« Home | 670 Serious Adverse Reactions to AVA - 5,300 Repor... » | GAO Report - 1-2% Have Adverse Events (Anthrax/Bio... » | 11 Rushed to Hospital after Anthrax Scare http://w... » | Smallpox Still Threatens, 30 Years After Its Demis... » | Judge Nixes Anonymity for Anthrax Vaccine Plaintif... » | Emergent (Bioport), DoD Amend Contract » | Health Care Protection for Military Signed Into La... » | U.S. Corporations Keeping Biowarfare Work Secret » | Biological Weapons Research and Development Pose R... » | CDC's anthrax vaccine trial exclusions tell us CDC... »

The Perfect Subject

The perfect subject
http://www.haaretz.com/hasen/spages/886709.html

By Avirama Golan, Haaretz Correspondent

A cool breeze wafted across Kibbutz Na'an one evening this past May. Dorit Tahan, 27, covered her two small sons with a blanket in the children's room. The tradition in which children slept in a separate children's house had long since been done away with. That is fine with Tahan, who always loved children and couldn't wait to become a mother. She dimmed the light and sat down to rest in front of the television.

Her husband, Noam, was visiting friends not far away. He, too, was watching TV, she knew, but he was riveted to a soccer game. The boisterous broadcast and the enthusiastic cheers did not reach the couple's small, modest apartment next to the kibbutz dining room.

Dorit luxuriated in the quiet moments of the day's end. The following morning they would have to rise early, as always, wake the children and send them to kindergarten. Noam, a student, would go to the university while Dorit would hurry to her job in security at Ben-Gurion International Airport.

Between putting things away and folding clothes and washing dishes, Dorit channel-surfed, looking for something light and interesting to pass the time. Suddenly her eye was caught by an odd image. A young man, his face in shadow, sat across from the camera on the investigative program "Fact" and in a hesitant, shy voice described the sores covering his legs and the back of his neck. Tahan sat down. She turned up the volume a bit - she had lowered it because of the sleeping children. She leaned forward so as not to miss a word. She knew these sores. Who is this person, she wondered.

The young man, who was identified only by his first name, Nir, continued to describe his health problems. He had difficulty breathing, he said, and Dorit found herself nodding her head in assent. Another young man related that during the spring and fall he needed an inhaler. Again she nodded. As yet she had no idea about the program's subject or why these people were describing exactly the same medical problems she had been suffering from for a few years.

The skin peels, Nir said, and Dorit looked down at the palms of her hands. It gets worse in the winter, and only an expensive steroid ointment helps. Her physician agreed to prescribe it only after all the allergy tests failed to determine why her young, healthy body betrayed her year after year.

Then the reporter said something that stunned her. "Omer 2," he said, as though it were something well known and could be talked about freely, not a deep secret that had been repressed into oblivion. "Omer 2," he repeated, explaining that he was referring to "the experiment in immunization against anthrax carried out on IDF [Israel Defense Forces] soldiers."

Dorit sat glued to the chair, mouth agape. Her heart skipped a beat. Only a few years had passed since that week at the Medical Corps base in which she had completed the officers course, yet until that moment it had all been a blank. Certainly she had not connected her worsening health problems with what had happened back then, in 1998, after she signed the document.

In rapid, random fragments, the moments and feelings passed before her eyes: the pride at taking part in a project that would save the country; the confidence that the anthrax injections were "nothing" and at most would provoke, as in the United States (so she was told, and the promise was repeated on the information sheet she received) a minor adverse reaction in the first 24 hours; the pledge to strict secrecy. It had all been erased somehow, but now, suddenly, it began to resurface. Her hands trembling, she called the number of the friends where Noam was watching the soccer game.

"Switch to 'Fact,' fast," she said. Noam didn't understand what could be important enough to make him abandon the game. "Watch it," she insisted. Noam watched. "What?" he asked. "I was there," she said.

Noam was astonished. They had both served as combat medics and had never been apart since. How could it be that she never told him about this? "It was a secret," she said. "I didn't tell my parents, I didn't tell my brothers, my friends. No one. I barely remembered it myself."

Theshame

"The first thing I felt was shame," Dorit said this week. "I just felt ashamed. Oy, I thought. What did I do? How did I let myself get involved in that stupid thing, and in a totally conscious manner? How did I endanger my health over something I didn't have a clue about? What happened to me? To me, alert Dorit, who always knows what she wants?"

Her face is round, smiling, girlish, but she projects a mature decisiveness, a clearheaded approach to life. Those are her chief characteristics, according to her and a number of her friends, and they were apparently what induced her to go public. In addition to this interview, she is spearheading a High Court of Justice petition involving a large group of people who were given the vaccine. They are demanding that the defense establishment reveal the conditions under which the test was conducted and take responsibility for them and their medical problems. Also propelling her may be the fact that the shame she felt quickly gave way to other feelings.

