Whooping Cough Outbreaks & Vaccine Failures

UPDATE: CLICK HERE TO VIEW NVIC'S PERTUSSIS VACCINE & DISEASE PAGE

by Barbara Loe Fisher
Reports of whooping cough outbreaks in California1,2 and in other states this summer are nothing new. Every four to five years – no matter how high the vaccination rate is - there are reports of whooping cough increases.

Whooping cough is a respiratory disease. Toxins in Bordetella pertussis bacteria stimulate the production of large amounts of thick, sticky mucus that can clog the airways of tiny babies and children, making it difficult for them to take a breath without vomiting, choking and making a whooping sound3 as they struggle to breathe.

There is an acellular pertussis vaccine – DTaP - which was licensed for American babies in 1996.4 DTaP replaced an older, very reactive whole cell pertussis vaccine - DPT - that was associated with more cases of high fever, collapse/shock, convulsions, brain inflammation and permanent brain damage.5,6

It is well known that pertussis vaccines, which can contain various amounts of bioactive toxins7,8,9,10,11 and also aluminum12,13,14 and mercury15 additives, have killed and brain injured some children. Over half of the 2,480 awards for vaccine injury and death totaling $2 billion dollars made under the 1986 National Childhood Vaccine Injury Act involve pertussis vaccine.16

Pertussis vaccination rates are very high in the U.S. According to the CDC, 84 percent of children under age three have received four DTaP shots.17 By the time American children enter kindergarten nearly every child has gotten all the CDC recommended pertussis shots.18 In 2009, the CDC said that the proportion of totally unvaccinated children in America is only six hundredths of one percent (0.06).19

Even with super high pertussis vaccine coverage in America and other countries like the Netherlands, Australia, Finland and Canada, whooping cough disease cannot be prevented.20 There are two main reasons for this fact.

First, pertussis vaccines widely used since the 1950’s have not prevented whooping cough disease from circulating in vaccinated populations. Unknown numbers of children and adults, who have gotten all government recommended pertussis shots, can and do develop whooping cough or are carriers without symptoms.21,22

Because pertussis vaccine immunity is only temporary and does not last, health officials are now telling teenagers and adults to get more booster shots.23 But that is not going to matter if scientific evidence that B. pertussis organisms have mutated and become vaccine-resistant turns out to be correct.24

A second important reason is that another Bordetella organism – parapertussis – also can cause whooping cough.25 B. parapertussis symptoms, while often milder, can look exactly like B. pertussis. But doctors rarely recognize or test for parapertussis.26 And there is NO vaccine for parapertussis.

The DTaP vaccine given 5 times to children under age 6 and booster doses for teenagers and adults does not protect against whooping cough caused by B. parapertussis. In highly vaccinated countries like the U.S., parpertussis is on the rise and it is estimated that perhaps 30 percent or more of whooping cough disease is actually caused by parapertussis!27

So which bacterial organism is causing much of the whooping cough being seen in California, Nevada,28 Oregon and other states this summer? Is it B. pertussis or B. parapertussis? Has there been any attempt by health officials to do expensive PCR lab tests on suspected whooping cough cases to find out?29

Another question: Are public health officials being transparent with the public about just how many children and adults reported to have whooping cough have been fully vaccinated? In 1985 there was a lot of publicity about whooping cough outbreaks in eight states and all the blame was put on parents of DPT vaccine injured children calling for a safer pertussis vaccine. But 25 years ago I investigated those whooping cough outbreaks and found 50 to 80 percent or more of the children and adults with whooping cough symptoms had been vaccinated.30

Bordetella organisms causing whooping cough disease live in animals like sheep, pigs, cats and dogs, as well as humans, and have been part of the earth’s ecosystem, evolving to survive, for thousands of years. 31 32 Yet, mass vaccination of humans with pertussis vaccine is only 60 years old.

So why are the unvaccinated being blamed for whooping cough outbreaks in California,33 Oregon34 and other states? The majority of Americans alive today have gotten 3 to 5 pertussis shots.

The truth is that, whether you are vaccinated or not, you can get a mild or serious case of whooping cough from B. pertussis or B. parapertussis organisms. And both whooping cough disease and pertussis vaccines carry a risk of injury or death, which can be greater for some than others.

There are no guarantees.

It is time for public health officials and doctors to look at themselves and stop pointing fingers at those, who have examined pertussis vaccine benefits and risks and come to a different conclusion.

After my precocious two year old son suffered a convulsion, collapse/shock and brain inflammation following his fourth DPT shot in 1980 and was left with multiple learning disabilities and attention deficit disorder, in 1993 my two youngest children, then 5 and 10 years old, came down with whooping cough. They coughed violently and spit up huge amounts of thick mucus for 8 weeks before fully recovering and going on to become honor roll students.

The profile on whooping cough in the 1985 book I co-authored with medical historian Harris Coulter, “DPT: A Shot in the Dark,”35 is about my sister and her family, who were fully vaccinated. Her newborn baby almost died of whooping cough but survived and attended college on a full academic scholarship. Even so, other babies who get whooping cough do not survive.

There are no guarantees.

A quarter century later, DPT: A Shot in the Dark still stands as the most comprehensive, referenced analysis of whooping cough and pertussis vaccine risks and why America’s mass vaccination system is in urgent need of reform. Become a family donor supporter of the National Vaccine Information Center and you will receive a complimentary copy of that historic book.
Protect yourself and your child by making educated vaccine decisions. It’s your health. Your family. Your choice.

