Important Recent Improvements in ADHD Medications

ADHD medications have made important improvements. Over the past ten years the greatest advances in Attention Deficit Hyperactivity Disorder medicines has not been the development of some wonder drug, though some good medications have been developed. Rather the biggest advances in ADHD medicine has been the improvement and greater variety of the delivery systems of time tested and valuable drugs for the disorder.

Now the time tested medication methylphenidate for ADHD comes in four different delivery forms:

• Pills
• Pumps
• Pellets
• Patches

And the newest development in Attention Deficit Hyperactivity Disorder medication also begins with the letter “P”. The development of the Pro-Drug Vyvanse is also a good step forward.

Pills are still in use for Ritalin and a few other forms of methylphenidate, but they are best suited for shorter acting doses of medications. But a three to four hour dose of Ritalin creates problems for an ADHD child in school having to get to the second dose at lunch. So the “holy grail” of stimulant development has always been an effectively released long lasting dosing mechanism.

The pump system was developed with Concerta, and it is an effective time release delivery system for Attention Deficit Hyperactivity Disorder medication. A pellet system was used for ADDerall XR by Shire which is also an effective time release system.

The patch delivery system of methylphenidate is sold as Daytrana. It delivers the medication through the skin, and lasts most of the day as well. No more swallowing of pills, pellets, or pumps.

ADHD Medications

The new ADHD medication is the pro-drug Vyvanse, which is a combination of methylphenidate, bound with a lysene molecule, so that the medicine is ineffective (inert?) until it reaches the stomach or intestines and is digested. Then the medication is released. The ingenuity in this is that the drug cannot be abused by teens or college students who want to snort Ritalin. It only works after you swallow it.

Of course Strattera is a newer ADHD drug. It is not a stimulant, but is a highly selective norepinepherine re-uptake inhibitor, which works well with a broad spectrum of ADHD symptoms (it may be most effective with Inattentive ADHD kids with some degree of anxiety or depression). Strattera is the first FDA approved non-Stimulant for children and adults

Intuniv is a newer medication for the treatment of ADHD in children and teens that gained its approval from the FDA and was available to pharmacies in November, 2009. Intuniv is not a stimulant medication, and may be helpful to the estimated 25-30% of children with ADHD who do not benefit from stimulant medications. Instead, Intuniv is a form of Guanfacine (Tenex) which has been used for years as a blood pressure medication in adults, and has also been used as an adjunct medication in the treatment of ADHD individuals with temper or anger problems, or oppositional defiant disorder. Now in the form of Intuniv, this medication seems to have a wider range of symptoms that benefit from its use than just anger or oppositional behavior. It appears that Intuniv is very targeted, working in the pre-frontal cortex to help the brain to increase the available supply of glutamate, and excitatory neurotransmitter.

Attention Deficit Hyperactivity Disorder is among the most treatable of psychiatric disorders thanks to the recent advances in medications.

This book section: ADHD Medication Issues and Research

Douglas Cowan, Psy.D., MFT is a licensed Marriage and Family Therapist in Tehachapi, CA who has been a counselor to children, teens, and adults helping them to overcome ADHD, find relief for depression or anxiety, and solve other problems in life since 1989. He served on the medical advisory board to the company that makes Attend and Extress from 1997 through 2011, and he is the Editor of the ADHD Information Library online resource at http://newideas.net/. His weekly ADHD Newsletter goes out to 9,500 families. Visit his website at http://DouglasCowan.me for more information on achieving greater health, personal growth, Christ-centered spirituality, stress management, parenting skills, ADHD, working out the stresses of being a care-giver to elderly parents and also being a parent to teenagers, or finding greater meaning in retirement years, Dr. Cowan can be a valuable resource to you.

Counselor counseling Tehachapi for ADHD, depression, anxiety, and more.

Douglas Cowan, Psy.D., MFT
27400 Oakflat Dr.
Tehachapi, CA 93561
(661) 972-5953

Press Release from Cortex Pharmaceuticals, October 6, 2011

Servier Exercises Option to Cortex’s Ampakine® CX1632, an Innovative Compound in Clinical Development for Alzheimer’s Disease

— Cortex to Receive an Additional $2 Million —

IRVINE, CA (October 6, 2011) — Cortex Pharmaceuticals, Inc. (OTCBB (CORX)) has received written notification from Servier of its decision to exercise its option to obtain all the remaining rights to the jointly discovered high impact Ampakine® compound, CX1632 (S47445). In connection with the option exercise, Servier will pay Cortex an additional $2,000,000, as well as certain royalties and milestone payments.

Servier, France’s largest privately held pharmaceutical firm, paid Cortex a non-refundable payment of $1,000,000 for the option in June 2011. Since then, Servier has completed a Phase I clinical study with the compound. With the option exercise, Servier will acquire exclusive rights to develop and market CX1632/S47445 on a worldwide basis. However, Cortex retains all rights for its remaining compounds and AMPAKINE technology on a global basis.

“Servier has been an excellent partner and we are pleased with their decision to exercise this option to continue with the clinical development of the high impact Ampakine CX1632/S47445,” said Mark Varney, Ph.D., Cortex’s President and CEO. “High impact Ampakine molecules such as CX1632/S47445 may well represent a disease-modifying approach to treating memory and cognitive impairments in patients with Alzheimer’s disease and other disorders, given the demonstrated ability of the compounds to stimulate protective growth factors within the brain.”

“We are very pleased to acquire from Cortex the remaining rights for this jointly discovered compound as it will allow us to expand our activities worldwide. S47445 is now in clinical development as a potential “first in class” compound. Such development exemplifies our commitment to finding innovative treatments for patients suffering from Alzheimer’s disease, and our belief that AMPA modulation is a promising way to improve cognitive disorders in such patients,” said Emmanuel Canet, MD, PhD, Head of Servier R&D.

About Servier
Servier is a privately-run French research-based pharmaceutical company with a 2010 turnover of €3.7 billion. Servier invests 25% of its turnover in R&D. Current therapeutic domains for Servier medicines are cardiovascular, metabolic, neurological, psychiatric and bone and joint diseases as well as oncology. Servier is established in 140 countries worldwide with over 20,000 employees. More information at: www.servier.com

Cortex Pharmaceuticals, Inc.
Cortex, located in Irvine, California, is a neuroscience company focused on novel drug therapies for treating psychiatric disorders, neurological diseases and sleep apnea. Cortex is pioneering a class of proprietary pharmaceuticals called Ampakine compounds, which act to increase the strength of signals at connections between brain cells. The loss of these connections is thought to be responsible for memory and behavior problems in Alzheimer’s disease. Many psychiatric diseases, including schizophrenia, occur as a result of imbalances in the brain’s neurotransmitter system. These imbalances may be improved by using the Ampakine technology. Additionally, recent studies have shown that the Ampakine compounds also impact areas in the brain stem that control breathing. Recent work has focused on the potential treatment of sleep apnea disorders which can have a deleterious impact on numerous disease states including congestive heart failure. Also, respiratory depression caused by opioid analgesics, anesthetic agents and benzodiazepines can be reduced by AMPAKINE compounds. For additional information regarding Cortex, please visit the Company’s website at http://www.cortexpharm.com

Forward-Looking Statement
Note — This press release contains forward-looking statements concerning the Company’s research and development activities. Words such as “believes,” “anticipates,” “plans,” “expects,” “indicates,” “will,” “intends,” “potential,” “suggests,” “assuming,” “designed” and similar expressions are intended to identify forward-looking statements. These statements are based on the Company’s current beliefs and expectations. The success of such activities depends on a number of factors, including the risks that the Company’s proposed products may at any time be found to be unsafe or ineffective for any or all of their proposed indications; that patents may not issue from the Company’s patent applications; that competitors may challenge or design around the Company’s patents or develop competing technologies; that the Company may have insufficient resources to undertake proposed clinical studies and that preclinical or clinical studies may at any point be suspended or take substantially longer than anticipated to complete. As discussed in the Company’s Securities and Exchange Commission filings, the Company’s proposed products will require additional research, lengthy and costly preclinical and clinical testing and regulatory approval. Ampakine compounds are investigational drugs and have not been approved for the treatment of any disease. Readers are cautioned not to place undue reliance on these forward-looking statements that speak only as of the date of this press release. The Company undertakes no obligation to update publicly any forward-looking statements to reflect new information, events or circumstances after the date of this press release or to reflect the occurrence of unanticipated events.

More information at www.cortexpharm.com

Contacts:

Company Contact:
Mark A. Varney, Ph.D.
President ad CEO
Cortex Pharmaceuticals, Inc.
949.727.3157 949.727.3157

Investor Contact:
Erika Moran/Dian Griesel, Ph.D.
Media Contact:
Janet Vasquez
The Investor Relations Group
212.825.3210 212.825.3210

This book section: ADHD Medication Issues and Research

Douglas Cowan, Psy.D., MFT is a licensed Marriage and Family Therapist in Tehachapi, CA who has been a counselor to children, teens, and adults helping them to overcome ADHD, find relief for depression or anxiety, and solve other problems in life since 1989. He served on the medical advisory board to the company that makes Attend and Extress from 1997 through 2011, and he is the Editor of the ADHD Information Library online resource at http://newideas.net/. His weekly ADHD Newsletter goes out to 9,500 families. Visit his website at http://DouglasCowan.me for more information on achieving greater health, personal growth, Christ-centered spirituality, stress management, parenting skills, ADHD, working out the stresses of being a care-giver to elderly parents and also being a parent to teenagers, or finding greater meaning in retirement years, Dr. Cowan can be a valuable resource to you.

Counselor counseling Tehachapi for ADHD, depression, anxiety, and more.

Douglas Cowan, Psy.D., MFT
27400 Oakflat Dr.
Tehachapi, CA 93561
(661) 972-5953

From the National Institute of Mental Health 2007

The first long-term, large-scale study designed to determine the safety and effectiveness of treating preschoolers who have attention deficit/hyperactivity disorder (ADHD) with methylphenidate (Ritalin) has found that overall, low doses of this medication are effective and safe. However, the study found that children this age are more sensitive than older children to the medication's side effects and therefore should be closely monitored. The 70-week, six-site study was funded by the National Institutes of Health's National Institute of Mental Health (NIMH) and was described in several articles in the November 2006 issue of the Journal of the American Academy of Child and Adolescent Psychiatry.

"The Preschool ADHD Treatment Study, or PATS, provides us with the best information to date about treating very young children diagnosed with ADHD," said NIMH Director Thomas R. Insel, MD. "The results show that preschoolers may benefit from low doses of medication when it is closely monitored, but the positive effects are less evident and side-effects are somewhat greater than previous reports in older children."

Methylphenidate is the most commonly prescribed medication to treat children diagnosed with ADHD. But its use for children younger than 6 years has not been approved by the Food and Drug Administration. And until PATS, very few studies—and no large-scale ones—have been conducted to collect reliable, consistent data to help guide practitioners treating preschoolers with ADHD.

The 303 preschoolers enrolled in the study ranged in age from 3 to 5 years. The children and their parents participated in a pre-trial, 10-week behavioral therapy and training course. Only those children with the most extreme ADHD symptoms who did not improve after the behavioral therapy course and whose parents agreed to have them treated with medication were included in the medication study. In the first part of the medication study, the children took a range of doses from a very low amount of 3.75 mg daily of methylphenidate, administered in three equal doses, up to 22.5 mg/day. By comparison, doses for school-aged children usually range from 15 to 50 mg total daily.

The study then compared the effectiveness of methylphenidate to placebo. It found that the children taking methylphenidate had a more marked reduction of their ADHD symptoms compared to children taking a placebo, and that different children responded best to different doses.

"The best dose to reduce ADHD symptoms varied substantially among the children, but the average across the whole group was as low as 14 mg per day," said lead author Laurence Greenhill, M.D., of Columbia University/New York State Psychiatric Institute. "Preschoolers with ADHD may need only a low dose of methylphenidate initially, but they may need to take a higher dose later on to maintain the drug's effectiveness."

To ensure the safety of the very young children involved, the study was governed by a strict set of ethical standards and additional review boards. The children's health was monitored carefully and repeatedly throughout the study's duration. Their parents were repeatedly consulted for consent prior to every step of the program. The researchers also reviewed the teacher ratings of the children who attended preschool at various stages in the study.

Similar to 1999 results found in NIMH's Multimodal Treatment Study of Children with ADHD (MTA study), and other studies on school-aged children, the medication did appear to slow the preschoolers' growth rates. Throughout the duration of the study, the children grew about half an inch less in height and weighed about 3 pounds less than expected, based on average growth rates established prior to the study.

Currently, no data exist that track long-term growth rate changes among preschoolers with ADHD who are medicated with methylphenidate. However, a five-year-long follow-up study is underway to track the children's physical, cognitive, and behavioral development, as well as health care services the family is using to care for the child. Those data will be available in two to three years.

Finally, 89 percent of the children tolerated the drug well, but 11 percent—about 1 in 10 children—had to drop out of the study as a result of intolerable side effects. For example, while some children lost weight, weight loss of 10 percent or more of the child's baseline weight was considered a severe enough side effect for the investigators to discontinue the medication. Other side effects included insomnia, loss of appetite, mood disturbances such as feeling nervous or worried, and skin-picking behaviors. Despite concerns that stimulants may increase blood pressure or pulse, any changes seen in the children's blood pressure or pulse were minimal.

"The study shows that preschoolers with severe ADHD symptoms can benefit from the medication, but doctors should weigh that benefit against the potential for these very young children to be more sensitive than older children to the medication's side effects, and monitor use closely," concluded Dr. Greenhill.

PATS was conducted by researchers at Columbia/New York State Psychiatric Institute, Duke University, Johns Hopkins University, New York University, the University of California Los Angeles, and the University of California Irvine, in collaboration with NIMH staff under a cooperative agreement.

