[NVIC] Medical Doctors Violating Informed Consent Rights

[Guest guest]

National Vaccine Information Center Newsletter

e-NEWS

October 13, 2006

Foolish Vaccine Exemptions

4 senior physicians arrested for illegal experiments on elderly patients

US weighs emergency research without consent

" The pendulum has swung too far toward letting parents opt out. States need

to work harder at educating parents about the value of vaccination and

should get tougher in granting exemptions. " - Editorial, New York Times,

October 13, 2006

" It is of paramount importance that the United States government stands on

solid ethical and scientific ground before sanctioning experimental

research on its citizens without their consent, " the Iowa Republican

[senator Grassley] said in a letter to HHS Secretary Mike Leavitt. "

- Richwine, Reuters, October 11, 2006

" Four senior doctors at Kaplan Hospital in Rehovot and the Hartzfeld

Geriatric Hospital in Gedera were arrested yesterday on suspicion of

carrying out hundreds of illegal experiments on elderly patients without

their consent. The doctors - including Shmuel Levy, deputy director of

Kaplan-Hartzfeld, who was responsible for Hartzfeld; Nadya Kagansky; and

Alona Smirnov - are suspected of wrongful death through negligence, abuse

of helpless victims, aggravated assault, fraud, violation of a statutory

obligation and interference in an investigation. " - Lis & Ran

Reznik, Haaretz, Israel, October 10, 2206

Barbara Loe Fisher Commentary:

When medical interventions are forced on individuals without their

voluntary, informed consent, the human right to self determination and

individual autonomy is violated. Medical doctors and scientists exploiting

others for ideological reasons or personal and professional gain, using the

immoral utilitarian rationale that some may be harmed for the theoretical

benefit of many others, often require the consent of government officials

to facilitate that exploitation. Therefore, it is extremely important for

citizens to be vigilant and oppose all attempts by scientists, medical

doctors and public health officials to erode individual rights when it

comes to voluntary, informed health care decision making. Those who choose

to become scientists or medical doctors are not exempt from the temptations

which plaque humans, including the desire for prestige, honor, money and

power. Over time, the public health will not be benefited by an erosion of

individual freedoms which serve as a needed check and balance on

accumulaton of too much power by any one person or elite group within

society. An examination of the role that scientists and medical doctors,

especially those in public health, have played in human rights abuses in

history is very instructive and serves as a warning to those who would give

up the right to informed consent to medical interventions, such as

vaccination. The book " Nazi Doctors and the Nuremberg Code " by s

and Grodin reinforces the need for restrictions on the power that

society takes away from individuals and gives to medical doctors and

scientists - for any reason.

Foolish Vaccine Exemptions

The NewYork Times

Editorial

Published: October 12, 2006

http://www.ncpa.org/sub/dpd/index.php?page=article & Article_ID=13254

States that make it easy for parents to opt out of vaccinating their

children are suffering increased disease rates as a consequence, according

to an article published yesterday in The Journal of the American Medical

Association. The findings should be a warning to all parents and state

officials who think they can let their guards down on immunizations that

are needed to protect both the children and the communities in which they

live.

We saw what happened in Indiana last year when measles broke out among

children who had been schooled at home and thus avoided the compulsory

shots required of those who attend public schools. At least 34 people

became ill, of whom three were hospitalized, one with life-threatening

complications. Their families had succumbed to fears that the vaccine was

dangerous, forgetting that the disease itself was the real danger.

Now the new article by researchers at s Hopkins University, the

University of Florida and the Centers for Disease Control and Prevention

has taken a broad look at the rates of whooping cough in the 48 states that

allow people to be exempted from required shots for various nonmedical

reasons. All 48 of the states allow exemptions based on religious

objections, but 19 of them also allow exemptions based on philosophical or

other personal beliefs. Some states make it easy for parents to claim an

exemption by simply signing a prewritten statement on the school

immunization form. Others make it harder by requiring a signature from a

local health official, a personally written letter, notarization or annual

renewal.

Sadly, states that readily grant exemptions or allow personal belief

exemptions have about 50 percent higher rates of whooping cough, or

pertussis, compared with stricter states, after adjusting for demographics.

This is disturbing given that pertussis, which can cause severe illness and

death in young children, has been on the rise in recent decades.

The pendulum has swung too far toward letting parents opt out. States need

to work harder at educating parents about the value of vaccination and

should get tougher in granting exemptions.

US weighs emergency research without consent

Reuters

October 11, 2006

By Richwine

http://www.sciam.com/article.cfm?chanID=sa003 & articleID=7078971350BCEFBC6EC2

779C9B84A9BD

ROCKVILLE, Md., Oct 11 (Reuters) - Emergency medical research without

patient consent should be allowed in some cases where quick treatment is

critical and getting permission is difficult or impossible, researchers on

Wednesday told U.S. officials who are reconsidering the rules for such

studies.

The issue gained new attention this year when the Food and Drug

Administration was criticized for letting Northfield Laboratories Inc.

(NFLD.O: Quote, Profile, Research) study an experimental blood substitute,

PolyHeme, in trauma patients without getting their permission first.

Several emergency medicine and trauma specialists, who dominated the

speakers at an FDA public meeting on the issue, said waiving the consent

requirement was needed in some cases.

" We as a society have a moral and ethical obligation to find more effective

and safe therapies. It's not possible to conduct life-saving research in

the emergency setting without an exemption to informed consent, " said Dr.

ph Ornato, who spoke on behalf of the National Institutes of Health

Resuscitation Outcomes Consortium.

