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The Vioxx scandal

(Scroll down for Bextra + Celebrex)

As a prelude to announcing that Vioxx has enabled her to plan her days around her life instead of her arthritis pain, America's darling , Dorothy Hammill, laces up her skates and glides gracefully across the ice in a television ad promoting Vioxx .

The pain problem solved, it seems all's right with the world and life is going to be better for millions of people who suffer from arthritis pain; but just a few years later, the joy is replaced with the knowledge that this extolled panacea increases the risk of heart disease for anyone who has taken it for 18 months or longer.

Now, lawyers are advertising for prospective clients who have ever taken Vioxx to get in touch with them so they can get the compensation that is due them and, of course, a generous cut for the prosecuting law firms.

Not long after Merck had withdrawn Vioxx, its erstwhile popular pain reliever, from the market, the Wall Street Journal (November 10, 2004) revealed that the company had known about the likelihood of increased risk of heart disease for at least eight years before the withdrawal.

An internal company memorandum of November 21, 1996 indicated concern that Vioxx could be responsible for adverse cardiovascular events.

On March 9, 2000, Edward Scolnick, the company's research chief, disclosed in an internal email that the association of Vioxx with cardiovascular events was "clearly there."

Another company email discussed the advisability of prescribing aspirin along with Vioxx in order to reduce the drug's potential to cause blood clots.

In March 2000 the results of a study begun in January 1999 of over 8,000 rheumatoid arthritis patients revealed that patients taking Vioxx had five times as many heart attacks as those taking the older drug, naproxen. Merck attributed this difference to naproxen's having a protective effect on the heart.

Meanwhile, the Food and Drug Administration (FDA) scientists charged with consumer protection were debating among themselves over an estimate that Vioxx was associated with 27,000 heart attacks.

In 2001, Deepak L Bhatt, a cardiologist at the Cleveland Clinic suggested Merck do a study of patients taking Vioxx who had severe chest pain, but the company declined, saying these patients were not typical Vioxx users.

"They should have done a trial like this," according to Bhatt. "If they internally thought this drug was safe in patients with heart disease, there was no reason not to do it."

Not wanting to do a special controlled study in which people suffering from pain would be assigned to the control group receiving a placebo, Merck opted instead to monitor data from trials already underway to see if Vioxx might be effective in preventing other diseases such as colon polyps. The unfavorable findings-- twice as many heart attacks, strokes and blood clots in patients taking Vioxx compared to those taking a placebo-- caused Merck to withdraw Vioxx from the market a month later on September 30.

With sales of $2.5 billion last year, it is easy to understand why the company was reluctant to share its earlier concerns with medical practitioners and the public. So doctors continued to prescribe and patients continued to take Vioxx, which at least one medical practitione ruing its withdrawal, described as "a valuable drug."

Vioxx at c. $3 a dose was not generally considered to afford better pain relief than over-the-counter N-saids at pennies a pop, but it did have the important advantage of not causing or aggravating stomach ulcers.

The New York Times November 14, 2004; Worst Pills Best Pills, November 2004

Bextra found to have similar adverse heart effects

Pfizer, the producer of two drugs similar to Vioxx, called Cox-2 inhibitors, is now under fire for not releasing similar results on Bextra for two months after they were known in September.

Pfizer also produces Celebrex, which appears to have been associated with fewer heart attacks, but was found by the FDA's Dr Douglas Throckmorton to be higher in "the incidence of adverse events related to cardiac ischemia (decreased blood flow to the heart)", especially in those who were not taking aspirin for protection. There was also a higher incidence of atrial fibrillation

A study by Eeric J Topol and cardiologists at the Cleveland Clinic reported in The Journal of the American Medical Association, which reviewed data from several clinical trials, found that both Celebrex and Vioxx caused heart problems, but that Celebrex caused fewer than Vioxx.

Celebrex generated $1.8 billion in sales last year compared to Bextra's $687 million.

A study presented by cardiologist Garret A FitzGerald at a meeting of the American Heart Association on November 9, found over twice as many heart attacks and strokes in patients taking Bextra than in those taking a placebo. The study combined data from 12 trials involving 5,930 patients.

"The magnitude of the signal with Bextra is even higher than we saw in Vioxx," FitzGerald commented. "This is a time bomb waiting to go off."

"Basically, we showed that Bextra is no different than Vioxx, and Pfizer is trying to suppress that information," said Curt D Furberg, professor of public health sciences at Wake Forest University School of Medicine, who worked on the study.

As a result of that remark, Furberg has been, as he put it,"disinvited " to serve on a Food and Drug Administration panel studying Cox-2 inhibitors. An FDA spokesperson said his exclusion was akin to asking a prejudiced juror to step down and that Furberg was free to present his views at a later hearing.

On October 15, Pfizer issued a warning of potential risks from Bextra to patients following heart surgery and announced that it would probably put a black box cautionary label on Bextra warning of heart disease and a rare, but fatal, skin disease attributed to the drug. Celebrex, on the other hand, has not so far been associated with a significant increase in heart attacks. All three Cox-2 inhibitors have been effective in relieving arthritis pain in some patients for varying lengths of time, but they have not been shown to be more effective than older medicines like ibuprofen and naproxin. They were developed to avoid the stomach irritation associated with the older (and cheaper) drugs.

The New York Times November10 and 13 2004

Worst Pills Best Pills, November 2004

Comment: Older drugs are usually safer than more recent ones because long term use enables deleterious side effects, which were not revealed by animal testing, to become recognized.

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