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Lipodystrophy and WastingLipodystrophy and Wasting
          
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FDA Hearing on NEWFILL/Sculptra
Apr 14, 2004

Hello People,

An Update on NewFill/Sculptra...

I just met with the FDC in Washington DC on Thursday 3/25/04 to deliver personal testimony of my experience with NewFill. Nelson Vergel was there to speak as well.

The meeting ran all day, from 8 a.m. - 5 p.m. And was filmed and audio taped, although to purchase a copy costs $350. There were 14 panel members, 10 of which were voting members.

I was one of 2 speakers, not including our friend Nelson (who gave a great statement), and the other was Brad, (fantastic guy!) that works within the HIV community in California, that had a tale of how he considered suicide and how his friends considered not taking medication, since they would rather die than look like those with facial atrophy.

I passed around personal (not clinical) photos of me prior to lipoatrophy, at my worst point, and after NewFill/Sculptra for the panel to review. I anonymously delivered my story (embarrassingly delivered with tears) was about how I wanted to *remain* anonymous with this disease and how lipoatrophy stripped me of that ability. If it wasn't for lipoatrophy that I could essentially live a fairly normal life. About how, people unaware of my diagnosis, such as family members, friends and co-workers, were concerned about my "failing health." and how I passed on consulting job opportunities since I would never be comfortable with face-to-face interaction. Telling my diagnosis and risking stigmatism for me and my child was not something that I could do. I was pressured into doing something for my face out of desperation. But after interviewing four plastic surgeons and trying other fillers that didn't work, I began to see that the options for us are just not there. And fat-transfers, collagen, fascian, implants, Mexico, etc were not treatment methods that met my need of: longetivity, a natural appearance, and safety, and that I wanted a licensed, insured and skilled Physician working on my face. NewFill was the only product that I could find that met these needs, and I could say it has honestly changed my life, professionally and personally.

It turns out, the testimonies provided by me and Brad were key components in persuading the entire panel to unanimously vote for the approval of this treatment.

When asked why each of the panel members voted for approval, here is what each of them had to say: - This is a vote of compassion - I voted with my heart, not my head - I want to give the perception of compassion toward patients - I have a desire to help patients like those that presented - I want to see something done for people suffering with this - I see a pressing need to treat this disfiguring condition and wants patients to have a sense of self, not a vote on data - Risk vs. Benefit was demonstrated today, and the non-science evidence was compelling - Data is lacking, but feel a motivation for patients - Can see the urgency of the need based upon personal testimonies - I can see that real pain is resolved with this product

I am overwhelmed that our testimonies had so much impact - The FDA does care about people living with this illness. I feel some satisfaction and emotion knowing that we have potentially helped many people's lives.

BTW - Because the medical evidence was so lacking, they were concerned about "off label" use, such as in the general public. So the FDA is going to put some type of restriction on the product so that it is only available to HIV patients, how they are going to implement this is unknown at this point. I'm sure we will hear more in the coming months.

They also wanted studies that included more women and minority populations. So chins up gals, there might be a study soon for you! There was even discussion about compassionate release.

Couple of links: http://www.aventis.com/main/page.asp?pageid=50238020040326155139&lang=en

http://www.aegis.com/channel/s/AD040645.html Stay tuned, I'm sure there will more information coming about NewFill/Sculptra.

Also, don't EVER think your voice can't make a difference! Thanks for your support. Adena

Response from Dr. Moyle

Thanks Some of the data can found in.......

Moyle GJ, Lysakova L, Brown S, Sibtain N, Healy J, Priest C, Mandalia S, Barton SE.A randomized open-label study of immediate versus delayed polylactic acid injections for the cosmetic management of facial lipoatrophy in persons with HIV infection. HIV Med. 2004 Mar;5(2):82-7


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