May 25, 1998
By Rod Hafemeister
Belleville News-Democrat
The U.S. Navy injected sailors in the Persian Gulf with a 5-year-old
batch of anthrax vaccine, two months after federal regulators
said the vaccine had been given a new expiration date improperly.
That's according to U.S. Food and Drug Administration records
that show the state-owned Michigan Biologic Products Institute
relabeled a 1993 batch of anthrax vaccine in February to extend
its shelf life past 1996. Sailors on two aircraft carriers in
the gulf say medical records list that same batch - FAV020 - as
the one given to the sailors in April, according to interviews.
There is no indication the vaccine could harm the sailors, but
the FDA can't certify that it's safe either.
Changing the date of a vaccine is legal, FDA spokesman Lenora
Gelb said, but the product has to be recertified as safe and effective.
Batch FAV020 was tested for potency, but not for other problems,
FDA records show. The Michigan plant made all of the more than
seven million doses of anthrax vaccine the Pentagon said it will
use this summer to begin its program to vaccinate every active
duty, reserve and National Guard service member - 2.4 million
in all.
But FDA records show that since 1993 the Michigan plant repeatedly
has been cited for violations of the FDA's Good Manufacturing
Practices rules and other quality control problems.
The records were obtained through the Freedom of Information Act
and with the help of GulfWatch, a veterans' advocacy organization
based in Hannibal, Mo.
The records include a March 11, 1997, letter from the FDA threatening
to revoke the plant's licenses if it did not correct its problems.
In February, FDA inspectors spent two weeks in the plant, with
much of their attention focused on the anthrax vaccine line, and
concluded: "The manufacturing process for anthrax vaccine is not
validated." Among the problems:
* Vaccine was being stored for years at a time with no way of
telling whether the vaccine remained effective and uncontaminated.
* Different batches of vaccine with widely varying manufacturing
dates were mixed together to create a final batch.
* Until August 1997, filters used to harvest the vaccine were
not validated as effective nor was their integrity tested.
* No written justification existed for redating batches of vaccine
that had expired, and there was no proof the plant had even tested
the batches for contamination before giving them new expiration
dates. Batches that failed potency tests were sometimes retested
until they passed, with no explanation of why they failed.
Run by the Michigan Department of Community Health, Michigan Biologic
Products Institute is the only licensed manufacturer of anthrax
vaccine for humans in the United States. For decades, the plant
made relatively small amounts of anthrax vaccine for veterinarians
and other workers who could be exposed to the deadly livestock
disease.
But the vaccine has gained new attention in recent years, in part
because Iraq's Saddam Hussein had an active biological warfare
program and in part because anthrax is believed to be one of the
easiest biological weapons for terrorists to make.
"We know there have been problems and we are working on them,"
said Geralyn Lasher, spokesman for the Michigan Health Department.
"But remember, the anthrax vaccine has more testing done on it
than pediatric vaccines." Vaccine batches submitted to FDA for
new expiration dates are supposed to be relabeled with an alternate
Lot Number that indicates it has been redated. Inspectors found
that didn't happen, specifically identifying Lot FAV020, which
was originally dated as being tested for potency on April 13,
1993, and redated on Feb. 6, 1998.
Sailors on both the USS Independence and the USS Stennis in the
Persian Gulf in April received vaccinations from Lot FAV020, according
to three sailors on the ships who say that lot number is in their
medical records. The sailors were reached through Lori Greenleaf
of Morrison, Colo., whose son Eric Julius is stationed on the
USS Independence.
One of those sailors reached aboard the Independence was Nhut
M. Nguyen, who refused the shots but claims other sailors' medical
records show the questionable batch number. An estimated 14 sailors
on the two ships refused to take the shots and have received administrative
punishments ranging from reductions in rank to discharge from
the Navy.
Navy spokesmen did not return repeated calls last week. Pentagon
spokesmen referred questions to the Navy.
The Pentagon in March ordered anthrax vaccinations for all troops
in the Persian Gulf, including the sailors on the Independence
and the Stennis. After its February inspection, the FDA didn't
close the Michigan plant - they didn't get the chance. The anthrax
line was shut down in March to begin an 18-month, $20 million
renovation program paid for by the Army. But in an April 7 letter,
John Taylor III, FDA's senior advisor for regulatory operations,
warned that Michigan Biologic Products needs to make "significant
improvements" before resuming production.
Critics think the FDA buckled to pressure from the Pentagon and
let the Michigan lab off easy.
"The FDA has really been talking out of both sides of their mouth
- the standards were sloppy but the product was fine," said Lingg
Brewer, a Michigan state lawmaker who has been investigating the
lab.
Meryl Nass, one of the few nonmilitary doctors who has studied
anthrax, said she was appalled by the FDA reports.
"It seems that thousands of vials were discarded if there was
visible evidence of contamination or development of particulates,"
she said. "But the remaining vials in those lots (batches) were
released for use in people without further testing."
Pentagon officials maintain the anthrax is safe and effective
On Friday, Defense Secretary William Cohen announced that the
Pentagon will proceed this summer with its plans to vaccinate
2.4 million active duty, reserve and National Guard service members
over the next six to seven years.
The same day, President Clinton called for stockpiling up to 30
million doses of vaccine for defense against biological terrorism.
Attorneys for Veterans for Integrity in Government, a Washington,
D.C., advocacy group, have been attempting to stop the anthrax
vaccination program, arguing that the Pentagon cannot show that
it will either work against anthrax used as a weapon or that it
is safe in the long term.
(c) 1998 Belleville News-Democrat