want FDA Approval for Treating Attention Deficit Hyperactivity Disorder
ADHD A Complete
Some of the
top-selling drugs of all time are those prescribed to treat attention
deficit disorders. Drug companies have physicians in every field of
medicine pushing these medications and dole out millions of dollars
worth of free samples each year to make sure they are passed out like
A new ADHD drug is set to come on
the market that supposedly can keep people awake for days at a time with
no problems. Just what we needed, especially for hyper little kids.
I wonder if this means they will
remain calm as they sit wide-awake watching TV and playing video games
for days while the rest of the family sleeps.
The drug Sparlon is manufactured by
Cephalon and is a clone of Provigil, another drug already on the market.
Sparlon contains modafinil, the same exact active ingredient contained
in Provigil which is approved for the treatment of patients with
narcolepsy, sleep apnea and shift work sleep disorder, according to the
approval will be considered by the FDA’s Psychopharmacologic Drugs
Advisory Committee at a public hearing scheduled for March 23, 2006.
The day before the Sparlon hearing,
the FDA’s Pediatric Advisory Committee is scheduled to meet to discuss
neuropsychiatric adverse events and cardiovascular adverse events
reported on patients who were treated with ADHD stimulant drugs already
on the market.
The drugs under review include
Ritalin from Novartis, Adderall and Adderall XR from Shire
Pharmaceuticals, Concerta from Johnson & Johnson, and generic versions
On February 9 and 10, 2006, the
FDA’s Drug Safety & Risk Management Advisory Committee held hearings on
the same topic, and after reviewing the information provided at the
hearing, the panel recommended that black box labels be added to the
labels of all stimulants.
However, the FDA is not bound by the
recommendations of its advisory panels, and critics of the drugs say the
close 8-7 vote by the panel, means there will be spirited debate within
the agency over whether black box labels will be added.
Several members of the panel said
they voted for the warning in part, because they were alarmed over the
sharp rise in prescriptions written for both children and adults.
During the hearing, the committee was informed that between 1999 and
2003, roughly 78 million prescriptions were written for children under
the age of 18, and 14 million more were written for adults.
In a stark contrast, only 190
million prescriptions were issued for children and adults during the 12
year period between 1992 and 2004.
According to the FDA numbers on
adverse events, between 1999 and 2003, there were 25 deaths reported for
persons using ADHD drugs, and 19 were children. The agency also
acknowledged that more than 50 cases of cardiovascular-related events
were reported in the same time period including stoke, heart attack,
hypertension, palpitations and arrhythmia.
Critics say the numbers revealed at
the hearings represent a gross understatement because only 1% to 10% of
adverse reactions are ever reported to the FDA, and it would therefore
be better to add a black box now and remove it later if studies prove
there is no link between the stimulants and sudden death and heart
Supporters of the drugs, say the
warning is based on inconclusive evidence and would deter physicians
from prescribing the medications and scare patients away from taking the
Because Cephalon claims Sparlon
should not be classified as a stimulant, analysts predict the company
could get a boost if the FDA agrees and requires the other drugs to
carry a black box warning. One of the issues discussed at the March 23,
hearing will likely be how to distinguish Sparlon’s labeling from other
approved, Sparlon will be co-marketed under an agreement with Johnson &
Johnson, which will focus on the pediatric market through its McNeil
Consumer & Specialty Pharmaceuticals unit.
McNeil’s sales team will promote
Sparlon to psychiatrists, pediatric neurologists and pediatricians,
while Cephalon’s 400-person sales force will focus on non-pediatric
specialists and primary care physicians.
When Cephalon requested FDA approval
for Sparlon, it submitted the results from three clinical trials on
children aged 6 to 17 that the company said indicated better results in
children taking Sparlon compared to children who received a placebo.
Each trial lasted 9 weeks and the most common side effects noted were
loss of appetite, mild insomnia and headaches.
But Cephalon has not been sitting
idle while waiting for approval of its Provigil clone. Last year it had
to figure out a way to deal with the fact that Provigil’s patent was set
to expire in 2006. Through some last minute legal footwork, the company
was able to negotiate agreements with 4 generic firms that will allow
Cephalon to continue to sell the drug unchallenged until at least 2011
Provigil’s approval for a silly
diagnosis like “shift-work sleep disorder” is a good example of
disease-mongering, described in the book, "Selling Sickness: How The
World's Biggest Pharmaceutical Companies Are Turning Us All Into
Patients," by Ray Moynihan and Alan Cassels, which explains how drug
companies foster the creation of bogus disorders to create markets for
their pills, through "medicalization" of normal states of health.