"All at once I become very angry. I felt betrayed. The system betrayed me. I gave myself without batting an eyelash, I even cooperated with a kind of idiotic pride, but from the moment I was vaccinated to this day the system disappeared. There is no one to take responsibility, no one to admit that maybe mistakes were made, not to mention irresponsible actions. But the main thing is that we as a group, the young people who were vaccinated in the experiment, are being ignored - we as a specific population that might be at risk or in need of special treatment and attention. Even after 'Fact,' when we started pressing the army to tell us the components of the vaccine so we could get the appropriate treatment, they replied by providing information on an individual basis, one at a time, depending on how much pressure each person applied. But as a special population, we do not exist."

At first, test subjects who complained about health problems and asked for a complete list of the substances with which they were injected were told that the information was classified. Then it was suggested that the information be made available to physicians whom the defense establishment considers reliable. And then, with impressive alacrity, each subject received the list of substances in the vaccine, but no quantities. It was only after Tahan began corresponding with the defense establishment via attorney Boaz Ben Zur, who is handling the High Court petition, that she received the specific dosages.

Tahan, who is among the 75 percent of the 800 or so vaccinees who received an Israeli-made vaccine (the others received one from the U.S.), now knows exactly what was injected into her body. The security classification of the information remains unclear. Defense officials maintain that it is top-secret, or was so prior to the decision to give the information to the complainants.

The head of the Israel Institute for Biological Research (IIBR), in Nes Tziona, Prof. Avigdor Shafferman, said recently that the information was unclassified from the outset (see box).

Who was vaccinated in the experiment, and why? Until a few months ago, when she attended a meeting of test subjects organized by "Fact," Tahan had no idea. It had all been so secret. She was a natural candidate.

"Of course, it was almost self- evident. My whole biography fits. I was more gung-ho than the guys. Always. I was born in a kibbutz, to idealistic parents. I am the youngest child and had two combat-soldier brothers. I studied psychology and literature at the [Kibbutz] Givat Brenner high school and I deferred my enlistment in order to do a year of service at MANOF, a residential school [for alienated adolescents] in Acre. I was a social counselor for distressed youth and enjoyed it a lot. I was all of 18, and there was a great deal of purpose in what I did."

After that very busy year, Tahan requested "the hardest, most combat- oriented and least 'close-to-home' assignment," but she was sent to the Medical Corps. "It wasn't my first choice, but I told myself, 'Fine, it's not so bad, I'll find a track for advancement.' I did a three-month, pre-enlistment army paramedics course on my own. The army agreed to send me to a difficult area, which turned out to be the combat engineers unit at the Zukei Uvda base [in the Arava desert]. Half a year later, I was already sent to an officer's course, but that wasn't enough for me, no way. Right after that course, at the Bahad 12 training base, I did an advanced Medical Corps course at Bahad 10.

"I was so enthusiastic," Tahan continued, "and I don't regret a single day there because it was terribly interesting. After that I asked to be posted as close to the front line as possible, to really be a combat medic, so I was sent to the northern brigade in Gaza, which later became the most 'popular' unit, because of the intifada. I was a medical organizational officer there. That's where I met Noam. We were in charge of the clinics in the brigade's sector, for all the medical management of events in the field, and there were many, a huge number. That is a truly great responsibility for such young people."

Repression

By the time she met Noam and the two of them experienced what she describes as a most riveting and satisfying period, the secret "Omer 2" experiment was already a thing of the past. "It was in the second part of the course at Bahad 10," she relates. "Representatives from the Medical Corps told us about the test. Over the past few days I reconstructed word by word what they said, in order to be precise, despite years of repressing [the events]. They said it was an experiment to vaccinate people against anthrax, that it was already being given in the United States and had caused no special problems there. Naturally, they talked about how important it was, about the secrecy, about everything that appears in the document I signed."

Did they say anything about side effects?

"They said there were minor phenomena: slight swelling and redness at the place of the injection, momentary pain. I wasn't all that focused on the explanations. I understood that it was a test, and I also wanted very much to do the right thing for the establishment."

Were you afraid?

"No. What was there to be afraid of? I had so much good will and motivation, and above all, I have to explain, I had unreserved faith in the system. I was convinced beyond any doubt that what they said was true, that there was no way that what they said could not be true."

In October 1999, Dorit signed a document declaring that she had volunteered for an experiment being conducted to aid Israel in the struggle against the threat of anthrax. She was told, and the document states, that the vaccine had been approved by the U.S. Food and Drug Administration and had been administered successfully in the United States. Only now, after restless surfing on the Internet, is it clear to her that this information was inaccurate. But what bothers her more is that the whole issue of the U.S. vaccine is actually irrelevant in her case, because she was part of the large group of soldiers who received the Israeli vaccine.

