Reader asks: Should we test the anthrax vaccine on children?

To the Editor,

Whether you are a parent, grandparent, military member, veteran, or a concerned citizen, you have been invited to participate in a vociferous debate regarding whether it is ethical to proceed with a clinical trial wherein children will be injected with the highly controversial anthrax vaccine.

The announcement posted in the Federal Register states that your letters must be received by Aug. 27, 2012. The notice in the Federal Register goes on to say that all letters must be sent by email to info@ bioethics.gov or by mail to Public Commentary, Presidential Commission For The Study Of Bioethical Issues, 1425 New York Avenue NW., Suite C-100, Washington, DC 20005.

The crux of the matter is that the Presidential Commission has the unenviable task of studying the ethics of experimenting on children with biological weapons vaccines, beginning with the anthrax vaccine, and other medical countermeasures.

The Federal Register makes it clear that there is a strong push for this experiment from the National Biodefense Science Board (NBSB): “… the National Biodefense Science Board recommended that the Department of Health and Human Services move forward with testing AVA [Anthrax Vaccine Adsorbed] before a public health emergency but only after the ethical considerations are adequately addressed and reviewed” which involves an in-depth, public discussion with the Presidential Commission For The Study Of Bioethical Issues concerning “… the ethical considerations of conducting a pre- and post- event pediatric study of Anthrax Vaccine Adsorbed (AVA) as a component of post-exposure prophylaxis” (“Department of Health and Human services: Request for Comments on Ethical Issues Associated with the Development of Medical countermeasures for Children” 38631-2). Your letters will become part of a public, historical document that may save the lives of our children.

Perhaps you’d like to know a few salient facts about this important debate and the anthrax vaccine’s side effects before responding to the request in the Federal Register. The debate began in Washington, D.C., during the “Protect Children from Anthrax Public Engagement Workshop” onJuly 7, 2011.

The NBSB under the Department of Health and Human Services (HHS) discussed in detail, for two days, how to conduct an experiment with the anthrax vaccine in children. Representatives from the National Institutes of Health (NIH), the Centers for Disease Control (CDC), and the Food and Drug Administration (FDA) were all there.

The CEO of Emergent BioSolutions, which manufactures the anthrax vaccine (Biothrax), was there as well. Col. John Grabenstein and Col. Arthur Friedlander, long-time supporters of the Department of Defense’s Anthrax Vaccine Immunization Program (AVIP) attended the workshop also. Representing the opposing point of view for non-profit groups such as Protecting Our Guardians and the National Vaccine Information Center were former military members who had been disabled by the anthrax vaccine.

With only two minutes of speaking time allotted to these veterans, the engagement with the public was somewhat limited. By the term “public engagement” did the NBSB intend to have a substantial dialogue with the public about the ethics of their proposal or was their intent to soften up the public to the notion of having their children participate in an experiment with the anthrax vaccine?

I don’t know, but it does seem strange that at the workshop the NBSB circulated a question-and-answer script for pediatricians to use when talking with parents or guardians about using the anthrax vaccine in their child. The last three questions on the script raised some eyebrows, especially the final question on the script:

15. Q- Since we do not know the exact dose of vaccine to give your child and its protective ability, except for the adult dose and data, would you want the U.S. government to collect data on pediatric dosing and protective ability during an event, that is, after an exposure? A study done only after an exposure would need to start with the adult dose that we believe will be effective, as a lower dose may not be effective.

We will not know if this is necessary, since a lower dose may be as protective, but with fewer side effects. Enrolling your child in a study will help us figure this out for future children (or future doses for your child). (“Vaccine to Protect Children from Anthrax Public Engagement Workshop Hosted by the Anthrax Vaccine Working Group National Biodefense Science Board Questions and Answers”)

Question 15 begs the question: “Will an event, or exposure to anthrax because of a terrorist or latent spores, really occur?” According to the CDC, in the entire history of the United States, only 22 adults became ill from inhalational anthrax in 2001, five of whom died. Extrapolating from these numbers, there is a potential risk of .000027 percent to America’s 81.5 million school children of getting sick with inhalational anthrax.

