Public health officials are concerned that more parents are requesting exemptions from childhood vaccines. In some states, as many as 1 in 20 public school kindergartners have skipped one or more of the required immunizations (AP 11/29/11).             The percentage of Arizona parents claiming a personal/religious exemption has increased from around 1% in 2000 to nearly 4% in 2011, according to a report by Karen Lewis, M.D., Medical Director, Arizona Immunization Program Office, at a Dec 8 meeting  of the Maternal and Child Health Committee of the Arizona Medical Association (ArMA). Vaccine refusers tend to cluster geographically, increasing the likelihood of outbreaks. They tend to be more highly educated and in more affluent socioeconomic groups.

“They think they’re cable of doing research!” lamented a committee member.

After one safety concern is addressed, another tends to surface. “First it was pertussis, then measles, then thimerosal, and now it must be the adjuvants since thimerosal has been removed.”

Some advocate more restrictive laws, but Dr. Lewis thinks education is preferable. It was noted that after the Wakefield furor (see below), the message seems to be that “parents may have the right to refuse, but we have the right to protect ourselves against them.” This is the tactic exemplified in vaccine advocate Paul Offit’s book Deadly Choices: How the Anti-Vaccine Movement Threatens Us All. Parents of children affected by a vaccine-preventable disease give programs entitled “Ruining It for the Rest of Us.” They suggest sending the unvaccinated to “their own infectious diseases island.” [My review of this book is available at: http://www.jpands.org/vol16no3/bookreviews.pdf.]

“Education” or promotional efforts have not been particularly effective in increasing influenza immunization in health care workers. In one study, uptake was only 21.9% in the intervention group versus 21.0% in controls (J Pub Health Med 2001;23:346-3438). Generally rates hover at less than 50%. Based on CDC recommendations, some facilities or states are mandating flu vaccine for all workers, sometimes on pain of being fired. In Colorado, proposed rules permit only limited medical exemptions. As with second-hand smoke laws, the rationale is that people have the constitutional right to risk their own health, but not to impose risk on others.

VACCINES AND HEALTH

             “A lot of people…should be held responsible” for four (4) measles deaths and hundreds of hospitalizations in the UK, Offit thinks, since an article in the Lancet by Andrew Wakefield M.D., and a dozen others suggested a possible link between MMR (measles-mumps-rubella) vaccine and autism, causing parents to decline the vaccine. The “bombshell” withdrawal of the allegedly fraudulent 1998 article might, Offit hopes, “ [end] the [autism] debate once-and-for-all” (CBSNews 2/4/10). [Wakefield’s presentation at the 2011 meeting of the Association of American Physicians and Surgeons (AAPS) may be viewed at http://www.youtube.com/watch?v=l67fWVrw8xU.]

Without mandates, advocates argue, U.S. chickenpox-related deaths, for example, might skyrocket from 66/y [1999–2001] back to the pre-vaccine level of 145/y.

As discussed in the January 2011 issue, an increasing number of vaccines has not been associated with overall good health. About 43% of U.S. children are said to have at least one of 20 chronic health conditions, not counting obesity, and 24% have some type of environmental or skin allergy (Acad Ped 2011;11:S22-S33). Food allergies affect about 6% of young children and 3% to 4% of adults. These result in some 317,000 visits each year to emergency rooms or physicians, and 9,500 hospital admissions (3.6 times as many in 2004-2006 as in 1998-2000). Food allergies cause 150 to 200 deaths per year, more than half caused by peanuts (www.AAAAI.org).

Peanut dust, like viruses, travels in the air, so sensitive persons can experience an anaphylactic response without actually eating a peanut. Schools are banning peanuts because of a problem that was virtually unheard of 50 years ago. Since vaccines, after all, stimulate the immune system, could we have exchanged the risk of infection during an outbreak for a need for constant vigilance against a ubiquitous antigen?

The CDC has never conducted a study of health outcomes in vaccinated versus unvaccinated persons. It has the Vaccine Adverse Event Reporting System (VAERS, www.vaers.hhs.gov), but it is likely that fewer than 10% of reactions are reported. Conditions developing months after a vaccine would not be noted. An internet survey, begun 10 years ago by a German homeopath Andreas Bachmair, contains more than 10,000 self-reports on the health of unvaccinated persons, compared with statistics from the German Health Interview and Examination Survey for Children and Adolescents (KiGGS). The site began as www.impfschaden.info and has been translated into English www.vaccineinjury.info. Allergies are reported in 10.6% of unvaccinated persons vs. 22.9% in KiGGS; asthma/chronic bronchitis in 2.4% vs. 18%.

