WASH POST: Antidepressant Makers Withhold Data on Children

Discussion in 'Health and medical' started by Ilena, Jan 29, 2004.

  1. Ilena

    Ilena Guest

    Antidepressant Makers Withhold Data on Children

    By Shankar Vedantam Washington Post Staff Writer Thursday, January 29, 2004; Page A01

    http://www.washingtonpost.com/ac2/wp-dyn/A58130-2004Jan28?language=printer

    Makers of popular antidepressants such as Paxil, Zoloft and Effexor have refused to disclose the
    details of most clinical trials involving depressed children, denying doctors and parents crucial
    evidence as they weigh fresh fears that such medicines may cause some children to become suicidal.

    The companies say the studies are trade secrets. Researchers familiar with the unpublished data said
    the majority of secret trials show that children taking the medicines did not get any better than
    children taking dummy pills.

    Although the drug industry's practice of suppressing data unfavorable to its products is legal,
    doctors and advocates say such secrecy distorts the scientific record.

    "Conflicts of interest and the company control of the data have thrown out the scientific method,"
    said Vera Hassner Sharav, a critic of the drugs and a patients' rights advocate. "If hundreds of
    trials don't work out, they don't publish them, they don't talk about them."

    "We need a journal of negative findings," agreed Darrel Regier, director of the American Psychiatric
    Association's division of research, who believes the drugs save children's lives. "The probability
    of those negative findings being published is far less than the chances of positive studies -- even
    journals are not interested in negative studies."

    Concerns over the safety of antidepressants among children have been heightened after a December
    warning by British regulators that the drugs may trigger suicidal thoughts and increase the rate of
    self-injury. An expert advisory panel of the Food and Drug Administration is scheduled to meet
    Monday to examine the issue, but the agency's full U.S. analysis of the data is not likely to be
    completed until summer.

    One industry executive, Philip Perera, a medical director at GlaxoSmithKline, said that his
    preference was to publish all trials but that negative studies could lead doctors to prematurely
    reject a medicine.

    "If you start publishing negative data, will it be concluded by practitioners and others that
    the drug is ineffective?" he asked, saying that genuinely effective medicines sometimes do no
    better than placebos, or dummy pills, in trials -- at least half of all children seem to get
    better on placebos.

    The U.S. psychiatric establishment largely supports the use of antidepressant medicines in children,
    with many arguing that abandoning the drugs would lead to more suicides in children with depression.
    But its critics, including consumer advocates and some psychiatrists , question whether mainstream
    psychiatry is biased by widespread financial ties to the pharmaceutical industry.

    The answer lies hidden in a maze of secret data, conflicting scientific interpretations and a corporate-
    funded clinical trial system that is not primarily designed to answer questions of public health.

    "If the companies wanted to publish negative studies they could, but companies don't like to publish
    negative studies," said Russell Katz, director of the neuropharmacology division at the FDA , which
    has access to all the data. "It's amusing so many people are making pronouncements about the data --
    scientists and physicians -- . . . without seeing the data."

    Advocates say openness about studies is important because, apart from Prozac, no antidepressant has
    been approved by the FDA for treating children with depression. Doctors writing prescriptions do not
    have approved labeling to guide them: They must rely on their own judgment and the available
    scientific knowledge -- even as information is being withheld.

    The medicines under scrutiny belong to a class of drugs called selective serotonin reuptake
    inhibitors, or SSRIs. Led by Prozac, the first to be approved, the medicines caused a revolution in
    psychiatry.

    Recent analyses suggest that as many as 1 percent of children in the United States are treated for
    depression in any year, said Mark Olfson, a professor of clinical psychiatry at Columbia University.
    Of those, 57 percent are on antidepressants.

    The lack of information is the one issue about which advocates and critics of the medicines agree.
    Lawrence Diller, a Walnut Creek, Calif., pediatrician and author of "Should I Medicate My Child?,"
    said that "as a front-line doctor dependent on research, it seems so contaminated by potential
    conflicts of interest. . . . The smoking gun is revelations from the British that negative studies
    were not published."

    Keeping data secret, critics said, has led to conflicting information, contradictory advice and
    heightened fears.

    For example, GlaxoSmithKline, which makes Paxil, has conducted three trials on depressed children.
    Company officials said all turned out negative -- the children on the drug did not do better than
    those on placebos -- but only one was published. Based on its data, the company warned British
    doctors that Paxil, sold there as Seroxat, "should not be prescribed as new therapy" to depressed
    children younger than 18. Its letter last June cited the risk of increased hostility, agitation, and
    suicidal thoughts and attempts.

    No such warning was issued in the United States, though Paxil is identical to Seroxat. Here, the
    company's official line on giving Paxil to children is "No recommendations can be made regarding the
    use of Paxil or Paxil CR in these patients."

    "There are differences" between the two recommendations, GlaxoSmithKline's Perera acknowledged in an
    interview. "They reflect the message that we receive from the respective regulatory bodies." British
    regulators have essentially prohibited the use of Paxil for children. The FDA is conducting a review
    of eight drugs, including Paxil.

    Perera said the company would await the FDA advisory panel's verdict before considering whether to
    make all its data public.

    Cathryn Clary, vice president for psychiatry and neurology at Pfizer, which makes Zoloft, said it
    had sponsored two trials in children. One had a negative result, but the company pooled it with a
    positive study and only published the combined result, which was positive.

