Expert Kept From Speaking at Antidepressant Hearing

  1. This 4/16/2004 New York Times article caught my eye. It's very interesting and potentially very disturbing. Understand that I am not an expert in psych issues. I'm most certainly not an expert in adolescent pyche issues and the effects of pych-drugs on adolescents. Honestly don't know what to believe. Don't know if Dr. Andrew D. Mosholder, an FDA epidemiologist, is an "alarmist"??? Or is Dr. Robert Temple, the Food and Drug Administration's associate director of medical policy, censoring important information???

    What do you all think??
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    http://www.nytimes.com/2004/04/16/po...16DEPR.html?hp

    Expert Kept From Speaking at Antidepressant Hearing
    By GARDINER HARRIS

    Published: April 16, 2004



    Top Food and Drug Administration officials admitted yesterday that they barred the agency's top expert from testifying at a public hearing about his conclusion that antidepressants cause children to become suicidal because they viewed his findings as alarmist and premature.

    "It would have been entirely inappropriate to present as an F.D.A. conclusion an analysis of data that were not ripe," Dr. Robert Temple, the Food and Drug Administration's associate director of medical policy, said in an interview. "This is a very serious matter. If you get it wrong and over-discourage the use of these medicines, people could die."

    Dr. Temple was seeking to quell a growing controversy into whether the agency's warnings on March 22 that antidepressant therapy could lead patients to become suicidal were sufficient.

    "There is concern that we hid data," said Dr. Temple. "We did not hide data. It was there for all to see."

    Recent studies have shown that children given antidepressants are more likely to become suicidal than those given placebos. But the studies have lead to different interpretations by psychiatrists. The refusal by drug companies to publish the studies has worsened the confusion. Internal agency documents obtained by The New York Times show that federal health officials are divided, too.

    Dr. Andrew D. Mosholder, an agency epidemiologist, was the man charged with analyzing 22 studies involving 4,250 children and seven drugs. In a carefully argued, 33-page memorandum, he concluded that children given antidepressants were almost twice as likely as those given placebos to become suicidal.

    He urged the agency to discourage doctors from prescribing to children all antidepressants except Prozac. Prozac is the only antidepressant proven effective in treating depressed children, and its studies showed no link with suicide, Dr. Mosholder wrote. Dr. Mosholder's conclusions mirrored those made by British health authorities.

    But Dr. Mosholder's supervisors, Drs. Mark Avigan and Anne Trontell, wrote memorandums disagreeing, according to the documents.

    "In particular, we disagree that the data are sufficiently robust to advocate preferential use" of Prozac in children, Dr. Trontell wrote.

    Health officials convened a special advisory committee on Feb. 2 to offer guidance on how the agency should respond to the studies. As the agency's principal reviewer, Dr. Mosholder was scheduled to speak. He was removed from the agenda, Dr. Temple said.

    Senator Charles E. Grassley, a Republican from Iowa and chairman of the Senate Finance Committee, said he was investigating whether the agency inappropriately suppressed crucial findings. Representative Joe L. Barton, a Republican from Texas who is chairman of the House Energy and Commerce Committee, said he was also investigating.

    "It would have been very wrong for the F.D.A. to withhold any information it had about unintended consequences that might result from the use of antidepressants, especially for children and adolescents," Mr. Grassley said.

    Dr. Temple was unapologetic about the decision.He said that Dr. Mosholder's underlying data were presented to the committee but that agency officials explained that Dr. Mosholder had failed to treat with the appropriate skepticism some reports of suicidal behavior.

    The Food and Drug Administration has hired investigators at Columbia University to examine reports from about 400 of the 4,250 children and determine independently which should be classified as suicidal.

    The controversy had its start when GlaxoSmithKline sought a six-month extension to its patents on Paxil. To help guide pediatricians' prescribing habits, federal law grants such extensions when companies test their medicines in children.

    The company's studies in depressed children failed to show any positive effect. It was a disappointing finding, but patent extensions are granted even when studies fail. Reviewing the data, Dr. Mosholder noticed in October 2002 that they showed a disturbing number of problems listed under the category, "emotional liability." Suicidal thoughts and self-injurious behavior were among the things lumped into this category. Dr. Mosholder asked GlaxoSmithKline to provide more detail about these cases, according to one of the documents.

