November 2000 (vol. 17, #1)
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c 2000 Physicians for Civil Defense
World public health authorities have a war-time mentality and are deploying an ever more massive array of vaccines, including protection against chickenpox and earaches.
As vaccine mandates and more oppressive enforcement measures proliferate in the U.S., more parents are asking about the casualties inflicted by the weapons themselves.
The debate is exceptionally acrimonious. On one extreme are persons opposed to all vaccinations, on principle, as ineffective and hazardous. On the opposite extreme, public health officials, the American Academy of Pediatrics, and supporters of Stephen Barrett's Quack Watch call anyone with reservations about any vaccine a ``chiro anti-vax quack.'' Any chink in the armor of the mandatory childhood vaccine schedule could lead to massive outbreaks of deadly disease, they say.
One of the most heated arguments concerns the suggested link between autism and measles-mumps-rubella vaccine (MMR) (see Civil Defense Perspectives Sept 1998 and May 1999). Activist parents and their allies have been have been crossing swords with vaccine advocates before the House Government Reform Committee chaired by Rep. Dan Burton (R-IN), who has an afflicted grandchild. Scientists are battling in the pages of The Lancet about the 1998 study by Andrew Wakefield et al. proposing a mechanism that involved inflammatory bowel disease:
``Such speculation may seriously damage important public health programmes.... Publication of [Wakefield's study] is especially tragic because WHO and all consulted national public health authorities agree that it does not alter in any way the continued recommendation to use measles-containing vaccines throughout the world'' (Lee JW et al, Lancet 3/17/98.)
The connection is challenged on both theoretical and epidemiologic grounds. Autism clearly preceded the appearance of MMR around 1977, though it was quite uncommon, rating only two tiny index entries in a 1970s major pediatrics textbook. The fact that incidence started increasing at the time of MMR vaccination campaigns does not, of course, prove anything-just as an increase in the birth rate at the time of an increase in the stork population does not prove that storks bring babies. It is suggestive, however, that the upswing in Britain was delayed for 10 years-as was the vaccination campaign (Wakefield, Lancet 9/11/99), as was pointed out on 60 Minutes this month.
It is claimed that an epidemiological study by Taylor et al (Lancet 1999;353:2026-2029) ``demolishes the link between MMR and autism'' (BMJ 1999;318:1643). (For a critique, see AAPS News, May 2000.) Letters to Lancet point out sources of bias in either direction. A definitive answer may be impossible in the absence of an adequate, unvaccinated control group. Moreover, the situation may turn out to involve more complex interactions.
Another prominent but seemingly unrelated source of concern has been thimerosal (TMS), a mercury-containing preservative used in DTaP, Hib, hepatitis B, and influenza vaccines, but not in chicken pox, polio, or MMR. The Coalition for SAFE MINDs (Sensible Action For Ending Mercury-Induced Neurologic Disorders) has asked the FDA to recall TMS-containing vaccines rather than permitting manufacturers to use up existing stocks, and litigation may be filed.
The FDA responded that an infant may receive up to 187.5 mcg of mercury from vaccines during the first 6 months of life; 200 mcg if influenza vaccine is given. This may exceed the EPA guidelines, which have 10-fold safety factor built in, but not guidelines for methylmercury set by the FDA, the Agency for Toxic Substances and Disease Registry, or WHO. (There are no guidelines for ethylmercury, the metabolite of TMS.)
There have been no case-control studies of TMS and autism, and the design of studies for TMS-containing vaccines did not permit any conclusions to be drawn about a possible relationship to autism, according to a letter from Kathryn Zoon, FDA Center for Biologics Evaluation and Research.
The first reason for suspecting TMS is ecological association. Autism was first described in 1943 among children born in the 1930s-the time when TMS was first added to vaccines. Prior to 1970, prevalence was estimated to be 1 in 2,000. From 1970 to 1990, when DPT vaccination rates were increasing, it averaged 1 in 1,000. In the early 1990s, after the introduction of TMS-containing Hib and hepatitis B vaccines, it was found to be 1 in 500 (Bernard S, et al, ARC Research, 7/2000). In 2000 the CDC found a rate of 1 in 149 children in Brick Township, NJ, all the affected children having received MMR-perhaps coincidentally, perhaps not (Gallup R, Lancet 7/8/00). While the existence of autism might be ascribed to genetics, that can hardly explain the increased prevalence.
Another clue is the similarity between the findings in autism and mercury poisoning, including great individual variation in the Hg levels. Some characteristic features of both include a lack of eye contact; speech difficulties; rocking and unusual postures; and self-injurious behaviors such as head banging.
Heavy metals such as Hg may also be involved in allergic reactions, which occur at much lower concentration than toxic reactions (Stejskal, Neuroendocrin Letters 1999;20:351-364.)
So what, if anything, does TMS have to do with Wakefield's results (ileal lymphoid nodular hyperplasia), or with parental observations that a profound change in their baby's behavior occurred after MMR? A cascade of events has been hypothesized: genetic susceptibility leads to an unusual immune response to TMS and/or other vaccine components such as aluminum adjuvants, which makes the child vulnerable to untoward effects of the live virus in MMR. There is no evidence to support this hypothesis. But then there have been no studies to test it. Published prelicensure studies of MMR safety, which restricted observations to three weeks, are ``woefully inadequate'' (Wakefield, Lancet 3/21/98) and would be inherently incapable of detecting such an effect.
