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Why vaccines for emergencies should not be mandated/ Nass testimony

Posted Apr 14 2011 8:14pm
UPDATE:  Both LD 941 and LD 694 made it out of committee and will be voted on by the entire legislature.--Meryl

Meryl Nass, MD
Mount Desert Island Hospital
Bar Harbor, Maine 04609

April 9, 2011

Dear HHS Committee Member (Maine Legislature):
I am writing with regard to LD 941 and the subject of mandatory vaccinations. I am an internistwho has practiced in Maine since 1997.  I am knowledgeable about medical emergenciesdesignated by the governor, or by the Secretary of DHHS, and about vaccine safety.  I havetestified to the US Congress on bioterrorism and emergency vaccinations 7 times (3 oral, 4written). I treat vaccine-injured patients. I have also submitted testimony for LD 694.
Governor Baldacci declared an emergency during the 2009 swine flu pandemic. We nowknow that swine flu caused fewer deaths than ordinary seasonal flu epidemics.[1] The swine flupandemic caused little disruption in Maine, but an emergency declaration was made nonetheless.It could have, but did not, lead to mandatory vaccinations in Maine. We now know swine fluvaccinations were unnecessary for all but high-risk patients.
Vaccines are an important component of public health. But they should not be seen as a panaceain times of emergencies and disasters.
Vaccines are drugs, and like drugs, their benefits and risks cannot be wholly understood untilthey have been given to large numbers of people. The numbers required, and the duration oftime that must elapse, preclude adequate data coming from clinical trials.[2] In other words, untilmillions of people have received a vaccine, we do not know what its risks are.
The recent swine flu pandemic is instructive. New vaccines were hurriedly developed [3] andgiven to hundreds of millions of people worldwide. Over a year later, we have learned thatthe CSL vaccine used in Australia caused one seizure for every 100-200 children vaccinated,approximately ten times the expected rate of this adverse reaction. In Finland, the GSK Pandemrixswine flu vaccine led to 20 times the expected rate of narcolepsy in children. Twelve othercountries are investigating narcolepsy increases.
In the US and worldwide, pandemic vaccine manufacturers (and those involved in planning andadministering vaccinations) were given a waiver of liability for adverse reactions caused by thesevaccines. [4] Injured recipients have no ability to sue for damages, and await (possible) payments from the federal government. [5]
Swine flu vaccinations in 2009 were voluntary. However, since the pandemic appeared, swineflu and/or seasonal flu vaccinations became required (outside Maine) for many hospital andclinic employees, by their employers and by NY State. Vaccinations were ordered by NY’sappointed public health chief. An injunction was then issued against mandatory vaccinations [6]and NY’s Governor Patterson reversed the vaccine mandate.
Surprisingly, no published data exist to show that vaccinating staff at health care facilities protects patients, either by reducing hospitalizations or by reducing deaths due to flu.
Smallpox vaccine caused so many serious side effects that the 2003 plan to vaccinate millionsof Americans stopped after only 40,000 civilian vaccinations. A National Academy of Sciencepanel found little evidence to support the program’s benefit. [7] Anthrax vaccinations have causedserious chronic illnesses in 1-2% of military personnel vaccinated, according to the GovernmentAccountability Office (GAO). [8] A little-known fact is that FDA can issue (and has issued)Emergency Use Authorizations, [9] allowing unlicensed drugs and vaccines (that may not haveundergone human testing) to be used.
To sum up:
1. When an emergency strikes, the need to “Do Something” is very strong, and emergencyvaccinations may be a solution chosen by government officials.2. Emergencies can be declared in Maine with very little basis, yet may result in forcedvaccinations.3. Vaccines developed for emergencies are more likely than standard vaccines to havesafety problems, due to rapid development, insufficient testing and the liability waivergiven to their manufacturers.4. Because vaccines for emergencies are given to large numbers of people in a short periodof time, their serious side effects probably won’t be known until after millions have beenvaccinated.5. Vaccines likely to be mandated will be those with unknown safety problems anduncertain effectiveness, or those that are already known to be dangerous.6. Vaccine mandates are increasing. They are controversial and lead to legal actions.7. Maine citizens should be protected from vaccine mandates issued by those who maybe unaware of their potential ramifications. Maine citizens deserve to choose what isinjected into their bodies. Please support this bill.
Sincerely yours,
Meryl Nass, M.D.


 1.  http://www.europarl.europa.eu/en/pressroom/content/20110308IPR15032/html/Swine-flu-learning-from-past-mistakes
 “H1N1 had caused 2,900 deaths in Europe by April 2010, which compares with 40,000 for seasonal flu in a moderate year.” [European Parliament]
 2.  http://www.who.int/csr/disease/swineflu/notes/h1n1_safety_vaccines_20090805/en/index.html
 “Special safety issues will inevitably arise during a pandemic when vaccine is administered on a massive scale. For example, adverse events too rare to show up even in a large clinical trial may become apparent when very large numbers of people receive a pandemic vaccine.” [WHO]
 3.  http://www.who.int/csr/disease/swineflu/notes/h1n1_safety_vaccines_20090805/en/index.html
 “Specific regulatory procedures have been devised to expedite the approval of pandemic vaccines. In the USA, for example, fewer data are required when the manufacturer already has a licensed influenza vaccine and intends to use the same manufacturing process for its pandemic vaccine.” [WHO]
 4.  http://www.pandemicflu.gov/professional/federal/vaccineliability.html [US Government]
 5.  http://www.pandemicflu.gov/professional/federal/vaccineliability.html [US Government]
 “The U.S. Department of Health and Human Services is establishing a Countermeasures Injury Compensation Program for H1N1 vaccines. Under this program, compensation may be available to eligible individuals who suffer serious physical injuries or death from administration of the vaccine under the declarations. Eligibility, and the types of injuries for which compensation may be available, will be defined by regulations. Compensation can include medical benefits, lost wages and death benefits.”
 6.  http://cityroom.blogs.nytimes.com/2009/10/16/judge-halts-mandatory-flu-vaccines-for-health-care-workers/?partner=rss&emc=rss [NY Times]
 7.  http://www.nap.edu/catalog.php?record_id=11240#toc [National Academy of Sciences]
 8.  http://www.gao.gov/new.items/d07787r.pdf [GAO]
 9.  http://www.fda.gov/RegulatoryInformation/Guidances/ucm125127.htm#categories [FDA]
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