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By Evelyn Pringle (about the author)
Become a Fan -- Page 4 of 4 page(s)
After listening to all the testimony, the Drug Safety panel voted to recommend that ADHD stimulant drugs carry a black box warning alerting patients and doctors about potential cardiovascular risks.
Panel member, Dr Steve Nissen said he was certain the public was not aware of the risks. "If the current warnings were adequate we wouldn't have 2.5 million children and 1.5 million adults taking these drugs," he noted.
"I mean," he continued, "it is just self-evident to me that the exponential growth in the use of the drugs suggests that the public and practitioners are unaware that there are people sitting around this table that have a serious concern about the safety."
Dr Nissen also said he was not very confident about the number of adverse events in the spontaneous reporting system. "We know that you get 1-10 percent of the actual events reported," he said.
Dr Nissen is correct. The number of deaths cited at the hearing does not portray an accurate picture. There were more deaths of children linked to ADHD drugs recorded by individual states than were reported for the whole country at the hearing.
For instance in Florida, the report, "Child Suicides In Florida Associated With Use Of Psychotropic Drugs, " by researcher Ken Kramer, recently released after a year long investigation, found that out of the 252 cases of suicide in children under 18, between 2000 and 2004, thirty-six of the children who committed suicide were on ADHD drugs.
As far as diagnosing attention deficit disorder, FDA official Dr Andrew Mosholder told the committee: "The etiology is unknown."
"Environmental, genetic, developmental and familial factors are all thought to play a role," he said. "The diagnosis is clinical."
But most importantly Dr Mosholder explained what experts believe all parents deserve to know. "There are no pathognomonic physical or laboratory findings," he said, "and there is no psychological testing that can make the diagnosis for certain."
By Evelyn Pringle
evelyn.pringle@sbcglobal.net
(Evelyn Pringle is a columnist for Independent Media TV and an investigative journalist focuses on exposing corruption in government)
Become a Fan -- Page 4 of 4 page(s)
Panel member, Dr Steve Nissen said he was certain the public was not aware of the risks. "If the current warnings were adequate we wouldn't have 2.5 million children and 1.5 million adults taking these drugs," he noted.
"I mean," he continued, "it is just self-evident to me that the exponential growth in the use of the drugs suggests that the public and practitioners are unaware that there are people sitting around this table that have a serious concern about the safety."
Dr Nissen also said he was not very confident about the number of adverse events in the spontaneous reporting system. "We know that you get 1-10 percent of the actual events reported," he said.
Dr Nissen is correct. The number of deaths cited at the hearing does not portray an accurate picture. There were more deaths of children linked to ADHD drugs recorded by individual states than were reported for the whole country at the hearing.
For instance in Florida, the report, "Child Suicides In Florida Associated With Use Of Psychotropic Drugs, " by researcher Ken Kramer, recently released after a year long investigation, found that out of the 252 cases of suicide in children under 18, between 2000 and 2004, thirty-six of the children who committed suicide were on ADHD drugs.
As far as diagnosing attention deficit disorder, FDA official Dr Andrew Mosholder told the committee: "The etiology is unknown."
"Environmental, genetic, developmental and familial factors are all thought to play a role," he said. "The diagnosis is clinical."
But most importantly Dr Mosholder explained what experts believe all parents deserve to know. "There are no pathognomonic physical or laboratory findings," he said, "and there is no psychological testing that can make the diagnosis for certain."
By Evelyn Pringle
evelyn.pringle@sbcglobal.net
(Evelyn Pringle is a columnist for Independent Media TV and an investigative journalist focuses on exposing corruption in government)
Evelyn Pringle is a columnist for OpEd News and investigative journalist focused on exposing corruption in government and corporate America.
The views expressed in this article are the sole responsibility of the author
and do not necessarily reflect those of this website or its editors.
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