Re: contacted by Weinberg

From: Sally Grigg (lostcst@mcn.org)
Sat May 12 12:52:59 2001


Right on. Such logical and deductive reasoning. I salute you. Sally Grigg

Mary Wade wrote:

> First, let me say that the fact that some of us, but not all, were
> individually solicited via email by Weinberg group seems strange to me.
> Makes me go “hmmmmmmmmmmmmmm.” (Insert picture of me with index finger
> on brow here.)
>
> I also received an email of solicitation from Weinberg group regarding
> the upcoming meeting of a panel appointed by the FDA to consider the
> advancement of the adhesion barrier, Intergel, through the FDA approval
> process. As you may know, the FDA has previously denied approval. Ever
> the curious one, I called the Weinberg group to learn about their
> solicitation. I had a pleasant visit with Kim Green. She said that she
> had gotten my name and email off of the IAS site. At first, this
> sounded really appealing to me. I thought, “I want to help others who
> are suffering. I want our story out there. I could do that.” We are
> soooooo starved for our pain and problems to be “believed.”
>
> Then, I was reminded of a very recent incident in my personal life.
> There was an appeal made to me to get involved in a legal matter “for
> the good of consumers.” I got involved, thinking that I had been told
> all the ins and outs. When the facts were known, the truth was far from
> the story to which I first responded. Emotional pleas and the truth
> just didn’t jibe. There were a lot of emotional issues involved. But,
> in the final analysis, I had to take the stand the emotional pleas
> didn’t cut it. The truth was the truth and that is what won.
> Rightfully, so.
>
> We VERY much need the scientific truth to prevail in this current
> matter.
>
> After my initial knee-jerk reaction to the opportunity to help out in
> this battle, I re-read and thought of what I know of FDA panels. My
> brother has served on FDA panels. These panels are not the “FDA.” They
> advise the FDA. To sit on these panels, a professional must be an
> expert in the issue being presented. Therefore, if there is a panel
> called to review an adhesion barrier, those experts on the panel are
> going to already be very knowledgeable about adhesions and the effects
> of adhesions. I got to thinking that I’d feel rather silly sitting
> there telling them “my story.” This needs to be ALL about good science
> and I’m not a scientist. Shouldn't Intergel or any adhesion barrier be
> forced to stand on its own proven scientific merits? Unfortunately, all
> the emotional stories in the world will not change scientific facts. The
> scientific rigors that the FDA sets for the approval of new products are
> the guide here. I have concluded that mixing my heart/soul/guts into
> that process would be a very unfair and unwise distraction to the
> scientific process.
>
> Also, my appearance at such a meeting in response to a corporate
> solicitation would place me in compromising situation. How so? There
> would be the appearance that I am advocating for the approval of
> Intergel. I can’t do this! I know NOTHING about the effectiveness of
> the product! I want no harm to come to any of us. What DO I know?????
> Well, I am 100% sure that no adhesion barrier can make up for sloppy
> surgical technique. I know that I got better when good surgical
> technique alone was applied in my case. So thanks, but no thanks. It
> seems obvious to me that we would be best served if Lifecore and
> Intergel can rise to the FDA approval standards on the merits of the
> product.
>
> --
> Mary Wade
>


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