March 19, 2013
The Presidential Ethics Committee for the Study of Bioethical Issues has not left the testing of a potentially deadly anthrax vaccine on children off the table, according to a report released today.
“The Bioethics Commission concluded that before ethical pre-event pediatric AVA trials can be considered, further steps must be taken, including additional minimal risk research with adult participants, in order to determine whether the research risks to children—who do not stand to benefit directly from it—can be reduced to a level that poses no substantial risk to their health or well-being,” stated the report titled, “Safeguarding Children: Pediatric Medical Countermeasure Research.”
The report was in response to a 2012 letter from U.S Department of Health and Human Services Secretary Kathleen Sebelius asking to review recommendations from the HHS’s National Biodefense Science Board (NBSB) which advised to “gather safety and immunogenicity data about AVA PEP in children prior to an anthrax event, rather than during a future crisis when the vaccine may be needed.”
“To address this issue, and the broader question of how best to obtain clinical data on medical countermeasures in children,” Sebelius’ letter, stated, “I ask you, as the Chair of the Presidential Commission for the Study of Bioethical Issues, to convene a panel to conduct a thorough review of the ethical considerations of conducting clinical trials of medical countermeasures in children.”
Speaking of the “common good” value of using children as guinea pigs, commission chair of the presidential commission Amy Gutmann reportedly stated, “There is something to be gained by going ahead with research on children. There is a common good to be gained in being prepared.”
Dr. John Parker, a retired army major general and chairman of the biodefense board, described to Reuters how potential testing on children might go. “You’d work your way down from 18-year-olds. If it were safe you’d go to 17-year-olds, then 16-year olds.” After each round showing minimal harm, “you’d ask permission to move on to younger children.”
The controversial government proposal is coming under fire for obvious reasons, not the least of which is the questionable necessity of developing a vaccine for an attack that may never occur.
The vaccine also carries a history of being blamed for the deaths of soldiers.
The death of 22-year-old Rachel Lacy, an Army specialist, was tied to the series of vaccines she received prior to deployment, including the anthrax and smallpox vaccines. Lacy developed pneumonia shortly after the innoculations and died at the Mayo Clinic in Rochester, Minn in 2003.
“Minnesota coroner Eric Pfeifer told the paper the smallpox and anthrax vaccines ‘may have’ contributed to her death,” reported WND in August 2003, and seven months after the death, a special team of medical and vaccine experts was assembled by the government, ruling her death a “possible” or “probable” result of the vaccinations.
During a 2003 investigation into a high pneumonia rate among soldiers, the Pentagon denied the vaccines were the causes of death for Army Spc. Joshua M. Neusche, 20, and Army Sgt. Michael L. Tosto, 24, each of whom died following similar, mysterious pneumonia-like illnesses and breathing problems.
According to a UPI Investigations report, “Others who got ill told United Press International they suffered a pneumonia-like illness after being given vaccines, particularly the anthrax shot.”
“At least two more soldiers deployed to Iraq died with fluid in their lungs, according to their families; one of those was found dead in his cot. The Pentagon has not released any information on two more soldiers found dead in Iraq under similar circumstances. In a fifth case, a 20-year-old died after what the Pentagon said were “breathing difficulties” and his mother has said she wants more information.”
The report goes on, “At least two more soldiers died after experiencing chest pain, including the Aug. 27 death of 43-year-old Lt. Col Anthony L. Sherman, who competed in triathlons and marathons. ‘The only thing they had to tell me was severe myocardial infarction,’ said his wife, Lisa Ann, from Pottstown, Pa. ‘In my heart of hearts, I believe there was more to it than just a heart attack. He was in too good of shape.’”
In May 2003, four British soldiers sued the Ministry of Defense following bouts of Gulf War Syndrome-like issues, experiencing depression, breathing problems and eczema, which they say stemmed from “vaccine overload.” The soldiers reportedly received multiple jabs of the anthrax vaccine in one day before falling ill. Rebecca Mowling of The Evening Standard reported that, as a result, 45,000 British soldiers subsequently refused the vaccine.
In addition, the following warning regarding the BioThrax vaccine, of which there were $215.9 million in sales last year, appeared in a 2002 report on the FDA’s own website suggesting the vaccine “may be linked with an increase in the number of birth defects” in a retrospective study conducted on infants born to women in the military who had received the vaccine.
Preliminary results of a recent unpublished retrospective study of infants born to women in the U.S. military service worldwide in 1998 and 1999 suggest that the vaccine may be linked with an increase in the number of birth defects when given during pregnancy (unpublished data, Department of Defense). Although these data are unconfirmed, pregnant women should not be vaccinated against anthrax unless the potential benefits of vaccination have been determined to outweigh the potential risk to the fetus.”
But surely the need for a vaccine to combat a threat that is virtually non-existent and benefiting “the greater good” should outweigh the risks involved in using unconsenting persons.
Reuters reports, “Under a 2005 law, children in an anthrax-vaccine study would be prohibited from seeking damages through the legal system.”