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Re: FDA intereference costs lives

From: Renee (anonymous@obgyn.net)
Sat, 17 Nov 2001 13:27:52 -0800


Another one I haven't been able to send for several days:

It actually is very effective for the diseases you mentioned: HIV, leprosy (aka Hansen's disease), etc.

However, remember that people with these diseases have to use good birth control to prevent problems with the child from the disease. Anyone prescribing, or using, Thalidomide has to understand the risk and use only in people who won't be childbearing for one reason or another, even by accident.

I'm sure the risks are very clearly outlined to the person taking it.

Renee

Dona wrote: >
> HI Renee you said exactly what I was thinking.I am old enough to
> remember babies being born with severe birth defects do to Thalidomide
> in the US and Canada.For those who don't remember it was a drug to
> prevent morning sickness and babies that were born to these mothers were
> missing arms,legs and sometimes feet and hands at the end of a tiny
> stump. I have a friend who is in her early 40's that was effected by
> this and has no arms and legs.I think our governemnt learned a very hard
> lesson when it approved Thalidomide so quickly without studying what the
> outcomes would be of this drug.I am sooo glad my mother refused this
> drug when it was offered to her when she was pregnant with me!This drug
> is still on the market and is being used to treat wasting syndrome in
> HIV patients ,to treat Leporasy, and severe mouth sores there are
> several other uses as well.It amazes me it is still marketed in this
> country with the rsks associated with it.
> Dona
>
> At Thu, 15 Nov 2001, Renee wrote:
> >
> >Genny,
> >
> >Yes, the FDA takes too long. However, sometimes it can go too fast. For
> >example, Rezulin, Propulsid (or Prevacid, I forget which one was pulled off
> >the market two years ago), Thalidomide. Sometimes the adverse effects aren't
> >seen first. If the trial only looks at people over 6 months, is there any
> >impact with longer use, such as a year, or 5, or 30?
> >
> >Does your insurance only cover Met if you're "diabetic?" Your doctor should
> >be able to write a letter of need explaining why you need it though you're not
> >diabetic. Or, you can keep with the needle reminders and not stir things up. :-)
> >
> >Renee
> >
> >"Genny H." wrote:
> >>
> >> 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).
> >>
> >> Genny
> >>--

--
Renee Cordrey, MSPT, MPH, CWS
---

Don't follow in the footsteps of the masters. Seek what they sought. --Zen saying




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