Food and Drug Administration (FDA) advisors met for a heated three-day meeting to discuss the safety of the widely used painkillers Celebrex, Bextra and Vioxx--and decide on recommendations for their future use. The three drugs, all members of the COX-2 inhibitors drug class, have come into question after studies linked them to heart risks. In September 2004, Vioxx was pulled from the market by its maker, Merck, after a study found that Vioxx doubled the risk of heart attacks and strokes. Another study found that high doses of Pfizer's Celebrex more than tripled the risk of heart problems.
Dr. David Graham, the assistant director of the FDA Office of Drug safety spoke to the panel and testified that using Vioxx would risk hundreds to thousands of heart attacks in older men. Specifically, he said that as few as 400 or as many as 10,800 additional heart attacks could occur in men aged 65 to 74 at low doses of the drug.
Previously, top FDA officials had forbidden Graham to discuss a pair of large studies with yet unpublished information that related directly to the drugs' safety. However, he did end up being able to present "what he thought was important to present" at the meeting.
Graham attributed the range in heart attack risk to the fact that patients in clinical trials are typically healthier than those in the "real world." The people who actually take Vioxx and other COX-2 inhibitors are likely to be in their 60s, have other health issues and may already be at an increased risk of heart attack. Therefore, the risks of Vioxx may be underestimated, he said.
Other interesting points made at the meeting:
Dr. Ned S. Braunstein, senior director of Merck Research Laboratories, believes the heart risks apply not just to Vioxx but to the entire class of COX-2 inhibitors.
A panel member accused Pfizer of hiding data.
Panel member Dr. Curt Furberg of Wake Forest University said he was troubled by inconsistencies in Pfizer's briefing document and wondered how much the company's presentations could be trusted
Dr. Garret A. FitzGerald of the University of Pennsylvania described his years of research to uncover how COX-2 drugs affect the "stickiness" of the blood and the likelihood that a person could have a heart attack or stroke. He noted that lower doses of the drugs would not eliminate the risks.
At the meeting's conclusion, the panel voted to advise the FDA that Celebrex, Bextra and Vioxx do indeed cause "worrisome" heart problems but do not need to be banned from the market. The vote was unanimous, but with narrow margins when it came to Bextra and Vioxx.
Panel members recommended that the FDA:
Place detailed warnings of heart risks on the drugs’ labels
Ban consumer advertising for the drugs
Require a guide describing the drugs’ risks be given with each prescription
The FDA is not required to follow the advice of the panel, but typically it does.
Before the heart risks were disclosed, Celebrex, Bextra and Vioxx had combined sales of $6 billion a year. It's expected that sales will rise again since the panel did not vote to ban the drugs from the market, but likely not to the same level as before.
In 2004, Celebrex sales reached $3.3 billion, while Bextra sales reached $1.3 billion. Sales for both drugs have fallen by about half.
New York Times February 19, 2005
Yahoo News February 17, 2005
USA Today February 12, 2005
Dr. Mercola's
I had been waiting to see the results of the FDA expert panel meeting, and to hear the testimony of Dr. David Graham, my newest hero, since before the event even started.
However, I was really surprised to find out the panel of experts voted unanimously to advise the FDA against banning Vioxx, Celebrex and Bextra from the market. As it says in the article, although the FDA is not bound to follow the advice of its panels, it usually does. Aside from the obvious health risks, letting the drugs remain on the market, after a thorough review of the clinical data, will help Merck to lower litigation costs related to Vioxx, which previously were estimated to exceed $20 billion.
It seems like I was prematurely elated that Vioxx’s removal from the market was marking the beginning of the end of conventional medicine. How could I ever think it would be so easy to keep a drug off the market that had killed over 50,000 people? A drug that in no way, shape or form treated any cause, but merely masked symptoms and killed tens of thousands of people.
At this time I have no details on the physicians who were on this "expert" FDA advisory panel, but I would not be surprised to find out that there is massive conflict of interest involved. Please don't be shocked, but massive conflict of interest is a regular event with the FDA.
An example of one of the worst cases I know of would be the approval of aspartame. If you haven't yet watched the Sweet Misery video, I would strongly encourage you to do so as the similarities will be immediately obvious.
Nutrasweet was kept off the market for over 10 years until Donald Rumsfeld was hired by Searle, aspartame’s maker, as their president. He immediately changed the FDA committee members that had voted against aspartame and it was approved. Later, the new FDA members quit their jobs to become "consultants" for Searle at over $250,000 per year salaries.
Sometimes things just don't seem to change much. However, this type of incredible nonsense simply can't continue to go on. It is my vision that eventually enough people will wake up and put an end to this type of public betrayal.
For now, though, after hearing what so many of the FDA panel members did have to say about the risks of COX-2 inhibitors, there’s even more incentive to try more sensible, natural and healthier approaches to treating pain:
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