.
To: Oversight and Investigations Subcommittee, House Energy and Commerce Committee
Senate Committee on Health, Education, Labor and Pensions
Re: Statement federal vaccine mandates
Feb. 26, 2019
The Association of American Physicians and Surgeons (AAPS) strongly opposes federal interference in medical decisions, including mandated vaccines. After being fully informed of the risks and benefits of a medical procedure, patients have the right to reject or accept that procedure. The regulation of medical practice is a state function, not a federal one. Governmental preemption of patients’ or parents’ decisions about accepting drugs or other medical interventions is a serious intrusion into individual liberty, autonomy, and parental decisions about child-rearing.
A public health threat is the rationale for the policy on mandatory vaccines. But how much of a threat is required to justify forcing people to accept government-imposed risks? Regulators may intervene to protect the public against a one-in-one million risk of a threat such as cancer from an involuntary exposure to a toxin, or-one-in 100,000 risk from a voluntary (e.g. occupational) exposure. What is the risk of death, cancer, or crippling complication from a vaccine? There are no rigorous safety studies of sufficient power to rule out a much lower risk of complications, even one in 10,000, for vaccines. Such studies would require an adequate number of subjects, a long duration (years, not days), an unvaccinated control group (“placebo” must be truly inactive such as saline, not the adjuvant or everything-but-the-intended-antigen), and consideration of all adverse health events (including neurodevelopment disorders).
Vaccines are necessarily risky, as recognized by the U.S. Supreme Court and by Congress. The Vaccine Injury Compensation Program has paid some $4 billion in damages, and high hurdles must be surmounted to collect compensation. The damage may be so devastating that most people would prefer restored function to a multimillion-dollar damage award.
The smallpox vaccine is so dangerous that you can’t get it now, despite the weaponization of smallpox. Rabies vaccine is given only after a suspected exposure or to high-risk persons such as veterinarians. The whole-cell pertussis vaccine was withdrawn from the U.S. market, a decade later than from the Japanese market, because of reports of severe permanent brain damage. The acellular vaccine that replaced it is evidently safer, though somewhat less effective.
The risk: benefit ratio varies with the frequency and severity of disease, vaccine safety, and individual patient factors. These must be evaluated by patient and physician, not imposed by a government agency.
Measles is the much-publicized threat used to push for mandates, and is probably the worst threat among the vaccine-preventable illnesses because it is so highly contagious. There are occasional outbreaks, generally starting with an infected individual coming from somewhere outside the U.S. The majority, but by no means all the people who catch the measles have not been vaccinated. Almost all make a full recovery, with robust, life-long immunity. The last measles death in the U.S. occurred in 2015, according to the Centers for Disease Control and Prevention(CDC). Are potential measles complications including death in persons who cannot be vaccinated due to immune deficiency a justification for revoking the rights of all Americans and establishing a precedent for still greater restrictions on our right to give—or withhold—consent to medical interventions? Clearly not.
Many serious complications have followed MMR vaccination, and are listed in the manufacturers’ package insert, though a causal relationship may not have been proved. According to a 2012 report by the Cochrane Collaboration, “The design and reporting of safety outcomes in MMR vaccine studies, both pre- and post-marketing, are largely inadequate” (cited by the National Vaccine Information Center).
Mandate advocates often assert a need for a 95% immunization rate to achieve herd immunity. However, Mary Holland and Chase Zachary of NYU School of Law argue, in the Oregon Law Review, that because complete herd immunity and measles eradication are unachievable, the better goal is for herd effect and disease control. The best outcome would result, they argue, from informed consent, more open communication, and market-based approaches.
Even disregarding adverse vaccine effects, the results of near-universal vaccination have not been completely positive. Measles, when it does occur, is four to five times worse than in pre-vaccination times, according to Lancet Infectious Diseases, because of the changed age distribution: more adults, whose vaccine-based immunity waned, and more infants, who no longer receive passive immunity from their naturally immune mother to protect them during their most vulnerable period.
