Legal ADHD Speed becoming drug of choice for Americans

Note from Ilena: No doubt, disbarred NY healthfraud flack, Mark S
Probert (or one of his many aliases which he denies he uses) will do
his usual defamation of Ms Pringle ... a respected journalist exposing
the sham of those like Probert's sponsors (who he also denies).


He either is paid for his defamatory opinions or he 'volunteers' to do
what others receive large PR budgets to promote con-med.



Legal ADHD Speed becoming drug of choice for Americans
By Evelyn Pringle
Online Journal Contributing Writer

http://onlinejournal.com/artman/publ...icle_613.shtml


Mar 22, 2006, 01:04

Email this article
Printer friendly page


A study published online in the February 2006 Journal of Drug and
Alcohol Dependence, which examined data from a 2002 survey of about
67,000 households, estimated that more than 7 million Americans have
misused stimulant drugs meant to treat ADHD, and “substantial numbers
of teenagers and young adults appear to show signs of addiction,
according to a comprehensive national analysis tracking such abuse.”

The statistics are alarming because people are using the drugs
recreationally or to boost academic and professional performance. The
scientists who published the study concluded that about 1.6 million
teenagers and young adults had misused these stimulants during a
12-month period and that 75,000 showed signs of addiction.

Last month, the FDA's Drug Safety and Risk Management Advisory
Committee held two days of hearings, and after listening to all the
testimony and reviewing the data presented, recommended that all ADHD
drugs carry a black box warning on increased cardiovascular risks.

This month, the Pediatric Advisory Committee is meeting today and will
focus on neuropsychiatric adverse event reports and trial data on ADHD
medications. The committee will also receive an update on efforts to
better understand cardiovascular adverse events possibly related to
ADHD medications, according to the FDA web site.

During the hearings last month, the Alliance for Human Research
Protection, asked the FDA to issue (1) a public advisory; (2) a "dear
doctor" letter to every doctor in America to apprise them of the
essentially lethal side effects that are being tracked; and (3) to
solicit the reporting of any and all adverse events of which they are
aware.

Allen Jones, speaking as a representative of the Alliance, told the
panel the FDA should instruct the pharmaceutical industry to advise
the FDA of all adverse events that have been reported concerning ADHD
drugs immediately, and also it should demand that all clinical trials
in possession of the drug companies be turned over to the FDA so that
independent researchers can review them for adverse events.

"We don't have the luxury of time to wait for the future trials," he
pointed out. "Children are dying," he said.

Ellen Liversridge, having lost her son to side effects of the drug
Zyprexa before they were made known in a black box warnings, appeared
to speak on behalf of all parents who have lost their children due to
adverse reactions to prescription drugs.

“I grieve particularly today for the 51 dead of ADHD drugs that were
announced yesterday by the FDA,” she told the panel.

“I guess my up-front message, front and center,” she continued, “is
that you know that ADHD drugs can cause serious side effects and
death, including sudden death, hypertension, myocardial infarction,
stroke, and possibly bipolar disorder.

“This being the case,” she said, “I urge you to recommend that these
drugs have an appropriate black box warning placed on the label
starting immediately.”

Sandra Lucas appeared at the hearing to speak on behalf of the
Citizens Commission on Human Rights, a psychiatric watchdog group, and
told the panel, “We do know that the side effects of the stimulants
are not only present, they are extremely serious and sometimes
lethal.”

“So,“ she asked the committee, “while the FDA ponders the problem of
studying the issue and conducting the studies that may have inherent
flaws, what real, immediate protections are to be put in place for
parents and children?”

During the hearing, Drug Safety panel member Dr Art Levin told the
committee, “I think we have to recognize that when a drug is approved
and marketed the public assumes a level of comfort in the safety of
that drug unless they are told otherwise.”

“And, for us to sit around and talk about this,” he continued, “to
have three advisory committee meetings discussing the signals and not
to make, at the very least, a very strong warning to people that there
is uncertainty here about the safety of these drugs and that they need
to be aware of that pending clarification, I just think is
inappropriate, unethical behavior.”

