Posted: 28 October 2005
From: "KP Stoller, MD" hbotnm@netzero.net
To: wstorey1960@cs.com, ABuesingRPh@aol.com, cross@warpdriveonline.com, hshaver@redw.com, buffie.saavedra@state.nm.us, delnortelvnm@hola-vegas.com, IBGEM66@aol.com, william.harvey@state.nm.us
Sent: Thu, 27 Oct 2005 18:33:56 GMT
Subject: Agenda issue for BoP meeting
Dear NM Board of Pharmacy Members:
A couple of weeks ago I forwarded a request to be put on the agenda for the next BoP meeting to discuss a violation of the New Mexico Drug Act. This is a follow-up on that request. The New Mexico Board of Pharmacy has the statutory power to promulgate rules, as well as the specific powers delineated in the New Mexico Drug Act, as well as the broader powers of review for safety and consumer protection in the act that created the Board of Pharmacy.
Six states have restricted the amount of mercury allowed in vaccines. Many European countries and Japan already restrict mercury in vaccines. A law passed in Missouri this year requires any immunization given to pregnant woman or children younger than 3 contain no more than 1 microgram of mercury per 0.5 ml dose.
As you know, thimerosal is 49.6 % mercury by weight, and there is a push to keep thimerosal in vaccines despite recommendations to remove it from all vaccines.
The current flu vaccine, for example, has 12.5 micrograms of mercury, which means one needs to weigh 275 lbs. for this amount of mercury to considered safe by the EPA. It is now know than even one acute exposure to even low concentrations of thimerosal can damage brain cells. The driving force for the mercury going into the brain is the concentration of mercury at any one time. Thimerosal is a very dangerous additive to vaccines - dangerous exceeding EPA guidelines and needs to be labeled as such to both consumer and physician.
I am respectfully requesting to be put on the agenda for the next meeting to discuss this issue and request that intervention be taken against the use of thimerosal in New Mexico, but at the very least that it should be labeled correctly and that patients receive informed consent about what they are receiving.
The following is a historical review of thimerosal use and abuse ...in 1978, the FDA ruled that thimerosal be removed from OTC products, but gave the industry another 16 years to phase out thimerosal's presence. In 1999, the FDA stated that mercury exposure from vaccines exceeded Federal Safety Guidelines. On November 15, 1999 the FDA nominated thimerosal to the Center for the Evaluation of Risks to Human Reproduction and on at least two occasions the core Scientific Advisory Board recommended further evaluation.
Also in 1999, the Public Health Service (PHS) and the American Academy of Pediatrics (AAP) first announced that thimerosal should be removed from vaccines:...because any potential risk is of concern, the Public Health Service (PHS), the American Academy of Pediatrics (AAP), and vaccine manufacturers agree that thimerosal containing vaccines should be removed as soon as possible. Similar conclusions were reached this year in a meeting attended by European regulatory agencies, European vaccine manufacturers, and FDA, which examined the use of thimerosal containing vaccines produced or sold in European countries. (Thimerosal in Vaccines: A Joint Statement of the American Academy of Pediatrics and the Public Health Service, July 09, 1999)
The prevalence of autism in the United States became epidemic (increase of 5 in 10,000 to 60 in 10,000) when additional thimerosal containing vaccines were introduced for newborns in the early 1990s, whereas in most other countries report a much lower autism prevalence, like Germany or Denmark, thimerosal doses were reduced (then newborns up to the age of 6 month were regularly exposed to a cumulative thimerosal dose of 187.5 µg). In California, for example, the autism rate increased by 634 % between 1987 and 2002, which was not to be attributed to shifts in the interpretation of diagnostic criteria, migration of the population, improved diagnostic accuracy, or better reporting. In New Mexico, the Department of Education data has the rate increasing by 2000% during the same time frame, but it may not be appropriate to just rely on that data alone.
The study that concerned the CDC (Stajiich, G. et al. Iatrogenic exposure to mercury after hepatitis B vaccination in pre-term infants. J Pediatr 2000;136;679-81) showed post-vaccination mercury levels were significantly higher in pre-term infants as compared with term infants in regard to the Hepatitis B injections at birth. The concern did not appear to be about the impact mercury could have on newborns but on the impact it could have on the vaccination compliance rates. To mitigate any problems the Stajich study might have, or if word leaked out about the then embargoed Verstraeten data (showing a direct link between thimerosal and the epidemic of neurodevelopmental disorders and discussed in detail below [Verstraeten, T., Davis, R.L., DeStefano: Thimerosal VSD Study, Phase One, Update 2/29/00 (2000). Available from: URL: http://www.autismhelpforyou.com/Thimerosal%20VSD%20study001.pdf ]), the CDC contracted with Dr. Pichichero, a strong proponent of thimerosal, to undertake a study similar to Dr. Stajich but produce different results.