    "We certainly understand the wish of academics and researchers and physicians to understand all of
    this data," she said. But small sample sizes in trials "run the risk of magnifying or diminishing a
    signal. Releasing an individual study can be as misleading as it is helpful."

    Graham Emslie, a professor of psychiatry at the University of Texas Southwestern Medical Center, who
    has helped conduct several trials for drug companies, counted nine recent trials of Prozac, Paxil,
    Zoloft and Celexa in depressed children. Results of two Prozac trials, one Paxil and the pooled
    Zoloft data have been published -- meaning that data from five trials, including the stand-alone
    Zoloft trial that was negative, have not.

    Emslie also counted six other studies on the related antidepressants Effexor, Serzone and Remeron --
    none of which has been published, he said. Data from several of the unpublished studies have been
    presented at scientific meetings, and one has been submitted for publication, he said.

    Studies reported at conferences are not subject to rigorous advance "peer review" by independent
    researchers, as are studies published by well-regarded journals. Emslie said he would like to see
    all the data published but he said the research had been paid for -- and belongs to -- the
    companies. "They have a legitimate right to do what they want with the data," he said.

    But David Healy, a Welsh psychiatrist and author of "The Antidepressant Era," rejected the notion
    that the safety information could be treated like any other private property. Healy prescribes the
    medicines but has campaigned for more cautious use and more accurate labeling.

    "On a pressing issue like this," he said, "there is no reason these data could not be put into the
    public domain in their entirety."

    The FDA said it is evaluating 20 studies in all, but agency officials have declined to
    identify them.

    In the end, some scientists believe, the only way to ensure that science is conducted in the public
    interest is for it to be funded with public dollars. The National Institutes of Health is therefore
    ramping up funding for clinical trials.

    "We have been dependent on the pharmaceutical industry to provide the answers," said Thomas R.
    Insel, director of the National Institute of Mental Health. "The questions they want answered are
    different than the public health questions."
     
    Tags:


  2. Jan

    Jan Guest

    >Subject: WASH POST: Antidepressant Makers Withhold Data on Children
    >From: [email protected] (Ilena)
    >Date: 1/29/2004 7:25 AM Pacific Standard Time
    >Message-id: <[email protected]>
    >
    >Antidepressant Makers Withhold Data on Children

    EVIL organized medicine exposed again!!

