Comments on: Speedy FDA Process Gets Observers’ Goats http://scienceprogress.org/2009/01/speedy-fda-process-gets-observers-goats/ Tue, 13 Sep 2011 13:59:48 +0000 hourly 1 http://wordpress.org/?v=3.2.1 By: Laurence V. Minter, Ph.D. http://scienceprogress.org/2009/01/speedy-fda-process-gets-observers-goats/comment-page-1/#comment-4086 Laurence V. Minter, Ph.D. Thu, 22 Jan 2009 03:19:14 +0000 http://www.scienceprogress.org/?p=942#comment-4086 I do not see any consideration of either animal well being or suffering, as from high failure rate and the pain involved involved for individuals who are "failed" experiments. Similarly, arbitrary assumption of safety for human consumers in the face of high prevalence of dangerous side effects and grossly inadequate understanding of complex biological and biochemical pathways impacted in both the donor goats and the targeted human experimental subjects, to me seems blatantly dishonest, dangerous and illegal on several grounds---including false and misleadiing medical claims, USDA animal cruelty regulations and relevant EPA guidelines. It makes mw sick to learn the details of this cruel and irresponsible marketing as a get-rich quick scheme that puts unknown thousands of human guinea pig consumers at risk. I do not see any consideration of either animal well being
or suffering, as from high failure rate and the pain involved involved for individuals who are “failed” experiments. Similarly, arbitrary assumption of safety for
human consumers in the face of high prevalence of dangerous
side effects and grossly inadequate understanding of complex
biological and biochemical pathways impacted in both the
donor goats and the targeted human experimental subjects,
to me seems blatantly dishonest, dangerous and illegal on
several grounds—including false and misleadiing medical
claims, USDA animal cruelty regulations and relevant EPA
guidelines. It makes mw sick to learn the details of this
cruel and irresponsible marketing as a get-rich quick
scheme that puts unknown thousands of human guinea pig
consumers at risk.

]]> By: Jaydee Hanson http://scienceprogress.org/2009/01/speedy-fda-process-gets-observers-goats/comment-page-1/#comment-4023 Jaydee Hanson Mon, 12 Jan 2009 21:16:00 +0000 http://www.scienceprogress.org/?p=942#comment-4023 Rick Weiss' comments are a good review of the meeting. Here are the comments I made to the FDA at the meeting. Jaydee Hanson, Policy Analyst, Center for Food Safety Jaydee Hanson comments to FDA Blood Products Advisory Committee, Jan. 9, 2009 As you consider possible approval of the first drug derived from a genetically engineered mammal, I would urge the committee to only approve the drug AFTER the approval of a regulatory framework for bio-pharmaceutical animals in general followed by a specific approval of the GTC Biotechnologies goats. The materials shared with the public about Atryn moreover, raise concerns about the product itself. There are significant differences between the genetically engineered form of the drug and the human form it is designed to replace. These include: glycosylation differences, increased heparin binding, and a shorter half life in the body of the patient. Significant associated problems have been reported in the small number of patients treated thus far (fewer than 40 patients). Scientific literature suggests that there are perhaps 130 variants of the gene believed to be associated with this condition. If the committee does approve the drug, strict post market surveillance should be required, including surveillance of the infants of women treated with the drug during pregnancy. Biological drugs have shown a high incidence of problems post market, we should not assume that this drug will be any different. Drug approval should be limited to products derived from this goat herd raised with the safe guards described here today. Animal approval should be given only for animals raised at this location and only as long as it is subject to continued review by FDA and USDA. No sale of animals to other facilities, or leasing of production techniques to other facilities should be given by the approval of these animals. Given that there have been cases of GE animals being consumed by workers or sold to others, studies on food safety on the meat, milk, and cheese products from these goats should be required prior to approval. Studies on the safety of these goats, if used as animal feed should also be required. Inadequate steps have been taken to address the infection of the animals by birds, rats, mosquitoes, and other vectors. Assessment of these issues should be part of an expanded environmental risk assessment on the goats that looks at all aspects of the goat lifecycle from creation of the animal to disposal of the animal after death. The full environmental risk assessment should be posted as part of any FDA approval of the animals. Data on the destruction of each animal created by GTC should be posted. This should include “no-takes” and all animals not kept in the herd. Finally, no drug approval should be given before FDA approves the animal. No animal approval should come prior to the FDA completion of regulations (not simply guidances) for Bio-Pharm animals wherein all data used for the approval of animals is made available to the public. The FDA has tried to fit the approval of animals themselves into the New Animal Drug approval process. If this process cannot be adapted to provide for complete transparency of data, then the FDA needs to delay approvals until it has this authority from Congress. Approving ATryn before the FDA has developed a framework for the approval of Bio-Pharm animals would make drug approval a back door approval of transgenic animals. This would be a case of FDA getting the cart before the horse, or in this case, the goat! The public deserves better. The patients deserve better. - Rick Weiss’ comments are a good review of the meeting. Here are the comments I made to the FDA at the meeting. Jaydee Hanson, Policy Analyst, Center for Food Safety

Jaydee Hanson comments to FDA Blood Products Advisory Committee, Jan. 9, 2009

As you consider possible approval of the first drug derived from a genetically engineered mammal, I would urge the committee to only approve the drug AFTER the approval of a regulatory framework for bio-pharmaceutical animals in general followed by a specific approval of the GTC Biotechnologies goats.

The materials shared with the public about Atryn moreover, raise concerns about the product itself. There are significant differences between the genetically engineered form of the drug and the human form it is designed to replace. These include: glycosylation differences, increased heparin binding, and a shorter half life in the body of the patient. Significant associated problems have been reported in the small number of patients treated thus far (fewer than 40 patients). Scientific literature suggests that there are perhaps 130 variants of the gene believed to be associated with this condition.

If the committee does approve the drug, strict post market surveillance should be required, including surveillance of the infants of women treated with the drug during pregnancy. Biological drugs have shown a high incidence of problems post market, we should not assume that this drug will be any different.

Drug approval should be limited to products derived from this goat herd raised with the safe guards described here today.

Animal approval should be given only for animals raised at this location and only as long as it is subject to continued review by FDA and USDA. No sale of animals to other facilities, or leasing of production techniques to other facilities should be given by the approval of these animals.

Given that there have been cases of GE animals being consumed by workers or sold to others, studies on food safety on the meat, milk, and cheese products from these goats should be required prior to approval. Studies on the safety of these goats, if used as animal feed should also be required.

Inadequate steps have been taken to address the infection of the animals by birds, rats, mosquitoes, and other vectors. Assessment of these issues should be part of an expanded environmental risk assessment on the goats that looks at all aspects of the goat lifecycle from creation of the animal to disposal of the animal after death. The full environmental risk assessment should be posted as part of any FDA approval of the animals. Data on the destruction of each animal created by GTC should be posted. This should include “no-takes” and all animals not kept in the herd.

Finally, no drug approval should be given before FDA approves the animal. No animal approval should come prior to the FDA completion of regulations (not simply guidances) for Bio-Pharm animals wherein all data used for the approval of animals is made available to the public. The FDA has tried to fit the approval of animals themselves into the New Animal Drug approval process. If this process cannot be adapted to provide for complete transparency of data, then the FDA needs to delay approvals until it has this authority from Congress.

Approving ATryn before the FDA has developed a framework for the approval of Bio-Pharm animals would make drug approval a back door approval of transgenic animals. This would be a case of FDA getting the cart before the horse, or in this case, the goat! The public deserves better. The patients deserve better.

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