Verstraeten (CDC/GlaxoSmithKline) diluted his original epidemiological study to show that there was no causation between thimerosal and autism or any other neurodevelopmental problem. Verstraeten published this article identifying himself as a CDC employee without divulging he was working for a major vaccine manufacturer.
In 2001, the CDC and its Office of the NIP also contracted with the Institute of Medicine (IOM) to create the Immunization Safety Review Committee (ISRC) presumably for damage control against the mounting thimerosal vaccine injury evidence (The transcripts of the IOM meetings are on file in the US District Court of Texas, Eastern District; Case #5:03-CV-141 and at the URL: www.nomercury.org/iom.htm). The IOM's first report on thimerosal was issued in October of 2001 (Immunization Safety Review: Thimerosal Containing Vaccines and Neurodevelopmental Disorders [2001] Institute of Medicine), but the IOM did not seem fully understand what the CDC wanted them to do, (the CDC) wants us to declare, well, these things are pretty safe on a population basis, announced Dr. Marie McCormick, Chairman of the ISRC. This committee was held to address the question if exposure to thimerosal containing vaccines could be associated with adverse neurodevelopmental disorders, and even though the committee stated they found the hypothesis biologically plausible they had different marching orders. We said this before you got here, and I think we said this yesterday, the point of no return, the line we will not cross in public policy is to pull the vaccine, change the schedule. We could say it is time to revisit this, but we would never recommend that level. Even recommending research is recommendations for policy. We wouldn't say compensate, we wouldn't say pull the vaccine, we wouldn't say stop the program, stated Kathleen Stratton, Ph.D., IOM staff and Study Director ISRC. We are not ever going to come down that it is a true side effect, said McCormick even before the IOM had considered any evidence. But the committee ended up making a different recommendation, The committee recommends that full consideration be given by appropriate professional societies and governmental agencies to removing thimerosal from vaccines administered to infants, children, or pregnant women in the United States.
In 2004, the IOM was reconvened on orders from the CDC to revisit this subject but this time it was predetermined that the IOM would not find causality between vaccines and autism or any other neurological injury and so state same in the most unequivocal manner. The IOM would base its final conclusions on epidemiological research already proven to be flawed or fabricated - the infamous Danish study that has left many, thinking that autism rates went up after Europe removed thimerosal from vaccines.
The IOM ignored anything that was not aligned with its orders from the CDC, no evidence was embraced that were in conflict with that policy, and on May 18th, 2004, the IOM's ISRC issued their final report which found the body of epidemiological evidence favors a rejection of a causal relationship between vaccine thimerosal exposure and autism.
In the year since it was issued, the IOM report has been successfully used to silence media inquires into vaccine safety, as a defense for dismissing of 4,500 petitions for vaccine injuries in federal court, as justification for eliminating federal funding on research of the vaccine/autism link, and as justification for the federal preemption of vaccine control.
Given previous recommendations to eliminate thimerosal from the AAP and the PHS, why would thimerosal find its way back into a vaccine that would become part of the routine schedule such as in the flu vaccine?
The WHO Strategic Group of Experts (SAGE) met in June of 2001, and stated their objective clearly: WHO was extremely anxious to preserve the production of vaccines, Industry is expecting clear signals from WHO on the thiomersal issue, and has been confirmed by informal consultations with some manufacturers during the first half of 2001 ( http://whqlibdoc.ho.int/hq/2002/WHO_V&B_02.07.pdf ). At the WHO HQ in Geneva, a meeting was held on May 21st 2002, WHO informal meeting on removal of thimerosal from vaccines and its implications for global vaccine supply. From the meeting summary more objectives were enumerated, such as: 1) Obtaining regulatory approval for the new formulated thimerosal reduced or removed vaccines involves complex activities that are costly and time consuming; 2) WHO is concerned about the current situation whereby manufacturers in developed countries have been forced to lower the thimerosal content of their vaccines; 3) The option of using single dose vaccines is not feasible for WHO... upgrading the infrastructure would result in huge increase in vaccine cost. The meeting memo went on to state, In view of the situation, WHO is faced with...support maintenance of thimerosal as an effective preservative in multi-dose and possibly also in single dose vaccines. Lastly, the memo stated, The actions required from WHO in order to ensure continued availability of these vaccines include the following: ...Develop a strong advocacy campaign to support ongoing use of thimerosal.
