Posted on 10/28/2001 1:18:03 AM PST by DaRocksMom
With the release this week of a on General Accounting Office (GAO) report on the anthrax vaccine and the recent publicity given a California lawsuit filed last year, an incredible series of bureaucratic blunders has been exposed both in handling of the anthrax vaccine and the drug used to treat anthrax exposure.
Major players involved in "looking the other way" (or not looking at all) are; the Food and Drug Administration (FDA), the Department of Defense (DOD), and the Center for Disease Control (CDC).
Also involved are Bioport in Michigan (and its predecessor organizations) and the giant German drug company Bayer.
The Michigan Department of Public Health received a license from the FDA to produce anthrax vaccine used primarily to inoculate animals and veterinarians and others coming into close contact with animal products. The license was subsequently transferred to the Michigan Biologic Products Institute (MBPI). The giant Merck pharmaceutical company produced the vaccine that had been tested by the FDA for human use in a study from 1955-1959.
In the late 1980’s the DOD requested larger amounts of the vaccine in anticipation of encountering biological anthrax attacks from Iraq because the U.S. had sold anthrax spores, equipment and technology to the Iraqis.
In order to meet the increased demand, the MBPI changed the process and chemical composition of its vaccine The FDA was not notified of the change, as required by law, and according to the GAO report claims it did not learn of the change until notified by the GAO ten years later.
As early as 1985, the DOD realized that the vaccine had not been approved for use in combating inhalation anthrax. In 1984 a group of military experts recommended that an application to FDA be made to obtain that approval. The FDA claims it was not aware of the Pentagon report until notified by the GAO on October 15th of this year.
In 1996, after the license had been transferred to the MBPI, the institute filed the application for such a license change. To date, no action has been taken by the FDA on the application. Processing of the application would have automatically thrown the vaccine back into the category of experimental or "investigational" drugs, which have to have the (informed) consent of the person getting the inoculation. Only the president can waive the informed consent requirement, which the first President Bush did in the Gulf War.
Over four hundred military personnel have either had to resign or face disciplinary action for refusing to take the vaccine which was made mandatory in 1998 by then Defense Secretary William Cohen. Thousands of others who took the vaccine claim debilitating diseases have resulted and at least two deaths have been attributed to it.
As the GAO disclosed before a congressional subcommittee this week, The FDA had uncovered serious problems at the MBPI and Bioport in earlier inspections, including contamination of the vaccine and serious falsification of records.
Bioport is controlled by a Company named Intervac owned by Admiral William Crowe (23%) Nancy El-Hibri, wife of the Bioport Chairman of the Board (30%), and the remaining 47% by I & F Holdings controlled by Fuad El-Hibri (husband of Nancy) and his father Ibrihim El-Hibri. At the time of acquisition of Bioport, Fuad was a German citizen. Ibrihim is Lebanese. Their company is incorporated in the Netherlands Antilles.
The treatment of those exposed to anthrax (both the cutaneous or skin contact kind and the inhaled variety) is just as muddled as the vaccine issue.
Until last week (October 15, 2001) the only drug recommended by the CDC for anthrax treatment was "Cipro" manufactured by the German company Bayer. This despite warnings by medical experts of severe side effects from the drug (too numerous to list here).
The FDA had ordered Bayer and other drug manufacturers to withdraw similar drugs given to animals to fight anthrax and other diseases. Abbot Laboratories voluntarily withdrew its product but Bayer is fighting the order in court.
In August, Bayer was forced to withdraw its anti-cholesterol drug "Baycol", admitting it might have killed 52 people and potentially crippled another 1,000. Several lawsuits are pending.
Bayer has a patent on its Cipro drug that expires in early 2003. It has dominated the market for this, one of the strongest anti-bacterial agents on the market. The problems of which experts warn, is that the active ingredient not only destroys the anthrax bacteria, but other (good) bacteria needed by humans’ gastro-intestinal tract to function properly.
