ADHD - Cash Cow
For Pharma - Possible Lawsuits Involving Drugs - Ritalin and Adderall and
Other Treatments Questioned
March 19th 2006
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ADHD Drugs |
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“Our society viewed with loathing those who 'pushed' stimulant drugs on
children," says child psychiatrist Dr Peter Breggin. "Yet today, there
are more children taking Ritalin and amphetamines from doctors than ever
received them from illegal pushers,” he says.
“Parents and teachers and even doctors have been badly misled by drug
company marketing practices,” he warns. “Drug companies have targeted
children as a big market likely to boost profits and children are
suffering as a result."
The marketing campaign referred to by Dr Breggin has proven to be
extremely successful At a February 10, 2006, FDA advisory committee
hearing, it was reported by Dr Andrew Mosholder, a medical officer in
the FDA's Office of Drug Safety, that about 2.5 million children in this
country between the age 4 and 17, currently take ADHD drugs. A
government survey found 9.3% of 12-year-old boys, and 3.7% of
11-year-old girls are on the drugs, he said.
In 1980, the so-called Attention Deficit Disorder (ADD), which amounts
to little more than a list of behaviors, was voted into existence as a
mental illness by the American Psychiatric Association, so it could be
included in the psychiatric billing Bible known as the Diagnostic &
Statistical Manual for Mental Disorders, DSM.
In 1987, an H was added to the label and the illness became, "Attention
Deficit Hyperactivity Disorder." Within one year, 500,000 children in
the US were diagnosed with this cash-cow disorder.
A few years later, it was classified as a disability and a cash
incentive program was initiated for low-income families with children
diagnosed with ADHD. A family could get $450 a month for each child
diagnosed with the disorder, and the cost of treatment and medication
for low-income children would be covered by Medicaid.
Then in 1991, schools began receiving educational grants of $400
annually for each ADHD child. The same year, the US Department of
Education classified the disorder as a handicap, which required special
services to be provided to each disabled child.
By 1996, close to $15 billion was spent annually on the diagnosis,
treatment, and study of the so-called attention deficit disorder.
Over roughly the past 2 years, public health officials in the US, Canada
and the UK have issued warnings about previously known, but undisclosed,
risks associated with the stimulant drugs used to treat ADHD.
In September 2005, Canadian public health officials asked drug makers to
turn over data from all clinical trials and post-marketing reports for
the medications by the end of 2005 to be reviewed in 2006.
The February 2006 hearings, represent the third time in 2 years that the
FDA has addressed the heart related side effects of ADHD drugs. This
whole charade is beginning to look more and more like a repeat of the
Vioxx debacle.
Foot-dragging earned the FDA a rebuke this month from Senator, Chuck
Grassley (R-Iowa), chairman of the Senate Committee on Finance, which
has exclusive jurisdiction over the Medicare and Medicaid programs
which, according to Sen Grassley, pay hundreds of millions of dollars
for prescription drugs each year, including drugs used to treat ADHD.
In a February 6, 2006, letter to acting FDA commissioner, Dr Andrew von
Eschenbach, Sen Grassley said in part, "I remain concerned that while
both psychiatric and cardiovascular risk signals have cropped up across
this class of drugs this past year, it appears that FDA is just now
beginning to 'discuss approaches' for studying these risks."
“More specifically," Sen Grassley wrote, "I question why it has taken
nearly an entire year for FDA to begin to address these concerns given
the serious nature of the adverse events associated with these drugs.”
In the letter, Sen Grassley noted that the FDA had recently announced
upcoming meetings of two different advisory committees to examine
different ways of studying adverse events related to ADHD drugs when
studies showing the risks had already been done. He accused the FDA of
taking a slow approach to regulating the drugs.
As examples of risk already established, Sen Grassley pointed out that
in February 2005, cardiovascular concerns raised in adverse event
reports led Canadian health officials to suspend market authorization of
Adderall XR for six months due to a review of safety information from
Shire that showed 20 international reports of sudden death and that in
2004, the FDA required Shire to include the risk of sudden death on the
label.
He noted that last summer, the safety of the drugs was called into
question when the FDA publicly stated that it had concerns about
psychiatric side effects from the use of Concerta and specifically
stated on its website that it had “identified two possible safety
concerns with the methylphenidate drug products: psychiatric adverse
events and cardiovascular adverse events.”
