US: Government considers stockpiling anthrax vaccine that may be as deadly as th

[Guest guest]

US: Government considers stockpiling anthrax vaccine that may be as

deadly as the disease. In case of bio-attack, citizens can be

vaccinated against their will.

 

 

 

 

http://www.upi.com/HealthBusiness/view.php?StoryID=20051027-055430-5633r

 

 

Anthrax treatment may be deadly

 

By STEVE MITCHELL

Senior Medical Correspondent

 

WASHINGTON, Oct. 27 (UPI) -- Preliminary studies obtained by United

Press International show serious and potential life-threatening

problems with a potential anthrax treatment the U.S. government is

developing.

 

Anthrax immune globulin, which the government is developing as a

possible treatment in the event of a bioterror attack, protects

animals from death if given prior to exposure to toxins from Bacillus

anthracis, the anthrax bacterium, but if the compound is formulated

incorrectly it can be fatal and it did not prevent death when given

after exposure.

 

Some anthrax immune globulin, or AIG, already may have been placed in

the Strategic National Stockpile for emergency use, but at least one

expert warned that the research data show the compound does not appear

to be effective and actually could kill people.

 

The Centers for Disease Control and Prevention in Atlanta initiated

the animal studies last year, and the Department of Health and Human

Services recently awarded a contract to Cangene, a Canadian biotech

company, for approximately $428,000 to supply 10 grams of AIG for

further testing. HHS researchers have been given a year to finish the

studies and decide if the government should order up to 100,000 doses.

 

The government is interested in developing AIG as an alternative

anthrax treatment due to the high mortality rate from the 2001 anthrax

letters that killed five people. The death rate was 45 percent, even

when intensive-care treatment and antibiotics were administered, and

future bioterror attacks could involve anthrax that has been

genetically engineered to evade current antibiotics, the CDC noted in

its report on the animal studies.

 

The CDC published a notice in June in the Federal Register that the

results of the studies were available, but the agency, for reasons it

has not explained, delayed sending the results to UPI until this week

-- more than four months after the Federal Register notice and several

weeks after HHS awarded the contract to Cangene. The biotech firm,

based in Winnipeg, Manitoba, said it was not involved in the animal

studies and would not be involved in the additional studies being

conducted by HHS.

 

CDC spokesman Dave Daigle requested that UPI e-mail him questions

about the studies, but then did not respond with comment.

 

" Obviously they can't use this stuff, " said Dr. Meryl Nass, an anthrax

expert and a physician in Bar Harbor, Maine, adding she would become

concerned if officials tried to use it on an emergency basis in the

event of another anthrax attack.

 

" It might kill people, " Nass told UPI.

 

AIG is obtained from the plasma of soldiers who have been inoculated

with the anthrax vaccine, which has had a controversial history. The

military requires all servicemen to receive the vaccination, but some

have objected because they claimed it caused chronic health problems,

including dizziness, muscle and joint pain and sleep disruption.

Others have said the vaccine may have played a role in causing Gulf

War Syndrome. Federal officials, including some in the military, have

insisted the vaccine is safe.

 

In the AIG studies, rats that received a high-enough dose of the

compound prior to being injected with anthrax " were completely

protected, " concluded the CDC report -- which does not cite the names

of the researchers who wrote it. The animals survived until the end of

the study, which lasted 48 hours.

 

AIG administered after exposure to anthrax may not confer much

protection, however. Rats that received the compound 5, 10 or 20

minutes after being injected with anthrax died within approximately

three hours. Only those given AIG immediately after the anthrax

injection survived the entire 48-hour study period.

 

Nass said a study period of 48 hours was short and " very odd. " With

most animals, it takes a few days before they die from anthrax, so

this raises the question whether the rats that were alive after 48

hours would have continued to survive if the study had gone on longer,

she said.

 

Nass also questioned the rationale for administering AIG only up until

20 minutes after the anthrax exposure.

 

" That means it doesn't work, " she said. " You're never going to give it

to a human that fast. "

 

Under real-life conditions, a person probably would not become aware

of the exposure and the need for treatment lasting a day or two, she said.

 

The CDC studies also indicate AIG can be deadly under certain

circumstances. A separate experiment in rabbits found that a high dose

was fatal in all the animals the received it.

 

" Since there were deaths among 100 percent of rabbits receiving 40

mg/kg AIG intravenously ... a thorough safety evaluation has been

initiated, " the report stated.

 

The investigators determined the likely problem was a change in

formulation of AIG. The concentration had been doubled from 5 percent

to 10 percent for the rabbit study. This was done to increase the

potency of the compound and to reduce the amount needed to protect the

animals.

 

" Evidence suggests that this likely clogged the renal tubules, causing

an acute toxic nephropathy (acute tubular necrosis) that was seen on

necropsy in the dead rabbits, " the CDC team concluded in the study.

 

The problem appeared to be the higher concentration of AIG combined

with the fact that it was prepared in a freeze-dried formulation meant

it required more time to dissolve into solution.

 

A less-concentrated dose of AIG still may cause problems, however. In

one study, all four animals that received a less-concentrated formula

" experienced rapid breathing and (one of the four) experienced

diarrhea, " the report noted.

 

The final sentence of the report said the CDC decided that switching

the AIG formulation to a 5 percent liquid version may avert some of

the dangers of the compound, and the agency " is currently planning

animal studies to evaluate AIG dosage and efficacy. "

 

The report does not mention whether those studies ever were conducted

or what the results were.

 

John Langstaff, president of Cangene, told UPI his company recently

shipped a supply of AIG to the CDC, which " still has some ongoing

activities. "

 

The HHS studies of AIG involve " testing to see if it's safe, "

Langstaff said.

 

Cangene was not participating in those studies, but the company would

be involved in human clinical trials if HHS elects to pursue

development of AIG, he said.

 

--

 

E-mail: healthbiz