"The medication has not been reported to produce euphoria, and there has been no indication of excessive use or abuse in clinical trials" As the scientific basis for his comments, Dr O'Brien references his own group's work
According to Psychiatrist, Dr Stefan P Kruszewski, MD, "the author's statement does not appear to be supported by his referenced work, nor is it supported by information widely available in the 2004 edition of the Physicians' Desk Reference."
The referenced article, Dr Kruszewski says, may demonstrate that modafinil can, in some cases, blunt cocaine euphoria. However, it does not say anything about modafinil's intrinsic ability to produce euphoria (or not), he says.
"Separately," Dr Kruszewski advises in the March 2006, American Journal of Psychiatry, "the 2004 PDR raises specific concerns about modafinil, saying that it can produce "psychoactive and euphoric effects, alterations in mood, perception, thinking and feelings typical of other CNS stimulants."
"The PDR also states that "modafinil is reinforcing, as evidenced by its self-administration in monkeys previously trained to self-administer cocaine," he adds.
In addition, says Dr Kruszewski, the comment about the lack of euphorigenic effects is contradicted by the FDA in a January 14, 2002, warning letter sent to Paul Kirsch, the senior director of regulatory affairs at Cephalon, that specifically reiterates the drug's package insert addressing the modafinil's euphorigenic effects and its potential for abuse.
That the euphorigenic side effects or abuse potential may be minimized has current treatment implications because modafinil is increasingly promoted for fatigue and excessive sleepiness unrelated to narcolepsy as well as for cocaine abuse, Dr Kruszewski says in the Journal.
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.
Evelyn Pringle
evelyn.pringle@sbcglobal.net
(Evelyn Pringle is a columnist for Independent Media TV and an investigative journalist focused on exposing government corruption)
According to Psychiatrist, Dr Stefan P Kruszewski, MD, "the author's statement does not appear to be supported by his referenced work, nor is it supported by information widely available in the 2004 edition of the Physicians' Desk Reference."
The referenced article, Dr Kruszewski says, may demonstrate that modafinil can, in some cases, blunt cocaine euphoria. However, it does not say anything about modafinil's intrinsic ability to produce euphoria (or not), he says.
"Separately," Dr Kruszewski advises in the March 2006, American Journal of Psychiatry, "the 2004 PDR raises specific concerns about modafinil, saying that it can produce "psychoactive and euphoric effects, alterations in mood, perception, thinking and feelings typical of other CNS stimulants."
In addition, says Dr Kruszewski, the comment about the lack of euphorigenic effects is contradicted by the FDA in a January 14, 2002, warning letter sent to Paul Kirsch, the senior director of regulatory affairs at Cephalon, that specifically reiterates the drug's package insert addressing the modafinil's euphorigenic effects and its potential for abuse.
That the euphorigenic side effects or abuse potential may be minimized has current treatment implications because modafinil is increasingly promoted for fatigue and excessive sleepiness unrelated to narcolepsy as well as for cocaine abuse, Dr Kruszewski says in the Journal.
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.
Evelyn Pringle
evelyn.pringle@sbcglobal.net
(Evelyn Pringle is a columnist for Independent Media TV and an investigative journalist focused on exposing government corruption)
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