Busted! Big Pharma epilepsy study rigged to push drug gabapentin

Monday, June 27, 2011 by: S. L. Baker, features writer
Tags: Neurontin, clinical trials, health news

eTrust Pro Certified

Delicious Pin It
(NaturalNews) If you think being concerned over natural health issues means you automatically dismiss everything that mainstream medicine has to say - think again. Not only are many mainstream researchers coming up with evidence that nutrition and other natural therapies really are effective but now comes a report published in none other than Archives of Internal Medicine, a Journal of the American Medical Association (JAMA), that blows the lid off an unethical Big Pharma practice.

Specifically, the article shows how drug pushing - not science - appears to have been the motivation behind a study that supposedly was testing the drug Neurontin (gabapentin), currently widely used to treat nerve pain. The test was allegedly designed to document how various doses could treat epilepsy. But it turns out the trial was set up to "seed" the results in order to sell the drug, much like a card shark might stack a deck of cards in order to cheat at a game of poker.

According to the just published article, when researchers are involved in so-called seeding research, they are conducting clinical trials primarily as marketing tools so the drug can be promoted and sales pushed by doctors. Bottom line: these are promotional trials used for selling drugs and research subjects and physicians may not be told the true purpose of the studies.

Surely, promoting a study as true scientific research when it is really a ploy used to market drugs must be illegal, right? According to the new report, Big Pharma is allowed to get away with seeding studies under the current law. However, the authors (Samuel D. Krumholz, B.A., David S. Egilman, M.D., M.P.H., and Joseph S. Ross, M.D., M.H.S., who are consultants at the request of plaintiffs currently suing Pfizer Inc. over the gabapentin seeding study in the U.S.), report the practice is clearly unethical.

To prepare their report, entitled "Study of Neurontin: Titrate to Effect, Profile of Safety (STEPS)", the researchers investigated whether the study was a seeding trial by looking into documents related to the marketing, sales practices, and product liability litigation of Neurontin (gabapentin), prescribed for epilepsy. Because the authors were consultants to the plaintiffs in a lawsuit involving the drug, they had access to depositions and the document database. And that meant they were able to get their hands on damning correspondence, clinical research reports and market research analyses for a look inside the workings of Big Pharma's pushing of the drug.

What did they discover? Although the trial's supposed purpose was to study dose-titration of gabapentin among 2,759 patients enrolled by 772 investigators, the study was uncontrolled and unblended. In other words, it didn't meet the basic criteria for a sound drug study.

However, articles based on the results of this anything-but-gold-standard-science study managed to be published in two journals - even though the sloppy study design was questioned by two outside sources and that "data quality during the study was often compromised."

But here's even more compelling evidence something was not on the up and up: the authors cite documents that strongly suggest drug company marketing personnel were involved in collecting the trial data. What's more, the Big Pharma marketing heads viewed the trial (and not only its results) as a way to push sales of gabapentin.

This involvement of the marketing team and the failure to disclose the study's real purpose from both research subjects and collaborators are the "smoking guns" that mark the STEPS study as a seeding trial, according to the authors. They are calling for institutional review boards (IRBs) to finally take a strong stance in discouraging these types of marketing-over-science trials. "Reform of the current IRB system," they wrote, "as well as promoting better clinical trial practice in the human subjects research community, are necessary to prevent continued conduct of seeding trials by the pharmaceutical industry."

In an accompanying commentary to the study, G. Caleb Alexander, M.D., of the University of Chicago, noted that seeding trials negatively affect scientific knowledge and clinical care. "The biomedical enterprise depends on good science for its foundation, and good science requires transparency of methods and integrity of purpose," he wrote.

He pointed out the evidence presented by Krumholz and colleagues "strongly supports the conclusion that STEPS meets key criteria of seeding trials." Dr. Alexander also stated that these unethical seeding trials can detract from the legitimate value of well-designed and well-conducted phase 4 studies of pharmaceutical drugs.

"Although the road is long and the hill steep, these and other changes offer the promise of incrementally improving and safeguarding the integrity of the biomedical enterprise. One can only hope that the report by Krumholz et al will contribute to this evolution," he concluded.

Let's be blunt here: the new report in the Archives of Internal Medicine shows that Big Pharma's research results cannot always be trusted and may place more importance of skewing data to promote and push drugs on the public than in coming up with true scientifically sound data.

For more information:

Get breaking news alerts on GMOs, fluoride, superfoods, natural cures and more...
Join over four million monthly readers. Email privacy 100% protected. Unsubscribe at any time.

Have comments on this article? Post them here:

comments powered by Disqus

Take Action: Support

Email this article to a friend

Permalink to this article:

Reprinting this article: Non-commercial use OK, cite with clickable link.

Embed article link: (copy HTML code below):
Most Popular
Today | Week | Month | Year

See all Top Headlines...