The National Institute of Mental Health (NIMH) mission is to reduce the burden of mental and behavioral disorders through research on mind, brain, and behavior. More information is available at the NIMH website.

The National Institutes of Health (NIH) - The Nation's Medical Research Agency - includes 27 Institutes and Centers and is a component of the U. S. Department of Health and Human Services. It is the primary federal agency for conducting and supporting basic, clinical, and translational medical research, and it investigates the causes, treatments, and cures for both common and rare diseases. For more information about NIH and its programs, visit http://www.nih.gov.

Greenhill L, Kollins S, Abikoff H, McCracken J, Riddle M, Swanson J, McGough J, Wigal S, Wigal T, Vitiello B, Skrobala A, Posner K, Ghuman J, Cunningham C, Davies M, Chuang S, Cooper T. Efficacy and Safety of Immediate-Release Methylphenidate Treatment for Preschoolers With ADHD. J Am Acad Child Adolesc Psychiatry. 2006 Oct 4; [Epub ahead of print]

Wigal T, Greenhill L, Chuang S, McGough J, Vitiello B, Skrobala A, Swanson J, Wigal S, Abikoff H, Kollins S, McCracken J, Riddle M, Posner K, Ghuman J, Davies M, Thorp B, Stehli A. Safety and Tolerability of Methylphenidate in Preschool Children With ADHD. J Am Acad Child Adolesc Psychiatry. 2006 Oct 4; [Epub ahead of print]

McGough J, McCracken J, Swanson J, Riddle M, Kollins S, Greenhill L, Abikoff H, Davies M, Chuang S, Wigal T, Wigal S, Posner K, Skrobala A, Kastelic E, Ghuman J, Cunningham C, Shigawa S, Moyzis R, Vitiello B. Pharmacogenetics of Methylphenidate Response in Preschoolers With ADHD. J Am Acad Child Adolesc Psychiatry. 2006 Oct 4; [Epub ahead of print]

Kollins S, Greenhill L, Swanson J, Wigal S, Abikoff H, McCracken J, Riddle M, McGough J, Vitiello B, Wigal T, Skrobala A, Posner K, Ghuman J, Davies M, Cunningham C, Bauzo A. Rationale, Design, and Methods of the Preschool ADHD Treatment Study (PATS). J Am Acad Child Adolesc Psychiatry. 2006 Oct 4; [Epub ahead of print]

Swanson J, Greenhill L, Wigal T, Kollins S, Stehli A, Davies M, Chuang S, Vitiello B, Skrobala A, Posner K, Abikoff H, Oatis M, McCracken J, McGough J, Riddle M, Ghuman J, Cunningham C, Wigal S. Stimulant-Related Reductions of Growth Rates in the PATS. Stimulant-Related Reductions of Growth Rates in the PATS. J Am Acad Child Adolesc Psychiatry. 2006 Oct 4; [Epub ahead of print]

See this NIMH page.

NIMH publications are in the public domain and may be reproduced or copied without the permission from the National Institute of Mental Health (NIMH). NIMH encourages you to reproduce them and use them in your efforts to improve public health. Citation of the National Institute of Mental Health as a source is appreciated.

PLEASE SEE OUR RESPONSE TO THIS STUDY on Preschoolers and ADHD Medications.
We really don't like this at all, or the recent actions to approve stimulant medications to treat children as young as four years old for ADHD.

More Opinions on Treating Preschoolers for ADHD with Medications

Analyzing ADHD Symptoms in Preschool-aged Children

Lee Kern: Education researchers are now better able to analyze ADHD-related symptoms among preschool-aged children. Lee Kern talks about this and other developments from her work and research.

Treating ADHD Symptoms in Early Childhood

George DuPaul describes how non-medicinal interventions are effective in treating ADHD symptoms in early childhood.

The Drugging of Our Children (Trailer)

Gary Null examines the increasingly common practice of prescribing psychotropic drugs for children - including preschoolers as young as age 2 to 4 - who have been diagnosed with ADD, or ADHD.In the absence of any objective medical tests to determine ...

Drugs to Treat ADHD Reach the Preschool Set - New York Times

news.google.com

ABC News (blog)Drugs to Treat ADHD Reach the Preschool SetNew York TimesLast week, the American Academy of Pediatrics revised its ADHD treatment guidelines, giving doctors a green light to prescribe drugs even to preschoolers with ADHD if behavioral ...

Preschool Children May Be Prescribed Attention-Deficit Drugs, Doctors Say - Bloomberg

news.google.com

Dixie Press OnlinePreschool Children May Be Prescribed Attention-Deficit Drugs, Doctors SayBloombergThe recommendations, the first in a decade, expand the age range of kids who may be prescribed the drugs from preschoolers through 18-year-olds. Earli ...

This book section: ADHD Medication Issues and Research

Douglas Cowan, Psy.D., MFT is a licensed Marriage and Family Therapist in Tehachapi, CA who has been a counselor to children, teens, and adults helping them to overcome ADHD, find relief for depression or anxiety, and solve other problems in life since 1989. He served on the medical advisory board to the company that makes Attend and Extress from 1997 through 2011, and he is the Editor of the ADHD Information Library online resource at http://newideas.net/. His weekly ADHD Newsletter goes out to 9,500 families. Visit his website at http://DouglasCowan.me for more information on achieving greater health, personal growth, Christ-centered spirituality, stress management, parenting skills, ADHD, working out the stresses of being a care-giver to elderly parents and also being a parent to teenagers, or finding greater meaning in retirement years, Dr. Cowan can be a valuable resource to you.

Counselor counseling Tehachapi for ADHD, depression, anxiety, and more.

Douglas Cowan, Psy.D., MFT
27400 Oakflat Dr.
Tehachapi, CA 93561
(661) 972-5953

Over the past five years we have seen an increase options for delivery systems of medications for ADHD, the next generation of medications for ADHD may be just around the corner. These NextGen medications are known as ProDrugs, and they have the potential to change the way medications are prescribed to individuals with ADHD.

Since there has been a recent explosion of new ADHD medicationssuch as Strattera, or new delivery systems such as Daytrana, or “old drugs in new dresses” such as Concerta, why in the world is it necessary to develop any more new drugs for ADHD? Why should we care?

To the extent that new medications are just “old drugs in new dresses” for a pharmaceutical company to make money, we don’t care. But to the extent that this NextGen of ProDrugs might actually make a difference in people’s lives, we are very interested in learning more.

And given that between 30% and 40% of patients cannot tolerate the side-effects of current stimulant ADHD medications, and given that today’s ADHD medications range from about 60% effective (Strattera) to 80% effective (Ritalin), there is a lot of room for improvement in this field. This is why we like Attend, which is not a drug, but is about 70% effective and with few or no side-effects. It is just not well known.

ProDrugs: The Next Generation of ADHD Medications

By developing this next generation of drugs, pharmaceutical companies are betting huge sums of monies that they can develop ADHD drugs that are more efficient for a given individual, and with fewer side-effects. Since there are different types of ADHD, different types of drugs, or drugs that will work on different parts or systems of the brain, will be more efficient than just broad acting CNS stimulants.

What is a ProDrug?

A ProDrug is an inactive precursor of another drug, an inactive precursor to a particular pharmacologic agent. It is a drug that is given in an inactive, or greatly less active form. But once taken, the person’s body metabolizes it into an active form. The person’s body becomes the “delivery system.”

A ProDrug is designed to be more efficient in treatment, by being better absorbed and better utilizied by the body, with less side-effects.

The goal of ProDrugs is for the drug to be highly targeted to a specific system or region of the body, a specific site of action, rather than just impact the entire body or CNS.

Shire Pharmaceuticals, a company that we have been very critical of in the past, is one of the companies leading the way in ProDrug development. Well, actually they are not, but they did by New River Pharmaceuticals for $2,600,000,000 (yes, that is 2.6 Billion dollars). And New River Pharmaceuticals was leading the lay in ProDrug development for ADHD with their drug Vyvanse (lisdexamgetamine dimesylate). The FDA approved Vyvanse as a “novel treatment” for ADHD in February of 2007, and the DEA will classify it as a Schedule II controlled substance.

See http://newideas.net/adhd/medication/vyvanse_shire

From the Shire press release of Feb. 2007:

“VYVANSE is a prodrug that is therapeutically inactive until metabolized in the body. In clinical studies designed to measure duration of effect, VYVANSE provided significant efficacy compared to placebo for a full treatment day, up through and including 6:00 pm. Furthermore, when VYVANSE was administered orally and intravenously in two clinical human drug abuse studies, VYVANSE produced subjective responses on a scale of “Drug Liking Effects” (DLE) that were less than d-amphetamine at equivalent doses. DLE is used in clinical abuse studies to measure relative preference among known substance abusers.

“The FDA approval of VYVANSE is exciting news for Shire as well as for patients, their families, and healthcare providers as it’s an important, novel approach for the treatment of ADHD,” said Matthew Emmens, Shire Chief Executive Officer. “The label we received with the approval letter includes information about the extended duration of effect and abuse-related drug liking characteristics of VYVANSE which illustrate benefits that differentiate this compound from other ADHD medicines. The addition of VYVANSE to our ADHD portfolio reaffirms Shire’s commitment to continue to address unmet medical needs and advance the science of ADHD treatment. Beginning with product launch in Q2 2007, Shire will make VYVANSE our top promotional priority within our ADHD portfolio.”

The big selling point of Vyvanse is that it may reduce the potential for abuse, as ProDrugs are not favored by those intending to abuse stimulants.

In regards to ADHD ProDrugs medications, admittedly Vyvanse is the only ProDrug that I have heard any lectures on or read anything about, but I don’t want to assume that it is the only ProDrug in development for ADHD. In the studies on Vyvanse, the researchers found that among all of the subjects, the ProDrug was metabolized very consistently in terms of time to optimum therapeutic levels in the body, and in terms of the predictability of the degree to which the ProDrug was utilized by the body.

To put it better, put ten kids in a room who each weigh 100 pounds. Let’s say that they each need treatment with methylphenidate (Ritalin, et al.). The variety of optimal doses in those ten children could range from 5mg per dose to 40mg per dose. But with the ProDrug, the study indicates that nearly everyone of that body weight will be taking the same size does to get the optimum dose.

To put it even more simply, it will be easier for doctors who aren’t paying attention well to get the right dose for the right child the first time. And the response to the drug will be more predictable. Everything will operate more efficiently with a more efficient drug.

In addition to ProDrug development, look for the use of various “Alpha-2 Noradrenergic Receptor Agonists” for the treatment of ADHD in the near future. Tenex (guanfacine) is already in use as ADHD medication, as well as being an anti-hypertesive and blood pressure medication, but more will be on the way. We will look at this class of medications, and their potential for ADHD treatment, in the near future.

Prodrugs ADHD Medication

This book section: ADHD Medication Issues and Research

Douglas Cowan, Psy.D., MFT is a licensed Marriage and Family Therapist in Tehachapi, CA who has been a counselor to children, teens, and adults helping them to overcome ADHD, find relief for depression or anxiety, and solve other problems in life since 1989. He served on the medical advisory board to the company that makes Attend and Extress from 1997 through 2011, and he is the Editor of the ADHD Information Library online resource at http://newideas.net/. His weekly ADHD Newsletter goes out to 9,500 families. Visit his website at http://DouglasCowan.me for more information on achieving greater health, personal growth, Christ-centered spirituality, stress management, parenting skills, ADHD, working out the stresses of being a care-giver to elderly parents and also being a parent to teenagers, or finding greater meaning in retirement years, Dr. Cowan can be a valuable resource to you.

Counselor counseling Tehachapi for ADHD, depression, anxiety, and more.

Douglas Cowan, Psy.D., MFT
27400 Oakflat Dr.
Tehachapi, CA 93561
(661) 972-5953

Ritalin and Adderall may be in Short Supply for the Summer of 2011

Have you experienced problems in filling your prescriptions for your ADHD medications such as Ritalin or Adderall?

Recently the FDA had to add some common ADHD medications to their list of drugs that are in short supply across the country, and many parents are reporting difficulty in finding a pharmacy that can fill their prescriptions.

According to the FDA, there are a number of medications that are on their “short supply” list. Today there are a total of 178 medications in short supply, while in 2005 there were only 61 on the list. Most of the medications on the list are injectable medications, or medications given intravenously. These include “medically necessary” drugs including certain cancer drugs, anesthetics for surgery, certain “crash cart” drugs for emergencies, and other IV medications.

But also on the list are certain drugs taken orally, including some of the drugs used to treat ADHD in both children and adults.

Go to the ADHD Diet Information site to get the full ADHD diet in eBook PDF format, including our UPDATES for 2013. We also have the full 21 minute information video on our ADHD eating program.

ADHD Medications : Updated Status

As of July 12, 2011, here is the status report:

Of the five companies that distribute Methylphenidate HCI (Ritalin or generic), two are backordered until the end of summer, but three have all strengths of the product in stock.

There are two companies that make Amphetamine Mixed Salts, ER capsults, (Adderall or generic). Shire makes the real stuff, but they are having “supply issues” and “uneven product distribution patterns” with Adderall. Teva makes generic medicines, and they are reporting “supply issues,” but are “releasing product as it becomes available.”

You can keep up to date on the status of these medications at the FDA’s “Current Drug Shortages” web page : http://www.fda.gov/Drugs/DrugSafety/DrugShortages/ucm050792.htm

If you are having problems finding and filling your prescriptions, be sure to talk with your doctor. There may be other strategies or interventions that would work just as well for you situation.

