 144 HIV Vaccine Trial Published Today in The New England Journal of Medicine and Presented at the AIDS Vaccine 2009 Conference Provide Insight for Future Research
10. Teen smoking-cessation trial first to achieve significant quit rates
11. Industrial and Laboratory Equipment Distributor Tovatech LLC Launches Redesigned Interactive Website
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:6/24/2016)... ... ... June 19, 2016 is World Sickle Cell Observance Day. In an effort to ... treatments, Serenity Recovery Center of Marne, Michigan, has issued a pain management ... (SCD) is a disorder of the red blood cells, which can cause episodes of ...
(Date:6/24/2016)... ... June 24, 2016 , ... Global law firm Greenberg Traurig, ... Elite. The attorneys chosen by their peers for this recognition are considered among the ... Traurig Shareholders received special honors as members of this year’s Legal Elite Hall of ...
(Date:6/24/2016)... Rhinebeck, NY (PRWEB) , ... June 24, 2016 , ... Topical BioMedics, Inc, makers of ... of companies that call for a minimum wage raise to $12 an hour by 2020 ... wage. This will restore the lost value of the minimum wage, assure the wage floor ...
(Date:6/24/2016)... New York, NY (PRWEB) , ... June 24, ... ... lifestyle publication Haute Living, is proud to recognize Dr. Barry M. Weintraub as ... believes that “the most beautiful women in the world, and the most handsome ...
(Date:6/24/2016)... ... June 24, 2016 , ... National recruitment firm Slone ... executive with extensive sequencing and genomics experience, as Vice President of North American Capital ... will be responsible for leading the sales team in the commercialization of the HTG ...
Breaking Medicine News(10 mins):
(Date:6/24/2016)... , Belgium , June ... MKT: VNRX), today announced the appointment of Dr. ... of Directors as a Non-Executive Director, effective June ... Company,s Audit, Compensation and Nominations and Governance Committees.  ... Dr. Futcher will provide independent expertise and strategic ...
(Date:6/23/2016)... -- Any dentist who has made an implant supported denture ... of them do not even offer this as a viable ... costs involved. And those who ARE able to offer that ... cost that the majority of today,s patients would not be ... , founder of Dental Evolutions Inc. and inventor of Implanova ...
(Date:6/23/2016)... Research and Markets has announced the addition of the ... to 2022" report to their offering. ... financial data derived from varied research sources to present unique ... on the market during the next five years, including a ... markets, regional and country level analysis. The report provides a ...
Breaking Medicine Technology: