2010年10月9日土曜日

米国人体実験 グアテマラに謝罪

米国が人体実験を実施しグアテマラに謝罪した。
 米政府は、中米グアテマラで1946~48年、当時新薬だった抗生物質
ペニシリンが性病に効くかどうか実験するため、刑務所囚人や精神
障害者らを故意に梅毒などに感染させたとして、同国に謝罪した。
 約700人が実験の対象になったとされ、オバマ米大統領は、グアテマラ
のコロン大統領に電話で遺憾の意を伝えた。

ジョン・カトラーが貧困で、より教育レベルが低い国としてグアテマラを
選び、米公衆衛生局の支援を受け、意図を隠して、性病を約1,500人の
男性と女性に感染させ、新薬の効果を人体実験したらしい。

米国内の人体実験は、1880から1972年の間で、約20件実施されたことが
報道されている。

アフリカの村単位でHIVワクチンの臨床実験が行われていた報道があった
が、臨床実験と人体実験の違いだけの問題なのだろうか。
HIVワクチンの場合、本人の承諾を得て、参加意思を表明して試験されて
いるようだが、予防を教育したことは報道されていない。
米国のように、教育レベルが低いから試験地域として選択した可能性も
あり、十分理解して試験に参加しているかは不明だ。

エイズ感染予防剤
HIVワクチン実証


US syphilis tests in Guatemala 'crime against humanity RT


---新薬実験、囚人らに売春婦あっせんし性病に---
2010年10月2日21時42分 読売新聞
http://www.yomiuri.co.jp/world/news/20101002-OYT1T00658.htm

 【ワシントン=本間圭一】米政府は1日、中米グアテマラで1946~48年、当時新薬だった抗生物質ペニシリンが性病に効くかどうか実験するため、刑務所囚人や精神障害者らを故意に梅毒などに感染させたとして、同国に謝罪した。
 約700人が実験の対象になったとされ、オバマ米大統領は1日、グアテマラのコロン大統領に電話で遺憾の意を伝えた。
 マサチューセッツ州のウェルズリー大学のスーザン・レバビー教授が、米公衆衛生局(PHS)のジョン・カトラー医官(故人)の実験に関する未公開資料を発見し、政府に通知した。
 米側の発表などによると、カトラー氏は同期間、PHSの支援を受け、グアテマラの刑務所や精神科病院で、囚人や入院患者に実験の意図を隠して売春婦をあっせんするなどの方法で性病に感染させた。


---医師がグアテマラで故意の梅毒感染実験 米政府が謝罪---
2010.10.02 Sat posted at: 15:36 JST
http://www.cnn.co.jp/usa/30000398.html

 ワシントン(CNN) 米政府は10月1日、米国の医師が中米グアテマラで1946~48年、性産業従事の女性、刑務所の受刑者や精神病院の患者らを対象に新薬の効果を確認する目的で故意に梅毒感染の実験を行っていた事実を明らかにし、同国政府に謝罪を表明した。
 クリントン国務、セベリウス厚生両長官が共同声明で非を認め、オバマ大統領もコロン・グアテマラ大統領に電話をかけて謝罪した。共同声明は、過去に起きたことを深く悔い、この種のおぞましい研究実験に巻き込まれたグアテマラの人々に謝罪するとしている。
 コロン大統領はグアテマラ市でCNNスペイン語放送の会見に応じ、64年前に起きたことだが、重大な人権違反であると語った。クリントン長官からも9月30日に電話をもらい、謝罪を受けたという。グアテマラ大統領府の報道官は、実験は認められないが、同長官の謝罪を受け入れると述べた。コロン大統領は法的措置を取るのかどうかは調査委員会の判断に委ねる考えを示した。
 実験は当時、新しく製造された抗生物質ペニシリンの治療効果などを調べるのが目的で、淋(りん)病も対象となった。故意に感染させられたのは1600人以上で兵士も含まれた。梅毒感染にさらされたのが696人、淋病が772人などとなっている。
 グアテマラでの実験の事実は米国の大学教授が公文書を調べていて判明したもので、未公表となっていた実験に関するメモが決め手となったという。教授は、米アラバマ州タスキーギーで1932~72年に実施されていた貧しいアフリカ系(黒人)約400人を対象にした梅毒の実験を調査中に、メモを見付けていた。この実験では故意の感染は実施していなかったが、梅毒を患っていた400人に治療を施さず、症状を悪化させて観察していた。梅毒感染の事実も被験者に伝えていなかったという。
 グアテマラ、アラバマ州での両実験はいずれも米公衆衛生当局所属の医師によって行われていた。この医師は2003年に死亡している。実験の場所としてグアテマラが選ばれた背景には、売春が当時合法で、刑務所受刑者が売春婦を獄内に呼ぶことを許可されていた事情などがあるという。
 実験に必要な資金は米国立衛生研究所が提供していたとみられる。同研究所の責任者は記者会見で、グアテマラでの実験は被験者に目的を説明せず実施するなど基本的な倫理違反を犯していると指摘した。米政府当局者は、現在の医学倫理規定はこの種の実験を認めておらず、再発は有り得ないと述べている。


