Monday, September 2, 2019

Why are legislatures imposing vaccine mandates now? My testimony to the New Brunswick, Canada legislature on August 27, 2019

... I am a veteran of the vaccine war in the US, and today I feel compelled to speak about what I saw in that war.  Legislators were forced to change their votes to revoke vaccine exemptions and rescind the historic right to consent to medical procedures. The vaccine war is a dirty war, in which platitudes about protecting the most vulnerable are invoked by the same pharmaceutical companies that paid $2.7 billion in criminal penalties in the US between 2012 and 2015. The vaccine industry generates enormous profits (estimated 10-40%), benefits from a government-guaranteed market, and receives almost total liability protection.  No other industry can rival these benefits.  And this industry's rapacious desire to grow and guarantee its Canadian market is the reason we are here today.

Let me add context to this discussion by noting that in 2014, the NY Times said it cost $2200 to fully vaccinate one child.  At that price, it cost $163 billion dollars to fully vaccinate every US child.

May I apologize at the outset for using mostly US data?  I provide Canadian and New Brunswick information when available.

1.  Pharma's Pilgrimage to New Brunswick

Since March 2019, representatives of the three largest vaccine manufacturers in North America:  GSK, Merck and Sanofi, have made their way to New Brunswick to meet with ministers, public servants and lawmakers. This is not coincidental. Pharmaceutical companies are colluding to expand on legislative victories gained in the US. Using a media storm over measles, censorship of numerous vaccine-related websites, new support for mandates from professional organizations that have benefitted from industry largesse, and deals with Democratic party leaders, the right to religious and philosophic vaccine exemptions has been voted away by legislatures in California, New York and Maine.  In the recent case of New York, the Speaker of the NY Assembly was caught on videotape directing a committee member to change his vote in order for the mandate legislation to move forward.

This was not an idle pilgrimage to one of Canada's smallest provinces. For Pharma it is the gateway to all of Canada. 

The vaccine industry in 2019 is at a crossroads.

On the one hand, the vaccine business is booming.  Several vaccines have been newly licensed, a robust industry-FDA revolving door has been established, and the children of North America are receiving more vaccines than ever before. Merck, for example, reported increased sales in the second quarter of 2019 for Gardasil HPV vaccine of 46% (to over $3 billion US annually) compared to last year, and increased sales of 58% for its MMRV (measles, mumps, rubella and varicella) vaccine.  These are Merck's 3d and 4th biggest sellers.  This year's US measles outbreak (about 1200 cases) and media-driven fears of contagion contributed to vaccine uptake.

On the other hand, the industry does not want to shoulder the considerable expense of developing, testing and licensing new vaccines--over 100 of which are in development--without a government guarantee that they will be purchased.

Vaccines are being developed for everything from acne to cancers.

Vaccine mandates guarantee a vaccine market, now and in the future. Mandates put in place today will enforce the uptake of vaccines on the currently required list, plus other vaccines yet to be added. 

Industry Challenges

In 2019, the vaccine industry faces threatening legal challenges:  

a)  An expert witness for the US Department of Justice (DOJ) in the 2007 omnibus vaccine autism case (affecting the outcome for thousands of cases of alleged vaccine injury leading to autism), neurology professor Andrew Zimmerman, MD recently filed an affidavit stating that his expert testimony was altered by DOJ lawyers--that he told them that in certain cases, autism can be a consequence of vaccination.  The case for which Prof. Zimmerman's testimony was allegedly changed resulted in a denial of benefits for thousands of families with autistic children.  It also led to a negative conclusion in the US Vaccine Court, for all future cases, that autism might be a consequence of vaccination.  Potentially thousands of denied cases will need to be re-litigated.

b)  Gardasil, a Merck vaccine used to prevent HPV infections and putatively cancer, is facing lawsuits around the world for neurologic injuries and deaths.  The Japanese government rescinded its recommendation for Gardasil due to the widespread side effects reported.  Recall that Merck, the manufacturer of Gardasil, MMR, varicella and other vaccines, hid the lethal side effects of Vioxx for nearly five years, paying out $4.85 billion US dollars to settle 27,000 injury claims. FDA scientist David Graham, MD estimated that 39,000 to 61,000 excess deaths occurred due to Vioxx.

c)  Danish physician and anthropologist Peter Aaby, and the group he leads, have been studying vaccines in Africa for 40 years.  After completing hundreds of vaccine studies, they have concluded that the DPT vaccine increases infant mortality, by 100% or more, in African infants.  His group notes, "All studies of the introduction of DTP have found increased overall mortality."  You may be interested in his eye-opening talk at a recent Symposium on Scientific Freedom in Copenhagen.