This is not a moot issue when thimerosal-laden flu vaccine can be brought back into the routine vaccine schedule years after the AAP recommended the elimination of thimerosal.
It is of interest to note that The Environmental Protection Agency considers any material that has greater than 200 ppb of mercury to be hazardous waste. A thimerosal vaccine (1:10000 thimerosal) exceeds this value by 250 times or 50,000 ppb mercury.
Autistic children seem to be genetically more susceptible for toxin derived inhibition of methylation processes. Deth, R.C.: Truth revealed: New scientific discoveries regarding mercury in medicine and autism. Congressional Testimony before the U.S. House of Representatives. Subcommittee on human rights and wellness, Sept. 8. (2004). Available from: URL: http://reform.house.gov/WHR/Hearings/EventSingle.aspx?EventID=1311
It has been estimated that about 15% of the population may show enhanced susceptibility to mercury exposure. Bradstreet, J.: A case control study of mercury burden in children with autistic Disorders and measles virus genomic RNA in cerebrospinal fluid in children with regressive autism. Immunization safety review: Vaccines and autism. Institute of Medicine, Feb. 9 (2004). Available from: URL: http://www.iom.edu/subpage.asp?id=18065
In a first analysis of the VSD datasets, Verstraeten et al (reference above) had described a 7.6 to 11.4 fold increase of autism risk in children at one month, with the highest mercury exposure levels compared to children with no exposure. In four subsequent separate generations of the analysis, which involve the exclusion of children with no thimerosal exposure and less than two polio vaccines, the statistical significance disappeared. Verstraeten added in information from another HMO (Harvard Pilgrim) to dilute the significance of his original findings - referred to as Generation Zero. This HMO was in receivership by the state of Massachusetts because its records were in shambles and therefore virtually worthless except for the fact that by adding in the numbers from this HMO it statistically made the true data, from his generation zero analysis, disappear by rendering it all statistically insignificant.
The infamous Danish study, compared the number of newly recorded autism cases prior to 1992, when thimerosal containing vaccines were used, with those after 1992, when such vaccines were no longer produced in Denmark. The authors observed a rise in autism rates after removal of thimerosal, and thus conclude that thimerosal plays no role in the aetiology of autism. However, the autism rates used after 1994 included children from the entire population while prior to 1994 only included hospitalized autistic children, hence the reported increase in the number of autistic children.
Again, Madsen et al, reported Danish autism rates for children born in the 1990's of 5 per 10,000. These Danish rates are very low in the 1990's compared to the U.S. or the U.K. Madsen et al report also inpatient rates for the pre1993 psychosis protoinfantilis (the term used at that time for autism) at well below 1 per 10,000. This low rate would contradict the single published survey of autism rates from Denmark, which indicated an autism rate of over 4 per 10,000 as far back as the 1950's. The rate of increase was elevated every time the Danes changed either the in versus out patients, the inclusion of a large Copenhagen clinic's data, and the change in the diagnostic criteria for autism.
Also, additional confounders were present in countries with high prevalence of autism that were not present in Denmark: During 1970-92, the only childhood vaccine given in Denmark until 5 months of age was the monovalent pertussis vaccine. In the United States, children were exposed to multiple doses of diphtheria, pertussis, tetanus, polio, hepatitis B and hemophilus influenza B (Hib) vaccines before five months of age in the 1990s. In the United Kingdom, injections before age 5 months included multiple doses of meningitis C, polio, diphtheria, tetanus, Hib, and pertussis vaccines. Denmark did not administer thimerosal containing RhoD immunoglobulin during pregnancy. Comparing the Danish autism rate with that of the USA rate is statistically invalid since the amount of thimerosal exposure and the age of exposures of Danish infants and USA infants were vastly different. The Danish study is like studying the effect of mosquitoes on the spread of malaria but doing the study in Minnesota versus Panama.
