Anthrax
Vaccine Consent Form / Should You Roll Up Your Sleeves_WSJ
Sat, 29 Mar 2003
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 Reed 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 Reed
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 Reed investigators have an
arrangement with the treating doctors at Walter Reed 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 Reed 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. Raul 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 Reed Army Institute of Research, Silver Spring, Md.;
301-319-9320
Copyright Dow Jones & Company Inc Mar 26, 2003
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