    Jan

    >By Shankar Vedantam Washington Post Staff Writer Thursday, January 29, 2004; Page A01
    >
    >http://www.washingtonpost.com/ac2/wp-dyn/A58130-2004Jan28?language=printer
    >
    >
    >Makers of popular antidepressants such as Paxil, Zoloft and Effexor have refused to disclose the
    >details of most clinical trials involving depressed children, denying doctors and parents crucial
    >evidence as they weigh fresh fears that such medicines may cause some children to become suicidal.
    >
    >
    >
    >The companies say the studies are trade secrets. Researchers familiar with the unpublished data
    >said the majority of secret trials show that children taking the medicines did not get any better
    >than children taking dummy pills.
    >
    >Although the drug industry's practice of suppressing data unfavorable to its products is legal,
    >doctors and advocates say such secrecy distorts the scientific record.
    >
    >"Conflicts of interest and the company control of the data have thrown out the scientific method,"
    >said Vera Hassner Sharav, a critic of the drugs and a patients' rights advocate. "If hundreds of
    >trials don't work out, they don't publish them, they don't talk about them."
    >
    >"We need a journal of negative findings," agreed Darrel Regier, director of the American
    >Psychiatric Association's division of research, who believes the drugs save children's lives. "The
    >probability of those negative findings being published is far less than the chances of positive
    >studies -- even journals are not interested in negative studies."
    >
    >Concerns over the safety of antidepressants among children have been heightened after a December
    >warning by British regulators that the drugs may trigger suicidal thoughts and increase the rate of
    >self-injury. An expert advisory panel of the Food and Drug Administration is scheduled to meet
    >Monday to examine the issue, but the agency's full U.S. analysis of the data is not likely to be
    >completed until summer.
    >
    >One industry executive, Philip Perera, a medical director at GlaxoSmithKline, said that his
    >preference was to publish all trials but that negative studies could lead doctors to prematurely
    >reject a medicine.
    >
    >"If you start publishing negative data, will it be concluded by practitioners and others that the
    >drug is ineffective?" he asked, saying that genuinely effective medicines sometimes do no better
    >than placebos, or dummy pills, in trials -- at least half of all children seem to get better on
    >placebos.
    >
    >The U.S. psychiatric establishment largely supports the use of antidepressant medicines in
    >children, with many arguing that abandoning the drugs would lead to more suicides in children with
    >depression. But its critics, including consumer advocates and some psychiatrists , question whether
    >mainstream psychiatry is biased by widespread financial ties to the pharmaceutical industry.
    >
    >The answer lies hidden in a maze of secret data, conflicting scientific interpretations and a corporate-
    >funded clinical trial system that is not primarily designed to answer questions of public health.
    >
    >"If the companies wanted to publish negative studies they could, but companies don't like to
    >publish negative studies," said Russell Katz, director of the neuropharmacology division at the FDA
    >, which has access to all the data. "It's amusing so many people are making pronouncements about
    >the data -- scientists and physicians -- . . . without seeing the data."
    >
    >Advocates say openness about studies is important because, apart from Prozac, no antidepressant has
    >been approved by the FDA for treating children with depression. Doctors writing prescriptions do
    >not have approved labeling to guide them: They must rely on their own judgment and the available
    >scientific knowledge -- even as information is being withheld.
    >
    >The medicines under scrutiny belong to a class of drugs called selective serotonin reuptake
    >inhibitors, or SSRIs. Led by Prozac, the first to be approved, the medicines caused a revolution in
    >psychiatry.
    >
    >Recent analyses suggest that as many as 1 percent of children in the United States are treated for
    >depression in any year, said Mark Olfson, a professor of clinical psychiatry at Columbia
    >University. Of those, 57 percent are on antidepressants.
    >
    >The lack of information is the one issue about which advocates and critics of the medicines agree.
    >Lawrence Diller, a Walnut Creek, Calif., pediatrician and author of "Should I Medicate My Child?,"
    >said that "as a front-line doctor dependent on research, it seems so contaminated by potential
    >conflicts of interest. . . . The smoking gun is revelations from the British that negative studies
    >were not published."
    >
    >Keeping data secret, critics said, has led to conflicting information, contradictory advice and
    >heightened fears.
    >
    >For example, GlaxoSmithKline, which makes Paxil, has conducted three trials on depressed children.
    >Company officials said all turned out negative -- the children on the drug did not do better than
    >those on placebos -- but only one was published. Based on its data, the company warned British
    >doctors that Paxil, sold there as Seroxat, "should not be prescribed as new therapy" to depressed
    >children younger than 18. Its letter last June cited the risk of increased hostility, agitation,
    >and suicidal thoughts and attempts.
    >
    >No such warning was issued in the United States, though Paxil is identical to Seroxat. Here, the
    >company's official line on giving Paxil to children is "No recommendations can be made regarding
    >the use of Paxil or Paxil CR in these patients."
    >
    >"There are differences" between the two recommendations, GlaxoSmithKline's Perera acknowledged in
    >an interview. "They reflect the message that we receive from the respective regulatory bodies."
    >British regulators have essentially prohibited the use of Paxil for children. The FDA is conducting
    >a review of eight drugs, including Paxil.
    >
    >Perera said the company would await the FDA advisory panel's verdict before considering whether to
    >make all its data public.
    >
    >Cathryn Clary, vice president for psychiatry and neurology at Pfizer, which makes Zoloft, said it
    >had sponsored two trials in children. One had a negative result, but the company pooled it with a
    >positive study and only published the combined result, which was positive.
    >
    >"We certainly understand the wish of academics and researchers and physicians to understand all of
    >this data," she said. But small sample sizes in trials "run the risk of magnifying or diminishing a
    >signal. Releasing an individual study can be as misleading as it is helpful."
    >
    >Graham Emslie, a professor of psychiatry at the University of Texas Southwestern Medical Center,
    >who has helped conduct several trials for drug companies, counted nine recent trials of Prozac,
    >Paxil, Zoloft and Celexa in depressed children. Results of two Prozac trials, one Paxil and the
    >pooled Zoloft data have been published -- meaning that data from five trials, including the stand-
    >alone Zoloft trial that was negative, have not.
    >
    >Emslie also counted six other studies on the related antidepressants Effexor, Serzone and Remeron
    >-- none of which has been published, he said. Data from several of the unpublished studies have
    >been presented at scientific meetings, and one has been submitted for publication, he said.
    >
    >Studies reported at conferences are not subject to rigorous advance "peer review" by independent
    >researchers, as are studies published by well-regarded journals. Emslie said he would like to see
    >all the data published but he said the research had been paid for -- and belongs to -- the
    >companies. "They have a legitimate right to do what they want with the data," he said.
    >
    >But David Healy, a Welsh psychiatrist and author of "The Antidepressant Era," rejected the notion
    >that the safety information could be treated like any other private property. Healy prescribes the
    >medicines but has campaigned for more cautious use and more accurate labeling.
    >
    >"On a pressing issue like this," he said, "there is no reason these data could not be put into the
    >public domain in their entirety."
    >
    >The FDA said it is evaluating 20 studies in all, but agency officials have declined to
    >identify them.
    >
    >In the end, some scientists believe, the only way to ensure that science is conducted in the public
    >interest is for it to be funded with public dollars. The National Institutes of Health is therefore
    >ramping up funding for clinical trials.
    >
    >"We have been dependent on the pharmaceutical industry to provide the answers," said Thomas R.
    >Insel, director of the National Institute of Mental Health. "The questions they want answered are
    >different than the public health questions."
    >
    >
    >
    >
     
  3. David Wright

    David Wright Guest

    In article <[email protected]>,
    Ilena <[email protected]> wrote:
    >Antidepressant Makers Withhold Data on Children
    >
    >By Shankar Vedantam Washington Post Staff Writer Thursday, January 29, 2004; Page A01

    And, once again, Ilena the dimwit posts to m.h.a an article that has nothing to do with alt health.
    And posts to a.s.b-i an article that has ntohing to do with breast implants.

    Good work, Ilena.

    -- David Wright :: alphabeta at prodigy.net These are my opinions only, but they're almost always
    correct. "If I have not seen as far as others, it is because giants were standing on my
    shoulders." (Hal Abelson, MIT)
     
  4. Jan

    Jan Guest

    >Subject: Re: WASH POST: Antidepressant Makers Withhold Data on Children
    >From: [email protected] (David Wright)
    >Date: 1/29/2004 7:15 PM Pacific Standard Time
    >Message-id: <C%[email protected]>
    >
    >In article <[email protected]>, Ilena <[email protected]> wrote:
    >>Antidepressant Makers Withhold Data on Children
    >>
    >>By Shankar Vedantam Washington Post Staff Writer Thursday, January 29, 2004; Page A01
    >
    >And, once again, Ilena the dimwit posts to m.h.a an article that has nothing to do with alt health.
    >And posts to a.s.b-i an article that has ntohing to do with breast implants.

