kebaldwin
Sat, Dec-24-05, 07:13
The FDA Won't Protect Your Children Either ...
A federal advisory panel has ruled that the first skin patch to treat attention deficit hyperactivity disorder (ADHD) in children is both effective and safe.
The panel also voted to recommend to the FDA the patch be considered an alternative treatment, for use only when taking pills is too difficult for a child.
Change of Opinion
This vote came shortly after a formerly skeptical FDA reviewer reversed his opinion about the drug. Dr. Robert Levin had said that trials showed troubling side effects too often. But before the panel vote, Levin told the committee he had reconsidered his opinion, and believed that the drug was safe.
Numerous Side Effects
During tests of the patch, some children reported side effects such as decreased appetites, headaches, insomnia, skin irritation, nausea and involuntary muscle spasms.
The patch, which, if finally approved by the FDA will be sold under the name Daytrana, is designed to go on a child's hip for nine hours. It releases methylphenidate, the same stimulant that is in Ritalin.
Yahoo News December 1, 2005
CBS News December 2, 2005
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Dr. Mercola's Comment:
I wonder why 24 hours obviously made such a big difference to FDA reviewer Dr. Robert Levin, who was complaining about the patch's side effects the day before he said the drug was safe enough to approve. In fact, the shift by the FDA researcher even surprised one of the drugmakers that developed the patch.
While I know of no particular evidence for malfeasance in this instance, it's wise to be distrustful of FDA advisory panels, which are often riddled with conflicts of interest and financial ties to the very industries they are called upon to regulate.
With all the problems associated with taking ADHD drugs -- among them liver damage and cancer -- why would anyone ever consider exposing their child to all those side effects and risks for the sake of convenience, especially when there are better, safer options that radically improve the problem in most children that adopt these simple changes:
Replace sugary soft drinks, milk and fruit drinks with clean water.
Rebalance their intake of omega-3 and omega-6 fats by giving them a high-quality fish or cod liver oil daily.
Limit, with the plan of eliminating, grains and sugars in their daily diet.
For a more comprehensive review of ADHD options please review the interview I conducted with Dr. Lendon Smith on this topic.
Related Articles:
USA Today Exposes Conflicts of Interest in FDA Drug Approvals
Does Your Child Have ADHD? Consider Fish Oil Over Ritalin
More Shady Dealings in the FDA
http://www.mercola.com/2005/dec/24/the_fda_wont_protect_your_children_either_.htm
A federal advisory panel has ruled that the first skin patch to treat attention deficit hyperactivity disorder (ADHD) in children is both effective and safe.
The panel also voted to recommend to the FDA the patch be considered an alternative treatment, for use only when taking pills is too difficult for a child.
Change of Opinion
This vote came shortly after a formerly skeptical FDA reviewer reversed his opinion about the drug. Dr. Robert Levin had said that trials showed troubling side effects too often. But before the panel vote, Levin told the committee he had reconsidered his opinion, and believed that the drug was safe.
Numerous Side Effects
During tests of the patch, some children reported side effects such as decreased appetites, headaches, insomnia, skin irritation, nausea and involuntary muscle spasms.
The patch, which, if finally approved by the FDA will be sold under the name Daytrana, is designed to go on a child's hip for nine hours. It releases methylphenidate, the same stimulant that is in Ritalin.
Yahoo News December 1, 2005
CBS News December 2, 2005
--------------------------------------------------------------------------------
Dr. Mercola's Comment:
I wonder why 24 hours obviously made such a big difference to FDA reviewer Dr. Robert Levin, who was complaining about the patch's side effects the day before he said the drug was safe enough to approve. In fact, the shift by the FDA researcher even surprised one of the drugmakers that developed the patch.
While I know of no particular evidence for malfeasance in this instance, it's wise to be distrustful of FDA advisory panels, which are often riddled with conflicts of interest and financial ties to the very industries they are called upon to regulate.
With all the problems associated with taking ADHD drugs -- among them liver damage and cancer -- why would anyone ever consider exposing their child to all those side effects and risks for the sake of convenience, especially when there are better, safer options that radically improve the problem in most children that adopt these simple changes:
Replace sugary soft drinks, milk and fruit drinks with clean water.
Rebalance their intake of omega-3 and omega-6 fats by giving them a high-quality fish or cod liver oil daily.
Limit, with the plan of eliminating, grains and sugars in their daily diet.
For a more comprehensive review of ADHD options please review the interview I conducted with Dr. Lendon Smith on this topic.
Related Articles:
USA Today Exposes Conflicts of Interest in FDA Drug Approvals
Does Your Child Have ADHD? Consider Fish Oil Over Ritalin
More Shady Dealings in the FDA
http://www.mercola.com/2005/dec/24/the_fda_wont_protect_your_children_either_.htm