America’s Healthcare Crisis–Part III-Vaccine Controversy

The US infant vaccine schedule is the most aggressive in the world.

US infants are subjected from birth to the highest number of vaccines—26 doses before age one—and 36 doses by age 5.[1]

The CDC claims that multiple simultaneous vaccines are safe “for children with normal immune systems.”

infant_vaccination_asssault.jpg

  • What about children with developmental immune deficiency or neurological impairment or mitochondrial enzyme deficit whose immune system may be impaired?
  • What evidence justifies the risk of exposing infants to excessive, repeated immune stimulation and toxic vaccine ingredients—especially for non-fatal illnesses?

Vaccines pose risks—some infants have suffered severe allergic reactions, brain damage (encephalopathy), seizures, and death.[2] Some vaccines include live viruses, animal and human DNA, heavy metals, and various foreign contaminants—some intentional, others unintentional.[22]

 Infants’ underdeveloped brain and immune system are overwhelmed by excessive vaccine doses—some for non-communicable diseases that pose no risk for well cared for babies.

 Neurosurgeons warn that the vaccine schedule “can result in brain inflammation and brain swelling that can be prolonged, even lasting years. This can result in seizures…”[3]     In Congressional testimony, the Association of American Physicians and Surgeons (1999)[4] stated:

“The federal policy of mandating vaccines marks a monumental change in the concept of public health. Traditionally, public health authorities restricted the liberties of individuals only in case of a clear and present danger to public health. For example, individuals infected with a transmissible disease were quarantined.”

Mandatory government vaccination policies have galvanized a parents’ movement that is gaining momentum because the magnitude of an epidemic of harm—in particular, autoimmune and neurological injuries—has affected ever more families.  State mandated vaccine policies are an inversion of medical ethics and human rights. These policies are predicated on three unsupportable rationales:

1.      The first rationale, that vaccines are “safe.”This rationale is belied by the Supreme Court’s acknowledgement that they are “unavoidably unsafe.”[5]   Vaccines pose inherent risks—for some children the risks are catastrophic.

2.      The second rationale applies the harmful “one size fits all” approach to medicine disregarding the bio-genetic vulnerabilities of the individual child, producing preventable catastrophic results.

3.       The third rationale endorses the utilitarian argument and its callous disregard for the individual: “some children” must be sacrificed for “the greater good.” That argument was the Nazi doctors’ defense for their crimes—and it was roundly rejected by the Nuremburg Court.

  • In 1986, the US government granted vaccine manufacturers almost total immunity from legal liability after thousands claimed serious injury.[5]
  • Vaccine safety data maintained by CDC are only selectively accessible for independent scientific review.
  • Vaccine risks are not disclosed to parents who are denied the right and duty to make an informed healthcare decision affecting their child.
  • The US recommended vaccination schedule is set by the federal government and vaccine manufacturers.
  • FDA-licensed vaccines pose inherent risks of harm—they’ve been ruled “unavoidably unsafe” by law, [5] and acknowledged as such by the US Supreme Court (2011). [6]

The vaccine industry has profited enormously from state mandatory vaccine policies, the absence of competition, a shield from all legal liability–and even a shield from having to disclose the risks to parents.

Public health officials and vaccine manufacturers set vaccine policies and control the information disseminated about vaccine safety. Industry and government maintain control over vaccine research by funding only researchers who support the government’s vaccine policy. Safety trials in medicine are inordinately costly requiring millions of dollars for sophisticated technology, laboratories and staff that only pharmaceutical companies or government can afford. Researchers who receive funding from government and / or industry do not design studies that are likely to detect serious safety issues, or to identify the cause of pervasive childhood disabling conditions—in particular, autism. Instead, their research tends to confirm the claims about the safety of vaccines in the schedule.[7]

Those who control the funding, control the data which is deemed proprietary and is accessible only selectively for independent review.

 rigged_research.jpgIn this way, vaccine stakeholders are able to suppress disclosure of severe adverse vaccine reactions—including deaths—and to suppress research that seeks to identify a specific cause.[8] This is a perfect example of how the calculated concept of “strategic ignorance” is preserved. Public health officials insist that adverse reactions to vaccines are “extremely rare.”[9]  And even credible information sources, such as the Institute of Medicine, downplay vaccine safety issues, assuring the public that vaccines are safe because “no scientifically confirmed cases of vaccine-induced neurodevelopmental harm have been found. And there is overwhelming evidence that vaccines don’t cause autism.”[10]

How Merck’s HPV vaccine, Gardasil, became the latest addition to CDC’s list of recommended universal vaccines (in this case for 9 to 26 year old females).

