An Undocumented Worker
08-13-12, 17:30
Here is a report about a culture of corruption within the ranks of the FDA, and some info regarding drug testing on our service men and women. There may be some possible links to Gulf War Syndrome aswell.
Either way this shit really pisses me off.
http://truth-out.org/news/item/10524-former-fda-reviewer-speaks-out-about-intimidation-retaliation-and-marginalizing-of-safety
Yes, pyridostigmine is intended to be given preventatively in case of a nerve gas attack with the nerve agent Soman and it was used experimentally on Gulf War troops. After the first Gulf War, there were concerns it was linked to Gulf War Illness. Then, prior to Operation Iraqi Freedom, the Defense Department (DoD) tried to have President Bush waive informed consent for pyridostigmine, even though it was still an investigational drug.
MR: Why?
RK: Possibly because there is less hassle medicating troops if no informed consent is required. When President Bush refused to waive informed consent, the FDA approved pyridostigmine using the "Animal Rule" which allows the approval of drugs for human use based on animal data. It was employed because it was unethical to dose humans with the nerve agent Soman to see if pyridostigmine would actually prevent death. However, the way the drugs were used in the animal studies didn't reflect how they would be used in humans and resulted in misleading conclusions.
MR: Another FDA reviewer turned down pyridostigmine before you?
RK: Yes. I was assigned to re-review his conclusions regarding pyridostigmine and even before I began my review I was pressured to approve it and this pressure continued through nearly two dozen meetings with FDA management. After it became clear that I would not be pressured into an approval and it became apparent that it would be approved according to the animal rule in spite of the science, I raised an even stronger objection: not only did it not work against nerve agents other than Soman, but pyridostigmine actually increased lethality in the presence of other nerve agents and we knew that Saddam Hussein was not using Soman and was instead using these other nerve agents.
This is just a snippet from the article, the full article is at the link.
Either way this shit really pisses me off.
http://truth-out.org/news/item/10524-former-fda-reviewer-speaks-out-about-intimidation-retaliation-and-marginalizing-of-safety
Yes, pyridostigmine is intended to be given preventatively in case of a nerve gas attack with the nerve agent Soman and it was used experimentally on Gulf War troops. After the first Gulf War, there were concerns it was linked to Gulf War Illness. Then, prior to Operation Iraqi Freedom, the Defense Department (DoD) tried to have President Bush waive informed consent for pyridostigmine, even though it was still an investigational drug.
MR: Why?
RK: Possibly because there is less hassle medicating troops if no informed consent is required. When President Bush refused to waive informed consent, the FDA approved pyridostigmine using the "Animal Rule" which allows the approval of drugs for human use based on animal data. It was employed because it was unethical to dose humans with the nerve agent Soman to see if pyridostigmine would actually prevent death. However, the way the drugs were used in the animal studies didn't reflect how they would be used in humans and resulted in misleading conclusions.
MR: Another FDA reviewer turned down pyridostigmine before you?
RK: Yes. I was assigned to re-review his conclusions regarding pyridostigmine and even before I began my review I was pressured to approve it and this pressure continued through nearly two dozen meetings with FDA management. After it became clear that I would not be pressured into an approval and it became apparent that it would be approved according to the animal rule in spite of the science, I raised an even stronger objection: not only did it not work against nerve agents other than Soman, but pyridostigmine actually increased lethality in the presence of other nerve agents and we knew that Saddam Hussein was not using Soman and was instead using these other nerve agents.
This is just a snippet from the article, the full article is at the link.