FYI
WSJ on anthrax vaccine study; comments on the consent form
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
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Last revised: April 2003