Another question arises here as well: was the HAZMAT clean up in the Hart Building on Capitol Hill, in the Brentwood postal center,  and  in Florida performed correctly? Our senators and congressmen/women have not reported any anthrax infections over the past 10 years since that event occurred.

Is anthrax really a legitimate concern for American families or is it just hypothetical?

The last questions in the script seem to lead a parent to the conclusion that it is one’s duty to enroll one’s child in the clinical trial. However, I would submit to all American citizens that it may be a parent or guardian’s duty to protect the child with a polite “No, thank you.” If one must weigh the ethical appeal of protecting one’s child against a risky vaccine and the ethical appeal of helping one’s country for nationalistic reasons, isn’t the logical choice to defend one’s child — our country’s future hope?

The side effects mentioned in question 15 include more than 40 possible adverse reactions such as seizures, arthritis, leukemia, lymphoma, heart attacks, kidney failure, skin lesions, stomach paralysis, migraines, ringing in the ears, auto-immune diseases such as MS and GBS, anaphylaxis, inflammation of the brain and/or heart, muscle aches, fevers, and even six deaths, according to the manufacturer’s product insert from Jan. 31, 2002.

Moreover, this product insert reveals a 5 percent to 35 percent adverse reaction rate, with about 6 percent “listed as serious. Serious adverse events include those that result in death, hospitalization, permanent disability or are life-threatening” (Bioport “Anthrax Vaccine Adsorbed [Biothrax]). According to retired Maj. Sonnie Bates, another study, conducted on adult medical personnel at Tripler Army Air Force Base, showed a 48 percent systemic adverse reaction rate; and the adverse reaction rate was 43 percent in the “Pitman Study”(http://www.mvrd.org/avn/sonnie/law/bates_21feb00.htm).

According to the Journal of the American Medical Association, during another study, the CDC’s phase 4 human clinical trial with the anthrax vaccine, there were seven deaths (which may or may not have been caused by the vaccine) and 229 severe adverse reactions (http://jama.ama-assn.org/cgi/content/short/300/13/1532).

The Government Accountability Office (GAO) conducted a survey and discovered that 85 percent of the National Guard and Reserve pilots, plus the aircrews, had experienced adverse reactions with one-fifth of those being systemic reactions (GAO-02-445 4). Another GAO report revealed an estimate that 1 percent to 2 percent of military members may become disabled or die from their vaccinations (GAO-07-787R 4).

Doctors and nurses have informed me that in general, excluding cancer drugs, any product or drug with an adverse reaction rate that is higher than 1 percent gets taken off the market. Is it ethical to allow this clinical trial to proceed forward when the facts show that at least 5 to 35 out of every 100 children who participate will possibly suffer from one or more of these side effects or potentially die?

Even if it weren’t for ethical considerations such as the Hippocratic Oath or the Nuremburg Code, there are still American policies in place that make this proposed clinical trial, using the anthrax vaccine in children, illegal. The 5 percent to 35 percent risk of an adverse reaction to Biothrax poses a higher threat than the possible exposure to inhalational anthrax. Any potential benefit is overshadowed by the risks of side effects.

The “Best Pharmaceuticals for Children Act of 2002” (P.L. 107-109) and the “Pediatric Research Equity Act of 2003” (P.L. 108-155) led to a report from the Institute of Medicine called, Ethical Conduct of Clinical Research Involving Children. It reads: “For research that involves a control group of healthy children without a disorder or condition and without prospect of direct benefit from the research, the research procedures for that group would have to involve no more than minimal risk.”

The definition of “minimal risk” in Subpart A of the HHS regulation (45CFR 46.102[i]; 21CFR 50.53[k]) is “that the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests.” Clearly, using anthrax vaccinations involves more than a minimal risk. The magnitude of harm posed by this clinical trial is much greater than that in ordinary life.

