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Introduction
Chapter I: pre-1999
There's Mercury In Vaccines?
Chapter II: 1999-2000
Simpsonwood
Chapter III: 2001
IOM: Biologically Plausible
Chapter IV: 2001-2002
CDC World Travel
Chapter V: 2003
It's Rotten In Denmark
Chapter VI: 2004
IOM slams the door (quickly)
Epilogue: present day
Better science, better kids, and a DJ
Chapter I: pre-1999
There's Mercury in Vaccines?
"The recognition that some children could be exposed to a cumulative level of mercury over the first six months of life that exceeds one of the federal guidelines on methyl mercury now requires a weighing of two different types of risks when vaccinating infants. On the one hand, there is the known serious risk of diseases and deaths caused by failure to immunize our infants against vaccine-preventable infectious diseases; on the other, there is the unknown and probably much smaller risk, if any, of neuro-developmental effects posed by exposure to thimerosal. The large risks of not vaccinating children far outweigh the unknown and probably much smaller risk, if any, of cumulative exposure to thimerosal-containing vaccines over the first six months of life.
Nevertheless, because any potential risk is of concern, the Public Health Service, the American Academy of Pediatrics, 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, the European vaccine manufacturers, and the US FDA which examined the use of thimerosal-containing vaccines produced or sold in European countries."
Joint Statement of The American Academy of Pediatrics and the Public Health Service (FDA & CDC), July 7, 1999, 4:15pm
At 4:15 pm Eastern time on a Friday afternoon in July 1999, a joint statement by the AAP and Public Health Service was released to the press advising Americans that the amount of mercury in vaccines administered to children, through a preservative called Thimerosal, exceeded Federal Health guidelines. This statement did not reveal the amount of panic, backdoor negotiating, and concern federal health officials had been engaged in for the past few weeks, after the levels of mercury had been calculated by dumbfounded federal officials reviewing submissions from vaccine manufacturers responding to a broad FDA inquiry regarding mercury in consumer products. While this article from Pediatrics ultimately looks at the policy makers favorably, it does help explain how frenetic the process was.
How could July 1999 be the first time Federal Officials realized there was mercury in vaccines exceeding our own safety standards? There are many answers to this question. For some officials, this was the first time they had learned mercury was even in vaccines. Others clearly knew and had been concerned for some time, and at least one vaccine manufacturer realized the levels were high eight years earlier, in 1991.
Thimerosal was first used as a preservative in vaccines in the late 1930s, long before we understood the extreme neurotoxicity of mercury. As the FDA ratcheted up safety standards, Thimerosal was grandfathered through due to its history without ever having to undergo any safety testing. We may not be reading so much about Thimerosal today if the CDC hadn't embarked upon an aggressive plan to add vaccines to the Recommended Childhood and Adolescent Immunization Schedule in the late 1980's. In 1988, the Haemophilus Influenzae type B (Hib) vaccine was added to the schedule, followed by the Hepatitis B (HepB) vaccine in 1991. Together, these two vaccines added six shots to the schedule, and tripled the amount of mercury children born after 1991 received compared to the previous generation.
The joint statement above downplayed the risk of mercury injected in newborns, and it downplayed the degree to which mercury exceeded federal safety standards. Doing the simple math, a child following the recommend schedule and receiving vaccines at birth, 2 months, 4 months, and 6 months was receiving mercury in excess of the EPA safe standards by a factor of 36x, 120x, 77x, and 66x, respectively. That's 120 times the safe Federal standard!! (See chart).
The start of the sharp increase in autism and other neurodevelopmental disorders matches the change in the vaccine schedule. In the 1980s the incidence of autism was somewhere between 1 in 10,000 and 1 in 5,000, today it is 1 in 150. (See chart).
"The Food and Drug Administration (FDA) Modernization Act of 1997 called for the FDA to review and assess the risk of all mercury containing food and drugs. In line with this review, U.S. vaccine manufacturers responded to a December 1998 and April 1999 FDA request to provide more detailed information about the thimerosal content of their preparations which include this compound as a preservative," said the statement.
