Conference rocks::weight_control

904.0. "Redux/dexfenfluramine obesity drug information" by TNPUBS::PAINTER (Planet Crayon) Wed Nov 15 1995 19:28

    
    AP 29 Sep 95 0:30 EDT V0962
 
    Copyright 1995 The Associated Press. All rights reserved.
 
    FDA Rejects Obesity Drug Sale

    ROCKVILLE, Md. (AP) -- A new drug effectively fools obese patients into
    feeling full so that they will lose weight, scientists told the Food
    and Drug Administration. 

    But a bitterly divided FDA panel couldn't put aside worries about a
    theoretical risk that it could cause brain damage, so the government
    advisers voted 5-3 Thursday to reject the drug's sale in this country. 

    The issue remains open, however, after a panelist won a revote. 

    "I cannot live with my conscience tonight," proponent Dr. Nemat Borhani
    of the University of California, Davis, said after he was outvoted. 

    His impassioned plea for the first new obesity drug in 22 years
    prompted the panel to revote -- but after three opponents had gone
    home. The three supporters again voted yes, two opponents voted no, and
    the ballot remained open Friday for the three missing panelists to
    finally decide the issue. 

    Interneuron Pharmaceuticals Inc. said its dexfenfluramine helped 40
    percent of patients studied lose up to 10 percent of their body weight,
    twice that lost with diet alone. The majority lost 5 percent to 10
    percent. 

    But when dexfenfluramine is given in ultra-high doses to animals it can
    permanently alter their brain chemicals. There is no proof that this
    happens in people and dexfenfluramine would only be given to Americans
    in one-tenth of the dose found to be risky. Still, the finding worried
    the FDA panel. 

    Two doctors raised the fear that Redux -- the drug's brand name --
    could hurt patients. Redux given at high doses cripple animals' ability
    to produce serotonin naturally after the drug is stopped, studies show. 

    These drugs "should be used with the greatest caution if at all," said
    Lewis Seiden of the University of Chicago. 

    Some FDA panelists questioned whether Seiden's concern was relevant
    because the animals were given doses 20 to 30 times higher than any
    person would take. The company said it has seen no sign of brain damage
    in the 10 million people who have taken Redux in the 65 countries where
    it is sold. 

    The panel said Interneuron should answer the concerns with a
    well-designed two-year trial of Redux in Americans. 

    The panel also was more concerned with indications that Redux could
    cause a fatal lung disease in certain patients. This disease, primary
    pulmonary hypertension, affects one or two of every million people, but
    obliterates the lungs' ability to get oxygen to the heart. 

    But most of the panelists agreed that Redux's risk was very small --
    and acceptable -- for this disease. One study shows that at worst Redux
    could cause 10 deaths in five years from this disease, compared with
    the hundreds of obesity-related deaths the drug could prevent in the
    same time, said Gerald Faich of the University of Pennsylvania. 

    Not everyone responds to the pill, however, and the company suggested
    that doctors discontinue therapy for any patient who does not lose four
    pounds within the first month of taking Redux. 

    Obesity, defined as being more than 20 percent over ideal weight,
    causes 20 million new illnesses in the United States yearly and kills
    300,000. 

    Doctors typically urge patients to diet and exercise to drop the
    pounds, but almost all the few who succeed regain the weight within
    five years. The FDA has not approved any drug that can be used by these
    patients for more than several months because of concerns about risks.
    The majority of approved obesity drugs are amphetamines, which can be
    addictive. 

    The only nonamphetamine treatment is called fenfluramine, and
    Interneuron is seeking to sell a chemical relative of that drug for
    patients to use for years at a time. Dexfenfluramine is safer and
    possibly more effective than its older cousin, the company said. 

    Interesting article.  Thanks, Cindy.
    
    What happened in the end?  Did the missing panellists return and veto
    the sale again?
    
    The numbers suggest that the value of this drug is considerable and its
    risks small.  So there seems to be no good reason why it shouldn't be
    on sale.  And yet I feel uneasy when reading about slimming drugs,
    foods, etc, which people may come to depend on to stay slim as well as
    for the initial weight loss.  Alternatively, if the idea is to come off
    the drug on completing your diet, the rebound must be doubly hard.  You
    take the drug, get used to feeling "full", don't eat so much, and lose
    weight.  Then you reach your target weight, come off the drug, and
    suddenly your insides are knocking together and you're s t a r v i n g!
    It's hard enough just to transition from a normal diet to weight
    maintenance, as I know all to well to my cost.
    
    A tough decision for the FDA.  To be honest, I'm glad I wasn't one of
    the panellists.
    
    Brian

    I believ this got approved to be sold.  I have been hearing
    clips here and there, but I haven't been able to get the whole
    news.  Does anyone know when it is coming out?
    
    RS