December 10, 2019
Testimony on MA Bills H.4095 and S.2359
December 3, 2019 • accompanying-documents-meryl-nass-md-testimony
Dear Senator Comerford, Representative Mahoney and the members of the Joint Committee on Public Health:
My name is Dr. Meryl Nass. I tried to be with you today to oppose H.3999 and aspects of the Community Immunity Act, Bills H.4095/S.2359, but all flights and buses were cancelled.
- I am an internal medicine physician in Ellsworth, Maine.
- I graduated from MIT and the University of Mississippi School of Medicine.
- I have testified to 6 Congressional committees, primarily on anthrax vaccine and Gulf War Syndrome, and the permanent injuries suffered by service-members who received military vaccines of poor quality.
- I have also spoken on the issue of vaccine exemptions to legislative committees in Maine, Vermont and New Brunswick. I saw firsthand how pharmaceutical industry lobbyists patrolled legislative halls, provided talking points, schooled public servants, and helped constrain the terms of this debate.
The pharmaceutical industry has undertaken a very ambitious campaign to legislate away vaccine exemptions in the United States and Canada. France, Italy and Germany have rescinded vaccine exemptions too, suggesting the campaign is worldwide.
The pharmaceutical industry exerts enormous influence on government regulators,1 their advisors,2 3 professional medical organizations,4 key opinion leaders5 and medical journals6 as well as the mass media and lawmakers.7 This is not debatable8–there are dozens of studies proving it. Merck has a list on its website of over 1,000 candidates for state and federal offices to whom they gave money in 2018.9 Merck also lists payments to hundreds of professional medical organizations, patient organizations, Pharma lobbying groups, and scores of Republican and Democratic PACs and committees.10 Julie Gerberding, the former CDC Director, became president of Merck Vaccines as soon as she was allowed.11 The last FDA Commissioner just left for Pfizer.12 The revolving door is slamming Americans.
Pharmaceutical manufacturers spent $6.4 billion on direct-to-consumer advertising in the US in 2016, and $29.9 billion total on medical marketing.13 Pharma money purchases the allegiance of our major media corporations, in addition to buying advertising. And it’s tax deductible.
The pharmaceutical industry does not play by the rules you and I must follow. Instead, the industry makes it a rule to break the law, regularly paying civil and criminal penalties in the billions of dollars. Big Pharma CEOs have not been sent to jail in decades, and paying settlements for their illegal behaviors has become simply the cost of doing business.
This is an industry that has thrived by taking big risks–even when manufacturers knew in advance that their products killed. Merck paid out $4.85 billion to settle 27,000 Vioxx injury claims, after it was estimated the drug caused 38,000 deaths from heart attacks.14 But annual sales had topped $2.5 billion/year, likely leading them to at least break even.
According to Public Citizen:
“From 1991 through 2015, a total of 373 settlements were reached between the federal and state governments and pharmaceutical manufacturers, for a total of $35.7 billion.”
Pharma’s latest risky strategy is trying to rid the world of vaccine exemptions, to prevent vaccine opt-outs–before a new crop of vaccines, with inadequate safety and efficacy testing,15 and for which they will have no liability once placed on the childhood schedule, are approved.
I doubt this is what you have been told. But the industry moves deliberately, one step at a time. First it got the 21st Century Cures Act passed, in December 2016. This Act:
- directed the FDA to more readily license vaccines, using “real world evidence” in place of controlled clinical trials.
- directed CDC to immediately place each newly licensed vaccine before its advisory committee, to be considered for inclusion in the childhood vaccine schedule. Inclusion in the schedule is the criterion needed to get a vaccine its waiver of manufacturer liability.
- directed that all vaccines recommended for use in pregnant women (currently influenza and Tdap, but many more are in the pipeline) were granted liability waivers.
“…pre-licensing clinical trials of vaccines do not usually include pregnant and lactating women. Reports available also provide limited post-licensing data, as once again, pregnant women are usually not included in clinical trials. This in turn has limited the ability to make evidence-based decisions and provide optimal guidance on the use of vaccines in this population.”
Despite this, pregnant women are being told to receive both flu and Tdap vaccines during every pregnancy. Don’t you see something sick in this?
