Re: FDA: 139,000 people had heart attacks that may be linked to Vioxx

From: Don Kirkman (donkirk_at_covad.net)
Date: 01/05/05


Date: Wed, 05 Jan 2005 13:49:55 -0800

It seems to me I heard somewhere that Sharon Hope wrote in article
<1NICd.281150$5K2.166760@attbi_s03>:

Restoring the order in which the messages were posted:

>"Don Kirkman" <donkirk@covad.net> wrote in message
>news:j5olt0t88qho57jfjii207fq4rjnps3qro@4ax.com...
>> It seems to me I heard somewhere that Sharon Hope wrote in article
>> <WpnCd.275148$5K2.269215@attbi_s03>:

>>>http://www.foxnews.com/story/0,2933,143170,00.html
[...]
>>>WASHINGTON - The Food and Drug Administration has given a whistle-blower
>>>scientist permission to publish data indicating that as many as 139,000
>>>people had heart attacks that may be linked to Vioxx, the scientist's
>>>lawyer said Monday.
>>>Dr. David Graham, who works in the FDA's office of drug safety, has said
>>>he was not allowed to publish his data questioning the safety of Vioxx, a
>>>pain medication principally used to treat osteroarthritis. Additionally, an FDA
>>>official sent e-mail messages to the medical journal Lancet trying to
>>>persuade the journal not to publish the data.

Incidentally, Graham has now been given the permission he requested.

>>>Citing its own safety concerns, manufacturer Merck voluntarily pulled
>>>Vioxx from the market in late September.

>>>Note that, just like Bayer did with Baycol, Merck VOLUNTARILY pulled the
>>>drug from the market. Pfizer had rhabdomyolysis deaths from Lipitor, but
>>>chose not to voluntarily pull the drug. Pfizer had problems with suicides
>>>with another of their drugs, but chose not to voluntarily pull that drug,
>>>either.

>> Note too, though, that many rheumatologists and arthritis patients feel
>> betrayed by the sudden pulling of Vioxx off the market, since they had
>> been seeing good results from the drug and were willing to accept the
>> level of risk shown in the studies. Now they do not have that option.

>Thing is, until now they were denied the information needed to make a true
>risk assessment. At least now they know the tradeoffs.

>Pfizer will continue to sell their version, just as they do their statin, so
>arthritis suffers can choose to risk heart attack if they determine that
>risk is an acceptable tradeoff for pain relief.

>But they will be dealing with real information for the first time.

But no matter how much or how good that information may turn out to be,
they've had their chance to choose for themselves taken away by a
pharmacals company afraid of current public opinion. That is not a good
precedent for those patients and practitioners nor for the system
itself.

-- 
Don
"I do not feel obliged to believe that the same God who has endowed
us with senses, reason, and intellect has intended us to forgo their
use.                                --Galileo Galilei


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