The Best Defense is a Good Offense

Facing these challenges, in 2019 the vaccine industry seized its opportunity from a prolonged US measles outbreak. A flawless PR campaign conducted for the industry helped ram through legislation for enforced vaccine mandates in the US, and now the industry is repeating the strategy in Canada.

In the wake of the 2015 Disneyland measles epidemic, coupled with millions of dollars in lobbying fees and direct donations to legislators, California's legislators voted to end non-medical vaccine exemptions. And this month, they passed a bill that restricted the granting of medical exemptions. 

One of the unforeseen consequences of California's vaccine mandate was the wholesale withdrawal of children from public schools.  California's Department of Public Health reported that the number of homeschooled, unvaccinated kindergartners soared from 2,000 to nearly 7,000 between 2016 and 2018, following California's vaccine mandate. 

Is New Brunswick, Canada prepared for a significant reduction in the number of children who attend public school?

2.  You have been assured that "Vaccines are safe and effective." 

It has a reassuring ring, but conveys nothing.  In fact, each vaccine is very different from every other.  Generally, we know something (but not enough) about the benefit, but only a little about the harms of different vaccines.  According to the Institute of Medicine, "The process of anticipating, detecting, and quantifying the risks of rare adverse events following immunization presents an enormous challenge."  Like drugs, each is appropriately used when the benefit outweighs the risk. Because vaccines are given to healthy people to prevent disease, they should be even safer than drugs.

The initial effectiveness of the different childhood vaccines ranges from about 40% to 93%.  Immunity then wanes over time.

There is a big problem at the heart of vaccine safety assessment:  adverse event information is cloaked in secrecy, withheld from physicians and the public by public health agencies.  Undesirable results are massaged or falsified until they appear acceptable.  Because this is hard to believe, I will give you 3 important examples of CDC's data manipulation.

    1.   Thomas Verstraeten was a young physician on a CDC fellowship who in 1999 studied the statistical relationship between cumulative amounts of thimerosal (mercury) infants received from vaccines and neurological illnesses. His results--including that children exposed to the highest levels of mercury from vaccines after birth had 7 times the level of autism as children not exposed--were so disturbing that CDC convened a private meeting of vaccine experts to discuss and manage them.  No reporters or members of the public were permitted, but a copy of the meeting transcript was leaked.  (I have provided you with an unpublished abstract obtained by FOIA showing some of Verstraeten's data before it was massaged to remove the effect of mercury.  His published 2003 paper says, "No consistent significant associations were found between thimerosal (mercury) containing vaccines and neurodevelopmental outcomes."  I also gave you a letter from physician Congressman Bill Weldon to Dr. Julie Gerberding, director of the CDC about this data manipulation.  The issue is unresolved.  Merck was later found to have misled the public about when it removed thimerosal from infant vaccines.

2.     Dr. William Thompson admitted that his group of CDC scientists was directed to destroy data in their study that linked early MMR vaccination in black males to increased rates of autism. The group met in a conference room, and put all data showing this effect into a garbage can. Thompson secretly retained a copy, and made it available to Congressman Bill Posey. The published paper denied any autism connection. Congressman Posey has called for an investigation, but none has occurred. The movie Vaxxed is about this matter.

3.    Poul Thorson was a physician, CDC employee and later CDC contractor who both manipulated Danish data to remove the adverse effects of thimerosal (50% mercury), and stole funds from the CDC.  Thorson is currently on the Department of Health and Human Services' list of fugitives from justice.