Until now, no one (that we know of) has written in detail about the unprecedented web of conflicts that arise when technology transfer and licensing is carried out within the US government.

In an illuminating chapter in Vaccine Epidemic[11] (paperback edition), Mark Blaxill and Dan Olmsted shed light on the significant financial interests the US Department of Health and Human Services (HHS) has in the development of vaccines. And, they demonstrate how these financial interests set in motion an extraordinary pattern of conflicts of interest affecting virtually all federal agencies within HHS whose task is to regulate the health and safety of medical products.

The authors document the direct involvement of numerous government agencies in the development,  patenting, clinical trial oversight, interpretation of safety and efficacy results, approval for licensure, promotion, selection of Merck’s controversial HPV vaccine, Gardasil, for CDC’s list of recommended vaccines, subsequent safety monitoring , and even determination of who would be compensated for vaccine injury from Gardasil.   The existence of a conflict of interest is acknowledged in a journal article by the two scientists employed by the National Institutes of Health (NIH) who developed the “virus-like particles” (VLP) technology for the vaccine.

“NIH filed for and received patents on their invention of the VLP technology; DHHS is the owner of the patent family that protects the commercial rights to the invention; in order to bring the product to market, OTT [Office of Technology Transfer] licensed the vaccine technology to Merck; and as Merck has generated billions in highly profitable Gardasil revenue, OTT has received millions in Gardasil profits as well.”

“But DHHS is also responsible for regulating Gardasil in numerous ways.   Its agency, the FDA, reviewed the clinical trials in which Gardasil was tested in human populations and passed judgment on Gardasil’s safety. An Advisory Committee on Immunization Practices (ACIP) of another of its agencies, the Centers for Disease Control and Prevention (CDC), decided whether or not to recommend Gardasil for young women and children. Together, the FDA and CDC now conduct the post-licensure surveillance to decide whether or not Gardasil is proving safe in larger populations. And as some families are now beginning to seek compensation based on claims that Gardasil caused injury in some of their children, the division of the Health Resources and Services Administration (HRSA), another DHHS agency, that oversees the Vaccine Injury Compensation Program (VICP) will soon sit in judgment as to whether, to whom, and how much compensation will be provided to Gardasil’s victims.”

“How is disinterested vaccine safety governance even remotely possible when DHHS employees stand as heroes at the head of the parade when a new vaccine is invented within its walls, while agency leaders are leading the cheering section, approving the new product’s launch, making the market for the product with its policy recommendations, and then turning around to cash multi-million dollar checks?

handshake_.jpgThe authors also provide a detailed analysis of FDA’s Gardasil safety review. A bone fide drug or vaccine safety test would require comparing the vaccine to an inert placebo, one not containing any active adjuvant toxins such as aluminum.  But that’s not how vaccines are tested. Gardasil, like other vaccines was tested using the “non-inferiority”[12] paradigm which compared the vaccine to an immunologically active compound containing aluminum and all ingredients in the vaccine except for VLP (“virus-like particles”) in 4 of 5 clinical trials.

Deaths and serious adverse events reported up to 12 months after exposure:
In one trial (018) the vaccine was compared to both to an aluminum adjuvant and a “carrier solution” that did not contain aluminum, but did contain sodium borate, a chemically reactive toxin.  594 children aged 9 to 15 (54% female) received the “carrier solution” while 11,778 (90% female, aged 9 to 23) received Gardasil, and 9,092 (100% female) received the adjuvant containing aluminum.

There were 17 deaths during clinical trials, 16 in females:
There were 10 deaths in the Gardasil group of which 3 were “sudden deaths” within two weeks of injection. There were 7 deaths in the aluminum adjuvant (“placebo”) group, and no deaths in the “carrier solution” group. That is an extraordinary high death rate in such a young, healthy group: In the group vaccinated with Gardasil the rate per 10,000 was 8.75. Yet FDA reviewers paid little attention.

