by Alan Phillips, J.D.
It is not enough to be informed about the many problems with current immunization policy and practice. We must effectively apply that knowledge to expand our right to make informed choices. Where the rubber meets the road with vaccine rights is in the statutes and regulations that provide or restrict those rights. Therefore, a great deal of my time is spent helping citizens throughout the U.S. present their case to state legislatures about the necessity of the right to make informed choices wherever vaccines are concerned.
The arguments are presented below. They are not comprehensive – books have been written on some of these topics – but the goal with legislatures is to make strong, concise arguments with credible support. Their time is often limited, and their ability to hear alternative points of view potentially limited as well. The question is not so much "What is the whole truth?" as it is "What will get the job done?" The actual letter is available at http://www.vaccinerights.com/legislativeprojects.html and revisions to the arguments may appear in the future on the Vaccine Rights website as well.
TEMPLATE: ARGUMENTS FOR THE ENACTMENT OF A PHILOSOPHICAL EXEMPTION TO IMMUNIZATIONS
I. Credit Given to Vaccines for 20th Century Childhood Infectious Disease Declines is Misplaced
Childhood infectious disease decline throughout the 20th Century is widely but erroneously attributed to vaccines. On average, about 90 percent of infectious disease decline preceded vaccines, while some diseases declined without any vaccines at all such as typhoid fever, scarlet fever, scurvy and tuberculosis.1 In fact, some disease rates actually increased following the introduction of vaccines. For example, during 1962 U.S. Congressional hearings, Dr. Bernard Greenberg, Biostatistics Department Head at the University of North Carolina School of Public Health,2 testified that cases of polio increased substantially after polio vaccines were introduced – 50 percent from 1957-58, and 80 percent from 1958-59 – and that the Public Health Service deliberately manipulated statistics to give the opposite impression.3 Meanwhile, polio declined in countries that didn't vaccinate.4 Therefore, 20th century disease declines do not support an absolute vaccine mandate.
II. A Reliable Vaccine-Disease Risk-Benefit Assessment is not Feasible
A. First, we do not have precise disease mortality data. For example, with regard to the recent H1N1 pandemic, the CDC reported U.S. laboratory confirmed flu deaths (both swine and seasonal) for the 2009-2010 flu season were 2,1175. However, the CDC estimated U.S. swine flu deaths alone at 8870 to 18,3006. In stark contrast, Flu Tracker (Rhiza Labs) estimated only 4642 fatal U.S. swine flu cases.7 Documenting disease deaths has been problematic historically as well. For example, in 1974, the CDC determined that there were 36 cases of measles in Georgia, while the Georgia State Surveillance System reported 660 cases.8 The truth is, we have only non-precise, widely varying "guesstimates" for disease mortality figures.
B. We know even less about the scope and severity of vaccine injury and death. The Vaccine Adverse Event Reporting System (VAERS) and National Vaccine Injury and Compensation Program (NVICP) have revealed irrefutably that vaccines cause permanent injuries and deaths, but they are inadequate measures of the scope of the problem. The FDA and CDC have admitted that reported adverse events represent as few as 1-10 percent of the events actually occurring.9 According to former FDA Commissioner David Kessler, reported events may be less than 1 percent.10 Furthermore, "No data get collected, and it remains unknown whether vaccination increases the incidence of most [chronic] diseases, particularly rare diseases."11 Where there are huge unknowns concerning how vaccines affect other disease rates, and when the actual number of vaccine injuries and deaths may be up to 100 times greater than the number documented by the federal government, state governments are ethically compelled to allow a conscientious exemption.
