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(单词翻译:双击或拖选)
Washington
24 January 2008
The world's largest drug company is embroiled1 in a global controversy2 over whether it tested an unapproved drug on sick children in Nigeria without their full understanding. The case involving Pfizer raises questions about how to protect human subjects as American companies conduct more and more drug trials around the world. VOA's Leta Hong Fincher has this report.
In 1996, a meningitis epidemic3 hit the Nigerian state of Kano. Researchers from the American company, Pfizer, treated 100 Nigerian children with the experimental drug, Trovan. The Nigerian government and the Kano state government are suing Pfizer over the drug trial. They say it caused the deaths of 11 children and seriously disabled others.
The Plaintiff's Attorney, Peter Safirstein says, "What Pfizer did here is despicable and reprehensible4 and what they did here was to take advantage of young children and use them for an unauthorized and unapproved medical experiment."
Safirstein, of the law firm Milberg Weiss, is representing 30 Nigerian families in a lawsuit5 filed in New York. He says Pfizer did not inform the children that they were taking part in a medical experiment and that there were other alternative medications available at the time.
Pfizer has filed its own lawsuit, charging that the report on which the Nigerian government based its claims against the company is illegal and inaccurate6. And the company says on its Web site that any deaths during the clinical trial were the direct result of the illness and not the treatment provided to patients.
Pfizer vice7 president Dr. Jack8 Watters also released a video statement. "This trial was conducted with the full approval of the Nigerian government, with the consent of the parents, the guardians9 of the children, and in consistency10 with the laws of Nigeria," he said.
Whatever the outcome of the lawsuits11, the Pfizer case illustrates12 the difficulty in protecting human subjects as more and more drug trials are conducted around the world.
International standards such as the Declaration of Helsinki govern the ethics13 of drug trials. But some health experts say these regulations are weak and have no enforcement mechanism14.
"It will always be tempting15 for any for-profit corporation to go to that place where regulation is the weakest, to that place where human subjects' protections are the worst, really going to the place with the lowest ethical16 standards, a kind of race to the ethical bottom," says, Dr. Peter Lurie, who is deputy head of health research at the advocacy group, Public Citizen, in Washington. "That temptation will always be there until such time as we have strong international standards. We don't have them now."
Dr. Lurie argues that many citizens of developing countries with poor health infrastructures17 are desperate for medical treatment and vulnerable to exploitation. "To the extent that they [trial participants] are motivated by desperation and needing to get treatment, to the extent that they believe that they will benefit from being in the trial even though that may not be the case, those are bad reasons for people to be in trials."
Alan Goldhammer is a regulatory official for the Pharmaceutical18 Research and Manufacturers of America, a lobbying group in Washington.
He says drug trials in developing countries are critical to researching treatments for diseases such as bacterial19 meningitis, which is rare in the United States. "Our companies are developing new pharmaceuticals20 for a worldwide market. They are also trying to make every effort to address diseases that are common in developing countries and certainly many new antibiotics21 that are being developed will have good therapeutic22 use in those countries."
Goldhammer says another reason American companies conduct trials in developing countries is to try to cut the time and cost required for drug development. "It's running now [at] about 800 million dollars to develop a new drug and it's anywhere from 12 to 14 years and clearly for patients who need new therapies this is too long and too costly23. So we're looking at a variety of ways to try to shorten the time period and reduce the cost."
Dr. Ezekiel Emanuel is head of clinical bioethics at the National Institutes of Health, the primary U.S. medical research agency.
He says the vast majority of drug research does not exploit human subjects. But he says researchers should provide what he calls "fair benefits" to the participants in a drug trial. "Is the community in which you're doing a trial getting other health benefits? Are there economic benefits? Are you preparing the community to be able to do a lot more research and maybe engage in the research enterprise? Are you training people?" he said.
As for Pfizer's 1996 trial of Trovan in Kano, the Nigerian government says the drug company did not behave ethically24. It is seeking compensation for the children and families of those involved.
1 embroiled | |
adj.卷入的;纠缠不清的 | |
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2 controversy | |
n.争论,辩论,争吵 | |
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3 epidemic | |
n.流行病;盛行;adj.流行性的,流传极广的 | |
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4 reprehensible | |
adj.该受责备的 | |
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5 lawsuit | |
n.诉讼,控诉 | |
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6 inaccurate | |
adj.错误的,不正确的,不准确的 | |
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7 vice | |
n.坏事;恶习;[pl.]台钳,老虎钳;adj.副的 | |
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8 jack | |
n.插座,千斤顶,男人;v.抬起,提醒,扛举;n.(Jake)杰克 | |
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9 guardians | |
监护人( guardian的名词复数 ); 保护者,维护者 | |
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10 consistency | |
n.一贯性,前后一致,稳定性;(液体的)浓度 | |
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11 lawsuits | |
n.诉讼( lawsuit的名词复数 ) | |
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12 illustrates | |
给…加插图( illustrate的第三人称单数 ); 说明; 表明; (用示例、图画等)说明 | |
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13 ethics | |
n.伦理学;伦理观,道德标准 | |
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14 mechanism | |
n.机械装置;机构,结构 | |
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15 tempting | |
a.诱人的, 吸引人的 | |
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16 ethical | |
adj.伦理的,道德的,合乎道德的 | |
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17 infrastructures | |
n.基础设施( infrastructure的名词复数 );基础结构;行政机构;秘密机构 | |
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18 pharmaceutical | |
adj.药学的,药物的;药用的,药剂师的 | |
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19 bacterial | |
a.细菌的 | |
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20 pharmaceuticals | |
n.医药品;药物( pharmaceutical的名词复数 ) | |
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21 antibiotics | |
n.(用作复数)抗生素;(用作单数)抗生物质的研究;抗生素,抗菌素( antibiotic的名词复数 ) | |
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22 therapeutic | |
adj.治疗的,起治疗作用的;对身心健康有益的 | |
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23 costly | |
adj.昂贵的,价值高的,豪华的 | |
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24 ethically | |
adv.在伦理上,道德上 | |
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