Committee member Dr Steve Nissan advised, “we have to elevate the
level of concern and if it slows the growth of this, that is probably
appropriate because I think most observers would argue that 10 percent
of 10-year-olds do not have this disease and what has happened is that
this is out-of-control use of drugs that have profound cardiovascular
effects and, as a cardiologist, I can tell you that,” he said.

Panel member Dr Curt Furberg recommended that ADHD drugs also come
with a patient guide “so that when parents are filling prescriptions
for their kids they get a written document laying out the state of
knowledge, or lack of the state of knowledge and the potential risks,
so they are reminded each time that there is a potential risk and we
are trying to find solutions to it,” he advised.

Since last month’s recommendation for a black box warning on
cardiovascular events, FDA reviewers announced a recommendation for
stronger warnings on all ADHD drugs due to reports of numerous adverse
events like mania and psychosis in clinical trials, including
modafinil.

On March 14, an FDA review was posted to the agency's web site in
advance of this week's meeting. The FDA said stronger warnings are
needed on the risk of psychosis, a mental disorder characterized by
the inability to distinguish real and imaginary events.

"The most important finding of this review is that signs of psychosis
or mania, particularly hallucinations, can occur in patients with no
identifiable risk factors, at usual doses of any of the drugs used to
treat ADHD," according to a memo dated March 3 from two members of the
agency's ADHD psychiatric review team.

The review said current labeling neither addresses those concerns nor
does it "clearly state the importance of stopping drug therapy in any
patient who develops hallucinations or other signs or symptoms of
psychosis or mania during drug treatment of ADHD."

From January 2000, through June 30, 2005, the review found nearly
1,000 reports of psychosis or mania possibly linked to the drugs,
including Adderall, Concerta, Ritalin and Strattera. The reports were
pulled from the FDA's database and from the drug makers themselves
after the FDA had requested additional information from the drug
companies.

The FDA found a "substantial portion of the psychosis-related cases
were reported to occur in children 10 years or less," an age group
which according to the FDA, does not typically suffer from psychosis.

"The predominance in young children of hallucinations, both visual and
tactile, involving insects, snakes and worms is striking and deserves
further evaluation," the FDA noted.

Last September 29, the FDA issued a public health advisory to alert
physicians of reports of suicidal thinking in children and adolescents
associated with Strattera, and directed Eli Lilly, manufacturer of
Strattera, to develop a Medication Guide for patients and caregivers.

Although Strattera is marketed as a "nonstimulant" medication,
according to pediatrician DuBose Ravenel, MD, FAAP, of Cornerstone
Pediatrics, “it is in fact a stimulant every bit as much as the
traditional stimulants, as evidenced by even a cursory consideration
of its pharmacological action, and evidenced by the fact that it is
classified as such by the World Health Organization.”

Dr Fred Baughman, ADHD expert and well-known author, will testify
before the committee this week on behalf of the International Center
for the Study of Psychiatry and Psychology.

“We know these drugs are poisons,” Dr Bughman warns, “and we know they
are highly addictive, dangerous and sometimes deadly.”

He points to the senseless death of children on ADHD drugs. “Matthew
Smith is dead today not because of ADHD,” he says, “but, as carefully
delineated by the medical examiner, his chronic
Ritalin/methylphenidate exposure.”

“Nor is there any other plausible explanation for the death of
Stephanie Hall, 11 years old of Canton, OH,” he advises. “No physical
predisposing factor other than Ritalin was present,” he notes,
“leading up to her death, in bed, by cardiac arrhythmia.”

“The main question the FDA needs to answer concerns ADHD,” Dr Baughman
says, “the 'disorder' these addictive, dangerous, sometimes deadly
drugs are used to treat.”

“The shocking fact of the matter is that it is not a disorder/disease
at all,” he explains. “Children said to have it are entirely normal,
meaning they bear no objective, demonstrable, diagnosable,
abnormality, meaning there is no justification for prescribing these
or any other drugs for so-called ADHD -- a wholly fictitious, wholly
subjective entity.”

