Have now retyped the scanned version of Dissecting Propaganda

[Guest guest]

Still have my computer down, but my assistant retyped the parts of this

that scanned poorly.

Meryl Nass

Dissecting Propaganda:

Dr. Greg Poland Supports the AVIP

Commentary by Meryl Nass, MD February 7, 2000

Introduction

Dr. Poland, influenza vaccine expert at the Mayo Clinic and

member of the Armed Forces Epidemiology Board, was hired by DOD to speak

to servicemembers in support of the anthrax vaccine immunization program

(AVIP). In addition to personally appearing at several bases, a video of

his talk has been widely circulated (and in some cases is shown hourly)

at bases where the vaccine is being given.

In early 1998, a gynecologist from Yale was asked to review the medical

aspects of the AVIP for DOD. The gynecologist, Dr. Gerard Burrow, later

informed Congress that he had " no expertise in anthrax " when asked to

testify as to his qualifications and the materials he reviewed in

support of the program. It will be interesting to see what Dr. Poland

has to say if Congress calls for his testimony.

Dr. Poland has performed admirably for his employer, using techniques

other DOD spokespersons have employed to support the AVIP, which

include:

1) Selectively quoting from published and unpublished studies to support

the vaccine and omitting other data from the studies which do not

support the points one wants to make

2) Casting the opposition as ill-informed or ridiculous, invoking " the

entire history of medicine and science " to support claims which are

incorrect

3) Providing outright misinformation when the strategies above are not

sufficient to convince the audience of one's viewpoint.

I will provide a point-by-point summary of the errors, omissions and

misinformation, which comprise the bulk of his lecture. When supporting

documents are available electronically, I will provide the URL.

Anthrax: The Disease

Poland says that cutaneous (skin infection) anthrax has a 5 to 20%

mortality rate. In fact, antibiotic treatment produces a rate less than

1%. He says inhalation anthrax is essentially 100% fatal. But the

epidemics in Sverdlovsk and Manchester, New Hampshire (the only

epidemics of inhalation anthrax in recent decades) each had

approximately 80% fatality rates.

He says, " Once anthrax starts, there is nothing you can do. It is 99%

fatal, like Ebola. " Actually, Ebola too has an 80% mortality rate.

Once an anthrax attack is detected, there is plenty you can do. You

administer antibiotics, passive immunoprophylaxis, and post-exposure

vaccination, (post-exposure vaccination is required for exposed troops

in DOD documents, though this is not an FDA-approved use) and it is

designed to provide immunity after exposed persons receive a course of

antibiotics for 30, 60 or more days. In the monkey studies, this has led

to greater than 90% survival, in monkeys who were not vaccinated until

after exposure. The possibility of antibiotic resistance does exist.

" Anthrax goes to the nodes and forms spores. " Not quite. The spores

(essentially the bacteria in hibernation) are not active until they

germinate and form vegetative cells. Spores are not formed in nodes. The

infection process requires transformation from the spore form.

" Vaccination is the only practical means of surviving. " I've listed

above the other two forms of treatment of anthrax following exposure

and/or illness above. If you treat people right after exposure, survival

is likely to be high. If you wait until people get sick, the survival

rate will plummet. Good detectors are key here.

Biowarfare

The other important point that needs to be made is that weaponized

anthrax is likely to defeat the vaccine. Even if the vaccine were 100%

effective against all strains of anthrax (and that is hardly the case)

an enemy would simply choose a different bioweapon, such as smallpox,

plague or botulinum. Every nation we know of that has had a biowarfare

program weaponized multiple microorganisms. And the Russians made a

vaccine-resistant strain of anthrax, publishing their results in 1997

(Pomerantsev AP et al. Expression of cereolysin AB genes in Bacillus

anthracis...Vaccine 15, p. 1846).

Dr. Poland reinvents history when he claims, " Iraq admitted it used

Bioweapons to the UN, and used them against its own people. " Iraq has

used chemical weapons against Iran and its own people, and possibly used

them in the Gulf War (but has not admitted this). Iraq never admitted

using biological weapons ever, anywhere. Anthrax vaccine is no help

against chemical weapons.

Here's something I agree with: of three scenarios for anticipated use of

bioweapons, Dr. Poland reported that a direct hit of bioweapons on our

troops is the least likely to take place.

Why would bioweapons be used? Here we move beyond the realm of medical

expertise. Dr. Poland entertains the audience by invoking enemies who

plan to " Bring on a new dawn after a cleansing apocalype " and others who

would " Mimic God. " Are these the enemies who so threaten us with anthrax

that we are willing to risk the health of our troops? Come on!

