单选题 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 using 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. /

单选题 According to Paragraph 1, the Alabama physician was accused of ______.
A. forcing people to join his study
B. administering illegal drugs to patients
C. exaggerating some drug's effects
D. inventing evidence for her research
【正确答案】 B
【答案解析】[解析] 考查第一段中阿拉巴马的内科医生遭到了怎样的指控。根据文中“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.”可知这位内科医生捏造假的签名书,给那些减肥的人服下非法药物,因此本题选B。
单选题 The key researcher had probably been put on probation by the California medical board because he had ______.
A. failed to fulfill his supervising duties
B. threatened to kill some of his neighbors
C. hidden a bag of cocaine in his office
D. abused his wife and children at home
【正确答案】 A
【答案解析】[解析] 考查主要的研究人员很可能会遭到加利福尼亚医委会对其缓刑的原因。根据文由“Another key researcher had been put on probation by the California medical board for gross negligence”可知这位主要的研究人员因为重大过失而遭到缓刑这一裁决,因此本题选A。
单选题 It can be inferred that Ketek is a medicine which ______.
A. helps lose weight B. helps improve memory
C. treats ear problems D. treats liver problems
【正确答案】 C
【答案解析】[解析] 考查可以推断出Ketek是一种怎样的药物。根据文中“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.”可知Ketek是一种用来治疗耳朵的药物,因此本题选C。
单选题 What does the passage say about Rosemary Johann-Liang's protest?
A. It was lodged in vain. B. It worried her superiors.
C. It was found groundless. D. It aroused public attention.
【正确答案】 C
【答案解析】[解析] 考查文中对Rosemary Johann-Liang的抗议是如何说的。根据文中““How does one j ustify 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.”可知此人的反对意见是毫无根据的,因此本题选C。
单选题 FDA suspected Sanofi-Aventis of ______.
A. being unqualified to make drugs
B. scheming to do the fraud
C. letting the misconduct go
D. being unaware of the crime
【正确答案】 B
【答案解析】[解析] 考查食品及药物管理局怀疑赛诺菲安万特什么。根据文中“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”可知怀疑该制药商有意欺骗,因此本题选B。