The year-long media blitz over measles didn’t only usher in bills to remove vaccine exemptions. It was also a bonanza for sales. Merck, which makes the only measles vaccines in the US, saw sales of its MMRV vaccine increase 58% in 2019.20
It has been claimed that vaccines are, by nature, extremely safe. Yet vaccines are usually injected, bypassing all the body’s natural barriers. Even minute contamination or inadequate microbial inactivation can maim or kill. Contaminated batches of vaccine do occur.21 Usually contaminated lots are discarded, but in the case of anthrax, polio and other vaccines, millions of doses were used.22 23
Vaccines have caused many autoimmune disorders, from Guillain-Barre syndrome to narcolepsy. (Both were side effects of swine flu vaccines used in the 2009 pandemic.)
Vaccines appear safe because the immediate side effects are usually mild and temporary. Serious vaccine side effects often take weeks or months to surface, and by then it is difficult to know what caused them. Only when vaccinated individuals have rates of illness 10 times higher than the unvaccinated, is the side effect likely to be linked to the vaccine.
A 2009 European swine flu vaccine (GSK’s Pandemrix) caused over 1300 cases of narcolepsy, mostly in adolescents.24 This vaccine was linked to narcolepsy only because approximately 15 times the usual number of narcolepsy cases suddenly appeared. Countries that bought the swine flu vaccines, through WHO, were required to waive manufacturer liability as a condition of purchase. Litigation by those injured continues to be active in the UK, where both the manufacturer and the UK government deny any responsibility for injuries.
✓ It should be apparent, but isn’t: government waivers of vaccine liability discourage manufacturers from ensuring that the vaccines they sell are as safe and effective as possible.
✓ The removal of vaccine exemptions, combined with liability waivers for vaccine side effects and recently loosened standards for licensing vaccines, create a highly toxic mix.
2. There is no crisis (no epidemic of deaths or disabilities) from infectious diseases caused by lack of vaccinations, either in Massachusetts or the United States.
- According to the CDC, vaccination rates in the Commonwealth are consistently better than the US average. Over 96% of Massachusetts children have been vaccinated with each of the MMR, DTaP and Polio vaccines before kindergarten.25 Only pertussis regularly circulates, due to failure of the vaccine. While measles made major headlines in the US all year, the last time a child died from measles in the US was 2003. This 13 year-old male had had a bone marrow transplant 3 months earlier. He was not exposed to anyone with measles, and may have become ill from vaccine strain measles present in his body. The US averages several hundred measles cases annually, mostly due to travelers who enter the US while incubating the disease.
- Massachusetts had 1 measles case this year.
- There may be a million cases of pertussis in the US yearly, because the vaccine works poorly and wears off quickly. Only a fraction of cases are diagnosed and counted. Studies show that most cases of pertussis occur in fully vaccinated people.26
- Therefore, you cannot achieve herd immunity for pertussis with current vaccines. The pertussis bacteria regularly circulate in the community, as they would even with a 100% vaccination rate.
- There are about 10 pertussis deaths in the US yearly, mostly in infants too young to be vaccinated. Vaccinating 100% rather than 96.4% of Massachusetts children for pertussis would not prevent pertussis deaths.
- There are approximately 2500 mumps cases in the US yearly, but according to CDC no recent mumps deaths.27 Two doses of vaccine are only about 86% effective.28 Most mumps cases occur in vaccinated students.
- There are approximately 10 rubella cases yearly in the US, but since 2012 all cases were infected outside the country.29
- There have been no wild polio cases originating in the US since 1979. However, cases of polio due to polio vaccine viruses (or their mutations) would occasionally occur. This led to the US switching to killed polio vaccines (Salk, not Sabin type) after 1999.
- There is approximately 1 diphtheria case every few years in the US.
- Varicella zoster causes chickenpox and shingles. Once infected (or vaccinated with live vaccine) the virus permanently resides in your body. Thus, it cannot be eliminated from the population. The vaccine is about 85% effective. Many countries, including the UK, do not recommend it.
- Most varicella cases occur in vaccinated children.
- However, there are highly effective treatments for varicella. While varicella infections are common in immunocompromised children, usually due to virus already in their bodies, there is only about 1 child death per year from varicella in the US.
- Tetanus does not spread from person to person. It is caused by Clostridium tetani bacterial spores in the outdoor environment. There are about 30 cases per year in the US.
- Hepatitis B is a viral infection that can only be spread through blood or sexual contact. Rates of infection in childhood are extremely low in the US. There is one new case reported per 100,000 Americans/year.30
- All pregnant women are screened for hepatitis B. The few who are positive are treated, and their newborns treated prophylactically.
