The Under Reported Story: ADHD, Stimulants, and the FDA

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Tue, 28 Feb 2006 13:26:23 -0500

[sSRI-Research] Jackson - The Under Reported Story: ADHD,

Stimulants, and the FDA

 

 

 

Dr. Grace Jackson is very special. This courageous North

Carolina psychiatrist resigned her Navy commission and left her job at

Bethesda Naval Hospital for reasons of conscience.

 

 

 

* The Under Reported Story: ADHD, Stimulants, and the FDA *

 

http://www.icspp.org/index.php?option=com_content & task=view & id=138 & Itemid=70

 

*by Grace E. Jackson, MD

February 18, 2006*

 

Recently, the media minimized a crucial story which deserved to be

front page news. Buried among the reports about Danish cartoons,

Iraqi bombings, and domestic wiretaps was a recommendation from Food

and Drug Administration safety advisors that stimulants, used in the

treatment of 3 to 8 million children with ADHD, carry new warnings

about the risks of heart disease, stroke, and death.*

 

*On February 9th 2006, members of the Drug Safety and Risk Manage-

ment Advisory Committee stunned FDA officials with an 8 to 7 vote

which called for the placement of Black Box Warnings on the labels

of stimulants. For many industry watchdogs, the recommendation was l

long overdue. *

 

* It was only eight months ago that the FDA convened a similar

hearing, partly in response to Health Canada's decision to remove

Adderall XR from the market in early 2005.*

 

*Although foreign authorities later rescinded that decision, concerns

about the cardiovascular risks of Adderall and other stimulants

remained. Dramatic media announcements preceded last June's

deliberations, but the FDA leadership assured the public that no new

warnings were warranted. *

 

* In their latest interviews with the press, FDA panelists cited a

figure of 25 deaths (1999-2003) among American stimulant users, but 51

deaths are listed in an agency staff report. According to California

neurologist, Dr. Fred Baughman, his Freedom of Information Act request

revealed 186 deaths in the MedWatch database between 1990 and 2000.

Given the fact that a mere 1% of all adverse events are believed to be

filed with the FDA under the nation's voluntary reporting system, the

true scope of stimulant lethality is much larger than the regulatory

agency concedes.

*

 

*Unfortunately for consumers, the cardiovascular risks of stimulants

are hardly new.*

 

*As early as 1977, Drs. Vernon Fischer and Hendrick Barner documented

the cell changes associated with heart muscle enlargement in a chronic

consumer of Ritalin (methylphenidate). Those findings were based upon a

tissue biopsy obtained from the patient during bypass surgery.

Intrigued by this discovery, Fischer teamed up Theodore Henderson in

1995 to publish the results of several animal experiments involving

Ritalin. Their research confirmed a causal link between normal doses of

the stimulant and the appearance of persistent heart cell abnormalities,

identical to the changes observed in humans.*

 

* The connection between stimulants, cardiovascular disability, and

death has long been documented in the medical literature, but physicians

and government regulators have refused to acknowledge the hazards

associated with prescriptions. In 2000, the FDA asked manufacturers to

voluntarily remove the stimulant ingredient, phenylpropanolamine, from

cold remedies and over-the-counter products used for weight control.

 

In 2004, the FDA issued a rule to prohibit the sale of dietary

supplements containing the stimulant, ephedra (ma huang). On January

13th 2006, the FDA issued a warning about the importation of Brazilian

diet pills which contain a stimulant called Fenproporex. Each of

these regulatory decisions stands in striking contrast to the agency's

ambivalence about stronger warnings on the labels of ADHD drugs.*

 

* Many facts about stimulant medications, and the ADHD industry which

sustains them, are commonly misreported or undisclosed. One example is

the secret identity of atomoxetine (Strattera), a selective

norepinephrine reuptake inhibitor approved by the FDA for children and

adults in 2002. Widely marketed in the United States as the first

" non-stimulant " for ADHD, the fact is that the World Health Organization

designates the compound as a centrally acting sympathomimetic

(psychostimulant), according to the international drug classification

system. As neurologists at Stanford University have noticed,

atomoxetine (and in Europe, the chemically similar reboxetine)

possesses stimulant properties which make it an effective treatment

for the sleep condition of narcolepsy.

*

 

*While this classification dispute may seem trivial on the surface, it

becomes salient in light of a recent report by North Carolina examiners

who detected cardiac abnormalities in the autopsies of Strattera

patients. If the FDA ever does decide to add Black Box Warnings about

the vascular risks of stimulants, without acknowledging the true

physiological effects of Strattera, one can expect Lilly's product to

emerge as the clear winner of this year's safety lottery.

*

 

*A word about regulatory authority is also in order. Contrary to the

usual media reports, a Black Box Warning -- which refers to the

appearance of an explicit safety alert on the product label of a

medication or medical device -- is not the strongest precautionary

measure in the Food and Drug Administration arsenal. The agency may

require wording which outlines contraindications. These are statements

about specific conditions or populations for which a medical product

or device must not be used. Beyond the identification of

contraindications, however, the FDA may issue advisories, enact rules,

or implement enforcement decisions. Ultimately, the agency may

initiate actions to remove a product from the market.

*

 

*Reflective observers are wondering at this point why stimulants have

not been removed from the market as a treatment for ADHD. Their

concerns include the preliminary findings of Texan investigators,

whose 2005 report in the journal Cancer Letters documented the

emergence of chromosomal abnormalities in 12 out of 12 juveniles

following three months of treatment with Ritalin. The unreported

story is what happened after the behind-the-scenes scramble by

officials from the FDA and other

governmental bodies, who were dispatched to Houston last May in an

effort to establish the validity of the methods and data of the Texan

team. Subsequently authenticated, the implications of that research

(namely, that Ritalin exposure in childhood may induce changes

associated with higher risks of cancer) have been serious enough to

trigger follow-up studies at other facilities.

*

 

*FDA leaders continue to affirm that new warnings on stimulants are

unnecessary. As Dr. Thomas Laughren and others have recently opined,

ADHD is a serious medical condition for which the benefits of

stimulant drug therapy outweigh the conceivable risks. Whether by

ignorance or design, however, the regulators remain oblivious to the

evidence-based limitations of the prescription pad: at least 40% of

all children fail to tolerate or respond to stimulant therapy; about

twice as many respond at least as well to non-pharmacological

interventions; and, as documented in the National Institute of Mental

Health's most prestigious

study to date (the MTA study), the long term outcomes for medicated

children demonstrate diminishing returns over time, persistent

suppression of growth (about 1 cm per year), and artificial behavioral

improvements which dissipate when treatment is withdrawn.

*

 

*The FDA and others are disingenuous when they ignore the contentious

nature of identifying ADHD as a neurological disorder for which

medications are the best solution. A strong body of evidence now

challenges both assertions. Clinicians question the ethic of drugging

children and adults, in an effort to suppress symptoms which may be

interpreted as transient, developmental delays (most children outgrow

ADHD in their teens); normal variants of temperament; contextually

appropriate reactions; and/or the failure of caregivers, social systems,

or culture to assist others in maximizing their capacities for moral

agency and self-control.

*

 

*It is time for consumers, physicians, educators, and policy makers to

confront the distorted and missing information which surrounds the

phenomenon of ADHD. More members of the medical community should doubt

the legitimacy of the condition, since no biological marker or

diagnostic test has been found or devised. When interviewed, a majority

of physicians state that they would prefer not to prescribe stimulants

to children, due to the physical and psychological side effects. Not

surprisingly, the world community observes the United States with

alarm for the unjustified chemical exploitation of those who are

different, but not diseased.

*