WSJ on anthrax vaccine study; comments on the consent form

[Guest guest]

ALLIANCE FOR HUMAN RESEARCH PROTECTION (AHRP)

http://www.ahrp.org

Contact: Vera Hassner Sharav

212-595-8974

e-mail: veracare@...

FYI

The Administration's determination to push its two controversial vaccine

programs forward--smallpox and anthrax--even as medical experts urge

caution in light of the serious health risks posed by these vaccines-

raises serious questions about whose interests are being served?

Whose lives are being put at risk of harm, and why?

But American public is clearly not following the Administration's

directives.

The Wall Street Journal reports (below) that government officials are

surprised that even a $2,000 offer doesn't attract many civilian volunteers

to

take the anthrax vaccine in clinical trials being conducted through a

collaborative agreement with the Defense Department. The Center for Disease

Control (CDC) is receiving $20 million dollars to study the effectiveness of

the anthrax vaccine. The CDC expects 1500 civilians to be enrolled in

clinical

trials to test the anthrax vaccine at five medical centers.

The WSJ says, " One possible deterrent to signing up: participants aren't

guaranteed that they'll get protection from the deadly bacteria. One-sixth

of them will be given a saltwater placebo, while others will be given

different doses to determine if fewer than eight injections are adequate.

Some shots will be given in muscle as opposed to under the skin to see if

the typical side effects of redness or irritation are lessened. "

There are other reasons:

First, the public knows that the vaccine is wrapped in controversy; that it

poses serious risks of harm--some of which are irreversible. And the public

knows that the government stonewalled, denied that ailments suffered by

military personnel were linked to the vaccine. Indeed, the nature of those

adverse reactions among service personnel prompted hundreds of Air Force

pilots to quit the service rather than be inoculated.

See: General Accounting Office Report: ANTHRAX VACCINE

GAO's Survey of Guard and Reserve Pilots and Aircrew

http://www.gao.gov/new.items/d02445.pdf

See also, http://www.avip2001.net/OfficialDocuments.htm

Center for Infectious Disease Research & Policy:

http://www.cidrap.umn.edu/cidrap/content/bt/anthrax/news/afreserve.html

http://www.ahrp.org/infomail/1102/18.html

The Alliance for Human Research Protection has obtained a copy of the

informed consent form given to civilian volunteers who are being recruited

for the trials. The consent document has been examined by several anthrax

vaccine experts and it is our opinion that although the document

provides civilian study subjects more information than military service

members are given, it fails to disclose fully the known serious adverse

reactions to potential civilian subjects.

The consent document understates the depth of knowledge the Department

of Defense has about the systemic adverse reactions caused by the vaccine.

Most significantly, the Army is giving the vaccine to study subjects and

simultaneously denying them knowledge of service members being seen at

Walter for vaccine-related illnesses that the Army cannot cure.

The anthrax vaccine consent form claims that only 1% of recipients have a

systemic reaction--yet the Pentagon has admitted the systemic reaction rate

is 5-30%.

The consent form contains several misleading statements, such as: " No

studies

have shown that illnesses among Gulf War veterans or chronic fatigue

syndrome are caused by the anthrax vaccine. " In fact, several studies have

linked the anthrax vaccine to both Gulf War illnesses and chronic fatigue.

More than 100 reports submitted to the FDA of anthrax vaccine reactions met

the CDC's definition of Gulf War Syndrome. Indeed, this syndrome is listed

in the package insert as a possible reaction, yet it is denied in the

informed consent form.

Furthermore, the " rare reactions " listed in the consent form, such as

" widespread pain in your body, severe difficulty in breathing, swollen

joints, or progressive weakness in your muscles " reveals that the

investigators are in fact well-informed about some of the commonest

adverse reactions.

They should be well informed; after all, Walter Hospital is the

tertiary referral center for troops in all branches of the military who

develop severe adverse reactions to the vaccine. Since the Walter

investigators have an arrangement with the treating doctors at Walter

hospital to handle adverse reactions that occur during the trial, we can

assume that the investigators have additional information on adverse

reactions that is not being revealed to subjects, such as the patient there

last week who became completely paralyzed and unable to speak, shortly after

vaccination.

The investigators can therefore anticipate adverse reactions, and have

offered care at their hospital for such reactions, but they fail to tell

civilian volunteers that the reactions frequently do not improve, and that

their success in treating those reactions is limited.

Given the myriad of ethical issues surrounding anthrax vaccine-induced

reactions (that may not resolve in a significant proportion of those

receiving the vaccine) one might ask why this trial is being conducted?

After all, 500,000 soldiers were vaccinated between 1998 and 2001, and

another 300,000 have been vaccinated in the past six months. Why not study

their reactions? The rationale given by the Pentagon for vaccinating

soldiers is that they have a significant risk of anthrax exposure.

But civilians do not face that risk. So why give them a vaccine with a

known high rate of adverse reactions?

Those conducting the trial have reason to anticipate that some of the study

subjects will become disabled, but the consent form advises volunteers: " You

will not receive any injury compensation, only medical care. "

Civilians are exercising their choice by foregoing the CDC offer:

" Since 1998, more than 800,000 soldiers have received the vaccinations, as

have other at-risk Americans. After the 2001 mailings, 10,000 congressional

staffers and mailroom workers were offered the vaccine, but fewer than 100

chose to receive them -- a harbinger, perhaps, of the dearth of volunteers

for the current study. "

Meryl Nass, MD, board member, AHRP

Vera Sharav, President, AHRP

~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~

The Wall Street Journal

Mar 26, 2003

Wanted: Volunteers for Anthrax Vaccine

Government Offers Injections To Civilians via Clinical Trials;

Should You Roll Up Your Sleeve?