" When, Not If. " How many times have we heard that remark used in support

of this program? As I've pointed out in other writings, anthrax was used

by Japan in WWII (Unit 731, and Wallace, The Free Press, NY,

1989) and against black guerrillas during the ian civil war in

1979 and 1980 (Anthrax Epizootic in Zimbabwe, Nass M, Physicians for

Social Responsibility Quarterly 2, p. 198, 1992). There has not been a

lot of use during the past 60 years. The US had a factory in Vigo,

Indiana producing anthrax weapons for cluster bombs during World War II

as well. So Dr. Poland is correct: it is not " if " , because it has

already been used. It may be used again. Neither of the episodes above

caused a large number of deaths. Use of anthrax will be unlikely to

affect large numbers of people, unless an enemy is allowed to perform

extended spraying of huge quantities of spores within our air space

under perfect weather conditions.

Vaccine Production and Testing

" It is a toxoid vaccine " : well, yes and no. PA (the vaccine's main

component) could be called a toxoid, but there are many other

uncharacterized substances in the vaccine which may be causing problems,

and no one knows what those substances are. So the vaccine is not simply

" a toxoid " but a mix of unknown molecules with unknown effects that are

injected into humans.

" The vaccine is filtrated and sterile. " It is supposed to be sterile,

but the FDA inspection reports (www.anthraxvaccine.org) indicate that

many sublots were not, and that lots with many contaminated vials were

used without further testing of the remaining lot. The vaccine goes

through one filtration step, which is supposed to sterilize it, but may

not always do so.

FDA lot release criteria do include tests for purity, potency, sterility

and safety. But there are two loopholes here you could drive a tank

through.

First, throughout the 1990s, until the vaccine program was announced,

FDA only reviewed test results from the manufacturer, and did not test

the lots itself. When Mitretek was hired to oversee the manufacturers

own test processes 25 lots (of 31 that were tested) which had initially

" passed " these tests, subsequently failed them. Independent of

Mitretek's review, FDA quarantined about 14 lots it had originally

" passed " , once it inspected the plant in 1998 and got a better look at

the manufacturing process.

Second, the names of these tests do not adequately convey what is being

tested. The " purity " test does not judge purity of the vaccine filtrate,

but rather the amount of aluminum and preservative in the vaccine. There

can be no test for vaccine purity, because the vaccine process includes

no purification step, and each vaccine lot contains different amounts of

products than every other lot produced. Even Dr. Friedlander, assistant

to the Commander at Fort Detrick and a vaccine spokesperson, has

acknowledged this (Brachman PS and Friedlander AM. Anthrax, in Vaccines,

eds Plotkin and Mortimer. WB Saunders, p. 729, 1994).

The sterility test does look for growth of some, but not all,

microorganisms, but sublots which failed the test were sometimes placed

into lots. The potency test has been found to be invalid and the

manufacturer is now trying to develop a newer, accurate test. The safety

test is performed by giving the vaccine to guinea pigs. If they do not

lose weight or die in 7 days the safety test is graded " pass " . Clearly

these lot release criteria do not assure the absence of vaccine

problems.

Development and Approval

Dr. Poland says the vaccine was licensed by FDA in 1970. Actually, it

was licensed by the Bureau of Biologic Standards (BBS) at NIH. Because

of problems with BBS' standards, the division was transferred to the FDA

several years later.

" The vaccine was developed by Merck. " Actually it was developed at Fort

Detrick, and the DOD still has the patent.

Package Insert Contraindications

He mentions the contraindications to vaccine use. These are noted on the

package insert, but there have been hundreds of reports of

servicemembers suffering the ill effects listed, but still being forced

to continue receiving the vaccine. Military practice in this case

appears to ignore standard medical practice.

How Many Doses?

" 68,000 doses were distributed between 1974 and 1989. " Discussing doses

distributed is a clever way of avoiding the fact that DOD cannot provide

numbers of whom and how many received the vaccine during this period.

The General Accounting Office told Congress that between 200 and 2,000

people were vaccinated, and no records were kept and no follow-up done.

The doses distributed were probably used primarily for the animal

experiments performed during this period in the US and elsewhere.

" 268,000 doses were distributed during the Gulf War " . But 170,000 or

less were supposed to have been used on troops. Where are the rest, and

have they been used on servicemembers in the past two years?

