See the FDA's smack-in-the-head letters

January 15, 2005

You can see all of the letters the FDA has sent to pharmaceutical

companies for inappropriate advertising/labeling here:

Here's a snippit of one to Merck regarding Vioxx --- in 2001!

" You have engaged in a promotional campaign for Vioxx that minimizes the

potentially serious cardiovascular findings that were observed in the

Vioxx Gastrointestinal Outcomes Research (VIGOR) study, and thus,

misrepresents the safety profile for Vioxx. Specifically, your

promotional campaign discounts the fact that in the VIGOR study,

patients on Vioxx were observed to have a four to five fold increase in

myocardial infarctions (MIs) compared to patients on the comparator

non-steroidal antiinflarnmatory drug (NSAID), Naprosyn (naproxen). "

" We have identified a Merck press release entitled, " Merck Confirms

Favorable Cardiovascular Safety Profile of Vioxx, " dated May 22, 2001,

that is also false or misleading for similar reasons stated above.

Additionally, your claim in the press release that Vioxx has a

" favorable cardiovascular safety profile, " is simply incomprehensible,

given the rate of MI and serious cardiovascular events compared to

naproxen. The implication that Vioxx's cardiovascular profile is

superior to other NSAIDs is misleading; in fact, serious cardiovascular

events were twice as frequent in the VIOXX treatment group (101 events,

2.5%) as in the naproxen treatment group (46 events, 1.1%) in the VIGOR

study. "

" Due to the seriousness of these violations, and the fact that your

violative promotion of Vioxx has continued despite our prior written

notification regarding similar violations, we request that you provide a

detailed response to the issues raised in this Warning Letter on or

before October 1, 2001. "

January 15, 2005

Maybe the FDA needs a smack in the head, too.

Leslye

>

>You can see all of the letters the FDA has sent to pharmaceutical

>companies for inappropriate advertising/labeling here:

>

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