"There have been three previous waves of doctor-prescribed stimulant abuse since World War II, the last being Dexedrine for weight reduction in the 1970s. In every previous case, American society, through congressional hearings and state laws, decided that the overall harm of prescription stimulants to the society was greater than the good they provided. With the case of ADHD, the decision may have to be bifurcated."

The FDA and the expert advisory panels they have convened have repeatedly dropped the ball by closing their eyes to the documented, major psychotropic drug related harms. They havee dones through a calculated strategy that isolates one or two risks for review from among a cluster of hazardous effects.  By fragmenting the reviews to selected risks, the FDA blurs the totality of risks associated with a drug (or combination of drugs) prescribed for ADHD. The children who ingest these drugs are exposed to a  multiple serious adverse drug effects that can erupt singly or in combination.

The addictive danger of ADHD drugs was the focus of  Dr. Lawrence Diller’s testimony before the advisory committee (March 22). But  the Pediatric Advisory Committee followed FDA’s narrowly selected menu of these drugs’ hazards and completely ignored the very prevalent issue of drug addiction.

The drugs, as is well documented, pose a significant risk of drug addiction–not only for the children for whom the drugs are prescribed, but also for their older siblings and school mates.

"Between the 1940s and 1970s, before their addictive properties were known, amphetamines were used to treat obesity, fatigue and depression, according to a 2005 report by the National Center on Addiction and Substance Abuse. Pilots used the stimulant during World War II to stay awake. Dieters used it to lose weight rapidly.

Between 1992 and 2002, the number of prescriptions for ADHD medications in the United States increased 369 percent to 23.4 million a year, according to the National Center on Addiction and Substance Abuse report. In 2005, there were 31.8 million prescriptions for such medications, according to IMS Health, a pharmaceutical information and consulting company. The most popular was Adderall."

" A survey of students at 119 colleges nationwide found that, on certain campuses, up to 25 percent of respondents had misused ADHD medication in the past year. A 2004 survey of students on a University of Wisconsin campus that found 14 percent had abused an ADHD medication."

FDA officials who have been maneuvering to keep physicians and parents in the dark about the full scope of the risks these drugs pose for children who are prescribed psychotropic drugs. They should be held personally accountable for maintaining a policy that pretends the dangers aren’t known.

Following a news report by Knight Ridder, is Dr. Diller’s OpEd piece that appeared in the San Francisco Chronicle. He cites an Eli Lilly study that corroborated the addictive qualities of psychostimulants:

"Some 3 million have abused only prescription stimulants, and 75,000 young people between the ages of 12 and 25 meet psychiatric criteria for  addiction and drug abuse."

"There have been three previous waves of doctor-prescribed stimulant abuse since World War II, the last being Dexedrine for weight reduction in the 1970s. In every previous case, American society, through congressional hearings and state laws, decided that the overall harm of prescription stimulants to the society was greater than the good they provided. With the case of ADHD, the decision may have to be bifurcated."

 Contact: Vera Hassner Sharav
veracare@ahrp.org

http://www.bradenton.com/mld/bradenton/news/local/14235454.htm
Sat, Apr. 01, 2006
Pills become an addictive study aid
MEGAN TWOHEY
 Knight Ridder Tribune News Service
MILWAUKEE – Samantha, a Marquette University sophomore, popped it on the eve of a big history test.

"I stayed up all night," she said, "and totally zoned in."  For years, students have used coffee, NoDoz caffeine pills and other stimulants to help them through exams, papers and other demands of college.

Today, some students are taking a study aid that can be deadly.

Adderall, a medication for attention deficit hyperactivity disorder, or ADHD, has become popular among college students who don’t have the disorder, according to students, college health officials and an emerging body of research.

Adderall is an amphetamine and works like cocaine. Those who use it can stay focused and awake for hours on end. Students with prescriptions sell it or give it away.

"If you can take a drug that allows you to stay awake through finals week and concentrate on relatively boring topics, you can see how the word would spread," said William Frankenberger, a psychology professor at the University of Wisconsin-Eau Claire. He led a 2004 survey of students on a University of Wisconsin campus that found 14 percent had abused Adderall or another ADHD medication.

But using the drug without a prescription is dangerous. The federal government has classified Adderall under the same category as cocaine, opium and morphine, drugs with a high potential for abuse. It is illegal to sell it or use it without a prescription.

Side effects include insomnia, irritability and loss of appetite. In extreme cases, the drug can cause paranoia, hallucinations and heart attacks. Adderall and other ADHD medications have been reportedly linked to the deaths of 25 people in recent years. U.S. Food and Drug Administration advisers are recommending warnings on the drugs’ labels.

Between the 1940s and 1970s, before their addictive properties were known, amphetamines were used to treat obesity, fatigue and depression, according to a 2005 report by the National Center on Addiction and Substance Abuse. Pilots used the stimulant during World War II to stay awake. Dieters used it to lose weight rapidly.

In the 1990s, amphetamines re-emerged. A growing number of children were being diagnosed with ADHD, a neurobehavioral disorder that makes people hyperactive and incapable of concentrating. Adderall and Ritalin, an amphetamine-like drug, were among the medications that were approved as effective treatments.

Between 1992 and 2002, the number of prescriptions for ADHD medications in the United States increased 369 percent to 23.4 million a year, according to the National Center on Addiction and Substance Abuse report.

In 2005, there were 31.8 million prescriptions for such medications, according to IMS Health, a pharmaceutical information and consulting company. The most popular was Adderall.

Colleges are now seeing waves of students who grew up on ADHD medication.

Some of the students don’t need it, said Davis Smith, director of student health at Wesleyan University in Connecticut who has been gathering information about the use of ADHD medication for the American College Health Association.