III. The Belief That Unvaccinated Persons Pose a Risk of Harm to Others is Without Merit
A. If vaccines work, then of course unvaccinated persons pose no risk to vaccinated persons at all. The persistent, widespread claim that unvaccinated people "put everyone else at risk" is, therefore, nothing more than absurd fear mongering. The likely real basis for such claims is the enormous profit potential from vaccines. From the perspective of the pharmaceutical industry, every man, woman and child on the planet is a potential recipient of vaccines from the moment of birth until their last breath. The pharmaceutical industry, responding to this vast marketing opportunity, now has over 330 vaccines either in development or already on the market,12 despite the profound drop in disease rates across the last century suggesting the need for fewer, not more, vaccines. Citizens should have a conscientious exemption allowing them to opt out of this mad, pharmaceutical feeding frenzy.
B. A more specific concern is the claim that the tiny percentage of persons not vaccinated for medical reasons, perhaps along with the larger percentage of vaccinated persons whose vaccines don't work, are put at risk by those exercising non-medical reasons. This belief is also without merit. It is based on the herd immunity theory, which states that if most of a population is immune, the entire population is protected. The presumed problem is that if too many people opt out of vaccines, the herd immunity effect will be compromised, and those not immune due to medical exemptions or failed vaccines are at risk.
Aside from the absurd implication that unvaccinated persons somehow become "disease magnets" that "create" or "attract" disease in communities where diseases have been absent for decades (and whose absence substantially preceded vaccines), this concern is erroneous because the herd immunity theory has been substantially disproved. For example, measles, mumps, small pox, pertussis, polio and Hib outbreaks have all occurred in vaccinated populations.13,14,15,16,17 In 1989, the CDC reported: "Among school-aged children, [measles] outbreaks have occurred in schools with vaccination levels of greater than 98 percent.18 [They] have occurred in all parts of the country, including areas that had not reported measles for years."19 The CDC even reported a measles outbreak in a documented 100 percent vaccinated population.20 A study examining this phenomenon concluded, "The apparent paradox is that as measles immunization rates rise to high levels in a population, measles becomes a disease of immunized persons."21 The disturbing implication here is that efforts to maximize immunization rates may actually be counterproductive. Recent outbreaks in California, New York and New Jersey also occurred in highly vaccinated populations.22,23
Official statistics for the recent swine flu pandemic show that the U.S. vaccinated 30 percent of the population against swine flu, yet had more than eight times its proportional share of international swine flu deaths. England vaccinated 8 percent of its population and had two times its proportional share. But Poland, which refused swine flu vaccines altogether, had only one-tenth of its proportional share of international swine flu deaths.24 These data strongly suggest that the swine flu immunization campaigns may actually have been counterproductive. Therefore, citizens should have the right, individually, to determine whether or not any given vaccine is appropriate for themselves and their children.
IV. Mandatory Vaccination Prevents Citizens From Choosing Proven Safer, Less Costly, More Effective Alternatives
A. In the fall of 2008, Cuba used homeoprophylaxis to protect 2.5 million residents of Cuba from a Leptospirosis outbreak following tropical flooding. The protective effect profoundly exceeded that of conventional immunizations – 10 infections and no deaths with homeoprophylaxis vs. thousands of infections with many deaths in prior years with conventional immunization. The cost was about one-fifteenth that of conventional immunization. This was achieved "with full scientific verification."25 [emphasis added] Numerous other instances of successful homeoprophylaxis have been documented around the world over the past 200 years, including here in the U.S.26 With homeoprophylaxis, adverse events are virtually non-existent; there is none of the resulting death and disability that inevitably occurs with the widespread use of conventional immunizations. For those who consider homeopathy unproven or believe that it can't work, the implications are even more dramatic. If that is really the case, the use of immunizations in Cuba prior to 2008 was necessarily profoundly counterproductive.
B. A recent Japanese study found that "Vitamin D [is] better than vaccines at preventing flu,"27 and experts say that vitamin D toxicity fears are unwarranted.28 In a 2010 review, the esteemed Cochrane Collaboration, an independent, international consortium of medical researchers, issued a WARNING stating that "reliable evidence on influenza vaccines is thin but there is evidence of widespread manipulation of conclusions."29 The review found that "vaccine use did not affect . . . working days lost" and "had no effect on hospital admissions or complication rates." State legislators would do better to mandate vitamin D supplements than to mandate flu vaccines.
