Posted on 10/07/2004 4:15:49 AM PDT by foolscap
Scientists in the United States and Great Britain are calling for a fresh look at Celebrex and other medications similar to Vioxx, the heavily advertised arthritis drug pulled from the market last week after a study suggested it doubled the risk of heart attacks and strokes. The European Medicines Agency in London announced Wednesday it would review all drugs of this type in the wake of Merck & Co.'s decision to voluntarily withdraw Vioxx.
In the United States, a cardiologist who had researched these drugs published an article in the New England Journal of Medicine suggesting problems might extend to the entire class of medications, not just Vioxx. Another prominent doctor writing in the same journal charged that the Food and Drug Administration did not do everything needed to make sure the drug was safe. He also called for a congressional review of the matter.
An FDA spokeswoman said the agency had no comment. Last week, FDA officials said problems were limited to Vioxx.
Pfizer, which makes Celebrex and a newer, similar drug called Bextra, disputed the medical journal reports and said its drugs are safe.
"The proof is really in the real-world data, and it hasn't been borne out," Pfizer's medical director, Dr. Gail Cawkwell, said of the heart problem risk.
The medical journal published two reports on the issue Wednesday on the Internet - more than two weeks ahead of their planned print publication - to help inform doctors and patients considering whether to stop using the drugs.
Studies done five years ago when Celebrex and Merck & Co.'s Vioxx were approved suggest the same mechanism that inhibits inflammation and makes the drugs easier on the stomach than traditional painkillers also blocks a substance that prevents heart problems, according to Dr. Garret FitzGerald, a University of Pennsylvania cardiologist. FitzGerald led the studies, which were designed by him but funded by the drug companies.
"I've been concerned all along," he said. "I believe this is a class effect," not just a problem with Vioxx, he said.
Cawkwell of Pfizer called his contention "an interesting theory," but said, "there is no evidence" of increased risk of heart problems among the 75 million Americans who have taken Celebrex. Long-term studies are not yet available on Bextra, which was approved in 2001.
Celebrex is the 10th most popular drug in the United States, with annual sales of $2.7 billion, up 5 percent in a year, according to IMS Health, a company that tracks drug industry trends.
An article in the medical journal by Dr. Eric Topol of the Cleveland Clinic chastised the FDA for not requiring Merck to do studies investigating heart problems with Vioxx when hints of them first appeared years ago, and for allowing the company to blitz consumers with TV ads touting the drug.
Vioxx was the largest prescription drug withdrawal in history, "but had the many warning signs along the way been heeded, such a debacle could have been prevented," Topol wrote. "Neither Merck nor the FDA fulfilled its responsibilities to the public...I believe there should be a full Congressional review of this case."
Merck and FDA officials said the mechanism underlying the problem with Vioxx wasn't known.
But FitzGerald and colleagues published two studies in 1999 and another in 2001 suggesting that by selectively blocking one of the two substances called prostaglandins that lead to inflammation, these so-called cox-2 inhibitors were sparing the stomach at the expense of the heart.
"There's a good prostaglandin and a bad prostaglandin as far as the heart is concerned," he explained.
Suppressing both, as older painkillers like aspirin and other non-steroidal anti-inflammatory drugs, or NSAIDS do, helps the heart. But shutting down just the "good" one raises the risk of high blood pressure, hardening of the arteries and clotting, he reports.
FitzGerald also challenged Pfizer's contention that no science shows increased risk from Celebrex. The original report from one study involving Celebrex found no increased risk of heart problems, but it covered only six months of a year-long study, according to the cardiologist. A look at the full data "reveals signs of increased cardiovascular risk," he writes.
The medical journal will publish the new reports in its Oct. 21 print edition.
Republican Congressman Tom Davis of Virginia, who chairs the House Government Reform Committee, has sent a letter to FDA's acting commissioner, Dr. Lester Crawford, giving him two weeks to answer questions about how FDA tracks problems with drug safety, how it dealt with issues surrounding Vioxx, and whether the agency will study potential risks in similar drugs.