Adverse Reaction Reports

Dr. Poland says not one report was sent to the manufacturer of an

adverse reaction during the first 20 years of licensure. This is not the

case. The manufacturer wrote a memo to FDA dated August 31, 1990

referring to 600 reactions that had been collected by DOD

(www.anthraxvaccine.org/suppdocs/doc4.htm). Perhaps technically the

reports " were not sent to the manufacturer " but the manufacturer was

certainly aware of them.

Misrepresenting the Brachman Trial

Dr. Poland makes numerous mistakes when referring to the Brachman trial,

the only human efficacy trial ever conducted of this vaccine, in goat

hair mills in New England. Actually, Brachman used a different vaccine

on most of the subjects in his study than the vaccine being used

currently.

Still, since this is the only published trial of a " killed " anthrax

vaccine in humans, it is worth reviewing the data (Brachman et al. Field

Evaluation of a human anthrax vaccine, Am J Pub Health 1962 pp 632-45).

I have copies of the data table I cite below.

a) Poland says 50% of the millworkers were vaccinated. Actually, only

30.3% were vaccinated. Nearly one third refused to participate, and

others dropped out after receiving initial vaccine doses.

He claims that 5 of 340 unvaccinated workers got inhalation anthrax.

Actually, a total of 719 were not vaccinated; 340 were vaccine trial

refusers and the rest received placebos. Inhalation cases were from both

groups.

c) He claims that 0 out of 793 fully vaccinated workers got inhalation

anthrax. Actually, only 379 were fully vaccinated, and one got

cutaneous anthrax.

d) Overall, there were 26 cases of anthrax at the 4 mills during the

trial. According to Brachman's table, 3 cases occurred in vaccinated

individuals, 17 in people who got the placebo vaccine, and 6 in

uninoculated employees (vaccine trial refusers).

Of the three vaccinated cases, two had received three doses of vaccine

(one of who was late for the fourth dose), and one received two doses.

This may be of interest, since you are now considered fully deployable

after three doses, and many servicemembers have had their fourth dose

delayed.

To be honest, Brachman himself didn't get the numbers right either.

Elsewhere in the text, he reports that there were four anthrax cases,

not two, in partially vaccinated employees, and only 15 cases in those

given placebo injections. If you use these numbers to compare those who

received placebo injections and developed anthrax (3.6%) with those who

received full or partial vaccinations and developed anthrax (1%), you

conclude that the vaccine was 72% effective, not 92% as Brachman

claimed. Brachman may have lumped refusers in with his placebo group, or

thrown out the anthrax cases in partially vaccinated individuals, to

arrive at a higher effectiveness rating for the vaccine.

By the way, Dr. Poland said the Brachman experience with an epidemic of

inhalation anthrax cases was an " accident of nature. " It is odd that 25%

of all inhalation anthrax cases documented in the United States during

the twentieth century occurred in one mill during a trial to determine

the inhalation efficacy of anthrax vaccine. Hooper, in the book

The River (Little, Brown 1999, pp 555-559) speculates that a deliberate

change in processing which occurred on the first day of the Manchester,

NH epidemic may have contributed, im proving the conditions of the field

trial for evaluation of inhalation anthrax. If Hooper is correct, Poland

may also be wrong about the " high moral development in our culture "

which has stopped us from testing inhalation anthrax on humans to assess

vaccine efficacy.

Misrepresenting the Fort Detrick data

Poland mentions a study at Fort Detrick of 500 employees who have

received up to 300 doses of numerous vaccines. He says there is no

increased rate of adverse events. The published study of Detrick workers

from 1974 is less sanguine about the results, suggesting that two lymph

cancers might be related and further studies should be ongoing.

The 1999 study by Pittman, Poland implies, shows no problem from the

anthrax vaccine. However, the vast majority of the 500 people studied at

Fort Detrick received experimental vaccines, but did not receive anthrax

vaccine.

VAERS

Poland discusses the VAERS reports filed for anthrax vaccine. He says

264 of these are for " other than serious " reactions. But the DOD has

defined serious as either requiring hospitalization or missing more than

24 hours' duty time. Nothing else counts as serious. Most of the serious

reactions did not meet these restrictive criteria. In many cases, lost

work did not start immediately after receiving the vaccine. Muscle and

joint pain and memory loss may have never caused loss of work or

hospitalization, but are considered very serious by those experiencing

these problems.

Poland claims that of 17 persons hospitalized, only 5 had illnesses due

to the vaccine, and four of these were for red arms. When did DOD start

hospitalizing servicemembers for red arms? There must have been a lot

more to these cases than a red arm.

As I write this paper, I am aware of two persons on life-support in the

Washington, DC area after receiving anthrax vaccine.

