Who Will Protect the Children?

Issue 117
By Peggy O'Mara

Many people have told me their concerns about the Homeland Security Act and the threat of smallpox vaccination. The questions now being raised about the smallpox vaccine mirror the concerns of parents of vaccine-damaged children as well as those of people who conscientiously object to vaccines.

Smallpox is a serious disease for which there is no treatment; in past outbreaks the mortality rate has been 30 percent. The disease was considered to have been eradicated in 1960, and vaccinations against it ceased in 1972. The live vaccinia virus that is used for the smallpox vaccination is admittedly the most dangerous vaccine in use. In the past it has caused about 15 life-threatening illnesses and one or two deaths for every thousand recipients.

In a recent survey by the Harvard School of Public Health, 61 percent of respondents said they would have a smallpox vaccination if it were offered to them. The RAND Center for Domestic and International Health Security calculates that 482 people will die of side effects if 60 percent of the US population is vaccinated.

This live vaccine virus is shed from the vaccination site for two to three weeks following the vaccination. People who come in contact with the vaccination site can become ill, particularly if they have certain skin conditions or weakened immune systems. Those most at risk for complications are those who have compromised immune systems, such as people with active AIDS or primary immunodeficiency disease (PI). Chemotherapy and radiation put patients at risk for vaccine-related complications, as does cancer, particularly cancers that affect the immune system, such as leukemia and lymphoma. People with active eczema or atopic dermatitis, pregnant women, and babies under age one are also at risk. Those with burns, certain skin infections, chicken pox, psoriasis, and severe or uncontrolled acne are advised to avoid the vaccine. These conditions would disqualify as many as 50 million Americans from vaccination.

Almost no one recommends mass vaccination at this time. Many groups have come forward, in fact, to oppose mass vaccination and to raise far-reaching ethical and logistical questions. A study by the RAND Corporation concluded that, barring a huge smallpox attack, vaccinating the general public would hurt more people than it would help. The Bush administration has said that it will begin to vaccinate healthcare workers who volunteer for the vaccine soon, and those individuals who request the smallpox vaccine in 2004.

Andrew L. Stern, president of the Service Employees International Union, the nation's largest healthcare-workers' union, criticized President Bush and Congress for not doing more to protect healthcare workers who might be harmed by the vaccine. Stern recommended risk education for healthcare workers and expressed concern about possible repercussions at work for those who refuse the vaccination. Stern also wants to ensure that workers who have to stay home because of vaccine side effects don't lose income.

An opinion piece in the New England Journal of Medicine criticized the plan to vaccinate hospital personnel on a volunteer basis. In fact, at least four hospitals, one in Georgia, one in Virginia, and two in Illinois, won't vaccinate employee volunteers, but will instead be prepared to inoculate staff quickly in the event of an outbreak. The hospitals say that the chance of a smallpox outbreak is too small to risk rare but serious complications from the vaccine.

The American Nurses Association (ANA) wants to make sure that healthcare workers have sufficient information to make informed decisions about the smallpox vaccine. The organization requests assurances that smallpox vaccination will be voluntary and that individual healthcare workers won't face reprisals for their decisions.

The ANA wants to know who would pay for the cost of vaccination and for the treatment for any possible side effects, including side effects suffered by family members of vaccinated nurses. Presently, the Vaccine Injury Compensation Program (VICP) does not cover voluntary vaccinations. The nurses also want to know who would bear the cost of lost work related to vaccinations and who would bear the liability regarding administration of the smallpox vaccination. The ANA is not alone in its concerns. The American Medical Association is not in favor of mass US smallpox vaccinations. The organization says that the potential threat of bioterror attack does not warrant mass inoculation. In fact, in a series of five articles published in the New England Journal of Medicine on January 20, 2003, doctors and scientists warned that unless a smallpox attack seems highly likely, the public should not be vaccinated.

Even the president has said that smallpox vaccination should be voluntary. In a December interview with Barbara Walters on ABC's 20/20, the president said, "I think it ought to be a voluntary plan. I don't think people ought to be compelled to make the decision which they think is best for their family." Even the military will allow medical exemptions unless there is an actual smallpox attack in the field.

This talk of voluntary smallpox-vaccine compliance belies the language of the recently passed Homeland Security Act. Section 304 of the bill gives the Department of Health and Human Services authority to declare a public health emergency and administer substances to individuals without exemption.

Speaking at the National Vaccine Information Center's Third International Public Conference in November 2002, George Annasa, a leading bioethicist and chair of the Department of Public Health, Bioethics, and Human Rights at the Boston University School of Medicine, said, "Public health historically has been a state level issue; it is not a power that was given to the federal government by the constitution." Annasa is an expert on informed consent. "There is never an exception to informed consent," he says, "even when there are threats of bioterrorism. Informed consent is not a form; it is a process of information exchange during which you are given some information about the risks and benefits of what is going to happen to you, and then you have to decide. ... The form is the evidence that this process took place." The Centers for Disease Control's Vaccine Information Statement (VIS) for smallpox requires vaccine recipients to sign a unique consent form.

Many speakers at the conference expressed growing concerns about thimerosal, the mercury vaccine preservative that got worldwide publicity because of Dick Armey's last-minute addition to the Homeland Security Act. Sections 1714 through 1717 of the act protect Eli Lilly, the manufacturer of thimerosal, from liability in cases of injury from FDA-approved vaccines. Ironically, thimerosal is not in the smallpox vaccine because live vaccines do not have preservatives, but it was in most childhood vaccines until 2000. Many parents of children with regressive autism believe that thimerosal may be associated with their children's condition.