Measles is a vexing problem, and more complete, forced vaccination will likely not solve it. Better public health measures—earlier detection, contact tracing, and isolation; a more effective, safer vaccine; or an effective treatment are all needed. Meanwhile, those who choose not to vaccinate now might do so in an outbreak, or they can be isolated. Immunosuppressed patients might choose isolation in any event because vaccinated people can also possibly transmit measles even if not sick themselves.
Issues that Congress must consider:
Manufacturers are virtually immune from product liability, so the incentive to develop safer products is much diminished. Manufacturers may even refuse to make available a product believed to be safer, such as monovalent measles vaccine in preference to MMR (measles-mumps-rubella). Consumer refusal is the only incentive to do better.
There are enormous conflicts of interest involving lucrative relationships with vaccine purveyors.
Research into possible vaccine adverse effects is being quashed, as is dissent by professionals.
There are many theoretical mechanisms for adverse effects from vaccines, especially in children with developing brains and immune systems. Note the devastating effects of Zika or rubella virus on developing humans, even though adults may have mild or asymptomatic infections. Many vaccines contain live viruses intended to cause a mild infection. Children’s brains are developing rapidly—any interference with the complex developmental symphony could be ruinous.
Vaccines are neither 100% safe nor 100% effective. Nor are they the only available means to control the spread of disease.
AAPS believes that liberty rights are unalienable. Patients and parents have the right to refuse vaccination, although potentially contagious persons can be restricted in their movements (e.g. as with Ebola), as needed to protect others against a clear and present danger. Unvaccinated persons with no exposure to a disease and no evidence of a disease are not a clear or present danger.
AAPS represents thousands of physicians in all specialties nationwide. It was founded in 1943 to protect private medicine and the patient-physician relationship.
Respectfully yours,
Jane M. Orient, M.D., Executive Director
Association of American Physicians and Surgeons
To: Oversight and Investigations Subcommittee, House Energy and Commerce Committee
Senate Committee on Health, Education, Labor and Pensions
Re: Statement federal vaccine mandates
Feb. 26, 2019
The Association of American Physicians and Surgeons (AAPS) strongly opposes federal interference in medical decisions, including mandated vaccines. After being fully informed of the risks and benefits of a medical procedure, patients have the right to reject or accept that procedure. The regulation of medical practice is a state function, not a federal one. Governmental preemption of patients’ or parents’ decisions about accepting drugs or other medical interventions is a serious intrusion into individual liberty, autonomy, and parental decisions about child-rearing.
A public health threat is the rationale for the policy on mandatory vaccines. But how much of a threat is required to justify forcing people to accept government-imposed risks? Regulators may intervene to protect the public against a one-in-one million risk of a threat such as cancer from an involuntary exposure to a toxin, or-one-in 100,000 risk from a voluntary (e.g. occupational) exposure. What is the risk of death, cancer, or crippling complication from a vaccine? There are no rigorous safety studies of sufficient power to rule out a much lower risk of complications, even one in 10,000, for vaccines. Such studies would require an adequate number of subjects, a long duration (years, not days), an unvaccinated control group (“placebo” must be truly inactive such as saline, not the adjuvant or everything-but-the-intended-antigen), and consideration of all adverse health events (including neurodevelopment disorders).
Vaccines are necessarily risky, as recognized by the U.S. Supreme Court and by Congress. The Vaccine Injury Compensation Program has paid some $4 billion in damages, and high hurdles must be surmounted to collect compensation. The damage may be so devastating that most people would prefer restored function to a multimillion-dollar damage award.
The smallpox vaccine is so dangerous that you can’t get it now, despite the weaponization of smallpox. Rabies vaccine is given only after a suspected exposure or to high-risk persons such as veterinarians. The whole-cell pertussis vaccine was withdrawn from the U.S. market, a decade later than from the Japanese market, because of reports of severe permanent brain damage. The acellular vaccine that replaced it is evidently safer, though somewhat less effective.