Safety

Dr. Poland cites the Brachman statistics to demonstrate vaccine safety.

What he doesn't tell you is that Dr. Brachman performed active

surveillance on vaccine recipients only for local effects and only for

the first 48 hours following vaccination. So the data may be reasonably

accurate for 48 hours and local reactions, but are meaningless for long

term reactions and systemic effects. Furthermore, the Brachman trial

used an earlier anthrax vaccine.

All the other unpublished trials at Forth Detrick show systemic reaction

rates of 20% - 48% when active surveillance was employed. Extracts of

data from these trials were presented in my testimony to Congressman

Shays' Subcommittee on April 29, 1999, and can be found on the

Committee's website or my own: www.anthraxvaccine.org.

The Korea Study

Dr. Poland claims that women had two times the local reaction rate of

men, but it was due to less muscular arms. This might be correct if the

vaccine were administered into the muscle; but it is given under the

skin, so different muscle mass should not be a consideration. He then

claims that women have the same rate of sytemic reactions as men.

However, Colonel Hoffman's data showed that women had three times the

systemic reaction rate as men, not the same rate. Data from the first

380 people studied in Korea can be found at

www.dallasnw.quik.com/cyberella/Anthrax/FtDetrick5_99.html.

VAERS filed from Dover AFB and Battle Creek Michigan ANG

Dr. Poland says he has personally reviewed every VAERS report from these

bases and he " has not found any pattern of reaction that is untoward or

different from tetanus vaccine. " Since when has tetanus vaccine caused

so many to become DNIF (duties not including flying)? Two pilots and a

nurse from Dover testified before Congressman Shays' Subcommittee on

July 21, 1999. Three people from Battle Creek testified on April 29,

1999. Their testimony, which can be found on the subcommittee website,

eloquently belies Dr. Poland's glib statement: many of these people are

very ill, and together have lost many months of work. He says it is

difficult to disprove a vaccine causality for rare events. That is

correct, but in the case of anthrax vaccine we are talking about common

adverse events. Poland says you would have to enroll hundreds of

thousands of women to get sufficient data on fertility. But at Tripler

Army Medical Center, where 600 medical personnel were enrolled in an

anthrax vaccine trial, there were a umber of vaccinated women who became

pregnant. They were already being studied. Why isn't the data on these

pregnancies being made available?

BioIogical Plausibility

Dr. Poland says, " No vaccine causes cancer or impairs fertility... I've

spent my whole career reading about vaccines and they don't do this...

There simply is no biologic evidence for it... "

Excuse me, but the veterinarians know all about vaccines causing cancer

in cats and dogs: fibrosarcomas. Right at the injection site. One

abstract is on my website about this, from a study done at U.C. in

1993 by Kass et al. (www.anthraxvaccine.org/vaccinearticles.htm)

Multiple other reports in the medical and veterinary literature show

that serious neurological illnesses and autoimmune problems, including

bleeding disorders, may develop following vaccination.

Dr. Poland makes a joke of how many in the audience have had a joint or

muscle pain or headache in the last month. III servicemembers report

being in chronic pain throughout most of their muscles and joints.

Dr. Poland claims Gulllain Barre cases are no greater after vaccination

than before. How does he know that? A 1996 article in the Journal of the

American Medical Association by Dr. Maurice Hillman, esteemed vaccine

expert, notes that the rate of Gulllain Barre after receiving Swine Flu

vaccine was sevenfold higher than the baseline rate. Hilleman also notes

that despite a seven-fold increase in vaccinated civilians, " No

increased risk was found in military personnel. " Maybe the military

isn't very good at identifying and reporting serious adverse events.

Misrepresenting the Knudson Study

The first author of this study is actually Little, not Knudson.

Seven out of 27 anthrax strains tested killed the majority of vaccinated

guinea pigs, which were injected with those strains.

a) Poland says the guinea pigs only received two doses of vaccine. The

paper says they got three. No animal study, including the monkey

studies, has used more than three doses, which is considered a complete

vaccine series in animals.

Poland says another problem is that the guinea pigs were given

intramuscular (im) injections, not the subcutaneous injections the

military is currently using. He fails to mention that the intramuscular

site is believed by DOD to offer as good or better protection, and DOD

has applied to FDA to give the injections to service m embers

intramuscularly.

c) Poland says the anthrax challenge spores were injected IV. The paper

says it was im, the standard way animal studies of anthrax have usually

been performed. In general, guinea pigs have responded the same to im

and aerosol (inhalation) challenge.