This book section: ADHD Medication Issues and Research

Douglas Cowan, Psy.D., MFT is a licensed Marriage and Family Therapist in Tehachapi, CA who has been a counselor to children, teens, and adults helping them to overcome ADHD, find relief for depression or anxiety, and solve other problems in life since 1989. He served on the medical advisory board to the company that makes Attend and Extress from 1997 through 2011, and he is the Editor of the ADHD Information Library online resource at http://newideas.net/. His weekly ADHD Newsletter goes out to 9,500 families. Visit his website at http://DouglasCowan.me for more information on achieving greater health, personal growth, Christ-centered spirituality, stress management, parenting skills, ADHD, working out the stresses of being a care-giver to elderly parents and also being a parent to teenagers, or finding greater meaning in retirement years, Dr. Cowan can be a valuable resource to you.

Counselor counseling Tehachapi for ADHD, depression, anxiety, and more.

Douglas Cowan, Psy.D., MFT
27400 Oakflat Dr.
Tehachapi, CA 93561
(661) 972-5953

ADHD Stimulant Medication and ER Visits for Heart Problems in Children

Are the risks of heart problems greater in children who are prescribed stimulant medications for ADHD than for children who are not taking such medications? The University of Florida researched this question and published their results in the journal Pediatrics in December, 2007.

What they found was that the use of stimulant medication for ADHD in children and teenagers may be the cause for an increased number of emergency room visits, or visits to the doctor’s office, because of cardiac symptoms such as a racing heart or increased blood pressure. But the study also found that deaths, or serious heart complications, are rare.

The researchers looked at the records of over 50,000 children and teenagers who had ADHD, and were treated with stimulants such as Ritalin and other Methylphenidate compounds, Dexedrine, and Adderall. Then they compared the findings from this group to a database of over 2 million children and teenagers to see if there were any differences.

What they found was the children and teenagers treated with stimulants for ADHD were about 20 percent more likely to have to go to a doctor’s office or emergency room with cardiac symptoms than children and teens that were not taking stimulant medications. In other words, for every 100 children or teens who have to go to the ER or doctor's office for scary heart symptoms, there are 120 children or teens who take stimulant medication who have to go to the ER.

However, rates of death or admissions to a hospital were no different that the rates among those not being treated with stimulant medications.

ADHD Medication and FDA Warnings

There is an ongoing controversy within various committees in the FDA about whether stimulant medications should carry a “black box” warning label. In 2006 the FDA added the “black box” warning to the labels of ADHD medications warning of possible heart risks from the medications. The warnings on the label included possible sudden death in patients who have heart problems or heart defects, stroke and heart attack in adults, and increased heart rates and increased blood pressure.

The authors note that they do not know the long-term implications of increased heart rate and blood pressure in children and teens treated with stimulant medications. They also noted that about 25 percent of children and teens treated with stimulants were also prescribed either an antidepressant medication or an antipsychotic medication, which can also impact the heart and blood pressure.

Read more about the study from the University of Florida.

Contrary Studies to Consider

ADHD Meds Do Not Increase Heart Risks: Study // Pharmalot

www.pharmalot.com11/1/11

The various drugs used to combat attention deficit hyperactivity disorder, or ADHD, do not increase the risk of heart attacks, strokes or sudden death, according to a new study published in The New England Journal of Medicine that ... as they describe their motivation for conducting their study as being based in part on a previous study showing a 20-21% increase in cardiac ER and physician office visits for youth on stimulants, but their study find a 640% increase in ...

NIMH · Continued Use of Stimulants for ADHD Likely Does Not ...

elbiruniblogspotcom.blogspot.com9/10/11

Chronic use of stimulant medication to treat attention deficit hyperactivity disorder (ADHD) in children does not appear to increase risk for high blood pressure over the long term, but it may have modest effects on heart rate, according to ...

This book section: ADHD Medication Issues and Research

Douglas Cowan, Psy.D., MFT is a licensed Marriage and Family Therapist in Tehachapi, CA who has been a counselor to children, teens, and adults helping them to overcome ADHD, find relief for depression or anxiety, and solve other problems in life since 1989. He served on the medical advisory board to the company that makes Attend and Extress from 1997 through 2011, and he is the Editor of the ADHD Information Library online resource at http://newideas.net/. His weekly ADHD Newsletter goes out to 9,500 families. Visit his website at http://DouglasCowan.me for more information on achieving greater health, personal growth, Christ-centered spirituality, stress management, parenting skills, ADHD, working out the stresses of being a care-giver to elderly parents and also being a parent to teenagers, or finding greater meaning in retirement years, Dr. Cowan can be a valuable resource to you.

Counselor counseling Tehachapi for ADHD, depression, anxiety, and more.

Douglas Cowan, Psy.D., MFT
27400 Oakflat Dr.
Tehachapi, CA 93561
(661) 972-5953

ADHD Medications - can they cause sudden death in children with ADHD ?

A recent study published in The American Journal of Psychiatry got everyone’s attention when it suggested that there may be an “association” between the use of stimulant medications, such as Ritalin, and “sudden cardiac deaths” in children that were considered to be “healthy” prior to their deaths.

But the details of the study, along with the “limitations” of the study, prompted the FDA to comment on the research and its conclusions, recommending that parents should not stop giving stimulant medication to their child just based on the conclusions of the study. Rather they recommend that parents have a discussion with the doctor who is prescribing and monitoring the medication.

Basically, the study looked at the medical records of 564 children who, though thought to be healthy, died suddenly. They found that 1.8 percent of these children, or exactly 10 children, had been taking stimulant medication for ADHD when they died. The researchers then compared this group to 564 other children who had died suddenly, though in car accidents. They reported that only 0.4 percent, or 2 children, in this group had been taking stimulant medication for ADHD.

Since 1.8 percent is statistically significant when compared to 0.4 percent, the researchers wondered if stimulant medication was "associated" in some way with "sudden death" in children.

May we note that some studies suggest that as many as 5 to 9 percent of children have ADHD. So it would not be unreasonable for any group of children studied to have some number of children who are prescribed medicine for ADHD. Both the 1.8 percent, and the 0.4 percent numbers seem "light" if the current estimates of the prevalence of ADHD are at all accurate.

ADHD Medication Controversy : FDA

Cardiovascular & Psychiatric Risks w/ ADHD Drugs (May 2007)

Patients with Attention Deficit Hyperactivity Disorder(ADHD) who are taking stimulant drugs such as Adderall (amphetamine-dextroamphetamine), Ritalin (methylphenidate) and Strattera (atomoxetine hydrochloride) will soon be given a Patient Medication ...

The FDA, which has been in the middle of the stimulant controversy over the past two years, focused their concerns more on the limitations of the study, than on the study’s concerns about stimulants. But the FDA will continue to “review drug safety information” regarding any medication used to treat children with ADHD, according to Dr. Janet Woodcock, who is the Director of the Center for Drug Evaluation and Research at the FDA.

As much as we’d like to be critical of the FDA for the way that they seem to want to manage our lives by regulating or warning us of everything from cigarettes, to Cheerios, to Toll House cookie dough, we have to admit that the FDA has been doing a very good job at being as objective as they can be regarding the safety of stimulants such as Ritalin. They have invited differing sides to the discussion and have considered the evidence objectively. And they have also resisted the temptation to over-react, at least so far.

Here are some of our past articles on the FDA committee hearings on stimulants for ADHD:

Parents Caught in the Middle as FDA Committee Debates ADHD Medications
The FDA Puts Black-Box Warning Labels on Stimulants Used to Treat ADHD
The Largest Study Ever on Stimulant Medications and Heart Risk

In their press release with their reaction to the study, the FDA stated the following:

The FDA is continuing its review of the strengths and limitations of this and other epidemiological studies that evaluate the risks of stimulant medications used to treat ADHD in children. The Agency for Healthcare Research and Quality (AHRQ) and the FDA are sponsoring a large epidemiological study that will provide further information about the potential risks associated with stimulant medication use in children. The data collection for this study will be complete later in 2009.

Recommendations for Healthcare Professionals:

Follow all the current prescribing information for use of these medications, including:
· Take a medical history for cardiovascular disease in the child and his or her family.
· Perform a physical exam with special focus on the cardiovascular system (including examination for the signs of Marfan syndrome).
· Consider obtaining further tests such as a screening electrocardiogram and echocardiogram if the history or examination suggests underlying risk for or the presence of heart disease.
The FDA intends to update this advisory when additional information or analyses become available.

Adverse reactions or quality problems experienced with the use of this Product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax, using the contact information at the bottom of this sheet.

Any child who develops cardiovascular symptoms (such as chest pain, shortness of breath or fainting) during stimulant medication treatment should immediately be seen by a doctor.

The medications examined in this study include Focalin, Focalin XR (dexmethylphenidate HCl ); Dexedrine, Dexedrine Spansules, Dextroamphetamine ER, Dextrostat (dextroamphetamine sulfate); Vyvanse (lisdexamfetamine dimesylate); Desoxyn (methamphetamine); Concerta, Daytrana, Metadate CD, Metadate ER, Methylin, Methylin ER, Ritalin, Ritalin-LA, Ritalin-SR (methylphenidate); Adderall, Adderall XR (mixed salts amphetamine); Cylert (pemoline) and generics

The FDA recommends that physicians follow the current prescribing information (labeling) for these products, which recommends that children, adolescents, or adults who are being considered for treatment with ADHD drug products work with their health care professional to develop a treatment plan that includes a careful health history for cardiovascular disease in the child and his or her family. This includes performing a physical exam with special focus on the cardiovascular system and consideration of further tests such as a screening electrocardiogram and echocardiogram, if the history or examination suggests underlying risk for or the presence of heart disease.

ADHD Medication or Alternative Treatments

Even though we are supporters of alternative treatments for ADHD such as diet interventions, Attend and Extress, and EEG biofeedback training, we are not “Ritalin bashers.” Through the years working with ADHD kids, teens, and adults, we have seen hundreds of people of all ages benefit from the use of stimulant medications – some moderately, and some tremendously. We have also seen some physicians who were both careful and insightful in prescribing stimulant medications to children, and some who were neither and in our opinion placed their patients at risk.

While there is a potentially great benefit to the use of stimulant medication for the treatment of ADHD, as with any medication there are potential side-effects, some of which may be very serious. Stimulant medications should be taken seriously. They are not toys. This is not a game. These medications are all too often stolen out of the medicine cabinets by older siblings and used or sold as recreational drugs at high schools and college campuses around the country. Far too many parents think that if a little dose is good, then a bigger dose must be better. We all have to be much more careful with these medications.

For years we have recommended what we think is a reasonable and careful approach to the treatment of ADHD, which in short is this:

Begin with an excellent diagnostic evaluation. A brief glimpse in a doctor’s office for ten minutes is not good enough to make a positive diagnosis.

As treatment interventions go, begin with the basics – and ADHD Eating Program or ADHD Diet. Why start here? For two reasons: first, because we have seen about 20%-25% of those who use it benefit greatly from it even without medication, and secondly, because it is a good habit to form even if someone needs other interventions in the future. No matter how much Attend and Extress, or EEG biofeedback, or Ritalin someone takes, if all they eat is junk all day none of the interventions are gong to work very well. No intervention will overcome bad eating habits in ADHD children, teens, or adults.

A trial of Attend, along with Extress for the Impulsive-Hyperactive Types of ADHD (see Tigger Type, Rabbit Type, or Piglet Type of ADHD), or Memorin for Inattentive Type (Winnie the Pooh Type) ADHD is the next step to consider. Use these along with the ADHD diet interventions. We have seen about a 70% positive response rate with these products and good nutritional habits. See the Different Types of ADHD here...

Then, if these interventions are not enough (and often they are not enough) consider a trial of stimulant medication in addition to the alternative treatment interventions. By using the ADHD diet, the Attend, and so on, along with the medication, we have often observed that a lower dose of medication will still get optimum results. And the lower the dose, the lower the chances of side-effects.

Some medications are better than others (we have been most impressed with the various forms of “old school” methylphenidate – but never in its generic forms, and with Adderall). And we have the opinion that there is some intervention that will give a “day and night difference” to any individual with ADHD. Patience and wisdom are needed in the journey to find that particular intervention that can make a life-changing difference, with few or no side-effects.

This book section: ADHD Medication Issues and Research

Douglas Cowan, Psy.D., MFT is a licensed Marriage and Family Therapist in Tehachapi, CA who has been a counselor to children, teens, and adults helping them to overcome ADHD, find relief for depression or anxiety, and solve other problems in life since 1989. He served on the medical advisory board to the company that makes Attend and Extress from 1997 through 2011, and he is the Editor of the ADHD Information Library online resource at http://newideas.net/. His weekly ADHD Newsletter goes out to 9,500 families. Visit his website at http://DouglasCowan.me for more information on achieving greater health, personal growth, Christ-centered spirituality, stress management, parenting skills, ADHD, working out the stresses of being a care-giver to elderly parents and also being a parent to teenagers, or finding greater meaning in retirement years, Dr. Cowan can be a valuable resource to you.

Counselor counseling Tehachapi for ADHD, depression, anxiety, and more.

Douglas Cowan, Psy.D., MFT
27400 Oakflat Dr.
Tehachapi, CA 93561
(661) 972-5953

The Associated Press is reporting that the Center for Disease Control (CDC) is estimating that each year cough and cold medicines send about 7,091 children to hospital emergency rooms.

Of these 7,000 cases, about two-thirds of the cases were children who took the medicines unsupervised. Of the remaining 2,600 cases, about 1,600 were were children under the age of 2 years old who were given over-the-counter cough and cold medicines that the FDA considers to be too dangerous for such young children.

However, about one-quarter involved cases in which parents gave the proper dosage and an allergic reaction or some other problem developed, the study by the U.S. Centers for Disease Control and Prevention reported.

Caution Giving Children Cough and Cold Medicines

FDA is cautioning parents and caregivers about giving their children cough and cold medicines. FDA strongly recommends that cough and cold medicines NOT be given to children younger than 2 years old because serious and potentially life-threatening si...

CDC researchers gathered case reports of children 11 and under who had taken cough and cold medications and wound up in 63 hospitals studied in 2004 and 2005. They used that number to come up with the national estimate.

