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FDA approves Abilify for pediatric "bipolar"

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    ALLIANCE FOR HUMAN RESEARCH PROTECTION Promoting Openness, Full Disclosure, and Accountability http://www.ahrp.org and http://ahrp.blogspot.com FYI Will
    Message 1 of 1 , Feb 29, 2008
      Promoting Openness, Full Disclosure, and Accountability
      http://www.ahrp.org and http://ahrp.blogspot.com

      Will somebody stop the FDA from approving chemical weapons of destruction
      aimed at America's children?

      The documented, demonstrable risks of severe harm produced by the second
      generation antipsychotic drugs is uncontestable.
      Even leading schizophrenia researchers with financial ties to manufacturers,
      such as Dr. Jeffrey Lieberman, chairman of psychiatry at Columbia
      University, acknowledge:
      ``The major problem with second-generation antipsychotic drugs is weight
      gain and diabetes. `The younger you are, the more severe and common these
      side effects.''

      Despite the severity of the risks, and despite the lack of evidence of a
      therapeutic benefit, the FDA has just approved Abilify for use in children
      for "bipolar" disorder, which is the "diagnosis" du jour for bad behavior.
      The FDA once again, acted irresponsibly, lending the government seal of
      approval without so much as a public hearing! The FDA approval of Risperdal
      for children was similarly meted out.
      See new Abilify label:

      The FDA seems to have launched an undeclared War on America's children whose
      mental and physical health are being jeopardized to increase profits and
      shield companies from illegal off-label promotion of the most toxic drugs
      used for non-life-threatening disease.

      Congressional action is urgently to stop the catastrophic consequences.

      Contact: Vera Hassner Sharav

      Bristol-Myers Drug Cleared to Treat Pediatric Bipolar
      By Beth Jinks

      Feb. 28 (Bloomberg) -- Bristol-Myers Squibb Co.'s antipsychotic medicine
      Abilify was cleared by U.S.
      regulators to treat bipolar disorder in children as young as 10.

      The U.S. Food and Drug Administration approved the added use for the pill,
      the agency said today in new prescribing information posted on its Web site.
      Abilify is already marketed for adults with bipolar disorder and major
      depression, and for schizophrenia in people 13 and older.

      Sales of Abilify, the New York-based company's second-best seller, climbed
      29 percent to $1.66 billion last year, helped by studies showing it caused
      less weight gain than competing treatments. The only other drug in the class
      known as atypical antipsychotics that is approved to treat bipolar disorder
      in children 10 and older is Johnson & Johnson's top-selling Risperdal, which
      won U.S. clearance for that use in August.

      Abilify offers a potential advantage over other atypical antipsychotics
      because ``it doesn't cause to the same degree weight gain and metabolic''
      disorders, said Jeffrey Lieberman, chairman of psychiatry at Columbia
      University in New York, in a telephone interview yesterday.

      ``The major problem with second-generation antipsychotic drugs is weight
      gain and diabetes,'' Lieberman said.
      ``The younger you are, the more severe and common these side effects.''

      Rising Diagnosis
      The number of American children diagnosed with bipolar disorder, once known
      as manic depression, jumped 40-fold from 1994 to 2003, according to a study
      in the Archives of General Psychiatry released in September.By 2003, the
      diagnosis was applied to 1 in 100 kids, researchers found.

      Bristol-Myers fell 29 cents, or 1.3 percent, to $22.91 at 4:17 p.m. in New
      York Stock Exchange composite trading. The company has dropped 13 percent in
      12 months.

      >From 2003 to 2006, U.S. prescriptions for Abilify for children 18 years and
      younger soared sevenfold to more than 1 million, according to data from
      Wolters Kluwer NV, a drug- tracking company. Doctors can prescribe medicines
      for uses not approved by the FDA, such as using Abilify in young children,
      although drugmakers can't market their products for such ``off- label''

      ``It wasn't well-recognized before, and in all candor there's probably an
      over-diagnosis,'' Lieberman said.
      ``There's some fuzziness around the diagnosis which leads to some children
      believed to have bipolar disorder, who don't turn out to have it when they
      grow up.''

      `Be Judicious'
      Doctors need to be ``very judicious in their use of these drugs,''
      particularly in children, Lieberman said.

      Adults with bipolar disorder often stay lodged for weeks or months in states
      of deep depression, then shift to a manic phase in which they sleep little,
      have intense energy, talk rapidly, and may engage in risky behavior.

      Some psychiatrists say the disorder looks different in children, who may
      alternate more rapidly between depression and mania, or demonstrate
      moodiness, irritability and volatility. The condition has been linked to
      poor school performance and substance abuse.

      In November, Abilify was cleared by U.S. regulators to treat adults with
      severe depression, and for use by teens with schizophrenia. The drug was
      first approved in 2002 to treat adult schizophrenia, a condition that causes
      distorted thinking, hallucinations and an inability to feel normal emotions.

      `Evidence of Commitment'
      ``The approval is one of a series we've had for Abilify in a short amount of
      time,'' Sonia Choi, a Bristol-Myers spokeswoman, said in a phone interview.
      ``This is evidence of our commitment to developing medicines to their full

      Abilify is second among Bristol-Myers' products to the blood-thinner Plavix,
      which had $4.76 billion in sales last year.

      Antipsychotic drugs reduce levels of dopamine, a brain chemical that, in
      excess, is thought to cause symptoms of psychosis and mania.

      Atypical psychotics, which include Abilify, Risperdal and Eli Lilly & Co.'s
      Zyprexa, first came on the market in the mid- 1990s. The products were
      marketed as causing fewer of the neurological side effects that made users
      of earlier medications, such as Haldol and Thorazine, tremble, doze off and
      jerk involuntarily.

      Seroquel and Geodon
      Other antipsychotics include AstraZeneca Plc's Seroquel and Pfizer Inc.'s
      Geodon. Bipolar disorder is often also treated with anticonvulsants,
      developed to treat epileptic seizures.

      Lilly's request to sell Zyprexa to treat schizophrenia and bipolar disorder
      in teenagers was delayed by the FDA in April. Lilly received what the FDA
      calls an approvable letter, indicating the agency needs more time to analyze
      data and to determine the drug's prescribing information.

      ``We don't have a time frame at this point,'' Lilly spokeswoman Marni Lemons
      said in a phone interview.
      ``We have no intention for promoting the drug for use in adolescents. We
      want to add information to the label.''

      J&J reported $4.7 billion in revenue from anti-psychotic medicines including
      Risperdal last year, up 12 percent from 2006. The company doesn't report
      separate sales figures for Risperdal.

      Bristol-Myers and Tokyo-based Otsuka Pharmaceutical Co. said Nov. 15 they
      had won priority FDA review of a study testing Abilify on patients 10 to 17
      years old diagnosed with bipolar disorder. Priority review speeds up the
      approval process, which typically takes about six months with pediatric

      Otsuka discovered Abilify and retains marketing rights to the drug in Japan
      and some other Asian markets.

      Europe's Committee for Medicinal Products for Human Use recommended Feb. 22
      that Abilify be approved to treat bipolar disorder. The drug was approved by
      the European Commission as a schizophrenia treatment in Europe in 2004.

      To contact the reporter on this story: Beth Jinks in New York at
      Last Updated: February 28, 2008 17:36 EST

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