Testifying as General Counsel for the Association of American Physicians & Surgeons (AAPS), and as a New Jersey father of two school-age children.

May 12, 2003

Re: Proposed New Rule N.J.A.C. 8:57-4.17 (Varicella Vaccine)

To the Department of Health and Senior Services, Division of Epidemiology, Environmental and Occupational Health:

The Association of American Physicians & Surgeons, Inc. ("AAPS"), founded in 1943, is a nationwide group of thousands of physicians. We oppose the proposed mandate for vaccination against chickenpox.

Prior to the development of the varicella (chickenpox) vaccine, the disease was widely recognized to be one of the most benign illnesses. For example, Encyclopedia of Medicine of the American Medical Association stated in 1989 that chickenpox is a "common and mild infectious disease of childhood" and that "all healthy children should be exposed to chickenpox … at an age at which it is no more than an inconvenience." Likewise, the American Academy of Pediatrics declared in a 1996 brochure that "[m]ost children who are otherwise healthy and get chickenpox won't have any complications from the disease."

Indeed, the chickenpox fatality rate is among the lowest of all known diseases, with only about 100 dying out of millions who contract chickenpox each year. Moreover, most of those fatalities are in adults rather than children. For example, a study published in the British Medical Journal on July 27, 2002, confirmed that 81% of the deaths attributable to chickenpox over a recent 12-year period in Britain were adults, not children.

The risk of contracting and dying from chickenpox is little more than the risk of being struck and killed by lightning, which is about 89 per year in the U.S. Nevertheless, those adults who are concerned about such a low health risk may obtain the varicella vaccine voluntarily. The vaccine manufacturer can advertise, and consumers can make their own decisions. Over time, the free market would force improvements in the cost and efficacy of the vaccine, and the consumer will be better off for it.

But what we object to here is the forcing of children to take this vaccine at public expense. Children have nothing to fear from the disease, and should not be forced by law to undergo unnecessary medical treatment. The varicella vaccine is still relatively new and unproven, both in safety and efficacy. Forcing millions to receive this vaccine, at substantial expense, would constitute an experiment on the public. Given the scarcity of money for medical care, our dollars are much better spent where people actually want the services.

The FDA Summary for Basis of Approval (SBA) is posted online at www.fda.gov/cber/sba/varmer031795sba.pdf. It conceals key data comparing the vaccine to the placebo. Nevertheless, the limited posted data about vaccine side effects are themselves alarming. For example, the data disclose that post-vaccine fatigue was reported in 27.4% of recipients in healthy children and 29% of healthy adolescents and adults; post-vaccine chills were reported in 4.8% of children and 8.7% of adolescents and adults; abdominal pain was reported in 8.2% of children and 7.7% of adolescents and adults; disturbed sleep in 24.1% of children and 15.6% of adolescents and adults; eye complaints in 6.2% of children and 8.5% of adults; and so on. These side effects are alone worthy of concern, and also suggest the likelihood of more serious injury.

This report ignores side effects occurring beyond 42 days of receipt of the vaccine, such as exacerbated asthma, diabetes or autism. Shingles is also a serious problem connected with the vaccine.

Against these significant adverse effects, what are a child's chances of being injured by the disease? Less than 1 in one million die from chickenpox annually, and it is unlikely most children today will ever contract the disease. A study of 3000 children in 11 daycare centers between 1995 and 1997 was published in "Conference Coverage (ICAAC) Unvaccinated Children Protected, But May Pay Later," Immunotherapy Weekly, Oct 12, 1998. Despite being in group care, chickenpox among the children studied was zero among children age 1 to 2 years, 5 percent in children age 2 to 3 years, and 13 percent in children age 3 to 4 years.

In a survey of pediatricians published in August 1998 in the Archives of Pediatrics & Adolescent Medicine (vol. 152, no. 8, p.792(5)), it was found that only 42% adhered to a report by the American Academy of Pediatrics recommending universal varicella vaccination of children. Why would New Jersey require a universal treatment that most pediatricians feel is unjustified?

The reason is profit for the companies selling the mandated products. Children need vaccines only 1/100th as much as adults, yet childhood vaccinations account for 65% of the multibillion dollar annual U.S. vaccine market. Vaccine manufacturers force their goods on kids, who do not need them, while failing to persuade adults to buy them in a free market. As with other vaccine mandates, disease data based on adults are used to force vaccines on children. There is no evidence that the vaccines will even remain effective into adulthood for those children. In the SBA for the varicella vaccine (cited above), Merck admits that "[t]he duration of protection of VARIVAX is unknown at present and the need for booster doses is not defined."

In addition, New Jersey does not have a philosophical exemption to these vaccine mandates and the varicella vaccine is a highly objectionable one on moral grounds. The vaccine was developed based on having been "serially passaged through primary human embryonic lung culture" (quoting the SBA cited above). The published SBA, however, has deleted and drawn a huge "X" through its explanation of the details of how human embryos were used in developing this vaccine. All indications are that the varicella vaccine was developed through use of abortion. Parents in New Jersey have a right to know the details, and there should not be mandatory vaccination of a morally offensive vaccine. A majority of New Jerseyans adhere to religions that reject abortion; why should they be forced to receive a vaccine based on it?

It is worth noting that the Physicians Desk Reference contains this warning: "Vaccine recipients should attempt to avoid, whenever possible, close association with susceptible high-risk individuals for up to six weeks. ... Susceptible high-risk individuals include immunocompromised individuals; pregnant women without documented history of chickenpox or laboratory evidence of prior infection; newborn infants of mothers without documented history of chickenpox or laboratory evidence of prior infection." (Emphasis added.) Thus this Department is proposing a mandate that creates a serious risk of harm, without legal remedy for the injured victims. AAPS strongly opposes this proposal.

Three months into the federally mandated smallpox inoculation, the federal government has recently permitted states to terminate the program if they choose. Only 35,000 of the half-million targeted workers had received the smallpox vaccine before it became necessary to reverse the mandate. In that relatively short period of time the smallpox mandate caused eleven cases of unusual heart inflammation, three civilian deaths, plus the unexplained death of NBC correspondent David Bloom within weeks of receiving the smallpox vaccine. Earlier, the federal government also had to reverse its mandate for the rotavirus vaccine after infants tragically and unnecessarily died from it. New Jerseyans should not be forced down the same road with a mandatory chickenpox vaccine.