Chickenpox Vaccine Loses Effectiveness in Study
One of the biggest scandals in American health care is coming to a head this March 27th, 2007. In the United States Court of Appeals for the District of Columbia, a case, called "Moms Against Mercury, et al., v. FDA" will get its time in the sunlight, and the Defendant, the United States Food & Drug Administration (FDA) isn’t doing well in its Defense.
The case is simple. Citizens are suing the FDA for NOT, during the last THIRTY YEARS, ruling on the safety, or danger, of mercury amalgam tooth fillings. The Plaintiffs want mercury amalgam tooth fillings banned completely, and forever.
And, the FDA has virtually no defense...
The US anti-amalgam movement, an aggressive division of the North American Health Freedom Movement, has for years, chipped away at "official dentistry’s" promotion of mercury amalgam tooth fillings, pointing out, correctly, their inherent dangers. But "official dentistry" doesn’t listen, and in fact, actively punishes dentists that shy away from, or actively advertise the removal of, mercury amalgam fillings. The war has been active for a long time.
With this legal assault the anti-amalgams have adopted an effective offense. In essence, you might say, the anti-amalgam people, armed with silver bullets, have found the secret entrance to the FDA’s dungeon, climbed down into the sanctuary during the daylight hours, opened the coffins of the FDA’s sleeping staff dentists, sprinkled holy water over them, and driven wooden stakes through their hearts. So to speak.
This case can be the decisive blow – for the FDA attorneys don’t have very good answers. The case reads:
SUMMARY OF ARGUMENT
Thirty years after being directed to classify all devices, 20 years after classifying all other dental fillings materials, 13 years after being mandamused to classify but winning on exhaustion grounds, nine years after specifically promising (in writing) to classify, four years after pleading no excuses to Congress for not classifying, it’s clear that FDA’s policy is not to classify encapsulated mercury amalgam. To say FDA ignores this issue is incorrect: FDA’s public relations machine is has been in high gear, as the Center for Devices bobs and weaves about its duty to classify through three “literature reviews,” three “consumer updates,” one “white paper,” and a plethora of sound bites.
The decision not to classify – a plain violation of the statute – is thus a reviewable decision.
FDA’s choice of cheerleader for amalgam, instead of regulator of amalgam, is not acceptable. FDA otherwise bans, limits, and warns against other products, drugs, or foods containing mercury, while other federal health agencies and the health regulators of other nations condemn mercury amalgam.
FDA not only ducks classifying, but also refuses to do an environmental assessment, which would plainly indicate the need for an environmental impact statement. Nor will FDA seek a timely and valid panel recommendation – the previous one being too old (1994), procedurally invalid (no statement for departing from Class III), and sub silentio overruled in September 2006. The writing is on the wall in both cases: An environmental assessment will plainly indicate the need for an environmental impact statement, which report would show alternatives to toxic mercury can be used in fillings, thereby eliminating the major source of mercury in the nation’s wastewater – amalgam. In September, the FDA panel decisively rejected the FDA staff’s pseudo-science about amalgam (e.g, it is safe because it’s been used for a long time), so FDA ducks asking the panel for formal action.
FDA keeps amalgam on the market via a sham substantial equivalence test, pretending that a powder half-device containing no mercury equates to a full device capsule that is 50% toxic mercury. When asked by Senator Kennedy why this practice is allowed, Commissioner Von Eschenbach in writing denied that FDA considers the two devices to be substantially equivalent. Since the staff has ten times approved amalgam under this test in the past six years (and many times before that), perhaps the Center for Devices is engaged in rogue activity unknown to the Commissioner’s office.
The correct recourse is not a mere order to classify, allowing an unclassified, unregulated device – with 50% mercury and for which substitute materials are legal and available for any dentist to place – to remain in commerce, but to remove it from commerce temporarily until FDA complies with its legal duties.
This Court must direct FDA to start being amalgam’s regulator instead of amalgam’s cheerleader. Whether by intention or lethargy, FDA’s Center for Devices has protected the marketing of mercury fillings by doing none of its regulatory duties – neither classifying nor requiring proof of safety nor doing an environmental assessment nor seeking a valid recommendation from the scientific panel. Since they have ducked and dodged classifying encapsulated amalgam after classifying all other dental filling materials in the 1980s, the mercury apologists at the Center for Devices by now realize that completing any of these tasks will lead straight to the end of mercury in dentistry.
Thus, an order to classify is not enough. The legal prerequisites (environmental impact statement and Panel referral) mean the process will take months; the record of bad faith suggests it will take years. Amalgam is illegally in commerce. It must be removed from commerce forthwith, temporarily, until FDA chooses to complete its regulatory duties.
What was the FDA’s response to this legal action?
