Pressure is already causing some changes within the pharmaceutical industry. And it has put the US Food and Drug Administration (FDA), which approves new drugs, in the hot seat. If reforms are carried out, they could bring an unprecedented level of transparency to drug research.
The solution now under consideration: a public database, or registry, of drug trials, where companies would post the results of those trials.
In congressional testimony Thursday, a spokesman for the American Medical Association endorsed the registry and said it should include information on each trial's purpose and objective, its design, and the dates it begins and ends. If the trial is not completed, the registry should include an explanation.
While drug companies have been eager to make public any positive results of their trials, recent revelations suggest they've balked at divulging tests when the results are not what they'd hoped to see. The furor has centered around the use of anti- depressants on children.
The industry has begun to make some moves to address the concerns about drug trials. Drug companies have agreed to set up a voluntary system of posting their drug trials on the Internet. But that seems unlikely to satisfy some members of Congress, who are expected to ! ntroduce legislation to establish a mandatory drug registry.
Last week, editors of a dozen influential medical journals announced that they would begin requiring drug companies to post a drug trial in a public database prior to accepting an article about it. Doctors rely on these articles to make treatment choices. The editors hope that the registry will force unfavorable drug studies, before kept secret, into the open.
Medical journals already had been tightening up on the authorship of their articles, insisting that authors declare if they had any conflicts of interest, such as any financial or other ties to the drug company, says Daniel Callahan, a director at the Hastings Center, a nonprofit bioethics research institute in Garrison, N.Y.
Information from previously undisclosed clinical trials could lower prices, reduce the number of badly designed trials, and help doctors considering the use of a drug for a non-approved purpose to know why it hash' t been approved for that use.
Antidepressant drugs "have some serious side effects ... that seem to be much more common than people realize.., much more common than you might think from seeing drug ads and from reports on drug studies," says Joel Gurin, executive vice president of Consumer Reports. His magazine just finished a survey of readers showing a "dramatic shift from talk therapy to drug therapy for mental health problems" during the
past decade. In 1995, less than half of people getting mental health treatment —40 percent- got drug therapy. Today 68 percent receive drug treatment, Mr. Gurin says.
Some studies coming to light show that antidepressants work no better than placebos. Even better than merely registering drug trials, Caplan (director of the Center for Bioethics at the University of Pennsylvania in Philadelphia) suggests, would be to require that a new drug not only be "safe and do what it' s sup- posed to do", but that it do it as well or better than other drugs already on the market. That, he says, would help push research into new areas and save money.
What causes the pressure to reform. the way clinical trials of all drugs are reported?
A.Growing concerns over the safety and efficacy of anti-depressant drugs prescribed to children.
B.The requirements of Congress and the New York state attorney general.
C.Changes within the pharmaceutical industry.
D.The information provided by a dozen influential medical journals.
第1题
关于老年性角化病,下列叙述正确的是
A、和脂溢性角化病同名
B、是老年人的生理性变化
C、好发于掌跖部
D、和日光性角化病不同名
E、是鳞癌的癌前期
第2题
皮肤老年性角化病是
A、角化亢进与肿瘤无关疾病
B、是癌前病变
C、是角化不全为主的疾病
D、是老年性表皮单纯增生
E、是病毒感染性疾病
第5题
脂溢性角化病是
A、良性表皮基底细胞肿瘤性增生
B、老年性非肿瘤性增生
C、炎症性皮肤病
D、色素痣
E、是癌前病变
第8题
下列皮肤病属于癌前期皮肤病的是()
A、脂溢性角化病
B、Bowen病
C、光化性角化病
D、皮肤纤维瘤
E、汗管瘤
第9题
下列除哪一项外均可能出现角化不良的病理变化()
A、毛囊角化病
B、白角化病
C、鳞状细胞癌
D、Bowen病
E、红斑
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