ABOUT THOSE ADJUVANTS

             An adjuvant is a substance added to a vaccine to increase immunogenicity, and perhaps to decrease cost by reducing the amount of antigen needed. The classic Freund’s adjuvant (antigen immersed in mineral oil) is far too toxic to use in human vaccines. The only adjuvant approved for human use is alum, aluminum salts or gel, present in hepatitis A and B, diphtheria-tetanus-pertussis, Haemophilus influenzae b (Hib), human papilloma virus (HPV), and pneumococcal vaccines. The major use of oil-in-water emulsions has been in therapeutic cancer and HIV vaccines. Vaccines, may, however, use oils as “carriers.” Also, vaccine components—or contaminants—may act as adjuvants even if not intended to be such. Dr. Lewis told ArMA that one reason for pertussis outbreaks may be that the cleaner, safer acellular (DTaP) vaccine is less effective than the older, “dirty”  whole-cell DTP that contained lots of bacterial fragments.

Vaccines can induce immunity to any vaccine component. To protect trade secrets, these may not all be listed on the label. They could include peanut oil (and trace bits of peanut protein), casein (milk protein), egg protein, soy peptone broth, calf serum, gelatin, neomycin, and other components of culture medium.

A speculation that I have not seen addressed is the induction of allergy to a substance that is not in the vaccine but to which the patient is simultaneously exposed. A friend reported that while mowing a field, his tractor ruptured a hydraulic line, and squirted oily fluid into his eyes. For years after that, he had severe hayfever on exposure to grass, which he had never before experienced. Mice were sensitized to peanuts by either intranasal or intragastric introduction of peanut protein together with cholera toxin as an adjuvant. A logical follow-up would be to feed common food allergens to animals on a day they were receiving a regular vaccine. Animals do have food allergies, and they get a lot of vaccines; are these connected? Should patients be on a hypoallergenic diet for a period of time while being immunized, especially with adjuvanted vaccine (and for how long)?

Instead of shaming parents—or firing health care workers—who raise vaccine safety concerns, physicians should be insisting on better safety studies and full disclosure.

The official faith of America is in Science. This idol is an erroneous construct of what the scientific quest for truth really is. When officials say that “the Science has spoken,” these days they generally mean that white-coated priests are interpreting the oracular conclusions derived from a mathematical model or a computer program.Mathematics is a beautiful, powerful, indispensable tool. It is, however, an abstraction. Science requires actual measurements and observations of Nature. If the data do not agree with the predictions of the model, the model must be questioned. Data that are validated and replicated cannot simply be ignored or discarded to save the reputation of a model, however beautiful or politically expedient.

The whole basis of the U.S. regulatory regime rests on models that have become powerful ideologies: linear risk models, and climate models. The models are wrong.

“To claim that the scientific discipline of medicine got the dose-response wrong and with this error damaged our health, environment, and economy sounds wrong, irresponsible, and unfair to such a dignified and life-serving profession,” writes Edward Calabrese (“Toxicology rewrites its history and rethinks its future: giving equal focus to both harmful and beneficial effects,” Environ Toxicol Chem 2011;30:2658-2673. doi: 10.1002/etc.687). Calabrese defends this claim in a historical detective adventure.

The fundamental principle of toxicology and pharmacology—the dose-response relationship—arose from a bitter political dispute, a power struggle between homeopathy and traditional medicine. The latter arose from the “heroic” medicine of the 18^th and 19^th centuries, which often, though with the best of intentions, tortured patients before sending them to an early grave. The impact of Samuel Hahnemann’s establishment of homeopathy was compared to that of Martin Luther’s posting the 95 Theses. While it may never have cured anybody, and any apparent benefit might have been a placebo effect, homeopathy was unlikely to harm or kill patients, and was gaining market share.

