ADHD Drugs -
Who Said What At Last Month's Hearings
The FDA's Drug
Safety & Risk Management Advisory Committee held a two-day meeting
last month on February 9th and 10th to review adverse events linked
to the widely prescribed ADHD drugs that included reports of sudden
death, high blood pressure, heart attacks and strokes among adults
and children taking the medications.
In the US,
between 1999 through 2003, the FDA had reports of 24 deaths among
patients who took the amphetamine, Adderall, the staff report said.
Eleven more deaths were reported among patients using other drugs in
the amphetamine class, it noted.
During the same
time frame, another 16 deaths were reported in patients who took
Ritalin or other drugs known as methylphenidates, the report stated.
deaths of methylphenidate patients were recorded but they were
either non-US cases or occurred outside the review period, the FDA
said. The agency also excluded cases that appeared linked to
intoxication from multiple drugs or other causes.
February hearings, the committee heard testimony by representatives
from several advocacy groups, as well as medical professionals and
other interested parties, basically advocating for or against the
use of ADHD drugs with children.
Sue Parry from
New Mexico appeared and told the panel that she had traveled to the
hearing at my own expense because she was concerned about the safety
of the stimulant drugs given to children, some as young as two years
old, she noted.
“I have worked as
a school-based occupational therapist with students, mostly boys,”
Ms Parry said, “who supposedly had ADHD.” “I am also the mother of
three sons who a decade ago,” she said, “like many young boys in
America, were at risk of being labeled ADHD.”
She advised the
panel that parents are not aware of the future harm that may result
from an ADHD diagnosis, as eloquently 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
Ms Parry said
parents are also not told that the 1998 ADHD Consensus Development
Conference statement reads: “However, we do not have an
independent, valid test for ADHD, and there are no data to indicate
that ADHD is due to a brain malfunction.”
epidemic is a disgrace,” she told the audience.
children do not need more federal studies,” she continued. “What
they need is a federal grand jury to investigate what may be the
biggest healthcare fraud our nation has ever seen,” she advised.
“Is the ADHD
epidemic about neurotransmitters and chemical imbalances,” she asked
the panel, “or is it about increased market share for drug
“Have our kids
simply become funding mechanisms to be screened, labeled and
medicated?” she asked.
government agency,” Ms Parry pointed out, “the DEA's Office of
Diversion Control, has stood up to this psychopharmaceutical
appeared on at the hearing on behalf of the Alliance for Human
Research Protection, and started his testimony by saying, "I look at
this panel and I am troubled."
"Most of you have
had past or current relationships with the drug industry," he
"I spent time
researching these relationships," he informed the panel.
Mr Jones said he
wondered how many people in the audience knew that Dr Elizabeth
Andrews, "who spoke earlier, is a past world vice president of
Then he said he
wondered how many knew that "Dr. Manasse heads an organization that
takes in millions of dollars from the pharmaceutical industry?"
were not, to my knowledge, disclosed," he said.
According to Mr
Jones, the adverse events caused by ADHD drugs are readily apparent
in hospital emergency rooms, case reports in the medical literature
and doctors' offices around the country, and the reporting of
regulatory agencies in other countries.
marketing in the United States seems to have far outstripped the
willingness of the FDA to track adverse events," he told the
"There is urgency
in this present situation," he said. “Millions of Americans who are
unaware of the dangers are taking drugs that threaten their lives,”
Mr Jones asked
the panel to take immediate action to make the medical community and
citizens aware of the risks. "We cannot rely on future clinical
trials to save the persons who are at risk today," he warned.
Dr Chris Griffith
appeared at the hearing as a representative of the group, Children
and Adults with ADHD, better known as CHADD, the notorious industry
funded front group responsible for promoting the sale of ADHD drugs.
According to Dr
Chris, "the medications used for treatment of ADHD are safe and very
she painted a dire picture of children who will probably burn in
hell if deprived of ADHD drugs. "What happens when a child loses all
hope and ambition;" she asked, "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?"
And it gets worse
according to the good doctor. She asked the audience to think
"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
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 told the audience. "Unfortunately, it is the
untold story of what happens when we fail to recognize and treat
ADHD," she said.
