2006年VOA标准英语-Nigerian Report Finds Violations in 1996 P

By Catherine Maddux
Washington
11 May 2006
 
An unreleased report by a panel of Nigerian experts says that the U.S. drug manufacturer, Pfizer, violated international and Nigerian law when it conducted a study of an experimental drug to treat meningitis in children a decade ago in Nigeria.

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World headquarters of Pfizer Inc. in New York   
  

The report sharply criticizes how Pfizer went about testing, in 1996, a drug that was at that time unapproved. The drug, Trovan, was tested on children suffering from a deadly strain of meningitis in the northern Nigerian state of Kano.

The confidential¹ report, recently obtained by The Washington Post, was written by a panel of medical experts appointed by Nigerian government to investigate the circumstances of the tests conducted by Pfizer. However, though the tests took place in 1996, the panel was not created until more than four years later, after The Washington Post newspaper published a series of articles on pharmaceutical² trials conducted abroad.

Staff reporter Joe Stephens wrote the original series for the Post in 2000 and the recent story about the unreleased report by the Nigerian medical experts.

"They said that the drug trial was not properly approved by Nigerian authorities, that there was no paperwork that could prove that the children or their families were told that they were part of a medical experiment," said Stephens. "And they said that the doctor who ran the experiment admitted that an ethics³ committee approval letter had been concocted⁴ and back dated long after the trial was over and it made to look as though an ethics committee had approved the trial ahead of time."

Out of nearly 100 children and infants who were treated with Trovan during the trial, five died and several others suffered complications after taking the antibiotic⁵. But it is not clear that Trovan was directly responsible for the deaths of the five children. Six others died after taking a comparison drug.

Pfizer told Nigerian authorities investigating the 1996 tests that a Nigerian doctor, Abdulhamid Dutse, ran the Trovan experiment in Kano, but the report says otherwise.

"The committee determined⁶ he was not in charge. That actually it was Pfizer physicians who flew in from the United States who were in charge," said Joe Stephens of The Washington Post. "And that, in fact, Dr. Dutse had not kept the results, did not know the results for a long time to the experiment, had nothing to do with putting together the plan or the protocol⁷. Dr. Dutse also acknowledged under questioning by the committee that he had personally falsified this medical ethics committee document when he had been asked for it much later by Pfizer."

Dr. Dutse spoke⁸ with VOA's Hausa service. He said during the experiment, he did the work he was assigned to do. Dr. Dutse also told VOA he was not in charge of the 1996 Trovan study. He said, initially⁹, he believed that Trovan was a good drug that would help Nigerian children who had become sick during the meningitis epidemic¹⁰ based on evidence he says Pfizer officials showed him regarding what they claimed were previously¹¹ successful trials of Trovan on children.

Pfizer Incorporated has denied repeatedly any wrongdoing in the 1996 clinical trial, although recently it has admitted the Nigerian ethics committee approval letter was written after the trial began and back dated.

Pfizer would not agree to several requests for an interview with VOA. It has released a written statement, saying the company "conducted this trial with the full knowledge of the Nigerian government and in a responsible way consistent with Nigeria law and Pfizer's abiding¹² commitment to patient safety."

The company statement goes on to say that, without question, Trovan saved lives and that it showed the highest survival rate of any other treatment given at the Kano hospital.

Though the drug remains¹³ available in the United States, it use is strictly¹⁴ limited. Washington Post reporter Joe Stephens points out that Trovan was never approved for use by children in the United States or anywhere else.

"But it was approved for adults in the U.S. and in Europe and it quickly became a major seller. But then was associated with liver damage and some deaths. It has now been severely¹⁵ restricted in the U.S. and it has been banned entirely¹⁶ in the EU [European Union]. "

Families of several Nigerian children who took part in the 1996 clinical trial who died or were disabled have filed suit in the United States accusing Pfizer of not fully¹⁷ informing them of the risks associated with the drug. The case has been dismissed on grounds that only Nigeria has jurisdiction¹⁸ over the matter. Lawyers representing the families are appealing the 2005 ruling.

Meanwhile, the controversy¹⁹ around the trial and the now public contents of the Nigerian panel's report have gotten the attention of U.S. lawmakers, including California Congressman²⁰ Tom Lantos. He is planning to introduce legislation tightening²¹ regulations on companies that conduct clinical drug trials in developing nations.
 
