E-DRUG: FDA Testimony opposing COX-2 inhibitor Arcoxia
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(advisory committee votes 20 to 1 against)
The full testimony can be seen at:
http://www.citizen.org/publications/release.cfm?ID=7515
The presentation summary follows
In summary, Merck seems to by trying to have it both ways: Looking at naproxen studies, there is some GI advantage but significant cardiovascular disadvantage (as was the case with Vioxx). Looking at diclofenac studies, there is no cardiovascular difference but also no GI advantage as far as confirmed serious gastrointestinal complications.
If Vioxx were coming up for approval vs. naproxen (Vigor study) would it get approved?
If the answer is no, then why should the similarly dangerous offspring of Vioxx, etoricoxib (Arcoxia), get approved just because its cardiovascular risks are no greater than an older NSAID with known cardiovascular risks (diclofenac) as in the MEDAL study when, like its parent Vioxx, it has been previously shown to have increased cardiac risks in randomized controlled trials in which it is compared to naproxen?
For etoricoxib, there is no evidence of a benefit in efficacy compared to older NSAIDs, nor evidence of a benefit in terms of reduced serious G-I complications such as perforations, ulcers or bleeding compared to older NSAIDS. Thus, in the face of seriously increased cardiovascular risk compared to drugs such as naproxen, how can the approval of etoricoxib and the large numbers of preventable, life-threatening cardiovascular adverse reactions be justified?
If you were prescribing etoricoxib to a patient with osteoarthritis, on the basis of what evidence would you inform them that the significantly increased risk of a heart attack or other cardiovascular events with this drug is outweighed by the increased benefits when there is no evidence that there are any such benefits unique to etoricoxib, as far as increased efficacy or reduced serious gastrointestinal adverse reactions? Since there is no basis for informing your patient of such a favorable risk/benefit ratio, there is no basis for recommending the approval of etoricoxib. Thousands, probably tens of thousands of patients have already had needless heart attacks because they took one of the marketed or previously marketed COX-2 drugs instead of clearly safer alternatives such as naproxen.
It is time to shut the door on further additions to this dangerous class of COX-2 inhibitor drugs. The idea that there may be certain patients, however unidentifiable they are, who might benefit from this drug is just not good enough as a basis for its approval. Such anecdotes often sufficed before 1962, when the FDA�s legal authority was finally expanded to include the requirement for evidence of effectiveness from randomized controlled trials. Only with this kind of information can an accurate assessment of benefits and risks be made.
Etoricoxib does not fulfill an �unmet need�, as required by the FDA, for any identifiable group of patients. The Merck discussion about �unmet need� for treating OA in their submission for this meeting merely describes how prevalent OA is, reviews the treatments. The company actually admits that for people with GI problems, the recommendation includes use of a traditional NSAID with a gastro protective agent (PPI or misoprostol) or a COX-2 inhibitor. No explanation is given as to why etoricoxib fills an unmet need.
In addition to strongly urging your committee and the FDA to reject Merck�s effort to approve etoricoxib in the U.S., I urge prompt removal of Arcoxia from the market in the 60+ countries where it is causing unacceptable risks to the hundreds of thousands of people using the drug.
Sidney M.Wolfe M.D.
Director, Public Citizen's Health Research Group
1600 20th St. NW, Washington, DC. 20009
202 588-7735 fax 588-7796
e-mail swolfe@citizen.org
Web sites: www.citizen.org/hrg
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