- Neither tetanus nor hepatitis B can be spread by casual contact. Neither can spread from child to child during ordinary school activities.
- Diphtheria–extremely rare
- Tetanus–non-communicable
- Pertussis–regularly circulates despite vaccinations
- Measles–rare, death extraordinarily rare31
- Mumps–several thousand cases/year in US, no recent deaths
- Rubella–no cases of US origin in recent years
- Varicella–can circulate despite vaccination, kills 1 highly compromised child/year in US
- Hepatitis B–non-communicable in school
- Polio–no US cases for decades
Were the Legislature to remove most vaccine exemptions, it would probably not prevent a single death from infection, and only a modicum of illness. However, significant vaccine injuries would almost certainly occur in currently exempted children.
3. Proportionality, the Supreme Court and Vaccine Mandates
The seminal Supreme Court case regarding a state or municipality’s authority to institute a mandatory vaccination program is Jacobson v Massachusetts. While this 1905 Supreme Court decision upheld the right of Cambridge, MA to impose smallpox vaccination on adults over 21 during a smallpox epidemic, according to the Congressional Research Service, the Court “did acknowledge limits to the state’s power to protect the public health, and set forth a reasonableness test for public health measures:
[I]t might be that an acknowledged power of a local community to protect itself against an epidemic threatening the safety of all, might be exercised in particular circumstances and in reference to particular persons in such an arbitrary, unreasonable manner, or might go so far beyond what was reasonably required for the safety of the public, as to authorize or compel the courts to interfere for the protection of such persons.”32
In the bills we are discussing today, the penalty for refusing vaccinations is insuperably harsh. The value of an education to a family is incalculable, but might be valued in the hundreds of thousands of dollars.33
In US law, the doctrine of proportionality means that the punishment should fit the crime.34 In the Jacobson case, the punishment for remaining unvaccinated was about $150, not the $150,000 or more cost of an education. As for the bills under discussion today, don’t they, as the Supreme Court noted, “go so far beyond what was reasonably required for the safety of the public…” — suggesting the courts should interfere to protect the unvaccinated? If versions of these bills pass, won’t the Commonwealth become entangled in litigation over them for years to come?
4. Parallel with the effort to end non-medical vaccine exemptions is a major federal/state effort to restrict medical exemptions.
- The CDC recently revised its advice on vaccine exemptions, significantly reducing the list of conditions for which vaccinations might be dangerous.35 36
- The CDC also issued revised “Vaccine Information Statements” in August and October 2019,37 which must be given to parents before their child is vaccinated, according to federal law.
- The new Vaccine Information Statements removed the statement, “Some people should not get this vaccine”; removed many reasons not to vaccinate; and removed information on adverse vaccine reactions.
- I am providing you with the old and new polio Vaccine Information Statements so you can see this for yourself
- The intention is to both restrict and federalize the granting of medical exemptions for vaccines.
- Proposed laws would have state health department employees issue medical exemptions for patients they have never seen, using suddenly appearing CDC guidelines which lack supporting evidence — usurping the role of physicians in determining eligibility to be safely vaccinated.
Informed consent includes the right to refuse and a lack of coercion. Isn’t withholding an education coercive?
Without any discussion of its moral or ethical dimensions by media, medical societies or government officials, the requirement for informed consent for medical procedures, including vaccinations, vanishes in the blink of an eye when patients are not allowed the right to refuse.
6. Must the issue of childhood vaccine exemptions be politicized?
- Both political parties enjoy Pharma’s largesse. In other states, party leadership has corralled Members and Senators in order to push through legislation to rescind and tighten vaccine exemptions, despite constituent opposition. Will this happen in Massachusetts?
- Please weigh carefully the risks to society against the risks to vulnerable children whose parents have decided not to fully vaccinate them.
- Please consider the damage such a law would make to our right to bodily autonomy and to informed consent.
- Eliminating the right to refuse vaccinations places us on a very slippery slope.
- Please do not allow yourselves to do the dirty work of Pharma, unscrupulously couched as an effort to protect vulnerable citizens.
- If passed, these bills will harm far more vulnerable citizens than they help.
Respectfully,
Meryl Nass, M.D.