 

1 confidential   

adj.秘（机）密的，表示信任的，担任机密工作的

参考例句：

• He refused to allow his secretary to handle confidential letters.他不让秘书处理机密文件。
• We have a confidential exchange of views.我们推心置腹地交换意见。

2 pharmaceutical   

adj.药学的，药物的；药用的，药剂师的

参考例句：

• She has donated money to establish a pharmaceutical laboratory.她捐款成立了一个药剂实验室。
• We are engaged in a legal tussle with a large pharmaceutical company.我们正同一家大制药公司闹法律纠纷。

3 ethics   

n.伦理学；伦理观，道德标准

参考例句：

• The ethics of his profession don't permit him to do that.他的职业道德不允许他那样做。
• Personal ethics and professional ethics sometimes conflict.个人道德和职业道德有时会相互抵触。

4 concocted   

v.将（尤指通常不相配合的）成分混合成某物( concoct的过去式和过去分词 )；调制；编造；捏造

参考例句：

• The soup was concocted from up to a dozen different kinds of fish. 这种汤是用多达十几种不同的鱼熬制而成的。
• Between them they concocted a letter. 他们共同策划写了一封信。 来自《简明英汉词典》

5 antibiotic   

adj.抗菌的；n.抗生素

参考例句：

• The doctor said that I should take some antibiotic.医生说我应该服些用抗生素。
• Antibiotic can be used against infection.抗菌素可以用来防止感染。

6 determined   

adj.坚定的；有决心的

参考例句：

• I have determined on going to Tibet after graduation.我已决定毕业后去西藏。
• He determined to view the rooms behind the office.他决定查看一下办公室后面的房间。

7 protocol   

n.议定书，草约，会谈记录，外交礼节

参考例句：

• We must observe the correct protocol.我们必须遵守应有的礼仪。
• The statesmen signed a protocol.那些政治家签了议定书。

8 spoke   

n.（车轮的）辐条；轮辐；破坏某人的计划；阻挠某人的行动 v.讲，谈（speak的过去式）；说；演说；从某种观点来说

参考例句：

• They sourced the spoke nuts from our company.他们的轮辐螺帽是从我们公司获得的。
• The spokes of a wheel are the bars that connect the outer ring to the centre.辐条是轮子上连接外圈与中心的条棒。

9 initially   

adv.最初，开始

参考例句：

• The ban was initially opposed by the US.这一禁令首先遭到美国的反对。
• Feathers initially developed from insect scales.羽毛最初由昆虫的翅瓣演化而来。

10 epidemic   

n.流行病；盛行；adj.流行性的，流传极广的

参考例句：

• That kind of epidemic disease has long been stamped out.那种传染病早已绝迹。
• The authorities tried to localise the epidemic.当局试图把流行病限制在局部范围。

11 previously   

adv.以前，先前（地）

参考例句：

• The bicycle tyre blew out at a previously damaged point.自行车胎在以前损坏过的地方又爆开了。
• Let me digress for a moment and explain what had happened previously.让我岔开一会儿，解释原先发生了什么。

12 abiding   

adj.永久的，持久的，不变的

参考例句：

• He had an abiding love of the English countryside.他永远热爱英国的乡村。
• He has a genuine and abiding love of the craft.他对这门手艺有着真挚持久的热爱。

13 remains   

n.剩余物，残留物；遗体，遗迹

参考例句：

• He ate the remains of food hungrily.他狼吞虎咽地吃剩余的食物。
• The remains of the meal were fed to the dog.残羹剩饭喂狗了。

14 strictly   

adv.严厉地，严格地；严密地

参考例句：

• His doctor is dieting him strictly.他的医生严格规定他的饮食。
• The guests were seated strictly in order of precedence.客人严格按照地位高低就座。

15 severely   

adv.严格地；严厉地；非常恶劣地

参考例句：

• He was severely criticized and removed from his post.他受到了严厉的批评并且被撤了职。
• He is severely put down for his careless work.他因工作上的粗心大意而受到了严厉的批评。

16 entirely   

ad.全部地，完整地；完全地，彻底地

参考例句：

• The fire was entirely caused by their neglect of duty. 那场火灾完全是由于他们失职而引起的。
• His life was entirely given up to the educational work. 他的一生统统献给了教育工作。

17 fully   

adv.完全地，全部地，彻底地；充分地

参考例句：

• The doctor asked me to breathe in,then to breathe out fully.医生让我先吸气，然后全部呼出。
• They soon became fully integrated into the local community.他们很快就完全融入了当地人的圈子。

18 jurisdiction   

n.司法权，审判权，管辖权，控制权

参考例句：

• It doesn't lie within my jurisdiction to set you free.我无权将你释放。
• Changzhou is under the jurisdiction of Jiangsu Province.常州隶属江苏省。

19 controversy   

n.争论，辩论，争吵

参考例句：

• That is a fact beyond controversy.那是一个无可争论的事实。
• We ran the risk of becoming the butt of every controversy.我们要冒使自己在所有的纷争中都成为众矢之的的风险。

20 Congressman   

n.（美）国会议员

参考例句：

• He related several anecdotes about his first years as a congressman.他讲述自己初任议员那几年的几则轶事。
• The congressman is meditating a reply to his critics.这位国会议员正在考虑给他的批评者一个答复。

21 tightening   

上紧，固定，紧密

参考例句：

• Make sure the washer is firmly seated before tightening the pipe. 旋紧水管之前，检查一下洗衣机是否已牢牢地固定在底座上了。
• It needs tightening up a little. 它还需要再收紧些。