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Merck & Co Marketing Created Vioxx Study

Posted by Jane Akre
Tuesday, August 19, 2008 12:03 PM EST
Category: Major Medical, Protecting Your Family
Tags: FDA and Prescription Drugs, Merck, Vioxx, Dangerous Drugs, Drug Products, Defective Products, Heart Attack, Stroke, Defective Drugs

Merck marketing created the ADVANTAGE study says published report. 

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IMAGE SOURCE: Merck Web site. "Where patients come first"

 

Merck & Co called the 1999 research study, Advantage.

The drug maker said it was testing the side effects of the soon-to-be-launched painkiller, Vioxx, compared to its nearest competitor, naproxen.

Lawyers preparing cases against Merck have released 100 pages of internal Merck documents that show the drug trial was a thinly-veiled marketing campaign framed as clinical science launched to promote the drug’s introduction to the market.

The Advantage study "was marketing masquerading as science,'' said lead author Kevin Hill, of Harvard Medical School in Boston, who was one of several authors paid as consultants by law firms preparing litigation against Merck. The authors were given access to the internal Merck documents, all part of litigation.

The papers are included in a report in the Annals of Internal Medicine called, “The ADVANTAGE Seeding Trial: A Review of Internal Documents.”

A seeding trial is a clinical study conducted by a drug maker that appears to answer a legitimate scientific question but in reality fulfills marketing objectives.

ADVANTAGE was actually crafted by the Merck marketing department, the report shows. (ADVANTAGE stands for Assessment of Differences between Vioxx and Naproxen To Ascertain Gastrointestinal Tolerability and Effectiveness.)

During the clinical trial, Merck distributed Vioxx to more than 5,500 patients through 600 family doctors, getting them in the fold pre-approval to boost confidence in the new drug.  In turn, the marketing department figured, those physicians would promote the new drug to their colleagues. 

Dr. Hill, says “Patients and physicians weren’t told about the marketing objectives of the trial.”  In other words, patients did not give informed consent which raises not only ethical questions about Merck and questions about the credibility of its research.

Dr. Conrad Butwinick, an internal medicine physician from St. Paul, Minnesota was recruited by Merck.  He tells Bloomberg News that he regrets he was one of the 600 doctors included in the trial. He found Vioxx effective in treating arthritis pain.

"If I had sensed that there was an ulterior motive, for physicians to have an amplified experience with the drug, I would have never done that.'' according to Butwinick, who tells Bloomberg he doesn’t remember participating in the study. ``I can't tell you that it didn't go on, but I would never go for that.''

Dr. Hill tells  Bloomberg News in an Aug. 15 telephone interview. ``They went about this in a very analytic way, picking doctors who would be most influential, who will talk to other doctors and recommend Vioxx to them, and thus increase prescriptions in the area, planting the seeds of additional Vioxx use.''

One internal memo, nominating the study for a marketing award, says the drug trial, “was designed and executed in the spirit of Merck marketing principles.”

The marketing department was right. Doctors who were given Vioxx to use on their patients during the trial were found to prescribe higher levels of the drug after it was approved.

Merck denies that Advantage was a seeding study or created for marketing purposes.  “This is a trial that had good, scientific merit and was judged by the editors of the Annals when they accepted it for publication,” says Jonathan Edelman of Merck.

It has long been suspected that drug companies use seeding trials for promotion purposes using physicians to create excitement about a new drug, but until now strong evidence has been lacking. 

The clinical trial was testing the gastrointestinal tolerability of Vioxx compared to naproxen. Merck tells Reuters that the journal article has “numerous inaccuracies” based on cherry picked documents prepared for Vioxx litigation.

The documents in the report come from two trials - Cona v. Merck & Co. and McDarby V. Merck & Co. and were created between 1998 and 2006.

Merck critic, Edward Scolnick, head of research at the time, says the clinical trial was dangerous because the data could compromise more meaningful clinical trials. He calls the study “intellectually redundant.”   

At least 50,000 plaintiffs have not joined a class action lawsuit and will soon receive portions of a $4.85 billion settlement Merck has set aside for plaintiffs. 

Vioxx generated approximately $2.5 billion in sales before it was pulled from the market in 2004 after studies showed it caused heart attacks and strokes.

Dr. David Graham, of the FDA’s Office of Surveillance and Epidemiology (OSE), told Congress in February 2007, “Vioxx was an enormous national catastrophe. Up to 60,000 Americans, most over the age of 50, died from Vioxx-related heart attacks, about as many as the number of US soldiers killed during the Viet Nam War." #


1 Comment

Anonymous User
Posted by Paul Tenenbaum
Tuesday, September 09, 2008 8:32 AM EST

My doctor Bruce Lipschutz here un Fort Myers, FL prescribed VIOXX for me due the very severe arthitic condition I had endured over many years. I found this product VIOXX very, very helpful. It was more effective than Celebrex. Personally I miss very much VIOXX. I understand that your product is available in Europe. If this is so, could I expect Merck & Co. to resume producing VIOXX? I would appreciate getting a positive response. Thank you.

Comments for this article are closed.

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