Even as doctors try to reassure the public, and TV news anchors get their swine flu shots on the morning news, there remains a great unease about vaccinations in the US. People hesitant to take the needle are marginalized as anti-vaccine nuts, regardless of the many justifiable reasons to distrust giant pharmaceutical producers and government regulators. Money can easily trump morality and the five drug companies contracted with the U.S. government to produce the H1N1 vaccines will be paid from $250 to $690 million each for mass production.
Profits are not evil, of course, and making money does not mean a company lacks principle. There are, however, causes for concern. The last time there was a mass vaccination attempt of this scale was the 1976 National Influenza Vaccination Program for swine flu. Vaccinations were suspended when 1,098 people suffered from Guillain-Barré syndrome, a disorder that causes the body's immune system to attack parts of the nervous system. There was a 1 in 100,000 rate of occurrence. Although we must assume vaccines have improved considerably in the intervening years, the insert on the Novartis swine flu vaccine being administered this fall lists Guillain-Barré as a possible side effect.
The public's wariness about pharmaceutical companies did not suddenly arise. Distrust is a product of consistent deception ranging from Merck's Vioxx debacle to the billions in fines paid by drug companies for marketing products "off label," which is a usage other than what has been approved by the FDA. American cynicism with big business has been born of corruption ranging from Wall Street to the boardrooms of Halliburton, and big pharma has played a significant role in this downfall of capitalism's image.
The government is also culpable. When Madoff and debt bundlers played no-lose poker under the nose of regulators, they made it even harder to believe that Washington can offer protection from unscrupulous companies. In the pharmaceutical industry, a decade ago, a congressionally mandated study conducted by the FDA recommended the removal of mercury-based preservatives from vaccines. Ethyl mercury, an ingredient in thimerosal, is used to prevent bacterial contamination of vaccines. But because it accumulates in the body as a potent toxin to the developing brain, in July of 1999 the CDC and the American Academy of Pediatrics agreed that "thimerosal-containing vaccines should be removed [from the market] as soon as possible." Although the joint statement insisted -- based upon no valid evidence -- the risk of harm to children was miniscule compared to the risk of disease from being unvaccinated, the change of policy still called for the end of thimerosal's inclusion in vaccine formulas.
Thimerosal, nonetheless, continues to be used as a preservative in sixteen vaccines, five of which are given to infants. Although it was taken out of the Hepatitis B, Diptheria,Tetanus and Pertussis, and the hemophillus B shots in the US in 2000, the mercury-based additive is included in the multi-dose seasonal flu shots and H1N1, and is also in some childhood formulations of meningitis vaccines. The CDC has identified pregnant women and children as "high priorities" to receive the flu shots with thimerosal. No one seems to know why the mercury has not been removed. In fact, the government has all but ignored the 1986 Mandate for Safer Childhood Vaccines, the Combating Autism Act, and a unanimous decision in June from the National Vaccine Advisory Committee, which all called for safety studies and research comparing vaccinated and unvaccinated humans and animals. This has never been done for thimerosal or even the Measles, Mumps, Rubella (MMR) vaccine, which an increasing number of parents have associated with the onset of autism in their children.
The failure of health institutions in the government to conduct these studies will eventually do great harm to the uptake of vaccines and will likely jeopardize critical herd immunity.
Private research, in collaboration with universities, is endeavoring to fill this gap and is turning up disturbing results. A new study from a group of scientists, which was just published in the journal NeuroToxicology, has shown that the birth dose of a thimerosal-containing Hepatitis B vaccine given to macaque monkeys caused developmental delays in key survival instincts. A team of scientists led by Dr. Laura Hewitson of the University of Pittsburgh and Dr. Andrew Wakefield of Thoughtful House in Austin, reported findings that indicated newborn rhesus macaques injected with Hepatitis B vaccines adjusted for their body weight experienced critical developmental delays in the reflexes of "root, snout, and suck," which are essential for survival. The peer-reviewed study was not designed to determine if the harm was caused by the thimerosal or some other ingredient in the vaccine, but revealed the neurodevelopment delays were statistically significant without regard to birth weight or gestational age.
"Had this study been done as a pre-clinical trial, the FDA could have never licensed a mercury-containing Hepatitis B vaccine, nor could the CDC have ever recommended one, at least for infants and young children," said Theresa Wrangham, president of the group SafeMinds. "We are especially alarmed because the seasonal influenza and swine flu vaccines contain mercury. We think pregnant women and young children should not be given mercury-containing medicines with such significant side effects."
The main effect on the macaques was measured in the function of the brainstem, which controls autonomic functions like breathing and heart beat. Unvaccinated "control" monkeys, either given saline or nothing, did not experience any developmental problems. Regardless, the CDC continues to insist that there is "no convincing evidence of harm" caused by vaccines, though the studies often cited in support of vaccines are criticized as deeply flawed and are frequently compared to "tobacco epidemiology" as proof of safety.
The Hewitson paper was published in the wake a recent epidemiological report from Stony Brook University Medical Center that demonstrates an association between Hepatitis B and a nine-fold increase in special education services and an apparent triplingof the risk for autism. The data are likely to increase pressure on the government to re-examine already approved vaccines. Health and Human Service's National Vaccine Advisory Committee, the American Academy of Pediatrics, the Institute of Medicine, Congress, Dr. Bernadine Healy, the former Director of the National Institutes of Health, and Dr. Lou Cooper, the former President of the American Academy of Pediatrics have all said that current research on vaccine safety is inadequate. Even the CDC has conceded that some safety "claims against vaccines cannot be disproved" and that it "does not have complete adverse events surveillance data on which to base health messages."
Who is reasonably against a reassuring level of "safety" in vaccines? Drug companies continue efforts to marginalize these scientists as anti-vaccine quacks but most of these researchers believe as strongly in the importance of vaccines as do other physicians. They simply demand proof of safety. The University of Pittsburgh study begins to deliver the kind of data required to identify what are clearly preventable vaccine-caused injuries in our children. Doctors and researchers who do not demand a safety-first agenda that is transparent and accountable will ultimately be responsible for the public's failure to vaccinate. More and more parents will continue to revolt until they are completely confident their children are safe.
Hardly seems like that's too much to ask.
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