"The main message is no medication left in the hands of a 3-year-old is safe," said the CDC's Dr. Melissa Schaefer.

Many of the ER case reports were not specific about symptoms, and the researchers did not follow cases through to conclusion. So they did not know if — or how many — deaths resulted, said Schaefer, an epidemiologist who was the study's lead author. For the children whose symptoms were reported, allergic reactions like hives and itching were most common, and neurological symptoms like drowsiness and unresponsiveness were next, she said. Most of the medicines involved were liquid combinations of cough and cold treatments, CDC researchers said.

The study was published online Monday. It will appear in the April issue of Pediatrics, a journal of the American Academy of Pediatrics.

This book section: ADHD Medication Issues and Research

Douglas Cowan, Psy.D., MFT is a licensed Marriage and Family Therapist in Tehachapi, CA who has been a counselor to children, teens, and adults helping them to overcome ADHD, find relief for depression or anxiety, and solve other problems in life since 1989. He served on the medical advisory board to the company that makes Attend and Extress from 1997 through 2011, and he is the Editor of the ADHD Information Library online resource at http://newideas.net/. His weekly ADHD Newsletter goes out to 9,500 families. Visit his website at http://DouglasCowan.me for more information on achieving greater health, personal growth, Christ-centered spirituality, stress management, parenting skills, ADHD, working out the stresses of being a care-giver to elderly parents and also being a parent to teenagers, or finding greater meaning in retirement years, Dr. Cowan can be a valuable resource to you.

Counselor counseling Tehachapi for ADHD, depression, anxiety, and more.

Douglas Cowan, Psy.D., MFT
27400 Oakflat Dr.
Tehachapi, CA 93561
(661) 972-5953

Parents, doctors, and others have wondered whether common treatments for attention-deficit hyperactivity disorder (ADHD) inadvertently predispose adolescents to future drug abuse. The answer may depend on the age at which treatment is started and how long it lasts, say the authors of a new brain-imaging and behavioral study conducted in animals at the U.S. Department of Energy's Brookhaven National Laboratory. The results appear in the June 5, 2007 online issue of the journal Pharmacology, Biochemistry and Behavior.

"Our study shows that the brain's reward pathways are definitely influenced by methylphenidate, one of the stimulant drugs commonly used to treat ADHD," said Brookhaven researcher Panayotis (Peter) Thanos, lead author of the study. "But the brain chemistry changes we observed suggest that the developmental stage at which treatment begins and the duration of treatment are important variables that need further study."

In the study, rats were given methylphenidate mixed with distilled water beginning one month after birth -- early adolescence for rats. Animals received either 1 or 2 milligrams methylphenidate per kilogram of body weight, consistent with clinical doses given to children with ADHD. A control group of rats was handled under identical conditions but given plain water.

After two months of treatment, and again after eight months, the scientists performed positron emission tomography (PET) scans to measure the levels of dopamine D2 receptors, a type of brain receptor important for experiencing reward and pleasure that has been linked to pleasure and drug abuse. After the eight-month treatment, animals were also tested for their propensity to self-administer cocaine.

Rats given the 2mg/kg dose of methylphenidate were significantly less likely to press a lever to self-administer cocaine, and received fewer self-initiated infusions of the drug following eight months of treatment than the lower-dose group or the control rats.

The changes observed in brain chemistry were specific to the age and duration of methylphenidate treatment: Specifically, after two months of treatment, brain scans revealed that both groups of treated rats had lower levels of dopamine D2 receptors in their brains than did control animals.

In contrast, after eight months of treatment, the brain scans revealed elevated levels of dopamine D2 receptors in treated rats compared with controls, with the higher-dose treatment group showing the highest level of D2 receptors. In the control group, D2 receptor levels declined with age. Research at Brookhaven and elsewhere has suggested that low levels of dopamine D2 receptors may increase the likelihood of drug abuse, while elevated levels of dopamine D2 receptors may attenuate the propensity to abuse drugs.

"This new study provides evidence that chronic methylphenidate treatment begun in adolescence affects the brain's dopamine D2 receptor levels, and thus the brain's reward circuitry, differently depending on the age and treatment duration," Thanos said. The scientists' observation of lower rates of cocaine self-administration in the animals treated for eight months with a 2kg/mg dose of methylphenidate supports this idea.

However, the observation of lower levels of D2 receptors after two months of treatment suggests that shorter lengths of treatment or the age at which treatment is evaluated could result in different effects. "Lower dopamine D2 receptor levels following short-term treatment could make the animals more vulnerable to drug self-administration during early adulthood," Thanos said. "Unfortunately, we cannot compare cocaine self-administration following eight months of treatment with that obtained after two months of treatment in the same animals, since animals were not tested for cocaine self-administration at this earlier time," Thanos said. "We wanted to avoid any confounding effect that might have resulted from cocaine exposure during this early developmental stage," he explained.

Evaluating the effect of treatment duration is one avenue the researchers are exploring in follow-up studies "to help assess optimal duration of treatment regimes to minimize adverse effects on the propensity to abuse drugs," Thanos said.

Thanos notes that the findings from this study cannot be directly extrapolated to treatment regimes used for ADHD. Also, these studies were done in healthy animals, not in rodent models of ADHD. All experiments were conducted in conformity with the National Academy of Sciences Guide for Care and Use of Laboratory Animals and Brookhaven National Laboratory Institutional Animal Care and Use Committee protocols.

This research was funded by the National Institute on Alcohol Abuse and Alcoholism intramural program and by the Office of Environmental and Biological Research within the U.S. Department of Energy's Office of Science.

Contacts: Karen McNulty Walsh, kmcnulty AT bnl.gov,
Mona Rowe, mrowe AT bnl.gov.

One of ten national laboratories overseen and primarily funded by the Office of Science of the U.S. Department of Energy (DOE), Brookhaven National Laboratory conducts research in the physical, biomedical, and environmental sciences, as well as in energy technologies and national security. Brookhaven Lab also builds and operates major scientific facilities available to university, industry and government researchers. Brookhaven is operated and managed for DOE's Office of Science by Brookhaven Science Associates, a limited-liability company founded by the Research Foundation of State University of New York on behalf of Stony Brook University, the largest academic user of Laboratory facilities, and Battelle, a nonprofit, applied science and technology organization.

Visit Brookhaven Lab's electronic newsroom for links, news archives, graphics, and more.

Human ADHD Studies Say "NO"

"Does the Treatment of Attention-Deficit/Hyperactivity Disorder With Stimulants Contribute to Drug Use/Abuse? A 13-Year Prospective Study"

Russell A. Barkley, PhD*, Mariellen Fischer, PhD, Lori Smallish, MA and Kenneth Fletcher, PhD* * Department of Psychiatry, University of Massachusetts Medical School, Worcester, Massachusetts Department of Neurology, Medical College of Wisconsin, Milwaukee, Wisconsin

American Academy of Pediatrics: Pediatrics 2003 111: 97-109: American Academy of Pediatrics

A pilot study of methylphenidate, clonidine, or the combination in ADHD comorbid with aggressive oppositional defiant or conduct disorder. Connor DF, Barkley RA, Davis HT Department of Pediatrics, University of Massachusetts Medical School, Worcester 01655, USA.

Objective. To examine the impact of stimulant treatment during childhood and high school on risk for substance use, dependence, and abuse by young adulthood.

Methods. A total of 147 clinic-referred hyperactive children were followed approximately 13 years into adulthood (mean: 21 years old; range: 19-25). At adolescent (age 15) and adult follow-up, probands were interviewed about their use of various substances and duration of stimulant treatment.

Results. Duration of stimulant treatment was not significantly associated with frequency of any form of drug use by young adulthood. Stimulant-treated children had no greater risk of ever trying drugs by adolescence or any significantly greater frequency of drug use by young adulthood. Stimulant treatment in high school also did not influence drug use in adulthood except for greater use of cocaine. This difference was no longer significant after controlling for severity of attention-deficit/hyperactivity disorder and conduct disorder in childhood, adolescence, and adulthood. Stimulant treatment in either childhood or high school was not associated with any greater risk for any formal Diagnostic and Statistical Manual of Mental Disorders, Third Edition, Revised drug dependence or abuse disorders by adulthood. Treatment with stimulants did not increase the risk of ever having tried most illegal substances by adulthood except for cocaine. Subsequent analyses showed that this elevated risk was primarily mediated by severity of conduct disorder by young adulthood and not by stimulant treatment in childhood.

Conclusion. This study concurs with 11 previous studies in finding no compelling evidence that stimulant treatment of children with attention-deficit/hyperactivity disorder leads to an increased risk for substance experimentation, use, dependence, or abuse by adulthood.

Key Words: hyperactivity, attention-deficit/hyperactivity disorder, stimulants, illicit drug use, drug abuse, conduct disorder

Abbreviations: ADHD, attention-deficit/hyperactivity disorder, CD, conduct disorder, SD, standard deviation, DSM, Diagnostic and Statistical Manual of Mental Disorders, CPRS-R, Conners Parent Rating Scale Revised, WWPARS, Werry-Weiss-Peters Activity Rating Scale, OR, odds ratio, SE, standard error

also,

"Does Stimulant Therapy of Attention-Deficit/Hyperactivity Disorder Beget Later Substance Abuse? A Meta-analytic Review of the Literature"

Timothy E. Wilens, MD*,, Stephen V. Faraone, PhD*,, Joseph Biederman, MD*, and Samantha Gunawardene, BS* * Clinical Research Program in Pediatric Psychopharmacology, Massachusetts General Hospital, Boston, Massachusetts Harvard Medical School, Boston, Massachusetts

American Academy of Pediatrics: Pediatrics 2003 111: 179-185: American Academy of Pediatrics

Objective. Concerns exist that stimulant therapy of youths with attention-deficit/hyperactivity disorder (ADHD) may result in an increased risk for subsequent substance use disorders (SUD). We investigated all long-term studies in which pharmacologically treated and untreated youths with ADHD were examined for later SUD outcomes.

Methods. A search of all available prospective and retrospective studies of children, adolescents, and adults with ADHD that had information relating childhood exposure to stimulant therapy and later SUD outcome in adolescence or adulthood was conducted through PubMed supplemented with data from scientific presentations. Meta-analysis was used to evaluate the relationship between stimulant therapy and subsequent SUD in youths with ADHD in general while addressing specifically differential effects on alcohol use disorders or drug use disorders and the potential effects of covariates.

Results. Six studies-2 with follow-up in adolescence and 4 in young adulthood-were included and comprised 674 medicated subjects and 360 unmedicated subjects who were followed at least 4 years. The pooled estimate of the odds ratio indicated a 1.9-fold reduction in risk for SUD in youths who were treated with stimulants compared with youths who did not receive pharmacotherapy for ADHD (z = 2.1; 95% confidence interval for odds ratio [OR]: 1.1-3.6). We found similar reductions in risk for later drug and alcohol use disorders (z = 1.1). Studies that reported follow-up into adolescence showed a greater protective effect on the development of SUD (OR: 5.8) than studies that followed subjects into adulthood (OR: 1.4). Additional analyses showed that the results could not be accounted for by any single study or by publication bias.

Conclusion. Our results suggest that stimulant therapy in childhood is associated with a reduction in the risk for subsequent drug and alcohol use disorders.

Key Words: attention-deficit/hyperactivity disorder, substance use, pharmacotherapy

Abbreviations: ADHD, attention-deficit/hyperactivity disorder, SUD, substance use disorders, OR, odds ratio, POR, precision of the odds ratio, SN, standard normal deviate, CI, confidence interval.

Our Thoughts : Does Stimulant Treatment for ADHD Increase Risk of Drug Abuse?

This is a debate that has been raging for years - does the use of stimulant medication to treat ADHD, such as Ritalin, increase the likelihood of later drug use?

If you read the material from the Church of Scientology, and their friends, the answer will be "absolutely - yes!" But if you read material from researchers and psychologists, the answer will be "probably not."

Our experience has been that, no, the use of stimulant medication such as Ritalin does not increase the chances of a child becoming a teenager who will abuse drugs.

But here's a real life story to illustrate how opinions are often formed on the question. It begins with my being in a classroom at Cal State Bakersfield where I was giving a lecture on ADHD to a class of future educators.

At the conclusion of my lecture, including a discussion on Ritalin, a hand was raised by one of our future classroom teachers. She stated, out loud for all to hear, that her brother was now in prison because of his Ritalin treatment for ADHD. She stated that having used Ritalin had turned him into a drug addict and criminal.

I asked the obvious clarifying questions, such as "how did that happen?" She replied that her brother had be prescribed Ritalin from the age of 9 until the age of 13. Then at the age of 13, because he had reached adolescence, his doctor believed (wrongly) that he no longer required medication and discontinued treatment. Then at the age of 15, two years after having discontinued treatment for ADHD, her brother began smoking, getting into trouble, and using drugs.

And now, at the age of 18, her brother was in prison. And in her opinion it was all the fault of a medication that was discontinued five years before his arrest, and two years before his drug career began.

When I pointed out that perhaps it was not the fault of the Ritalin (since he had discontinued it two years before beginning to get into trouble), and that perhaps the treatment of his ADHD might have been more successful, for more years, if he had continued using stimulants, she just muttered something about my being an idiot. Because in her mind, her brother's trouble could not be her brother's responsibility, but had to be the fault of something outside of her brother's control - such as evil doctors and evil Ritalin.

Score 1 for opinion, score 0 for logic.

Finally, I'm not here to defend Ritalin. It has lots of potential problems and side-effects. I'd much rather see people use Attend and Extress, and our ADHD Diet. But the research has strongly indicated for years that treatment with stimulant medication does not increase the risks of future drug use in teenagers. However the facts are that un-treated ADHD does increase the risks of future drug use.