    Translation:

    David is calling names because the works of evil organized have been exposed.

    It has everything to do with alt. medicine.

    That's just another reason people are fed up with conventional.

    Alternative is alternative to conventional.

    David's lame excuses fall flat and show the hate of the EOM lovers, who would rather not get real.

    Drugging kids and making them suicidal should be a concern on ANY health newsgroup. Evidently David
    could care less, just protect the drug companies and to heck with our kids.

    Attacking the messenger, another evil of the *gang*

    Jan

    Antidepressant Makers Withhold Data on Children

    By Shankar Vedantam Washington Post Staff Writer Thursday, January 29, 2004; Page A01

    http://www.washingtonpost.com/ac2/wp-dyn/A58130-2004Jan28?language=printer

    Makers of popular antidepressants such as Paxil, Zoloft and Effexor have refused to disclose the
    details of most clinical trials involving depressed children, denying doctors and parents crucial
    evidence as they weigh fresh fears that such medicines may cause some children to become suicidal.

    The companies say the studies are trade secrets. Researchers familiar with the unpublished data said
    the majority of secret trials show that children taking the medicines did not get any better than
    children taking dummy pills.

    Although the drug industry's practice of suppressing data unfavorable to its products is legal,
    doctors and advocates say such secrecy distorts the scientific record.

    "Conflicts of interest and the company control of the data have thrown out the scientific method,"
    said Vera Hassner Sharav, a critic of the drugs and a patients' rights advocate. "If hundreds of
    trials don't work out, they don't publish them, they don't talk about them."

    "We need a journal of negative findings," agreed Darrel Regier, director of the American Psychiatric
    Association's division of research, who believes the drugs save children's lives. "The probability
    of those negative findings being published is far less than the chances of positive studies -- even
    journals are not interested in negative studies."

    Concerns over the safety of antidepressants among children have been heightened after a December
    warning by British regulators that the drugs may trigger suicidal thoughts and increase the rate of
    self-injury. An expert advisory panel of the Food and Drug Administration is scheduled to meet
    Monday to examine the issue, but the agency's full U.S. analysis of the data is not likely to be
    completed until summer.

    One industry executive, Philip Perera, a medical director at GlaxoSmithKline, said that his
    preference was to publish all trials but that negative studies could lead doctors to prematurely
    reject a medicine.

    "If you start publishing negative data, will it be concluded by practitioners and others that
    the drug is ineffective?" he asked, saying that genuinely effective medicines sometimes do no
    better than placebos, or dummy pills, in trials -- at least half of all children seem to get
    better on placebos.

    The U.S. psychiatric establishment largely supports the use of antidepressant medicines in children,
    with many arguing that abandoning the drugs would lead to more suicides in children with depression.
    But its critics, including consumer advocates and some psychiatrists , question whether mainstream
    psychiatry is biased by widespread financial ties to the pharmaceutical industry.

    The answer lies hidden in a maze of secret data, conflicting scientific interpretations and a corporate-
    funded clinical trial system that is not primarily designed to answer questions of public health.

    "If the companies wanted to publish negative studies they could, but companies don't like to publish
    negative studies," said Russell Katz, director of the neuropharmacology division at the FDA , which
    has access to all the data. "It's amusing so many people are making pronouncements about the data --
    scientists and physicians -- . . . without seeing the data."

    Advocates say openness about studies is important because, apart from Prozac, no antidepressant has
    been approved by the FDA for treating children with depression. Doctors writing prescriptions do not
    have approved labeling to guide them: They must rely on their own judgment and the available
    scientific knowledge -- even as information is being withheld.

    The medicines under scrutiny belong to a class of drugs called selective serotonin reuptake
    inhibitors, or SSRIs. Led by Prozac, the first to be approved, the medicines caused a revolution in
    psychiatry.

    Recent analyses suggest that as many as 1 percent of children in the United States are treated for
    depression in any year, said Mark Olfson, a professor of clinical psychiatry at Columbia University.
    Of those, 57 percent are on antidepressants.

    The lack of information is the one issue about which advocates and critics of the medicines agree.
    Lawrence Diller, a Walnut Creek, Calif., pediatrician and author of "Should I Medicate My Child?,"
    said that "as a front-line doctor dependent on research, it seems so contaminated by potential
    conflicts of interest. . . . The smoking gun is revelations from the British that negative studies
    were not published."

    Keeping data secret, critics said, has led to conflicting information, contradictory advice and
    heightened fears.

    For example, GlaxoSmithKline, which makes Paxil, has conducted three trials on depressed children.
    Company officials said all turned out negative -- the children on the drug did not do better than
    those on placebos -- but only one was published. Based on its data, the company warned British
    doctors that Paxil, sold there as Seroxat, "should not be prescribed as new therapy" to depressed
    children younger than 18. Its letter last June cited the risk of increased hostility, agitation, and
    suicidal thoughts and attempts.