The risk: benefit ratio varies with the frequency and severity of disease, vaccine safety, and individual patient factors. These must be evaluated by patient and physician, not imposed by a government agency.
Measles is the much-publicized threat used to push for mandates, and is probably the worst threat among the vaccine-preventable illnesses because it is so highly contagious. There are occasional outbreaks, generally starting with an infected individual coming from somewhere outside the U.S. The majority, but by no means all the people who catch the measles have not been vaccinated. Almost all make a full recovery, with robust, life-long immunity. The last measles death in the U.S. occurred in 2015, according to the Centers for Disease Control and Prevention(CDC). Are potential measles complications including death in persons who cannot be vaccinated due to immune deficiency a justification for revoking the rights of all Americans and establishing a precedent for still greater restrictions on our right to give—or withhold—consent to medical interventions? Clearly not.
Many serious complications have followed MMR vaccination, and are listed in the manufacturers’ package insert, though a causal relationship may not have been proved. According to a 2012 report by the Cochrane Collaboration, “The design and reporting of safety outcomes in MMR vaccine studies, both pre- and post-marketing, are largely inadequate” (cited by the National Vaccine Information Center).
Mandate advocates often assert a need for a 95% immunization rate to achieve herd immunity. However, Mary Holland and Chase Zachary of NYU School of Law argue, in the Oregon Law Review, that because complete herd immunity and measles eradication are unachievable, the better goal is for herd effect and disease control. The best outcome would result, they argue, from informed consent, more open communication, and market-based approaches.
Even disregarding adverse vaccine effects, the results of near-universal vaccination have not been completely positive. Measles, when it does occur, is four to five times worse than in pre-vaccination times, according to Lancet Infectious Diseases, because of the changed age distribution: more adults, whose vaccine-based immunity waned, and more infants, who no longer receive passive immunity from their naturally immune mother to protect them during their most vulnerable period.
Measles is a vexing problem, and more complete, forced vaccination will likely not solve it. Better public health measures—earlier detection, contact tracing, and isolation; a more effective, safer vaccine; or an effective treatment are all needed. Meanwhile, those who choose not to vaccinate now might do so in an outbreak, or they can be isolated. Immunosuppressed patients might choose isolation in any event because vaccinated people can also possibly transmit measles even if not sick themselves.
Issues that Congress must consider:
Manufacturers are virtually immune from product liability, so the incentive to develop safer products is much diminished. Manufacturers may even refuse to make available a product believed to be safer, such as monovalent measles vaccine in preference to MMR (measles-mumps-rubella). Consumer refusal is the only incentive to do better.
There are enormous conflicts of interest involving lucrative relationships with vaccine purveyors.
Research into possible vaccine adverse effects is being quashed, as is dissent by professionals.
There are many theoretical mechanisms for adverse effects from vaccines, especially in children with developing brains and immune systems. Note the devastating effects of Zika or rubella virus on developing humans, even though adults may have mild or asymptomatic infections. Many vaccines contain live viruses intended to cause a mild infection. Children’s brains are developing rapidly—any interference with the complex developmental symphony could be ruinous.
Vaccines are neither 100% safe nor 100% effective. Nor are they the only available means to control the spread of disease.
AAPS believes that liberty rights are unalienable. Patients and parents have the right to refuse vaccination, although potentially contagious persons can be restricted in their movements (e.g. as with Ebola), as needed to protect others against a clear and present danger. Unvaccinated persons with no exposure to a disease and no evidence of a disease are not a clear or present danger.
AAPS represents thousands of physicians in all specialties nationwide. It was founded in 1943 to protect private medicine and the patient-physician relationship.
Respectfully yours,
Jane M. Orient, M.D., Executive Director
Association of American Physicians and Surgeons
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