ADHD Experts Head
To Washington - Is the FDA Up To The Task?
Heavy-hitters from across the
country are heading to Washington this month to debate representatives
of the pharmaceutical industry during FDA hearings on the controversy
surrounding the over-prescribing of attention deficit drugs to children.
The International Center for the
Study of Psychiatry and Psychology (ICSPP) will be represented by five
of the leading experts on attention deficit disorders at the FDA's
Pediatric Advisory Committee's meeting on March 22, to include Dr Fred
Baughman, Dr Peter Breggin, Dr S DuBose Ravenel, Dr Grace Jackson, MD,
and Dr David Stein. These experts combined have authored hundreds of
books, papers and reports on attention deficit disorders.*
And all five have one common goal;
to put an end to the drugging for profit of the nation's most vulnerable
citizens and pharma's most lucrative customer base - innocent children.
says drugging kids is commonplace today. "Its happening all across
country not by thousands but tens of thousands, picking most on the
disenfranchized, powerless," he warns.
"These children become for-profit
receptacles for psychiatric drugs," he says, "which will, undoubtedly
alter their bodies and brains."
The harm caused by these medications
is well-documented. Although the FDA staff reports shows 51 deaths
between 1999-2003 in persons using ADHD drugs, according to Dr Baughman,
the MedWatch database contains 186 deaths between 1990 and 2000. Because
only 1% to 10% of all adverse events are reported to the FDA, the actual
number of deaths is known to be much higher.
Studies have determined that ADHD
drugs endanger the cardiovascular system and according to Dr Jackson,
"the cardiovascular risks of stimulants are hardly new."
"As early as 1977," she says, "Drs.
Vernon Fischer and Hendrick Barner documented the cell changes
associated with heart muscle enlargement in a chronic consumer of
"The connection between stimulants,
cardiovascular disability, and death has long been documented in the
medical literature," Dr Jackson notes, "but physicians and government
regulators have refused to acknowledge the hazards associated with
Dr Jackson takes exception with FDA
officials who say warnings on ADHD drugs are unnecessary and that their
benefits outweigh their risks.
"Whether by ignorance or design," Dr
Jackson states, "the regulators remain oblivious to the evidence-based
limitations of the prescription pad: at least 40% of all children fail
to tolerate or respond to stimulant therapy; about twice as many respond
at least as well to non-pharmacological interventions; and, as
documented in the National Institute of Mental Health’s most prestigious
study to date (the MTA study), the long term outcomes for medicated
children demonstrate diminishing returns over time, persistent
suppression of growth (about 1 cm per year), and artificial behavioral
improvements which dissipate when treatment is withdrawn."
"Not surprisingly," she says, "the
world community observes the United States with alarm for the
unjustified chemical exploitation of those who are different, but not
Dr David Stein also rejects the pill
solution, and promotes a parent training program called the caregivers’
skills program that helps children learn appropriate behavioral and
cognitive skills permanently, without drugs. For over twenty-five
years, he has conducted workshops providing realistic, practical and
effective alternatives to stimulant medications.
Dr DuBose Ravenel agrees with Dr
Stein's overall assessment that "this behavioral syndrome likely
represents basically a culturally derived phenomenon rather than a
biological or neurological one."
He stresses the importance of
providing positive reinforcement for appropriate behavior while dealing
with oppositional behavior and encourages fellow professionals to employ
Dr Stein's approach when dealing with children with attention deficit
ADHD drugs are known to have serious
adverse psychological effects on children which is one of the main
reasons Dr Breggin is dead against giving stimulants to kids. "That we
are doing this," he says, "I believe, is ethically and scientifically
"We're the only country in the
world, along with Canada, that is doing this to such massive numbers of
our children," Dr Breggin notes. "It's a reflection not on our children,
but on ourselves as parents and as teachers."
Dr Breggin describes an all too
common occurrence in recent years. "As the child's emotional control
breaks down due to medication effects, mood stabilizers may be added,"
he explains. "Eventually, these children end up on four or five
psychiatric drugs at once and a diagnosis of bipolar disorder by the age
of eight or ten," he says.
In addition, there is now a mountain
of evidence that stimulants disrupt growth hormone production on a daily
basis and that they also can reduce the child's overall growth,
including height and weight, according to Dr Breggin.
"All stimulants impair growth," he
notes, "not only by suppressing appetite but also by disrupting growth
"This poses a threat to every organ
of the body, including the brain, during the child's growth," Dr Breggin
warns. "The disruption of neurotransmitter systems adds to this threat."
"It is hard to imagine a more
serious warning flag than growth inhibition," he says, "since it affects
the overall growth of the body and all its organs, including the brain."
Its a well documented fact that the
pharmaceutical industry funnels money to front groups, which in turn
fund marketing campaigns and come out to do battle at times like this
when drug company profits are threatened and scrutinized.
On February 15, 2006, Children and
Adults with Attention-Deficit/Hyperactivity Disorder (CHADD), the
leading Pharma backed front group responsible for pushing ADHD drugs
issued a press release criticizing the FDA Advisory Committee's
recommendation last month to add black box warnings to the labels of
In the press release, E Clarke Ross,
identified as CEO of CHADD stated: "The committee's recommendation to
include warning language about rare and unproven cardiac health risks on
medications used to treat ADHD is premature, at best, and could
unnecessarily alarm patients and clinicians."
"The committee," the press release
continued, "directed by the FDA to decide how to move ahead with
additional research on the medication's safety, endorsed future studies,
trials and surveys for both pediatric and adult patients, and then
approved the unsolicited recommendation to include warning language on
patient inserts and labels."
Clarke said the committee "approved
the unsolicited recommendation to include warning language on patient
inserts and labels."