In the same vein, many experts say
the sale of ADHD drugs in general is nothing but a racket. Dr Fred
Baughman, a board certified child neurologist and Fellow of the American
Academy of Neurology, calls ADHD the "greatest health care fraud of
Clinical social worker Peter Dwyer,
has seven years' experience working with troubled children, and has
served as director of a large therapeutic foster care program. He also
attributes the ever-rising sales numbers for ADHD drugs to a grand
"It is easy to see why stimulants
dominate the treatment of ADHD," he says, "drug companies spend over $20
billion a year on promotion - more than they spend on research."
"The bottom line," Mr Dwyer
explains, "professionals and the public are bombarded with a stream of
"research" and "information" financed and spun by the people who make
and sell these drugs."
"The conflict of interest is
palpable," he adds.
And anyone who believes Provigil is
free of the side effects associated with other ADHD medications needs to
speak to Susan Florence who experienced a terrifying adverse reaction to
"I took one pill and I thought I was
coming out of my skin," she recalls, "I felt as if someone had climbed
"It was one of the worst experiences
of my life," she says.
Nonetheless, Cephalon has done an
excellent job of promoting Provigil. The US Air Force has even adopted
the drug as one of its official "go pills" for pilots whose missions
stretch out more than 12 hours, according to Business Week on November
Ever since Provigil hit the market,
Cephalon stayed busy figuring out ways to promote its off-label use for
a multitude of ailments including ADHD, and with obvious success. SG
Cowen & Co analyst, Eric Schmidt, told Business Week he figures more
than 50% of Provigil sales are for unapproved uses.
And 50% in off-label sales adds up
to enormous profits. In 2004, US doctors wrote 1.9 million prescriptions
for Provigil, generating $414 million in sales. In 2005, Cephalon saw
Provigil sales reach $512 million, according to Forbes.com on March 13,
While waiting for Sparlon to be
approved, the company has been using every trick in the book to boost
sales of Provigil for the treatment of ADHD.
For instance, Dr Fletcher Taylor,
from Tacoma, Washington, was paid to meet with small groups of doctors
to talk about Provigil.
He conducted a study on the use of
Provigil for ADHD, which he claims showed positive results. However,
according to Business Week, Dr Taylor says "he does not bring up the use
of Provigil for ADHD in his talks, but he answers questions -- as he is
permitted to do -- if one of the doctors in the group brings it up."
"Usually people do ask," he told
I’m quite sure they do ask, probably
much like the people on TV who used to just happen to step out of the
audience to be cured by faith-healer 50 years ago.
Cephalon also employs the well-known
off-label marking technique of funding continuing medical education
seminars (CMEs), under the guise of providing doctors with information
related to how certain ailments can be treated by drugs that the company
just happens to sell.
For example, Cephalon paid for a CME
that focused on the treatment of daytime sleepiness experienced by
Parkinson patients and explained how Provigil might be a useful therapy.
The sponsor of the program, a firm
called Projects in Knowledge, told Business Week that Cephalon paid for
the program but had no input on the material discussed.
And of course I believe that.
Another tried and true method of
promoting off-label use involves publishing the results of favorable
studies funded by drug companies in medical journals. “Journals have
devolved into information laundering operations for the pharmaceutical
industry,” according to Richard Horton, editor of the Lancet, in March
In a prime example of this practice,
the August 4, 2005 New England Journal of Medicine, published a report
on a study funded by Cephalon in which the lead author, Dr Charles
Czeisler, from Harvard Medical School and Brigham and Women’s Hospital,
had a professorship endowed by $2 million from Cephalon.
In the report, Dr Czeisler claimed
night-shift workers remained more alert with Provigil and wrote a
glowing summary of the study. "I would characterize [Provigil] as the
treatment of choice with patients with shift-work disorder," he said.
However, Dr Robert Basner, director
of Columbia University's Cardiopulmonary Sleep and Ventilatory Disorders
Center, published an editorial on the study in the same issue of the
NEJM and said the researchers' data showed only slight improvements in
workers wakefulness and productivity with Provigil, and pointed out that
the drug seemed to exacerbate insomnia for some patients.
"That's not a very robust
endorsement of the drug coming from the investigators themselves," Dr
Basner wrote. "This drug is little better than nothing in terms of
making them less sleepy during shift work at night," he added.
Expert pretty much agree that
Sparlon will be approved for treating children with ADHD so before too
long the “little better than nothing” clone will not doubt be ringing up
the cash registers all over the US.
For more information
for injured parties go to
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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