The Gardasil trials were supervised by FDA-CBER officials who then approved the Gardasil license. Within three weeks after FDA licensure, Gardasil was on the CDC list of universal recommended vaccines.

“In order to better understand the real lessons of Gardasil under the harsh light of the business interests at work, let’s take a closer look at how the Merck-NIH partnership on Gardasil was forged.”  Read the full chapter, “A License to Kill” in Vaccine Epidemic [11]

AUTISM: Compelling Epidemiological Evidence Cannot Be Ignored

In 1976, children in the US received 10 vaccines before attending school. Autism was rare– for decades, until the 1980s, the autism prevalence rate had been about 1 in 2,000.[13] Since 1983, the US vaccine schedule for infants and children under age 5 has more than tripled: US infants are subjected from birth to one—to 26 vaccine doses—and 36 doses by age 5.[1]

During the same period, there has been a striking upward spiral in the prevalence of autism.
In 2009, the CDC reported the autism prevalence rate as 1 in 110.[14]
In 2012, the autism spectrum prevalence in the US shot up to 1 in 88.
[15]

In 2011, the US Interagency Autism Coordinating Committee (IACC, 2011) declared Autism “a national emergency:”[16]

 “Two decades ago, autism was a little-known, uncommon disorder. Today, autism is more common in the United States than childhood cancer, juvenile diabetes, and pediatric AIDS combined, and the increasing numbers of children being diagnosed with autism has created a national health emergency.”

This dramatic spike led the Director of the National Institute of Mental Health (NIMH) and Chair of the IACC, Dr. Thomas Insel, to acknowledge,

“There is no question that there has got to be an environmental component here.”[17]

Yet, public health officials have done nothing to find the cause. No academic or public health institution has initiated research to find the cause of this “national emergency.”

When independent researchers present scientific findings that identify a potential environmental component, raising questions about the safety of the US vaccination program, their findings are either ignored or trashed, and the scientists are tarred and feathered as a danger to the community. Worse yet, if they suggest that vaccines may be linked to autism, they risk losing their jobs and reputations—and they may find themselves charged with research misconduct.[18]

Physicians and scientists who publicly raise doubt about the safety of vaccine policy are vilified with a fervor bordering on religious fundamentalism. This disproportionate vitriolic reaction is a sure indication of how much is at stake and to what extremes vaccine stakeholders will go to destroy dissident voices.

In 2010, scientists at the Environmental Protection Agency pinpointed 1988-89 as the “changepoint year” at which the dramatic rise in autism began.[19]

They stated that it would be “prudent to assume that at least some portion of this increase is real and results from environmental factors.”

A major environmental factor that coincided with the “changepoint year,” was the expansion of the US vaccine schedule for children in the first 15 months of life between 1988 and 1996. During those years, the following vaccines were added:[20]   children.jpg

·      HiB – Improved Hib conjugate vaccine licensed in December 1987.
Single dose added to childhood schedule in 1988.
·      DTaP – Additional dose at younger age added around 1990.
·      HiB – Three additional doses added to schedule in 1991.
·      Hep B – Three doses – Added to childhood schedule in 1992.
·      Chicken Pox – Approved in 1995, added to schedule in 1996.

“Infant Mortality Rates Regressed Against the Number of Vaccine Doses Routinely Given:
Is There a Biochemical or Synergistic Toxicity?”

This study, published in Human and Experimental Toxicology (2011)[21] compared infant immunization schedules of 34 countries. Recommendations vary greatly among the 34 countries: they range from 12 doses before one year—in Sweden, Denmark, Japan, and Norway—to 26 does in the US (which is the outlier).  The authors found: “a high statistically significant correlation between increasing numbers of vaccine doses and increasing infant mortality rates…nations that require more vaccine doses tend to have higher infant mortality rates.”  Although correlation is no proof of causality, clearly there is a need for independent investigation.