Endnotes
1 https://www.sciencemag.org/news/2009/12/mercks-new-vaccine-honcho-former-cdc-chief-gerberding
2 https://www.sciencemag.org/news/2018/07/hidden-conflicts-pharma-payments-fda-advisers-after-drug-approvals-spark-ethical
3 https://www.nytimes.com/2009/12/18/health/policy/18cdc.html
4 http://politicalcorrection.org/factcheck/200906110008
5 https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4500705/
6 https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2964336/
7 https://khn.org/news/drugmakers-funnel-millions-to-lawmakers-a-few-dozen-get-100000-plus/
8 https://www.nap.edu/read/12598/chapter/1
9 https://s3.amazonaws.com/msd19-assets/wp-content/uploads/2019/09/13122047/US.pdf
10 https://www.msdresponsibility.com/reporting/transparency-disclosures/
11 https://www.mrknewsroom.com/news-release/corporate-news/merck-announces-appointment-dr-julie-gerberding-executive- vice-president “Gerberding joined Merck as president of Merck Vaccines in January 2010. Since then, Merck’s vaccines are reaching more people than ever, and Merck became the global leader in the vaccine market based on sales. In addition, the Sanofi Pasteur MSD joint venture in Europe, Merck’s European vaccine business for which Gerberding is the Board co-chair, has improved in both population reach and financial performance. She also helped lead the successful launch in India of the Merck Wellcome Trust non-profit joint venture for vaccine development”
12 https://thehill.com/blogs/congress-blog/politics/452654-for-big-pharma-the-revolving-door-keeps-spinning
13 https://jamanetwork.com/journals/jama/fullarticle/2720029
14 https://bangordailynews.com/2019/03/28/opinion/contributors/why-americans-dont-trust-vaccine-makers/
15 https://ccl.yale.edu/sites/default/files/files/Avorn%20Kesselheim%20-%20NEJM%20-%2021st%20Century%20Cures%20Act.pdf The 21st Century Cures Act — Will It Take Us Back in Time? Jerry Avorn and Aaron Kesselheim. NEJM 6/3/2015.
16 http://www.cidrap.umn.edu/news-perspective/2017/09/study-signals-association-between-flu-vaccine-miscarriage
17 https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6501798/
18 https://anthraxvaccine.blogspot.com/2009/04/2008-naval-environmental-health-center_6897.html
19 https://www.who.int/vaccine_safety/publications/safety_pregnancy_nov2014.pdf
20 https://investors.merck.com/news/press-release-details/2019/Merck-Announces-Second-Quarter-2019-Financial- Results/default.aspx
21 https://www.ncbi.nlm.nih.gov/pmc/articles/PMC523142/ Owen Dyer. BMJ. 2004 Oct 16; 329(7471): 876. Factory’s loss of license halves supply of flu vaccine to US.
22 https://www.congress.gov/congressional-report/106th-congress/house-report/556/1
23 https://www.cdc.gov/vaccinesafety/concerns/concerns-history.html
24 https://science.sciencemag.org/content/349/6243/17.summary
25 2017-2018 Kindergarten Vaccination and Effective Exemption Rates. CDC
26 https://www.cdc.gov/mmwr/volumes/67/rr/pdfs/rr6702a1-H.pdf
27 https://www.cdc.gov/mumps/hcp.html
28 https://www.ncbi.nlm.nih.gov/pubmed/24252695
29 https://www.cdc.gov/rubella/about/in-the-us.html
30 “Selected nationally notifiable disease rates and number of new cases: United States, 2016”
31 https://www.massafp.org/latest-news/measles-in-massachusetts-2019-summary-to-date-and-new-measles-resources/trainings
32 https://fas.org/sgp/crs/misc/RS21414.pdf Mandatory Vaccinations: Precedent and Current Laws. Congressional Research Service. Jared P. Cole Legislative Attorney Kathleen S. Swendiman Legislative Attorney. May 21, 2014
33 http://profiles.doe.mass.edu/statereport/ppx.aspx
34 https://en.wikipedia.org/wiki/Proportionality_(law)
35 https://www.cdc.gov/vaccines/hcp/acip-recs/general-recs/contraindications.pdf#page=5
36 https://www.cdc.gov/vaccines/hcp/acip-recs/general-recs/contraindications.html
37 https://www.cdc.gov/vaccines/hcp/vis/what-is-new.html#vis-10-30-19
No comments:
Post a Comment