Charlie Brown, two-time elected Attorney General for the State of West Virginia, and now attorney for the Plaintiffs, says of the case:
Our case, filed April 27, 2006, by 9 petitioners (names below)* charges FDA with illegally allowing the sale of mercury fillings. For thirty years, FDA has defiantly refused to classify amalgam — even though this step is required as the legal prerequisite to sale of any implants. Even the repudiation of its pseudo-science by two FDA Scientific Panels on September 7, 2006 has not deterred FDA, who is making false and deceptive claims to mask the vote of these Panels.
Faced with standing before a federal court, FDA now departs from its role as chief cheerleader for mercury fillings. In its brief, FDA admits, five times, that it does not know if mercury amalgam is safe or unsafe!
The nine petitioners who sued FDA: Four organizations: Moms Against Mercury (Amy Carson, Angela Medlin), Connecticut Coalition for Environmental Justice (Mark Mitchell, M.D.), Oregonians for Life (Mary Starrett), and California Citizens for Health Freedom (Frank Cuny); two state officials: California Dental Board Public Member Kevin J.Biggers, and Arizona State Senator Karen Johnson; three individuals: Dr. Andy Landerman, Linda Brocato, and Anita Vazquez Tibau.
This is a breakthrough not thought possible a year ago. To repeat, FDA now admits that the evidence is “changing,” thus the safety of mercury fillings is not “definitive” and is “the subject of intense disagreement.” Quotations from FDA’s brief, containing those admissions, are below.**
FDA’s admissions in its brief to the US Court of Appeals: “there is a lack of conclusive evidence regarding the health effects of mercury fillings”; “constantly changing scientific evidence” exists on mercury amalgam; “complex issues and intense disagreement [exist] about the scientific evidence regarding mercury and its potential health effects”; “the complexity of the issue and the lack of conclusive scientific evidence on the health effects of dental amalgams”; “the lack of … definitive scientific evidence.”
Let’s see what happens next.
Stay tuned…Tim Bolen – Consumer Advocate
Loss of Vaccine-Induced Immunity to Varicella over Time
New England Journal of Medicine | March 15, 2007 |Volume 356:1121-1129 Number 11
Sandra S. Chaves, M.D., M.Sc., Paul Gargiullo, Ph.D., John X. Zhang, Ph.D., Rachel Civen, M.D., Dalya Guris, M.D., M.P.H., Laurene Mascola, M.D., M.P.H, and Jane F. Seward, M.B., B.S., M.P.H.
Background: The introduction of universal varicella vaccination in 1995 has substantially reduced varicella-related morbidity and mortality in the United States. However, it remains unclear whether vaccine-induced immunity wanes over time, a condition that may result in increased susceptibility later in life, when the risk of serious complications may be greater than in childhood.
Methods: We examined 10 years (1995 to 2004) of active surveillance data from a sentinel population of 350,000 subjects to determine whether the severity and incidence of breakthrough varicella (with an onset of rash >42 days after vaccination) increased with the time since vaccination. We used multivariate logistic regression to adjust for the year of disease onset (calendar year) and the subject’s age at both disease onset and vaccination.
Results: A total of 11,356 subjects were reported to have varicella during the surveillance period, of whom 1080 (9.5%) had breakthrough disease. Children between the ages of 8 and 12 years who had been vaccinated at least 5 years previously were significantly more likely to have moderate or severe disease than were those who had been vaccinated less than 5 years previously (risk ratio, 2.6; 95% confidence interval [CI], 1.2 to 5.8). The annual rate of breakthrough varicella significantly increased with the time since vaccination, from 1.6 cases per 1000 person-years (95% CI, 1.2 to 2.0) within 1 year after vaccination to 9.0 per 1000 person-years (95% CI, 6.9 to 11.7) at 5 years and 58.2 per 1000 person-years (95% CI, 36.0 to 94.0) at 9 years.
Conclusions: A second dose of varicella vaccine, now recommended for all children, could improve protection from both primary vaccine failure and waning vaccine-induced immunity.
From the Centers for Disease Control and Prevention, Atlanta (S.S.C., P.G., J.X.Z., D.G., J.F.S.); and the Los Angeles County Department of Health Services, Los Angeles (R.C., L.M.).
Address reprint requests to Dr. Chaves at the Centers for Disease Control and Prevention, 1600 Clifton Rd., NE, Mailstop A-47, Atlanta, GA 30333, or at email@example.com
Barbara Loe Fisher Commentary:
In March 1995, when Merck’s chickenpox vaccine, VARIVAX, was licensed, the National Vaccine Information Center issued a public statement and I appeared on NBC’s "Today Show" questioning why the CDC and AAP were calling for mass use of the live varicella zoster vaccine by all healthy children. Originally developed for leukemic children for whom chicken pox could be deadly, it had taken Merck decades to get VARIVAX licensed for healthy children because it had such a high failure rate: efficacy was known to be 80 percent or less.