The National Institute on Drug Abuse makes this statement about ADHD Medications:

"One of the most controversial issues in child psychiatry is whether the use of stimulant medications to treat ADHD increases the risk of substance abuse in adulthood. Research thus far suggests that individuals with ADHD do not become addicted to their stimulant medications when taken in the form and dosage prescribed by their doctors. Furthermore, several studies report that stimulant therapy in childhood does not increase the risk for subsequent drug and alcohol abuse disorders later in life."

We will admit that there are many college students abusing Ritalin and Adderall, etc., to help them in their studies. But this is not the same question. In this case, these students are abusing stimulants for ADHD because it does work - it does help them concentrate and study better.

Other Opinions : ADHD Medications and Drug Abuse Risk

ADHD - To medicate or not?

Dr Russel Barkley talks about ADHD and treatment against the problem. Advantages and disadvantages. adhdhistory.com

See also:

Wilens TE, Faraone SV, Biederman J, Gunawardene S. Does stimulant therapy of attention-deficit/hyperactivity disorder beget later substance abuse? A meta-analytic review of the literature. Pediatrics 111:179–185, 2003.

Mannuzza S, Klein RG, Truong NL, et al. Age of methylphenidate treatment initiation in children with ADHD and later substance abuse: prospective follow-up into adulthood. Am J Psychiatry 165(5):604–609, 2008. Epub April 1, 2008. Available at: http://www.ncbi.nlm.nih.gov/pubmed/18381904?dopt=Abstract.

Biederman J, Monuteaux MC, Spencer T, Wilens TE, MacPherson HA, Faraone SV. Stimulant therapy and risk for subsequent substance use disorders in male adults with ADHD: a naturalistic controlled 10-year follow-up study. Am J Psychiatry 165(5):597-603, 2008. Epub March 3, 2008. Available at:
http://ajp.psychiatryonline.org/cgi/content/abstract/appi.ajp.2007.07091...

This book section: ADHD Medication Issues and Research

Douglas Cowan, Psy.D., MFT is a licensed Marriage and Family Therapist in Tehachapi, CA who has been a counselor to children, teens, and adults helping them to overcome ADHD, find relief for depression or anxiety, and solve other problems in life since 1989. He served on the medical advisory board to the company that makes Attend and Extress from 1997 through 2011, and he is the Editor of the ADHD Information Library online resource at http://newideas.net/. His weekly ADHD Newsletter goes out to 9,500 families. Visit his website at http://DouglasCowan.me for more information on achieving greater health, personal growth, Christ-centered spirituality, stress management, parenting skills, ADHD, working out the stresses of being a care-giver to elderly parents and also being a parent to teenagers, or finding greater meaning in retirement years, Dr. Cowan can be a valuable resource to you.

Counselor counseling Tehachapi for ADHD, depression, anxiety, and more.

Douglas Cowan, Psy.D., MFT
27400 Oakflat Dr.
Tehachapi, CA 93561
(661) 972-5953

Ritalin : Long Term Use and Consequences Studied

"Does Ritalin Use Alter a Child’s Brain? " This was a common headline in the media regarding another of the really interesting studies published this summer. The actual name of the study was: “Methylphenidate Administration to Juvenile Rats Alters Brain Areas Involved in Cognition, Motivated Behaviors, Appetite, and Stress.”

The study attempted to answer questions regarding the consequences of using Ritalin (Methylphenidate) long-term in children. The researcher’s had concerns that no one really knows what long-term use of Ritalin does to a child’s brain, so they studied the impact of Ritalin use on 16 areas of the brains of young male rats, hoping to find clues.

The rats were first given Ritalin at 7 days old. Some rats were studies after 35 days of use (rat adolescence), while others were studied after 135 days (rat adulthood).

Changes were found in the rats who were given Ritalin, compared to the control group that was never given Ritalin. “The changes we saw in the brains of treated rats occurred in areas strongly linked to higher executive functioning, addiction and appetite, social relationships and stress. These alterations gradually disappeared over time once the rats no longer received the drug,” according to the study’s lead researcher Dr. Teresa Milner from the Weill Cornell Medical College.

The study revealed Ritalin-associated changes in four main areas:

• First, there were alterations in brain chemicals such as catecholamines and norepinephrine in the rats’ prefrontal cortex, which is the part of the brain responsible for higher executive functions and decision-making;
• Second, there were also significant changes in catecholamine function in the hippocampus, a center for memory and learning;
• Third, there were alterations in the stratium, a key region for motor function;
• Fourth, there were changes in the hypothalamus, a center for appetite, addictive behaviors, and vigilance.

The rats given the Ritalin also lost weight, a common side-effect to stimulants.

Dr. Milner reported that it is too early to say whether the changes found in the Ritalin-exposed brains would be of benefit or harm to humans, but warned that physicians need to be very careful in their diagnosis of ADHD before prescribing Ritalin to children because the brain changes from the use of Ritalin might be helpful in “battling the disorder” but harmful if given to a child with a healthy brain.

One good indication was that three months after discontinuing the Ritalin treatment the rats’ neurochemistry largely had resolved back to the condition they would have been in had they never received treatment – normal rat brains.

This finding gave the research team hope that short-term Ritalin use might be OK, but that Ritalin use should be replaced by other treatment options for the long-term. Dr. Milner said, “We are concerned about longer-term use (of Ritalin). It’s unclear from this study whether Ritalin might leave more lasting changes, especially if treatment were to continue for years. In this case it is possible that chronic use (long-term) of (Ritalin) would alter brain chemistry and behavior well into adulthood.”

The study was funded by the U. S. National Institutes of Health. Weill Cornell Medical College is Cornell University’s Medical School located in New York City.

Other Opinions on Long Term Ritalin Use

Long-Term Side Effects of Ritalin

adhd.emedtv.com3/8/07

This eMedTV Web page discusses the long-term Ritalin side effects seen in animal studies, which may include growth suppression and brain changes. However, this page also reminds that more research is needed to fully understand these ...

Pediatric Ritalin Use May Affect Developing Brain

www.emaxhealth.com7/19/07

Use of the attention deficit/hyperactivity disorder (ADHD) drug Ritalin by young children may cause long-term changes in the developing brain, suggests a new study of very young rats by a research team at Weill Cornell ...

This book section: ADHD Medication Issues and Research

Douglas Cowan, Psy.D., MFT is a licensed Marriage and Family Therapist in Tehachapi, CA who has been a counselor to children, teens, and adults helping them to overcome ADHD, find relief for depression or anxiety, and solve other problems in life since 1989. He served on the medical advisory board to the company that makes Attend and Extress from 1997 through 2011, and he is the Editor of the ADHD Information Library online resource at http://newideas.net/. His weekly ADHD Newsletter goes out to 9,500 families. Visit his website at http://DouglasCowan.me for more information on achieving greater health, personal growth, Christ-centered spirituality, stress management, parenting skills, ADHD, working out the stresses of being a care-giver to elderly parents and also being a parent to teenagers, or finding greater meaning in retirement years, Dr. Cowan can be a valuable resource to you.

Counselor counseling Tehachapi for ADHD, depression, anxiety, and more.

Study Reports More Teenagers are Intentionally Abusing ADHD Medications

More teenagers college students are abusing ADHD medications as "study drugs" and "party drugs." ADHD is a neurological disorder that impacts between 5% and 9% of children, teens, and even adults. Over the years, as more pharmaceutical companies enter the market, and more medications are developed, there has been a signficiant increase int he use of ADHD medications - and a recent study suggests an increase in the misuse of such medications.

The study is titled "Adolescent Prescription ADHD Medication Abuse is Rising Along With Prescriptions for These Medications," and was published August 24, 2009 in the journal Pediatrics. The authors, Jennifer Setlik, MD, Randall Bond, MD, and Mona Ho, MS, looked at the information available from the American Association of Poison Control Center's National Poison Data System from 1998 to 2005 for all incidents involving teenagers who intentionally abused or misused ADHD medications, which are most commonly stimulants such as Ritalin.

They found that incidents of reported and treated abuse rose 76 percent, from just over 300 incidents to 581 incidents. Estimated prescription rates for teens and preteens increased 133 percent for amphetamine products, 52 percent for methylphenidate products, and 80 percent for both together. The authors emphasized that the majority of adolescents use their ADHD medication appropriately. But doctors need to remember that the more medication is prescribed to teenagers, the more likely there are to be incidents of abuse, so the doctors need to monitor the medications closely.

The author's conclusion stated, "The sharp increase, out of proportion to other poison center calls, suggests a rising problem with teen ADHD stimulant medication abuse. Case severity increased over time. Sales data of ADHD medications suggest that the use and call-volume increase reflects availability, but the increase disproportionately involves amphetamines."

We believe that medications for ADHD can be highly effective, but the potential for significant side-effects and also now for mis-use and abuse is real. This is why we advocate alternative treatments as the first intervention whenever possible. We like EEG biofeedback traning, our ADHD Diet, and Attend by VAXA as an alternative to stimulant medications.

Other Opinions : ADHD Medication Abuse

ADHD Rx Drug Abuse at College, Lock me ups?

Ashley, a College student is interviewed by Dr. Charles Shinaver about prescription drug abuse at college. Is Adderall Abuse or the Abuse of other ADHD Drugs on College Campuses a Big Deal? Students ask ADHD Students all the time to sell or give thei...

Teen ADHD Drug Abuse

Dr. Alanna Levine spoke with Chris Wragge about the prevalence of ADHD drug abuse in teens and what parents can do to educate their children.

Adult ADHD research and misuse of medications

Lenard Adler, MD, Professor of Psychiatry and Child & Adolescent Psychiatry, Director, Adult ADHD Program, NYU School of Medicine, discusses adult ADHD research for which longitudinal studies are currently being conducted. There is also data about th...

This book section: ADHD Medication Issues and Research

Douglas Cowan, Psy.D., MFT is a licensed Marriage and Family Therapist in Tehachapi, CA who has been a counselor to children, teens, and adults helping them to overcome ADHD, find relief for depression or anxiety, and solve other problems in life since 1989. He served on the medical advisory board to the company that makes Attend and Extress from 1997 through 2011, and he is the Editor of the ADHD Information Library online resource at http://newideas.net/. His weekly ADHD Newsletter goes out to 9,500 families. Visit his website at http://DouglasCowan.me for more information on achieving greater health, personal growth, Christ-centered spirituality, stress management, parenting skills, ADHD, working out the stresses of being a care-giver to elderly parents and also being a parent to teenagers, or finding greater meaning in retirement years, Dr. Cowan can be a valuable resource to you.

Counselor counseling Tehachapi for ADHD, depression, anxiety, and more.

DrugWatch.com is a comprehensive Web site containing information about many medications, including common prescriptions and over-the-counter drugs available worldwide. The Web site features an A-Z index of the medications, making it easy for patients to find information about specific drugs, such as Adderall, Ritalin, Vyvanse, and Concerta, which are commonly used to treat ADD and ADHD.

DrugWatch.com is updated daily with important information about drug recalls, up-and-coming medications involved in clinical trials, and U.S. Food and Drug Administration alerts and warnings. Additionally, numerous drug pages are uploaded to the site every day, as new pages are created constantly. Drugs are organized both alphabetically (by brand and generic name) and by drug type to help visitors quickly find information about specific medications.

Along with general medication information such as recommended dosages, the site features important information about drug side effects and drug interactions that may cause adverse reactions in some patients. Patients who are taking medications to treat ADD and ADHD should be fully aware of the potential risks associated with these drugs, as well as other drugs, foods and supplements that they may interact negatively with.

Press release by Kristin Dambrauskas

Take a look at the website. It could be a handy resource for parents of ADHD kids. This book section: ADHD Medication Issues and Research

Douglas Cowan, Psy.D., MFT is a licensed Marriage and Family Therapist in Tehachapi, CA who has been a counselor to children, teens, and adults helping them to overcome ADHD, find relief for depression or anxiety, and solve other problems in life since 1989. He served on the medical advisory board to the company that makes Attend and Extress from 1997 through 2011, and he is the Editor of the ADHD Information Library online resource at http://newideas.net/. His weekly ADHD Newsletter goes out to 9,500 families. Visit his website at http://DouglasCowan.me for more information on achieving greater health, personal growth, Christ-centered spirituality, stress management, parenting skills, ADHD, working out the stresses of being a care-giver to elderly parents and also being a parent to teenagers, or finding greater meaning in retirement years, Dr. Cowan can be a valuable resource to you.

Counselor counseling Tehachapi for ADHD, depression, anxiety, and more.

ef="http://www.drugwatch.com" target="blank" rel="nofollow"> DrugWatch.com

ADHD Medications and the FDA

After much debate the following medications carry the "black box warnings" on the labels of the bottles. These are the strongest warnings that the FDA requires, a step away from pulling the medications.

• Adderall Tablets (mixed salts of a single entity amphetamine product)
• Adderall XR (mixed salts of a single entity amphetamine product) Extended-Release Capsules
• Concerta (methylphenidate hydrochloride) Extended-Release Tablets
• Daytrana (methylphenidate) Transdermal System
• Desoxyn (methamphetamine hydrochloride) Tablets Label (will be updated soon)
• Dexedrine (dextroamphetamine sulfate) Spansule Capsules and Tablets
• Focalin (dexmethylphenidate hydrochloride) Tablets
• Focalin XR (dexmethylphenidate hydrochloride) Extended-Release Capsules
• Metadate CD (methylphenidate hydrochloride) Extended-Release Capsules
• Methylin (methylphenidate hydrochloride) Oral Solution
• Methylin (methylphenidate hydrochloride) Chewable Tablets
• Ritalin (methylphenidate hydrochloride) Tablets
• Ritalin SR (methylphenidate hydrochloride) Sustained-Release Tablets
• Ritalin LA (methylphenidate hydrochloride) Extended-Release Capsules
• Strattera (atomoxetine hydrochloride) Capsules

Warnings for Amphetamine, Dextroamphetamine, Lisdexamfetamine dismesylate, Methamphetamine, Mixed Salts of a Single Entity Amphetamine Products :Adderall, Adderall XR, Desoxyn, and Dexedrine (SR)

• High abuse/diversion potential: Amphetamines have a high potential for abuse. Particular attention should be paid to the possibility of subjects obtaining amphetamines for non-therapeutic use or distribution to others, and the drugs should be prescribed or dispensed sparingly.
• Drug dependence: Administration of amphetmaines for prolonged periods of time may lead to drug dependence and must be avoided.
• Serious Adverse Events: Misuse of amphetamines may cause sudden death and serious cardiovascular adverse events

Warnings for Dexmethylphenidate, and Methylphenidate Medications :Ritalin, Ritalin LA, Ritalin SR, Concerta, Daytrana, Desoxyn, Focalin, Metadate, Methylin

All Dexmethylphenidate, Methylphenidate Products

• Chronic abusive use can lead to a marked tolerance and psychological dependence with varying degree of abnormal behavior
• Frank psychotic episodes can occur, especially with parenteral abuse.