According to David Stein, Ph D, professor of Psychology at Longwood
University, “The risks of psychiatric drugs in the bodies of children
and teenagers is well documented and needs no further elaboration.”

He wants the advisory committee to address two issues: (1) the
validity of ADD/ADHD as diseases; and (2) effective alternative
behavioral treatments that reduce reliance on drugs.

Dr Stein’s behavioral/cognitive treatment methods have won awards from
the American Psychological Association (one of top 10 research
projects in 1998), the International Center for Psychiatry and
Psychology (2005), and the Ritalin Litigation Conference (2001).

“It is my hope,” he said, “that the committee will consider that
within the decision tree, the physician's choice to use drugs can be
lowered in favor of, at the very least, recommending properly designed
behavioral parent training.”

“The risks of legal liability and the risks of medical damage to
children,” Dr Stein advises, “can be reduced with the augmentation and
further development of proper behavioral treatments.”

According to court certified expert and author of many books on ADHD
Dr Peter Breggin, all stimulants commonly cause “a continuum of
stimulation, including agitation and irritability, anger, hostility,
disinhibition, hypomania and mania.”

The stimulant or activation syndrome, he advises, was originally
observed decades ago with stimulant drugs such as amphetamines,
Adderall, and Dexedrine, and methylphenidates such as Ritalin and
Concerta.

It also occurs, he notes, with dexmethylphenidate such as Focalin, and
selegilines like Sparlon and Provigil, as well as the atomoxetine,
Strattera.

In a review of the summary data for the FDA Spontaneous Reporting
System through March 1997, Dr Breggin counted the following:
Psychosis, 43; hallucinations, 44; and psychotic depression, 11. His
review also counted more than 50 reports in the combined category of
overdose, overdose intentional, and suicide attempt.

“In regard to both amphetamines and methylphenidate,” he explains,
“there are a surprising number of animal and human studies showing
persistent biochemical changes and atrophy after several weeks or more
exposure.”

“While the changes in children are sometimes mistakenly attributed to
ADHD or OCD, they are a known effect of stimulants on the animal
brain,” he advises. “A known toxic drug effect is a far more likely
culprit than a highly speculative 'biochemical imbalance' in these
children,” he adds.

Dr Breggin will also testify at the advisory committee hearing on
behalf of the International Center for Psychiatry and Psychology, and
will recommend that labels for stimulant drugs include the following
neuropsychiatric warnings:

(1) A warning concerning depressive/OCD ADRs that includes depression,
apathy, lethargy, listlessness, tiredness, sadness, crying,
withdrawal, and social isolation as well as worrying, ruminating,
over-focusing, and other obsessive-compulsive behaviors.

(2) A warning concerning stimulation or activation ADRs that includes
insomnia, anxiety, agitation, panic attacks, irritability, hostility,
aggressiveness, violence, impulsivity, disinhibition, hypomania, and
mania.

(3) Strengthened warning concerning psychosis, paranoid ideation and
hallucinations.

(4) Strengthened warning about rebound, dependence and abuse,
especially for methylphenidate products (all current methylphenidate
labels especially inadequate).

(5) A specific warning that the combination of depressive,
obsessive-compulsive and stimulant ADRs poses a serious risk of
dyscontrol or disinhibition with suicidal and/or violent behavior.

(6) A warning in the labels for amphetamine and methylphenidate
products about persistent brain dysfunction and atrophy.

Information released by the FDA last month showed that between 1999
and 2003, 78 million prescriptions were written for ADHD drugs in
children ages 1 to 18, and more than 14 million prescriptions were
written for adults.

During last month’s hearings, Safety Drug committee member, Dr Steve
Nissen, said he is certain the public is 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.”

Evelyn Pringle is a columnist for Independent Media TV and an
investigative journalist focusing on exposing corruption in
government.

Copyright © 1998-2006 Online Journal

*** Free account sponsored by SecureIX.com ***
*** Encrypt your Internet usage with a free VPN account from http://www.SecureIX.com ***

And the doctors and now taking their turn, saying they need more evidence.
If I was there, I could present a list of side effects from each drug, but
of course they know that already. One doctor states: "I always think of
this medication as one of the safest medications we can give to anyone,
really," ( she prefers not to think, or to lie?) Then there are lies from
the psychiatrists' saying it is political, and not scientific. As if
political causes hallucinations.

