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...wait, haven't we heard this story before? Does the phrase "water pill" ring a bell? Three years ago another big NIH study showed that a cheap, old-fashioned diuretic (a.k.a. water pill) worked better for most folks with high blood pressure than did costly, cutting-edge medications. (These included a calcium-channel blocker and an ACE inhibitor). Then there's the sad lesson of Vioxx and its ilk. That category of painkillers captured a $5 billion-a-year market on the celebrated promise that they were safer than older, cheaper analgesics like Tylenol or Advil. In this case...

Author: /time Magazine | Title: Viewpoint: Why New Drugs Don't Live Up to the Hype | 9/30/2005 | See Source »

...surprising answer is no. Sure, the FDA is supposed to make sure that new drugs are safe and effective and that promotional claims about them don't get out of hand, but the agency defines efficacy as outperforming a sugar pill. "You do not have to show one drug is better than another," explains Dr. Robert Temple, who heads the FDA's office of medical policy. (The exception: new drugs are tested against older therapies in devastating ailments like cancer or AIDS, when it would be unethical to give a control group placebos.) While Temple plainly sees the value...

Author: /time Magazine | Title: Viewpoint: Why New Drugs Don't Live Up to the Hype | 9/30/2005 | See Source »

...politics keeping the long-delayed emergency contraceptive known as the morning- after pill, or Plan B, off the over-the-counter market? Advocates of making the drug more easily available were infuriated when U.S. Food and Drug Administration (FDA) Commissioner Lester Crawford announced on Aug. 26 that he was delaying a decision on the pill yet again to allow time for additional study and public comment. Assistant commissioner Susan Wood, who heads the FDA'S Office of Women's Health, last week resigned in protest, saying she could "no longer serve as staff when scientific and clinical evidence, fully evaluated...

Author: /time Magazine | Title: Morning After at the FDA | 9/6/2005 | See Source »

...unusual in contradicting the advice of scientists at his own agency. In a 12-page internal memo obtained by TIME, Dr. Steven Galson, acting director of the FDA's Center for Drug Evaluation and Research, urged that Barr Laboratories, which makes the drug, be allowed to sell the pill over the counter, albeit with age restrictions. In the memo, written on Aug. 26, Galson argued that Plan B had been proved "safe and effective without the supervision of a practitioner licensed by law for women ages 17 and older." Subordinates had argued for an even less restrictive rule, with...

Author: /time Magazine | Title: Morning After at the FDA | 9/6/2005 | See Source »

Opponents of the pill, who say they consider its effects indistinguishable from abortion, make no apologies about treating it as a political issue. Two days before Crawford's announcement, a group headed by conservative activist Paul Weyrich forwarded an e-mail to like-minded advocates, asking them to "call the White House comment line as soon as possible to say 'No Plan B!'" Why were the calls directed to the White House and not the FDA? "I'm told they take notes on the calls," says Paul Caprio, author of the e-mail, "and that information gets to the President...

Author: /time Magazine | Title: Morning After at the FDA | 9/6/2005 | See Source »

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