Vaccine ingredients may include deadly live viruses and toxic contaminants.[22]

The worst vaccine disaster that had been kept from the public for decades involves the deadly contaminated polio vaccine. In an authenticated censored interview (2002) conducted by  medical historian Professor Edward Shorter, Dr. Maurice Hilleman,[23] Merck’s chief of vaccine division, who had developed more vaccines than anyone in the world, acknowledged that “Vaccines have to be considered the bargain basement technology for the 20th Century.”

Dr. Hilleman admitted importing Rhesus monkeys from Africa that were infected with wild viruses—including SV40, AIDS and cancer. The monkeys were used to grow the polio virus used in both the Salk and Sabin polio vaccine. By 1960, more than 98 million American children had been vaccinated with the SV40 contaminated Merck polio vaccine. Dr. Hilleman defended the practice of including “wild viruses” in vaccines as “good science”—even as AIDS and leukemia had become a pandemic as a result. The SV40 virus had never before been seen in humans.

The link between the SV40 contaminated polio vaccine and cancer tumors was made independently by two scientists: Dr. Bernice Edy (1960) at the National Institute of Health and Dr. Michele Carbone (1966) at Loyola University, and later confirmed. But public health officials and a chorus of scientists scoffed (or ignored) the evidence. The FDA failed to recall the contaminated vaccine. The Institute of Medicine report (2002)[24] concluded,

“Although SV40 has biological properties consistent with a cancer-causing virus, it has not been conclusively established whether it might have caused cancer in humans.”

The tragic consequences this contaminated vaccine apparently caused was a huge upswing in brain cancer and leukemia in children.

More recently, a study published by the American Society of Microbiology, in the Journal of Virology (2010)[25] examined the viral particles in vaccines, reporting that they had found numerous non-vaccine viral sequences. They found;
                                       “pig and monkey viral particles in a number of vaccines” including Rotarix and Rotateq.

                         “human endogenous retrovirus K” in the MMR II (Measles, Mumps, Rubella) and Varivax (Chicken Pox) vaccines.

Of note, their tests on different lots of a vaccine detected different contaminants. Vaccine ingredients are not stable.

They note that since the year 2000, 426 cases of acute paralysis have been attributed to outbreaks of pathogenic vaccine-derived poliovirus from the oral polio vaccine. An unintended, but real risk of vaccines is that they may induce, in some individuals, the virus they are intended to prevent.

What is the rationale for vaccinating newborns with hepatitis B?
Hepatitis B is not transmitted by casual contact: those at risk are intravenous drug users, homosexuals, prostitutes and individuals who engage in high risk sexual behavior. 
Harrison‘s Principles of Internal Medicine
states that perinatal transmission of hepatitis B is “Uncommon in North America and Western Europe.”[26]

  •  Francis D Moore, MD, Surgeon in Chief, Emeritus, with expertise in immunology, Harvard Medical School, recommended:
      • “absolute avoidance of neonatal vaccination, particularly against hepatitis B…”
      •         “To put any child at risk of autism with the excuse of this extremely rare disease, is, of course, preposterous.”[27]  
  • Russell Blaylock, MD, a neurosurgeon says:
  •              “Vaccinating millions of children with the hepatitis B vaccine at birth can only be described as dangerous idiocy.”[3]
  • French health authorities responded to parental safety concerns and ended the mandatory hepatitis B vaccination.
  • Parents are demanding that they be allowed to make a responsible, informed, voluntary decision as to which diseases and vaccines their children should be subjected to in our country’s battle against disease.
  • Despite the known severe risks, despite the lack of medical justification, rather than modify the vaccine schedule to protect infants from preventable death, the CDC has added yet additional vaccines to the children’s schedule.

 

Vera Sharav

This is Part III of V.

See, Part I: America’s Healthcare Cris is Demonstrable:
America’s Health Ranking has Plummeted Compared to the Industrialized Nations of the World. Americans have the Lowest Life-Span and Highest Infanty Mortality Rate; Americans spend the most on healthcare–who benefits?   The third Leading cause of death is medical intervention; Commercially profitable, wasteful, inefficient and exceedingly harmful.

See Part II: What Do We Get for All That Money?
A preventable epidemic of injury and death from prescription drugs; FDA’s contribution to the epidemic;  Big Pharma’s business model: manufactured myths, propaganda and a hidden agenda.