In 1995, NVIC went on record as opposing chicken pox vaccine mandates for the following reasons: (1) the childhood disease is highly communicable but mild for the vast majority of young children; (2) disease-induced immunity is qualitatively superior and lasts longer than vaccine induced, temporary immunity so mass vaccination sets up the need for booster shots; (3) mass vaccination will change the epidemiology of the disease and drive it into atypical older age groups where it is far more likely to cause permanent injury or death; (4) shingles cases may increase as chicken pox cases decrease.
On March 14, 2007, CDC officials published an article in the New England Journal of Medicine and confirmed the warning that NVIC issued exactly twelve years earlier: Merck’s VARIVAX vaccine has a high failure rate and mass vaccination of American children has driven the disease into atypical older age groups where it can be far more dangerous. Already the CDC has said children between 4 and 6 years need a booster dose and a third booster may well be planned for teenagers..
And what about the chicken pox vaccine’s safety? In September 2000, the FDA reported that in the first three years of the vaccine’s use, 1 in 33,000 doses was followed by shock, convulsions, encephalitis, thrombocytopenia or death. About 82 percent of the adverse event reports to VAERS occurred in individuals who only received the chicken pox vaccine and led to the addition of 17 adverse events to the Merck product label, including secondary bacterial infections (cellulitis); secondary transmission (infection of close contacts); transverse myelitis; Guillain Barre syndrome and herpes zoster (shingles). On Sept. 13, 2000, NVIC issued a press release and stated "This vaccine should not be mandated. There are too many questions about the true adverse event and efficacy profile of this relatively new live virus vaccine and it is up to the manufacturer marketing the vaccine and the federal agencies regulating the vaccine to conduct further follow-up."
Since 2000, NVIC and VAERS have received continuing reports of brain inflammation, convulsions, vaccine strain chicken pox, shingles, regression into autism and other serious health problems following receipt of VARIVAX alone or in combination with MMR, DTaP, influenza, pneumococcal and other vaccines.
In the past few years, Gary S. Goldman, Ph.D., founder and editor of Medical Veritas, published research in Vaccine and the International Journal of Toxicology documenting an increase in shingles (herpes zoster) in the U.S. after the states mandated use of chickenpox vaccine following the CDC’s 1995 "universal use" recommendation. Goldman’s research revealed that shingles, a painful nerve inflammation and rash that develops into pus-filled blisters that break open and form scabs and can cause three times as many deaths and five times the number of hospitalizations as chicken pox, is suppressed naturally in a population when older children and adults have their chickenpox-induced immunity asymptomatically "boosted" by coming into contact with younger children infected with chicken pox. Dr. Goldman’s findings, summarized in his article "The Case Against Universal Varicella Vaccination" (International Journal of Toxicology, 25:313-317, 2006) corroborate those of other independent researchers questioning the cost-benefit rationale for mandatory vaccination of all children with chickenpox vaccine.
Goldman and others have pointed out that, even if chickenpox was nearly eradicated by mass vaccination, the higher number of shingles cases could continue in the US for up to 50 years with any chickenpox deaths prevented by vaccination offset by deaths from increasing shingles disease. Goldman published a cost-benefit analysis of the mass varicella zoster vaccination program in Vaccine which demonstrated that the 50-year shingles epidemic will cost an excess $4.1 billion in health care costs to the U.S. According to Goldman, "The principal reason that chicken pox vaccines in Japan maintained high levels of immunity 20 years following vaccination was that only 1 in 5 Japanese children were voluntarily vaccinated. Those vaccinated received immunologic boosting from contact with children with natural chickenpox. But the mandatory vaccination program in the U.S. will nearly eradicate this natural boosting mechanism and leave our population vulnerable to shingles."
On May 26, 2006, the FDA approved Merck’s shingles vaccine, ZOSTAVAX, for adults 60 years and older who have had chickenpox at some point in their lives. In October, 2006 the ACIP provisionally recommended it for all adults over 60 regardless of whether they did or did not have chickenpox. ZOSTAVAX is based on Merck’s VARIVAX but is considered to be 14 times more potent. Cost for a single dose of ZOSTAVAX costs $150 or more.
The CDC recommendation that all American children get booster doses of chickenpox vaccine and all adults over 60 years old get a dose of shingles vaccine will generate billions of dollars for Merck, the sole supplier of chickenpox and shingles vaccine in the U.S.
Note: Gary Goldman has written several books about his experience as a varicella zoster vaccine researcher for the CDC and what happened when he attempted to inform the public about the vaccine’s risks.