The Federal Health authorities were well aware of the potential damage their public announcement could cause to the National Immunization Program, and they did their best to downplay risks, slow down change, and avoid blame or liability. Perhaps most astonishing of all, there is still Thimerosal, at high levels, being injected in our children before their first birthday, 7 years after this joint statement was released.
What's Egregious About This Time Period?
1.   The FDA missed (or tolerated) mercury being injected in babies at levels well in excess of Federal safety standards and despite thousands of studies documenting Thimerosal's extreme toxicity. The job of the FDA is to protect our children from, amongst other things, unsafe drugs.
2.  When the FDA realized its mistake, they did not choose to recall vaccines.
3.  Merck, a vaccine manufacturer, was aware of the mercury issue in vaccines in 1991, yet failed to do anything to protect children.
4.  When adding vaccines to the schedule in the late 80s and early 90s, the FDA only required vaccines to be tested independently. No testing was ever done to determine the risk of cumulative exposure of multiple vaccines, often received on the same day.
5.  When faced with the information regarding high mercury levels in vaccines, the federal health authorities seemed more concerned with the risk of undermining the National Immunizations Program and creating liability for pharmaceutical companies than the health of our children.
6.  In 2006, Thimerosal remains in vaccines, despite statements like this that are on the FDA's own website today: "During the past ten years, the FDA has provided informal and formal advice to manufacturers recommending that new vaccines under development be formulated without thimerosal as a preservative."
7.  In 2006, despite the 1999 announcement, both CDC and AAP are actively fighting laws at the state level intended to ban mercury once and for all from children's vaccines.
Where is the Evidence?
1.  Merck Internal Memo Citing Dangerous Levels of Mercury In Vaccines
March 1991
Written By Dr. Maurice Hilleman and sent to Dr. Gordon Douglas, President of Merck Vaccine Division
This memo was written 8 years before the FDA "discovered" there was mercury in vaccines well in excess of Federal safety standards. Among the many unsettling comments, Dr. Hilleman notes that, "Sweden is requiring Thimerosal-free single-dose packaging of all products...The U.S. Food & Drug Administration (CBER) does not have this concern." He writes:
"If 8 doses of Thimerosal-containing vaccine were given in the first 6 months of life (3 DPT, 2 HIB, and 3 Hepatitis B) the 200 ug of mercury given, say to an average size of 12 lbs., would be about 87X the Swedish daily allowance of 2.3 ug of mercury for a baby of that size. When viewed in this way, the mercury load appears rather large."
What happened to this memo? Did FDA ever see it? Did CDC ever see it? What did Merck do with this information?
Source: Leaked transcript from sealed court filings.
2.  Patriarca FDA/CBER Internal Email: "Asleep at the Switch"
July 2 1999
Written by Dr. Peter Patriarca, CBER/FDA, and sent to Dr. Lawrence Bachorik, FDA.
This memo was written by Dr. Peter Patriarca, who at the time was the Director of the Office of Vaccines Research and Review, within the FDA Division of the Center for Biologics Evaluation and Research. This is the division of the FDA with responsibility for vaccine safety. The email was written to Dr. Lawrence Bachorik, Ph.D, the FDA's Senior Adviser for communication. It was written in the frenzy leading up to the public announcement on July 7. It highlights the concern on vaccination policy over the safety of our children and the genuine concern FDA had for how this announcement would cause their inaction to be perceived. He writes:
"You should also be aware that if the U.S. (and perhaps the EU) adopts a position that the theoretical risk of ethyl mercury exposure outweigh its potential benefits to the point where no vaccines used in the US or Europe will contain thimerosal [which is where things appear to be headed}, this could also have a severe impact on global ('third world') vaccination programs, particularly for hepatitis B and whole-cell DTP vaccines. which for various reasons, will almost certainly have to have thimerosal as an ingredient for potentially many years to come. WHO has already made a plea to the American Academy of Pediatrics to "tread lightly" and "consider the global ramifications" of their evolving policy. Finally, in my own personal opinion - and as a heads-up because I believe it could come up -- the greatest point of vulnerability on this issue is that the systematic review of thimerosal in vaccines by the FDA could have been done years ago and on an ongoing basis as the childhood immunization schedule became more complex. The calculations done by FDA are not complex. I'm not sure if there will be an easy way out of the potential perception that the FDA, CDC and immunization policy bodies may have been 'asleep at the switch’ re: thimerosal until now."