Methylphenidate Products: Concerta, Metadate, Ritalin, Daytrana
Dexmethylphenidate Products: Focalin

• Should be given cautiously to patients with a history of drug dependence or alcoholism.
• Careful supervision required during drug withdrawal from abusive use since severe depression may occur.
• Withdrawal following chronic therapeutic use may unmask symptoms of the underlying disorder that may require follow-up.

Methylphenidate Products: Methylin Products

• Should be given cautiously to emotionally unstable patients, such as those with a history of drug dependence or alcoholism, because such patients may increase dosage on their own initiative.
• Careful supervision required during drug withdrawal, since severe depression as well as the effects of chronic over-activity can be unmasked.
• Long term follow-up may be required because of the patient's basic personality disturbances.




Strattera Atomoxetine

Strattera Suicidal Ideation in Children and Adults



• Atomoxetine increased the risk of suicidal ideation in short-term studies in children or adolescents with attention-deficit/hyperactivity disorder (ADHD).
• Anyone considering the use of atomoxetine in a child or adolescent must balance this risk with the clinical need.
• Patients who are started on therapy should be monitored closely for suicidality (suicidal thinking and behavior), clinical worsening, or unusual changes in behavior.
• Families and caregivers should be advised of the need for close observation and communication with the prescriber.

This book section: ADHD Medication Issues and Research

Douglas Cowan, Psy.D., MFT is a licensed Marriage and Family Therapist in Tehachapi, CA who has been a counselor to children, teens, and adults helping them to overcome ADHD, find relief for depression or anxiety, and solve other problems in life since 1989. He served on the medical advisory board to the company that makes Attend and Extress from 1997 through 2011, and he is the Editor of the ADHD Information Library online resource at http://newideas.net/. His weekly ADHD Newsletter goes out to 9,500 families. Visit his website at http://DouglasCowan.me for more information on achieving greater health, personal growth, Christ-centered spirituality, stress management, parenting skills, ADHD, working out the stresses of being a care-giver to elderly parents and also being a parent to teenagers, or finding greater meaning in retirement years, Dr. Cowan can be a valuable resource to you.

Counselor counseling Tehachapi for ADHD, depression, anxiety, and more.

Guest Author Shane Wong : Storm in a Western Pill

Our guest author is Shane Wong. Mr. Wong is the Editor-in-Chief for Juxtaposition Global Health Magazine, a student-run publication based at the University of Toronto. According to the author: "This article will explore how ADHD medication can empower diagnosed patients, and why fears towards such drugs and the pharmaceutical industry persist across North America."

"Ritalin, Ritalin, seizure drugs, Ritalin.” Such is the lunchtime rhyme for a typical school nurse in the U.S. as she trots from class to class, dispensing pills into outstretched hands of young children (01/18/99 - New York Times).

Welcome to the uniquely North American psychotropic environment. A continent featuring a prescription drug market for attention-deficit hyperactivity disorder (ADHD) worth over 2-billionUS annually, and where the number of prescriptions have grown four-fold in 20 years and over 90% of prescriptions worldwide originate.

But when patients as young as two-years-old are prescribed drugs that a government puts in the same category as morphine and cocaine, controversy concerning the use of drug treatment for ADHD is bound to

arise. This article will explore how ADHD medication can empower diagnosed patients, and why fears towards such drugs and the pharmaceutical industry persist across North America.

ADHD Diagnosis

Attention Deficit Hyperactivity Disorder (ADHD) is among the most commonly diagnosed behavioural disorder in school-aged children, with prevalence rates ranging from 2% to 7%.

According to the Diagnostic and Statistical Manual of Mental Disorders (DSM-IV-TR), the standard diagnostic manual for all North American mental health professionals, ADHD is differentiated into two clusters of behavioural symptoms: inattention, as well as hyperactivity and impulsivity.

Problems with attention primarily involve lack of sustained focus, which can manifest as a rapid shift between toys when young children play or a lack of persistence shown by older children during tasks that lack intrinsic appeal or immediate reward. Additionally, children may also have trouble controlling impulsive behaviour, such as speaking out irrationally or engaging in unnecessary risk-taking behaviour. Finally, hyperactivity includes a tendency to fidget excessively, making it often the most obvious feature in young children.

Burden of Disease: In the Classroom

These tendencies naturally contribute to problems in a variety of domains for many children classified as having ADHD. Academically, children with ADHD are more likely to be expelled or suspended, and 25% of ADHD children develop learning disabilities that range from reading disorders to dyscalculia, a very specific math related disorder where individuals have trouble manipulating simple calculations and numbers. Consequently, it is no surprise that researchers found that ADHD is associated with lower rates of high school graduation and post-secondary education.

Burden of Disease: Outside the Classroom

Apparently the sing-song echo of kids in the playground, “sticks and stones may break my bones, but words will never hurt me”, is only partly true. ADHD children not only have higher rates of accidents, but they have a lower sense of self-esteem and self-efficacy due to frequent negative feedback in academic and social settings.

More troublingly, one study found that 30% of ADHD youth also suffer from anxiety disorders, while 11% experience major depression. Due to their often unrestrained and overbearing social behaviour, ADHD children are also less popular among their peers. Using their classmates’ ratings, researchers found that only 1% of 7-9 year-old children with ADHD were of ‘popular’ status, while 52% fell into the ‘rejected’ category.

A Childhood Syndrome?

Contrary to popular belief, many of the symptoms of ADHD remain present throughout an individual’s lifetime. With growing attention towards adults with ADHD, researchers have found many negative outcomes associated with ADHD that are exacerbated in adulthood as individuals are gaining increasing responsibility and autonomy.

Adults with ADHD generally face greater marital and drug abuse problems, and become involved in more serious accidents. For instance, a unique German study revealed that nearly 45% of inmates in a prison facility suffer from ADHD, suggesting an increased risk of run-ins with the law. Furthermore, at the workplace, ADHD adults display lower work ratings and often change jobs more frequently.

Ritalin: An Empowerment Tool?

Given the negative health, social and academic outcomes associated with ADHD, psychostimulant medications such as Ritalin and Adderall offer the potential to empower children and adults by reducing the risk of negative consequences. In a landmark study lasting over 18 years, researchers at the famed Mayo Clinic found that ADHD medication was associated with improved long-term academic success in children with ADHD. Compared to untreated children diagnosed with ADHD, medication improved reading achievement scores, decreased absenteeism, and decreased the likelihood for a child to be retained in a grade. More specifically, children were able to handle general tasks and manage requests better, while increasing academic productivity.

Outside the classroom, treatment with psychostimulants also reduced the risk of substance abuse by about half compared to children without treatment. The growing research into the benefits of psychostimulant treatment suggest that current ADHD medications can empower individuals to achieve success in academic, employment, self-care and social relationships.

Yet, how does this ‘magic’ pill work? With advances of brain imaging technology, researchers have made tremendous progress in illuminating how medication ‘empowers’ at a neurochemical level. Contrary to one of the first coherent descriptions of ADHD in 1902, which attributed the disorder to an “abnormal defect in moral control,” current drug treatments have actually uncovered a characteristic difference in the brains of patients with ADHD, which stems from a lack of dopamine receptors in the attentional network.

Therefore, ADHD psychostimulant treatments, like Ritalin, actually work by increasing dopamine in the brain by blocking re-uptake transporters, in a fashion analogous to a powerful brick that blocks a drainage pipe, preventing neurochemicals from being flushed away. According to our knowledge of dopamine, the enhancement of dopamine signals in the brain helps patients focus and learn.

One theory that can explain the lowered risk of drug abuse, hypothesizes that an increased dopamine signal lengthens ‘the temporal window’ for associating behaviours to consequences, leading to more effective extinction of impulsive behaviours. Psychostimulants were also shown to increase dopamine in brain regions known as the attentional network, leading to a greater level of attention and focus. Based on these findings, psychostimulant treatments appear to empower patients by reducing symptoms at a neurochemical level and minimizing the risks of negative outcomes associated with ADHD.

Long Term Effects of Psychostimulants: Dependency?

Despite the demonstrated benefits of drug treatment, there remain uneasy fears towards the ADHD medication as a result of its potential side-effects. According to fundamental neurobiological principles, the brain will compensate for the artificial changes in brain chemistry caused by drugs.

This suggestion was confirmed in a 2001 brain imaging study that found three months of
psychostimulant treatment in ADHD children significantly reduced the number of dopamine receptors in the attentional network, the very deficit characterizing ADHD brains in the first place. In other words, if children are taken off the medication, it is likely that their ADHD symptoms will worsen, at least in the short-term. Currently, ADHD medication labelling warns for the risk of sudden death in children and adolescents with structural cardiac abnormalities or other serious heart problems, and psychotic symptoms such as hallucinations and delusions.

For Every Action, There is a Reaction: Abuse and New Formulations of Medication

There are also fears directed towards the potential abuse of psychostimulant medication. In 2001, the Journal of the American Medical Association published an article titled: “Pay Attention: Ritalin Acts Much like Cocaine”, confirming that the clinical effects of ADHD drugs are indistinguishable
from cocaine if both are similarly administered. Furthermore, psychostimulants have been abused by students needing to stay awake and study, or hoping to lose weight. As quoted in the New York Magazine, “You swallow Adderall to study, and snort it for fun”.

One survey examining the prevalence of ADHD drug abuse found that more than 16% of students at a liberal arts college had tried Ritalin recreationally and nearly 13% had ‘snorted’ it. According to a 2007 report from US Office of the National Drug Control Policy, prescription drugs are now second only to marijuana when it comes to drug abuse among the college age group.

However, the issue of psychostimulants drug abuse to achieve a ‘high’ has been circumvented by recent advances in drug formulation and delivery. By embedding the psychoactive ingredients within a thick paste, newer psychostimulants such as Concerta prevents drug abusers from snorting or injecting it intravenously to achieve a “high,” limiting the medicine’s street value. Furthermore, a once-a-day formulation administered in the morning before school is less likely to be given away or sold to other student.

Pharmaceutical Industries Role Over the Prescription of Psychostimulants Among the scientific community and media, there is also a fear towards potential abuse and undue influence by the thriving pharmaceutical industry. Until 2004, it was the most profitable industry in the U.S.20 Given the rapid growth of the global market for ADHD drug treatment that has witnessed drug spending rise nine fold between 1993 and 2003, pharmaceutical corporations are undoubtedly major stakeholders in the debate over how to treat ADHD.

With more money spent on ‘marketing and administration’ than ‘research and design,’ there is concern that the pharmaceutical industry can use its vast financial resources to promote medication as the ADHD treatment of choice to patients and physicians.

According to Dr. Marcia Angell, pharmaceutical companies already have “too much” influence over the education of physicians. It has been estimated that the pharmaceutical industry spends over $6 billion annually on marketing to physicians. Sales representatives hired to visit physicians is a common avenue to market the latest drug product. One physician recalls being “offered $100 [to simply] sit and listen for 15 minutes on the telephone” to a pharmaceutical representative talk about ADHD and Adderrall. More troublingly, Dr. Harold Koplewicz of New York University believes sales representatives can influence “prescription practice more than reading a peer-reviewed journal”.

There is also a growing new industry called Medical Education and Communication Companies (MECC), for-profit companies now numbering more than 100 that are supported by pharmaceutical companies and put together educational programs, presentations and teaching materials for physicians.

While representatives of the pharmaceutical companies say their intention is simply to generate goodwill by financially assisting providers of Continuing Medical Education with the costs of the educational programs, studies have found industry-supported educational activities are slanted in favour of the financial supporter's products, and that physicians attending such courses later prescribe these products more often than competing drugs.

Pharmaceutical Industries Influence of Research Publications

Pharmaceuticals also exert influence over research activities through funding. In the United States, 70% of the $5.56 billion that goes into funding for clinical research comes from the biopharmaceutical industry. According to a recent survey of 107 U.S. medical schools, a startling 62% of industry-funded research permits the sponsor to alter the study design after an agreement has been executed while 80% allow the sponsor to own the data.

One telling example of the consequences of this conflict of interest, between scientific research and the pharmaceutical industry’s interests, is told by Dr. William Pelham, a leading ADHD research author to over 275 publications.

In 1997, Dr. Pelham was funded by the McNeil Pharmaceuticals to conduct a study to gain FDA approval for the ADHD medication Concerta. The original intent was to measure both the side effects and main effects of the drug, but the study was fundamentally flawed because the participants were screened to ensure they were already taking and responding well to a similar ADHD medication. By stacking the studies with patients already successfully taking stimulants, McNeil Pharmaceuticals ensured the participants would be unlikely to register side-effects.

Furthermore, Dr. Pelham claims that there was direct pressure from the company to tweak the
findings in the paper. Recalling a conference call with senior executives of the pharmaceutical company funding the study, he was “pushed to delete a paragraph in the article” advocating combined treatment (medication and behavioural), and pressured to water down or eliminate other phrases that did not dovetail into their interests. In the end, the paper was accepted without his knowledge and published with his name on it.