She received the first injection in early November, a month after signing the release. The second injection was in late November, the third in early December. Even though she had no side effects, apart from redness and a mild pain, she did not want the fourth injection.

Why not?

"It's hard for me to reconstruct whether I felt any regret - probably not - but I just wasn't interested anymore. I wasn't at the training base by then, I was in the field, in Gaza, I was very busy, and I didn't feel like it."

The army tracked down other soldiers, going to their homes to persuade them to complete the series of injections. They were promised fewer rounds of reserve duty if they agreed to be injected after their release. Didn't anyone say anything to you?

"No, they let it go, and I didn't give it any further thought. Only now I understand why they didn't persist with me but did with others."

Why?

"Because I received the Israeli vaccine."

Yes?

"There was a significant difference between the two [series of] vaccines. The American one consisted of six injections. The Israeli one came in different forms: one of seven full vaccines; one of three full ones; one full plus three placebos; and one of four full, two placebos and one full."

And you didn't know that?

"I had no idea there were several types, certainly not that there were different configurations. No one knew. Not even the doctors who gave the shots knew."

Well, that's how it goes in trials.

"Right."

So it's possible that you had actually completed your part in the experiment, and the person in charge knew that and therefore didn't try to get you to continue.

"Yes."

TheFacts

Dorit, like the other subjects in the experiment, had no way of knowing either what the vaccine contained or whether what the medical officials told her or wrote in the release form was correct and authenticated. Now, after reading the legal opinion drafted by attorney Michael Sfard at the request of Physicians for Human Rights Israel (PHRI), she realizes that she was misled. She only hopes that those who misled her were themselves misled, at worst.

Sfard based his opinion on facts that were a matter of public record, and it is unlikely that they were not known to those who administered the trial - maybe not to all the physicians who took part, but certainly to the IIBR directors who ran it. The IDF's chief medical officer, as well, should have known what every newspaper reader in the U.S. or anyone who has flipped through a popular scientific journal knew.

In a briefing before the experiment began, Dorit and the other test subjects were told that, "Already 30 years ago, a vaccine against anthrax was developed in the United States and England to immunize groups of people at risk... This vaccine was approved for use by the U.S. Food and Drug Administration in the 1970s." This was reiterated in the information sheet given to the volunteers, which went on to emphasize, "The American vaccine, which is registered by the U.S. Food and Drug Administration, has been given to hundreds of thousands of individuals to date without any special problems. The American army has embarked on a process aimed at vaccinating all soldiers."

The facts are somewhat different. In the early 1970s, the anthrax vaccine was indeed approved in the U.S. but in 1972, the FDA decided to review it and later declared the vaccine safe but determined that dosage levels had not been tested and still needed to be approved.

By 1985, a total of 11,000 U.S. soldiers had received the vaccine. In 1991, amid fears relating to the Gulf War, 150,000 soldiers were vaccinated. Beginning in 1993, however, the FDA issued warnings to the effect that the firm manufacturing the vaccine was violating procedures. The first side effects began to be noticed in 1994, and were collectively known as the "Gulf War syndrome": Soldiers who received the vaccine complained about joint pain, memory lapse, chronic fatigue, headaches, dizziness, muscle laxity, digestive problems, shortness of breath and skin problems. The circumstantial connection between the vaccination and these phenomena was verified in 1999. Thus, the information sheet detailing the possible side effects, which maintains that they are localized and disappear within 48 to 72 hours after the injection, is puzzling, to say the least.

The project that was "aimed at vaccinating all the soldiers in the U.S. armed forces" was in fact launched in 1997. However, precisely as Dorit and the others were taking part in the experiment, president Bill Clinton announced that the Pentagon would have to get written agreement from each soldier, or authorization from the president himself, before experimental treatment was administered to soldiers. In December 2003, U.S. District Court Judge Emmet G. Sullivan ruled that the Defense Department's mass inoculations of troops against anthrax violated a law stipulating that experimental drugs can be administered only with personal consent or the authorization of the commander-in-chief (the president). The program was terminated. Even after the FDA finally approved the vaccination, Judge Sullivan allowed its use only on a voluntary basis.

According to news reports, as of 2005, about half the soldiers in the U.S. armed forces declined to receive the vaccine. But in Israel the testing continued until 2006.

Questions

Five weeks ago, Dorit Tahan (and the other volunteers) received a letter from the army's chief medical officer, Brigadier General Hezi Levy. "Dear volunteer," he wrote, then repeated the solemn declaration that the tests had been conducted to protect the country "from one of the harshest strategic threats it has faced." He added, "We are writing you in order to refresh the information on the vaccination and the research provided to you before you volunteered and during the period of your participation, and to answer questions that have been asked by volunteers and their parents in recent weeks."