Despite strong evidence of scientific misconduct in these 3 CDC cases, the papers published in top medical journals with these manipulated data have never been retracted from the medical literature.  Instead, they provide foundational support for the safety of the MMR vaccine and for the safety of mercury in vaccines.  The fraudulent papers pollute the medical literature, making it impossible to discern the true adverse effects of vaccines.

Vaccine safety science

It is very difficult to link an adverse reaction to a vaccination unless it occurs soon afterward.  In general, late adverse reactions are only identified as caused by vaccines if they occur many times more often than expected.

The National Academy of Sciences was chartered by Congress in 1863 to provide expert advice to government.  Congress requested the National Academy of Sciences' Institute of Medicine to conduct a series of vaccine safety studies to inform vaccine policy.

In 2011, the US National Academy of Sciences' Institute of Medicine examined the evidence for vaccine causality for 8 vaccines and 158 possible adverse effect-vaccine combinations.  In the vast majority (85%) of cases, in the language used by the Academy, "the evidence was inadequate to accept or reject a causal relationship."  The science remains unsettled.

President Harvey Fineberg of the Institute of Medicine/National Academy of Medicine wrote, in the US National Vaccine Plan 2013 Annual Report: (pages 44-45)

"While few health problems are clearly associated with vaccines and some putative associations can be rejected based on evidence, in the majority of cases evidence was inadequate to accept or to reject a causal relationship... Confidence in vaccine safety requires more than surveillance and reporting in real time. In light of the paucity of strong conclusions about possible vaccine side effects, continued and selective investment in epidemiologic and other investigations into the risks of immunization will be necessary... About the best one can do is to estimate, based on the evidence, the probability that the frequency of an adverse event is less than a specified, low level. This may be enough for the physician who weighs the public health and personal health benefit against a very low risk, but not enough to satisfy a wary parent.

Continued, candid, and open communication is also an essential ingredient to a successful vaccine safety regime. This means more than the experts explaining the benefits and risks to parents and families. It means listening carefully to the anxieties and doubts, staying true to the strength of evidence without exaggeration or misrepresentation, and reporting fully and fairly on scientifically sound investigations into possible adverse events."

By 2019 the winds had changed at the Academy of Medicine.  A new President, Victor Dzau, himself and some of his advisory panelists tainted with undisclosed financial conflicts of interest, dismissed the concerns of his predecessor about lack of vaccine safety evidence, signing a brief whitewash:  "Our work has validated that the science is clear--vaccines are extremely safe."

We now know that the National Academies of Sciences' Institute of Medicine/National Academy of Medicine has received millions of dollars from drug companies that have interest in its work. Merckhas given between $5 and $10 million dollars; AstraZeneca, Bristol Myers Squibb, GlaxoSmithKline, Johnson and Johnson, Eli Lilly, Novartis, Pfizer, Sanofi-Aventis, and United Therapeutics have each given between $1 and $5 million. 

Understanding of the adverse effects due to single vaccines, combinations of vaccines, or the number of vaccines remains murky.

Canadian physicians examined the health of babies after their 12 and 18 month vaccinations.  They found an excess emergency room visit for one in every 168 babies vaccinated at 12 months with the MMR vaccine, occurring between one and two weeks later.  They concluded, "There are significantly elevated risks of primarily emergency room visits approximately one to two weeks following 12 and 18 month vaccination. Future studies should examine whether these events could be predicted or prevented."

1300 cases of narcolepsy were caused by the 2009 swine flu Pandemrix vaccine.   This particular side effect was able to be linked to the vaccine because millions of people were vaccinated simultaneously, the narcolepsy that developed was severe and required intense medical attention, the rate of narcolepsy was 10-16 times higher than expected, and vaccine oversight had been increased to evaluate new pandemic vaccines.  Canadians received a virtually identical vaccine (Arepanrix) but it was manufactured in a different facility, and by chance alone the Canadian version did not cause narcolepsy.

3.  Is New Brunswick undergoing a crisis of vaccine-preventable disease?

The answer is no.  And if there was a crisis, Bill 39 would not wait to go into effect until 2021.

Pertussis.  Canada averages one death from whooping cough per year. There are many cases, most going undiagnosed and unreported.  Some estimate a million US cases of whooping cough yearly.  This is because vaccine protection wanes rapidly. More than 80% of whooping cough cases occurred in fully vaccinated children in a recent study.