Sen Grassley also pointed out that in September of 2005, the FDA had
issued an alert to healthcare professionals regarding the use of
Strattera, after reviewing data showing an increase in suicidal thoughts
in 12 separate studies, and directed Eli Lilly, to “revise the
labeling…to include a boxed warning and additional warning statements
regarding an increased risk of suicidal thinking in children and
adolescents.”
As an added pressure, Sen Grassley asked for a complete list of names of
participating panel members and a complete list of conflict disclosures
for both the February 9-10 2006, advisory committee and the March 22,
2006, Pediatric Advisory Committee.
The latest report made public by the FDA at the February 2006 hearings,
said that between 1999 and 2003, there were twenty-five deaths in
persons using ADHD drugs, including the deaths of 19 children. Officials
also admitted to receiving reports of more than 50 cases of
cardiovascular problems, including stoke, heart attack, hypertension,
palpitations and arrhythmia.
The report only covers a 4 year period and because only between 1 and
10% of adverse events are ever reported, the numbers above represent a
gross understatement of actual cases of harm from these drugs.
The report could not have considered the increase in emergency room
visits associated to Ritalin abuse alone over the past decade. According
to the Drug Abuse Warning Network, while there were 271 Ritalin-related
emergency room visits in 1990, there were 1,478 Ritalin-related visits
in 2001.
According to the National Institute of Drug Abuse, in 1999, some 165
Ritalin-related poison calls were made in Detroit; 419 cases were
reported in Texas, and only 114 of those cases involved intentional
misuse or abuse.
While the FDA foot-dragging has continued for years, the drug companies
have been making a fortune by pushing the exact same pills that have
been pedaled on the street for 50 years under names like black beauties,
yellow jackets, uppers, white crosses, and bennies.
These are the exact same drugs that were handed out like candy in the
1960s and 1970s, when prescribed under the guise of diet pills, and used
by truckers to stay awake, by entertainers and athletes to perform, and
by people who wanted to party for days in the general population, until
they were banned.
The drugs contain the exact same amphetamine that was THE main
ingredient in the once popular "B-12" injections given weekly to wealthy
patients in doctor's offices all over the country until they were
banned.
So here we are in 2006, with pharma making a killing by selling
dangerous drugs that have been outlawed time and time again. What kind
of profits are we looking at? As of September 2005, Walgreen's prices
for a 30 day supply for the lowest dosage of the top selling drugs were:
• Methylphenidate (generic Ritalin) $15.69
• Ritalin (brand name): $27.79
• Amphetamine/dextroamphetamine (generic Adderall): $47.09
• Adderall (brand name): $94.49
• Concerta: $103.99
• Strattera: $123.99
According to Dr Mosholder, since March 2002, prescriptions written for
adults rose by 90%, to about 1 million a month as of June 2005, and to
about 2 million a month for children.
If the three million people are on the lowest priced Ritalin, a round
number of $30 per month times 3 million would create over $1 billion a
year for the drug company alone. Then add in the medical and
psychological professional fees and the grand total easily exceeds $2
billion per year. And if the patients are on Adderall, the cost of the
drug triples to over $3 billion a year.
The money earned by prescribing shrinks is nothing to sneeze at either.
A 2003 American Psychological Association study on "financial
disincentives" for psychotherapy found that doctors could earn about
$263 an hour for doing three 15-minute "medication management" sessions,
verses about $156 for a single 45 to 50-minute therapy session. That
represents a pay cut of 41% an hour for doing therapy only, the study
determined.
However, hopefully we are about to see a dwindling of the above profit
margins.
On February 10, 2006, the Drug Safety and Risk Management advisory
committee said that ADHD drugs should carry the strongest warning label
that they may be linked to an increased risk of death and injury.
One of the committee members who pushed for the label, Cardiologist,
Steven Nissen, said something must be done to curtail the prescription
rates. "I feel strongly we need to slow the growth of utilization," he
said. "When you have that kind of exposure for drugs that are
suspicious, that does create a major public health concern," he added.
This legally prescribed speed is being passed around between students in
schools and colleges all over the nation. A 2002 study by the University
of Wisconsin estimated that one of five college students takes Adderall,
many for recreational reasons.
On July 25, 2005, CBS News reported that "Adderall and Ritalin have in
fact become "street drugs" at America’s colleges and universities, where
prescription stimulants often replace coffee and CliffsNotes as the
study aids for today’s college students."
According to Dr Sean Esteban McCabe, interim director of the University
of Michigan Substance Abuse Research Center, a recent survey found that
6.9% of American college students have taken prescription stimulants
illicitly, and up to 25% at certain elite universities with high
academic pressures and admission standards.