References

1 California Department of Health. Press Release: Whooping Cough Epidemic May Be Worst in 50 Years. June 23, 2010.
2 Scheck J. Whooping cough afflicts region. Wall Street Journal. June 24, 2010.
3 Centers for Disease Control (CDC). Pertussis (Whooping Cough) Sounds. Accessed June 6, 2010.
4 CDC. FDA Approval of a Second Acellular Pertussis Vaccine for Use Among Infants and Young Children. MMWR. 1997;46:110-111.
5 Gold, R. Pertussis: The Disease & the Vaccine. Canadian Family Physician. Vol 32, January 1986, pp. 79-83.
6 Legido A, Tenembaum SN, Katsetos CD, Menkes JH. Autoimmune & Postinfectious Diseases (Chapter 8). Child Neurology – 7th Edition. Lippencott Williams & Wilkins, 2006. Pages 631-634 (Neurologic Complications of Immunizations).
7 Sidney M, Furman BL, Wardlaw AC. Effect of hyperreactivity to endotoxin on the toxicity of pertussis vaccine and pertussis toxin in mice. Vaccine. Vol. 7, Issue 3. June 1989. Pages 237-241.
8 World Health Organization (WHO). Requirements for Diphtheria, Tetanus, Pertussis 7 Combined Vaccines (Revised 1989). Technical Report Series, No) 500. 1990.
9 Steinman L, Weiss A et al. Pertussis toxin is required for pertussis vaccine encephalopathy. Proc Natl Acad Sci, 1985. December; 82(24) 8733-8736.
10 Businesswire. Chiron Biocine Genetically Engineered Acellular Pertussis Vaccine Proves Superior to Currently Licensed Vaccine. Chiron Press Release: July 13, 1995.
11 Hofstetter HH, Shive CL, Forsthuber TC. Pertussis Toxin Modulates the Immune Response to Neuroantigens Injected in Incomplete Freund’s Adjuvant: Induction of Th1 Cells and Experimental Autoimmune Encephalomyelitis in the Presence of High Frequencies of Th2 Cells. The Journal of Immunology, 2002. 169: 117-125.
12 Gupta RK, Relyveid EH. Adverse reactions after injection of adsorbed diptheria – pertussis – tetanus (DPT) vaccine are not due only to pertussis organisms or pertussis components in the vaccine. Vaccine. Vol. 9, Issue 10. October 1991. Pages 699-702.
13 Bergfors E, Trollfors B, Inerot A. Unexpectedly high incidence of persistent itching nodules and delayed hypersensitivity to aluminum in children after the use of adsorbed vaccines from a single manufacturer. Vaccine. Vol. 22, Issue 1. December 8, 2003. Pages 64-69.
14 Rimaniol AC, Gras G et al. Aluminum hydroxide adjuvant induces macrophage differentiation towards a specialized antigen-presenting cell type. Vaccine. Vol. 22, Issues 23-24. 13 August 2004. Pages 3127-3135.
15 Waly M, Olteanu H. Activation of methionine synthase by insulin-like growth factor – 1 and dopamine: a target for neurodevelopmental toxins and thimerosal. Molecular Psychiatry (2004) 9, 358-370.
16 HRSA. National Vaccine Injury Compensation Program (VICP). Claims Filed and Compensated or Dismissed by Vaccine. (up to May 5, 2010). and Statistics Report: Awards Paid (as of June 7, 2010).
17 CDC. Immunization Rates Remain Stable at High Levels Among the Nation’s 19 through 35 month old children. CDC Press Release: August 27, 2009.
18 CDC. Vaccination Coverage Among Children Entering School – United States, 2005-2006 School Year. MMWR. October 20, 2006. 55(41); 124-1126.
19 See Reference #17.
20 Mooi F R, van LooIHM, King A. Adaptation of Bordetella pertussis to Vaccination: A Cause for its Reemergence? Emerging Infectious Diseases. Vol. 7, No. 3 Supplement June 2001.
21 Grilc E, Pirnat N. Pertussis outbreak in recently vaccinated children in a kindergarten in Ljubljana during a resurgence in pertussis incidence. Eurosurveillance. Vol. 10, Issue 33. 18 August 2005.
22 Srugo I, Benilevi D et al. Pertussis Infection in Fully Vaccinated Children in Day-Care Centers, Israel. Emerging Infectious Diseases. Vol. 6, No. 5 September-Oct. 2000.
23 Brooks DA, Clover R. Pertussis Infection in the United States: Role for Vaccination of Adolescents and Adults. Journal of the American Board of Family Medicine 19:603-611. 2006.
24 See References #20 and #21
25 Kheief N, Danve B etal. Bordetella pertussis and Bordetella parapertussis: two immunologically distinct species. Infection & Immunity. 1993 February; 61(2): 486-490.
26 He Q, Vijanen MK et al. Whooping Cough Caused by Bordetella pertussis and Bordetella parapertussis in an Immunized Population. JAMA. 1998; 280: 635-637.
27 Liese JG, Renner C. Clinical and epidemiological picture of B pertussis and B parapertussis infections after introduction of acellular pertussis vaccines. Archives of Diseases in Childhood 2003; 88: 684-687. Also see Reference #26.
28 Magin K. Low vaccination rates cause worry over whooping cough. The Union (Nevada). June 15, 2010.
29 LabCorp. A Technical Review: Bordetella pertussis and Bordetella parapertussis Detection using Real-time PCR. 2007.
30 Fisher, BL. Presentation to the Advisory Committee on Immunization Practices, Centers for Disease Control, May 12, 1986.
31 Preston A. Bordetella pertussis: the intersection of genomics and pathobiology. Canadian Medical Association Journal. July 5, 2005. 173 (1)
32 Diavatopoulos DA, Cummings CA et al. Bordetella pertussis, the Causative Agent of Whooping Cough, Evolved from a Distinct Human-Associated Lineage of B. brohchiseptica. PLOS Pathogens. December 2005: Vol. 1, Issue 4.
33 Weerasekara P. California Mulls Mandatory Shot for Whooping Cough. New American Media. July 3, 2010.
34 The Oregonian. Putting other kids in harm’s way. July 4, 2010.
35 Coulter HL, Fisher BL. DPT: A Shot in the Dark. New York: Harcourt Brace Jovanovich. 1985.


Click here to watch video commentary
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FDA Proposes Dangerous Vaccine Rule Change

by Barbara Loe Fisher

This past spring, the FDA took a hands-off approach to Merck’s admission that DNA from a lethal pig virus is contaminating doses of RotaTeq vaccine being swallowed by millions of newborn babies.1 Now the agency responsible for making sure pharmaceutical products do not hurt people is proposing a Rule Change to give one staff employee the sole authority to allow “exceptions or alternatives” when drug companies want to change vaccine ingredients, such as preservatives (like thimerosal) or adjuvants (like aluminum) or the amount of residual protein and antibiotics in vaccines.

The FDA’s proposed change to Requirements for Constituent Materials was quietly published in The Federal Register on March 30 and the deadline for public comment is only days away - on Monday, June 28. 2

The FDA is arguing that the rule change is necessary to “reduce burdens on industry” and to provide “greater flexibility and reduced regulatory requirements.” It gives one FDA staff Director the power to give drug companies the green light to “employ advances in science and technology as they become available” when companies want to make new vaccines really fast and get more bang for the buck.

If the proposed Rule Change is put into effect, a vaccine manufacturer could request a change in the content or amount of vaccine ingredients by simply writing a “brief statement describing the basis for the request and supporting data” as part of the original license application or for a pending or approved application. There is no information about how much scientific evidence the drug companies will have to submit to prove the new ingredients are safe; or whether the FDA’s Vaccine Advisory Committee will be able to review that evidence; or whether the American public will have a chance to comment before vaccine ingredients are changed.

This does not look like the transparency, public participation and collaboration in government that President Obama said he supports. 3 It removes the checks and balances necessary for good government.

