"By your logic , Bayer should remove all aspirin tablets from the market -- the fact is , far more people die every year due to untoward side effects of aspirin therapy such as GI bleeding than ever died or were harmed by Vioxx."
You are missing the point completely.
Merck HID the findings that it's product was dangerous. Most drug makers let you know what the side effects are and some get a black box warning. That way your doctor and you can decide if the medicine is worth the risks posed.
However, you are stating that it is okay for Merck to HIDE the fact it's own research revealed their product was dangerous to patients. The public was uniformed.
And no, I am not a lawyer and I am in the healthcare field.
"Having prescribed Vioxx hundreds if not thousands of times, I can tell you that I rest easy that even with what we know today,"
That's funny.
I remember when patients were getting Phen-Phen. It was 'safe' as well, remember.
I warned my patients and the doc's that did not listen had nice malpractice cases.
You are wrong -- Merck did not NOT hide the evidence of possible heart effects -- in particular , a suggestion in the phase three trials of the drug that the treatment group may have had a higher incidence of heart attacks than the placebo group. The information was discussed in an open forum of experts, including cardiologists and rheumatologists at an FDA convened meeting prior to the drugs approval. The committee, after duly considering the evidence , felt that Vioxx represented an additional anti-inflammatory med for physicians which had the unique benefit of a lower GI bleeding rate, and on balance, if it in fact had a tendency to increase the risk of heart disease, the lower risk of GI bleeding outweighed that risk in certain ppatients.
The trouble with the phase three trial was that it was relatively short term, as I recall 3 months, which is standard for the industry. The increase in heart attacks in the treatment group did not meet standards of statistical significance. But the information was made widely availble , including in the package insert, and I can tell you was widely discussed amongst physicians who used the drugs ( at least in the group I circulate in ).
What next happened is that Merck launched a large long term trial of the drug designed to test its efficacy in the prevention of colorectal polyps and cancer. It was during this trial that the number of heart attacks and strokes reached unacceptable levels, but the numbers only began to go up at the two year treatment mark. Merck stopped the trial, notified the study investigators, and made a public announcement.
I think it is important that you and others know these facts , because to accuse Merck of a coverup is a calumny -- this company as far as I can tell operated above board, and went the extra mile to make all players aware of the risks of this drug.