Diphtheria.  There is one case of diphtheria every two years in the US. 

Polio.  There is no polio in Canada.  The last wild (natural) polio case in Canada occurred in 1977.  There have been 3 reported cases in the US since 2005, all from vaccine strains of polio.  Worldwide, there are more new polio cases due to vaccine strains that became virulent than there are due to wild polio viruses.  Last year, vaccine-derived viruses paralyzed 105 children worldwide; the wild virus just 33.

Vaccines containing live viruses, such as the MMR, Varicella, and oral polio can infect, harm and very rarely kill the recipient, especially if the child has an unknown immune deficiency.  There are extensive warnings on the MMR vaccine information sheet which I have provided you, about who should not receive the vaccine. 

UPDATE:  On August 15, 2019 CDC changed most of its Vaccine Information Statements (which must be provided to parents before vaccines are given, according to the 1986 National Childhood Vaccine Injury Act) eliminating many of the warnings associated with each vaccine.  The MMR Vaccine Information Statement no longer says, "Some People Should Not Get this Vaccine." The purpose for the changes appears to be to restrict the indications for medical exemptions, and create a federal standard to be applied by states that pass legislation like California's.

Although it is not usually acknowledged, vaccination is not a one-size-fits-all procedure.  According to the Mayo Clinic, "Human antibody response to measles vaccine is highly variable in the population."  Females have more adverse reactions than males.  Gender and race influence the response.  As does heredity.  

Families that have experienced a serious vaccine reaction are right to be concerned about additional vaccinations and the safety of sibling vaccination, for their family is probably at higher than average risk of a reaction.  What goes unreported is that many unvaccinated children are themselves a vulnerable group, and should not be vaccinated.  However, there are no existing standards for doctors to use to determine the risk of vaccination to most children.  So medical exemptions have been improvised, and are generally hard to come by.

4.  Herd Immunity is undermined by high rates of vaccine failures

The Quebec measles epidemic I mentioned demonstrates that even a vaccination rate over 95% didn't prevent a large measles outbreak. Herd immunity rates are based on statistical modelling, and are only projections.  The reason that 50% of measles cases occurred in vaccinated children is primary or secondary vaccine failure.  Primary vaccine failure means the vaccine never produced immunity, while secondary failure means the immunity was lost over time.

For most vaccines, primary and secondary failures go unnoticed, because children are not being exposed to most of these infections.  The infections children do get exposed to are pertussis and influenza, and then vaccine failure is obvious--because most cases of pertussis and many of influenza occur in fully vaccinated children.

5.  Do unvaccinated children put immunocompromised children at risk?

The fact is that immunocompromised children are not dying from vaccine preventable diseases, and few are getting them, with the exceptions of influenza, pertussis and varicella--because vaccines for these 3 infections provide limited immunity.

Fewer than one American dies yearly from measles, mumps, rubella, polio, or diphtheria. On average, one Canadian dies from whooping cough (pertussis).  Ten Canadian children die from influenza.  One American child dies yearly from varicella (chickenpox).

You are looking at 11 child deaths per year in Canada.  Would vaccinating every child fully against whooping cough, varicella and influenza prevent these deaths? Remember, most whooping cough and varicella patients are fully vaccinated.  And while the immunity generated in young children from flu shots varies yearly, it is usually less than 50%. 

Herd immunity cannot be achieved for whooping cough or influenza because neither vaccine is adequate.  Pertussis vaccine immunity wanes so quickly that little protection is left after 3-4 years.  Transmission to others can occur before you realize you have influenza or pertussis. 
Even if 100% of Canadians were vaccinated, these diseases would continue to circulate within the vaccinated and the unvaccinated population.

Varicella cannot be eradicated both because the vaccine is not optimal (85% efficacy), waning occurs, and because the virus stays in your body permanently after vaccination or infection.  Most immunocompromised children who develop varicella infections do so from virus already resident in their bodies.  The claim that vaccine exemptions put immunocompromised children at risk was invented by PR firms, with no evidence behind it.  In fact, immunocompromised children are at more risk from the shedding of live viruses in vaccines by other children who were recently vaccinated.