About Adderall

• Adderall is the most widely prescribed medication for attention deficit hyperactivity disorder, a neurobehavioral disorder that makes people hyperactive and incapable of concentrating. There were 8.7 million prescriptions for Adderall in 2005.

• Adderall is an amphetamine that allows users to stay focused and awake all night. The federal government has classified Adderall under the same category as cocaine, opium and morphine, drugs with a high potential for abuse. It is illegal to sell it or take it without a prescription.

• Adderall can cause insomnia, irritability and loss of appetite. In extreme cases, the drug can cause paranoia, hallucinations and heart attacks.

• A survey of students at 119 colleges nationwide found that, on certain campuses, up to 25 percent of respondents had misused ADHD medication in the past year. A 2004 survey of students on a University of Wisconsin campus that found 14 percent had abused an ADHD medication.

Sources: IMS Health; the January 2005 edition of the journal Addiction; "Illicit Use of Prescribed Stimulant Medication Among College Students," 2004 study, led by University of Wisconsin-Eau Claire professor
~~~~~~~~~~~~~~

http://www.sfgate.com/cgi-bin/article.cgi?file=/chronicle/archive/2006/03/24/EDGU9GJG091.DTL
San Francisco Chronicle
Friday, March 24, 2006
Evaluating Health Warnings/Ritalin abuse
Lawrence Diller

The Food and Drug Administration’s pediatric advisory committee earlier this week not surprisingly failed to support an earlier recommendation to
affix black-box warning labels of sudden death on bottles of Ritalin, the FDA’s most severe action short of banning the use of the drug for
attention deficit hyperactivity disorder (ADHD). There were moments at Wednesday’s hearing that looked staged, and as if they were intended to
get a different verdict from a friendlier jury. The pediatricians obliged, in contrast to last month’s renegade activist panel of cardiologists, led
by Steven Nissen, who was also instrumental in bringing to light the Vioxx scandal.

That advisory committee’s warning recommendation shocked FDA officials and reopened a Pandora’s box of concerns about side effects and overuse of Ritalin. The real dangers from Ritalin, however, were not even mentioned by the committee members. That is the growing concern among frontline doctors, like me, of increasing signs of prescription-stimulant abuse by teenagers and college students.

In my own practice, many teenagers and young adults have told me they had already tried a stimulant, usually Adderall, which is an amphetamine, on their own. They liked the effects and wondered if they had ADHD? One high-school senior told me he had been able to buy or trade for Adderall
for the last two years, taking the pills before important exams, like the SAT, and for big projects. He never saw a doctor until meeting with me.

My two sons, one a freshman in college and the other a high-school senior, report the wide availability of these drugs at their schools, especially
around exam time.

 So what’s the problem here? Do all these kids have ADHD because they think they do better by taking these drugs? Not true. It has been known for
decades that these medications will improve anyone’s performance on repetitive and boring tasks. It is not as clear whether they improve
test-taking abilities, but the high interest in the illegal use of these drugs suggests, at least "on the street," the belief that they do.

Until two weeks ago, my concerns about prescription-stimulant abuse were based only on rumor and anecdote. Now, the first hard data come from a study funded, not surprisingly by Eli Lilly, the maker of Strattera, the only nonstimulant approved for the treatment of ADHD (but also vetted by
the officials at the Drug Enforcement Administration). The study, published in the journal Drug and Alcohol Dependence, uses a government
survey of 54,000 people from 2002 and projects that, nationwide, 21 million individuals have misused a prescription stimulant at least once.

Some 3 million have abused only prescription stimulants, and 75,000 young people between the ages of 12 and 25 meet psychiatric criteria for
addiction and drug abuse. Since 2002, rates of prescription stimulants to adults have continued to rise, suggesting that this number of 75,000 may
be higher today.

With the suggested black-box warning, the committee clearly wanted to get the nation’s attention, not only about the cardiovascular risks of the
prescription stimulants, which include other well-known drugs such as Adderall and Concerta, but also to alert everyone to their potential
overuse in children. The panel kept referring to a study where 1-in-10 11-year-old boys around the country take Ritalin or its equivalent.

The possibility of dying from Ritalin is extremely small for a child without a pre-existing heart condition (on the order of 0.0002 percent).
However, 75,000 prescription-stimulant addicts dwarf the number of children who died taking the drug. It also represents a real, not an
hypothetical, risk such as that for heart attack and stroke, which so worried the FDA cardiovascular committee.

Of those who casually misused Ritalin, according to this survey, 1 in 10 went on to develop tolerance and addiction to the drug. If one recalls the
graffiti on the walls of San Francisco’s Haight-Ashbury in the 1960s that read "Speed Kills," the concerns about a 10 percent-addiction rate are
indeed chilling.

There have been three previous waves of doctor-prescribed stimulant abuse since World War II, the last being Dexedrine for weight reduction in the 1970s. In every previous case, American society, through congressional hearings and state laws, decided that the overall harm of prescription
stimulants to the society was greater than the good they provided.

With the case of ADHD, the decision may have to be bifurcated. Ritalin has had a 70-year history of safety with preteens. No kid under the age of 13 has ever become addicted. But if history is a guide, the real risk from Ritalin to our country will be for Johnny’s older brother doing this drug
on his own, illegally, while away at college. The safe use of these drugs in young adults and teenagers will require much stricter legal controls on
prescribing. Unfortunately, it will likely take increasing drug-abuse casualties and young people’s deaths to mobilize the necessary public
pressure to make that change.

Lawrence Diller, M.D., practices behavioral-developmental pediatrics in Walnut Creek. He is the author of "Running on Ritalin" (Bantam, 1998) and
"Should I Medicate My Child?" (Basic, 2002).

Copyright 2006 SF Chronicle

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