See, Part IV: Vaccine Injury Compensation Program

See,  Part V: FDA, a complicit partner in crimes and corrupt industry practices

 

REFERNCES


[2] CDC. Chart of Contraindications and Precautions to Commonly Used Vaccines, 2011;  See also, HHS. Health Resources and Services Administration. Vaccine Injury Table.

[3] Blaylock, RS. The Danger of Excessive Vaccination During Brain Development: The Case for a Link to Autism Spectrum Disorders (ASD), Medical Veritas, 2008 posted at HeartMind Institute.

[4] Jane Orient, MD, Vaccines: Public Safety and Personal Choice. Statement of The American Physicians and Surgeons, before the Committee on Gov. Reform and Oversight. US. House of Representatives, Aug. 3, 1999.

[5] National Childhood Vaccine Injury Act (1986) PL 99-660 shields vaccine manufacturers from product liability: “No vaccine manufacturer shall be liable…if the injury or death resulted from side effects that were unavoidable even though the vaccine was properly prepared and was accompanied by proper directions and warnings.”

[6] See Dissenting Opinion. Justice Sotomayor joined by Justice Ginsberg:  562 U. S. (2011) Supreme Court of the US Russell Bruesewitz, et al . v.Wyeth Laboratories, [February 22, 2011]  Dissenting.  http://www.law.cornell.edu/supct/html/09-152.ZD.html

[7] American Academy of Pediatrics. AAP Bibliography Vaccine Studies: Examine the Evidence,  November 2010.

[8] See, an example, Dr. Bonnie Dunbar, professor of Cell Biology at Baylor College of Medicine in Texas, a distinguished scientist specializing in autoimmunity and vaccine development.  She submitted a proposal to the NIH for funding studies that would address her hypothesis that recombinant HBsAg (the surface protein of the HBV contained in the vaccine) can act as a molecular mimic to induce severe autoimmune reactions in genetically susceptible hepB vaccinated individuals or can generate anti-idiotypic antibodies with similar effects. Dr. Dunbar’s Proposal was rejected.
Cited by Kotzer, N. The Captive Audience: A Review Of Public Information On The Safety Of The Hepatitis B Vaccine, Especially As It Is Being Mandated For Newborns And Young Children. Third Year Paper, Harvard Law School.

[9] “Vaccines are one of the most effective public health interventions of all time. We give hundreds of millions of doses of vaccines. Severe adverse reactions are extremely rare.”
AAFP News . IOM: Serious Adverse Events Rare With Vaccines, Sept. 12, 2012.

[10] Gross,L.A Broken Trust: Lessons from the Vaccine–Autism Wars, PLoS Biology, May, 26, 2009; Salzberg, S. Anti-Vaccine Movement Causes the Worst Whooping Cough Epidemic in 70 Years, Forbes, July 23, 2012; “Vaccines Exonerated on Autism,” Editorial. The New York Times, February 12, 2009; “A Message to Baby Boomer Grandparents”, University Pediatric Associates.

[11] Vaccine Epidemic: How Corporate Greed, Biased Science, and Coercive Government Threaten Our Human Rights, Our Health, and Our Children Edited by Louise Kuo Habakus  and Mary Holland, Skyhorse Publishing, 2011. Chapter 19, A  License to Kill

[12] Schumi, J and Wittes, JT. “Through the Looking Glass: Understanding Non-Inferiority,” Trials Journal, 2011:106.

[13] Rice, P. Prevalence of Autism Spectrum Disorder. Autism and Developmental Disabilities Monitoring Network. US 2006, Morbidity & Mortality Report, Vol 58. 2009

[15] CDC. Prevalence of Autism Spectrum Disorders—ADS Monitoring Network, 14 Sites, US, 2008. MMWR Report, March 2012

[16] Report of the 2011 Interagency Autism Coordinating Committee Strategic Plan for Autism Spectrum Disorder Research – January 18, 2011.

[17] Kirby, D. Rising Autism Numbers—Leading Federal Official Says “No Question” That Environmental Exposures Are A Factor, Huffington Post, Dec. 21, 2009.  Transcript of interview with IACC Chair Dr. Thomas Insel.

[18] Dominus, S. “The Crash and Burn of an Autism Guru,” The New York Times,  April 20, 2011.