---米学者が梅毒感染実験 大統領、グアテマラに謝罪---
2010年10月2日 10時15分
http://www.tokyo-np.co.jp/s/article/2010100201000179.html

 【ワシントン共同】米国の科学者が60年以上前、薬の効果を確かめる目的で、中米グアテマラの刑務所や精神科病院で、故意に梅毒を感染させる実験をしていたことが1日、明らかになった。
 米政府は「倫理に反し非難されるべき実験だった」との声明を発表、米大統領は同日、グアテマラのコロン大統領に電話で謝罪した。
 米メディアによると、実験したのは米公衆衛生当局所属の医師。1946年から48年にかけ、当時は新しかった抗生物質ペニシリンの治療効果や、予防にも有効かなどを調べるため、刑務所受刑者ら計696人に梅毒を感染させた。実験はグアテマラ政府の許可を得て行われたとされるが、詳しい目的は伝えていなかったという。この医師は既に死亡している。
 米政府は、現在ではこのような研究は行われていないとしているが、グアテマラで何が起き、今の研究に対する規制が十分かどうかを調べるため、大統領委員会で調査するとしている。

---U.S. infected Guatemalans for STD tests---
By Rob Stein
Washington Post Staff Writer
Saturday, October 2, 2010
http://www.washingtonpost.com/wp-dyn/content/article/2010/10/01/AR2010100107299.html

The United States revealed on Friday that the government conducted medical experiments in the 1940s in which doctors infected soldiers, prisoners and mental patients in Guatemala with syphilis and other sexually transmitted diseases.

The experiments, led by a federal doctor who helped conduct the famous Tuskegee syphilis study in Alabama, involved about 1,500 men and women who were unwittingly drafted into studies aimed at determining the effectiveness of penicillin.

The tests, which were carried out between 1946 and 1948, infected subjects by bringing them prostitutes who were either already infected or purposefully infected by the researchers and by using needles to open wounds that could be contaminated.

"Although these events occurred more than 64 years ago, we are outraged that such reprehensible research could have occurred under the guise of public health," Secretary of State Hillary Rodham Clinton and Health and Human Services Secretary Kathleen Sebelius said in a joint statement apologizing for the experiments. "We deeply regret that it happened, and we apologize to all the individuals who were affected by such abhorrent research practices."

President Obama had been briefed about the revelations and called Guatemalan President Alvaro Colom to "personally express that apology," White House spokesman Robert Gibbs said."Obviously, this is shocking. It's tragic. It's reprehensible," Gibbs said.

The Guatemalan government planned to investigate, saying it "deeply deplores that these experiments affected innocent people," according to a statement issued late in the day.

In addition to exposing another episode of unethical medical experimentation, officials said the revelations were concerning because they could further discourage already often-suspicious minorities and others from participating in medical research. They also come as U.S. drug companies are increasingly going to poor, less-educated countries to test new drugs and other therapies.

"At a time when so much medical research is global, it behooves us to take account of what has been done in the past by American researchers in other countries," said Susan M. Reverby, a professor in the history of ideas and professor of women's and gender studies at Wellesley College in Massachusetts who discovered the experiments while investigating Tuskegee for a book.

In Tuskegee, perhaps the most notorious medical experiment in U.S. history, hundreds of African American men with late-stage syphilis were left untreated to study the disease between 1932 and 1972. In the Guatemala case, the subjects were treated, but it remains unclear whether they were treated adequately or what became of them.