Last year when federal health officials declared a pandemic H1N1 “swine flu” national emergency, drug companies put a full court press on the FDA to fast track licensure of highly reactive oil based squalene adjuvants 4 and the use of new technology, like insect cells, 5 to make pandemic influenza vaccines. During meetings of the FDA’s Vaccine Advisory Committee, the National Vaccine Information Center opposed both the quick licensure of squalene adjuvants, 6 which hyperstimulate the immune system and have been associated with autoimmunity, 7 8 9 10 and the use of insect cells, 11 which could be contaminated with insect viruses. 12 13 14

Neither technology was licensed by the FDA last year 15 16 but there are tens of thousands of doses of squalene that the federal government bought and is stored in warehouses waiting to be used. 17 If the proposed Rule Change goes into effect, will drug companies be able to put those doses of squalene in flu vaccines by getting only one FDA employee to say “yes?” This and other risks to health are waiting for the American people if drug companies can get quick approval from one person to raise the amount of mercury, 18 19 aluminum 20 21 22 23 or residual protein in vaccines, 24 25 which have been associated with chronic inflammation, brain and immune system damage. 26

This summer the American people are watching the horrifying consequences of inadequate federal regulation of the oil industry play out in the oil soaked Gulf coast. There are legitimate questions being asked about the cozy relationship and financial conflicts of interest between federal agency regulators and big oil companies partnering with the U.S. Government to generate billions of dollars for the U.S. Treasury. 27 Calls for an independent federal safety oversight agency to monitor offshore drilling are being made in congressional hearings.

NVIC has been calling for an independent vaccine safety oversight agency free from financial and ideological conflicts of interest 28 since Congress passed a law in 1997 allowing drug companies to pay the FDA to fast track licensure of new vaccines and drugs. 29 30 During the last decade, that fast track system has seen scores of risky drugs like Vioxx and reactive vaccines like Gardasil quickly licensed, only to be followed by tragic reports of deaths and injuries. 31 32

While federal health officials are spending millions of dollars of taxpayer money to persuade every American from infancy through the last year of life to take a flu shot every year, 33 and hundreds of new vaccines are now in clinical trials, 34 35 it is no time for the FDA to make it easier for drug companies to put whatever they want in vaccines. Giving absolute power to one FDA employee, who reports to unelected political appointees, who could be subjected to heavy pressure from Big Pharma lobbyists, is not the way to regulate vaccines for safety.

If you want to make your voice heard and tell the FDA Commissioner, President Obama and your elected congressional representatives in Washington, D.C. what you think about the proposed rule change making it easier for drug companies to put whatever potentially dangerous ingredients they want to in vaccines, take action now. Remember, you only have until this Monday, June 28 to take action.

It’s your health, Your family. Your choice. Help send a strong message to Washington that it is time for government to stop partnering with the pharmaceutical industry and RAISE the safety bar for drug companies enjoying congressionally mandated liability protection while making big profits from selling government mandated vaccines.
Click here to watch the video



1 Fisher, BL. Vaccine Contamination: A Threat to Human Health. NVIC Vaccine E-News. May 27, 2010.
2 DHHS. Food & Drug Administration. Proposed Rule Revision of Requirements for Constituent Materials. Federal Register. March 30, 2010 (Vo. 75, No.60)
3 The White House. Memo from President Barack Obama to Heads of Executive Departments & Agencies on Transparency and Open Government. January 21, 2009.
4 FDA. Centers for Biologics Evaluation & Research (CBER). Regulatory Consideration Regarding the Use of Novel Influenza A (H1N1) Virus Vaccines. Transcript of July 23, 2009 Meeting of the FDA Vaccines & Related Biological Products Advisory Committee (VRBPAC).
5 FDA. CBER. Safety & Efffectiveness of Purified Recombinant Influenza Hemagglutinin Vaccine for the Prevention of Influenza. Transcript of November 19, 2009 Meeting of the FDA Vaccines & Related Biological Products Advisory Committee (VRBPAC).
6 Fisher BL. NVIC. Public Comment on Fast Tracking of Unlicensed Adjuvants for H1N1 Pandemic Influenza Vaccine. July 23, 2009 Meeting of the FDA Vaccines & Related Biological Products Advisory Committee. Also see Reference #4, pages 161-162.
7 Kuroda Y, Nacionales DC et al. Autoimmunity induced by adjuvant hydrocarbon oil components of vaccine. Biomedicine & Pharmacotherapy 58 (2004) 325-337.
8 Carlson BC, Jansson AM et al. The Endogenous Adjuvant Squalene Can Induce a Chronic T-cell-Mediated Arthritis in Rats. American Journal of Pathology2000; 156: 2057-2065.
9 Asa PB, Cao Y, Garry RF. Antibodies to Squalene in Gulf War Syndrome. Experimental & Molecular Pathology 2000; 68, 55-64.
10 Petrovsky N, Heinzel S et al. New Age Vaccine Adjuvants: Friend or Foe? International BioPharm. August 2, 2007.
11 Fisher BL. NVIC. Public Comment on Use of Insect Cells for Influenza Vaccine Production. November 19, 2009 Meeting of the FDA Vaccines & Related Biological Products Advisory Committee. Also see Reference #5, pages 119-121.
12 Becker AL. Momentum builds for cell culture flu vaccines. Center for Infectious Disease Research & Policy (CIDRAP). June 27, 2005.
13 Khan AS. Cell Substrates for Viral Vaccines: A Regulatory Update. FDA Centers for Biologics, Evaluation & Research (CBER). New Cells for New Vaccines IV: October 14, 2009. Pages 16-19.
14 Cummins J, Ho MW. Dangers of HPV Vaccine Production in Plants, Microbes and Viruses. Institute of Science in Society. July 1, 2009.
15 Miller, T. US Passes on Unlicensed H1N1 Boosters Despite Shortage. PBS NewsHour. November 9, 2009.
16 Randall T. Flu Shot Made from Caterpillars Fails Safety Vote (Update 3). Bloomberg News. November 19, 2009.
17 Ehart W. Pandemic’s workshop: Making Policy, making money, making vaccine. The Washington Times. December 7, 2009.
18 SafeMinds. Summary of Science Demonstrating the Harmful Nature of Mercury in Vaccines. Accessed June 21, 2010.
19 Egan W. FDA Statement: Additives in Childhood Vaccines. House Committee onGovernment Reform. July 18, 2000.
20 Gherardi M et al. 2001. Macrophagaic myofastitis lesions assess long-term persistence of vaccine-derived aluminum hydroxide in muscle. Brain, Vol 124, No. 9, 1821-1831.
21 Redhead K. et al. 1992. Aluminum-adjuvanted vaccines transiently increase aluminum levels in murine brain tissue. Pharmacol.Toxico;70: 278-280.
22 Kawahara M et al. 2001. Effects of aluminum on the neurotoxicty of primary cultured neurons and on the aggregation of betamyloid protein. Brain Res. Bull. 55, 211-217.
23 Sahin G. et al. 1994. Determination of aluminum levels in the kidney, liver and brain of mice treated with aluminum hydroxide. Biol. Trace. Elem. Res. 1194 Apr-May;41 (1-2):129-35.
24 Gandy A. Report of Motor Neuron Disease After HPV Vaccine. ALS TherapyDevelopment Institute. October 28, 2009.
26 Orbach H. Vaccines and Autoimmune Diseases of the Adult. DiscoveryMedicine. February 4, 2010.
27 Efstathiou J. Oil-Spill Agency Fetches $13 Billion Amid “Cozy” Ties (Update 4). May 11, 2010. Bloomberg Business Week.
28 NVIC. Public Engagement Group Reviews U.S. Vaccine Safety System. NVIC E-News. April 16, 2010.
30 Find Law. The FDA Modernization Act of 1997 (Summary). February 22, 1999.
31 Burst S, Muhtadie L, Walters J. Dangerous Medicine: Blind Faith (What happens when drugs, science & money mix). The Hamilton Spectator. June 27, 2005.
32 NVIC. Gardasil: The Damage Continues. Gardasil & HPV Infection Information.
33 Stobbe M. Panel recommends flu shots for nearly every American. Associated Press.February 25, 2010.
34 Rosenthal KS, Zimmerman DH. Vaccines: All things considered. Clin VaccineImmunol. 2006 August; 13(8): 821-829
35 NIH. Vaccine Clinical Trials. Accessed June 21, 2010.
Posted by at 3 comments:

VACCINE CONTAMINATION: A THREAT TO HUMAN HEALTH

by Barbara Loe Fisher

In the past few months, the American public has been informed that two infant diarrhea vaccines – GlaxoSmithKline’s Rotarix and Merck’s RotaTeq – are contaminated with pig virus DNA. 1,2 But there’s a difference between the two vaccines: Rotarix contains parts of a pig virus that does not make pigs sick while Merck’s RotaTeq contains parts of a pig virus that kills baby pigs. 3,4,5

How many mothers know that, when Merck’s diarrhea vaccine is squirted into the mouths of their two month old babies, they are swallowing parts of a pig virus that suppresses the immune systems of baby pigs so badly, they waste away and can suffer respiratory, kidney, reproductive and brain damage before dying? 6,7,8

And how many doctors and nurses making babies swallow rotavirus vaccines know that?

And how many members of Congress, who are responsible for oversight of federal health agencies charged with ensuring vaccine safety, know that?

And how many mainstream media outlets are not covering this important story, a story that broke on March 22, 2010, when the FDA recommended temporary suspension of Rotarix vaccine because of contamination with parts of a non-lethal pig virus, only to withdraw the recommendation after a meeting on May 7th, when it was revealed that RotaTeq is contaminated with DNA from a pig virus that is lethal? 9

Why should we care about vaccines being contaminated with foreign DNA from deadly animal viruses?

Because it is a well known fact that DNA from animal viruses can infect human cells and change human DNA to cause disease in humans. 10, 11

Last fall public health officials declared an international pandemic emergency after a new pig-bird-human hybrid influenza virus was identified in Mexico and several people died. 12 Animal viruses can evolve to infect and make us sick and there are no guarantees that won’t happen because doctors are pouring parts of a virus that kills baby pigs down the throats of two, four and six month old babies.

Scientists working in the labs of Merck and the FDA don’t know if pig virus DNA will infect human cells and change human DNA so that the babies given contaminated rotavirus vaccines - or their children – will someday suffer immune suppression that damages lungs, kidneys, brains and reproductive ability before they die just like the baby pigs are dying today.

I attended the May 7 FDA meeting and made two public comments on behalf of the National Vaccine Information Center. 13 At that meeting I heard GlaxoSmithKline officials pledge to clean up Rotarix but Merck did not show up to answer any questions or make any public pledges.

A lot of experts sitting around the table used words like “we believe” and “we don’t think” and “there is no evidence” when they defended the assumed safety of contaminated rotavirus vaccines. Nobody seemed to know exactly how the vaccines became contaminated or why the tests used by drug companies and the FDA did not detect the contamination before they were licensed and released. Nobody seemed to know if the pig virus DNA was infectious or not, but then, quickly almost everyone at the table agreed the contaminated rotavirus vaccines should still be given to babies. 14

THIS is science? This is the kind of science we are supposed to trust to keep us healthy?

Drug companies are racing to develop vaccines that use human, animal, insect, plant and even cancer cells for production. 15,16,17 Living cells can be contaminated with viral DNA that could evolve in humans to make us sick or kill us. 18

Is Big Pharma seeking big profits putting pressure on the FDA, CDC and politicians to allow them to keep parts of deadly animal viruses and other potentially harmful ingredients in vaccines? 19,20,21,22,23

I think that is exactly what is happening. The bigger question is: will the American public let the pharmaceutical industry and special interest groups taking money from drug companies get away with it?

If you want to take action in your community to raise awareness about why vaccines contaminated with animal virus DNA and other toxic ingredients should be cleaned up, 24,25 go to the websites of the National Vaccine Information Center at www.NVIC.org and www.Mercola.com
to learn more.

It’s your family. Your health. And your choice. If we don’t protect our health and choices today, we will lose both tomorrow.

TAKE ACTION NOW!

Click here to watch the video



REFERENCES

1 FDA. Early Communication on Rotarix Vaccine. March 22, 2010.

2 FDA. Update on Recommendations for the Use of Rotavirus Vaccines. May 14, 2010.

3 FDA. May 7, 2010: Vaccines & Related Biological Products Advisory Committee Meeting Presentations: Dr. Gordon Allan: Porcine Circovirus.

4 West KH, Bystrom JM et al. Myocarditis and abortion associated with intrauterine infection in sows with porcine circovirus 2. JVDI 1999 Nov; 11(6): 530-2.

5 Fenaux M, Opriessnig T et al. Immunogenicity and pathogenicity of chimeric infectious DNA clones of pathogenic procine circovirus type 2 (PCV2) and non-pathogenic PCV1 in weanling pigs. Journal of Virology 2003 Oct; 77(20): 11232-11243.

6 Chianini F, Majo N et al. Immunohistochemical characterization of PCV2 associate lesions in lymphoid and non-lymphoid and non-lymphoid tissues of pigs with natural postweaning multisystemic wasting syndrome (PMWS). Veterinary Immunology and Immunopathology 2003 July; 94(1-2): 63-75.

7 The Pig Site. Post-weaning multisystemic wasting syndrome (PMWS). Accessed May 25, 2010.

8 Correa AMR, Zlotowski P et al. Brain lesions in pigs affected with postweaning multisystemic wasting syndrome. JVDI 2007; 19(1): 109-112.