Source: FOIA filing by parents.
3.  Patriarca FDA/CBER to CDC Email: "A Plan is In Place"
June 29 1999
Written by Dr. Peter Patriarca and sent to Dr. Roger Bernier and Dr. Jose Cordero, CDC
This memo was also written by Dr. Peter Patriarca, a few days before the memo above, and sent to two of the leaders of the National Immunization Program at CDC, Dr. Roger Bernier and Dr. Jose Cordero. In it, Dr. Patriarca shows even more fully how concerned FDA was about their image after the pending announcement, and Dr. Patriarca stresses that a plan to deal with Thimerosal has "already been in place for many years." He writes:
"The fact of the matter is that an 'interim plan' (for potential removal of thimerosal) has already been in place for many years we just need to 'speed up' the existing plan not create a 'new' interim plan."
Patriarca noted that hastening the removal of thimerosal would, "...raise questions about FDA being 'asleep at the switch' for decades by allowing a potentially hazardous compound to remain in many childhood vaccines, and not forcing manufacturers to exclude it from new products. It will also raise questions about various advisory bodies regarding aggressive recommendations for use. We must keep in mind that the dose of ethylmercury was not generated by 'rocket science'. Conversion of the percentage thimerosal to actual micrograms of mercury involves ninth grade algebra. What took the FDA so long to do the calculations? Why didn't CDC and the advisory bodies do these calculations when they rapidly expanded the childhood immunization schedule?"
Source: FOIA filing by parents.
4.  Dr. Maurer to Congressman Burton Email: "Risks which can be avoided"
December 4 2002
Written by Dr. Wolfgang Maurer to Congressman Dan Burton (R-IN), Committee on Government Reform
Dr. Maurer is an international expert on mercury in medicine from Vienna University (Austria). His email helps highlight how much was known about Thimerosal's toxicity and how far ahead of the FDA Europe appeared to be on the issue of mercury in vaccines. This email highlights FDA's inexplicable complacency in dealing with Thimerosal in vaccines. He writes:
"... more organic mercury was given with vaccines in the 1st yr of live (sic) compared to food. During all this time I addressed my concerns also to representatives of the pharmaceutical industry at meetings in Austria and abroad, also to representatives of US-manufacturers of vaccines...In a letter to the European Pharmacopoiea (addressed to Jean-Marc Spiesser) dated 21.May 1996 I again formulated my concerns and proposed a ban on organomercurials...To my opinion it was very clear in the [1980s], that [thimerosal] is an unappropiate preservative in medicines. Major toxicity concerns regarding its use in preparations with a high volume per injection and/or low body weight and major concerns due to potential mass sensitization so jeopardizing every vaccination programm (sic)...In medicine risks which can be avoided must be avoided. I urge you to ban organomercurials in medicinal products and also in medical devices."
Source: Committee on Government Reform, U.S. House of Representatives.
5.  Dr. Ruth Etzel to AAP Email: "Be Open and Honest Now"
July 2 1999
Written by Dr. Ruth Etzel, USDA Division of Epidemiology and Risk Assessment, to the American Academy of Pediatrics team involved with the announcement
This email was written soon after Dr. Etzel learned of the strategy regarding the July 9, 1999 announcement. In it, she expresses her concern with the approach being recommended and the risk of loss of trust. Perhaps no better email exists that predicts what has taken place over the last seven years. We only wish Dr. Etzel's advice had been followed. She writes:
"The AAP should be dedicated to promptly providing truthful information about this situation to pediatricians. We must follow the three basic rules: (1) Act quickly to inform pediatricians that the products have more mercury than we realized (2) Be open with consumers about why we didn't catch this earlier (3) Show contrition...To keep faith, we must be open and honest now and move forward quickly to replace these products...This is what American parents want to hear from their pediatricians. Anything less may cause them to lose faith in our recommendations."
Source: FOIA filing by parents.
6.  Dr. Fred Varrichio FDA/CBER Email: "7,000 Reports on Thimerosal"
January 19, 1999
Written by Dr. Fred Varrichio to Dr. Leslie Ball, internal FDA email within the FDA Division of the Center for Biologics Evaluation and Research.
