ADHD Drugs - Who Said What At Last Month's Hearings

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March 17, 2006

 

ADHD Drugs - Who Said What At Last Month's Hearings

by Evelyn Pringle

 

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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.

 

Thirty additional 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.

 

During the 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 her 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 who states:

 

" The label may be stigmatizing and harmful in the long term in ways

that are only dimly 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 disability. "

 

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. "

 

" The ADHD epidemic is a disgrace, " she told the audience.

 

" Our nation's 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 companies? "

 

" Have our kids simply become funding mechanisms to be screened,

labeled and medicated? " she asked.

 

" Only one government agency, " Ms Parry pointed out, " the DEA's Office

of Diversion Control, has stood up to this psychopharmaceutical cartel. "

 

Allen Jones, 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 continued.

 

" 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 GlaxoSmithKline? "

 

Then he said he wondered how many knew that " Dr. Manasse heads an

organization that takes in millions of dollars from the pharmaceutical

industry? "

 

" These things 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.

 

" Pharmaceutical marketing in the United States seems to have far

outstripped the willingness of the FDA to track adverse events, " he

told the audience.

 

" 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, " he advised.

 

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 effective. "

 

While testifying, 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 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 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:

 

" With untreated 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 described above.

 

" 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. "

 

" Instead, " he 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. "

 

Actually, aside 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.

 

Dr Kruszewski 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. "

 

Dr Kruszewski 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.

 

Sandra Lucas 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

children?

 

" If anyone 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.

 

" Yet, " she 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 highly

profitable. "

 

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. "

 

After listening 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 noted.

 

" 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. "

 

" Environmental, genetic, developmental and familial factors are all

thought to play a role, " he said. " The diagnosis is clinical. "

 

But most 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. "

 

By Evelyn Pringle

evelyn.pringle

 

(Evelyn Pringle is a columnist for Independent Media TV and an

investigative journalist focuses on exposing corruption in government)