9 FDA. Video Webcast: May 7, 2010 VRPBAC Meeting.

10 Weiss RA. The Leeuwenhock Lecture 2001. Animal origins of human infectious disease. London School of Hygiene & Tropical Medicine. The Royal Society. March 8, 2001.

11 Science Daily. Evolutionary Surprise: Eight Percent of Human Genetic Material Comes From a Virus. Jan. 8, 2010.

12 Neumann G, Noda T, Kawaoka Y. Emergence and pandemic potential of swine origin H1N1 influenza viruses. Nature. June 18, 2009 Editor’s Summary: Swine Flu so far: the emergence of pandemic H1N1.

13 Fisher BL. Statements on Finding of PCV DNA Sequences in Rotavirus Vaccines and on Advanced Analytical Methods in the Characterization of Cell Substrates. May 7, 2010 Meeting of the Vaccines & Related Biological Products Advisory Committee.

14 See Reference # 9.

15 WHO. Initiative for Vaccine Research: Use of Cell Lines for the Production of Influenza Virus Vaccines: the Appraisal of Technical, Manufacturing and Regulatory Considerations. April 10, 2007.

16 FDA. Vaccines & Related Biological Products Advisory Committee. Safety & Effectiveness of Purified Recombinant Influenza Hemagglutinin Vaccine for the Prevention of Influenza (FluBlok). November 19, 2009.

17 FDA. Designer Cells as Substrates for the Manufacture of Viral Vaccines. 2001.

18 Medical News Today. Combined Viruses Cause More Deadly Disease in Pigs, Researchers Discover. Feb. 14, 2008. and see Reference # 10.

19 The Guardian (UK). GlaxoSmithKline swine flu sales boost profits. April 28, 2010.

20 Doherty D. Novartis Profit Rises on Pandemic Flu Vaccine Sales (Update 5). Bloomberg Businessweek. April 20, 2010.

21 Visiongain. Influenza Vaccine Market Outlook 2010-2020. Published December 2009.

22 Carlsen B. Adults Now Drive Growth of Vaccine Market. Genetic Engineering & Biotechnology News. June 1, 2008.

23 The Pharma Letter. Aventis says human vaccines business will maintain double digit growth. October 6, 2003.

24 FDA. Memorandum: Clinical Review of New Biologics License Application– RotaTeq (Description of the Product). Page 12. April 6, 2005.

25 FDA. Guidance for Industry:Characterization and Qualification of Cell Substrates and Other Biological Materials Used in the Production of Viral Vaccines for Infectious Disease Indications. February 2010.




ADDITIONAL RESOURCES:

June 1, 2010 Press Release: Vaccine Safety Critics Call for RotaTeq Vaccine Recall & Clean-Up

June 1, 2010 NVIC PSA (60 sec) on RotaTeq vaccine contamination

June 1, 2010 VIDEO INTERVIEW (30 min) with Dr. Joe Mercola and NVIC President Barbara Loe Fisher on RotaTeq Vaccine Contamination

NVIC Information on Rotavirus & Rotavirus Vaccine

Posted by at 2 comments:

Vaccine Contamination: Pig Virus DNA Found in Rotarix

by Barbara Loe Fisher

On March 22, 2010, Food and Drug Administration (FDA) officials adhering to the precautionary principle advised American doctors to suspend use of Rotarix 1 vaccine until the agency finds out why DNA from a swine virus (porcine circovirus 1 or PCV1) was found in the live rotavirus vaccine. The FDA said there is “no evidence at this time” that the vaccine manufactured by GlaxoSmithKline and given to babies at 2,4 and 6 months of age to prevent diarrhea poses any safety risk. 2


Independent Lab Using New Technology Found Contamination

The discovery that viral DNA is contaminating Rotarix vaccine was made by a team of scientists at an independent research lab in San Fransisco, California, where they used new technology to detect fragments of viral genetic material in vaccines using genetic sequencing. 3

More testing confirmed that many copies of DNA from the pig virus were present in all Rotarix vaccine lots released since the vaccine was licensed in 2008 because the pig virus DNA also contaminated the working cell bank and the original viral “seed” stock, from which Rotarix vaccine was first produced. 4

Two Other Live Virus Vaccines Contaminated

The surprising discovery reportedly was made after the independent lab used new technology to evaluate the purity of eight live virus vaccines for polio, rubella, measles, yellow fever, human herpes 3 (varicella or chicken pox), rotavirus (Rotarix and RotaTeq) and MMR. In addition to pig viral DNA found in Rotarix vaccine, low levels of DNA fragments from avian (bird) leukosis virus (a retrovirus) was found in measles vaccine and DNA fragments of a virus similar to simian (monkey) retrovirus was found in RotaTeq vaccine. 5

FDA Looking For Answers

After the team double checked their findings, researchers notified GlaxoSmithKline (GSK) on February 9, 2010 and GSK notified the FDA on March 15, 2010, which prompted the FDA’s action on March 22, 2010 to suspend use of Rotarix. The FDA says it “does not know how DNA from PCV1 came to be present in Rotarix” or whether “this means that intact virus is present. Additional studies are being conducted.” 6

Rotavirus Vaccines Use Monkey, Cow, Pig Materials for Production


Rotarix is a genetically engineered vaccine that GSK created by isolating human rotavirus strain infecting a child in Cincinnati and using African Green monkey kidney cells to produce the original viral seed stock from which all Rotarix vaccine has been made. 7 In the FDA licensing process, Rotarix had to meet certain FDA standards, that included demonstrating the vaccine was not contaminated with, for example TSE (Transmissable Spongiform Encephalopathy or “mad cow” disease, a brain wasting disease) 8 or with cow viruses because bovine (cow) serum was used to prepare the original viral seed stock. Porcine trypsin, an enzyme in the pancreatic juice of a pig, was also used to make the viral seed stock. 9
RotaTeq is a genetically engineered vaccine containing five human-cow reassortment strains of rotavirus that were created at the Children’s Hospital of Pennsylvania (CHOP), where strains of rotavirus that give cows diarrhea were combined with strains of rotavirus that cause diarrhea in humans. The reassortment viruses were transported to Merck, where master seeds were produced using African Green Monkey kidney cell cultures. Fetal bovine (cow) serum and porcine trypsin was used to make the “seed” stock. 10 There are small amounts of bovine serum and cell culture media (monkey viral DNA) that remain in RotaTeq vaccine. 11 12

FDA Suggests Drug Companies Test for Vaccine “Purity”

In a February 2010 FDA document, Guidance for Industry: Characterization and Qualification of Cell Substrates and Other Biological Materials Used in the Production of Viral Vaccines for Infectious Disease Indications, the FDA lists “non-binding recommendations” for drug companies making vaccines using animal and human cell substrates. 13 Under the heading “Testing for Adventitious Agents,” the FDA states “assurance that products are free of adventitious agents is a critical component of meeting the [FDA regulations] requirement for purity.” Under the heading “Testing for Residual Cellular DNA,” the FDA states, “Residual DNA might be a risk to your final product because of oncogenic (cancer causing) and/or infectivity potential.”