The study canvassed students at 119 four-year colleges and universities
nationwide and was published in the January 2005 issue of the journal
Addiction. The specific focus of the study was the non-medical use of
Ritalin, Dexedrine and Adderall.
Based on his survey, Dr McCabe found that, prescription stimulant abuse
tends to lead to higher rates of other drug abuse and driving while
drinking.
The survey found that students who had used a prescription stimulant
non-medically in the past year were 10 times more likely to report the
use of marijuana, twenty times more likely to use cocaine, and 5 times
more likely to report driving after binge drinking.
On December 5, 2005, the Nashville, Tennessee based newspaper, The
Tennessean reported that Athletes aren't the only ones popping pills to
gain a competitive edge these days.
"College students are turning to prescription stimulants such as
Adderall and Ritalin to get them through late-night cram sessions,
risking potential side effects and unknown long-term effects for a
chance at a better grade," it wrote.
"I would say it's pretty common," says Matthew Fleischer, a senior
philosophy major at Vanderbilt University. "I know people who use it; I
know people who call me and ask me if I can find some for them," he told
the Tennessean.
More than 50 college newspapers have already published articles
describing Adderall abuse on campus according to CBS News.
For school age children, these drugs are providing a spring-board into
early addiction. Over the past few years, high school students have been
busted for using the legal speed all across the country.
For instance, on March 16, 2001, in Norwich Connecticut, 3
eighth-graders were hospitalized when they overdosed on Adderall at
school.
On September 12, 2002, NBC TV News reported that 11 students were
transported to Antelope Valley and Lancaster Community Hospital in Los
Angeles California, for treatment of possible overdose from Ritalin. The
school confiscated a large amount of Ritalin pills. "I would say in
excess of 150," said school principal Mark Bryant.
In three separate cases in 2004, Tucson, Arizona area students were
caught with Adderall. Six Catalina Foothills High School students were
suspended for taking or possessing Adderall while on campus, according
to reports from the Pima County Sheriff's Department reports.
Two Ironwood Ridge High School students, ages 15 and 17, were cited for
exchanging Adderall in January, 2004, according to an Oro Valley,
Arizona police report.
And 6 football players at Millennium High School in Goodyear, Arizona
were disciplined by the Agua Fria Union High School District for taking
Adderall before a game.
In both of the Tucson cases, students who had legal prescriptions for
Adderall and brought the pills to school and gave them to classmates.
On October 13, 2005, a 17-year-old Waukesha, Wisconsin boy was arrested
on felony charges for possession of Adderall, after the car he was
riding in was stopped for a broken taillight.
On January 20, 2006, Florida Okaloosa County Sheriff Department received
word that a student at Richbourg Middle School had illegally shared the
prescription drug Adderall.
"Unfortunately and sadly," Sheriff Rick Hord told reporters, "the news
value may not be how unusual this is but rather how common it is."
"We've had 22 cases so far that have been investigated primarily by the
resource officers but in a couple of incidents by other deputies, of
drugs on campus at just about every school you can name," he said.
On February 7, 2006, two Harrington, Delaware middle school students
were arrested for distributing Adderall at WT Chimpan Middle School over
a period of 3 months. Both students were expelled.
If children are having problems, they need therapy not speed.
William Pelham, a well-known researcher involved with clinical trials of
both Concerta and Adderall, says a major study, sponsored by the
National Institute of Mental Health, showed that behavioral therapy
often eliminates the need for drugs altogether.
During a one-year trial, he told The Street.com, 75% of the children who
relied on behavioral treatments functioned well without the drugs.
Moreover, he added, most of those children remained off the drugs a full
year later.
"What this means to me is that two-thirds of ADHD kids could be taken
off the medications," Pelham told Street.com. "I do think they are
grossly overused as a first line of intervention," he added.
According to Dr Peter Breggin: "We are encouraging a generation of
youngsters to grow up relying on psychiatric drugs rather than on
themselves and other human resources."
"In the long run," he warns, "we are giving our children a very bad
lesson, that drugs are the answer to emotional problems."
Injured parties seeking justice can find more information at: Lawyers
and Settlements
http://www.lawyersandsettlements.com/articles/adhd_cash.html
By
Evelyn Pringle
Evelyn Pringle is a
columnist for Independent Media TV and an investigative journalist
focused on exposing corruption in government.
Contact Evelyn
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Keywords and Misspellings: ADD ADHD attention deficit
disorder atention defecit attension dissorder |
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