    No such warning was issued in the United States, though Paxil is identical to Seroxat. Here, the
    company's official line on giving Paxil to children is "No recommendations can be made regarding the
    use of Paxil or Paxil CR in these patients."

    "There are differences" between the two recommendations, GlaxoSmithKline's Perera acknowledged in an
    interview. "They reflect the message that we receive from the respective regulatory bodies." British
    regulators have essentially prohibited the use of Paxil for children. The FDA is conducting a review
    of eight drugs, including Paxil.

    Perera said the company would await the FDA advisory panel's verdict before considering whether to
    make all its data public.

    Cathryn Clary, vice president for psychiatry and neurology at Pfizer, which makes Zoloft, said it
    had sponsored two trials in children. One had a negative result, but the company pooled it with a
    positive study and only published the combined result, which was positive.

    "We certainly understand the wish of academics and researchers and physicians to understand all of
    this data," she said. But small sample sizes in trials "run the risk of magnifying or diminishing a
    signal. Releasing an individual study can be as misleading as it is helpful."

    Graham Emslie, a professor of psychiatry at the University of Texas Southwestern Medical Center, who
    has helped conduct several trials for drug companies, counted nine recent trials of Prozac, Paxil,
    Zoloft and Celexa in depressed children. Results of two Prozac trials, one Paxil and the pooled
    Zoloft data have been published -- meaning that data from five trials, including the stand-alone
    Zoloft trial that was negative, have not.

    Emslie also counted six other studies on the related antidepressants Effexor, Serzone and Remeron --
    none of which has been published, he said. Data from several of the unpublished studies have been
    presented at scientific meetings, and one has been submitted for publication, he said.

    Studies reported at conferences are not subject to rigorous advance "peer review" by independent
    researchers, as are studies published by well-regarded journals. Emslie said he would like to see
    all the data published but he said the research had been paid for -- and belongs to -- the
    companies. "They have a legitimate right to do what they want with the data," he said.

    But David Healy, a Welsh psychiatrist and author of "The Antidepressant Era," rejected the notion
    that the safety information could be treated like any other private property. Healy prescribes the
    medicines but has campaigned for more cautious use and more accurate labeling.

    "On a pressing issue like this," he said, "there is no reason these data could not be put into the
    public domain in their entirety."

    The FDA said it is evaluating 20 studies in all, but agency officials have declined to
    identify them.

    In the end, some scientists believe, the only way to ensure that science is conducted in the public
    interest is for it to be funded with public dollars. The National Institutes of Health is therefore
    ramping up funding for clinical trials.

    "We have been dependent on the pharmaceutical industry to provide the answers," said Thomas R.
    Insel, director of the National Institute of Mental Health. "The questions they want answered are
    different than the public health questions."
     
  5. Rich Andrews

    Rich Andrews Guest

    [email protected] (David Wright) wrote in news:C%jSb.2065$BV6.657
    @newssvr31.news.prodigy.com:

    > In article <[email protected]>, Ilena <[email protected]> wrote:
    >>Antidepressant Makers Withhold Data on Children
    >>
    >>By Shankar Vedantam Washington Post Staff Writer Thursday, January 29, 2004; Page A01
    >
    > And, once again, Ilena the dimwit posts to m.h.a an article that has nothing to do with alt
    > health. And posts to a.s.b-i an article that has ntohing to do with breast implants.
    >
    > Good work, Ilena.
    >

    David,

    You have to remember that her agenda is NOT to help people, but to slam any organiziation of
    authority whenever she has the chance.

    r

    --
    Nothing beats the bandwidth of a station wagon filled with DLT tapes.
     
  6. Rod

    Rod Guest

    Well it is a tough assignment and Jan does it so well. Any other volunteers ?

    Rod.

    PS: Funny though, it featured in our Daily paper front page news about this dilemma with the
    recommendation to avoid these drugs as the results may have been skewed by the drug companies.
    Good Corporate Citizens do not do these things, do they ?

    "Rich Andrews" <[email protected]> wrote in message
    news:[email protected]...
    > [email protected] (David Wright) wrote in news:C%jSb.2065$BV6.657
    > @newssvr31.news.prodigy.com:
    >
    > > In article <[email protected]>, Ilena <[email protected]> wrote:
    > >>Antidepressant Makers Withhold Data on Children
    > >>
    > >>By Shankar Vedantam Washington Post Staff Writer Thursday, January 29, 2004; Page A01
    > >
    > > And, once again, Ilena the dimwit posts to m.h.a an article that has nothing to do with alt
    > > health. And posts to a.s.b-i an article that has ntohing to do with breast implants.
    > >
    > > Good work, Ilena.
    > >
    >
    > David,
    >
    > You have to remember that her agenda is NOT to help people, but to slam any organiziation of
    > authority whenever she has the chance.
    >
    > r
    >
    >
    >
    > --
    > Nothing beats the bandwidth of a station wagon filled with DLT tapes.
     
  7. Ilena

    Ilena Guest

    Thanks Quack Flacks for your opinions ...

    My opinion is you two Net Nanny Posts are perfect examples of what losing Plaintiffs Barrett and
    Grell would like the public to believe about me ...

    as well as distraction from the subject of this thread: the deceit of the Pharma Cartels while
    putting the public at risk.

