Thursday, April 14, 2011

Why vaccines for emergencies should not be mandated/ Nass testimony

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 internist
who has practiced in Maine since 1997.  I am knowledgeable about medical emergencies
designated by the governor, or by the Secretary of DHHS, and about vaccine safety.  I have
testified to the US Congress on bioterrorism and emergency vaccinations 7 times (3 oral, 4
written). 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 now
know that swine flu caused fewer deaths than ordinary seasonal flu epidemics.[1] The swine flu
pandemic 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 flu
vaccinations were unnecessary for all but high-risk patients.

Vaccines are an important component of public health. But they should not be seen as a panacea
in times of emergencies and disasters.

Vaccines are drugs, and like drugs, their benefits and risks cannot be wholly understood until
they have been given to large numbers of people. The numbers required, and the duration of
time that must elapse, preclude adequate data coming from clinical trials.[2] In other words, until
millions 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] and
given to hundreds of millions of people worldwide. Over a year later, we have learned that
the 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 Pandemrix
swine flu vaccine led to 20 times the expected rate of narcolepsy in children. Twelve other
countries are investigating narcolepsy increases.

In the US and worldwide, pandemic vaccine manufacturers (and those involved in planning and
administering vaccinations) were given a waiver of liability for adverse reactions caused by these
vaccines. [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, swine
flu and/or seasonal flu vaccinations became required (outside Maine) for many hospital and
clinic employees, by their employers and by NY State. Vaccinations were ordered by NY’s
appointed 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 millions
of Americans stopped after only 40,000 civilian vaccinations. A National Academy of Science
panel found little evidence to support the program’s benefit. [7] Anthrax vaccinations have caused
serious chronic illnesses in 1-2% of military personnel vaccinated, according to the Government
Accountability 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 have
undergone human testing) to be used.

To sum up:

1. When an emergency strikes, the need to “Do Something” is very strong, and emergency
vaccinations may be a solution chosen by government officials.
2. Emergencies can be declared in Maine with very little basis, yet may result in forced
3. Vaccines developed for emergencies are more likely than standard vaccines to have
safety problems, due to rapid development, insufficient testing and the liability waiver
given to their manufacturers.
4. Because vaccines for emergencies are given to large numbers of people in a short period
of time, their serious side effects probably won’t be known until after millions have been
5. Vaccines likely to be mandated will be those with unknown safety problems and
uncertain 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 may
be unaware of their potential ramifications. Maine citizens deserve to choose what is
injected into their bodies. Please support this bill.

Sincerely yours,

Meryl Nass, M.D.


 “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]


 “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]


 “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. [US Government]

 5. [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. [NY Times]

 7. [National Academy of Sciences]

 8. [GAO]

 9. [FDA]

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