>Sue Ann,
>
>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.
>>
>