    In May 2003, the company submitted a new report. It showed that children given Paxil were more likely to become suicidal than those given placebos. In June, the agency announced that doctors should avoid using Paxil in depressed children.

    Three days later, according to documents and interviews, the agency asked for similar data from the makers of Prozac, Zoloft, Luvox, Celexa, Wellbutrin, Effexor, Serzone and Remeron.

    Dr. Mosholder found that 108 of the 4,250 children had done something that merited being called suicidal. He divided the cases into those who were given drugs and those given placebos and found that children given drugs were almost twice as likely to become suicidal as those given placebo.

    The agency declined to make Dr. Mosholder available for an interview.
    Last edit by Ted on Apr 16, '04 : Reason: Spelling. . . always spelling! :o
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  2. 7 Comments

  3. by   teeituptom
    Anyone who works ER can tell you that one
  4. by   SmilingBluEyes
    -------------and in nursing school.
    Remember, when on antidepressant therapy, ESPECIALLY ON STARTING THERAPY, a depressed person is at increased risk of suicidal attempts as he/she emerges from severe depression. The reason is the person who may be too depressed to take action in the beginning, may actually gain the energy and "will" to actually follow thru with his/her ideation when the antidepressant lifts the fog he/she is in.

    This is in all the basic psych textbooks in nursing school. I am not surprised by this one bit.
  5. by   maureeno
    after 30 years of mental health work
    I trust nothing
    especially Big Pharma
    and
    those I have come to term
    'drug whores'
    [prescribers who consort]

    a huge topic too big for me today...


    edited to add
    SSRI's have a peculiar effect for some
    beyond the increased energy and ability to form suicidal goals
  6. by   Ted
    Quote from SmilingBluEyes
    -------------and in nursing school.
    Remember, when on antidepressant therapy, ESPECIALLY ON STARTING THERAPY, a depressed person is at increased risk of suicidal attempts as he/she emerges from severe depression. The reason is the person who may be too depressed to take action in the beginning, may actually gain the energy and "will" to actually follow thru with his/her ideation when the antidepressant lifts the fog he/she is in.

    This is in all the basic psych textbooks in nursing school. I am not surprised by this one bit.
    I remember this now that I read your post. (It's been many years since taking the psych nursing course. :imbar ) Makes a great deal of sense.

    Quote from maureeno
    after 30 years of mental health work
    I trust nothing
    especially Big Pharma
    and
    those I have come to term
    'drug whores'
    [prescribers who consort]
    For many reasons, I don't trust "Big Pharma" either . . .

    Ted
    Last edit by Ted on Apr 16, '04
  7. by   maureeno
    I want to revive this thread because it is
    our responsibility as nurses
    to be informed of the event
    of our F.D.A.
    suppressing information

    this is the pattern of this administration
    further proof of their caring for corporate over human interests

    the F.D.A. is to protect us, not drug companies

    it is well documented drug companies distort and suppress
    http://www.reuters.co.uk/newsArticle...9&section=news


    in checking about Dr. Robert Temple, M.D.
    Director Office of Medical Policy and Office of Drug Evaluation I, Center for Drug Evaluation and Research, U.S. Food and Drug Administration
    I found he has engaged in four debates with Dr. Jay Cohen
    whose web site I will share along with my opinion:
    Dr. Cohen "cool"
    Dr. Temple "pharm cat""

    http://www.medicationsense.com/recent_lectures.html
  8. by   teeituptom
    revive it away hay hay hay
  9. by   sbic56
    I took part in a grief session for parents, friends and family of an adolescent who suicided while on SSRI therapy. It had a profound effect on me. This mom trusted that her son was being given the best treatment possible for his depression. I could only imagine how she must feel now. I always question when SSRI's are prescribed for anyone under 18 now. Adolosent depression differs from adult depression. Their inpulsivity is much greater, for one. All it takes is that few moments of extreme emotion and impulsivity to make a choice they can never take back.

    I also hate the big drug companies. So much money to be made at the expense of anyone who takes their drug. Big business has no heart. Thank goodness for us; we advocate for our patients best interest where the drug companies surely don't.

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