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"That vaccine has never received FDA approval to this day despite
By Jim Rarey <firstname.lastname@example.org> of MEDIUM RARE
With the possibility of an anthrax terrorist incident in Florida, the anthrax vaccine has regained prominence in the news. In that respect, there is bad news and worse news, both for those who want the vaccine and those who have taken it.
There is only one source for the vaccine in the United States and that is Bioport located in Lansing, Michigan. The company has not shipped any in three years due to a string of foul-ups that could portend long range health problems and even death for American servicemen forced to take the vaccine.
In September of 1998 a group of unidentified investors, organized by Fuad El-Hibri, acquired the assets of the Michigan Biologic Products Institute (a state agency) after a public bidding process. The for profit company created was named Bioport.
El Hibri, who became Chairman and CEO of the company, is an international wheeler-dealer who specializes in acquisitions. He has been involved in setting up companies around the world in the biomedical and telecommunications fields. El Hibri has managed projects for the high-powered law firm of Booze-Allen & Hamilton in Indonesia, Singapore, Australia and New Zealand. He also set up large telecommunication operations in Russia and Poland.
Prior to his association with the law firm he was manager for Citigroup of their Mergers and Acquisitions from New York and Operations and Credit in Saudi Arabia.
Another member of the four-man Board of Directors for Bioport is Admiral William J. Crowe, Jr., former Chairman of the Joint Chiefs of Staff and former chairman of the President's Foreign Intelligence Advisory Board. Crowe, a member of the Council on Foreign Relations (CFR), is also chairman of the Senior Advisory Board for Global Options which has five other CFR members including R. James Woolsey former CIA director. Global Options is a multinational company that provides consulting on security, intelligence and propaganda to a variety of private and governmental entities.
Bioport was obviously created in anticipation of large-scale military operations by U.S. servicemen facing possible exposure to biological agents including anthrax. Bioport's only customer is the Department of Defense (DOD) which has an exclusive contract forbidding sale of the vaccine to anyone except the DOD.
The original vaccine produced by the State of Michigan was primarily
used to immunize animals against anthrax as well as veterinarians and others
coming into close contact with animals or animal products. That vaccine
had received approval from the Food and Drug Administration (FDA) When
the Pentagon began placing orders for huge quantities of the vaccine,
One of the several reasons FDA approval is withheld is that the three scientists who developed the new formula have refused to divulge it to Bioport (or the FDA) until they obtain royalty agreements. As of September of last year, the matter was still in the courts.
Over 400 servicemen have been subjected to disciplinary measures for
refusing to take the vaccine. One is Air Force doctor Captain John Buck.
Buck refused to allow the vaccine to be injected in him citing a stack
of solid scientific reasons why he considered it unsafe, untested and unnecessary.
Buck asserts that Russia has developed a strain of anthrax (among the
An October 26, 2000 FDA report of an inspection at Bioport detailed other problems. Bioport failed to meet FDA sterility standards. It failed to follow-up on reports of adverse reactions to vaccine forwarded to it by the Pentagon. Quality control forms were post-dated and improper calculations were made.
Bioport failed to investigate the death of Army Sergeant Sandra Larson who died twelve weeks after receiving the last in a series of six shots the vaccination procedure requires. Cause of death was determined to be "aplastic anemia" an autoimmune disease. In a congressional hearing Larson's sister testified, "This was not a gradual case of aplastic anemia. She went from a healthy woman just four weeks prior to having no bone marrow, platelets and an extremely low count of red and white blood cells. It was as if there was something in her that was killing her immune system, shutting her down."
The FDA report also said Bioport failed to accurately track vials of vaccine rejected by the Pentagon and returned to Bioport and in one case had changed its records.
Bovine derived materials have traditionally been used in the manufacture of vaccines. In 1993 and again in 1996 the FDA warned manufacturers, including the Institute in Michigan, not to use materials derived from cattle that were "born, raised or slaughtered" in countries where Mad Cow disease is known to exist. Last fall the FDA's Center for Biologics Evaluation and Research reported that Bioport was still using bovine-derived materials of unknown geographic origin.
A spokesperson for Bioport, Chief Scientific Officer Robert C. Myers claims, "Now licensed for thirty years, with two million doses given in the last two and a half years alone, the vaccine is proven safe. In total, there have been 13 safety studies of many types involving 366,000 patients and there is no pattern emerging that would call the vaccine's safety into question." What Mr. Myers conveniently omits is that those two million doses were of the new "recipe" and has not been licensed by the FDA.
The Pentagon also dissembles on the question. A spokesperson stated, "Thirty years of experience with anthrax vaccine in the United Sates suggests that it has a side-effect profile similar to other commonly used vaccines."
Pentagon stocks of the vaccine were down to 60,000 at the end of last year. Only troops deployed in the Persian Gulf region and on special missions are receiving the vaccinations.
Permission is granted to reproduce this article in its entirety. The author is a free lance writer based in Romulus, Michigan. He is a former newspaper editor and investigative reporter, a retired customs administrator and accountant, and a student of history and the U.S. Constitution.
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