As of last week, the CDC finally added to its list for effective anthrax treatment other antibiotics that do not have the same dangerous side effects.
Earlier this week, Tommy Thompson, Secretary of HHS, renegotiated a contract with Bayer cutting the government’s price per dose nearly in half to $095 each. Apparently ignoring the proven side effects of Cipro, the government intends to still make it its sole medication for use in anthrax cases.
Bayer has been charging the American public nearly $3.00 each for doses of Cipro. The recommended treatment is two pills per day for 60 days bringing the total cost up to about $350. In India, a comparable generic drug costs an individual about $10.00 for the full treatment. In Africa, Bayer has been charging up to double the amount paid by Americans.
What the government is not telling the public is why Bayer was able to charge such prices having a virtual monopoly on the drug. In November of last year, a California company filed a lawsuit against Bayer and five producers of the generic equivalent of Cipro. It charges that Bayer had signed marketing agreements in 1997 with those companies to pay them $26 to $30 million per year to keep their products off the market.
Earlier this week, on Fox Cable News, the CEO of one of the generic manufacturers (under sharp questioning by broadcaster Neil Cavuto) admitted to the arrangement with Bayer. However, he said, the company had the option of buying Cipro from Bayer and marketing it. He said his company could make a reasonable profit selling the drug for less than $1.00 per dose.
As for testing for the presence of Anthrax, Dr. Scott Lillibridge, the Anti-Terrorism coordinator for HHS dropped a bombshell during testimony before the House Subcommittee on National Security, Veterans Affairs and International Relations last Tuesday. He stated that there is no present technology that can detect the presence of anthrax spores in the air.
To make sure they had heard right, the question was repeated with the same reply. HHS Secretary Tommy Thompson confirmed the statement. This certainly brings in to question how effective is the testing in areas where anthrax spores have been detected on the surface of objects.
This article was not written to add to the mounting apprehensions the public has about anthrax. This writer believes most of the American public is capable of handling the truth, no matter how unsettling it may be. Evidently, the government does not share that view.
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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Major players involved in "looking the other way" (or not looking at all) are; the Food and Drug Administration (FDA), the Department of Defense (DOD), and the Center for Disease Control (CDC).
Let us not forget about members in House and Senate IGNORING the pleas since the Gulf War.
I also find this article a strange choice of words...experimental?
"The Wall Street Journal reported Friday " that the CDC has asked the U.S. Food and Drug Administration for permission to dip into military's stockpile to use the vaccine on an experimental basis to treat at least some of the civilians exposed as part of the recent attacks. The CDC says it believes that approval is "imminent."
Please Read & Sign DESTROY QUARATINED ANTHRAX VACCINE Petition
Intervac owned by Admiral William Crowe (23%)!!!!!
The internet contains very little info on the El-Hibris considering their obvious wealth and influence. Fuad El-Hibri owns(?) the Georgetown Polo Club. They play against other DC polo teams and military academies.
All about anthrax. Weekly Standard.
...day-to-day responsibility for the company, for what it's worth, falls to a German immigrant of Lebanese ancestry named Fuad El-Hibri. Fuad El-Hibri's father, an international businessman named Ibrahim El-Hibri, is prominently associated with an Islamic charity headquartered in Beirut. Tad bit of info on charity..
Again I ask: Why is our government trying to kill or destroy it's own citizens ???
Actually the Postal union is probably pushing to use the anthrax vaccine.
And if the don't get it they'll be screaming: "RAY SIZ UM . . . RAY SIZ UM" !!!
"the CDC has asked the U.S. Food and Drug Administration for permission to dip into military's stockpile to use the vaccine on an experimental basis to treat at least some of the civilians exposed as part of the recent attacks."
Well isn't that special. Now they want civilian guinea pigs to use up their stockpile of vaccine. Our government at work!
Thanks for the article, I had heard a nurse talking about this on the radio when we had the first attack of anthrax
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