According to the
doc, depriving kids of what amounts to legalized speed, leads to
every misbehavior and sin known to mankind:
ADHD 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."
Its a drama all
right, but the good doctor has it backwards. Kids who are fed speed
from age 2 on up are the ones likely to end up in the situations
"Children who are
medicated early," Psychiatrist Dr Stefan Kruszewski warns, "can’t
adapt or learn to find coping strategies that work for them as they
move through different developmental stages."
explains, "they learn to rely on a psychopharmaceutical behavior,
i.e., that drugs can solve problems, rather than their innate
creative potential to solve problems by themselves or with the help
of family, friends, schooling, music and the arts, church, social
outings, recreation and sports."
from the cheerleading by CHADD, the only good news that came out at
the hearing for pharma was when Dr Kate Gelperin stated: "Drug
treatment of ADHD is increasing in all age groups ... and also drug
treatment for ADHD can now potentially be life-long." That remark
definitely describes a customer base that drug companies have been
chasing after for years.
says, "one of the problems with the diagnostic assessment of ADHD,
is that a pre-screening statement is so inclusive that virtually
every child meets pre-screening criteria and therefore every child,
under prevailing treatment modalities for ADHD, becomes eligible for
‘chronic’ medication therapies."
says once screened, "children become ‘eligible’ for further
screening for co-morbid conditions (social anxiety, bipolar
disorder, obsessive-compulsive disorder, etc) and therefore eligible
for the possibility of even more medications."
Thus, an ADHD
diagnosis marks the beginning of a nightmare for many kids.
appeared at the hearing and testified on behalf of the Citizens
Commission on Human Rights, a psychiatric watchdog group.
Ms Lucas told the
audience, “we do know that the side effects of the stimulants are
not only present, they are extremely serious and sometimes lethal.”
“So, while the
FDA ponders the problem of studying the issue and conducting the
studies that may have inherent flaws,” she said, “what real,
immediate protections are to be put in place for parents and
proposed to study the issue of giving cocaine to children to
suppress symptoms of inattention, that individual would be regarded
as off his rocker,” Ms Lucas said.
continued, “there is already ample evidence that stimulant drugs
given to children are similar in their effects to cocaine, the major
difference being, of course, that cocaine is illegal, that drug
companies do not profit from it, while stimulants are legal and
Ms Lucas also
noted the conflicts of interest between several members of the
panels that were exposed. “In fact,” she said, “I can think of one
member from previous committees who was so beholden to the drug
companies that one might liken his presence to any hearings to
inviting Osam bin-Laden to a national security meeting.”
to all the testimony, the Drug Safety panel voted to recommend that
ADHD stimulant drugs carry a black box warning alerting patients and
doctors about potential cardiovascular risks.
Panel member, Dr
Steve Nissen said he was certain the public was 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," he
"I mean," he
continued, "it is just self-evident to me that the exponential
growth in the use of the drugs suggests that the public and
practitioners are unaware that there are people sitting around this
table that have a serious concern about the safety."
Dr Nissen also
said he was not very confident about the number of adverse events in
the spontaneous reporting system. "We know that you get 1-10 percent
of the actual events reported," he said.
Dr Nissen is
correct. The number of deaths cited at the hearing does not portray
an accurate picture. There were more deaths of children linked to
ADHD drugs recorded by individual states than were reported for the
whole country at the hearing.
For instance in
Florida, the report, “Child Suicides In Florida Associated With Use
Of Psychotropic Drugs,” by researcher Ken Kramer, recently released
after a year long investigation, found that out of the 252 cases of
suicide in children under 18, between 2000 and 2004, thirty-six of
the children who committed suicide were on ADHD drugs.
As far as
diagnosing attention deficit disorder, FDA official Dr Andrew
Mosholder told the committee: "The etiology is unknown."
genetic, developmental and familial factors are all thought to play
a role," he said. "The diagnosis is clinical."
importantly Dr Mosholder explained what experts believe 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."
Injured parties seeking justice can find more information at: Lawyers
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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