As for Mark, he has proven himself to be untruthful, many times over.

Ilena wrote in message ...
Note from Ilena: No doubt, disbarred NY healthfraud flack, Mark S
Probert (or one of his many aliases which he denies he uses) will do
his usual defamation of Ms Pringle ... a respected journalist exposing
the sham of those like Probert's sponsors (who he also denies).


He either is paid for his defamatory opinions or he 'volunteers' to do
what others receive large PR budgets to promote con-med.



Legal ADHD Speed becoming drug of choice for Americans
By Evelyn Pringle
Online Journal Contributing Writer

http://onlinejournal.com/artman/publ...icle_613.shtml


Mar 22, 2006, 01:04

Email this article
Printer friendly page


A study published online in the February 2006 Journal of Drug and
Alcohol Dependence, which examined data from a 2002 survey of about
67,000 households, estimated that more than 7 million Americans have
misused stimulant drugs meant to treat ADHD, and "substantial numbers
of teenagers and young adults appear to show signs of addiction,
according to a comprehensive national analysis tracking such abuse."

The statistics are alarming because people are using the drugs
recreationally or to boost academic and professional performance. The
scientists who published the study concluded that about 1.6 million
teenagers and young adults had misused these stimulants during a
12-month period and that 75,000 showed signs of addiction.

Last month, the FDA's Drug Safety and Risk Management Advisory
Committee held two days of hearings, and after listening to all the
testimony and reviewing the data presented, recommended that all ADHD
drugs carry a black box warning on increased cardiovascular risks.

This month, the Pediatric Advisory Committee is meeting today and will
focus on neuropsychiatric adverse event reports and trial data on ADHD
medications. The committee will also receive an update on efforts to
better understand cardiovascular adverse events possibly related to
ADHD medications, according to the FDA web site.

During the hearings last month, the Alliance for Human Research
Protection, asked the FDA to issue (1) a public advisory; (2) a "dear
doctor" letter to every doctor in America to apprise them of the
essentially lethal side effects that are being tracked; and (3) to
solicit the reporting of any and all adverse events of which they are
aware.

Allen Jones, speaking as a representative of the Alliance, told the
panel the FDA should instruct the pharmaceutical industry to advise
the FDA of all adverse events that have been reported concerning ADHD
drugs immediately, and also it should demand that all clinical trials
in possession of the drug companies be turned over to the FDA so that
independent researchers can review them for adverse events.

"We don't have the luxury of time to wait for the future trials," he
pointed out. "Children are dying," he said.

Ellen Liversridge, having lost her son to side effects of the drug
Zyprexa before they were made known in a black box warnings, appeared
to speak on behalf of all parents who have lost their children due to
adverse reactions to prescription drugs.

"I grieve particularly today for the 51 dead of ADHD drugs that were
announced yesterday by the FDA," she told the panel.

"I guess my up-front message, front and center," she continued, "is
that you know that ADHD drugs can cause serious side effects and
death, including sudden death, hypertension, myocardial infarction,
stroke, and possibly bipolar disorder.

"This being the case," she said, "I urge you to recommend that these
drugs have an appropriate black box warning placed on the label
starting immediately."

Sandra Lucas appeared at the hearing to speak on behalf of the
Citizens Commission on Human Rights, a psychiatric watchdog group, and
told the panel, "We do know that the side effects of the stimulants
are not only present, they are extremely serious and sometimes
lethal."

"So," she asked the committee, "while the FDA ponders the problem of
studying the issue and conducting the studies that may have inherent
flaws, what real, immediate protections are to be put in place for
parents and children?"

During the hearing, Drug Safety panel member Dr Art Levin told the
committee, "I think we have to recognize that when a drug is approved
and marketed the public assumes a level of comfort in the safety of
that drug unless they are told otherwise."