Meanwhile, the documented manipulation of scientific data in flu vaccine studies raises serious questions about the quality of studies on other vaccines, if not also about the reliability of medical research generally. Indeed, according to Newsweek, the new chief of Stanford University's Prevention Research Center says that people are "being hurt and even dying" due to widespread errors in medical research.30 It is no longer sufficient to base policy on study conclusions alone. We must scrutinize the studies' methods, data, funding sources, potential conflicts of interest, etc., before accepting and acting on their conclusions.
Surely it is not the intent of state legislatures to implement health policy based on erroneous information, or to prohibit citizens from accessing the most efficacious, cost-effective, and safest choices for disease prevention available. The serious questions concerning the reliability of vaccine medical research and the availability of proven alternatives to conventional immunizations compel state legislatures to provide citizens with the right to a conscientious exemption from immunizations.
V. Conflicts of Interest Raise Serious Questions About Vaccine Policy
A. The Advisory Committee for Immunization Practices (ACIP) develops written immunization recommendations that are adopted by the CDC. These become CDC recommendations that in turn are substantially enacted into law by the states. However, some ACIP members have conflicts of interest; some are right out of the vaccine industry or otherwise situated such that they stand to profit from the very policies they create. Therefore, states must scrutinize ACIP recommendations carefully, and accept or reject those recommendations based on the findings of that scrutiny, and not merely accept federal agency recommendations at face value.
B. There are conflicts of interest in the CDC as well. In December of 2009, Julie Gerberding, M.D., M.P.H., announced her job change from CDC Director (where she promoted vaccines) to President of Merck Vaccines31. Given the revolving door between agency and industry, we cannot presume that CDC recommendations are necessarily always objective. Given this interrelationship between industry and government, states have an ethical and moral imperative to exercise careful scrutiny of CDC policies and recommendations, and to implement state policy based upon the findings of their own investigations.
C. Conflicts of interest exist at the international level. On June 3, 2010, the British Medical Journal (BMJ) revealed the existence of undisclosed, serious conflicts of interest in the WHO along with scientifically unsupportable distortions of information from the WHO concerning the swine flu pandemic.32 BMJ's Editor in Chief advised: "The current leadership of WHO may need to resign . . . We must create a world in which the best experts are those that are free from commercial influences."33 The WHO did not volunteer any conflict of interest information until Aug. 11, 2010, after the pandemic was declared to be over,34 and no one at the WHO resigned.
Given that conflicts of interest exist throughout federal and international vaccine policy-making agencies, states are morally and ethically compelled to scrutinize meticulously the recommendations of those agencies, and to base state immunization policy and law on the findings of their own, independent analyses. Unless and until that occurs, and unless such analyses clearly dictate otherwise, states are morally and ethically obligated to provide citizens the right to informed choice, by way of a conscientious exemption to mandatory vaccines.
VI. Reliance on the Pharmaceutical Industry is Severely Misplaced
A. In December of 2009, the WHO reported: "Corruption in the pharmaceutical sector occurs throughout all stages of the medicines chain, from research and development to dispensing and promotion."35 Thus, a high level of scrutiny is required when considering products, claims and recommendations coming from this industry.