On March 13, 2006, the Shreveport
Times published an article by Terry Davis, that seems to directly
address the issue raised by CHADD, which began with the question: “Do
drugs used to treat attention deficit hyperactivity disorder need a
black box warning because of reports that they may cause sudden death?”
Ms Davis was a member of the FDA
advisory committee that decided last month that they did. In the article
she explains the reasoning behind the decision.
“The panel felt the parents of the
2.5 million children taking medication such as Ritalin or Adderall --
the 1.5 million adults also on these medicines, as well as their
physicians -- need to be alerted about the drugs' significant risks,”
“The advisory panel was also
concerned that ADHD drugs are overused,” she said and noted that more
than "30 million prescriptions -- valued at $3.1 billion -- are filled
“ADHD medications help,” Ms Davis
acknowledged, “however, they are also known to increase blood pressure
and heart rate and may increase risk of stroke and arrhythmia in
adults,” she said.
She pointed out that last year, “25
people, mostly children, died suddenly after taking these prescribed
In light of this logical
explanation, CHADD's criticism of the panel's recommendation is
obviously unwarranted but hardly surprising.
The group bills itself as the
nation's largest patient education group for persons affected by ADHD,
and says it provides consumer, patient, and professional information.
But those familiar with the marketing tactics of ADHD drugs know all
about CHADD's long history of concerted effort to increase drug company
profits through the sales of stimulants.
According to Dr Baughman, as far
back as 1995, the DEA was contacted by the United Nations International
Narcotics Control Board (INCB), about the financial ties between CHADD
and Ciba-Geigy, the manufacturer of Ritalin at the time.
The INCB discovered CHADD had
received over $775,000 from Ciba-Geigy and charged the organization with
being a vehicle for marketing a controlled substance to the public in
violation of the international statute known as the Controlled
Substances Act of 1971.
Ritalin is classified as a Schedule
II medication. In order for a product to be classified as a Schedule II
drug under the Federal Controlled Substances Act, it must meet three
criteria: one, it has to have a high potential for abuse; two, it has to
have a currently accepted medical use in treatment in the US; and three,
it has to show that abuse may lead to severe psychological or physical
It seems CHADD was lobbying the Drug
Enforcement Agency to get Ritalin removed from the Schedule II class and
moved into a less controlled group to make the drug easier to buy.
"They couldn't do anything more
valuable for the drug company, and more dangerous to the public,"
according to Dr Baughman.
However, it's lobbying failed, in
part because of the disclosure about CHADD receiving so much money from
the drug companies, according to Dr Breggin.
After conducting its own research,
the DEA not only refused to reclassify the drug, on May 16, 2000, the
agency issued a report to Congress that said Ritalin use had reached
epidemic proportions, and that it was being abused as a recreational
DEA told Congress that police were
reporting that Ritalin was being stolen, sold and traded on playgrounds,
as well as snorted, injected, and cut much like any other amphetamine.
Although the DEA presented a thorough report, nothing was done to slow
the sale of Ritalin to children.
And nothing changed as far as
CHADD‘s employment status as a major pusher for Pharma either. For the
fiscal year 2002-2003, the group’s financial statements showed it
received more than $670,000 from various drug companies.
In the November 29, 2004 Alternet
article “Drug Companies Pushing ADHD Drugs for Children,” reporter Kelly
Hearn further discussed the ties between CHADD and the drug companies in
an interview with Dr William Pelham, director of the Center for Children
and Families at State University of New York at Buffalo, a leading ADHD
researcher for 30 years, and a former advisory board member of McNeil
Pharmaceuticals, which markets the ADHD drug Concerta.
Over his career, Dr Pelham has
written over 250 research papers on ADHD, and in 2002, he even received
a lifetime achievement award from CHADD.
However, he has few good words to
say about CHADD, regulatory officials, medical professionals, or anybody
else involved in selling ADHD drugs to children.
"In recent years," Dr Pelham told
Alternet, "I have come to believe that the individuals who advocate most
strongly in favor of medication - both those from the professional
community, including the National Institutes of Mental Health, and those
from advocacy groups, including CHADD - have major and undisclosed
conflicts of interest with the pharmaceutical companies that deal with
"I believe that parents of ADHD
children and the public at large should be made aware of this
situation," he told Ms Hearn.
According to Dr Breggin, front
groups like CHADD use pharma money in several marketing techniques that
increase the sale of drugs. "They put out newsletters and other
information that praise medications," he says.
"Sometimes," he notes, "they
actively suppress viewpoints that are critical of drugs—for example, by
discouraging the media from airing opposing viewpoints."
Representatives of CHADD showed up
at the FDA hearings last month and the group will no doubt be out in
full force this month ready to go head to head against pharma's number
one enemy - the advocacy groups opposed to the mass drugging of children
*Dr Fred Baughman, author of The
ADHD Fraud: How Psychiatry Makes "Patients" of Normal Children (2004);
Dr Peter Breggin, author of a dozen books including Toxic Psychiatry
(1994), Talking Back to Ritalin (2001), and The Ritalin Fact Book
(2002); Dr Grace Jackson, author of Rethinking Psychiatric Drugs: A
Guide for Informed Consent (2005); S DuBose Ravenel, MD, FAAP, one of 34
signers of "A Critique of the International Consensus Statement on
ADHD," published in Clinical Child and Family Psychology Review, Vol 7,
No 1, March 2004; and David Stein, PhD, author of Stop Medicating, Start
Parenting: Real Solutions for Your Problem Teenager (2005), Unraveling
The Add/Adhd Fiasco (2002), and Ritalin is Not the Answer (1999).
Evelyn Pringle is a
columnist for Independent Media TV and an investigative journalist
focused on exposing corruption in government.
Books on ADHD
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