By Greg Bluestein

Page D1

WORRIED ABOUT ANOTHER round of anthrax letters if terrorists strike again?

The more than 200,000 troops in the Persian Gulf don't need to worry about

getting a vaccine to fend off the deadly bacteria. They and other high-risk

people, from Centers for Disease Control and Prevention officials to some

veterinarians, can receive injections administered in an six-shot sequence

over a year and a half, plus regular boosters.

But there is an option for the rest of us. In a government-sponsored

clinical trial, five major hospitals around the country are recruiting

civilian volunteers for a test of the vaccine. The goal is to figure out how

many shots are required, and where they should be administered in the arm,

in order for the vaccine to be more effective.

Yet curiously, even as the war against Iraq heightens the threat of a

biological attack, recruiters are struggling to find enough volunteers to

roll up their sleeves. " I'll be honest with you. I thought after putting our

ads out, we'd be swarmed, " says Col. Janiine Babcock, a lead investigator at

the Army's Walter Institute of Research in Silver Spring, Md. Her

hospital, along with Emory University, the University of Alabama-Birmingham,

the Mayo Clinic and Baylor College of Medicine, is rounding up a total of

1,560 volunteers for the 43-month study.

Researchers are looking for people age 18 to 61 years old, in good health.

Volunteers must be willing to receive six injections of the vaccine over a

period of 18 months, followed by two years of clinical visits and booster

shots. Depending on which clinic administers the shots, participants can be

paid up to $2,000.

Some are volunteering for the money, while others hope to get protection

from the potentially deadly disease. Others are doing it as a show of

patriotism.

" The men and women over there are doing a lot for us and it seemed to be a

minimal thing that we could help them with, " says Kay Vydareny, who is

participating in the trial. Her son is in the U.S. Army in the Persian Gulf

region.

Without vaccination or powerful antibiotics, anthrax can be fatal after

entering the body's respiratory system, infecting lymph tissues in the chest

with toxins that attack cells. But the only way for the general public to

get protection is to take part in the clinical trial.

One possible deterrent to signing up: Participants aren't guaranteed that

they'll get protection from the deadly bacteria. One-sixth of them will be

given a saltwater placebo, while others will be given different doses to

determine if fewer than eight injections are adequate. Some shots will be

given in muscle as opposed to under the skin to see if the typical side

effects of redness or irritation are lessened.

So who would be willing to weather multiple injections, keep a diary, have

blood regularly drawn, meet with doctors for 26 study visits, and possibly

suffer from side effects like soreness, itching, redness and swelling, among

others?

While the health risks for volunteers are minimal, the final decision may

boil down to how concerned you are of an anthrax attack. Says 47-year-old

Angel Candelario, minutes after his third injection, " You have no idea what

a good feeling I have. It gives me a little relief, a lot of confidence,

that something's in my body, just in case. Even if I just got the placebo. "

Scientists insist the risks are minimal. Among the side effects: pain,

swelling and, less frequently, headaches and more severe reactions. Brad

Perkins, CDC's principal investigator of the anthrax trial, says these

possibilities are " very much in line " with other vaccines routinely given to

adults. Col. Babcock says trial volunteers have suffered no serious

reactions so far.

The anthrax vaccine test actually predates the fatal anthrax mailings of the

fall of 2001, just after the Sept. 11 terrorist attacks on the U.S. In 1999,

Congress provided $20 million for the CDC to oversee trials designed to

improve the existing vaccine, AVA, which the Food and Drug Administration

approved 33 years ago.

Research on AVA gained momentum after the deadly 2001 attacks, for which no

suspect has been implicated. That string of mailings killed five people from

Florida to New England, sickened more than a dozen others, and panicked

Americans nationwide. While anthrax spores don't spread easily through

air -- health officials worry more about contagious viruses such as

smallpox -- government officials do fear that terrorists are stockpiling the

bacteria.

Since 1998, more than 800,000 soldiers have received the vaccinations, as

have other at-risk Americans. After the 2001 mailings, 10,000 congressional

staffers and mailroom workers were offered the vaccine, but fewer than 100

chose to receive them -- a harbinger, perhaps, of the dearth of volunteers

for the current study.

Yet for 23-year-old Sami Hamed, whose daily duties include opening mail for

Rep. Grijalva, a Texas Democrat, joining the trial made sense. " It

didn't bug me too much, but with all these news stories of anthrax here and

there, you can never be too safe, " he says.

Col. Babcock expects to reach full capacity at her clinic in two months;

nationwide, researchers still hope to sign up 400 more participants by July.

But it has been tough going finding enough volunteers lately. Plastering a

few bulletin boards with ads is usually enough for most studies, she says,

but she has already spent $75,000 -- more than double the allotted budget --

for ads in places such as the Washington Post and Roll Call, a periodical

read by congressional staffers and lobbyists on Capitol Hill.

For now, the AVA vaccine is the only option. The biotech company Human

Genome Sciences Inc. says it has developed a potentially more effective drug

called ABthrax that could protect against and treat exposure to anthrax, but

it is still in development.

--

Where to Sign Up

-- Baylor College of Medicine, Houston, Texas; 713-798-4912

-- Emory University School of Medicine, Atlanta, Ga.; 404-727-4044

-- Mayo Clinic and Foundation, Rochester, Minn.; 507-266-4522

-- University of Alabama at Birmingham, Birmingham, Ala.; 205-934-6777

-- Walter Army Institute of Research, Silver Spring, Md.; 301-319-9320

Copyright Dow & Company Inc Mar 26, 2003

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