B. The pharmaceutical industry regularly engages in criminal behavior. In 2008, Merck was fined $650 million under the False Claims Act. In 2009, Pfizer was assessed a $1 billion criminal fine, along with a $1.3 billion civil fine, in its fourth settlement since 2002 over illegal marketing. In 2009, Ely Lilly was assessed a $515 million criminal fine and a $900 million civil fine. In 2010, GlaxoSmithKline was assessed a $150 million criminal fine and $750 million civil fine. Over the past 10 years, these and other companies including TAP, Tenet Healthcare, HCA, Serono, AstraZenica, Abbott Labs, Bristol Myers Squibb, SmithKline Beecham, Shering-Plough, and Bayer Corporation were assessed criminal and/or civil fines for unlawful acts in the hundreds of millions of dollars. The pharmaceutical industry has become the biggest defrauder of the federal government under the False Claims Act, and the problem has gotten consistently worse over the past few years.36
It is critical to understand that criminal behavior, by definition, means that the perpetrator had knowledge of the unlawfulness of the acts committed. These companies knew exactly what they were doing each and every time. We can't know how many crimes were committed that were not caught and prosecuted, but based on those that were, we know that criminal behavior in the pharmaceutical industry is routine, presumably because it is, on the whole, profitable (which strongly suggests that there are crimes committed that don't get caught – not unlike the drug cartels). Since this behavior has gotten worse in recent years, we know that it is substantially likely to continue to occur in the future. Given that the pattern of behavior has been widespread and decades in the making, it is absolutely fair – indeed, necessary – to factor this pattern of behavior into an overall assessment of the character of this industry, and to assess the general credibility and reliability of their products accordingly.
The point is this: NO ONE SHOULD EVER BE REQUIRED ABSOLUTELY TO TAKE A PRODUCT FROM AN INDUSTRY THAT ROUTINELY ENGATES IN CRIMINAL BEHAVIOR.
Having the right to say 'NO' to the criminal pharmaceutical industry is a moral and ethical imperative.
VII. Philosophical Exemptions Are Time-Tested and Safe
Currently, about 20 states containing a majority of U.S. citizens have philosophical exemptions to immunizations. If these exemption rights were causing serious problems, these exemption laws would either not have been enacted in the first place, or would have been quickly repealed. However, this has not happened. Apparently, philosophical exemptions have had no significant adverse effect on infectious disease rates.
Furthermore, all states have authority under the U.S. Constitution to mandate vaccines in the event of an emergency,37 regardless of citizens' religious or philosophical objections, and to quarantine unvaccinated persons when necessary. So, if the unvaccinated should ever prove to pose a serious risk of harm in the future, there is authority for the state to act as it deems necessary to protect its citizens.
VIII. Medical Experts Disagree About Vaccine Safety and Effectiveness
There is a growing body of medical experts who are speaking out with concerns about vaccines.38 Independent medical research contradicts pro-vaccine research funded by the pharmaceutical industry. The question, then, is whether or not government should assume the role of deciding who is correct, and impose its opinion in a one-size-fits-all policy on constituencies that consist of individuals with varying needs. The far better health care policy is one where individuals have the flexibility to make a customized risk-benefit analysis for themselves and their children in consultation with their health care providers – professionals who know their needs. Some may choose vaccines, but others may find that for them, the risks outweigh the benefits. Whatever the choice, all should have the right to make that assessment without government interference. With herd immunity having been disproved, there is no scientific basis for government imposing its will on the people, collectively, usurping the rights of the individual.
IX. Vaccination Raises a Fundamental Rights Question
Government mandate of immunizations absolutely, without a conscientious exemption, raises a profound fundamental rights question. Vaccines carry a risk of permanent injury and death, and that risk is presently neither quantifiable nor preventable. In a society where the vast majority of disease decline preceded vaccines, where in some instances vaccines caused a reversal of prior disease declines, where in some instances vaccines have proven to be counterproductive, where policy is based on a disproven herd immunity theory, and where policy is substantially driven by a corrupt industry that routinely engages in criminal behavior and that profits handsomely by the policy it drives, such a mandate is contrary to the very essence of what it means to be a democratic republic.
