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To: grey_whiskers
The situation with Vioxx was that the effect size was too small to detect in a clinical trial population. The initial clinical trial population was 5,000 people. The risk of cardiovascular events occurring after taking Vioxx was low enough that it might not be detected in a study group this size.

The challenge for people analyzing drug safety is to determine whether the rate of cardiovascular events is higher in the population taking the study drug than it is in a matched control population. Doing this kind of analysis requires very heavy-duty statistical analysis.

Merck voluntarily initiated post-approval studies when its own post-market data suggested there might be a problem. And Merck voluntarily recalled Vioxx from the pharmacies in 2004 so that it could no longer be prescribed. The FDA did not order these actions. The FDA did request for Merck to do more studies in order to reintroduce Vioxx into the market, which Merck did not do. In October, 2021, Merck sent a letter to the FDA requesting the FDA to withdraw approval for the drug. The FDA withdrew approval for all of the previously approved forms of the drug in September, 2022.

The actual sequence of events does not suggest to me that Merck is some eeeeeevil big pharma company that pushes dangerous drugs onto the market. Instead, it shows that Merck was being responsible and took the initiative to recall the drug themselves.

The FDA went on to require all manufacturers of NSAID drugs to include labelling describing gastrointestinal and cardiovascular risks resulting from taking these drugs. In addition, the FDA now requires a black box warning to be included in the labelling of all prescription NSAIDs. Editorial note: A black box warning is the most serious kind of warning. When you are prescribed a drug with a black box warning, it is because your primary care provider has determined that the benefit of taking the drug outweighs the risk.

Instead of reading some inflammatory anti-science blog, try reading more factual articles. You can tell an article is based on facts by the lack of incendiary language and lack of blaming "Big Pharma" or "Big Government" or whatever the bogeyman of the day is. The FDA has an informative webpage on Vioxx and there is also an entry in the Federal Register about it. I also included an article published by a group called drugwatch.

Sources:

Vioxx (rofecoxib) Questions and Answers

Merck Sharp & Dohme Corp.; Withdrawal of Approval of New Drug Applications for VIOXX (Rofecoxib) Tablets and Suspension.

Vioxx

76 posted on 10/27/2023 5:23:07 AM PDT by exDemMom (Dr. exDemMom, infectious disease and vaccines research specialist.)
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To: exDemMom; bitt; ransomnote; Melian; Jane Long
The challenge for people analyzing drug safety is to determine whether the rate of cardiovascular events is higher in the population taking the study drug than it is in a matched control population. Doing this kind of analysis requires very heavy-duty statistical analysis.

Speaking of that.

$hot $hill Troll. Forensic study just published found Pfizer hid cardiac deaths in the vaccinated arm of their report. Had they not done that, the world would have been aware of a 3.7 fold increase in cardiac deaths among the vaccinated.

Crimes are finally being revealed. https://t.co/Zjyw0hcmvB— Pierre Kory, MD MPA (@PierreKory) October 21, 2023

93 posted on 10/27/2023 9:16:02 AM PDT by grey_whiskers ( The opinions are solely those of the author and are subject to change without notice.)
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