Today's National Post features an article on the dangers of Celebrex and Vioxx, with particular reference to actress Kathleen Turner's use of the said drugs. The prominent article occupies most of the front page of the Arts & Life section.
Perhaps somebody with a little spare time today could email the author and extol the virtues of Pennsaid. While you're at it, maybe send a copy to Ms Turner.
joe
nationalpost.com
'Why should I take chances?'
When Celebrex and Vioxx hit the market, the anti-inflammatory drugs took off faster than Viagra. Some wonder if side effects were overlooked in the rush
Brad Evenson
National Post
Jessie Dunn had heard all the hype about Celebrex long before it reached pharmacy shelves at her home in coastal Parksville, B.C. Dunn, 89, had suffered from arthritis for decades. The pain snaked across her pelvis and down her back, coiling around the four vertebrae of her lower back. It had crippled her fingers and hips. Some days, she would sink into the deep armchair in her living room and weep silently with despair. Celebrex sounded like the answer to her prayers.
"They kept telling people how good it was, no side effects, not anything, for nearly six months or a year before it came out," says Dunn. "And we couldn't wait for it, people couldn't wait for it."
Celebrex is known as a Cox-2 inhibitor. It acts by controlling painful inflammation, and research reports said the drug caused fewer ulcers than older painkillers. Some magazines dubbed the pills "Super-Aspirin."
Dunn's grandson, a medical writer, advised her to get a bottle right away. But as Dunn discovered three months after she began taking the drug in 1999, the only thing super about Celebrex was its marketing. Troubled by warnings she read on the label, and finding it ineffective, she quit taking it.
"It had no reaction whatsoever on me except on my pocketbook" she says. "And it was expensive enough, but I would pay anything, I wouldn't have cared how much it cost. But I still have the pain."
Others, like actress Kathleen Turner, have found Celebrex effective. Turner recently received an award from the Massachusetts Arthritis Foundation for her commitment to raising funds and awareness about rheumatoid arthritis, which usually occurs in middle age but can be contracted by people in their 20s. Her doctor, David Trentham of Beth Israel Deaconess Medical Center in Boston, recently told USA Today that "Ms. Turner was quite sick and now she is doing quite well. The drugs she's taking are good for her and aren't so financially prohibitive."
However, there is growing concern these drugs may not be as wonderful as initially thought. New research indicates Celebrex and its fellow Cox-2 inhibitor, Vioxx, may have a worse side effect than ulcers: an increased risk of heart attack. The study, by prominent cardiologists Eric Topol and Steven Nissen of the Cleveland Clinic, was published last week in the Journal of the American Medical Association (JAMA).
For the millions of of people who suffer from heart disease as well as arthritis, that's troubling news. Dunn, who has a heart condition, says: "I mean to say, if I had known I wouldn't even have started it. Why should I take chances?"
The manufacturers of the drugs dispute the results of the study, the second dose of bad publicity for Celebrex and Vioxx in recent months. Earlier this year, a University of British Columbia pharmacy professor, Dr. James Wright, sharply criticized Pharmacia Inc., which manufactures Celebrex, for releasing only half its clinical trial data on the drug for publication. When the longer-term data are considered, Celebrex does not appear any better at preventing ulcers than older painkillers that cost a fraction of its $3-a-day price.
Few drugs have enjoyed the blockbuster success of Celebrex and Vioxx. Three months after Celebrex was launched in the summer of 1999, Canadian pharmacies had filled more than 428,400 prescriptions worth $20.7-million in sales, the fastest product acceptance ever recorded. Not even Viagra, the erectile dysfunction drug, sold so swiftly.
Vioxx, a drug developed by Canadian scientists, was soon to follow. The drugs' popularity was buoyed by a six-month-long study published in JAMA last September that suggested Cox-2 inhibitors do not cause damage to the lining of the gut, a side effect that dogged earlier drugs such as Aspirin, ibuprofen and naproxen, drugs known collectively as non-steroidal anti-inflammatory drugs (NSAIDS). In an interview with the National Post several months ago, Dr. Wright described that earlier JAMA report on Celebrex as "highly effective advertising" for the drug.