Homeopaths claimed that the dose-response is biphasic. The paradoxic stimulatory effect of low doses was called hormesis. Physician/pharmacologist Hugo Schulz proposed it in 1884 to explain the effects of varying doses of disinfectants on yeast metabolism. He also suggested it as an explanation for a striking series of clinical observations by Bloeudau, in which a homeopathic preparation (veratrine) was successfully used to treat gastroenteritis. Schulz did not subscribe to the homeopathic belief in extreme dilutions (which result in zero concentration of the agent), but he was unfairly linked to it, derided as the Greifswald Homeopath, and ostracized for the rest of his 50-year academic career.

The threshold dose-response model was accepted by traditional medicine, largely through the work of pharmacology professor Alfred J. Clark. Though an outstanding scholar, researcher, and mathematician, Clark failed to present or discuss Schulz’s  dose-response model, or even to try to refute the substantial body of widely published research that supported it. He relied on the monotonic probit dose-response model, which mathematically constrains responses to asymptotically approach the control response, and never drop below it. This biostatistical model denies the existence of a biphasic response. Measurements that didn’t fit were disregarded (censored).

Although never experimentally proven, the threshold dose-response model became the gold standard for regulating exposure to chemical carcinogens, accepted by the scientific elite, “leaving no room for confusion, debate, or compromise.”

Calabrese and associates found that over a 70-year period, no attempt to assess the capacity of the threshold dose-response to make predictions in the low-dose zone had ever been published. Hence, they undertook their own review of published data. If the threshold model is correct, the ratio of responses above and below the control value should be very close to 1; in fact, it exceeded this value by 250%. Responses displayed a consistent pattern, closely paralleling the hormetic model.

In the second half of the 20^th century, a group of detractors arose, who supported the linear no-threshold model (see July issue), which became dogma, despite the evidence. For example, the largest rodent study ever conducted, involving some 24,000 mice, provided strong evidence that low doses of a chemical carcinogen are beneficial.

The hormesis concept is becoming central in the fields of anti-aging medicine, performance enhancement, and biogerontology. It is likely, however, in Calabrese’s view, that government research funding will continue to ignore hormesis, lest it challenge environmental exposure standards.

Calabrese notes that hormetic effects are not necessarily beneficial. Harmful ones might include endocrine disruption (e.g. early puberty) or the capacity of numerous anti-tumor drugs to stimulate proliferation of tumor cells.

Substituting ideologically appealing models for data can cause harm either from costly regulatory overkill, or from missing unexpected effects.

CLIMATE MODELS CAN’T BE VALIDATED

In defending its “Endangerment Finding” that carbon dioxide and other greenhouse gases are a threat to public health and welfare, the U.S. Environmental Protection Agency (EPA) declares that “climate models have been properly validated.” IPCC expert reviewer Vincent Gray, however, states that the Intergovernmental Panel on Climate Change cannot call the results of its models predictions —because the models have never been validated. Hence, results are referred to as “projections” (The Week That Was 10/8/11).

Current climate models cannot be validated at all, writes Fred Singer, because they are nonlinear chaotic models that produce different results each time they are run. In efforts to show consistency between results and observations, error bars have been extended so far as to be almost meaningless. While at least 10 runs are needed to establish a mean, the model with the greatest number of published runs is one from Japan, which had five, showing widely varying results.

Table 2.11 in an appendix of the IPCC Fourth Assessment Report assesses the level of understanding of 16 Forcing Factors found in the models: in 11, the level is “low” or “very low.” The Pacific Decadal Oscillation (PDO), among other possibly important factors, is not considered at all. For the EPA to claim models are validated is the equivalent of a “government agency certifying that a passenger aircraft is reliable after the engineers state that the reliability of 69% of the components is low to very low, and some important components may be missing” (ibid., available at www.sepp.org).

Another missing component, now coming to attention, is the effect of cosmic rays on clouds. According to scientists at the European Organization for Nuclear Research (CERN), cosmic rays may enhance the formation of pre-cloud seeds as much as ten-fold. The results might have been available 10 years ago had the research been funded. Based on satellite data since 1979, Danish physicist Henrik Svensmark found a correlation between solar activity, cloud cover, and cosmic rays. But when he reported possible climatic implications at a 1996 space conference, the sitting IPCC chair called him “scientifically…irresponsible”; it was a “really bad career move” (TWTW 9/10/11).

Climate models were supported by $32 billion in U.S. government spending alone between 1989 and 2009, writes Paul Driessen—without finding a single piece of evidence that human-caused CO₂ emissions significantly affect climate (http://tinyurl.com/kqx4pe).