Fw: DOD'S myths vs realities for anthrax vaccine

[Guest guest]

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| From: Meryl Nass <mnass@...>

| MNASS@...

| Subject: DOD'S myths vs realities for anthrax vaccine

| Date: Monday, November 30, 1998 6:58 PM

|

| From: Meryl Nass <mnass@...>

|

| It was brought to my attention that I did not make clear my concerns

| with the new DOD web page on anthrax vaccine myths vs reality.

| Therefore, I am posting a copy of the page with my comments

| (CAPITALIZED), to indicate clearly which DOD " facts " are actually

| " myths " :

|

| MYTH: There is no defense against anthrax.

|

| FACT: Vaccination is the best

| defense against biological warfare involving anthrax. Nuclear,

| Biological and Chemical (NBC) gear

| and protective masks should also be used as added

| measures to reduce exposure.

|

| MYTH: Antibiotics are just as

| effective against anthrax as the vaccine.

|

| FACT: Antibiotics can be effective

| in cases of cutaneous anthrax, which means it was

| contracted through the skin.

| However, antibiotics have not been proven effective against the

| more deadly forms of anthrax:

| inhaled and ingested. ACTUALLY, IN THE MONKEY MODEL, ANTIBIOTICS CAN BE

| VERY USEFUL IF STARTED RIGHT AFTER EXPOSURE AND BEFORE PEOPLE GET SICK,

| IF THE ANTHRAX STRAIN HAS NOT BEEN MADE ANTIBIOTIC RESISTANT.

|

| MYTH: The anthrax vaccine can cause

| me to catch anthrax. It works like the flu

| vaccine and actually injects live

| cells into my body to build immunity.

|

| FACT: The anthrax vaccine does not

| use live bacteria. It is a sterile product made from a strain

| of anthrax that does not cause

| disease.

|

| MYTH: Anthrax spores can be

| destroyed by common disinfectants.

|

| FACT: Spores can only be destroyed

| by steam sterilization or burning.

|

| MYTH: Nobody can survive in an

| anthrax contaminated area.

|

| FACT: People who have been

| vaccinated for anthrax can survive in an anthrax contaminated

| area. Protective masks and NBC suits

| can also provide protection against contamination.

| EVEN IN ANIMALS, PROTECTION BY THE VACCINE IS ONLY PARTIAL, IE SOME

| PROPORTION OF EXPOSED ANIMALS DIE AFTER EXPOSURE. DEPENDING ON THE

| STUDY, THE DEATH RATE HAS RANGED FROM 0 - 100%. NBC GEAR IS LIKELY MUCH

| MORE RELIABLE.

|

| MYTH: Service members will have

| ample warning of an anthrax attack due to

| effective detection devices.

|

| FACT: Interim systems of detecting

| biological agents are just now being fielded in limited

| numbers. Until reliable detectors

| are available in sufficient numbers, usually the first indication of

| a biological attack in unprotected

| soldiers will be the ill soldier. Even with detection systems,

| medical protection (vaccines),

| intelligence, and physical protection will be required to provide

| layered primary defenses against a

| biological attack.

|

| MYTH: Anthrax must be

| hand-delivered; it cannot survive any other means of

| deployment.

|

| FACT: Anthrax bacteria can be

| deployed by missiles and artillery shells, thereby allowing the

| enemy a greater distance from which

| to attack.

|

| MYTH: Anthrax can be transmitted

| from person to person.

|

| FACT: There is no evidence of

| person-to-person transmission of anthrax. Quarantine of

| affected individuals is not

| recommended.

|

| MYTH: One injection of the anthrax

| vaccine will protect you for life.

|

| FACT: As with other vaccines, annual

| booster shots are required to maintain immunity after the

| initial six-shot series.

|

| MYTH: The anthrax vaccine will

| protect me against all biological agents.

|

| FACT: The vaccine will protect you

| against all known strains of anthrax. It will not protect you

| against other biological agents.

|

| THE ONLY TWO STUDIES IN THE PUBLIC DOMAIN TO LOOK AT THIS ISSUE WERE

| DONE AT FORT DETRICK, BY DIFFERENT RESEARCHERS, TWELVE YEARS APART. THE

| FIRST STUDY, BY LITTLE AND KNUDSON, (Infection and Immunity 1986, vol

| 52, pp 509-12) LOOKED AT 27 ANTHRAX STRAINS. NINE OF THE 27 STRAINS

| CAUSED THE DEATH OF 50 - 100% OF THE VACCINATED GUINEA PIGS.

|

| THE SECOND STUDY, BY IVINS, LINSCOTT AND FELLOWS, PRESENTED AT THE

| INTERNATIONAL ANTHRAX CONFERENCE IN PLYMOUTH UK ON SEPT 9, 1998, LOOKED

| AT 33 STRAINS ISOLATED FROM AROUND THE WORLD. 27 OF THE 33 STRAINS

| CAUSED THE DEATH OF AT LEAST 50% OF THE VACCINATED GUINEA PIGS.