The FDA is revisiting a 1996 regulation that allows consent to be waived in

certain cases. Generally patients need to have a life-threatening condition

that requires immediate attention and be unconscious or otherwise unable to

give permission.

The agency has received 56 requests for emergency research without consent

over the past decade, said FDA bioethicist Dr. Sara Goldkind. The FDA

approved 21 of them, and about 2,700 patients had been treated in the

studies as of April, she said.

The trials are supposed to include safeguards such as oversight by

independent review boards and consultation with the local community.

Available treatments must be deemed " unproven and unsatisfactory. "

Criticism of the Polyheme study has focused in part on whether the

alternative - blood transfusions - is unproven and unsatisfactory. Senate

Finance Committee Chairman Grassley on Wednesday asked the U.S.

health secretary to convene an advisory committee to consider that question.

Grassley said internal correspondence showed there was strong disagreement

within the Department of Health and Human Services about whether that was

the case.

" It is of paramount importance that the United States government stands on

solid ethical and scientific ground before sanctioning experimental

research on its citizens without their consent, " the Iowa Republican said

in a letter to HHS Secretary Mike Leavitt.

Northfield has said its study met FDA requirements and took patient safety

into account.

ISRAEL

4 senior physicians arrested for illegal experiments on elderly patients

Haaretz

October 10, 2006

By Lis and Ran Reznick

http://www.medgadget.com/archives/2006/10/4_senior_physic.html

Four senior doctors at Kaplan Hospital in Rehovot and the Hartzfeld

Geriatric Hospital in Gedera were arrested yesterday on suspicion of

carrying out hundreds of illegal experiments on elderly patients without

their consent.

The doctors - including Shmuel Levy, deputy director of Kaplan-Hartzfeld,

who was responsible for Hartzfeld; Nadya Kagansky; and Alona Smirnov - are

suspected of wrongful death through negligence, abuse of helpless victims,

aggravated assault, fraud, violation of a statutory obligation and

interference in an investigation.

The Tel Aviv Magistrate's Court yesterday extended the reprimand for Levy

and Kagansky by three days and put Smirnov under house arrest for five

days. A fourth suspect was released. Police searched the homes of all four

suspects and confiscated documents.

A report by a Health Ministry inquiry committee, whose findings were

revealed in Haaretz, found that illegal and unethical experiments were

conducted over several years, in a systematic manner, on thousands of

elderly patients. At least one patient is suspected of having died as a

direct result of one of the experiments. In addition, 12 patients died

either during or shortly after one of the experiments, but the incident was

not reported to the Health Ministry or investigated, in contravention of

the law.

Haaretz reported the charges in March 2005, two months before the state

comptroller released a scathing report of its own on the matter.

At least four doctors at Hartzfeld and Kaplan became known as geriatrics

experts on the basis of research allegedly based on illegal experiments.

Some doctors submitted articles to medical journals in Israel and abroad on

the basis of the experiments, which appear to have provided a foundation

for their professional and academic advancement.

The Health Ministry report found that doctors violated the law by

experimenting on patients who either did not provide consent or were not

mentally capable of providing consent. Some of the experiments did not have

any medical or scientific benefit, and some were conducted even though

senior doctors warned that they were illegal and unethical.

The report sharply criticized the hospitals' Helsinki committee for human

experimentation, saying that by approving inappropriate experiments, it

failed in its mandate to protect the public interest. The report also

blasted the hospital administration for failing to do anything about the

flawed procedures, despite receiving complaints and information about what

was going on in the hospitals.

Committees to control experimentation with human subjects were established

in hospitals in accordance with Health Ministry protocol implementing the

Helsinki Accord signed in 1964, which came in response to human experiments

conducted by the Germans in World War II. The comptroller found that

experiments approved by the Helsinki committee included genetic experiments

and research studies involving drugs not yet certified for use in Western

nations.

The comptroller's report features a laundry list of grave oversights and

continuous negligence on the part of the Health Ministry and public

hospital management regarding their supervisory role in the experiments.

NVIC E-News is a free service of the National Vaccine Information Center

and is supported through

<http://rs6.net/tn.jsp?t=87oudzbab.0.8elt9wbab.oblmlwbab.8914 & ts=S0209 & p=htt

ps%3A%2F%2Fwww.nvic.org%2Fmakingcashdonations.htm>membership donations.

NVIC is funded through the financial support of its members and does not

receive any government subsidies. Barbara Loe Fisher, President and Co-

founder.

Learn more about vaccines, diseases and how to protect your informed

consent rights at

<http://rs6.net/tn.jsp?t=87oudzbab.0.jcsy6wbab.oblmlwbab.8914 & ts=S0209 & p=htt

p%3A%2F%2Fwww.nvic.org%2F>www.nvic.org

NVIC

NVIC

National Vaccine Information Center

email: <mailto:news@...>news@...

phone: 703-938-dpt3

web:

<http://rs6.net/tn.jsp?t=87oudzbab.0.hmy4rwbab.oblmlwbab.8914 & ts=S0209 & p=htt

p%3A%2F%2Fwww.nvic.org>http://www.nvic.org

National Vaccine Information Center | 204 Mill St. | Suite B1 | Vienna | VA

| 22180

--------------------------------------------------------

Sheri Nakken, R.N., MA, Hahnemannian Homeopath

Vaccination Information & Choice Network, Nevada City CA & Wales UK

Vaccines - http://www.nccn.net/~wwithin/vaccine.htm