6.  Sufficient population immunity appears to exist

While vaccination rates reported in New Brunswick are low, non-medical exemption rates are also low:  2%.  The likeliest explanation for lack of epidemics despite low recorded vaccination rates is inadequate recordkeeping.

In Maine, with similar demographics, vaccination rates for each of the required vaccines is about 95%. Exemption rates vary by vaccine.  Only 1% of US children receive no vaccines.  Up to 25% receive some, but not every available vaccine. 

7.  Should we be concerned about vaccine quality and origin?

Vaccines are biologics.  According to the FDA, "Most biologics are complex mixtures that are not easily identified or characterized."  Translation:  vaccines contain unknown substances, unknown even to the FDA and Public Health Agency of Canada.  This makes them challenging to regulate.  The FDA relies on vaccine manufacturers to provide accurate data about each step in the manufacturing process.  When a problem occurs during manufacturing, the FDA expects to be told and expects the manufacturer to recall affected lots of vaccine when necessary.  I have provided you information on 5 vaccine recalls or other issues in Canada since 2012.

The quality of manufactured drugs has been diminishing.  Over 80% of the drugs sold in the US are manufactured overseas, mostly in India and China.

The FDA usually redacts information about the locations where vaccine ingredients are manufactured. I am under the impression that at present, US vaccine products are made in Europe and North America.

However, the World Health Organization has a system for approving (or "prequalifying") vaccines made in underdeveloped countries for sale internationally--generally to other underdeveloped countries. 

Large multinational pharmaceutical companies, such as Sanofi, which has vaccine manufacturing facilities in both India and China, are manufacturing vaccines in underdeveloped nations.  China and India each have over 20 vaccine manufacturers.  It is probably only a matter of time before vaccines manufactured in countries known for inadequate government monitoring of pharmaceuticals are being used in Canada and the US. 

China experienced vaccine scandals in 2016 and in  2018:

"In July, China experienced its “worst public health crisis in years” as stated by South China Morning Post. Chinese vaccine maker Changsheng Biotechnology was found to have fabricated production and inspection records and to have arbitrarily changed process parameters and equipment during its production of freeze-dried human rabies vaccines. Furthermore, substandard diphtheria, pertussis, and tetanus (DPT) vaccines produced by Changsheng Biotechnology were administered to 215,184 Chinese children; and 400,520 substandard DPT vaccines produced by Wuhan Institute of Biological Products were sold in Hebei and Chongqing. On July 25, China's drug regulator launched an investigation into all vaccine producers across the country. Fifteen people from Changsheng Biotechnology, including the chairman, have been detained by Chinese authorities.
This latest vaccine scandal follows on from a series of fake and substandard food and drugs issues in China. As a result, many parents have lost faith in the vaccine system."

8.  Influenza, and the Fluad vaccine

Influenza is a disease that affects from 3-20% of the population yearly.  There were 6515 reported influenza deaths in the US in 2017, during the decade's worst outbreak.  CDC uses mathematical models to estimate influenza deaths, and the estimates include deaths from other heart and lung conditions, in people who had influenza. These estimates usually range from 30-50,000 deaths yearly, related to influenza.  Ninety percent of influenza deaths occur in those over age 65.  While most people over 65 receive annual flu vaccines in the US, this age group is less likely to develop immunity from the vaccine, compared to younger people.  Overall, flu vaccine effectiveness averages about 40%, according to the CDC. 

Each year, influenza vaccines are newly made to contain the dominant strains predicted for that season.  Because of the need to make different products each year, and make them rapidly available for each flu season, they are not tested to the same extent as other vaccines.  Clinical trials to test for safety are not required for yearly changes to flu vaccines.  Effectiveness trials are impossible to do prior to mass use.  Yearly flu vaccines are "grandfathered in," although they are checked for manufacturing defects.

In 2009, a GSK vaccine for pandemic flu caused 1300 cases of narcolepsy in Europe, mainly in adolescents and young adults. The European Medicines Agency failed to warn the public of this problem in a timely manner, leading to extended use of the problematic vaccine.

