October 26, 2001
With the release this week of a General Accounting Office
(GAO) report on 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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