Anthrax Vaccine Consent Form / Should You Roll Up Your Sleeves_WSJ

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.php

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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