This is Karla again. If you go back to Dr. Weissman's explanation of why he felt the approval was not recommended you will see where he mentions an increased rate of infection. At first I thought the amount was trivial...but then I realized that if it was a rate they were not comfortable with accepting maybe I should be uncomfortable with it as well.
As far as phenfen goes...unfortunately I was prescribed these drugs...and suffer the consequences...as if I needed that too....I have learned to question everything...and to take nothing for granted.
Take care and God Bless. I will try to find the posting and forward it to you.
Karla
>----- Original Message -----
From: Sue Ann Murray <murraysa@penn.com>
To: Multiple recipients of list ADHESIONS <adhesions@forum.obgyn.net>
Sent: Wednesday, January 26, 2000 2:09 PM
Subject: Re: FDA and Intergel
> >The FDA was aware of the potential problems of the drugs phenfen...and
> chose
> >to ignore them despite many, many letters begging them not to approve the
> >drugs. I happen to have copies of some of those letters and it angers me
> to
> >think that the FDA went ahead with them anyway. As for the doctors
> >prescribing the two drugs together....it was on the advice of the drug
> >companies that they do this and they had been tested in combination.
>
> THis is interesting, because all the news reports I heard said that they
had
> not been tested together -- maybe they meant not tested together by the
FDA?
> But they were tested by the companies?
>
> >is where American Home Products is in trouble...because they hid the
> >negative information from everyone. I prefer to let the FDA do their
> >job...as they should have done with phenfen. We as consumers need to be
> >assured that all efforts have been made to provide us with a reliable
> >product....free from any potential problems.
> ..>expecting too much to have an evaluation as to why the incidence of
> >infection is increased and take steps to correct the problem. I look
> forward
> >to the day when Intergel is available for use in this country...but I
want
> >to feel confident that when it is used on me everything has been done to
> >correct its flaws.
>
> Okay, this is the first I've heard anything about infections. Are you
> saying that with intergel there was an increased risk of infection? Was
> this only in the laparotomy trials in this country? I keep wondering why
> it was seemingly easily approved in so many other countries and not this
> one. The only mention of possible infection in the protocal papers they
> gave me is the risk of "infection in the area of surgery", which to me
> implies that it has more to do with the surgery than with the gel itself.
> Frankly, if I find out that they knew about an increased risk of infection
> and didn't tell that information to study participants, I will not be
happy,
> even though I did not have a problem.
>