"In light of Merck's withdrawal of Vioxx from the market and other recent news stories examining FDA's review of the safety and efficacy of antidepressant drug use by children, I am concerned whether FDA has been sufficiently aggressive in monitoring drug safety," Davis wrote.
I took Vioxx for almost 2 yrs, now I have cad, thanks Merck.
What's cad?
Coronary Artery Disease.
I took it for a few weeks many years ago. It was powerful stuff and really helped with a temporary back problem.
I was really surprised to see the TV ads advocating everyday use.
Yep; I'm sure it's ALL Merck's fault.
I didn't have it before Vioxx, and it developed while taking Vioxx, yeah it's not their fault.
I took 3 Cataflam a day to control the pain of arthritis in my back. When Vioxx came out my doc said that I would only have to take two Vioxx a day. i jumped at thae less med aspect of it. That's how they got you, For long term sufferers the thought of less pills a day is very inticing.
| Modifiable CAD Risk Factors | Non-modifiable CAD Risk Factors |
|---|---|
| Cigarette smoking | Males > 45 years Females > 55 years |
| Obesity | Males |
| Hypertension (blood pressure >= 140 / 90 mmHg) | Family history of coronary artery disease |
| Physical inactivity |  |
| Kidney disease | |
| Diabetes mellitus | |
| Alcohol consumption | |
| Stress | |
| Kidney disease | |
| Elevated LDL | |
I've taken Bextra almost every day for the past couple of years for some bothersome joint pain in my hands and knees, and I'm only 43. It helped me exercise and loose weight, so there were real benefits, I don't think I could have been nearly as active without it. It worked much better than anything I tried that is over the counter. Also, I've had bad sinus headaches for the past 5 years or so, but they just go away when I take Bexta.
I haven't taken one in two weeks. My sinuses have been killing me, my hands have started to hurt again, luckily my knees haven't acted up, but I've been just sitting around, so the jury is still out.
I will wait for further studies before I start up again on the drug.
The only advantage the COX 2's have over traditional NSAIDS is the decreased risk of GI side effects. There are no more effective at controlling pain and inflammation, and they are still potentially harmful to the kidneys.
I thought that Vioxx caused spikes in blood pressure when somone took it as opposed to creating chronic circulatory problem.
Interestingly, FreeRepublic has been a life saver for me. I love our talented humor freepers, they just don't know.
When my PCP referred me to a Cardiologist, the first thing he did was take me off Vioxx,and do an angiogram.
The circulatory problems as causation for srtokes and heart attacks.
(confessing I stole that from a Funny FReeper)
Here is the link to the New England Journal of Medicie articlehttp://content.nejm.org/cgi/reprint/NEJMp048288v1.pdf
Leaving your home in the morning is a potential risk.
Good luck. arthritis makes these test really difficult to pass.
Thank you. I wish you luck as well. I have arthritis in my neck, shoulders and hips. I have always been active, but this has slowed me down alot.
I try to push thru it. I'm not good at aimless walking, so I go to Ikea and walk around, lots to look at.
How can you tell whether it was the Vioxx or whether it was something that was fixing to happen anyhow. Even if Merck's worst results are to be believed, roughly half the people who developed heart trouble while on Vioxx would have developed it anyhow. I had taken Vioxx off and on for several months. Then afterwards I had one of those new Agatston score tests involving electron scans of my coronary arteries (it was offered through a local health and fitness center). My score: zero (the best possible); I got a congratulatory note from my own doctor! I was well into my forties, myself several tens of pounds overweight, and a family history including a mother who had died of stroke in her fifties. I ascribe this to God, who chose what genes I was going to get.
he took me off Lipitor and my cholestol shot up over 600. I now have to take Lipitor 80mg, Welchol 625 mg 4 times a day, and Zetia 10 mg a day just to keep my cholesterol below 200. Considering I eat very little and salad is my main diet. the damage is not reversible.
Marck should be very proud of themselves for what they have done to peoples lives. all any of us wanted was a little relief from the pain. As I said, I now get injections in my spine to help relieve the pain.
Disclaimer: Opinions posted on Free Republic are those of the individual posters and do not necessarily represent the opinion of Free Republic or its management. All materials posted herein are protected by copyright law and the exemption for fair use of copyrighted works.