Celebrex and Vioxx seemed to be safer because the studies showed they caused fewer ulcer-like lesions than NSAIDS. However, nobody has ever proved these lesions are really indicators of ulcers. So drug regulators, including Health Canada and the U.S. Food and Drug Administration (FDA), forced the companies to print the same warnings that appear on NSAIDS, advising users that 2% to 4% of those taking the drugs for at least 12 months get ulcers. In spite of the warning, most doctors prescribed Cox-2 inhibitors on the grounds they caused less stomach pain.
Earlier this year, in an attempt to persuade the FDA to drop the ulcer warning, Merck & Co., which makes Vioxx, and Pharmacia gave the federal agency a look at their long-term data. The move backfired. Not only did the FDA reject the companies' request, it released Pharmacia's 12-month data on Celebrex on the Internet.
Dr. Wright was alarmed when he saw the popular drug's side-effect rate, which showed Celebrex caused many more ulcers than September's six-month study had indicated. Dr. Wright alerted JAMA, and editors later learned Pharmacia had withheld the more damning results from the second half of the study.
"I was very upset when I found out they had a full year's data," JAMA editor Catherine DeAngelis told reporters.
According to reports, regulators at the FDA later grew concerned about other aspects of the data submitted by the two companies. It appeared Celebrex and Vioxx caused more heart attacks than a placebo. So the FDA asked Dr. Nissen, vice-chairman of cardiovascular medicine at the Cleveland Clinic, to analyze the data.
Last week, Dr. Nissen and Dr. Topol concluded patients taking Vioxx had more than twice as many heart attacks, strokes and other cardiovascular events as patients taking the older NSAID, naproxen.
To make matters worse, it appears that taking the drug slightly increases a person's overall odds of having a heart attack. Among patients with a medium risk of cardiac events who take a placebo drug, the rate of heart attacks is 0.52%, the researchers said. With Vioxx, it's 0.74%, and with Celebrex, 0.80%.
The researchers conclude that, "given the remarkable exposure and popularity of this new class of medications, we believe that it is mandatory to conduct a trial specifically assessing cardiovascular risk and benefit of these agents." Until then, they added, "we urge caution in prescribing these agents to patients at risk for cardiovascular [disease]."
Not everyone is as convinced of the risk. A separate study, published two weeks ago in the New England Journal of Medicine of the same data on Celebrex and Vioxx which were analyzed in JAMA, came to much less alarming conclusions. And the study's author, Dr. Garrett Fitzgerald, chairman of the University of Pennsylvania's School of Pharmacology, said he found the Cleveland Clinic's recent analysis distorted the medical data.
Pharmacia and Pfizer Inc., which co-market Celebrex, said the Cleveland Clinic's report was "inconsistent with the clinical experience of Celebrex." They added it was "essential to exercise extreme caution in drawing any conclusions" from an analysis of this type. Merck, which markets Vioxx, said it "stands behind the overall and cardiovascular safety profile" of the drug. It said safety data not included in the report suggests "there is no increase in the risk of cardiovascular events as a result of treatment with Vioxx."
Both companies point out that their labels already warn that all nonsteroidal anti-inflammatory agents should be used with caution in patients with fluid retention, high blood pressure or heart failure. And continued worldwide sales of the drug clearly suggest that many patients find the drugs effective and less painful to their stomachs than NSAIDS.
Dr. Nissen acknowledges the risk of Celebrex or Vioxx inducing a heart attack is very low. But given the worldwide popularity of the drugs, which together are expected to generate $10-billion in sales this year, a small statistical increase translates into many lives. He said more studies need to be conducted to determine a more accurate safety profile of the drugs.
But for Dunn there is nothing further to consider. As someone with both heart disease and arthritis, she's not taking any chances "What ... am I playing around for?" she says. "I'm not a gambler, I never was a gambler." |