    As far as your opinion on my work ... here's another's:

    Subject: Thanks from husband who wrote for support .... McGhan (Inamed) implants saline

    Subject: Wifes Implants

    I Would just like to Thank You all for the overwhelming support you have sent me in your e-mails for
    my wife's implant situation. I am trying to have her join the group and sit down and respond to some
    of you who had asked for specific information type of implant etc.. where we live to refer best
    Doctor and so forth, but I feel she is avoiding it now as in reading the first few e-mails you all
    sent it became apparent that generally the best means of getting your health back begin with having
    the implants removed and although we have not had the time to discuss this yet I am sure emotionally
    it cannot be easy for her to realize that chances are she is going to have to lose the implants and
    undergoe extensive rehabilitation to get well. In case my wife doesn't find the energy to

    Thank You all I would like to and for those who have asked and offered help thank you. Her implants
    where both originally from Mcghan Medical Corporation then one deflated and the replacement was from
    INAMED Aesthetics according to the cards that came with them they are both Style 68- Saline and for
    those who referred Doctors Thank You but we are hoping to find one in Southern California as we live
    about 100 miles North of San Diego she had agreed to listen to my advice if I can prove to her the
    Implants are in deed the source of the health issues.

    And also, would like to Thank Ilena who even took the time out of her busy schedule to give a phone
    call unfortunately I was in a meeting at the time but did receive your caring message

    Thank You Ilena for getting me in touch with such well informed people, and finally for those who
    prayed for my wife Thank You, I believe prayers are not only always heard but many times are felt
    and I felt the love and concern you all have and I am sorry for the pain and hurt your implants have
    caused you. I wanted to respond to each of you individually but am very limited on time as I am
    preparing for two very big annual events within my company in the next week. God Bless you all,

    Steve r

    Rich Andrews <[email protected]> wrote in message
    news:<[email protected]>...
    > [email protected] (David Wright) wrote in news:C%jSb.2065$BV6.657
    > @newssvr31.news.prodigy.com:
    >
    > > In article <[email protected]>, Ilena <[email protected]> wrote:
    > >>Antidepressant Makers Withhold Data on Children
    > >>
    > >>By Shankar Vedantam Washington Post Staff Writer Thursday, January 29, 2004; Page A01
    > >
    > > And, once again, Ilena the dimwit posts to m.h.a an article that has nothing to do with alt
    > > health. And posts to a.s.b-i an article that has ntohing to do with breast implants.
    > >
    > > Good work, Ilena.

    > David,
    >
    > You have to remember that her agenda is NOT to help people, but to slam any organiziation of
    > authority whenever she has the chance.
    >
    > r
     
  8. Ilena

    Ilena Guest

    NOTE: All of the Distractors from the various Pharma / Med Device Team's have done a clever job of
    turning this important thread into yet another opportunity to bash their critics.

    If a reader were to click on the thread ... they would see Net Nannies talking blah blah instead of
    their Funders getting caught in dangerous cover ups ... (or Black Helicopters, as they love to call
    their PR campaigns)

    Antidepressant Makers Withhold Data on Children

    By Shankar Vedantam Washington Post Staff Writer Thursday, January 29, 2004; Page A01

    http://www.washingtonpost.com/ac2/wp-dyn/A58130-2004Jan28?language=printer

    Makers of popular antidepressants such as Paxil, Zoloft and Effexor have refused to disclose the
    details of most clinical trials involving depressed children, denying doctors and parents crucial
    evidence as they weigh fresh fears that such medicines may cause some children to become suicidal.

    The companies say the studies are trade secrets. Researchers familiar with the unpublished data said
    the majority of secret trials show that children taking the medicines did not get any better than
    children taking dummy pills.

    Although the drug industry's practice of suppressing data unfavorable to its products is legal,
    doctors and advocates say such secrecy distorts the scientific record.

    "Conflicts of interest and the company control of the data have thrown out the scientific method,"
    said Vera Hassner Sharav, a critic of the drugs and a patients' rights advocate. "If hundreds of
    trials don't work out, they don't publish them, they don't talk about them."

    "We need a journal of negative findings," agreed Darrel Regier, director of the American Psychiatric
    Association's division of research, who believes the drugs save children's lives. "The probability
    of those negative findings being published is far less than the chances of positive studies -- even
    journals are not interested in negative studies."

    Concerns over the safety of antidepressants among children have been heightened after a December
    warning by British regulators that the drugs may trigger suicidal thoughts and increase the rate of
    self-injury. An expert advisory panel of the Food and Drug Administration is scheduled to meet
    Monday to examine the issue, but the agency's full U.S. analysis of the data is not likely to be
    completed until summer.

    One industry executive, Philip Perera, a medical director at GlaxoSmithKline, said that his
    preference was to publish all trials but that negative studies could lead doctors to prematurely
    reject a medicine.

    "If you start publishing negative data, will it be concluded by practitioners and others that
    the drug is ineffective?" he asked, saying that genuinely effective medicines sometimes do no
    better than placebos, or dummy pills, in trials -- at least half of all children seem to get
    better on placebos.

    The U.S. psychiatric establishment largely supports the use of antidepressant medicines in children,
    with many arguing that abandoning the drugs would lead to more suicides in children with depression.
    But its critics, including consumer advocates and some psychiatrists , question whether mainstream
    psychiatry is biased by widespread financial ties to the pharmaceutical industry.

    The answer lies hidden in a maze of secret data, conflicting scientific interpretations and a corporate-
    funded clinical trial system that is not primarily designed to answer questions of public health.