Dr. Levy went on to emphasize, as though nothing had changed, that in the U.S., "no late patterns of later phenomena for the vaccination against anthrax were found." At the same time, he notes with caution, in Israel "43 systemic phenomena that were defined by the research physicians or by the Safety Commission as phenomena that cannot be separated from the receipt of the vaccination" have been recorded. According to what can be gleaned from this convoluted formulation, these are long-term side effects.

These developments raise two equally grave questions. First, regarding what the volunteers were told about the U.S. vaccine: Even if it had turned out to be perfectly safe and even if not one U.S. soldier had complained about it, the fact is that 75 percent of the soldiers in Israel received an Israeli vaccine, not the U.S. one. If so, the composition of the U.S. vaccine and its side effects are relevant only to a minority of the test subjects and making the information about it available would seem, on the face of it, to constitute misleading the other participants.

The second question is one of principle. It relates to the IDF and the way it ran the experiment from its inception, as well as to the issue of experiments on humans in general. In 2005, the state comptroller found serious flaws in the way human testing was being conducted. For example, the comptroller's report noted that the Helsinki Committees overseeing human testing in institutions carrying out such tests were not fully staffed according to protocol. Worse, the candidates chosen "to participate" in the experiments were a "captive" population (prisoners, people with mental illness and old people in institutions) who in many cases were incapable of giving "informed consent."

The report referred to institutions under Health Ministry supervision. In Israel, however, there is no law permitting, overseeing or regularizing human testing outside of hospitals. It follows that the IDF effectively acted outside the law, even if the experiment was conducted under civilian supervision. In the information sheet given to volunteers and in all the correspondence with the volunteers and their lawyers, the IDF states explicitly that such supervision existed.

As part of PHRI's in-depth investigation into Omer 2, the association's executive director, Hadas Ziv, asked the head of the Health Ministry's clinical trials department, Dr. Mina Arinos, whether a clinical trial could be conducted without the department's involvement and whether any other body had the authority to register and supervise human experimentation. Dr. Arinos replied to both questions in the negative, as she did to the question of whether her department had supervised Omer 2.

The Public Health Regulations, which include the procedures for human testing, refer only to hospitals, are signed by the director general of the Health Ministry and apply exclusively to bodies under the ministry's responsibility. The IDF is not included in that category. "According to our information," Arinos added, "the army adopted the Public Health Regulations and has a Helsinki Committee whose composition I do not know." If so, why does the IDF continue to refuse to disclose the names of the people on the Helsinki Committee that oversaw the experiment?

Thedamage

According to the Health Ministry procedure for human experimentation, the director of the experiment must receive "the informed consent of every participant without the exertion of undue pressure or influence." Moreover, the volunteer must receive a declaration that the trial involves an unforeseeable risk. The regulations warn that "A relationship of paid employment... or any other relationship, including a subordinate work relationship... could be construed as a conflict of interest or dependence."

In the case of soldiers in elite units, nearly all of whom are highly motivated youngsters near the beginning of their military service, gathered in a top-secret forum that implies a mission of supreme importance for the survival of the homeland, it would be difficult to say that no relationship of dependence exists. It would also be difficult to argue that no undue pressure or influence was brought to bear.

"When I was given the consent form to sign," Dorit Tahan notes, "I told them I had asthma as a girl. They didn't think it was important. For the past six years I haven't been able to breathe in the fall and spring and have had to use an inhaler. I don't want to be pitied, I hate people who complain about their troubles and make all kinds of demands because of them, but it is inconceivable for the system to turn its back on me, for me to be forced to prove that I was harmed by the experiment."

When she rolls up her pants, almost unwillingly, two red circles surrounded by dry skin are visible on Tahan's thighs. In the center of each circle is a pustule from which, she says, the odd, irritating eczema-like rash begins each time. "The hands - that's even worse for me," she says. "There are days when I can barely look after the children. Every contact with the skin on my hands causes me excruciating pain, and the skin gets even more cracked.

"What scares me most now," she continues, "is the thought that maybe my children got something from me that I have no way of knowing about, that something bad was transmitted to them. What's really funny is that the letter I received from the current chief medical officer says that I am now immunized against anthrax. That's just great. What I want to know is what I am not immunized against."

Leaving these worries aside for a moment, she asks herself why the test was carried out at all, when it had been known for years that antibiotics could be distributed during the 24 hours after an anthrax attack, providing a proven, successful solution. "I want a commission to be set up to investigate how an experiment of this kind is conducted in Israel, who is responsible for the results when medical officers are replaced and when someone hides behind a convenient cloak of secrecy so as not to answer questions. And I want the hands of the next person who even thinks about doing tests on soldiers, or on any other captive population, to tremble. Let that be the last time."

Archives