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...that 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. I don't think it would be 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.
Karla
-----Original Message----- From: Sue Ann Murray <murraysa@penn.com> To: Multiple recipients of list ADHESIONS <adhesions@forum.obgyn.net> Date: Tuesday, January 25, 2000 11:01 PM Subject: Re: Warning on Propulsid
>
>>Now can people understand just why it may have been in our best interest
>NOT
>>to have had the Intergel appproved by the FDA?? Better to be safe then
>sorry
>>and I sure don't want to have to know the first fatality in the event
>>something isn't ready to be be approved...let the experiments stay in the
>>research labs and not get out until things are ready to be used safely on
>>those who need them!
>>
>>If any of you still harbored any feelings against the FDA for not
approving
>>the Intergel...may those feelings be laid to rest with this announcement!
>>
>
> I understand what you're saying, but hasn't propulsid already been
>approved by the FDA? If not, how would it already be on the market?
> And while I'm not saying that intergel should be approved or not,
>specifically for the use of adhesion prevention, I can only speak from my
>experience and it did help me. And the non-approval of the intergel had
>nothing to do with its safety or anything like that, from what I've been
>told. "Sodium hyaluronate ("hyaluronate"), the chemical which is the base
>for intergel, is already approved for other medical uses. The approval
>lifecore was seeking this time was specifically for its use in pelvic
>surgery to prevent adhesions. If it doesn't get approved, it would simply
>mean that they can't sell it/advertise it for adhesion prevention (in this
>country), but could still market it for its other uses. The panel
>recommended against it (as I understand) because Lifecore hadn't done it's
>statistics correctly, according to FDA standards, so there wasn't
>statistical proof that it made any significant difference for the
prevention
>of adhesions. According to Dr. Wiseman, it was lifecore's problem, not the
>FDA'S. But intergel is way beyond the research lab stage. It has already
>been approved for use in Europe a couple of years ago so has passed
clinical
>trials there. It has already been through a laparotomy trial here in the
>US, (which are the results the FDA panel was looking at) and I don't know
if
>the laproscopic trial is done yet or not. I haven't gotten my copy of the
>results yet, in any case. I do believe the FDA has our best interests at
>heart. But even they aren't infallible. Keep in mind that once a drug
>(and I'm not sure if this works the same with a "device" like intergel) is
>approved, the FDA has no control over how doctors prescribe it. And even
>though they are not supposed to make any claims that haven't been tested,
it
>happens. Fenphen is a good example. The two individual drugs that made up
>fen -phen were both tested and approved separately. It was doctors who
>started putting them together, and that's when problems developed.
>