The four published articles that are collectively known as the Danish Study compromise a deliberate and coordinated effort to overshadow the emerging evidence connecting thimerosal to autism by a single network of authors almost all beholden to a single employer. The four articles were based on a slightly different, but analytically non-comparable, view of the same overtly flawed data. The authors all had ties to a for-profit Danish vaccine manufacturer, the Statens Serum Institute (SSI), and this significant conflict of interest was not disclosed or reported in any of the journals that published the Danish study. CDC employees and consultants were 3 of the 17 authors. SSI directly employed 6 of the remaining 15 authors, and SSI, through the Danish Epidemiology Science Centre, indirectly employed the remaining authors. SSI has a direct financial interest in the assessment of past thimerosal vaccine issues as well as in maintaining the continued viability of thimerosal-laden vaccines. Their overshadowing of these studies and direct participation via SSI employees has compromised the integrity of all these articles.
Both published and unpublished studies demonstrate that autism is apparently caused by repetitive mercury exposure during pregnancy through thimerosal and amalgam, and after birth, through thimerosal containing vaccinations. The FDA panel in 1982 said thimerosal was toxic, caused cell damage, was not effective in killing bacteria or halting their replication and that thimerosal is not generally recognized as being safe or effective (1982 Vol 47, No. 2 Federal Register). Learning disabled and autistic children are living the burden of proof. So, what happened? Where is the precautionary principle? When something atrocious is done there always seems to be the justification that it is preventing something even more atrocious.
As the evidence continues to mount on what may be the largest iatrogenic public health disaster to affect this nation, so too does it appear that the apparent justification for deliberately letting this continue was about protecting the vaccine program's viability (or profitability). However, such rationalizations have propelled matters down a slippery slope. What little altruism there is in this justification belies individuals protecting careers, status and reputations. This disaster did not come out of nowhere, and ultimately it will be found that it could have been mitigated if not for the irresponsible use of power and influence by an unholy alliance between corporation and state. It also calls into question whether this public health fiasco was an isolated scenario.
Mercury in biologics is a clear and present danger to the public health. Thimerosal has been banned in virtually all first world countries, while the Autism pandemic continues in the United States unabated with the hope of mercury free childhood vaccines dashed with the introduction of the flu vaccine into the routine infant immunization schedule. Of course, this will have a cost just as the Roman Empire was destroyed by the untoward effects of lead plumbing and a runaway malaria epidemic, so too will a country of jobless and dependent learning disabled and autistic children change the United States as we know it. Fifteen years from now the United States may no longer be a first world country because of this.
On May 20, 2004, the Office of Special Counsel (OSC) forwarded to Congress hundreds of disclosures relating to the link between thimerosal and autism. But the OSC requires a federal employee, specifically one from within the FDA or CDC, to come forward and whistleblow. The OSC would then have jurisdiction in this matter. I believe these allegations raise serious continuing concerns about the administration of the nation's vaccine program and the government's possibly inadequate response to the growing body of scientific research on the public health danger of mercury in vaccines...(but) because OSC lacks jurisdiction, we are closing our files on these cases....sincerely (Special Counsel) SJ Bloch.
This goes beyond just individuals that do not want to lose their jobs or accept culpability that might injure their careers. Removing thimerosal out of vaccines doesn't destroy the vaccination program, but it does require the infrastructure to change, and there are organizations that simply don't want that change to take place. The disinformation itself is as much a danger as the mercury, but where there is danger there is also opportunity; however, the public can only perceive what is shown to them. So, more galling than anything has been the effort to keep the public from knowing, and the intimidation of many to violate the public trust. Regrettably it seems, we have entrusted the public safety to others whose conscious awareness of the common well-being often fades in the face of compromising interests. This is illogical for these individuals have put these interests above children and grandchildren, except for those like Dr. Johnston who was clear about protecting his own family. Dick Johnston, M.D., University of Colorado School of Medicine and National Jewish Center was Chairman of the Simpsonwood meeting that met in June of 2000 to review Verstraeten's Phase One/Generation Zero data and this is what he said at this meeting (page 198), "Forgive this personal comment, but I got called out at eight o'clock for an emergency call and my daughter-in-law delivered a son by C-section. Our first male in the line of the next generation, and I do not want that grandson to get a Thimerosal containing vaccine until we know better what is going on. It will probably take a long time. In the meantime, and I know there are probably implications for this internationally, but in the meantime I think I want that grandson to only be given Thimerosal-free vaccines."
KP Stoller, MD
Assistant Clinical Professor, Pediatrics UNM, School of Medicine
Medical Director, Hyperbaric Medical Center of New Mexico
505-955-8560