|

| MYTH: The anthrax vaccine is

| experimental and under investigation.

|

| FACT: The anthrax vaccine is not

| experimental or investigational. It has been used safely to

| protect at-risk industrial and

| laboratory workers for almost 30 years.

|

| MYTH: The reliability of the anthrax

| vaccine is based on only one human

| efficacy group -- wool mill workers.

|

| FACT: Clinical studies with

| approximately 1,200 wool mill workers have demonstrated

| protection against cutaneous

| anthrax. Since conducting lethal challenge studies in humans is

| considered unethical, determining

| the actual efficacy of the vaccine is not possible. However,

| there have been numerous tests of

| the anthrax vaccine involving animal models

| (i.e., Rhesus monkey model) upon

| which the FDA determined its safety and efficacy. THE RHESUS STUDIES

| ONLY SUBJECTED THE MONKEYS TO CHALLENGE WITH VOLLUM AND AMES STRAINS,

| AND DID NOT CHALLENGE THEM TO THE MOST VIRULENT STRAINS FOUND BY IVINS’

| GROUP. FURTHERMORE, IT IS DIFFICULT IF NOT IMPOSSIBLE TO ASSURE SAFETY

| WHEN STUDIES ARE DONE IN ANOTHER SPECIES.

|

| MYTH: The anthrax vaccine may cause

| sterility.

|

| FACT: The vaccination has been

| routinely used for the past 28 years and has not been

| associated with sterility. Although

| we cannot conduct experiments with lethal agents on the

| human reproductive system (for

| ethical reasons), there is ample evidence that it does not cause

| any harm or sterility. THERE IS NO

| MEANINGFUL EVIDENCE, AS NO TRIAL HAS BEEN DONE THAT LOOKED FOR SIDE

| EFFECTS AFTER A VERY BRIEF PERIOD (WEEKS).

|

| MYTH: It is safe for pregnant women

| to receive the anthrax vaccine.

|

| FACT: It is not considered safe for

| women to receive ANY vaccines during pregnancy.

| Deferment of ALL immunizations is

| standard procedure for pregnant women.

|

| MYTH: Anthrax kills only farm

| animals.

|

| FACT: Anthrax kills both animals and

| humans.

|

| MYTH: Anthrax is a new, manufactured

| disease.

|

| FACT: Anthrax dates back to 1500

| B.C., first recorded by the Egyptians as the cause of the

| fifth Egyptian plague.

|

| PEOPLE SPECULATE ABOUT THIS. I'D NOT CALL IT A FACT.

|

| MYTH: Anthrax vaccine caused Gulf

| War Illnesses.

|

| FACT: For the simple reason that it

| has been routinely used for 28 years with no resulting

| symptoms indicative of Gulf War

| Illnesses, the anthrax vaccine cannot be responsible for the

| illness.

|

| VERY FEW PEOPLE RECEIVED THE VACCINE BEFORE THE GULF WAR, PROBABLY

| 3,000-4,000. THEY WERE NOT STUDIED FOR LONG TERM EFFECTS. SINCE THE

| ANTHRAX VACCINE LOTS VARY IN TERMS OF POTENCY BY A FACTOR OF 40, AND IN

| TERMS OF STERILITY AND STABILITY AS WELL, IT MAY BE THAT SOME LOTS ARE

| MORE HARMFUL THAN OTHERS.

|

| MYTH: The Michigan Biologic Products

| Institute (MBPI) was shut down as a

| result of an FDA inspection in

| November 1996.

|

| FACT: Production stopped when the

| production contract expired. This was timed to

| accommodate the planned renovation

| of the vaccine production suite as part of the Department of

| Defense’s acquisition strategy. The

| renovation will assure that MBPI (now Bioport Corporation)

| remains in compliance with stringent

| federal manufacturing practices.

|

| MYTH: The FDA report of MBPI caused

| the Department of Defense’s decision

| to conduct additional testing on the

| anthrax vaccine stockpile.

|

| FACT: Conducting additional testing

| on the anthrax vaccine stockpile was a self-directed

| Department of Defense action and was

| not based on any report from the FDA.

|

| FDA DIRECTED DOD TO PERFORM SUPPLEMENTAL TESTING. SEE NUMBER 2, IN THE

| STATEMENT WRITTEN BY DOD’S “INDEPENDENT VACCINE CONSULTANT” GERALD

| BURROW FOR CONFIRMATION AT THE FOLLOWING URL:

|

| http://dallasnw.quik.com/cyberella/Anthrax/burrows.htm#supplemental

| --

| Meryl Nass, M.D.

| Parkview Hospital, Brunswick, Maine 04011

| email mnass@...

| phone (207) 865-0875

| fax (207) 865-6975

|

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