Just What Kids Need - Sparlon - Another ADHD Drug

http://www.opednews.com/articles/gen...kids_need_.htm

Just What Kids Need - Sparlon - Another ADHD Drug

Excerpts:

The pharmaceutical company, Cephalon Inc, is going through the motions of
legitimizing the sale of Sparlon for the treatment of ADHD even though its
active ingredient, modafinil, has been heavily promoted and sold under the
name Provigil, for off-label treatment of ADHD by Cephalon for years.

Last October, the FDA sent an "approvable" letter to Cephalon for the
pediatric use of Sparlon pending a March 23, 2006, meeting of the
Psychopharmacologic Drugs Advisory Committee to review the drug's approval.

"Doctors now prescribe it to treat everything from attention deficit
hyperactivity disorder (ADHD) to fatigue associated with multiple sclerosis
and depression," according to the November 1, 2004 Business Week Online.

Cephalon gets nearly half of its $1.2 billion in annual sales from
modafinil. Its original patent ran out in December 2005. However, in a
sweetheart deal, Cephalon agreed to pay 4 generic drug makers, including
Mylan Laboratories and Teva Pharmaceutical, over $200 million to postpone
marketing generic versions of the medication until October 2011, GoozNews
reported on March 17, 2006.


Dr Dubose Ravenel is a pediatrician with 25 years experience in private
practice with
a heavy emphasis upon behavioral issues, including diagnosing and managing
ADHD.

In addition, he notes, with regard to potential conflicts of interest,
itemized conflicts for each of the Pediatric study's authors are numerous.

For instance, "Dr. Biederman received research support from 10 companies,
serves on speakers' bureaus for 4 companies, and is on advisory boards of 6
companies," Dr Dubose Ravenel reveals.

"Dr. Kratochvil," he advises, "has received research support from, served as
a consultant for, and/or served on speakers' bureaus for 10 pharmaceutical
companies."

And come to find out, it seems Sparlon is not so "well-tolerated" after all.
Last week the FDA announced that an analysis provided by Cephalon as part of
its response to the FDA's "approvable" letter found 4 suicidal events, 2
events of psychosis/mania and 9 aggression events in the double blind
clinical studies of Sparlon, in a summary report for the Pediatric Advisory
Committee.

In addition, two events of psychosis/mania and 14 aggression events were
seen in open-label studies of modafinil for ADHD, the FDA said. These rates
are compared to 5 aggression events and no suicidal or psychosis/mania
events in placebo patients from the double-blind trials.


Sparlon's approval is set to be reviewed by the Psychopharmacologic Drugs
Advisory Committee on March 23, 2006.

Last month, Allen Jones, testifying as a representative of the Alliance for
Human Research Protection, told the advisory panel: "Most of you have had
past or current relationships with the drug industry."

As it turn out, conflicts of interest exist on this month's advisory panel
as well. Wayne Goodman, the chairman of the Psychopharmacologic Drugs
Advisory Committee that will consider Sparlon's approval heads the
psychiatry department at the University of Florida, that receives hundreds
of thousands of dollars a year in research grants from 2 of Cephalon's
competitors in the field of ADHD drugs.

Another member of the Committee, Andrew Leon of Cornell University,
disclosed he owns less than $25,000 in stock in a Cephalon competitor,
according to GoozNews on March 18, 2006.

The Pediatric Advisory Committee is meeting on March 22, 2006, the day
before the Sparlon hearing, to focus on neuropsychiatric adverse event
reports and clinical trial data from approved ADHD medications, and will
also receive an update on cardiovascular adverse events possibly related to
ADHD medications, according to the FDA web site.

Thaks for posting that. It seems good. I guess time will tell if it
works better than other drugs over all. The figure for aggression
events seem quite good considering how these tests are usually done and
on whom.

Dont worry to much about the claims of conflict of interest. Why even
in the artile they get it wrong. Why does that always seem to happen?

I quote

"Another member of the Committee, Andrew Leon of Cornell University,
disclosed he owns less than $25,000 in stock in a Cephalon competitor,
according to GoozNews on March 18, 2006."

So what's the problem? Not enough shares in a competitor? Really.

And this lot, the Alliance for Human Research Protection. Well you can
forget about them. Whatever their agenda is it's not what it says on
the top of their web site. A quick Google soon shows that.

Anyway thank you Jan, over all a most informative post about a new and
maybe better way to combat ADHD, well done.

James