"And, for us to sit around and talk about this," he continued, "to
have three advisory committee meetings discussing the signals and not
to make, at the very least, a very strong warning to people that there
is uncertainty here about the safety of these drugs and that they need
to be aware of that pending clarification, I just think is
inappropriate, unethical behavior."

Committee member Dr Steve Nissan advised, "we have to elevate the
level of concern and if it slows the growth of this, that is probably
appropriate because I think most observers would argue that 10 percent
of 10-year-olds do not have this disease and what has happened is that
this is out-of-control use of drugs that have profound cardiovascular
effects and, as a cardiologist, I can tell you that," he said.

Panel member Dr Curt Furberg recommended that ADHD drugs also come
with a patient guide "so that when parents are filling prescriptions
for their kids they get a written document laying out the state of
knowledge, or lack of the state of knowledge and the potential risks,
so they are reminded each time that there is a potential risk and we
are trying to find solutions to it," he advised.

Since last month's recommendation for a black box warning on
cardiovascular events, FDA reviewers announced a recommendation for
stronger warnings on all ADHD drugs due to reports of numerous adverse
events like mania and psychosis in clinical trials, including
modafinil.

On March 14, an FDA review was posted to the agency's web site in
advance of this week's meeting. The FDA said stronger warnings are
needed on the risk of psychosis, a mental disorder characterized by
the inability to distinguish real and imaginary events.

"The most important finding of this review is that signs of psychosis
or mania, particularly hallucinations, can occur in patients with no
identifiable risk factors, at usual doses of any of the drugs used to
treat ADHD," according to a memo dated March 3 from two members of the
agency's ADHD psychiatric review team.

The review said current labeling neither addresses those concerns nor
does it "clearly state the importance of stopping drug therapy in any
patient who develops hallucinations or other signs or symptoms of
psychosis or mania during drug treatment of ADHD."

From January 2000, through June 30, 2005, the review found nearly
1,000 reports of psychosis or mania possibly linked to the drugs,
including Adderall, Concerta, Ritalin and Strattera. The reports were
pulled from the FDA's database and from the drug makers themselves
after the FDA had requested additional information from the drug
companies.

The FDA found a "substantial portion of the psychosis-related cases
were reported to occur in children 10 years or less," an age group
which according to the FDA, does not typically suffer from psychosis.

"The predominance in young children of hallucinations, both visual and
tactile, involving insects, snakes and worms is striking and deserves
further evaluation," the FDA noted.

Last September 29, the FDA issued a public health advisory to alert
physicians of reports of suicidal thinking in children and adolescents
associated with Strattera, and directed Eli Lilly, manufacturer of
Strattera, to develop a Medication Guide for patients and caregivers.

Although Strattera is marketed as a "nonstimulant" medication,
according to pediatrician DuBose Ravenel, MD, FAAP, of Cornerstone
Pediatrics, "it is in fact a stimulant every bit as much as the
traditional stimulants, as evidenced by even a cursory consideration
of its pharmacological action, and evidenced by the fact that it is
classified as such by the World Health Organization."

Dr Fred Baughman, ADHD expert and well-known author, will testify
before the committee this week on behalf of the International Center
for the Study of Psychiatry and Psychology.

"We know these drugs are poisons," Dr Bughman warns, "and we know they
are highly addictive, dangerous and sometimes deadly."

He points to the senseless death of children on ADHD drugs. "Matthew
Smith is dead today not because of ADHD," he says, "but, as carefully
delineated by the medical examiner, his chronic
Ritalin/methylphenidate exposure."

"Nor is there any other plausible explanation for the death of
Stephanie Hall, 11 years old of Canton, OH," he advises. "No physical
predisposing factor other than Ritalin was present," he notes,
"leading up to her death, in bed, by cardiac arrhythmia."

"The main question the FDA needs to answer concerns ADHD," Dr Baughman
says, "the 'disorder' these addictive, dangerous, sometimes deadly
drugs are used to treat."

"The shocking fact of the matter is that it is not a disorder/disease
at all," he explains. "Children said to have it are entirely normal,
meaning they bear no objective, demonstrable, diagnosable,
abnormality, meaning there is no justification for prescribing these
or any other drugs for so-called ADHD -- a wholly fictitious, wholly
subjective entity."

