And Mania: ADHD Drug Warnings Come Too Late For Many
By Evelyn Pringle
11 March, 2007
The makers of drugs used to treat
attention disorders have known about the serious health risks associated
with the medications for years but instead of warning the public, the
industry has consistently focused its efforts on expanding the market
and colluding with FDA officials to keep warnings off the labels of
On February 21, 2007, the
FDA finally directed the drug companies to develop Patient Medication
Guides to inform patients about the adverse psychiatric symptoms associated
with Adderall, Concerta, Daytrana, Desoxyn, Dexedrine, Focalin, Metadate
CD, Methylin, Ritalin, Strattera, and the extended-release, patch and
chewable versions of these drugs.
An FDA report titled, "Adverse
Events Associated with Drug Treatment of ADHD: Review of Postmarketing
Safety Data," by Kate Gelperin and Kate Phelan, was presented at
the March 22, 2006, Pediatric Advisory Committee meeting and stated
"The most important
finding of this review is that signs and symptoms of psychosis or mania,
particularly hallucinations, can occur in some patients with no identifiable
risk factors, at usual doses of any of the drugs currently used to treat
Between January 2000, and
June 30, 2005, the FDA identified nearly 1,000 cases of psychosis or
mania linked to the drugs in its own database and those from the drug
makers themselves. A substantial proportion of the cases occurred in
children age ten years or less, a population in which hallucinations
are not common, the authors said.
"The occurrence of such
symptoms in young children," they wrote, "may be particularly
traumatic and undesirable, both to the child and the parents."
"The predominance in
young children of hallucinations, both visual and tactile," it
stated, "involving insects, snakes and worms is striking, and deserves
But the fact that these drugs
cause psychosis is not news. The rate of psychotic events was reported
in a 5-year Canadian study of children diagnosed with ADHD, by Cherland
and Fitzpatrick in 1999. Among the 192 children studied, 98 had been
placed on stimulant drugs, mostly methylphenidate, and psychotic symptoms
developed in more than 9% of the children and ceased as soon as the
medication was stopped.
Researchers reported no psychotic
symptoms in children who did not receive stimulants and the authors
noted that due to poor reporting, the rate of drug induced psychosis
and psychotic symptoms was probably much higher.
Dr Chris Griffith testified
at the March 26, 2006, hearing on behalf of the industry funded front
group, known as CHADD, and as much as said, kids would burn in hell
without ADHD drugs. "What happens when a child loses all hope and
ambition;" she asked the panel, "what happens when it is easier
to find a vial of crack cocaine or 40 ounces of beer as opposed to a
park or community recreation center?"
According to psychiatrist,
Dr Stefan Kruszewski, the opposite is true. "Children who are medicated
early," he says, "do not learn to develop coping strategies
that work as they move through different developmental stages."
"Instead," he says,
"they learn to rely on drugs to solve problems, rather than their
creative potential to solve problems on their own or with the help of
family, friends, schooling, music and the arts, church, social outings,
recreation and sports."
Dr Griffith also asked the
advisory panel to think about:
"What happens to a future
generation of minority youth, African-American, Latino males who disproportionately
populate our juvenile justice system? What happens to a teenager's sense
of fun when we are dealing with high rates of teen pregnancy, sexually
transmitted diseases and even abortions?
"Finally, what does
it say about all of us? We turn on the news each night and we tragically
see young drivers, teenagers, killed in automobile accidents--so many
that we forget their names, their faces and their stories. We develop
a sense of apathy."
"This may all seem like
drama," she stated, but "it is the untold story of what happens
when we fail to recognize and treat ADHD."
According to Dr Griffith,
depriving kids of legalized speed leads to every sin known to man. "With
untreated ADHD," she told the panel, "we see higher rates
of school and occupational failure; greater rates of incarceration;
juvenile delinquency; substance abuse; teen pregnancy; sexually transmitted
diseases; more problems with depression and self esteem and, finally,
greater numbers of automobile accidents and fatalities."
This is a drama all right,
but it's the other way around. A study in the February 2006, Journal
of Drug and Alcohol Dependence, examined data from a 2002 survey of
about 67,000 households, and reported that more than 7 million Americans
have misused ADHD stimulant drugs, and "substantial numbers of
teenagers and young adults appear to show signs of addiction, according
to a comprehensive national analysis tracking such abuse."
The researchers found that
in one 12-month period, about 1.6 million teens and young adults had
misused the drugs and that 75,000 showed signs of addiction.
In addition, for years there
have been reports of suicide and violence in persons on ADHD drugs.
For example, back on January 30, 1999, Adderall use resulted in the
death of 5-week-old, Tyra Ehlis, in Grand Forks, North Dakota, when
Ron Ehlis killed his daughter ten days after his doctor wrote the a
prescription for Adderall.