Since Congress reconvened in January, two bills to repeal the thimerosal lawsuit provision have been introduced. The bill in the House was introduced by Congressman Dan Burton(R-IN), whose Government Reform Committee held more than a dozen hearings to investigate vaccine safety. The bill is cosponsored by Congressmen John Duncan (R-TN), Ron Paul (R-TX), Steve King (R-IA), and Dennis Kucinich (D-OH), and Congresswoman Carolyn Maloney (D-NY). In the Senate, Olympia Snowe (R-ME), Susan Collins(R-ME), and Lincoln Chafee (R-RI) have negotiated language that will eliminate the thimerosal bailout. The new legislative language should have been incorporated into the Omnibus Appropriations Bill considered by Congress in late January. The language also requires the Senate to consider and pass reforms to the VICP within the next six months.

VICP, or "the vaccine court," as it has popularly been called in the media, was established in 1986 by the National Childhood Vaccine Injury Act, a bill that was crafted and lobbied for by parents of children damaged by the DTP vaccine. The intention of the act was to provide fair and uncomplicated recompense for vaccine injuries. While it's good news for healthcare workers that the VICP will be amended to include smallpox, legislators are threatening to repeal a parent's right to sue for damages if the damages offered by the program are not satisfactory or if a parent chooses not to enter the program. As it is, the program's statutes of limitations have continually been eroded since 1986. As it stands now, a parent has up to three years after a vaccine injury to enter the program. Autism, however, may not even be diagnosed until a child is older than three.

It is a proper use of tort law for the federal government to protect children from liability from publicly mandated programs like vaccinations. Children also need to be protected from dishonest research. While the federal government was once the major funding source of medical research, corporations are now the primary sponsors. Over the past several years, there have been many examples of companies that have prevented researchers from publishing unpleasant study results. Recently, a group of researchers from Duke University evaluated the degree to which agreements between academia and industry were in compliance with guidelines established by the 2001 International Committee of Medical Journal Ethics (ICMJE). The results were dismal. In only one percent of studies did investigators and coordinators have unfettered access to all research data. No study contracts required that research be published.

Research objectivity has been further eroded by the New England Journal of Medicine's new editorial policy. The prestigious journal will no longer require that doctors who write and review articles and editorials be truly independent of financial ties with industry. The journal says that the drug companies' reach is just too deep and that it has given up on finding truly independent doctors. Under the new policy, doctors writing reviews in the journal can accept up to $10,000 a year in speaking and consulting fees from each drug company. In 2000, the drug industry sponsored more than 314,000 events for physicians at a cost of almost $2 billion. In addition, many doctors accept speaking and consulting fees from drug companies.

Independent research has raised reasonable questions about thimerosal. Nonetheless, thimerosal is in flu vaccines currently being recommended for infants as young as seven months. And, despite unanswered questions about an infant's capacity to handle vaccines in combination, a new vaccine, Pediatrix, is expected to receive FDA approval soon. Pediatrix will combine diphtheria, tetanus, pertussis, polio, and hepatitis B into one vaccine. While choice is blithely debated for adults and the smallpox vaccine, the reality for children is increasing risk and diminished choice.

The American Academy of Pediatrics (AAP) recently posted a one-page "Refusal to Vaccinate" form on its website for doctors to download and use with patients. It is not clear if this form is to be used to protect the doctor from liability in the case of disease or to harass the parent. The explanatory text that accompanies the form states, "The use of this or a similar form may in some instances induce a wavering parent to accept your recommendations because it emphasizes the importance you place on being appropriately immunized." You can access the form at www.cisp.immu nize.org.

Intimidating a patient into accepting a treatment using the tactics that this form encourages, as well as the form itself, is a violation of medical ethics and the ethics of informed consent. For consent to be truly informed, one must not be coerced.

Congressman Burton has called for a White House conference on autism. Parents deserve answers to the epidemic rates of autism. In addition, we want reforms of the Homeland Security Act. The thimerosal bailout must be removed, exemptions must be allowed, and the Freedom of Information Act (FOIA) must be fully restored. It was through an FOIA request that the organization Safe Minds was able to discover an undisclosed Centers for Disease Control study showing a link between thimerosal and autism (see Mothering, no. 111, page 27).The lack of public knowledge about government activities, the documented corruption of medical research, and the coercion to accept standard treatment make it increasingly difficult for parents to find honest information and to make truly informed decisions.

Insist that your elected representatives repeal Section 304 of the Homeland Security Act, which allows federal control of vaccinations without exemption. Ask them to support the efforts of the House and Senate to repeal the thimerosal liability protection for industry, found in Sections 1714 through 1717. And demand a robust Freedom of Information Act, Section 214, not one whose effectiveness has been intentionally destroyed. It's time to do our duties as citizens and talk truth to power.

Thanks to Barbara Loe Fisher, Kathi Williams, and Lisa Reagan for their contributions to this editorial.

Peggy O’Mara is the mother of four grown children. She has gained international celebrity as publisher, editor and owner of Mothering Magazine. She is also the author of four books: Having a Baby Naturally: The Mothering Magazine Guide to Pregnancy and Childbirth, Natural Family Living: The Mothering Magazine Guide to Parenting, The Way Back Home: Essays on Life and Family, and A Quiet Place: Essays on Life and Family, all of which can be purchased in the Mothering Shop. A dynamic speaker, she has lectured and conducted workshops in conjunction with organizations such as the Omega Institute, Esalen, La Leche International, and Bioneers. She has appeared on numerous television and radio programs and has been featured in national publications including The Wall Street Journal, USA Today, The Washington Post, Chicago Tribune, Mother Earth News, and Utne Reader.

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