According to David Stein, Ph D, professor of Psychology at Longwood
University, "The risks of psychiatric drugs in the bodies of children
and teenagers is well documented and needs no further elaboration."

He wants the advisory committee to address two issues: (1) the
validity of ADD/ADHD as diseases; and (2) effective alternative
behavioral treatments that reduce reliance on drugs.

Dr Stein's behavioral/cognitive treatment methods have won awards from
the American Psychological Association (one of top 10 research
projects in 1998), the International Center for Psychiatry and
Psychology (2005), and the Ritalin Litigation Conference (2001).

"It is my hope," he said, "that the committee will consider that
within the decision tree, the physician's choice to use drugs can be
lowered in favor of, at the very least, recommending properly designed
behavioral parent training."

"The risks of legal liability and the risks of medical damage to
children," Dr Stein advises, "can be reduced with the augmentation and
further development of proper behavioral treatments."

According to court certified expert and author of many books on ADHD
Dr Peter Breggin, all stimulants commonly cause "a continuum of
stimulation, including agitation and irritability, anger, hostility,
disinhibition, hypomania and mania."

The stimulant or activation syndrome, he advises, was originally
observed decades ago with stimulant drugs such as amphetamines,
Adderall, and Dexedrine, and methylphenidates such as Ritalin and
Concerta.

It also occurs, he notes, with dexmethylphenidate such as Focalin, and
selegilines like Sparlon and Provigil, as well as the atomoxetine,
Strattera.

In a review of the summary data for the FDA Spontaneous Reporting
System through March 1997, Dr Breggin counted the following:
Psychosis, 43; hallucinations, 44; and psychotic depression, 11. His
review also counted more than 50 reports in the combined category of
overdose, overdose intentional, and suicide attempt.

"In regard to both amphetamines and methylphenidate," he explains,
"there are a surprising number of animal and human studies showing
persistent biochemical changes and atrophy after several weeks or more
exposure."

"While the changes in children are sometimes mistakenly attributed to
ADHD or OCD, they are a known effect of stimulants on the animal
brain," he advises. "A known toxic drug effect is a far more likely
culprit than a highly speculative 'biochemical imbalance' in these
children," he adds.

Dr Breggin will also testify at the advisory committee hearing on
behalf of the International Center for Psychiatry and Psychology, and
will recommend that labels for stimulant drugs include the following
neuropsychiatric warnings:

(1) A warning concerning depressive/OCD ADRs that includes depression,
apathy, lethargy, listlessness, tiredness, sadness, crying,
withdrawal, and social isolation as well as worrying, ruminating,
over-focusing, and other obsessive-compulsive behaviors.

(2) A warning concerning stimulation or activation ADRs that includes
insomnia, anxiety, agitation, panic attacks, irritability, hostility,
aggressiveness, violence, impulsivity, disinhibition, hypomania, and
mania.

(3) Strengthened warning concerning psychosis, paranoid ideation and
hallucinations.

(4) Strengthened warning about rebound, dependence and abuse,
especially for methylphenidate products (all current methylphenidate
labels especially inadequate).

(5) A specific warning that the combination of depressive,
obsessive-compulsive and stimulant ADRs poses a serious risk of
dyscontrol or disinhibition with suicidal and/or violent behavior.

(6) A warning in the labels for amphetamine and methylphenidate
products about persistent brain dysfunction and atrophy.

Information released by the FDA last month showed that between 1999
and 2003, 78 million prescriptions were written for ADHD drugs in
children ages 1 to 18, and more than 14 million prescriptions were
written for adults.

During last month's hearings, Safety Drug committee member, Dr Steve
Nissen, said he is certain the public is 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."

Evelyn Pringle is a columnist for Independent Media TV and an
investigative journalist focusing on exposing corruption in
government.

Copyright © 1998-2006 Online Journal

*** Free account sponsored by SecureIX.com ***
*** Encrypt your Internet usage with a free VPN account from
http://www.SecureIX.com ***