In this case, Ron had been
on Ritalin as a child, and when he went to a psychiatrist at age 26,
because he was having difficulties with his college studies, without
conducting any tests whatsoever, the doctor prescribed Adderall.
A few days later, Ron doubled
the dose per his doctor's instructions, and he began experiencing delusions,
hallucinations, and out-of-body experiences, including talks with God
and his dead grandfather.
Shortly thereafter, acting
under a belief that he was carrying out God's orders, Ron shot Tyra,
and then himself in the stomach, but he survived.
Ron went on trial for the
murder of his daughter, but the charges were dismissed after several
doctors testified that Ron suffered from an Adderall-induced psychosis.
The infant's mother also testified that Ron had not acted like himself
from the first day that he began taking the Adderall.
Adderall also caused the
violent death of 8-year-old, Jessica Curry, in Spokane, Washington.
In late September 1999, she was a happy little third-grader sitting
on her mother's lap in a Mustang convertible telling mom what she wanted
to wear for Halloween.
After saying she wanted to
be a princess, Jessica's mother, who was on Adderall at the time, stabbed
her daughter 5 times and then stabbed herself. Here too, the mother
lived but child did not. A short time later, a policeman came across
mother and daughter still sitting in car in the driveway all covered
Jessica's mother was also
found not guilty by reason of insanity brought on by the Adderall after
doctors for the prosecution and the defense agreed that her mental state
was so acute that she could not have distinguished right from wrong
at the time that she killed her daughter.
The death of 3-year-old Nathaniel
Branson must also be classified as an Adderall fatality. On March 18,
2000, Nat's mother Dawn was driving in Scottsdale, Arizona with her
son in the car when she suffered a psychotic episode while under the
influence of Adderall.
According to court documents,
Dawn heard a voice saying: "Let go of the steering wheel and gas.
God will drive the car don't you trust him?"
Dawn did as she was told
and a car accident caused the death of her son and serious injuries
to herself. She had never been psychotic before taking Adderall and
she has had no more psychotic episodes since she quit taking the drug.
So when the FDA reported
that the agency had received hundreds of reports of aggressive behavior
in children taking ADHD drugs, and up to 20% resulted in a significant
injury or hospitalization, this was not news either.
Experts say to expect more
of the same as the prescriptions for these drugs continue to multiply.
At the advisory meeting, Dr Gelperin noted the expansion of the customer
base stating: "Drug treatment of ADHD is increasing in all age
groups ... and also drug treatment for ADHD can now potentially be life-long."
It hard to imagine how sales
could go higher. In 2005, according to Research and Markets, the value
of the ADHD market was $2.6 billion and is now the 9th largest segment
of the CNS market by sales with growth of 8% year-on-year.
Attorney, Barry Turner, a
lecturer in law and medical ethics at Leeds Law School in the UK, warns
about of dangers of "pathologising" children's behavior. He
says psychiatric drugs have a disinhibitory effect on children and those
who grow up disinhibited become psychopathic.
he explains, "are unable to benefit from guilt, fear or empathy
and pray on victims without inhibition."
"ADHD drugs are creating
a generation of psychopaths," he warns, "not because it is
real, but because children are being brainwashed into believing they
"It becomes a self fulfilling
prophecy," Mr Turner says.
By disrupting the brain development
of small children, he explains, drug makers are manufacturing a small
army of "artificial psychopaths."
When testifying at the hearing,
FDA scientist, Dr Mosholder, told the advisors what all parents deserve
to know. "There are no pathognomonic physical or laboratory findings,"
he said, "and there is no psychological testing that can make the
diagnosis for certain."
The panel was informed that
children are being stigmatized for life by being wrongfully diagnosed
and put on drugs. Sue Parry, a school-based occupational therapist from
New Mexico, testified that parents are not aware of the future harm
that may result from an ADHD diagnosis, as described by Dr William Carey
"The label may be stigmatizing
and harmful in the long term in ways that are only dimply appreciated
today. The diagnosis of brain malfunction, which seems so useful and
comforting today, may at a later time come back to plague the person.
"We have not yet had
sufficient time to observe fully the possible consequences it may have
for education opportunities, employment, the military service or security
clearances. Labels stick firmly, especially when they involve neurological
Allen Jones, speaking on
behalf of the Alliance for Human Research Protection, told the advisors
that the FDA should instruct the pharmaceutical industry to advise the
FDA of all adverse events that have been reported on the drugs immediately,
and demand that all clinical trials be turned over so that independent
researchers can review them.
"We don't have the luxury
of time to wait for the future trials," he said, "children
Having lost her son to the
side effects of Zyprexa before a warning was added to its label, Ellen
Liversridge, testified on behalf of parents who lost children. "I
grieve particularly today," she said, "for the 51 dead of
ADHD drugs that were announced by the FDA."