Furthermore, 45CFR46.407 states that one of the criteria for pediatric research is that there must be a “serious problem affecting the health and welfare of children,” which is not the case with anthrax exposure. Not one child in the United States is affected by inhalational anthrax, and that is good. Anthrax is not an infectious disease that can be transmitted from one person to another like a cold or flu. The anthrax bacterium has to be inhaled or get into an opening on the skin.

However, I submit for general consideration the fact that many children in military families are affected by the anthrax vaccine’s impact on their parent. For example, the Las Vegas Sun printed an article on June 16, 2005, titled “More Than 1,200 Who Had Anthrax Vaccine Now Sick.”

Moreover, the FDA has received more than 5,300 reports about adverse reactions to the anthrax vaccine in their Vaccine Adverse Event Reporting System (VAERS). The policy requirement that there already be a “serious problem” offers further protection for children from unnecessary testing under the law.

The Belmont Report, from 1979, is another statement of the department’s policy regarding biomedical research on human subjects. It states the importance of judging whether or not the assumptions behind the research are correct (i.e., will children be attacked with anthrax?), being clear about risks (i.e., 5 percent 35 percent adverse reactions), and looking at all other available studies (i.e., side effects on military members) (http://ohsr.od.nih.gov/guidelines/belmont.html). Isn’t it ethical for theHHSto abide by these government policies and not proceed further with this clinical trial?

Real public engagement again seemed to be lacking, at the Public Engagement Workshop on Sept. 22, 2011, when protesters held up posters and distributed copies of retired Col. Thomas S. Heemstra’s book, “Anthrax: a Deadly Shot in the Dark,” to those attending the meeting. After all that, the NBSB committee decided that the Presidential Commission for the Study of Bioethical Issues would have to study the ethics of using the anthrax vaccine on children in a clinical trial, before the clinical trial could move forward.

Doesn’t common sense dictate that if the ethics of any action must be put into question, then that action is ethically questionable and, thus, unethical? Will the Presidential Commission be able to perform its task: to find a way to ethically give the anthrax vaccine to children in a clinical trial? Is that even possible given the facts? The benefit to risk ratio does not add up.

Perhaps Americans would like to know that in January of this year, someone claiming to be the director of emergency response from the University of Chicago contacted one family that I know of (perhaps there were more parents contacted) to request that their child participate in this clinical trial.

Why was a child volunteer being solicited before the Presidential Commission had had its first meeting — let alone made a final decision about the ethics of this clinical trial? Is that an ethical action? Has a decision already been reached while the public goes through the empty motions of saying “Yea” or “Nay” to testing the anthrax vaccine in children? Perhaps.

During the meeting of the Presidential Commission on May 17, 2012, Secretary of Health and Human Services Kathleen Sebelius told everyone in attendance that the work the commissioners are doing is “incredibly important and that it “is critical to the President [Barack Obama].” Sebelius did state that “safety is the highest priority,” which is something everyone can agree upon (http://www.tvworldwide.com/events/bioethics/120517/).

Would President Obama really be pushing this clinical trial forward in an election year when Mitt Romney, Ron Paul and other opponents might use it to strengthen their campaign platforms? Why is this ethical advice from the Presidential Commission so “critical” to President Obama?

Jim Wagner, vice chairman of the Presidential Commission, later asked an important question that brings to mind the IOM’s Ethical Conduct report. He wanted to know if the risk of an “event” was assumed to exist by the NBSB, and Maj. Gen. John Parker replied that the board (the NBSB) had never deliberated the actual risk of an event but had left that up to others in higher positions.

If one was to follow this train of thought and agree that indeed there are biologically weaponized threats to our children that government officials are aware of, then one would expect detection equipment checking the air and water every hour in every city and a notice to parents that shares the information about possible dangers from a terrorist in their area. It would be akin to a nationwide Amber Alert. It would be announced on every radio, TV channel, and in newspapers. One would not expect an attempt at a clinical trial using the anthrax vaccine on children back in 2005 (which was averted due to the efforts of many people), or Dr. Nicole Lurie’s concern about the possibility of latent spores in D.C.’s soil, or a lengthy preemptive plan to be prepared just in case our children need biological countermeasures such as the anthrax vaccine and the others that are to follow. Doesn’t the voice of reason demand that facts and evidence of a possible event be established before carrying out a clinical trial with the anthrax vaccine (and later, other biological countermeasures) on children?

