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unit 4 REDUX ON THE ROPES time july 7.doc
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Unit 4. Taking chances

Read the article.

REDUX ON THE ROPES

Bad news, bad luck and too high hopes add up to disappointing sales for last year’s hot new diet pill.

By Christine Gorman

1. The distinctive black-and-white sweater-striped pill was supposed to make millions of Americans thin – and its manufacturer rich. But a year after the drug called Redux was approved for sale by the U.S. Food and Drug Administration, the hot new pill has fallen short on both counts. At $200 million a year, sales are flat and lagging far behind the initial $1 billion-a-year expectations. …………………….

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2. There is more bad news to come. Last month the FDA received a letter signed by several dozen neuroscientists blasting the agency for not opening up the post-approval monitoring process more fully. The FDA, these doctors charge, continues to ignore animal tests that suggest prolonged use of Redux can destroy nerve tissue. “Laboratories around the world have found that the drug has serious brain toxi­city,” says Dr. Mark Molliver of the Johns Hopkins Medical School. …………………………………..

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3. In some respects Redux has been a vic­tim of its own early success. The first new antiobesity medication in more than 20 years, the drug enjoyed one of the fastest launches in U.S. pharmaceutical history. Both the FDA and Wyeth-Ayerst Laborato­ries, which market Redux, knew about the possibility of brain damage at high doses. But they also knew people who are mor­bidly obese —individuals who weigh 30% more than average — face even greater risks that they will die young from heart disease, diabetes or stroke. …………………………………………………………………………

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4. Still, the FDA was not entirely satisfied, and as a condition of approval it required that Wyeth-Ayerst conduct a follow-up study to determine whether Redux users were suffering any ill effects from the drug. ………………………………………………………………………………………………………

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5. In the meantime, the drug has become a magnet for bad press – most of it unwarranted, if not downright false. In February, after the FDA met behind closed doors with officials from Wyeth-Ayerst to iron out details of the follow-up study, critics cried “cover-up” – as if the FDA never granted drug companies private meetings in order to protect trade secrets. In April the Associated Press reported that a 38-year-old, 54 kg woman had died after taking Redux for just a few days. ………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………

6. Bad press can, with time and a big enough marketing budget, be surmounted. Failing to deliver is another matter. “It just doesn’t seem to work that well”, says Dr. Richard Joseph, an obesity expert in Naperville, Ill. …………………………………………………………………………………………….

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7. Joseph is not sure why Redux has not panned out for more of his patients. It may be that they put too much faith in the pill to make them thin without their having to eat less or exercise more. But Joseph also suspects a biochemical explanation. Redux, like “fen/phen” before it, boosts the levels of serotonin, a neurochemical that, among other things, signals the brain that the body has had enough food. “If a lack of serotonin is the reason patients are overeating, then Redux should work beautifully,” Joseph says. “But if they are overeating for some other reason, then it probably won’t do any good. The question no one has answered is, What percentage of overweight people have low serotonin levels?”

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8. Meanwhile, competition is heating up. Last month an FDA advisory panel recommended approval of a drug called orlistat that works on the gut instead of the brain – reducing calorie intake by blocking the body’s ability to absorb fat. Orlistat has its problems – its side effects include intestinal leakage. That doesn’t mean orlistat will not be a big seller, at least at first. …………………………………………….

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Reported by Lawrence Mondi/New York and Dick Thompson/Washington

“Time”

II. Match the endings with the appropriate paragraphs.

  1. Such studies are impossible, experts say, without doing a biopsy on living brain tissue.

  2. It turned out that she weighed 100 kg and was in fact murdered – a turn of events that can hardly be blamed on the diet pill. The AP issued a correction, but the damage to the drug’s image had been done.

  3. “We made the decision that the benefits outweigh the risks, at least for the population we identified,” says Dr. James Bilstad, the FDA official who over­sees drugs for metabolic disorders.

  4. But if folks buy it expecting weight-loss miracles, they are found to be as disappointed next year as Redux users are today.

  5. Some who have taken Redux have discovered that it is not the magic melting potion they hoped it would be; others who were thinking of taking it have been frightened off by stories about potentially harmful side effects – including a news report (later proved false) that a woman had died after taking Redux.

  6. Wyeth-Ayerst's critics say the company has been dragging its feet.

  7. “I consider only a few of my patients Redux success stories.”

  8. “It has the po­tential for producing brain damage.”

Vocabulary work

  1. Do the matching and memorize the words and their definitions.

    1. disappointing

  1. introduce (a new product or publication) to the public for the first time

    1. distinctive

  1. to overcome (a difficulty or obstacle)

    1. lag behind

  1. an examination of tissue removed from a living body to discover the presence, cause, or extent of a disease

    1. potion

  1. failing to fulfil someone's hopes or expectations

    1. to blast (informal)

  1. to soak up or take in

    1. vic­tim

  1. a chemical produced naturally in your brain that affects the way you feel, for example making you feel happier, calmer, or less hungry

    1. launch

  1. to help or encourage (something) to increase or improve

    1. to market

  1. to supervise (a person or work)

    1. to oversee

  1. to criticize fiercely

    1. cover-up

  1. a person harmed, injured, or killed as a result of a crime, accident, or other event or action

    1. to surmount

  1. an attempt to prevent people's discovering the truth about a serious mistake or crime

    1. to boost

  1. has a special quality or feature which makes it easily recognizable and different from other things of the same type.

    1. serotonin

  1. to fall behind in movement, progress, or development; not keep pace with another or others

    1. biopsy

  1. to offer for sale

    1. to absorb

  1. a liquid with healing, magical, or poisonous properties

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