by Alliance for Human Research Protection

A strong case for the anthrax vaccine trial would be made “if the community that’s most supportive of moving this forward would volunteer their own children for the study.” Amy Gutmann, Chair,  Presidential Commission for the Study of Bioethical Issues.

The Obama administration continues to push for approval of a highly controversial, ethically untennable experiment to test the safety and efficacy of the Anthrax Vaccine Adsorbed on children.  When discussed at a recent meeting of the Presidential Commission for the Study of Bioethical Issues (May 17, 2012), it was apparant that the Commission had not been provided with any factual evidence–from the adult safety / efficacy data–to support such an radical departure from ethical principles that–at the very least–require strong justification for putting any children at risk of any potential harm inasmuch as there is no direct benefit for the children who would be used as guinea pigs.

The likely explanation for the failure to provide the commission with data that might support a pediatric anthrax vaccine trial, is the fact that there is no favorable efficacy data.  Indeed, the only direct human efficacy study for a US manufactured anthrax vaccine was conducted in the 1950s at 4 goat hair mills by Philip Brachman MD for the Army and the Centers for Disease Control. [1] His study demonstrated efficacy for cutaneous anthrax but not inhalation anthrax–and the vaccine differed significantly fromn the one used today. There is no demonstrable data for the vaccine’s efficacy against inhallation anthrax.

The claimed findings in several safety studies carried out by Colonel John Grabenstein, PhD, who oversaw the military vaccine program, are suspect because Dr. Grabenstein who is a member of the National Biodefense Science Board, had and continues to have a significant financial  conflict of interest in promoting the claim that the vaccine is safe. Dr. Grabenstein has been a consultant for several vaccine companies and is currently employed by Merck, which produced anthrax vaccine for the US government in the 1960s and is today a major US vaccine manufacturer.

In her detailed, fact-filled, fully referenced commentary subitted to the Commisison in January 2012, Meryl Nass, MD , provided compelling arguments against the exposure of children to the serious risks of the anthrax vaccine.  Dr. Nass  points out that “a 1998-2000 study was designed to use active surveillance for long-term side effects and to determine their duration, according to principal investigator Colonel Glenn Wasserman. [2]  But when the study was published in 2003, with Colonel Grabenstein as second author, information on prolonged or late onset adverse events was not disclosed.  Eleven women who had been vaccinated while pregnant, mentioned by Wasserman in oral presentations, failed to be mentioned in the published paper.  Half the subjects were lost to follow-up by the end of the study.  The exit questionnaire was not designed to capture specific information about vaccine-related adverse events and their duration, and did not mention anthrax vaccine.”

Furthermore, “CDC conducted a multicenter trial of Biothrax in 1563 subjects, 83% of whom received anthrax vaccine, between 2002 and 2007.  Two hundred twenty-nine serious adverse event reports were filed with the federal Vaccine Adverse Event Reporting System during the 43-month trial.  About 12% of subjects experienced a serious [3] adverse event.  But only a preliminary report on the first seven months and first 1000 subjects in the trial was published, in 2008. [4] There has been no final report, nor any publicly available accounting of these adverse events.”

These facts, coupled with the uneasy question– Whose children will be subjected as involuntary experimental subjects in an anthrax vaccine trial?–should result in a resounding rejection of the proposed trial by the Presidential Commission for the Study of Bioethical Issues.

References

1.  Brachman PS, Gold H, Plotkin SA, Fekety FR, Werrin M and Ingraham NR. Field Evaluation of a Human Anthrax Vaccine. Am J Public Health 1962; 52(4): 632-645.

2. Wasserman G. Tripler Army Medical Center Survey. First Annual Department of Defense Conference for Biological Warfare Defense Immunizations. May 26, 1999. Fort Detrick, Maryland. Transcript.

3.    http://www.fda.gov/safety/medwatch/howtoreport/ucm053087.htm

4.Marano M, Plikaytis BD, Martin SW et al. Effects of a Reduced Dose Schedule and Intramuscular Administration of Anthrax Vaccine Adsorbed on Immunogenicity and Safety at 7 Months. JAMA 2008; 300(13): 1532-1543

Read the Full Article Here: http://www.ahrp.org/cms/content/view/851/9/