Monday, February 25, 2008

Two stories: Israeli Army cedes supervision of experiments on troops to the Ministry of Health; Israeli Air Force refused to give pilots anthrax shots,7340,L-3510509,00.html

Anthrax tests on troops to be conducted 'strictly under supervision'
Aviram Zino
Published: 02.24.08, 14:19 / Israel News

Following deliberation on petition protesting IDF medical experimentation on
soldiers, government announces Ministry of Health to supervise such

State officials reported to the High Court of Justice on Sunday that all
medical experiments on IDF soldiers are to be conducted only under strict
Health Ministry supervision and approval.

The State also reported to the court that the Health Ministry protocol for
human experimentation is to be implemented in the IDF as standard command.

This announcement was made following a petition brought to the court by the
human rights group Physicians for Human Rights, in conjunction with several
Israeli Defense Force soldiers, protesting medical experimentation on active
duty soldiers in the IDF.

Most prominently, petitioners protested the use of IDF soldiers in secret
experiments testing Anthrax vaccines, codenamed "Omer 2".

Physicians For Human Rights petitioned the High Court three months ago,
demanding that the IDF stop medical experimentation on soldiers, and
demanding the establishment of a commission of inquiry on this matter.

The IDF soldiers petitioning the court demanded that they be compensated for
pain and suffering endured during such experimentation.

The "Omer 2" Anthrax experiment that triggered this petition was held
between 1999 and 2006, and included some 800 IDF soldiers. The experiment
included a series of seven injections, some including an American Anthrax
vaccine, and others a recently developed Israeli formula.

Physicians for Human Right has maintained that the experiment failed to
uphold several ethical imperatives, including garnering the informed consent
of the soldiers in question, as well as following up on their general health
and well being at the conclusion of the experiment.

Israeli law regulates medical experiments on human beings through
sub-ordinances rather than through major legislation. In the IDF, the
legislative status of human medical experiments is even more uncorroborated.

Guinea Pigs
May 17, 2007

TV documentary reveals army tested experimental anthrax vaccines on elite
combat soldiers, but refused to treat them after adverse symptoms appeared
Ines Ehrlich

The IDF secretly used elite combat soldiers as "guinea pigs" for
experimental anthrax vaccines, according to an expose broadcast Wednesday
night by the "Uvda" (Fact) documentary program.

Presenter Ilana Dayan revealed how in 2000, the army decided to carry out
anthrax antibody experiments ahead of independent manufacture in Israel.

According to the report, hundreds of young recruits into Israel's elite
combat units were offered the opportunity to partake in a top secret
experiment codenamed "Omer 2". They were led to believe they were performing
a national service of the utmost importance to the state.

The soldiers were told that the antibody had been approved by the American
FDA as far back as 1970 and was used on thousands of American military
personnel. It was explained that the experiment they would undergo
constituted the final phase prior to anthrax vaccine production in Israel,
which would cater to a possible eventuality of a biological attack on
military or civilian populations.

In 2004, a US district judge ruled that the program of anthrax vaccine for
use on American military personnel be stopped due to a series of side
effects experienced by US troops.

Classified information

Since 2000, the soldiers selected for the experiment underwent a series of
seven inoculations, all carried out in top secret, without even the
knowledge of their commanding officers. When various symptoms such as
serious skin lesions and pneumonia began to appear, the soldiers did not
relate them to the experiment and sought standard medical treatment provided
by the military.

Once soldiers began to suspect that there may be a connection between the
vaccines and their symptoms, they contacted the secret unit in charge of the
program and presented their case. The symptoms, it was explained to them,
had absolutely nothing to do with the inoculations.

Regular army doctors were unable to diagnose the mystery ailments without
knowing what drugs had been administered in the shots.

Nir, a fictitious name, who was interviewed throughout the program, was the
only soldier to receive the full series of seven shots. When forced to
involve his parents after being hospitalized, he tried to find out what the
vaccine contained so that he could receive adequate treatment. He called the
unit begging to be told what he had been given - his request was refused
outright as it was "classified information".

'Citizens can sleep peacefully'

Professor Tzvi Bentowitz, head of the research institute researching
infectious diseases at Ben Gurion University, said, "The fact that this
matter was shrouded in secrecy here while it created such an outcry in the
US is astonishing, to say the least."

The secret medical unit had also contacted the air force in an attempt to
recruit pilots for the experiment, but air force officials refused, saying
that possible side effects could interfere with pilots' performance.

In response, the IDF's chief doctor, Brigadier-General Hezi Levy, told the
program that the citizens of the State of Israel will be happy to know that
Israel has developed its own anthrax vaccine and can now "sleep peacefully".

He added that from now on the army would take full responsibility for any
adverse symptoms experienced by the group of soldiers, and that it would
coordinate treatments with the relevant medical institutions.

Tuesday, February 19, 2008

Editorial: Israeli government admits anthrax experiment caused injuries and takes responsibility for their care

w w w . h a a r e t z . c o m

Last update - 02:23 20/02/2008

Experiments in full responsibility

By Haaretz Editorial

The state's response to a High Court of Justice petition by soldiers who were subjected to medical experiments with anti-anthrax drugs (the experiments known as Omer 2) is a small but important step on the road to regulating one of the most neglected human rights issues in Israel. Admittedly, the state - in contrast to the soldiers - claims that the experiments were performed in accordance with accepted medical and ethical norms, and that there was nothing wrong with them. Nevertheless, it also stated, "The defense establishment bears full responsibility for the care of the soldiers who were harmed."

This announcement includes two important points: an admission of the causal link between the experiments and the damage to the soldiers' health, and an assumption of full responsibility for the soldiers' care and treatment.

The state thereby demonstrated a different approach than the one that has hitherto characterized the Defense Ministry, the chief of staff, the army's chief medical officer and the health minister. All had previously tried to deny any connection between the experiments and their results, as well as to evade any responsibility for the soldiers suffering to this day.

As part of the Omer 2 experiments, some 800 soldiers doing their compulsory service were injected with a vaccination against anthrax, a disease that had been defined as one of the great dangers facing Israel's citizens. The soldiers who were chosen, all from elite units, accepted at face value the establishment's promises that they would suffer no side effects other than mild discomfort, and that the injection had been successfully tested in the United States. At the insistence of those conducting the experiment, the soldiers maintained strict secrecy and did not even inform their commanders.

This secrecy was maintained even years later, when some of them developed serious symptoms: pneumonia, breathing problems, digestive tract inflammations, severe coughs, severe migraines, recurrent sores and other problems. Despite the army's promises of close and continuous medical monitoring, each of them was forced to deal with these problems on his own.

Only in 2007, when some of the injured soldiers discovered that they were not alone in the war and began comparing their medical problems, was the story of the secret experiment finally revealed in the press, and a group was formed to go to the bodies responsible - this time in an organized fashion. The soldiers had a simple and reasonable demand: that the system recognize them as a distinct group and take responsibility for the harm done to them, and that it give them their medical files so that they could obtain appropriate treatment.

When their repeated applications met only with repeated evasions, the group, numbering 34 soldiers, petitioned the High Court. As noted, the state's response to this petition bodes well. And no less important is its response to another petition, by Physicians for Human Rights, which asked the court to ban medical experiments on Israel Defense Forces personnel unless the issue is regulated through legislation. The state responded by undertaking to abide by certain interim restrictions until the necessary legislation is passed.

This response, which does not evade a fundamental discussion of the question of experiments on human beings in general, and on IDF soldiers as a "captive audience" in particular, arouses hope that the defense establishment will finally grasp the importance of human rights, and that the suffering caused to the petitioners will serve as a warning to defense and medical personnel.

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Israeli government agrees to hand over data on anthrax vaccine tests

w w w . h a a r e t z . c o m

Last update - 02:14 19/02/2008

Soldiers sue government over harmful anthrax tests

The state informed the High Court of Justice yesterday that it assumes full responsibility for the treatment of soldiers harmed during the testing of drugs countering the anthrax bacteria. The state was responding to a petition brought against senior officials last month by 34 soldiers who had been part of a biological weapons research project code named Omer-2.

In its response, the state insists that the tests were carried out by the military authorities in line with accepted medical and ethical standards, through the application of strict safeguards, and with the authorization of all relevant parties.

The state also said that there were no mistakes in the experiment. However it also said that "the defense establishment carries full responsibility for the treatment of soldiers who were injured by their participation in the research," and accepted the request of the soldiers to provide them with complete medical information and documents relevant to the experiment.

The documents will be given to the soldiers "with a minimum number of deletions that are necessary for security purposes."

The state was responding to a petition filed on behalf of the 34 soldiers by attorneys Boaz Ben-Tzur and Michael Sfard against the defense minister, the chief of staff, the chief medical officer in the Israel Defense Forces, and the minister of health.

The petitioners argued that hundreds of soldiers were involved in the Omer-2 project in 1999, and that they received an injection of a mixture developed at the Biological Institute in Nes Tsiona. According to their petition, the process was flawed in the most basic ways, and that there were many violations of the law including basic standards set out by the law, such as the Helsinki Declaration on norms of experimentation on human beings.

The soldiers also claim they had been presented with misleading, partial and false data on the tests, which had suggested that the side-effects of the trials would be minor and temporary.

In practice, the petitioners claim, the soldiers suffered serious health problems as a result of the trials, including pneumonia, infections in the intestinal tract, coughing and spitting blood, migraines, and muscular problems.

In a parallel petition filed by the organizations Physicians for Human Rights, the court is asked to ban all trials on humans in the IDF until the necessary legislation is passed - already approved in a first reading by the Knesset last year - on controlling and supervising such trials.

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Monday, February 4, 2008

One reason drugs may be used for years before risks become evident is that we have no active drug surveillance system-Mark McClellan, FDA Commissioner

Although no significant improvements in drug safety occurred while he was FDA Commissioner from 2002 to 2004, Dr. McClellan now acknowledges the need for improved safety surveillance at FDA, in a commentary in the April 26, 2007 New England Journal of Medicine.

This issue contains several articles on FDA assessment of drug safety. Jerry Avorn, a Harvard professor of pharmacoepidemiology, noted that 4 former FDA commissioners have called for an end to industry funding of FDA's new drug evaluations. As a result of industry funding, first introduced 15 years ago, FDA scientists were transferred from assessing drug safety to assessing new drug applications.

Dr. Avorn points out that FDA lacks the statutory authority to require companies to conduct follow-up studies of drugs after they are licensed. When FDA issues a new drug license, FDA is frequently very specific about the number and types of additional studies of safety and efficacy it expects to be performed. Yet despite this, the majority of postmarketing studies have not been done. According to the Federal Register, only 11% of 1,259 requested drug studies and 20% of requested biologics studies have been completed and reported on.

In 1970, at the time of licensure, the anthrax vaccine manufacturer was asked to conduct a clinical trial for efficacy, which never took place. Thirty-seven years after it was licensed, there is still no human efficacy data for the anthrax vaccine. (Don't even ask me about the quality of the safety data, which FDA has chosen to ignore.)