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