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-u
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
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-u
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
Some heartening statistics were reported last year by the Journal of the National Cancer Institute: the mortality rate for breast cancer dropped nearly five percent between 1989 and 1992, the Largest decline since 1950. The numbers were even more dramatic for young women: between 1987 and 1992, the mortality rate plummeted nearly 18 percent among white women younger than 40.
But discouraging news also surfaced: the mortality rate among black women has gone up, and the number of reported breast cancer cases is rising as well. Twenty years ago a woman’s lifetime risk of breast cancer was one in 12; now it’s one in eight.
Nevertheless, we’re on the verge of a revolution in treating this disease. Researchers now have a clear picture of how a cancer cell becomes a tumor -- and how cells break free from a tumor and glide through the bloodstream to seed a new one in another part of the body. And they better understand how the female hormone estrogen mak
A. The mortality rate for breast cancer dropped.
B. The mortality rate among black women has increased.
C. The number of reported breast cancer cases is rising.
D. A woman’s lifetime risk of breast cancer is rising.
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