[19] McDonald, ME, Pau, JF. “Timing of Increased Autism Disorder Cumulative Incidence,” Environmental Science & Technology, 2010.

[21] Miller NZ, Goldman GS. Infant mortality rates regressed against number of vaccine doses routinely given: Is there a biochemical or synergistic toxicity? Human and Experimental Toxicology: Published online May 4, 2011.  

[22] See, CDC. Vaccine Excipient & Media Summary, Excipients Included in U.S. Vaccines, by Vaccine, 2012.

[23] Dr. Edward Shorter inteview Dr. Maurice Hilleman, 2002 http://www.youtube.com/watch?v=edikv0zbAlU. Or  www.youtube.com/watch?v=e93q7ANOO8k Transcript at: http://www.naturalnews.com/033584_Dr_Maurice_Hilleman_SV40.html. See also, Horwin, ME. Simian Virus 40 (SV40): A Cancer Causing Monkey Virus from FDA-Approved Vaccines, Albany Law Journal of Science and Technology, 2003,Vol 13.

[25] Victoria, JG, Wang, C, Jones, MS et al “Viral Nucleic Acids in Live-Attenuated Vaccines: Detection of  Minority Variants and an Adventitious Virus, Journal of Virology, April 7, 2010. Cited by Kirby [40].

[27] See, Letter (1999) reprinted in Appendix in Vaccine Epidemic, p.376.

[28] Ratajczak, HV, Theoretical aspects of autism: Causes—A review, Journal of Immunotoxicology, 2011; 8(1): 68–79.  http://www.rescuepost.com/files/theoretical-aspects-of-autism-causes-a-review1.pdf Dr. Ratajczak waited until her retirement to write about vaccine safety and autism—because the issue is so contentious.

[29] Whitaker-Azmitia PM. Behavioral and Cellular Consequences of Increasing Serotonergic Activity During Brain Development: A Role in Autism? International J Developmental Neuroscience, 2005, Vol 23 cited by Hadjikhani.

[30] Hadjikhani N. Serotonin, pregnancy and increased autism prevalence: Is there a link?. Medical Hypotheses (2009).

[31] Croen LA, Gether, JK, Yoshida, CK, Odouli, R and Hendrick, V. Antidepressant Use During Pregnancy and Childhood Autism Spectrum Disorders, Archives of General Psychiatry, 2011

[32] “The committee finds that evidence convincingly supports a causal relationship between some vaccines and some adverse events—such as MMR, varicella zoster, influenza, hepatitis B, meningococcal, and tetanus-containing vaccines linked to anaphylaxis.” “However, for the majority of cases, the evidence was inadequate to accept or reject a causal relationship. Overall, the committee concludes that few health problems are caused by or clearly associated with vaccines.” See, Institute of Medicine. Report, Adverse Effects of Vaccines: Evidence and Causality, 2011

[33] Harris, G. “ Vaccine Cleared Again as Autism Culprit,” The New York Times, August 25, 2011.

[34] Holland, M, Conte, L, Krakow, R and Colin, L. Unanswered Questions from the Vaccine Injury Compensation Program Pace Environmental Law Review, vol. 28, no. 2, 2011

[35] Jon Poling: Mitochondrial Dysfunction Not Rare In Autism. Adventures in Autism Blog.  April 11, 2008. http://adventuresinautism.blogspot.com/2008/04/jon-poling-mitochondrial-dysfunction.html

[36] Elliott, HR, Samuels, DC, Eden, JA, Relton, CL, Chinnery, PF. Pathogenic Mitochondrial DNA Mutations Are Common in the General Population, The American Journal of Human Genetics, Vol.  83(2): 254-260, July  31, 2008.

[37] See, Vaccine Injury Compensation Program. Statistics Report (February 2011). US. DHHS, Health Resources and Services Administration (HRSA). http://www.hrsa.gov/vaccinecompensation/statistics_report.htm

[38] HRSA e-mail reprinted [p. 144] in: Vaccine Epidemic  See, Ref. 55

[39] McGoey, L The Logic of Strategic Ignorance, British Journal of Sociology, 2012, Vol. 63:533-76.

[40]  Utah Dept. of Health. Utah Atlas of Health, September 2010.