Today, Concerta is on the market, but Dr. Pelham argues that it reflects how companies are “really pushing meds without telling the full picture”. As Dr. Angell, former editor-in-chief of the New England Journal of Medicine, asserts, pharmaceutical industry’s control over the evaluation of their own product constitutes a fundamental conflict of interest. The growing partnership between the pharmaceutical industry and scientists may potentially compromise that of intellectual honesty in clinical research.

Marketing of Quick Fixes

The pharmaceutical industry in North American has also begun to directly market ADHD drug treatments to families. In 1996, the United Nations International Narcotics Control Board ANNUAL REPORT 1995 publicly raised concerns regarding the active promotion of psychostimulant treatment by the parent support group Children and Adults with Attention Deficit/Hyperactivity Disorder, who had received a donation of more than $1 million from the American pharmaceutical industry.

Further in 2001, the American ADHD pharmaceutical industry began launching direct-to-consumer advertisements in magazines and on television promoting ADHD drug treatments. This ended nearly 30 years of the global industry’s observance of the 1971 Convention on Psychotropic Substances, an international treaty discouraging consumer advertising of controlled substances.

While advertisements can inform parents of treatment options and raise awareness about the disorder, marketing tends to drive up parental demands for specific drugs regardless of whether they are the best treatment option for a particular child afflicted with the disorder. A study in 1999 showed that 80 percent of patients who asked for an advertised drug were prescribed it. Moreover, advertising may create the impression that medication is an “easy quick fix” for the often confusing and frustrating behaviour of ADHD children. With a for-profit pharmaceutical industry thriving in a capitalist economy, the central concern is that industry-funded research, education and marketing may push physicians, researchers and families towards only one way of thinking about the problem; that the only solution to ADHD lies in a daily pill for lifetime, coincidentally a highly profitable solution.

Broader Range of Empowerment Tools

In a 2000 review of the use of stimulants for ADHD children, the American Medical Association asserted that “medication . . . should never be regarded as the whole treatment.” Apart from a fear for potential side-effects, the problem is that stimulant drugs can only provide short-term management of behaviour as they do not confer benefits once the drug has been withdrawn. Use of drugs over an entire lifetime in order to manage behavioral symptoms is not, however, an attractive option to those lacking medical insurance and the financial resources to purchase daily medication for their child.

Among the plethora of non-medication treatments that includes herbal medicines to dietary modifications, one of the most promising treatments is neurofeedback. Underlying this treatment is the finding that electroencephalogram (EEG) patterns, brain electrical activity as measured by
electrodes on the scalp, are different in those with ADHD. More specifically, all children with ADHD show increased theta (4-8 Hz) compared to beta (16-20 or 13-21 Hz) relative to healthy age peers. Using an EEG net, brain electrical activity can be converted into visual or acoustic signals that are continuously fed back in real time.

Since finding that conditioning brain activity patterns is possible, changes that are made in the desired direction are rewarded. For children, such training is often framed as a type of computer game. In essence, neurofeedback is an operant conditioning procedure in which patients learn to gain self-control over their own brain activity to produce EEG activity associated with being calm, alert while minimizing activity associated with ADHD symptoms.

Self-regulation through neurofeedback, which simply involves the client learning to produce brain wave patterns that are associated with being calm and focused, has advantages over medication. Neurofeedback offers a non-medicinal alternative for the management of ADHD symptoms and produces long-lasting effects 10 years later in children who successfully changed brain wave patterns.

It is also non-invasive and without negative side-effects, thus making it a much more benign intervention. More importantly, several research studies have concluded that that neurofeedback is an efficacious treatment for ADHD with symptom reduction equivalent to what can be achieved with Ritalin.

However, the treatment is not without its drawbacks. The typical treatment requires a time commitment of about 40 sessions that last about an hour-long each. Neurofeedback also requires the child to be motivated to complete the full treatment, although increasing attention to designing fun computer games in this context may be helpful.

Ultimately, for those who suffer from constant setbacks and failures due to inattention, hyperactivity or impulsivity, drug treatment can be a very empowering tool. ADHD drug treatment can act as a powerful stimulant for learning which is often important for success in school, at the workplace, or interpersonally within a social environment.

However, it is critical to remain mindful of the financial pressures exerted by the pharmaceutical industry on physicians, research and families. With recent research suggesting alternative treatments such as the effectiveness of neurofeedback, a multi-modal treatment that incorporates medication and neurofeedback may be the most effective longterm strategy to manage or even treat ADHD.

Biography:
Shane Wong is the Editor-in-Chief for Juxtaposition Global Health Magazine, a student-run publication based at the University of Toronto. The most recent issue “Fear and Empowerment in Global Health” can be downloaded from www.juxtapose.ca in PDF format, including all of the footnotes which we had to exclude here.

Shane will be graduating with a BSc in Human Behavioural Biology and Psychology from University of Toronto in 2008. He hopes to pursue a career in paediatric psychiatry, with a concentration on ADHD and autism spectrum disorders. He is also interested in working internationally and exploring how socio-cultural forces shape our understanding of mental health.

The views expressed in this article are not necessarily those of the ADHD Information Library or its staff, but are printed for the educational benefit of our readers, and for the encouragement of young authors and researchers. Keep up the good work. The ADHD Information Library.

This book section: ADHD Medication Issues and Research

Douglas Cowan, Psy.D., MFT is a licensed Marriage and Family Therapist in Tehachapi, CA who has been a counselor to children, teens, and adults helping them to overcome ADHD, find relief for depression or anxiety, and solve other problems in life since 1989. He served on the medical advisory board to the company that makes Attend and Extress from 1997 through 2011, and he is the Editor of the ADHD Information Library online resource at http://newideas.net/. His weekly ADHD Newsletter goes out to 9,500 families. Visit his website at http://DouglasCowan.me for more information on achieving greater health, personal growth, Christ-centered spirituality, stress management, parenting skills, ADHD, working out the stresses of being a care-giver to elderly parents and also being a parent to teenagers, or finding greater meaning in retirement years, Dr. Cowan can be a valuable resource to you.

Counselor counseling Tehachapi for ADHD, depression, anxiety, and more.

Douglas Cowan, Psy.D., MFT
27400 Oakflat Dr.
Tehachapi, CA 93561
(661) 972-5953

I recently read an article about ADHD kids and the treatments that they receive, or don't receive. The point of the article was that even though most kids diagnosed with ADHD will receive appropriate medical treatment such as Ritalin or Adderall, the common stimulant medications for ADHD, but that the majority of kids with ADHD who would benefit from talking therapy will never receive it. Of course, being a therapist I love this article - or at least the topic that is raised. But there still remains a question, "Why would therapy be worth it for a child or teen with ADHD?"

The particular study was done by the Rand corporation, and published in the JAMA pediatrics journal. The researchers were very supportive of psychotherapy along with treatment with stimulant medications. They point out that the classic ADHD child may be socially awkward, and not have the skills or tools to be successful in school or at home, and may have other challenges due to their impulsivity and hyperactivity. It is also well understood that many with ADHD, no matter what their age, are more susceptible to developing other issues such as anxiety disorders or depressive disorders. So supportive psychotherapy is a very helpful tool in the life of one of these ADHD individuals.

The results of the study found that less than 25% of all children or teenagers who are receiving stimulant medications for ADHD ever saw a counselor at all. And only about 7% sat and talked with a counselor on a regular basis for more than two months. They also found that there were 200 counties in the United States where no child or teenager receiving stimulant medication went to a counselor at all. At least there was nothing in their medical records that indicated that the child or teen was receiving any counseling.

So there is something out of whack here. Most people do have some kind of insurance coverage that would cover counseling for a child or teenager diagnosed with ADHD. And yet they do not access treatment. Perhaps they live in an area where finding a counselor is hard to do. Or perhaps family simply don't know the benefits that can be derived for their child or their teenager.

There are probably fifty good reasons to take your child or teen to a counselor for ADHD, but here are my five favorite reasons to take your ADHD child, or teen, or spouse to counseling with a professional who understands both ADHD, and the potential of the human spirit:

• Working on having a good approach and attitude toward people, school, and work;
• Learning to take personal responsibility, learning to make sacrifices to improve and succeed;
• Learning to think about other options that are available, and developing strategies that can increase success;
• Practicing breathing techniques to help to slow down, relax, and focus;
• Considering the virtues, values, and character traits that lead to greatness in one's self, and in others.

The ADHD information library has three articles in the "Skills Not Pills" series beginning here: http://newideas.net/attitude-approach

Anyway, if you can afford it, please consider providing quality counseling services for your child or teen with ADHD - or even your spouse with ADHD. It can make quite a difference in both the short term, and over the years to come. And if you cannot find a therapist in your area who provides this kind of service, please contact me directly. I do provide counseling services over Skype. But there are some age limitations, or maturity issues that need to be addressed before proceeding. But Skype counseling can be helpful with adults or teens who live away from the cities where the counselors and psychologists work. The best way to connect with me to find out more is to email me directly at newideas.net AT gmail.com.

Douglas Cowan, Psy.D. is a licensed Marriage and Family Therapist who has been helping people to be more successful in life for over 25 years. He has offices in Tehachapi and Bakersfield, CA. He also consults with people via Skype over the internet.

This book section: ADHD Medication Issues and Research

Douglas Cowan, Psy.D., MFT is a licensed Marriage and Family Therapist in Tehachapi, CA who has been a counselor to children, teens, and adults helping them to overcome ADHD, find relief for depression or anxiety, and solve other problems in life since 1989. He served on the medical advisory board to the company that makes Attend and Extress from 1997 through 2011, and he is the Editor of the ADHD Information Library online resource at http://newideas.net/. His weekly ADHD Newsletter goes out to 9,500 families. Visit his website at http://DouglasCowan.me for more information on achieving greater health, personal growth, Christ-centered spirituality, stress management, parenting skills, ADHD, working out the stresses of being a care-giver to elderly parents and also being a parent to teenagers, or finding greater meaning in retirement years, Dr. Cowan can be a valuable resource to you.

Counselor counseling Tehachapi for ADHD, depression, anxiety, and more.

Douglas Cowan, Psy.D., MFT
27400 Oakflat Dr.
Tehachapi, CA 93561
(661) 972-5953

Psychiatrists Say Schools Steer Parents To Over Medicate Kids

New York Times Syndicate
Judy Holland
October 02, 2000

WASHINGTON - Psychiatric leaders warned Congress Friday that too many educators are urging parents of problem children to give them prescription drugs rather than address their real problems at home or school.

Dr. Peter R. Breggin, director of the International Center for the Study of Psychiatry and Psychology, a nonprofit research group in Bethesda, Md., said school officials are pressing parents to give such children stimulant drugs such as Ritalin, Concerta, Metadate, Dexedrine and Adderall.

"Teachers, school psychologists and administrators commonly make dire threats about their inability to teach children without medicating them,'' Breggin told a panel of the House Committee on Education and the Workforce.

ADHD Medication Issues : Are Kids Being Over Medicated ?

ADHD: The Multimodal Treatment Study—Questions and Answers

Children with attention deficit hyperactivity disorder (ADHD), the most common of the psychiatric disorders that appear in childhood, are often the subject of great concern on the part of parents and teachers. Children with ADHD are unable to stay focused on a task, cannot sit still, act without thinking, and rarely finish anything. If untreated, the disorder can have long-term effects on a child's ability to make friends or do well at school or in other activities. Over time, children with ADHD may develop depression, lack of self-esteem, and other emotional problems.

Experts estimate that ADHD affects 3 to 5 percent of school-age children and two to three times as many boys as girls. Children with untreated ADHD have higher than normal rates of injury. ADHD frequently co-occurs with other problems, such as depression and anxiety disorders, conduct disorder, drug abuse, or antisocial behavior.

Although ADHD is relatively common, our knowledge of the problem is incomplete. Current ADHD treatment includes a mix of approaches, such as drug therapy, counseling, supportive services in schools and communities, and various combinations of the three. The medical literature offers many studies carried out over brief treatment periods (3 months or less), but a pressing question remains: what is the best kind of help we can offer children with ADHD over a longer term?

To answer this question, NIMH is sponsoring an ongoing, multisite, cooperative agreement treatment study of children with ADHD entitled The Multimodal Treatment Study of Children with Attention Deficit Hyperactivity Disorder. The first findings from this study, which were published in December 1999, provide important guidance for physicians and parents of children with ADHD and are discussed below. Ongoing follow-up reports will be published, with an additional 10-15 papers expected to be released in calendar year 2000.

Questions and Answers

Q. What is the Multimodal Treatment Study of Children with ADHD?

A. The Multimodal Treatment Study of Children with ADHD–"MTA" for short–brought together 18 nationally recognized authorities in ADHD at 6 different university medical centers and hospitals to evaluate the leading treatments for ADHD, including various forms of behavior therapy and medications. The study has included nearly 600 elementary school children, ages 7-9, randomly assigned to one of four treatment modes: (1) medication alone; (2) psychosocial/behavioral treatment alone; (3) a combination of both; or (4) routine community care.

Q. Why is this study important?

A. ADHD is a major public health problem of great interest to many parents, teachers, and health care providers. Up-to-date information concerning the long-term safety and comparative effectiveness of its treatments is urgently needed. While previous studies have examined the safety and compared the effectiveness of the two major forms of treatment, medication and behavior therapy, these studies generally have been limited to periods up to 4 months. The MTA study demonstrates for the first time the safety and relative effectiveness of these two treatments (including a behavioral therapy-only group), alone and in combination, for a time period up to 14 months, and compares these treatments to routine community care. The children involved in the study will be tracked into adolescence to document and evaluate long-term outcomes.

