2006年VOA标准英语-Human Trials of New Drugs Carry Risks for

By Jane M Friedman
Washington, D.C.
02 May 2006
 
watch Clinical Trial report
 

Human Trials, preparing for the shot  
  
Six Londoners almost died recently during a human trial of a new drug.  The British government reacted by announcing it will convene¹ an international panel to consider stricter rules for drug trials. Those trials continue in the United States and other western nations in the search for a bird flu vaccine².

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When a virus is deadly enough to kill birds and humans who come into direct contact with them, testing a vaccine against bird flu can be complicated, and potentially dangerous.

But American researchers, fearing a global pandemic, are testing experimental vaccines³ on human subjects.  More than 700 Americans have taken a vaccine that researchers hope will protect against the bird flu virus should it mutate and spread among humans. So far, the vaccine has been safe, if not easily mass produced.   

Dr. Anthony Fauci (file photo)  
  
Dr. Anthony Fauci is head of infectious diseases at the U.S. National Institutes of Health, which is funding the trials.  "The good news is that you can induce an immunity⁴ that would be protective. The sobering news is that the dosage that is required to get to that level of immunity is prohibitively high, so we're confronted with an important challenge."

Human trials of new drugs are always full of unknowns. In the 1970s, a U.S. trial of a swine flu vaccine killed several volunteers and caused paralysis⁵ in hundreds of others.

Six years ago, at the University of Pennsylvania, a teenager died during a trial of a new gene⁶ therapy.  The U.S. government stopped the trial.  But at congressional hearings afterward⁷, Paul Gelsinger, the boy's father, demanded strict regulation to screen out volunteers whose health could be put at risk by experimental drugs. 

Paul Gelsinger   
  
"I am not against gene therapy,” said Mr. Gelsinger. “I recognize it holds so much promise for so many people. But we cannot allow what happened to Jesse to happen again."

In March, British relatives waited outside a London hospital to hear if their loved ones would survive a trial of an immune-boosting drug. The six men made it, but say the American company running the trial didn't tell them about serious side effects.  

Dr. Fauci remarked, "There are adverse⁸ events associated with any intervention⁹ you give.  Hopefully the adverse events are, A, not serious and, B, they occur very rarely"

Human trials in the third world have come under special scrutiny¹⁰ from public interest groups that say drug companies frequently ignore international standards when they test new drugs in poorer nations.

 
Dr. Peter Lurie
  
Dr. Peter Lurie is a deputy director of the watchdog group Public Citizen, which is calling for stricter controls on tests in Africa and elsewhere.  "Probably the best known example of this is a series of studies that were planned in the last century in which HIV positive pregnant women were randomized to sometimes get active drug to prevent transmission of HIV from themselves to their infants, but a large fraction of the women got nothing at all ... That kind of stuff would be completely unacceptable in the United States."

U.S. officials respond by saying that overseas trials benefit people in countries where the diseases being researched are endemic.

As bird flu trials enter a second phase, researchers are testing a vaccine reinforced with minerals, called adjuvants, so that a smaller dose can deliver greater protection. At several universities, scientists are trying out the vaccine on elderly people to see if they too will be protected.

Dr. Fauci says a bird flu vaccine is not yet within view. "It is difficult to say how long that would take.  It will depend on so many factors, but it will not happen in the next month or so. This is something that will take years to get where we want to be."

For volunteers in the bird flu trials, the worst part is over.  But future trials of new vaccines, for example, against HIV AIDS, will carry risks for the thousands of volunteers a trial requires. And drug companies will have to balance their desire to go to market with the need to protect their human volunteers. 

1 convene   

v.集合，召集，召唤，聚集，集合

参考例句：

• The Diet will convene at 3p.m. tomorrow.国会将于明天下午三点钟开会。
• Senior officials convened in October 1991 in London.1991年10月，高级官员在伦敦会齐。

2 vaccine   

n.牛痘苗，疫苗；adj.牛痘的，疫苗的

参考例句：

• The polio vaccine has saved millions of lives.脊髓灰质炎疫苗挽救了数以百万计的生命。
• She takes a vaccine against influenza every fall.她每年秋季接种流感疫苗。

3 vaccines   

疫苗，痘苗( vaccine的名词复数 )

参考例句：

• His team are at the forefront of scientific research into vaccines. 他的小组处于疫苗科研的最前沿。
• The vaccines were kept cool in refrigerators. 疫苗放在冰箱中冷藏。

4 immunity   

n.优惠；免除；豁免，豁免权

参考例句：

• The law gives public schools immunity from taxation.法律免除公立学校的纳税义务。
• He claims diplomatic immunity to avoid being arrested.他要求外交豁免以便避免被捕。

5 paralysis   

n.麻痹(症)；瘫痪(症)

参考例句：

• The paralysis affects his right leg and he can only walk with difficulty.他右腿瘫痪步履维艰。
• The paralysis affects his right leg and he can only walk with difficulty.他右腿瘫痪步履维艰。

6 gene   

n.遗传因子，基因

参考例句：

• A single gene may have many effects.单一基因可能具有很多种效应。
• The targeting of gene therapy has been paid close attention.其中基因治疗的靶向性是值得密切关注的问题之一。

7 afterward   

adv.后来；以后

参考例句：

• Let's go to the theatre first and eat afterward. 让我们先去看戏，然后吃饭。
• Afterward,the boy became a very famous artist.后来，这男孩成为一个很有名的艺术家。

8 adverse   

adj.不利的；有害的；敌对的，不友好的

参考例句：

• He is adverse to going abroad.他反对出国。
• The improper use of medicine could lead to severe adverse reactions.用药不当会产生严重的不良反应。

9 intervention   

n.介入，干涉，干预

参考例句：

• The government's intervention in this dispute will not help.政府对这场争论的干预不会起作用。
• Many people felt he would be hostile to the idea of foreign intervention.许多人觉得他会反对外来干预。

10 scrutiny   

n.详细检查，仔细观察

参考例句：

• His work looks all right,but it will not bear scrutiny.他的工作似乎很好，但是经不起仔细检查。
• Few wives in their forties can weather such a scrutiny.很少年过四十的妻子经得起这么仔细的观察。