Déjà Vu: Monkey Viruses Contaminated Polio Vaccines

Contamination of vaccines with animal viruses is not new. In the 20th century, polio vaccines given to tens of millions of people worldwide were contaminated with simian virus 40 (SV40), which was found to cause cancer in animals and is associated with human brain, bone and lung cancers but the government denies SV40 is causing those cancers in humans. 14 15 16 17

There has been controversy about the link between experimental polio vaccines tested in Africa in the 1950’s and 1960’s that were contaminated with a monkey virus, simian immunodeficiency virus (SIV). Soon after the polio vaccine trials in Africa, the human immunodeficiency virus (HIV) emerged. 18 Many questions about the failure of researchers and technology to screen for monkey viruses in those vaccines remain to this day.

Using Cancer Cells to Produce Vaccines?

Vaccine manufacturers have long used cell material that comes from the bodies of mammals, including humans, monkeys, cows, pigs, dogs and rodents, as well as birds or insects to make vaccines now in use or to make experimental vaccines. There is an inherent risk of contamination with viruses and other microbes (or DNA from those microbes) that can escape detection during the vaccine development, testing, licensing, manufacturing and oversight process. 19 There has even been discussion among vaccine manufacturers and the FDA in the last decade about using neoplastic (cancer) cell substrates to make vaccines but the risk of contamination with cancer cell DNA is a big risk. 20

New Influenza Vaccines: Is Contamination Possible?

In searching for ways to make seasonal influenza vaccines in a faster, easier and less expensive way than relying on chicken eggs for production, drug companies have experimented with using dog kidney cells and human fetal retinal cells. However, these cell lines have been documented to cause tumors in animals, especially dog kidney cells (MDCK). 21

At a November 19, 2009 meeting of the FDA Vaccines & Related Biological Products Advisory Committee, a vaccine manufacturer asked for permission to use insect (caterpillar) cells to make pandemic influenza shots. But insect cells can be contaminated with insect viruses that are hard to detect. The FDA Committee, on that day, voted “no.” 22

Unanswered Questions about Rotarix Contamination

There are lots of questions about how the manufacturer of Rotarix vaccine and the FDA both missed the pig virus DNA contaminating the original seed stock and all doses of Rotarix vaccine given to more than one million American children in the past few years. 23

Is there state-of-the-art technology that is being used by private laboratories but not by drug companies and the FDA?

Why did the independent team of scientists, who found the contamination, notify the vaccine manufacturer first rather than also immediately reporting their finding directly to the FDA?

What about the significance of finding bird viral DNA in measles vaccine and the monkey viral DNA in RotaTeq vaccine?

Wake Up Call for Industry & Government

The contamination of Rotarix vaccine is only the latest in a long history of vaccine contamination issues that require a re-examination of the way vaccines are made and tested. It is a wake-up call for industry and government

The big question people are asking is: why do drug companies making vaccines continue to use cells from animals, birds and insects that can be contaminated with viruses and other adventitious agents that are hard to detect?

The FDA was right to suspend use of Rotarix vaccine until they know more. Hopefully, this serious vaccine production and testing issue will be addressed immediately by vaccine manufacturers. If not, the next pandemic or serious health problem affecting large populations may be one that comes out of a vaccine lab.

REFERENCES:


1 National Vaccine Information Center (NVIC). Rotarix and Rotarix Vaccine.
http://www.nvic.org/Vaccines-and-Diseases/Rotavirus.aspx

2 FDA. News Release: Components of Extraneous Virus Detected in Rotarix Vaccine: No Known Safety Risk, FDA Recommends Clinicians Temporarily Suspend Use of Vaccine As Agency Learns More. March 22, 2010. http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm205625.htm

4 FDA. Detection of DNA from PCV1 in Rotarix. March 22, 2010. http://www.fda.gov/BiologicsBloodVaccines/Vaccines/ApprovedProducts/ucm205545.htm

5 See Reference #3 above.

6 FDA. See Reference #4 above.

7 FDA. Memorandum: Review of Vero Cell Banks used for Vaccine Production and Adventitious Agent Testing of Virus Seeds and Vaccine Human Rotavirus Vaccine (HRV) – Rotarix. April 1, 2008. http://www.fda.gov/BiologicsBloodVaccines/Vaccines/ApprovedProducts/ucm134138.htm

8 FDA. Summary Basis for FDA Regulatory Action – Rotarix. June 4, 2007. http://www.fda.gov/BiologicsBloodVaccines/Vaccines/ApprovedProducts/ucm133543.htm

9 European Medicines Control Agency. Evaluation of Medicines for Human Use: Rotarix Vaccine (Control of Materials (Reagants) page 4). 2006. http://www.ema.europa.eu/humandocs/PDFs/EPAR/rotarix/063906en6.pdf

10 European Medicines Control Agency. Evaluation of Medicines for Human Use: RotaTeq Vaccine (Active Substance (Manufacture). Pages 3-10. http://www.ema.europa.eu/humandocs/PDFs/EPAR/Rotateq/066906en6.pdf

11 FDA. Memorandum: Clinical Review of New Biologics License Application – RotaTeq (Description of the Product). Page 12. April 6, 2005. http://www.fda.gov/downloads/BiologicsBloodVaccines/Vaccines/ApprovedProducts/UCM142304.pdf

12 European Medicines Control Agency. See Reference #10 above. Page 6.

13 FDA. Guidance for Industry: Characterization and Qualification of Cell Substrates and Other Biological Materials Used in the Production of Viral Vaccines for Infectious Disease Indications. February 2010. http://www.fda.gov/downloads/BiologicsBloodVaccines/
GuidanceComplianceRegulatoryInformation/Guidances/Vaccines/UCM202439.pdf

14 Bookchin D, Schumacher J. The Virus and the Vaccine: The True Story of a Cancer-Causing Monkey Virus, Contaminated Polio Vaccine, and the Millions of Americans Exposed. St. Martin’s Press: New York. 2004. http://www.nvic.org/resource-center/books.aspx

15 Fisher BL. Congressional Testimony: The SV-40 Virus: Has Tainted Polio Vaccine Caused an Increase in Cancer? U.S. House Government Reform Committee. September 10, 2003. http://www.nvic.org/vaccines-and-diseases/Polio-SV40/BLFTestimonySV40.aspx

16 U.S. Congress. Congressional Hearing: Preventing Another SV40 Tragedy: Are Today’s Vaccine Safety Protocols Effective? U.S. House Government Reform Committee. November 13, 2003. http://frwebgate.access.gpo.gov/cgi-bin/getdoc.cgi?dbname=108_house_hearings&docid=f:92772.wais

