Healthy Skepticism Library item: 14158

Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.

Publication type: news

Lopatto E, Cortez MF.
Merck Vioxx Trial Was Strategy to Boost Drug's Sales
Bloomberg.com 2008 Aug 19
http://www.bloomberg.com/apps/news?pid=20601087&sid=a8ZT4hT0XK0Q&refer=home

Full text:

A Merck & Co. study of Vioxx that the company said showed whether the painkiller was easier on the stomach than an older drug was actually a marketing tool to boost sales, according to researchers.

Their conclusions are based on 100 internal company memos and reports about the study known as Advantage obtained from lawsuits against Whitehouse Station, New Jersey-based Merck over heart risks tied to Vioxx, now withdrawn. The trial of 5,557 patients started in 1999, just as Vioxx was cleared for sale, according to the Annals of Internal Medicine report.

The study, which recruited 600 doctors, was crafted by Merck’s marketing department to get physicians to prescribe Vioxx, the researchers wrote. The report provides some of the first evidence of what is thought to be a widespread practice: enlisting doctors for a study to boost their confidence in a new drug and get them to promote it to colleagues, they said.

The Advantage study ``was marketing masquerading as science,’‘ said lead author Kevin Hill, of Harvard Medical School in Boston, 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.’‘

The researchers had access to the data as part of their work as paid consultants to lawyers suing Merck about the heart risks from Vioxx. The drug, which was introduced after Pfizer Inc.‘s similar pain medication Celebrex, generated $2.5 billion in annual sales before it was pulled from the market.

Merck shares fell 46 cents, or 1.3 percent, to $35.25 at 4:15 p.m. in New York Stock Exchange composite trading. Merck’s shares have fallen 39 percent this year.

Participating Doctor

Conrad Butwinick, an internal medicine physician in St. Paul, Minnesota, was one of the 600 doctors recruited to participate in the study. He lamented the lack of information about the heart risks of the drug, which he considered one of the most effective treatments for arthritis.

``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,’‘ said Butwinick, who said he didn’t remember participating in the study. ``I can’t tell you that it didn’t go on, but I would never go for that.’‘

Merck said the researchers from Harvard, Brown and Yale universities, and the Mt. Sinai School of Medicine in New York, erred in their analysis and took the memos out of context. They also didn’t contact the company about their work.

Scientific Affairs

The study was conducted by the medical and scientific affairs unit, not the marketing unit, in its U.S. Human Health division, said Jonathan Edelman, executive director of Merck Research Laboratories’ global center for scientific affairs. It compared Vioxx to naproxen, which hadn’t been previously studied, when given to patients already taking aspirin. Those patients were excluded from earlier trials, he said.

``As with all Merck clinical research, there is a commercial interest,’‘ Edelman said. ``The documents included in this article include an example of the marketing use for the data. The allegation by the authors that the primary goal of the study was marketing is simply wrong.’‘

The original study was published by the Annals of Internal Medicine in 2003. A subsequent analysis found several patients suffered cardiovascular complications that weren’t reported in the original trial. That makes the new findings even more disturbing, said editor Harold Sox in a telephone interview.

`Patients at Risk’

``By publishing this article, we hope to shine a light on a practice that appears to be widespread, that really involves an element of deception because patients aren’t told the true purpose of the trial,’‘ Sox said. ``This is one practice that appears to put patients at risk when there may be little or no scientific benefit to the research. Indeed, some patients were injured by the drug.’‘

Merck pulled Vioxx from the market in 2004 after a study linked it to heart disease. The drugmaker has agreed to pay $4.85 billion to settle patient claims that Vioxx, used by 84 million people worldwide, caused heart attacks or strokes.

The Advantage study compared Vioxx to naproxen, an older medication, to see if it was gentler on the stomach. About the same time, Merck started another trial, Vigor, at the request of the U.S. Food and Drug Administration to determine if Vioxx was safer for the gastrointestinal tract. That made Advantage unnecessary, the researchers said.

`Moral Offense’

Such a trial is a ``moral offense,’‘ the authors wrote, because it’s impossible to know the intent for a pharmaceutical company’s trial without access to internal documents. Further, ``seeding trials,’‘ may harm patients for marketing purposes. Findings from Advantage confirmed the increased risks for heart attack and stroke seen in Vigor.

The study was called a seeding trial in many internal documents and the marketing officials in charge of it were nominated for the company’s ``Best Physician Program Award.’‘ The physicians who participated in the study prescribed Vioxx significantly more often than other doctors, the award memo said.

Jeffrey R. Lisse from the University of Arizona’s Arthritis Center in Tucson, the first author on the Advantage paper, has said he didn’t have a role in data collection or analysis of the study results. He is on medical leave and was unable to comment on the new study.

The documents in the report were from two trials, Cona v. Merck & Co. and McDarby v. Merck & Co., and were created between 1998 and 2006. All of the authors worked as paid advisers to the plaintiffs.