Reports Criticize Anthrax Vaccine's Manufacturer

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Reports Criticize Anthrax Vaccine's Manufacturer

By THOMAS D. WILLIAMS

The Hartford Courant

May 22, 2000

Behind the news that state Attorney General Blumenthal may seriously

challenge the military's anthrax vaccination program are lingering questions

about the safety and legality of the drug's manufacturing process.

Annual federal inspection reports sharply criticize different aspects in the

production of the vaccine by a Michigan company.

For example, U.S. Food and Drug Administration inspection reports from 1996

through 1999 repeatedly cite similar concerns.

In a March 1997 report to Myers, one of the manufacturer's operators

still in control today, the FDA criticized the company's ``failure to

establish and/or follow written procedures for product and process controls

designed to assure that products have the identity, strength, quality and

purity they purport or represent to possess.''

``We note that your firm has repeatedly promised corrective actions,'' the

FDA wrote, ``but follow up inspections continue to show that adequate

effective long term corrective action has not been taken.''

Still, FDA officials insist the company has done enough to produce a safe

vaccine.

The FDA has continued to approve certain batches, or ``lots,'' of the

vaccine, some of which are 9 years old, for use in the controversial program

of mandatory inoculation of U.S. armed service members intended to protect

them during biological warfare. The normal life of the vaccine is three

years, but the FDA has extended the approved life of some lots.

The vaccine has been assailed by some who believe there is no proof it works,

and by those using it who say it produces adverse reactions. More than 350

active service members have been disciplined for refusing to take the

vaccination, and hundreds of National Guard and military reserve members have

quit rather than take it.

State Consumer Protection Commissioner Fleming confirmed Thursday he

has been asked by Blumenthal to conduct a joint inquiry into the vaccine. He

said he and the attorney general are concerned about the health effects of

the vaccination on National Guard troops, who are state employees.

The FDA inspection reports detail scores of problems faced by Michigan

Biologic Products Institute, the state-run company that until two years ago

made the vaccine. Last year, MBPI's successor, BioPort Inc., failed an FDA

inspection required before distributing its own new batches of the vaccine.

The military is expected to run out of the vaccine by July.

Among the problems found by the FDA in the most recent inspections of the old

vaccine production operations:

* ``Prior to August 1997, the filters used for harvest of anthrax vaccine

were neither validated nor integrity tested. This filter is the only sterile

filtration step in the anthrax manufacturing process,'' says a 1998

inspection report. Filters are used to keep impurities out of the drug.

* ``Documented numerous violations in the following areas: organization and

personnel, buildings, facilities, equipment controls, laboratory controls and

records and reports,'' a 1996 report says. Some of these same areas were

criticized by the FDA in 1997, 1998 and 1999 reports.

* Four fermenters, major pieces of equipment used to formulate the vaccine,

were not approved in advance in 1990 by the FDA. The new equipment was made

of stainless steel, and was not glass-lined as the originals were.

* Some lots of vaccine were not properly labeled, a potential violation of

federal law, and one lot's shelf life was extended after it had expired.

``Based on my reading of the 1997 and 1998 inspection reports of MBPI, this

is a company that is completely out of control, and they should not be

producing medicinal products for human use,'' said Sammie R. Young, a retired

FDA inspector and supervisor for 29 years. Young said he became interested in

the FDA inspections of the manufacturers after reading about the dispute over

the drug's safety and effectiveness.

Young, who retired in 1992, had nothing to do with inspections of MBPI.

``It appears from the [1996, 1997 and 1998] FDA inspection reports, [MBPI]

did not conduct their manufacturing operations in accordance with current

good manufacturing practices which guarantee the safety, purity and potency

required under the federal food, drug and cosmetic act and its related public

service act,'' Young said.

``The concern I have about the FDA,'' said U.S. Rep. Shays, R-4th

District, ``is that they treat BioPort as rigorously as any other vaccine

maker, and not show favoritism because the company is the Defense

Department's captive customer.''

BioPort is the sole supplier of the vaccine aimed at protecting 2.4 million

service members. The inoculation regimen includes six shots and booster shots

per person.

Lenore Gelb, a spokeswoman for the FDA, said BioPort is allowed to continue

providing vaccine supplies because agency officials have seen enough

improvements that they believe the products being released are safe and

effective.

Gelb said there is no evidence to show the anthrax vaccine filters did not

work before 1997, even though they were not validated or integrity tested.

The results of lot testing by the manufacturer, she explained, give

assurances the product is pure, stable and potent.

BioPort recently submitted a supplement to its license to now approve the

change in fermenters some years back, said Gelb. And even if lot numbers are

not brought up to date, Gelb said, the critical information - the expiration

date - is on those labels. The vaccine was developed to protect veterinarians

and farmers from anthrax viruses in animals they touched. The drug's new use

is to protect military troops from inhaled anthrax spores, a use some legal

experts argue requires an entirely new vaccine approval from the FDA.

Representatives of the Defense Department and BioPort insist that animal

studies show the vaccine is effective for the new use.

Opponents of the vaccination program acknowledge there is no way to prove a

link between deficiencies found during inspections and reports of negative

reactions from service members given the vaccine.

Before anyone can know with reasonable scientific certainty whether vaccine

users are getting sick from it, the government must study humans who have

already used it, said Dr. Meryl Nass, a Maine doctor who has assisted many

who say they have had adverse reactions to the vaccine.

Nass said the government should have tested the long-term effects on more

than 150,000 Persian Gulf War veterans who took the shots, or the short-term

effects on the more than 406,000 service members most recently vaccinated.

More than 800 of those vaccinated have had adverse reactions to the drug,

according to government figures.

The government has said the vast majority of those with adverse reactions

suffered minor, short-term effects. Nass said information supplied by the

Defense Department has understated the number of those claiming to have

adverse reactions, and the severity of their reactions.

For more Hartford Courant articles on the anthrax vaccine dilemma see:

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