17 Carlsen W. Rogue Virus in the Vaccine: Early Polio Vaccine Harbored Virus Now Feared to Cause Cancer in Humans. San Francisco Chronicle. July 15, 2001. http://www.sfgate.com/cgi-bin/article.cgi?file=/chronicle/archive/2001/07/15/MN193825.DTL

18 Carlsen W. Quest for the Origin of AIDS: Controversial Book Spurs Search for How the Worldwide Scourge of HIV Began. San Francisco Chronicle. January 14, 2001. http://www.sfgate.com/cgi-bin/article.cgi?file=/chronicle/archive/2001/01/14/MN140641.DTL

19 See Reference # 13 above.

20 FDA. Designer Cells as Substrates for the Manufacture of Viral Vaccines. 2001. http://www.fda.gov/OHRMS/DOCKETS/AC/01/briefing/3750b1_01.pdf

21 WHO. Initiative for Vaccine Research: Use of Cell Lines for the Production of Influenza Virus Vaccines: the Appraisal of Technical, Manufacturing and Regulatory Considerations. April 10, 2007.
http://www.who.int/vaccine_research/diseases/influenza/WHO_Flu_Cell_Substrate_Version3.pdf

22 FDA. Vaccines & Related Biological Products Advisory Committee. Safety & Effectiveness of Purified Recombinant Influenza Hemagglutinin Vaccine for the Prevention of Influenza (FluBlok). November 19, 2009. http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/
BloodVaccinesandOtherBiologics/VaccinesandRelatedBiologicalProductsAdvisoryCommittee/UCM197912.pdf

23 FDA. Background on Rotavirus Vaccines: How Many Doses of Rotarix Have Been Sold? March 22, 2010. http://www.fda.gov/BiologicsBloodVaccines/Vaccines/ApprovedProducts/ucm205543.htm


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Harris Coulter Was a Brave Visionary

by Barbara Loe Fisher

Sometimes, when you least expect it, you get news that makes you stop and think about someone you care about, who taught you something important. Recently I learned of the death of my co-author of the ground breaking book he and I wrote together and published in 1985: DPT: A Shot in the Dark.

Harris was only 77 years old when he died on October 28, 2009. He had struggled for 12 years with the debilitating effects of a brain hemorrhage he suffered at age 65 while he was in Paris. It was a paralyzing stroke that would end his remarkable career.

When I last spoke with Harris two months before his death, I had called him to check out a rumor that he had passed away. With characteristic wit and clarity, he laughed and quoted Mark Twain, saying “The rumors of my death are greatly exaggerated.”

Although the stroke had left him paralyzed, it did not rob him of his personality or ability to recall details from the past. And every single time we had spoken in the decade following his stroke, Harris wanted to talk about the journey of discovery we took together when we wrote what would become the first major, well documented book examining the scientific and clinical evidence that vaccination can and does cause brain inflammation, permanent brain damage and death for some. Among his many accomplishments, Harris considered our collaboration on that book - which was published exactly a quarter century ago - to be his greatest one.

I remember the first time I spoke with Harris. It was the fall of 1982. I had been researching the side effects of DPT vaccine and interviewing parents of vaccine injured children for eight months following the broadcast of the emmy award winning television documentary DPT: Vaccine Roulette earlier that year. Along with other parents in the Washington, D.C. area, whose children had been brain injured or died after DPT shots, I helped establish the non-profit educational organization known today as the National Vaccine Information Center.

Back then, I was a young mother in my early 30’s with a four year old DPT vaccine injured son and I was pregnant with my second child. Working as a freelance writer out of my home, I was gathering information for a book I wanted to write for parents about preventing DPT vaccine injury and death.

Back then, nobody had personal computers or cell phones, and the internet was just a dream. If you wanted to write a book, especially on a medical topic, you did your research the old fashioned way – by going to the Library of Medicine or corresponding with authors of studies. So, when Harris called me up looking for information for an article he was writing on vaccination, it didn’t take me long to realize that this was a really smart man who knew his way around a medical library.

But I didn’t know he was a visionary medical historian, who had chronicled the history of homeopathy and the epic philosophical battles waged during the history of medicine from ancient times to the present in what would become his formidable four volume series of books called “Divided Legacy.” When I talked with him on the telephone that day in 1982, I didn’t know that Harris had graduated from Yale in Russian studies; that he was fluent in Russian, Hungarian, French, German, Spanish and Latin and was a well known oral and written translater for the State Department and at the United Nations; or that he earned a masters degree in political science and a PhD in philosophy from Columbia University.

I just knew, after talking with him for about 30 minutes, that he was an independent thinker and fearless about critiquing bad science and flawed assumptions made by the medical profession. Fearless was something I already figured out was a pre-requisite for writing a book that would challenge long standing assumptions parents and doctors have had about the safety of mass vaccination policies.

So I asked him if he wanted to co-author a book with me. He said “yes” and arrived on my doorstep a few days later to outline our game plan. And from that day on, Harris Coulter and I embarked on a truth seeking journey about vaccine safety that would take us into a labyrinth, where the history of science, medicine, politics, economics, law, and ethics intersected.

During this unlikely collaboration between a mother and writer, who loves Shakespeare, and a father and medical historian, who loved nothing better than to expose the arrogance and ignorance of medical orthodoxy, he and I managed to write a book that would be the first to inform the public about the link between vaccination and brain inflammation that can lead to chronic illness, including learning disabilities; attention deficit and ADHD; medication resistant seizure disorders; autism, asthma, severe allergies, mental retardation and other manifestations of brain and immune dysfunction given convenient labels by the medical profession.

As I interviewed hundreds of parents of DPT vaccine injured children and Harris set up camp at the Library of Medicine, my mantra became “brain damage by any other name is still brain damage” and his mantra was “when in doubt, don’t leave it out,” of our historic challenge to industry, government and organized medicine for refusing to acknowledge vaccine risks and failing to improve the crude and toxic whole cell DPT vaccine.

When he and I came under attack by medical writers at the New York Times and Wall Street Journal after our book was first published by Harcourt Brace Jovanovich in 1985, Harris told me “don’t listen to them, Barbara. They know we are right and that is why they are attacking us.”

At an NIH meeting in 1988, when an auditorium full of scientists and health officials informed American parents that they were not going to license the safer and more effective DTaP vaccine that Japan had been using since 1981 until after they conducted eight more years of studies, Harris called out from the back of the auditorium “I’ve got cases of DPT: A Shot in the Dark back here for anyone who wants a copy.” Within an hour, every last book had been sold.