Reverby discovered the experiments while reading papers in the University of Pittsburgh's archives from John C. Cutler, a doctor with the federal government's Public Health Service who later participated in Tuskegee. He died in 2003.

"I almost fell out of my chair when I started reading this," Reverby said in a telephone interview. "Can you imagine? I couldn't believe it."

The studies were sponsored by the Public Health Service, the National Institutes of Health and the Pan American Health Sanitary Bureau (now the World Health Organization's Pan American Health Organization) and the Guatemalan government. The goal was to assess whether taking penicillin right after sex would prevent sexually transmitted infections.

Cutler, Guatemalan health official Juan Funes and colleagues decided to study men in Guatemala City's Central Penitentiary because its prisoners were allowed to have sex with prostitutes. Some of the prostitutes tested positive for syphilis; in other cases, doctors put infectious material on the cervixes of uninfected prostitutes before they had sex with prisoners.

But because so few men were getting infected, the researchers then attempted "direct inoculations made from syphilis bacteria poured into the men's penises and on forearms and faces that were slightly abraded . . . or in a few cases through spinal punctures," Reverby wrote in a synopsis of the experiments.

They conducted similar experiments involving gonorrhea and chancroid and on soldiers in an army barracks and on men and women in the National Mental Health Hospital. In some cases, the subjects drank "syphilitic tissue mixed with distilled water," Reverby wrote in a synopsis of the testing. Doctors used needles to scrape the arms, faces or mouths of the women to try to infect them.

A number of high-ranking U.S. government officials knew about the research, including Thomas Parran Jr., who was then U.S. surgeon general, the documents show. "You know, we couldn't do such an experiment in this country," Parran said, according to Cutler. Parran died in 1968.

The gonorrhea studies involved 772 subjects, 234 of whom became infected and 233 of whom received treatment, according to an investigation by the federal Centers for Disease Control and Prevention. The chancroid studies involve 142 subjects, including 138 who became infected and 129 who received treatment. The syphilis experiments involved 497 subjects who were exposed to the bacteria that causes the disease, 427 of whom became infected and 332 of whom received treatment. A total of 443 of the subjects actually developed syphilis; 331 received treatment, although only 85 could be documented to have received full treatment, the CDC found.

Gonorrhea can cause a variety of complications, including infertility. Chancroid can cause painful ulcers. Syphilis can cause blindness, major organ damage, paralysis, dementia and death.

Seventy-one of the syphilis subjects died during the study, including one from a fatal epileptic seizure, but it was unclear whether any were caused by the studies. The fates of the other subjects will be investigated, officials said.

The researchers also took blood samples from 438 children at the National Orphanage, but in that case, they did not purposefully infect anyone, Reverby said.

Cutler discontinued the experiments "when it proved difficult to transfer the disease and other priorities at home seemed more important," she wrote. The results were never published. Cutler died in 2003.

Reverby shared her discovery last spring with David Sencer, a retired director of the CDC, who notified current CDC officials, leading to Friday's public disclosure. Reverby describes the tests in a 29-page paper that will be published in January in the Journal of Policy History.

NIH Director Francis S. Collins condemned the experiment and said strict prohibitions are in place to prevent such abuses from happening today.

"This case of unethical human subject research represents an appalling example from a dark chapter in the history of medicine," Collins told reporters during a telephone briefing Friday.

Although Collins said it was important that the experiments had been made public, he acknowledged that the revelation could deepen entrenched suspicions about scientists and doctors. The Tuskegee experiment continues to be blamed for making many minorities reluctant to participate in medical studies or even seek medical care.

"We are concerned about the way in which this horrendous experiment, even though it was 60 years ago, may appear to people hearing about it today as indicative of research studies that are not conducted in an ethical fashion," Collins said. "Today, the regulations that govern research funded by the United States government, whether conducted domestically or internationally, would absolutely prohibit this type of study."

The National Academy of Sciences' Institute of Medicine will also investigate the experiment and the Presidential Commission for the Study of Bioethical Issues will form a panel of international experts to "ensure that all human medical research conducted around the globe today meets rigorous ethical standards," officials said.

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