Reuters on VIOXX
The benefits of COX-2 inhibitors VIOXX and CELEBREX were the lowered incidence of GI problems, not enhanced pain relief. For people who did not suffer GI problems with NSAIDS, there were no benefits.
from Reuters on November 14, 2004:
As the implications of Vioxx sink in, companies are likely to reexamine the relationship between risk and reward in the drug development process, especially for those products that offer only incremental benefits over existing treatments, they said.
"Vioxx is a crystallizing event for the drug industry," said Roger Longman, managing partner at Windhover Information, a healthcare information company. "Investors, patients, doctors and regulators are questioning the whole notion of how big pharma does its work."
from a post by Lehmann on corante (Derek Lowe):
Responding to the question whether the cardiac dangers of Vioxx are drug-specific or relate to the entire class of COX-2 inhibitors (Coxibs), scientific evidence based on gene knockout studies pointed out that it is an adverse reaction associated with the mechanism, hence the whole class of drugs. See DrugIntel for details, where these problems for Vioxx were predicted in spring 2003. Clinical studies confirming this danger take longer and suffer from less precision, and are more difficult to conduct objectively for obvious reasons. The Cochrane Reviews (2004) commented "For individuals in whom cardio-prophylactic low dose aspirin is indicated, the evidence suggests that celecoxib [Celebrex] offers no additional benefit in terms of GI safety." On the social aspects, agreed that withdrawing every drug with side effects or dangers would leave us with no drugs. However, judging Vioxx on medical risk-benefit, it never was a winning proposition - omeprazole + ibuprofen was judged to be safer, not to mention cheaper, by the Oregon Health & Science University / Oregon Health Resources Commission cogent and objective review on the topic. Hopefully the constructive result will be that Merck returns to its tradition of research resulting in truly novel drugs addressing unmet medical needs, rather than overmarketed, overpriced drugs with selling points rather than medical superiority.
from Reuters on November 14, 2004:
As the implications of Vioxx sink in, companies are likely to reexamine the relationship between risk and reward in the drug development process, especially for those products that offer only incremental benefits over existing treatments, they said.
"Vioxx is a crystallizing event for the drug industry," said Roger Longman, managing partner at Windhover Information, a healthcare information company. "Investors, patients, doctors and regulators are questioning the whole notion of how big pharma does its work."
from a post by Lehmann on corante (Derek Lowe):
Responding to the question whether the cardiac dangers of Vioxx are drug-specific or relate to the entire class of COX-2 inhibitors (Coxibs), scientific evidence based on gene knockout studies pointed out that it is an adverse reaction associated with the mechanism, hence the whole class of drugs. See DrugIntel for details, where these problems for Vioxx were predicted in spring 2003. Clinical studies confirming this danger take longer and suffer from less precision, and are more difficult to conduct objectively for obvious reasons. The Cochrane Reviews (2004) commented "For individuals in whom cardio-prophylactic low dose aspirin is indicated, the evidence suggests that celecoxib [Celebrex] offers no additional benefit in terms of GI safety." On the social aspects, agreed that withdrawing every drug with side effects or dangers would leave us with no drugs. However, judging Vioxx on medical risk-benefit, it never was a winning proposition - omeprazole + ibuprofen was judged to be safer, not to mention cheaper, by the Oregon Health & Science University / Oregon Health Resources Commission cogent and objective review on the topic. Hopefully the constructive result will be that Merck returns to its tradition of research resulting in truly novel drugs addressing unmet medical needs, rather than overmarketed, overpriced drugs with selling points rather than medical superiority.
posted by Lawrence B. Ebert at 7:13 AM
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