Harris never let his critics get him down. In fact, he celebrated the negative attention. He took a stalwart “Damn the torpedoes, full steam ahead!” attitude that echoed the advice my Dad gave me when I was young, which was: “If everybody likes you, then you probably aren’t doing anything important.”

Harris Coulter was a very special man. He was a brilliant historian, a remarkable visionary, a brave seeker and defender of the truth. He left his mark on the history of medicine and he changed my life. When I think of Harris, I remember a quote from Shakespeare’s play, Julius Caeser: “A coward dies a thousand deaths, a hero only once.”

Thank you, Harris, for being a hero for me and many others, who will always remember and miss you.

To receive a copy of A Shot in the Dark, become a donor supporter of the National Vaccine Information Center.


Harris Coulter, PhD October 8, 1932 - October 28, 2009

Harris Livermore Coulter, PhD, born in Baltimore MD on October 8, 1932 died on October 28, 2009 in Washington, D.C. after a long illness following a stroke in 1997.

The co-author of DPT: A Shot in the Dark in 1985 and author of Vaccination, Social Violence and Criminality: A Medical Assault on the American Brain in 1990, Dr. Coulter attended Milton Academy and graduated Yale University with a BA degree in Russian Studies. He earned a masters degree in political science and a doctorate in philosophy from Columbia University. He worked for the State Department and United Nations as an English/Russian interpreter and authored nine books on medical history.

He is survived by his sons, Andrew and Alex and by his daughters, Elizabeth and Marian.


Curriculum Vitae for Harris Coulter, PhD

June 1997 - Paris, France - Meetings with Dr. Jacques Benveniste on writing a history of his discovery of the "memory of water."

January 1997 - Lectured to homeopathic and other physicians specializing in alternative medicine in Berlin, Germany, Moscow, Russia and London, UK.

October 1996 - Lectured on cancer immunotherapy at the 51st Annual Conference of the World Homeopathic League (LIGA) in Capri, Italy and at the Third Dead Sea Conference on Potentiating Health and the Crisis of the Immune System in Zichron Yaacov, Israel. Guest Lecturer at the Convention of the Romanian Homoeopathic Society in Bucharest, Romania.

November 1995 - Lectured on medical and homeopathic history at Centre de Techniques Homeopathiques, Montreal, Canada (lectures published by the Centre under the title: Histoire de l'Homeopathie).

October 1995 - Lectured at 50th Congress of International Homeopathic Medical League (Oaxaca, Mexico) on dangers of childhood vaccinations.

September 1995 - Lectured at Conference on Genetic Causes of Violence (University of Maryland) on childhood vaccinations as a cause of violent behavior.

February 1995 - Spoke at 49th Congress of International Homeopathic Medical League (New Delhi, India), and to homeopathic physicians in Calcutta, India, on 'Vitalism and the Future of Medicine.'

December 1994 - Published: Divided Legacy. Volume IV. Twentieth Century Medicine: The Bacteriological Era.

April 1994 - Lectured at 150th Anniversary meeting of The American Institute of Homeopathy on: 'American Medicine, Where We've Been and Where We're Going.'

September-October 1993 - Ad Hoc Advisory Panel of the Office of Alternative Medicine. Worked with Office of Alternative Medicine supervising trial of shark cartilage in treatment of cancer.

May 1993 - Honorary member of the 'Syndicat Professionel des Homeopathes du Quebec'.

September 1992 - Pharmacological and Biological Treatments Panel Member on the NIH's Workshop on Alternative Medicine. The report published was Alternative Medicine: Expanding Medical Horizons, also known as the Chantilly Report.

September 1992 - Lectured at the Fifth International Conference on Neuro-Developmental Issues (Cherry Hill, New Jersey) on the post-encephalitic syndrome.

March 1992 - Lectured at Fourth European Conference on Neuro-Developmental Delay (Chester, England) on the post-encephalitic syndrome.

1990-96 - Advisory board of the Cancer Chronicles.

1990-91 - Board of Directors, International Foundation for Homeopathy.

1990 - Published The Controlled Clinical Trial: An Analysis

1990 – Published Vaccination, Social Violence, and Criminality: The Medical Assault on the American Brain.

May 1990 - Lectured at 45th Congress of International Homeopathic Medical League, Barcelona, Spain, on dangers of childhood vaccinations. Awarded the Centenary Gold Medal of the Academica Medico-Homeopatica de Barcelona.

1990-96 - Lectured in France, Norway, Brazil, and Russia on homeopathic, vaccination, and medical history issues.

1988 - Testified before House of Representatives, Committee on Appropriations, Subcommittee on Labor: on AIDS and Syphilis: the Hidden Link.

1987 - Published AIDS and Syphilis: the Hidden Link.

1985 - Published with Barbara Loe Fisher: DPT: A Shot in the Dark.

1985 - Awarded the Hahnemann Prize of the Belgian Faculty of Homeopathy.

1983-89 - Editorial board of the Journal of the American Institute of Homeopathy.

1987 - Lectured at 42nd Congress of the International Homeopathic Medical League, Arlington, Virginia: 'DPT Vaccine. The DPT Shot and Public Health.'

1983-96 - Honorary member of the American Institute of Homeopathy.

1981-82 - Vice President of the American Center for Homeopathy and editor of The American Homeopath; Secretary of the Homeopathic Pharmacopoeia Convention. Organized homeopathic summer programs in Melbourne, Florida, and Scottsdale, Arizona.

1981 - Published Homeopathic Science and Modern Medicine.

1980 - Lectured to 35th Congress of the International Homeopathic Medical League, Acapulco, Mexico: 'Hahnemannian Homeopathy and Revisionism.'

1977 - Published: Divided Legacy. Volume II. The Origins of Modern Western Medicine: J. B. Van Helmont to Claude Bernard.

1975 - Published Divided Legacy. Volume I. The Patterns Emerge: Hippocrates to Paracelsus.
May-June 1974 - 39th Congress of the International Homoeopathic Medical League, Washington, D.C. George Vithoulkas and Harris L. Coulter honored as writers on homeopathy.

1973 - Published Divided Legacy. Volume III. The Conflict Between homeopathy and the American Medical Association, and Homeopathic Influences in Nineteenth-Century Allopathic Therapeutics.

1972 - Published: Homeopathic Medicine.

July 1969 - Awarded degree of Doctor of Philosophy (Ph.D.) by Columbia University, NY; dissertation title: Political and Social Aspects of Nineteenth-Century Medicine in the United States: The Formation of the American Medical Association and its Struggle with the Homeopathic and Eclectic Physicians.

1965-75 - Director of Publications, American Foundation for Homeopathy.

1961 - Awarded M.A. by Columbia University, NY (Political Science).

1954 - Awarded B.A. by Yale University, CT (Russian Area Studies).

Languages: German, French, Spanish, Latin, Russian, Hungarian, Serbo-Croatian.
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