The first part is a story in the Irving's paper. The second section is an email I received days ago. This is all BULLSH@T!!! It's just another way for big drug companies to make money!!!!
We must pray for an early Provincial election. With Shawn Graham as Premier? The issue of drugging our kids will be studied but with Bernard Lord as Premier? The drugging and the killing of our children will continue!!!!
The Fredericton Daily Gleaner
Life & Entertainment, Saturday, December 3, 2005, p. C12
Health
ADHD patch for kids approved by U.S. officials
The Associated Press
WASHINGTON - A U.S. federal advisory panel determined Friday that the first skin patch to treat attention deficit hyperactivity disorder in children is both effective and safe, bringing the patch a step closer to regulatory approval.
However, the panel of independent experts voted to recommend to the Food and Drug Administration that the patch's label encourage its use as an alternative treatment for children with ADHD - in effect, saying doctors should prescribe it only if taking pills is too difficult for a child.
The unanimous vote by the FDA's Psychopharmacologic Drugs Advisory Committee, saying the patch was acceptably safe, came after a formerly critical FDA reviewer reversed his opinion about the drug.
The agency will now decide whether to approve the patch. It usually follows the advice of its advisory committees but is not required to. A decision is expected by Dec. 28, said a spokesman for U.K.-based Shire Pharmaceuticals, which developed the patch along with Noven Pharmaceuticals of Miami.
In documents posted by the FDA, agency reviewer Dr. Robert Levin had said that trials showed the patch produces troubling side-effects too often to be considered safe. But on Friday, Levin told the committee he had reconsidered his opinion and now judged the drug was safe enough to approve.
The patch is designed to go on a child's hip for nine hours, according to submissions by the companies that developed it. It releases into the body methylphenidate, which has been shown to help children with ADHD. It is the same stimulant that is in Ritalin.
The patch is designed for children between the ages of six and 12. The developers said it is a way to treat ADHD in children for whom taking pills is difficult or unpleasant. Unlike a pill, it can be removed from the body if it causes harmful side-effects.
Some children who received the patch during trials reported decreased appetites, headaches, insomnia, nausea and tics, the FDA said. These occurred more often than in children taking Concerta, a pill that uses methylphenidate, and others taking a placebo. Some in the patch test also had skin irritation.
In documents submitted to the FDA, the developers of the patch said it was safe and that problematic side-effects were similar to those occurring in children who take methylphenidate orally.
Category: Society and Trends
Uniform subject(s): Children
Length: Medium, 307 words
© 2005 The Daily Gleaner - Fredericton. All rights reserved.
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WASHINGTON (Reuters) - An experimental skin patch to treat attention deficit hyperactivity disorder in some children should not be approved in the United States because of safety risks, U.S. regulatory staff recommended on Thursday.
Two new studies for the patch, which is made by Britain's Shire Pharmaceuticals Group Plc and U.S. Noven Pharmaceuticals Inc. did not prove it was safe enough, Food and Drug Administration reviewers said in memos posted on the agency's Web site.
Shares of both Noven and Shire tumbled on the news.
In midday trading on Nasdaq, Noven shares were off 20.8 percent, or $2.81, to $10.70. Meanwhile, in London Stock Exchange trading, Shire closed near flat after earlier falling about 2 percent.
The staff review was released ahead of a meeting of FDA advisors Friday to consider whether to recommend approval of the patch. The FDA usually follows its panels' advice.
The patch, known as the methylphenidate transdermal system (MTS), aims to deliver via the skin a generic version of one of the most popular ADHD treatments -- Swiss drug maker Novartis AG's Ritalin.
FDA officials in April 2003 rejected the patch citing high rates of insomnia, anorexia and weight loss when used for 12 hours.
Since then, the companies conducted additional studies that they said showed MTS was safe and effective when used for nine hours. They hope to market it under the name Daytrana.
FDA reviewers on Thursday said the patch, designed for once-daily use in children 6 to 12 years old, still caused too many side effects.
MTS was also linked to a high risk of a muscle spasm disorder, or tic, and skin irritation, they wrote.
"The safety and tolerability profile of MTS treatment in these two new studies does not appear to be significantly more acceptable than that in the previous MTS submission," the staff said.
Company officials, in other documents released on Thursday, said the problems were no worse than with pill versions.
Thomas Laughren, head of the FDA's Division of Psychiatry Products, agreed most of the side effects were found with tablets, but in some instances occurred more with the patch.
Some FDA scientists also had concerns about the potential for children to abuse the patch by extracting the active ingredients with a solvent like alcohol, but others said it was unlikely.
Some reviewers with the agency's controlled substance division said extraction would be a complicated, time-consuming and expensive process that was most likely not worth the time or trouble by a would-be abuser for the resulting small amount of the drug.
The bigger threat, they said, was children sharing the patch. Still, "there would be no 'rush' from applying the patch" because it takes two to three hours to have an effect, the reviewers said.
Ritalin and its generic versions are one of the most commonly abused pills among youth, studies have shown.
The companies said the patch was not misused or shared during trials.
Between 73 percent and 82 percent of parents whose children participated in late-stage studies "strongly agreed that MTS afforded them control over their child's treatment and peace of mind over potential misuse," they said.
The documents are available online at http://www.fda.gov/ohrms/dockets/ac/05/briefing/2005-4195B-index-with-disclaimer.htm/.
© Reuters 2005. All Rights Reserved.
2 comments:
It's all about money!
No more! No less!
No need to say you're sorry Charles, you have freedom of speech, just the same as those Politicians we fought for, at one time or another.
The only difference is, they are full of BS ?
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