PCOS Messages for November, 2001: FDA intereference costs lives

FDA intereference costs lives

From: Genny (anonymous@obgyn.net)
Thu, 15 Nov 2001 10:44:31 -0600

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What is the problem? It is over-regulation. People die every day waiting for FDA approval on medications. As a result of the FDA's insistence on testing for meds already proven effective and safe, those of us with PCOS must be labeled as diabetic so that we can get Glucophage. Once a month I get reminders from my pharmacy to come in and get needles and injectable insulin, which I neither use or are PXed. This is simply the result of the doctor informing my pharmacist that I am diabetic (wink wink nudge nudge).

I also cannot blame drug companies for dragging their feet. Approval costs money. The money spent on excess testing must come from somewhere. Hence, the cost of Glucophage goes up. The drug companies do not want that, and neither do I.

Genny

Date: Wed, 14 Nov 2001 16:55:51 -0600 (CST) From: anonymous@obgyn.net (jodi) To: anonymous@obgyn.net Subject: Re: Lisa - Re: Spoke to Glucophage company Message-ID: <200111142255.fAEMtp815696@mail.medispecialty.com>

Oh WHATEVER! I'd bet my left ovary (cysts and all!) that BMS would have no problem whatsoever getting hundreds if not thousands of women to volunteer as guinea pigs in whatever testing they would need. So what's the problem? :-)

- jodi

At Wed, 14 Nov 2001, Sonnet wrote: >
>Ohhhh they know. They just don't want to go through all the testing
>that would be required for FDA approval for PCOS. They have really
>dragged their heels on this.
>
>At Wed, 14 Nov 2001, jodi wrote:
>>
>>I'm a little confused as to why you are contacting the drug company...
>>surely with all the hype about Met and PCOS they KNOW about the
>>connection? I thought it was the FDA we had to get on to approve the
>>drug! Is it possible that brystol myers doesn't know that glucophage
>>works for PCOS (or might work for some women with PCOS) and if they
>>knew, THEY could convince the FDA to approve it? Explain, please...
>>inquiring minds want to know! :-)
>>
>>- jodi
>>
>--
>Sonnet Fitzgerald, PCOS Association, Online Community Liaison. Email:
sonnet@pcosupport.org >

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