This email was from Dr. Varrichio to Dr. Ball. Dr Varrichio was charged with doing research on Thimerosal's toxicity, and this email highlights how much information was already present in the scientific literature on the dangers of Thimerosal. He writes:
"I have some results for you. Problem is that there are 7000 reports that mention Thimerasol. What to do now. Obviously looking at all 7000 is a brute force approach."
Source: FOIA filing by parents.
7.  Dr. Ben Schwartz CDC/NIP Email: "Cumulative Exposure"
July 3, 1999
Written by Dr. Ben Schwartz to all the leaders of the National Immunizations Program at CDC.
This email was from Dr. Ben Schwartz to all the key decision makers at CDC, written just six days before the July 9, 1999 announcement, and it highlights the intense focus of the participants on CYA and moderation, rather than the safety of children. Dr. Schwartz recommends a form of trickery that many members of CDC and FDA have used since: focusing on "cumulative exposure" rather than daily exposure of mercury. This is analogous to a Doctor saying, "Take one aspirin a day for 90 days", the patient instead takes 90 aspirin on one day, and viewing those two events as having equivalent outcomes. Dr. Scwartz is recommending adding up the safe daily dose of mercury, looking at that dosing over a six month period, and comparing it to the amount of mercury children receive, without bothering to note that all the mercury is received in 2 visits to the doctor.
"As a parent of a 3-month old, I was very uncomfortable with the good vaccine/bad vaccine dichotomy and would have been reluctant to accept a Thimerosal containing product for my baby. Given the approach presented below, I would be very comfortable knowing that my child would receive a Thimerosal containing product as long as the defined safe cutoff for mercury is not exceeded [PCF note: it was exceeded, by any standard]...When the focus of the communication was on the vaccine product rather than the child, there was an inherent contradiction: why are we moving to Thimerosal free vaccines if vaccines containing this product are safe? Parents inevitably would want vaccines that don’t contain thimerosal, leading to shortages, deferral of vaccination, and receipt of mercury concentrations that exceed the cutoff by some children. The communication problem is avoided by presenting child focused messages."
Source: FOIA filing by parents.
8.  Thimerosal MSDS from Eli Lilly
Update December 22, 1999
Official Material Safety Data Sheet
This is a copy of the actual MSDS for Thimerosal from its manufacturer, Eli Lilly. Any scientist at CDC or FDA would have had access to this MSDS. Excerpts:
"Exposure Guidelines: Thimerosal - no known occupational limits established...Exposure to mercury in utero and in children can cause mild to severe mental retardation and mild to severe motor coordination impairment...Use of chelating agents such as BAL may be needed to treat ingestion of mercury...Target Organ Effects: Mercury - Nervous system effects (insomnia, tremor, anorexia, weakness, headache), liver effects (jaundice, digestive effects (hypermotility, diarrhea)."
9.  Quiet Scientist No More: Dr. David Graham
November 19, 2004
USA Today
This article from USA Today from famed whistleblower Dr. David Graham of the FDA highlights the internal climate of the FDA as it relates to people who come forward with safety concerns:
"Graham says he has heard concerns similar to his from counterparts who monitor medical devices and biologics, such as vaccines, but they're reluctant to come forward. "They are absolutely afraid for their jobs," Graham says. "We've got families to support." He's married to his college sweetheart, and they have six children ages 9 to 23."
10. Jon Ryter: Warning to Be Downplayed
July 1, 1999
Freerepublic.com
This was written 8 days before the announcement and represent one of the few journalists who accurately predicted the strategy and approach of the Public Health Service in "warning" about Thimerosal.
"The CDC, like all other bureaus of government recognizes that when you need to release negative information, release it on Friday since most Americans ignore the news on the weekends. The concern of the IAG staffer who turned this document over to me was that the CDC was engaging in a coverup that was deliberately attempting to play down the danger of the chemical THIMEROSAL, an organomecurial preservative used to stabilize many of the vaccines, immoglobins and some food products simply because the government cannot afford to dispose of its entire inventory of vaccines containing this substance."
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