Measles virus can cause brain damage. Subacute sclerosing panencephalitis (SSPE) occurs in 1 in 8,000 children infected with measles before age 2. Measles is said to cause 10% of childhood deaths in undeveloped nations, and had a mortality rate of about 2 in 1000 in the 1989-1991 outbreak in the U.S. (120 deaths in 55,000 cases, Lancet 4/22/00).
Could deliberate biological warfare produce a more devastating result than severe brain damage to 1 in 150 children? Vaccine questions need answers, not denials.
The EPA states: ``The lack of clear indication of disease in the general population attributable to *** should not be considered strong evidence for no effects of exposure to ***. Rather a lack of clear indication of disease may be the result of the inability of our current data and scientific tools to directly detect effects at these levels of exposure'' (Environmental and Climate News, 9/00).
Note that this statement applies to hazards that have not been found but that might exist; actually, to hazards that could not be detected if they did exist because they would be too small or too rare. For the *** in the statement, insert ``dioxin-like compounds'' and ``dioxins.'' For such demons, the EPA takes an absolutist approach: no risk is too low, and no economic benefit too great to affect the precautionary policy.
Environmental and public health policy in the U.S. government seems to emanate from two separate poles. There are demons (``pollutants'') and sacred cows (such as vaccines).
There is a possible unifying assumption: a low value placed on the life and liberty of the individual human being.
Few debates on vaccines will fail to mention the great public health triumph of the elimination of smallpox worldwide through mass compulsory vaccination. But the final chapter has not been written. The campaign may have actually enhanced the virtue of smallpox as a biological weapon: harmless to an immune aggressor, highly lethal to a susceptible population. With the loss of natural immunity and the termination of vaccine programs, virtually the entire world is now susceptible.
According to a Sept. 22 press release from BioReliance Corp., the company has teamed up with OraVax in a contract with the U.S. Centers for Disease Control and Prevention (CDC) for the development and production of human smallpox vaccine to counter threats of bioterrorism. The 20-year contract has an estimated value of $343 million. The plan is to produce 40 million doses initially for a national civil defense stockpile to be delivered in mid- 2004 and to develop capacity to expand production on demand.
BioReliance also has been awarded a contract with DynPort in support of the Joint Vaccine Acquisition Program to develop and manufacture smallpox vaccine for a military stockpile.
The problem of maintaining a civil defense stockpile of drugs is a daunting one if supplies have to be destroyed and replaced every two to three years. The military has the same problem with its $1 billion stockpile and so undertook a testing program conducted by the FDA about 15 years ago.
The expiration date on the package typically has no bearing on whether the drug is usable for a longer time. The manufacturer is only required to demonstrate that the drug is still safe and effective on whatever date it chooses to set.
If the drug is dispensed in any container other than the original one, the pharmacist usually cuts the expiration period to one year after the date of dispensing; in many states, this practice is required by law.
Only about 100 drugs were actually tested. However, Joel Davis, a former FDA expiration date compliance chief stated that most drugs are probably as durable as those tested for the military. Exceptions include nitroglycerin, insulin, some liquid antibiotics, water purification tablets, and mefloquine (used for malaria prophylaxis).
The only known example of toxicity from an expired drug was of renal tubular acidosis from out-dated tetracycline, reported in the Journal of the American Medical Association in 1963. This study has been challenged by other scientists, and Francis Flaherty, former director of the military testing program, stated that the Shelf Life program found no toxicity. Tetracyclines were typically shown to be effective for more than two years beyond the expiration date.
The expiration date was expanded by 10 years for chloroquin injection; 4 years for chloroquine phosphate tablets; 15 years for pralidoxime chloride (Protopam); 7 years for heparin; 12 years for ciprofloxacin; 6 years for injectable cephapirin (Cefadyl); 5 years for injectable atropine; 5 years for injectable diazepam (Valium) and about 5 years for saline and lactated Ringer's intravenous solutions.
Between 1993 and 1998, the military spent $3.9 million on testing and saved $263.4 million on drug expenses.
According to the FDA, drug makers have never objected to the procedures or findings, although they don't like them.
Expiration dates are useful for ``marketing'' purposes, though companies deny any effort to spur sales through planned obsolescence. Customers are protected against getting a ten-year-old package insert, for example.
Civilians are encouraged to discard out-dated drugs, as through the National Expired and Unused Medication drive, which has collected and destroyed 36 tons of medication since 1991. Wal-mart and Johnson & Johnson sponsor such campaigns; Wal-mart may even give out a bottle of free vitamin pills to customers who bring in expired prescription drugs.
What a great potential source for a civil defense stockpile! What if drugs were stored for five years and then discarded?
Source: Laurie P. Cohen, Wall St J 3/28/00, 1A.
For more information about the program at the Johns Hopkins University Applied Physics Laboratory, see www.jhuapl.edu/digest, and for a description of other activities of the Defense Advanced Research Projects Agency (DARPA), see Science 1999;285, 1476.
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