Merck's Ghost Story

Once again the pharmaceutical industry has demonstrated it has more in common with Hollywood than healthcare.

First Pfizer (PFE) used a stunt double in their now discontinued Lipitor commercials featuring Dr. Robert Jarvik. Now Merck (MRK) has taken a cue from celebrities who employ ghostwriters to author their books.

Two articles appearing in today’s issue of JAMA (Journal of the American Medical Association) show Merck’s deceptive practices concerning its anti-inflammatory drug Vioxx that it pulled off the market in 2004. Merck faces a pending legal settlement of $4.85 billion to compensate 47,000 plaintiffs involved in the class action lawsuit.

It was through the plaintiffs’ lawyers combing through piles of documentation that they discovered instances where Merck’s consultants or employees in their marketing department would write studies showing Vioxx in a favorable light, and then recruit academic researchers to attach their name to it.

The first JAMA article describes Merck’s ghostwriting concerning Rofecoxib (Vioxx). Reading the article’s introduction shows that Merck is not the first to ghostwrite research papers. In one instance, a draft of a Vioxx study Merck had Scientific Therapeutics Information (described as a specialist in the development of scientific literature), prepare a manuscript that was awaiting the name of a well known researcher to “author” it. Merck compensated researchers with “honoraria” for agreeing to serve as authors. These payments ranged from $750 to $2500. Merck paid Health Science Communications, a health marketing communications company, $23,841.00 to provide a 20-page review manuscript for a cardiology conference. Merck also contracted the company to prepare review manuscripts for nephrology and primary care audiences.

The second JAMA article describes how Merck misrepresented clinical trial numbers reported to the FDA. Merck wanted to promote Vioxx for use in slowing the progression of Alzheimer’s disease. In fact, the results of two Merck-sponsored trials showed that Alzheimer’s patients taking Vioxx were three times more likely to die vs. patients on placebos. Studies showing Vioxx causing increased deaths from heart attack and stroke prompted Merck to pull Vioxx off the market.Dr. Catherine DeAngelis, JAMA’s Editor-in-Chief, outlines in her editorial steps that medical publications need to take to ensure all the authors involved in medical studies are disclosed, their contributions to the study, and any compensation received.

As time goes on, we are witnessing more and more of these so-called “lifestyle” drugs, medications taken for an issue that may or may not ever occur, as a “preventative.” Whether it’s hormone replacement therapy, statins, restless leg, attention deficit disorder, purple pills, etc., one thing has become crystal clear. The longer a person takes one of these types of drugs, the greater the chance that medication will cause adverse side effects - sometimes creating the very disease the drug was supposed to help prevent.

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Comments

[NoBigDeal]

Once again, the media has nothing important to talk about so they drag up the Vioxx story again. Welcome to the world of marketing. Pharma is no different than any other company that wants to sell a product except they have to deal with the apathy of so-called specialists to put out their opinion on topics that they don't have time to sit down and write about. So what do they do, they write down the facts and ask them to attest to it by putting their name on it. So What!!! Atleast now you have someone that is outside the company agreeing with the facts. You don't get that with any other product outside of Pharma that you are buying these days.

[Wall Street Weather]

To "No Big Deal": Of course you'll have "someone that is outside the company agreeing with the facts" when they're receiving compensation to do so.

[Worrisome]

To “No Big Deal”: After watching documentaries and reading countless reviews, it has become apparent that pharmaceutical companies may obtain signatures from specialists who have not even read the article or do not know anything about the topic. This is worrisome. Pharma is different than any other company. You don’t need to have someone attest that Nike shoes are comfortable. It won’t hurt anybody to buy a “bad” pair of Nikes. Yeah, you may be out a couple bucks, but you won’t have to spend the hundreds or thousands of dollars on medical expenses. Medications can be extremely harmful. As Americans we want to put trust in our pharmaceutical companies in that they are giving us accurate, credible data. As Merck made absolutely clear, this may not be the case. During the past two weeks, I have reviewed the approval and withdrawal of Vioxx from the market. It appears that Merck made some crucial errors and omissions in their studies about cardiovascular risks. At this point, it doesn’t matter who reads and signs the study because relevant and vital information was not included.

To “Wall Street Weather”: Americans have become so used to getting a quick-fix for their problems that they immediately turn to medications as the answer. The United States spends billions of dollars on adverse drug reactions each year. As a future health-care employee, I feel we need to promote social and physical lifestyle changes before we turn to drugs as the answer.

[Doubly Worried]

I have to agree with “Worrisome”. It’s a big deal when pharmaceutical companies and their scientists neglect to do real science. They aren’t selling vacuum cleaners; they are meddling with the delicate and sensitive biochemistry of human beings, which can have disastrous effects if done carelessly. I also agree that Americans turn to prescription medications too excessively to solve their medical problems. You can’t abuse your body for decades and then expect a bottle of pills to negate the damage that has been done. You should be concerned about your health before problems arise. That way, health issues will be less frequent and less severe when they inevitably do happen due to aging and other reasons. Part of the problem is that pharmaceutical companies, especially Merck with vioxx, have toted the chemicals they sell as “miracle drugs.” Just take a look at the vioxx advertisements. They have actors claiming that vioxx has given them a new lease on life. Never mind the fact that vioxx was not more effective than cheaper, older, and therefore more time-tested NSAIDs. Never mind that vioxx was likely to give patients heart attacks and strokes. These concerns are not expressed in advertising. That’s why it’s critical that people wise up and become more realistic, especially about their health.

[PharmStudent]

The so called “authors” of the studies done by Merck regarding Vioxx are an embarrassment the healthcare community. By attaching their names to the studies it gave the data credibility and after much of the information was found out to be misleading, I hope that the credibility of these ghost writers has been diminished. In the 12 month VIGOR study Vioxx was shown to have a reduced risk of GI bleeding in comparison to Naproxen. This study was incomplete in regard to cardiovascular risk however, noting that cardiac events were present but rare in both drugs. The APPROVE study that followed showed a significantly greater risk of cardiac events when using Vioxx after 18 months. It is incomplete studies such as the VIGOR study that should raise red flags to “specialists” who add their names to studies that they did not conduct.