2007年VOA标准英语-Calls For Stricter US Drug Safety Process

By Melinda Smith
Washington
01 June 2007
 

A growing number of critics are calling for stricter regulation of the pharmaceutical¹ industry and how drugs are sold in the United States.  The concern comes from medical experts, consumer groups and even from within the government agency in charge of the drug approval process.  VOA's Melinda Smith has details.

It takes an average of 12 years for a drug to make its way through laboratory and clinical testing, government approval, and finally to the pharmacy².  Drug companies invest millions of dollars in the long process.  And that is just the beginning.

A report in the New England Journal of Medicine indicates that U.S. drug advertising³ to consumers rose by almost 300 percent from 1997 to 2005.  Spending by pharmaceutical companies to promote their products to doctors increased by 86 percent.  Money spent on drug research and development was up by at least 100 percent.

Critics say the massive investment to sell these drugs is part of the problem.  At present the U.S. Food and Drug Administration, the government agency which approves drugs and regulates their safety, has no power to block the marketing⁵ of new drugs before safety studies have been completed. There is a bill pending⁴ in the U.S. Congress to give that power to the FDA.

But critics say the Food and Drug Administration's handling of older drugs on the market is also flawed.  Recent studies showing the risk of heart attacks associated with the diabetes⁶ drug Avandia – as well as the 2004 voluntary withdrawal⁷ of the pain reliever Vioxx – have been cited as failures of the drug approval process.

Even Dr. Janet Woodcock, a senior official with the FDA, admits the situation is troublesome. "We are finding more problems with marketed medications, but not just with recently marketed medications, with drugs that were approved long ago."

One report indicates at least half of drugs already approved have needed further safety labeling.  In some cases, drugs were considered so unsafe they were removed from the market.

Dr. Jerry Avorn of Brigham and Women's Hospital in Boston, Massachusetts says the regulations are out of date. "We don't have a good system for finding out if a drug is dangerous until it's been on the market for many years.  And that's not acceptable."

Another problem: participants in human trials are often healthier than patients for whom the drug is designed.  Dr. Avorn says, "A drug that works well in hand-picked patients who are guaranteed not to be terribly sick is not likely to have the same safety or efficacy as it does in typical patients."

There are also concerns the duration of drug trials are often too short and too few people are tested.  After a new drug winds up on drugstore shelves, the FDA requires pharmaceutical companies to continue studies on that drug.  The FDA acknowledges that companies routinely fail to complete that process. 

Dr. Brian Strom of the University of Pennsylvania says the U.S. Congress needs to give greater enforcement authority to the FDA. "Congress hasn't given the FDA the authority to force companies to do such studies."

Before the AIDS scare 20 years ago, the Food and Drug Administration had been criticized for taking too long to approve new medications.  Now it is criticized for not taking long enough.

1 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。

2 pharmacy   

n.药房，药剂学，制药业，配药业，一批备用药品

参考例句：

• She works at the pharmacy.她在药房工作。
• Modern pharmacy has solved the problem of sleeplessness.现代制药学已经解决了失眠问题。

3 advertising   

n.广告业；广告活动 a.广告的；广告业务的

参考例句：

• Can you give me any advice on getting into advertising? 你能指点我如何涉足广告业吗?
• The advertising campaign is aimed primarily at young people. 这个广告宣传运动主要是针对年轻人的。

4 pending   

prep.直到，等待…期间；adj.待定的；迫近的

参考例句：

• The lawsuit is still pending in the state court.这案子仍在州法庭等待定夺。
• He knew my examination was pending.他知道我就要考试了。

5 marketing   

n.行销，在市场的买卖，买东西

参考例句：

• They are developing marketing network.他们正在发展销售网络。
• He often goes marketing.他经常去市场做生意。

6 diabetes   

n.糖尿病

参考例句：

• In case of diabetes, physicians advise against the use of sugar.对于糖尿病患者，医生告诫他们不要吃糖。
• Diabetes is caused by a fault in the insulin production of the body.糖尿病是由体內胰岛素分泌失调引起的。

7 withdrawal   

n.取回，提款；撤退，撤军；收回，撤销

参考例句：

• The police were forced to make a tactical withdrawal.警方被迫进行战术撤退。
• They insisted upon a withdrawal of the statement and a public apology.他们坚持要收回那些话并公开道歉。