Dr. Poland says guinea pigs are a flawed, inappropriate model for

anthrax. But they are the species used for all the tests, which must be

performed to release every lot of vaccine by FDA. I was amused by his

evocation of Iraqi soldiers attacking troops with anthrax syringes, but

his metaphor is inappropriate. These are the animal experiments,

performed by our top experts at Fort Detrick. They are done this way for

good reason. The (fewer) studies using aerosol challenge yield similar

results. These studies suggest that our vaccine will not protect against

all strains of anthrax. You can't pick and choose which studies matter

based on whether they give you the results you want. Dr. Poland calls

himself a scientist, but he flouts the basic tenets of science: honesty

regarding data, and careful analysis of all your results, whether you

like them or not.

The data from Little's paper can be found at

www.anthraxvaccine.org/testimon.htm

Dr. Poland does not mention the unpublished study by Linscott, Fellows

and Ivins at Fort Detrick, in which 24 out of 33 anthrax strains killed

more than half the guinea pigs tested. Data from this study were

presented at the International Anthrax Conference in 1998 and were

included in my April 1999 testimony, at the website in the paragraph

above.

Gulf War Illness (GWl) and anthrax vaccine

Please see my April 29,1999 Congressional testimony (the URL just above)

for more information on this. All the expert committees convened by DOD,

which commented, on anthrax vaccine and GWI reviewed no independent

data, and received their information on the vaccine from DOD briefers.

Thus they concluded that anthrax vaccine was not a problem. Of over 130

studies funded by DOD in the US to explore the causes of GWI, none have

looked at anthrax vaccine, though 16 other possible causes have been

studied.

However, a single study of many Gulf War exposures, which included

anthrax vaccine, was done in England. British veterans received British

anthrax vaccine, which is similar but not identical to ours, but it is

likely some received the US vaccine as well. In any event, anthrax

vaccine was shown to be highly correlated with the development of GWI

(Unwin, The Lancet, Jan 16, 1999).

Dr. Poland says that all of NIH, CDC and the National Academy of

Sciences would have to be in a conspiracy together in order for all the

committees to say the vaccine is safe, if it really were not.

On the contrary, all that is required to cover up the possible role of

anthrax vaccine in GWI is controlling the free dissemination of data.

There are no published studies of safety for this vaccine. The DOD has

performed multiple studies, which are unpublished, and these show high

rates of systemic reactions (between 20 and 48%) over the short term.

None of these studies obtained any longer term data. The (ongoing)

Tripler Army Medical Center study was designed to get this information,

but DOD refuses to release any data, after the initial results showed

very high side effect rates.

Although these studies suggest there may be long-term problems, given

the high initial reaction rates, because the studies are not published,

DOD briefers can misrepresent them to the expert committees. I attended

a DOD briefing to the National Academy of Sciences committee currently

looking into Gulf War exposures (including anthrax vaccine) and GWI. The

briefer both misrepresented the unpublished anthrax studies, and also

misrepresented the reaction types and rates currently being seen from

anthrax vaccinations.

An article published in the JAMA in December 1999 by Dr. Friedlander et

al cited these unpublished studies and also misrepresented them.

The message is clear: When only the DOD has access to the studies, and

there has been no civilian peer review, it is very easy to convince an

entire nation and its free press that a vaccine is safe.

This concept is not trivial, as 40 more vaccines are now being developed

for DOD and are slated to be given to all servicemembers as prophylaxis

against biological warfare. Will the actual data for those vaccines be

provided to the public, or will it be predigested and packaged into

palatable morsels for public distribution, while the " raw " data remains

hidden from view?

Conclusion

Maybe Dr. Poland just heard the DOD briefings and never actually read

the primary data sources on this vaccine. Maybe he read them but is

unable to review the literature critically. Perhaps he doesn't care

about the details.

How Dr. Poland, of the Mayo Clinic, came to give this talk doesn't

really matter.

By offering up misinformation disguised as fact, he has performed a

grave disservice to many thousands of servicemembers who have made major

decisions about their careers and their health based on his

presentation. He has furthermore sullied his own reputation.

I have written this because of the many people that have contacted me to

ask about this material, and the many thousands more who are being asked

to watch the video at military bases across the United States. I believe

Dr. Poland may have caused significant harm, and therefore his video

requires a critique, a " peer review " . I hope this will spur him to admit

his errors, pick up his video and go home. He may know about the flu,

but he doesn't know much about anthrax. Attempting to dazzle people with

his position and institution while deceiving them is hardly ethical

behavior. I'd suggest he begin to reclaim his reputation by

acknowledging his mistakes. A physician should do no less.