The international debate about vaccine safety and effectiveness is anything but resolved. Indeed, a fair and open conversation is, if ultimately inevitable, still yet to be fully had. Pending a final outcome of this debate, and given the high stakes involved and problems cited above, citizens in a free society should have the right to decide for themselves what is in their own best interests. Those who believe in vaccines are welcome to have them, and if vaccines really work, they have nothing to fear from the unvaccinated. In the meantime, state governments have authority under the U.S. Constitution to require unvaccinated children to stay home during outbreaks, and to impose vaccines or quarantine on unvaccinated citizens in declared emergencies. So, governments have nothing to fear by granting their citizens the right to informed choice. Indeed, given the above, governments have nothing less than a moral, ethical and legal imperative to provide that right.
CONCLUSIONS
1. Credit given to vaccines for 20th century infectious disease declines is misplaced. Vaccine history does not support an absolute mandate for vaccines.
2. Data for accurate vaccine-disease risk-benefit is not available. Therefore, government lacks the means by which to adequately determine whether or not vaccines provide a net benefit and are in fact actually necessary, and therefore, must allow conscientious exemptions.
3. Claims that the unvaccinated pose a risk of harm to the vaccinated are unfounded (if vaccines work, how could an unvaccinated person harm a vaccinated person?). Claims that the unvaccinated pose a risk of harm to those who can't be vaccinated or whose vaccines don't work are based on a misplaced belief in the disproven "herd immunity" theory. Therefore, the unwarranted, fear-based concerns about risks posed by the unvaccinated do not present a legitimate bar to the enactment of a conscientious exemption right. Furthermore, those who can't be vaccinated or whose vaccines don't work have viable alternatives that may work better than vaccines and that are safer and less expensive.
4. The evidence shows that vaccines were actually counterproductive in some instances. Clearly, then, government should allow a conscientious exemption so that citizens can assess the merits of individual vaccines.
5. There are viable, proven alternatives to immunizations. Homeoprophylaxis is far less expensive, more effective, and safer with no risk of injury or death. Vaccines carry a risk of permanent injury or death, are more costly, and are of questionable efficacy when scrutinized objectively. Therefore, citizens should have the right to choose from among all of the available options. Absent this option, government is endorsing only one of many legitimate health care modalities, to the exclusive profit of one industry, thereby substantially interfering with the free market.
6. Where conflicts of interest exist with those setting policy, there is a moral and ethical imperative for citizens to have and retain the right to evaluate and disagree with the resulting policy. Immunization policy is driven by the very industry that manufactures the vaccines, and that industry routinely engages in criminal behavior. NO ONE SHOULD EVER BE REQUIRED TO USE PRODUCTS CREATED BY AN INDUSTRY THAT ROUTINELY ENGAGES
IN CRIMINAL BEHAVIOR.
7. Conscientious exemptions are time-tested. About 20 states representing a majority of the U.S. population currently have philosophical exemptions. If these exemptions caused serious problems, these exemption laws would have been repealed long ago. Clearly, philosophical exemptions have not created serious health problems, and if they ever should pose a problem, states retain the authority to impose emergency vaccines and/or quarantines as needed. A conscientious exemption poses no significant health threat to the state.
8. There is a growing body of lay persons and professionals, including credible medical professional and researchers, who are speaking out about problems with the conventional thinking on immunizations. There is a valid vaccine controversy. Given this reality, individuals should have and retain the right to make informed decisions.
9. Vaccines carry a risk of permanent injury and death. That risk may vary substantially from individual to individual, and the medical community has no gauge by which to assess that risk for healthy individuals. The herd immunity theory is flawed, so individual citizens cannot be said to have a responsibility to vaccinate for the sake of the community. Therefore, by definition, our democratic republic requires that citizens have the right to decide for themselves, as individuals, whether or not vaccines are right for them and their children.
In view of the above, and the scientific, legal, moral and ethical imperatives presented and supported therein, we respectfully request that the Honorable Senators and Representatives of this Great State support and pass the Bill adding an exemption from immunizations for conscientious beliefs.
Alan Phillips, J.D. is a nationally recognized legal expert on vaccine rights issues. He helps clients, activists and other attorneys nationally with vaccine rights issues and legislative initiatives. Learn more at www.vaccinerights.com