Possible reasons this occurred include the revolving door between vaccine manufacturers and regulators, the abbreviated safety testing of flu vaccines, and the liability protection given to manufacturers by governments.  The episode provides a warning that regulators' first priority may not always be the public's welfare.

The response of elders to flu vaccines is particularly poor.  Two strategies are being tried to enhance vaccine immunity in this age group.  The first involves using higher concentrations of antigens in the vaccines.  The second involves using novel adjuvants, which are substances that provide increased stimulation to the immune system.  Potentially this can improve immunity, but it might increase inflammation and autoimmune illnesses.

The Fluad vaccine is the only influenza vaccine in Canada and the US to contain a novel, immune-boosting adjuvant.  The adjuvant is called MF59 C1.  Originally produced by an Italian company, the adjuvant-containing flu vaccine was licensed for elders only, in Italy, in 1997.  It was not licensed in the US until 2015, for elders only, presumably because they were less likely to experience complications from the vaccine's additional immune stimulation.  I have been unable to find unbiased literature on the MF59 adjuvant or the Fluad vaccine, as all the research has been sponsored by its manufacturers (Sclavo, then Chiron, then Novartis, and now Sequirus).

Fluad was licensed for elders in Canada in 2011.  The government of Ontario's fact sheet on the vaccine makes clear that by 2016 it was still not known whether the excess immune stimulation it provides actually improved protection against the flu:

"How well does the Fluad® vaccine protect against influenza? Influenza vaccines may decrease hospitalizations and deaths among elderly individuals. According to the product monograph, Fluad® produces a higher immune response in elderly individuals when compared to other influenza vaccines without an adjuvant. The higher immune response may indicate that Fluad® works better than unadjuvanted vaccines, although this is not known for certain."

Nor is it known how safe the adjuvanted vaccine is.  It causes about 15% more local reactions than nonadjuvanted flu vaccines, but we don't know if it causes more serious, or later onset, adverse reactions.

FluWatch reports that 10 Canadian children died from flu last season, 8 aged 2-4 years old.  Nine children died the prior season.  Canada and the US recommend yearly flu vaccines for all eligible children aged over 6 months, while most of Europe does not recommend flu vaccine for healthy children.  Very young children generate a poor immune response to current influenza vaccines.  But few die from the disease. 

"Severe reactions are rare, but several of the reviewed studies were too small to detect clinically significant but rare adverse events. In particular, the safety information is limited for ATIV (adjuvanted trivalent influenza vaccines) in children with immunodeficiencies and other chronic illnesses...
There are insufficient data to assess whether ATIV (adjuvanted flu vaccine) is more effective than UTIV (unadjuvanted flu vaccine) or LAIV (live attenuated flu vaccine) in practice or to make an informed risk-benefit analysis."

The reviewers also noted that the European Medicines Agency (EMA) failed to license the vaccine for European children in 2012.  The EMA report found a number of problems with the single pivotal clinical trial of Fluad in children. Furthermore, the EMA report states, "The current application, although related to a product developed more than 15 years ago and authorized for use in the elderly, includes only one study addressing clinical vaccine efficacy." The report concludes, "The overall benefit-risk balance of Fluad Paediatric is negative."

Despite a) the lack of evidence of benefit, b) limited and c) unreliable safety information, d) rejection in Europe, and e) no evidence of any other country using it for children, f) let alone use in infants--in 2015 the Public Health Agency of Canada (PHAC) licensed Fluad pediatric for use in infants and babies aged 6 months to 2 years. 

It seems that Canada's youngest children have been selected to serve as the unwitting guinea pigs in a massive immune stimulation experiment of this novel-adjuvanted vaccine. 

What was the PHAC thinking?  Will Canadian children serve as experimental subjects, without their parents' knowledge, for additional vaccines selected for them by their public health agency? 

If vaccine exemptions are removed, how can they be protected from public health officials whose primary allegiance may not be to the public?

Public health officials use the mass media, medical professionals and the levers of government to encourage, exhort and cajole vaccinations.  Their conduct with the Fluad pediatric vaccine has shown they must not be given the power to compel.