It would appear that the NBSB and the Presidential Commission are operating from the assumption that we really need biological countermeasures for children, of which the anthrax vaccine is one, when there are no facts to support this assumption. Unfortunately, looking at the facts regarding the anthrax vaccine is not pretty.

If one investigates the opposing point of view, one discovers that the anthrax vaccine is a Category D drug as written on the 2002 product insert. It is teratogenic and might harm a developing fetus. In fact, Assistant Secretary of Defense for Health Affairs William Winkenwerder sent directives out to be careful not to vaccinate pregnant military members with the anthrax vaccine. Therefore, one might ask “What will the anthrax vaccine do to the development and maturation of a child in this proposed clinical trial?” It is a logical question that the Presidential Commission should take into consideration before allowing the anthrax vaccine to ever be given to children in a test.

It is a fact that there are four Vaccine Healthcare Centers (VHCs) in this country to treat thousands of military members and veterans who are ill from their anthrax and/or smallpox vaccinations. At Walter Reed’s VHC, a study is being done with blood samples to try to determine why some people have adverse reactions to the anthrax vaccine, yet many people with serious cases are not allowed to participate in the study.

Shouldn’t we find out if there is a genetic predisposition in those with serious reactions to the anthrax vaccine, and what that genetic marker is, before conducting a clinical trial on children?

It is a fact that the FDA shut down production of the anthrax vaccine, in March 1998, while the manufacturing plant was renovated after four failed inspections (February 1998, March 1997, August 1995, March 1992) (GAO/T-NSIAD-00-140 2). It is a fact that Sammie Young, a former FDA inspector, said on camera that the anthrax vaccine is “adulterated.”

It is a fact that some anonymous military members filed a civil lawsuit in March 2003 against the manufacturer Bioport, now known as Emergent BioSolutions, because of the illnesses they developed after their anthrax vaccinations. It is a fact that Evanston Insurance sued its own client, Bioport, for allegedly not revealing knowledge it had about “incidents” to the insurance company.

It is a fact that Federal Judge Emmet G. Sullivan enjoined the AVIP on October 27, 2004 “unless or until” the anthrax vaccine could be proven safe and effective. It is a fact that then Health and Human Services Secretary Tommy Thompson was able to maneuver around this court ruling with an Emergency Use Authorization (EAU) on Jan. 27, 2005 to restart the AVIP.

It is a fact that the CDC’s Morbidity and Mortality Weekly Report on Jan. 24, 2003, revealed that the anthrax vaccine is one of the most reactogenic vaccines on the market with 1,818 VAERS reports sent to the FDA between 1998 and 2001 (and four more sent in 1993) (14-5). It is a fact that Emergent BioSolutions has indemnity due to “unusually hazardous risks,” and it cannot be sued if someone becomes ill or dies from Biothrax, as shown in Loius Caldera’s memorandum from Sept. 3, 1998.

Maybe President Obama and the HHS are right. We must protect our children from biological threats. We must be ready. If a psychopath used anthrax to attack our children or if spores “hatched” after 10 years of dormancy, we have other options. For instance, Cipro, Dioxycyclene and intravenous penicillin will kill the anthrax bacterium if administered within 72 hours. Does HHS have enough of those particular antibiotics stockpiled for every American citizen too? In addition, we already have enough BIDS equipment to monitor the air for biological weapons as well, if we would just use it here in the United States.

After reviewing these facts, I strongly encourage every American citizen to send his or her opinion to the Presidential Commission regarding the ethics of conducting a clinical trial using the anthrax vaccine on children. You may agree with me or disagree with me, but we can all certainly agree on the importance of free speech. So just do it. After Aug. 27, 2012, this opportunity to share your thoughts and insights will close. As the adage goes, “If we are not part of the solution, we are part of the problem.”

Marguerite M. Armistead, M.A.

Founding member of Protecting Our Guardians (POG), a 501(c)(4) military family advocacy group