"I guess my up-front
message, front and center," she told the panel, "is that you
know that these drugs can cause serious side effects and death, including
sudden death, hypertension, myocardial infarction, stroke, and possibly
"This being the case,"
she stated, "I urge you to recommend that these drugs have an appropriate
black box warning placed on the label starting immediately."
A grieving mother, Jacqueline
Bessner, told the story of her 15-year-old daughter, Leanne, a high
school sophomore who she said, was popular, beautiful, acted in school
plays, loved sports, played baseball, and was on the varsity basketball
Ms Bessner informed the panel
that Leanne "will not run another base, or shoot another free throw
or tease her little sister, or share memories with her own children
because on October 9th 2005, she took her life."
This family's nightmare began
when Leanne complained to her mother about problems concentrating and
she took Leanne to a counselor, who diagnosed her with ADD and sent
a recommendation to their family doctor to prescribe Concerta.
On September 18, 2005, the
doctor doubled the dose after Leanne told her mother she was not feeling
any better, and 3 weeks later, Ms Bessner found her daughter hanging
from a loft bed with a belt around her neck in her bedroom.
"Amongst my screams,"
she told the panel, "I recall her beautiful brown eyes partially
The family has retained the
Conshohocken, Pennsylvania-based law firm of, Pogust & Braslow,
for the purpose of bringing a wrongful death claim against the manufacturer
of Concerta, and attorney, Derek Braslow attended the hearings with
Mr Braslow says, "Leeane's
story should be required reading for every pediatrician and child psychiatrist
in the country."
According to WebMed on March
26, 2006, Dr Tom Laughren, head of the FDA's division of psychiatric
products, said, the committee appeared "unimpressed" by more
than 350 reports of suicidal thoughts or behaviors in treated children
over the last five years.
"Up to 20% of middle
and high school students," he stated, "already report such
thoughts, and it was unclear that drugs other than Strattera led to
Any street addict knows that
crashing after taking amphetamines brings on the most severe depression,
in large part, experts says, because speed almost always disrupts the
appetite and sleep cycle. However, unwitting consumers of ADHD drugs
would have no way of knowing this if they start feeling suicidal when
they cannot eat or sleep as the speed wears.
According to Attorney Braslow,
"Dr Laughren's comments are offensive and lack sympathy for those
families in grief."
He points out that Leeane
was not on Strattera, she was on Concerta, and she was not depressed
or suicidal before she began taking the drug. "These drugs take
the life out of children," he said.
"They do one of two
things to children and teenagers," Mr Braslow explains, "turn
them into zombies, making them passive and non-responsive or as they
affected Leeane - turn them into hyperfocused, anxious kids who can't
sleep and who become consumed with minor typical teen issues like friendships,
boyfriends and school."
"I don't doubt that
these drugs may help some adolescents or children," he notes. "But
at what price?" he states, "Better grades? Quieter class rooms?"
"The FDA has finally
admitted that these drugs can cause sudden death, serious cardiovascular
events, hallucinations, psychosis, suicidality, mania and suppression
of growth among others," he says, "but these warnings come
too late for Leeane and her family."
And Mr Braslow points out
that despite the new warnings, physicians continue to prescribe ADHD
drugs in record numbers.
"These warnings are
worthless," he says, "unless first, doctors inform families
of the risks, so families can make informed decisions about these drugs
and so they can look out for signs of suicidality or psychosis and second,
doctors stop giving these drugs out like candy, stop giving samples
of these drugs to families based upon the whim of a teacher or nurse."
Mr Braslow says, "doctors
need to actually weigh the risks and benefits of these drugs before
"While the newest warnings
on these drugs are certainly necessary," he notes, "albeit
many years late, these warnings still are not strong enough to adequately
inform physicians about the true risks of these drugs."
"The FDA advisory committees,"
he states, "should stop worrying about frightening doctors with
valid warnings and start giving doctors all the warnings so they can
make fully informed choices."
"That is the job of
the FDA," he states. "Our children deserve better."
The number of ADHD related
deaths cited at the hearing does not reflect an accurate picture. There
are many more deaths recorded in the individual states. For instance,
according to the report, "Child Suicides In Florida Associated
With Use Of Psychotropic Drugs," by Ken Kramer, of the 252 cases
of suicide in children under 18, between 2000 and 2004, thirty-six were
on ADHD drugs.
Because the FDA system of
reporting is voluntary, the agency admits that only between one and
10% of adverse reactions get recorded. Which means, because the FDA
and Big Pharma intentionally delayed warning the public about the dangers
of ADHD drugs, there are probably tens of thousands of ADHD victims
who do not even know what happened.
Persons interested in more
information on legal matters related ADHD drugs can contact the Pogust
& Braslow law firm at 610-941-4204, or http://www.pogustbraslow.com/
Evelyn Pringle is an investigative
reporter. She can be reached at: email@example.com