    "If the companies wanted to publish negative studies they could, but companies don't like to publish
    negative studies," said Russell Katz, director of the neuropharmacology division at the FDA , which
    has access to all the data. "It's amusing so many people are making pronouncements about the data --
    scientists and physicians -- . . . without seeing the data."

    Advocates say openness about studies is important because, apart from Prozac, no antidepressant has
    been approved by the FDA for treating children with depression. Doctors writing prescriptions do not
    have approved labeling to guide them: They must rely on their own judgment and the available
    scientific knowledge -- even as information is being withheld.

    The medicines under scrutiny belong to a class of drugs called selective serotonin reuptake
    inhibitors, or SSRIs. Led by Prozac, the first to be approved, the medicines caused a revolution in
    psychiatry.

    Recent analyses suggest that as many as 1 percent of children in the United States are treated for
    depression in any year, said Mark Olfson, a professor of clinical psychiatry at Columbia University.
    Of those, 57 percent are on antidepressants.

    The lack of information is the one issue about which advocates and critics of the medicines agree.
    Lawrence Diller, a Walnut Creek, Calif., pediatrician and author of "Should I Medicate My Child?,"
    said that "as a front-line doctor dependent on research, it seems so contaminated by potential
    conflicts of interest. . . . The smoking gun is revelations from the British that negative studies
    were not published."

    Keeping data secret, critics said, has led to conflicting information, contradictory advice and
    heightened fears.

    For example, GlaxoSmithKline, which makes Paxil, has conducted three trials on depressed children.
    Company officials said all turned out negative -- the children on the drug did not do better than
    those on placebos -- but only one was published. Based on its data, the company warned British
    doctors that Paxil, sold there as Seroxat, "should not be prescribed as new therapy" to depressed
    children younger than 18. Its letter last June cited the risk of increased hostility, agitation, and
    suicidal thoughts and attempts.

    No such warning was issued in the United States, though Paxil is identical to Seroxat. Here, the
    company's official line on giving Paxil to children is "No recommendations can be made regarding the
    use of Paxil or Paxil CR in these patients."

    "There are differences" between the two recommendations, GlaxoSmithKline's Perera acknowledged in an
    interview. "They reflect the message that we receive from the respective regulatory bodies." British
    regulators have essentially prohibited the use of Paxil for children. The FDA is conducting a review
    of eight drugs, including Paxil.

    Perera said the company would await the FDA advisory panel's verdict before considering whether to
    make all its data public.

    Cathryn Clary, vice president for psychiatry and neurology at Pfizer, which makes Zoloft, said it
    had sponsored two trials in children. One had a negative result, but the company pooled it with a
    positive study and only published the combined result, which was positive.

    "We certainly understand the wish of academics and researchers and physicians to understand all of
    this data," she said. But small sample sizes in trials "run the risk of magnifying or diminishing a
    signal. Releasing an individual study can be as misleading as it is helpful."

    Graham Emslie, a professor of psychiatry at the University of Texas Southwestern Medical Center, who
    has helped conduct several trials for drug companies, counted nine recent trials of Prozac, Paxil,
    Zoloft and Celexa in depressed children. Results of two Prozac trials, one Paxil and the pooled
    Zoloft data have been published -- meaning that data from five trials, including the stand-alone
    Zoloft trial that was negative, have not.

    Emslie also counted six other studies on the related antidepressants Effexor, Serzone and Remeron --
    none of which has been published, he said. Data from several of the unpublished studies have been
    presented at scientific meetings, and one has been submitted for publication, he said.

    Studies reported at conferences are not subject to rigorous advance "peer review" by independent
    researchers, as are studies published by well-regarded journals. Emslie said he would like to see
    all the data published but he said the research had been paid for -- and belongs to -- the
    companies. "They have a legitimate right to do what they want with the data," he said.

    But David Healy, a Welsh psychiatrist and author of "The Antidepressant Era," rejected the notion
    that the safety information could be treated like any other private property. Healy prescribes the
    medicines but has campaigned for more cautious use and more accurate labeling.

    "On a pressing issue like this," he said, "there is no reason these data could not be put into the
    public domain in their entirety."

    The FDA said it is evaluating 20 studies in all, but agency officials have declined to
    identify them.

    In the end, some scientists believe, the only way to ensure that science is conducted in the public
    interest is for it to be funded with public dollars. The National Institutes of Health is therefore
    ramping up funding for clinical trials.

    "We have been dependent on the pharmaceutical industry to provide the answers," said Thomas R.
    Insel, director of the National Institute of Mental Health. "The questions they want answered are
    different than the public health questions."
     
  9. David Wright

    David Wright Guest

    In article <[email protected]>,
    Ilena <[email protected]> wrote:
    >NOTE: All of the Distractors from the various Pharma / Med Device Team's have done a clever job of
    > turning this important thread into yet another opportunity to bash their critics.
    >
    >If a reader were to click on the thread ... they would see Net Nannies talking blah blah instead of
    >their Funders getting caught in dangerous cover ups ... (or Black Helicopters, as they love to call
    >their PR campaigns)
    >
    >Antidepressant Makers Withhold Data on Children

    You're still off-topic in both these newsgroups, Ilena, you numbskull. And you will *still* be off-
    topic no matter how many times you post it. Hint: posting something more than once does not
    magically make it appropriate.