Now Available at

O3 Essentials OraJuvenate™
A powerful, cleansing dental cream for maximum oral/dental health.
New Cancer Solutions
Over 3 hours of content covering today’s best cancer tests, how to kill cancer cells and the best diets and exercise routines.
Freeze-Dried 100% Organic Whole Corn
Our freeze-drying method preserves taste, texture and nutrients better than any other food preservation method ever invented.
Fenix TK35 Flashlight
Tough, waterproof, extremely bright and it’s touted to throw an 800+ lumen beam more than 1,000 feet into the night.
Inca Treasure Smoothie Pack
This pack of our four most popular superfoods from South America is the perfect combo pack for smoothie lovers.
Pink Himalayan Salt
This salt delivers significant levels of magnesium, zinc and selenium, with trace levels of dozens of other elements.
Pinhole Glasses - Aviator Style
Pinhole glasses are becoming famous for helping people improve their vision without the risks of laser surgery.
Oxy-Rich Facial Serum
O3 Essentials Jojoba Oxy-Rich Facial Serum is cellular nourishment for your skin. Helps smooth fine lines while enhancing tissue elasticity.
Freeze-Dried 100% Blackberry Halves
Our freeze-dried blackberry halves are grown in Serbia under strict organic standards.

Also on NaturalNews:

Health Ranger Videos
Activist music
CounterThink Cartoons
Food documentaries
FREE Special Reports
Colloidal Silver

Advertise with NaturalNews...

Support NaturalNews Sponsors:

Advertise with NaturalNews...

Most Popular Stories

Flu shot kills 19-year-old, but vaccine industry still has total immunity against lawsuits
Here's a nutty fact: Eating more tree nuts lowers the risk of all-cause death by up to 20 percent
Six important facts you're not being told about lost Malaysia Airlines Flight 370
Malaysia Airlines Flight 370 now clearly a government cover-up: All evidence contradicts official story
10 other companies that use the same Subway yoga mat chemical in their buns
BLM fracking racket exposed! Armed siege and cattle theft from Bundy ranch really about fracking leases
High-dose vitamin C injections shown to annihilate cancer
U.S. treating meat with ammonia, bleach and antibiotics to kill the '24-hour sickness'
USDA to allow U.S. to be overrun with contaminated chicken from China
Vaccine fraud exposed: Measles and mumps making a huge comeback because vaccines are designed to fail, say Merck virologists
Battle for humanity nearly lost: global food supply deliberately engineered to end life, not nourish it
Diet soda, aspartame linked to premature deaths in women

25 Amazing Facts About Food

This FREE downloadable report unveils a collection of astonishing and little-known facts about the food we eat very day. Click here to read it now...


Resveratrol and its Effects on Human Health and Longevity - Myth or Miracle.

Unlock the secrets of cellular health with the "miracle" nutrient Resveratrol Click here to read it now...


Nutrition Can Save America

FREE online report shows how we can save America through a nutrition health care revolution. "Eating healthy is patriotic!" Click here to read it now...

The Healing Power of Sunlight and Vitamin D

In this exclusive interview, Dr. Michael Holick reveals fascinating facts on how vitamin D is created and used in the human body to ward off chronic diseases like cancer, osteoporosis, mental disorders and more. Click here to read it now...

Vaccines: Get the Full Story

The International Medical Council on Vaccination has released, exclusively through, a groundbreaking document containing the signatures of physicians, brain surgeons and professors, all of which have signed on to a document stating that vaccines pose a significant risk of harm to the health of children. Click here to read it now...

Health Ranger Storable Organics

GMO-free, chemical-free foods and superfoods for long-term storage and preparedness. See selection at

Recommended Resources On:

Natural News trends
Health Ranger news
Natural News GMOs
Mike Adams tracker
Natural News photos
Natural News Global
Natural News in focus
Natural News connect
Natural News shocking stories
Natural News radar
Health freedom
Dr. Paul Offit

This site is part of the Natural News Network © 2014 All Rights Reserved. Privacy | Terms All content posted on this site is commentary or opinion and is protected under Free Speech. Truth Publishing International, LTD. is not responsible for content written by contributing authors. The information on this site is provided for educational and entertainment purposes only. It is not intended as a substitute for professional advice of any kind. Truth Publishing assumes no responsibility for the use or misuse of this material. Your use of this website indicates your agreement to these terms and those published here. All trademarks, registered trademarks and servicemarks mentioned on this site are the property of their respective owners.

eTrust Pro Certified Android app on Google Play

Sign up for the FREE Natural News Email Newsletter

Receive breaking news on GMOs, vaccines, fluoride, radiation protection, natural cures, food safety alerts and interviews with the world's top experts on natural health and more.

Join over 7 million monthly readers of, the internet's No. 1 natural health news site. (Source:

Your email address *

Please enter the code you see above*

No Thanks

Already have it and love it!

Natural News supports and helps fund these organizations:

* Required. Once you click submit, we will send you an email asking you to confirm your free registration. Your privacy is assured and your information is kept confidential. You may unsubscribe at anytime.