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  3. The "issues" reported were unthinkable. The physician who enrolled the most

The "issues" reported were unthinkable. The physician who enrolled the most

游客2025-04-16  29
问题     The "issues" reported were unthinkable. The physician who enrolled the most patients in the study, an Alabama weight-loss doctor, allegedly forged scores of signatures, enrolling "volunteers" every few minutes.
    By the time of the FDA review, she was under criminal investigation. (She’s now in federal prison. ) Another key researcher had been put on probation by the California medical board for gross negligence. He was arrested shortly after the study ended, when police, called to his home on a domestic violence complaint, found him with a bag of cocaine and waving a loaded gun at imaginary people. The study was so riddled with fraud and error that FDA reviewers decided it was useless.
    Yet Dr. Ross says he was told to reveal nothing about those problems to the advisory board, which recommended that the drug be approved. Later, he says, he was pressured to soften his report about Ketek’s liver toxicity to gain approval of higher-ups.
    Six million Americans have now used the drug, including hundreds of infants in a clinical trial designed to test Ketek’s effectiveness against ear infections. "How does one justify balancing the risk of fatal liver failure against one day less of ear pain?" One FDA scientist, Rosemary Johann-Liang, protested—to no avail—in a memo to her superiors. Most ear infections clear up in a few days on their own, she says.
    The agency says the controversy is overblown. "There was enough good, solid scientific data to make that decision. " Says FDA spokeswoman Julie Zawisza, pointing to what appeared to be a history of safe use of Ketek in other countries. Ketek has now been linked to 18 deaths and at least 134 cases of liver damage, according to an independent analysis u-sing FDA data. The real toll, some researchers say, may be far greater.
    Last October the FDA sent a warning letter to Sanofi-Aventis, Ketek’s maker, accusing the company of knowingly presenting compromised data to the agency, a charge the company denies. "We were not aware of the fraud," says spokeswoman Melissa Feltmann. "It was not until the FDA’s criminal investigators uncovered it that we became aware of it. "
    The question remains, What did the FDA and the drugmaker know about the fake safety data, and when?
    Congressmen John Dingell and Bart Stupak, both Michigan Democrats, are investigating that mystery right now in Congressional hearings.
    "Unfortunately," Stupak says, "the truth comes too late for some victims. " [br] What does the passage say about Rosemary Johann-Liang’s protest?
选项 A、It was lodged in vain.
B、It worried her superiors.
C、It was found groundless.
D、It aroused public attention.
答案 A
解析 本题考查归纳能力。第四段第二句：“How does one justify balancing the risk of fatal liver failure against one day less of ear pain?”one FDA scientist，Rosemary JohannLiang，protested--to no avail—in a memo to her superiors．Most ear infections clear up in a few days on their own，she says．句意为：食品和药品管理局的科学家Rosemary Johann—Liang抗议说：“甩肝功能衰竭的致命危险来减少一天的耳朵疼痛，有谁能权衡这一做法的合理性呢?”但是这种抗议对她的上级无济于事。她表示：大部分的耳朵感染患者在几天之内就能自行恢复。据此推断，此人的抗议是没有用的，所以A项符合题意。
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