    -- David Wright :: alphabeta at prodigy.net These are my opinions only, but they're almost always
    correct. "If I have not seen as far as others, it is because giants were standing on my
    shoulders." (Hal Abelson, MIT)
     
  10. David Wright

    David Wright Guest

    In article <[email protected]>,
    Rich Andrews <[email protected]> wrote:
    >[email protected] (David Wright) wrote in news:C%jSb.2065$BV6.657
    >@newssvr31.news.prodigy.com:
    >
    >> In article <[email protected]>, Ilena <[email protected]> wrote:
    >>>Antidepressant Makers Withhold Data on Children
    >>>
    >>>By Shankar Vedantam Washington Post Staff Writer Thursday, January 29, 2004; Page A01
    >>
    >> And, once again, Ilena the dimwit posts to m.h.a an article that has nothing to do with alt
    >> health. And posts to a.s.b-i an article that has ntohing to do with breast implants.
    >>
    >> Good work, Ilena.
    >>
    >
    >David,
    >
    >You have to remember that her agenda is NOT to help people, but to slam any organiziation of
    >authority whenever she has the chance.

    Oh, sure, I know that. And, just as I expected, she got all huffy about it when I pointed out her
    inappropriate postings.

    -- David Wright :: alphabeta at prodigy.net These are my opinions only, but they're almost always
    correct. "If I have not seen as far as others, it is because giants were standing on my
    shoulders." (Hal Abelson, MIT)
     
  11. David Wright

    David Wright Guest

    In article <[email protected]>,
    Ilena <[email protected]> wrote:
    >Thanks Quack Flacks for your opinions ...
    >
    >My opinion is you two Net Nanny Posts are perfect examples of what losing Plaintiffs Barrett and
    >Grell would like the public to believe about me ...

    "Net Nanny" is Ilena's endearing term for anyone who points out any of her actions that are
    objectionable, idiotic, or both.

    Your posting was still off-topic for both these newsgroups, Ilena, no matter how much you try to
    dodge and obfuscate.

    -- David Wright :: alphabeta at prodigy.net These are my opinions only, but they're almost always
    correct. "If I have not seen as far as others, it is because giants were standing on my
    shoulders." (Hal Abelson, MIT)
     
  12. Rich Andrews

    Rich Andrews Guest

    [email protected] (David Wright) wrote in news:ihFSb.30641$Cw4.26460
    @newssvr33.news.prodigy.com:

    > In article <[email protected]>, Ilena <[email protected]> wrote:
    >>Thanks Quack Flacks for your opinions ...
    >>
    >>My opinion is you two Net Nanny Posts are perfect examples of what losing Plaintiffs Barrett and
    >>Grell would like the public to believe about me ...
    >
    > "Net Nanny" is Ilena's endearing term for anyone who points out any of her actions that are
    > objectionable, idiotic, or both.
    >
    > Your posting was still off-topic for both these newsgroups, Ilena, no matter how much you try to
    > dodge and obfuscate.
    >

    How typical for a chick with no brains. Someone should write a chick- speak dictionary. For example.

    "Whatever" actually means "Yes I know you are right, but as I am a bitch, I refuse to face that
    truth and also refuse to acknowledge it."

    r

    --
    Nothing beats the bandwidth of a station wagon filled with DLT tapes.
     
  13. Happy Oyster

    Happy Oyster Guest

  14. "Mark ProbertJanuary 31, 2004" <[email protected]>
    wrote:

    >
    >"Jan" <[email protected]> wrote in message news:[email protected]...
    >

    >
    >I also open my home to people. Iguess that makes me right, eh, Jan? Or, is your double
    >standard showing?
    >
    >

    When I was in Las Vegas I was continually offered business cards in the street inviting me to
    open up my hotel room to women. Perhaps I should have done so, which would make Jan think I am a
    good person.

    --
    Peter Bowditch
    The Millenium Project http://www.ratbags.com/rsoles
    The Green Light http://www.ratbags.com/greenlight
    and The New Improved Quintessence of the Loon with added Vitamins and C-Q10 http://www.ratbags.com/loon
    To email me use my first name only at ratbags.com
     
  15. Happy Oyster

    Happy Oyster Guest

  16. "Peter Bowditch" <[email protected]> wrote in message
    news:[email protected]...
    > [email protected] (Jan) wrote:
    >
    > >>Subject: Re: WASH POST: Antidepressant Makers Withhold Data on Children From: Peter Bowditch
    > >>[email protected] Date: 1/31/2004 2:15 PM Pacific Standard Time Message-id:
    > >><[email protected]>
    > >>
    > >>"Mark ProbertJanuary 31, 2004" <[email protected]> wrote:
    > >>
    > >>>
    > >>>"Jan" <[email protected]> wrote in message news:[email protected]
    > >>>m26.aol.com...
    > >>>

    > >>>
    > >>>I also open my home to people. Iguess that makes me right, eh, Jan? Or,
    is
    > >>>your double standard showing?
    > >
    > >That is very sad, however it shows the lowness of Mark Probert.
    > >

    > >
    > >And then Peter joins with further lowness of character.
    > >
    > >We are seeing a disconnection from God.
    > >
    > >Sad, very sad.
    > >
    > >Opening a home for women is a wonderful thing, not to mention the risks,
    but
    > >all Mark and Peter can do it belittle.
    > >
    > >Proving the exact EVILNESS of EOM members, who will some day answer to
    God.
    > >
    > >Jan
    >
    > Notice how Jan snipped (without mentioning) the bit about me opening my hotel room to women.
    > Surely that would have been a good thing to do.

    Jan has a dirty mind.
     
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