Q. What are the major findings of this study so far?

A. The MTA results published in December 1999 indicate that long-term combination treatments as well as medication-management alone are both significantly superior to intensive behavioral treatments and routine community treatments in reducing ADHD symptoms. The study also shows that these differential benefits extend as long as 14 months. In other areas of functioning (specifically anxiety symptoms, academic performance, oppositionality, parent-child relations, and social skills), the combined treatment approach was consistently superior to routine community care, whereas the single treatments (medication-only or behavioral treatment only) were not. In addition to the advantages provided by the combined treatment for several outcomes, this form of treatment allowed children to be successfully treated over the course of the study with somewhat lower doses of medication, compared to the medication-only group. These same findings were replicated across all six research sites, despite substantial differences among sites in their samples' sociodemographic characteristics. Therefore, the study's overall results appear to be applicable and generalizable to a wide range of children and families in need of treatment services for ADHD.

Q. Given the effectiveness of medication management, what is the role and need for behavioral therapy?

A. As noted in the NIH ADHD Consensus Conference in November 1998, several decades of research have amply demonstrated that behavioral therapies are quite effective. What the MTA study has demonstrated is that on average, carefully monitored medication management with monthly follow-up is more effective than intensive behavioral treatment for ADHD symptoms, for periods lasting as long as 14 months. All children tended to improve over the course of the study, but they differed in the relative amount of improvement, with the carefully done medication management approaches generally showing the greatest improvement. Nonetheless, children's responses varied enormously, and some children clearly did very well in each of the treatment groups. For some outcomes that are important in the daily functioning of these children (e.g., academic performance, familial relations), the combination of behavioral therapy and medication was necessary to produce improvements better than community care. Of note, families and teachers reported somewhat higher levels of consumer satisfaction for those treatments that included the behavioral therapy components. Therefore, medication alone is not necessarily the best treatment for every child, and families often need to pursue other treatments, either alone or in combination with medication.

Q. Which treatment is right for my child?

A. This is a critical question that must be answered by each family in consultation with their health care professional. For children with ADHD, no single treatment is the answer for every child; a number of factors appear to be involved in determining which treatments are best for which children. For example, even if a particular treatment might be effective in a given instance, the child may have unacceptable side effects or other life circumstances that might prevent that particular treatment from being used. Furthermore, findings indicate that children with other accompanying problems, such as co-occurring anxiety or high levels of family stressors, may do best with approaches that combine both treatment components, (i.e., medication management and intensive behavioral therapy). In developing suitable treatments for ADHD, each child's needs, personal and medical history, research findings, and other relevant factors need to be carefully considered.

Q. Why do many social skills improve with medication?

A. This question highlights one of the surprise findings of the study: although it has long been generally assumed that the development of new abilities in children with ADHD (e.g., social skills, enhanced cooperation with parents) often requires the explicit teaching of such skills, the MTA study findings suggest that many children can often acquire these abilities when given the opportunity. Children treated with effective medication management (either alone or in combination with intensive behavioral therapy) manifested substantially greater improvements in social skills and peer relations than children in the community comparison group after 14 months. This important finding indicates that symptoms of ADHD may interfere with their learning of specific social skills. It appears that medication management may benefit many children in areas not previously well known to be salient medication targets, in part by diminishing symptoms that had previously interfered with the child's social development.

Q. Why were the MTA medication treatments more effective than community treatments that also usually included medication?

A. There were substantial differences between the study-provided medication treatments and those provided in the community, differences mostly related to the quality and intensity of the medication management treatment. During the first month of treatment, special care was taken to find an optimal dose of medication for each child receiving the MTA medication treatment. After this period, these children were seen monthly for one-half hour at each visit. During the treatment visits, the MTA prescribing therapist spoke with the parent, met with the child, and sought to determine any concerns that the family might have regarding the medication or the child's ADHD-related difficulties. If the child was experiencing any difficulties, the MTA physician was encouraged to consider adjustments in the child's medication (rather than taking a "wait and see" approach). The goal was always to obtain such substantial benefit that there was "no room for improvement" compared with the functioning of children not suffering from ADHD. Close supervision also fostered early detection and response to any problematic side effects from medication, a process that may have facilitated efforts to help children remain on effective treatment. In addition, the MTA physicians sought input from the teacher on a monthly basis, and used this information to make any necessary adjustments in the child's treatment. While the physicians in the MTA medication-only group did not provide behavioral therapy, they did advise the parents when necessary concerning any problems the child may have been experiencing, and provided reading materials and additional information as requested. Physicians delivering the MTA medication treatments generally used 3 doses per day and somewhat higher doses of stimulant medications. In comparison, the community-treatment physician generally saw the children face-to-face only 1-2 times per year, and for shorter periods of time each visit. Furthermore, they did not have any interaction with the teachers, and prescribed lower doses and twice-daily stimulant medication.

Q. How were children selected for this study?

A. In all instances, the child's parents contacted the investigators to learn more about the study, after first hearing about it through local pediatricians, other health care providers, elementary school teachers, or radio/newspaper announcements. Children and parents were then carefully interviewed to learn more about the nature of the child's symptoms, and rule out the presence of other conditions or factors that may have given rise to the child's difficulties. In addition, extensive historical information was gathered and diagnostic interviews were conducted to establish whether or not the child exhibited the long-standing pattern of symptoms characteristic of ADHD across home, school, and peer settings. If children met full criteria for ADHD and study entry (and many did not), informed parental consent with child assent and school permission were received; the children and families then were eligible for study entry and randomization. Children who had behavior problems but not ADHD were not eligible for study participation.

Q. Where is this study taking place?

A. Research sites include:

* New York State Psychiatric Institute at Columbia University, New York, N.Y.
* Mount Sinai Medical Center, New York, N.Y.
* Duke University Medical Center, Durham, N.C.
* University of Pittsburgh, Pittsburgh, PA.
* Long Island Jewish Medical Center, New Hyde Park, N.Y.
* Montreal Children's Hospital, Montreal, Canada
* University of California at Berkeley, CA.
* University of California at Irvine, CA.

For More Information on Mental Disorders in Children, Contact:

Public Information and Communications Branch, NIMH
6001 Executive Boulevard, Room 8184, MSC 9663
Bethesda, MD 20892-9663
Phone: 301-443-4513
TTY: 301-443-8431
FAX: 301-443-4279
Mental Health FAX 4U: 301-443-5158
E-mail: nimhinfo@nih.gov
NIMH home page address:
http://www.nimh.nih.gov

ADHD Treatment : NIMH Research

Ability to Quit Smoking May Depend on A.D.H.D. Symptoms: Press Release Columbia University Medical Center

Press Release: NEW YORK - November 21, 2008

Tobacco use is more prevalent and smoking cessation less likely among persons with Attention Deficit Hyperactivity Disorder (A.D.H.D.) In a study of smokers with attention deficit and hyperactivity symptoms, those who exhibited elevated hyperactivity and impulsivity, with or without inattention, showed lower quit rates after 8 weeks than those with inattention symptoms alone or those without the A.D.H.D. symptoms. The study, now available online in Nicotine and Tobacco Research, could help smokers and physicians to better tailor cessation treatment for individuals with A.D.H.D.

“Greater understanding of the divergent associations that exist between the different kinds of A.D.H.D. have important public health consequences for smoking cessation and decreased tobacco-related mortality in this population,” said the study’s lead author Lirio Covey, Ph.D., professor of clinical psychology (in psychiatry) at Columbia University Medical Center and the New York State Psychiatric Institute.

“The effect of A.D.H.D. by itself on smoking cessation has rarely been examined; the effects of the individual A.D.H.D. symptoms on smoking cessation, even less so. To our knowledge, the effects of inattention or hyperactivity at baseline as separate domains of A.D.H.D. on cessation treatment outcome have never been examined,” Dr. Covey reported.

During the initial, eight-week phase of a maintenance treatment study, 583 adult smokers, 43 of whom were identified with clinically significant A.D.H.D. symptom subtypes using the A.D.H.D. Current Symptom Scale, were treated with the medication buproprion (brand name Zyban®), the nicotine patch and regular cessation counseling. Compared to smokers without A.D.H.D., smokers of both A.D.H.D. subtypes combined showed lower abstinence rates throughout the study.

Breakdown of the A.D.H.D. group by subtype, however, revealed a more complicated picture. The researchers found that by the end of the treatment, the proportion of abstainers among A.D.H.D. smokers with inattention were nearly identical to those without A.D.H.D. (55 percent compared to 54 percent, respectively).

By contrast, the A.D.H.D. subgroup with hyperactivity, with or without inattention, exhibited lower quit rates throughout the treatment period compared to smokers without A.D.H.D., essentially finding that only in the presence of hyperactivity and impulsivity, were differences observed between smokers with or without A.D.H.D. symptoms.

“The knowledge gained from further study of how these early onset disorders of nicotine dependency and A.D.H.D. are related could lead to early prevention of either one or both of these conditions,” concluded Dr. Covey. More research is needed to tease out why hyperactivity causes less cessation success.

The greater propensity to smoke and difficulty quitting among persons with mental illness is thought to play a role in the “hardening” phenomenon, or the increased resistance to smoking cessation among certain smokers.

Much evidence that nicotine improves attentiveness and performance deficits among persons with A.D.H.D. provides a “self-medicating” rationale for tobacco use among persons with A.D.H.D. Pre-clinical data showing that dopamine, a neurotransmitter relevant to attentional processes and impulse control, is released upon smoking, is consistent with the self-medication hypothesis.

A.D.H.D. is a neuropsychiatric condition that begins in early childhood and, in most cases, persists to adolescence and adulthood. The core symptom domains in A.D.H.D. are inattention and hyperactivity/impulsivity. A.D.H.D. has been sub-classified into three subtypes: predominantly inattention, predominantly hyperactivity/impulsivity, and combined inattention and hyperactivity/impulsivity.

For more information about smoking cessation and the A.D.H.D. study, Dr. Covey can be reached at 212-543-5736, lsc3@columbia.edu.

This study was supported by the National Institute on Drug Abuse (NIDA). In addition, study medications were donated by GlaxoSmithKline, Inc.

- ### -

Columbia University Medical Center provides international leadership in basic, pre-clinical and clinical research, in medical and health sciences education, and in patient care. The medical center trains future health care leaders at the College of Physicians & Surgeons, the Mailman School of Public Health, the College of Dental Medicine, the School of Nursing, the biomedical departments of the Graduate School of Arts and Sciences, and allied research centers and institutions. Established in 1767, Columbia’s College of Physicians and Surgeons was the first in the country to grant the M.D. degree. Among the most selective medical education institutions in the country, CUMC is home to the largest medical research enterprise in New York state and one of the largest in the United States. Visit www.cumc.columbia.edu.

Columbia Psychiatry
Columbia Psychiatry is ranked among the best departments and psychiatric research facilities in the nation and has contributed greatly to the understanding of and current treatment for psychiatric disorders including depression, suicide, schizophrenia, bipolar and anxiety disorders, and childhood psychiatric disorders. Located at the New York State Psychiatric Institute on the NewYork-Presbyterian Hospital/Columbia University Medical Center campus in the Washington Heights community of Upper Manhattan, the department enjoys a rich and productive collaborative relationship with physicians in various disciplines at Columbia University’s College of Physician and Surgeons. Visit http://columbiapsychiatry.org/ for Smoking and ADHD

When the Detroit Tigers placed pitcher Dontrelle Willis on the disabled list last Sunday (3/29/2009) with the diagnosis of "anxiety disorder" it was very interesting to me for two reasons:

First, because my nephew Casey Fien was trying to make the Tigers as a pitcher and we had just recently returned from a trip to spring training to follow the Tigers and watch Casey pitch (Casey is now with the Minnesota Twins organization), and we have started following the Tigers very closely; and

Secondly, because of the reports that although Willis had not reported any symptoms of an anxiety disorder, he was diagnosed solely through the results of a blood test, according to news reports.

I must confess that I had never heard of a blood test for anxiety disorder, so I began looking around the internet for information to see if this was true, or if the Tigers were just trying to find a reason to put Willis on the DL so that they wouldn't have to pay all of the $11 million owed him for this season.

Here is what I discovered, and it may be helpful to you if you or your child with ADHD also has symptoms of anxiety, panic, rigid thinking, or OCD...

While WebMD doesn't know about any blood tests for anxiety disorder, they write: "Although there are no laboratory tests to specifically diagnose mental illness, the doctor may use various tests to make sure something else isn't causing the symptoms. If no other illness is found, you may be referred to a psychiatrist or psychologist, mental health professionals who are specially trained to diagnose and treat mental illnesses."

Our local family practice doctor doesn't know anything about a blood test for anxiety disorders either.

However, over three years ago (January, 2006) a research team from Hebrew University in Israel announced the development of a blood test for anxiety disorders. The blood test looks for abnormally high levels of the neurotransmitter Acetylcholine (ACh) by measuring the levels of related enzymes. According to the website, "(the) team found more than a 90% correlation between people who were diagnosed with higher than usual anxiety by a psychologist and people with abnormal AChE, BChE and PON levels."

The entire 2006 article is here: http://www.isracast.com/article.aspx?ID=45 and it is worth the read. There is also a 2005 report on the research here: http://blogs.zdnet.com/emergingtech/?p=47

Hebrew University, through Yissum Research Development Company, which is the technology development company of the University, then applied for a patent on the blood test in April of 2006. They were just awarded the patent on February 24, 2009, which would mean that the test would be commercially available soon if not already.

The patent award is here: http://www.pharmcast.com/Patents200/Yr2009/Feb2009/022409/7494783_Anxiet... and it gives very detailed information about the test. How do you buy stock in this?

As of March, 2007, the University of Iowa was also developing a blood test for anxiety disorders based on the genetic profiles of individuals that they hoped would be commercially produced. Their study was publishes in the American Journal of Medical Genetics, and according to reports, "The team compared gene expression in lymphoblasts (immature white blood cells) culled from 16 participants with panic disorder and 17 participants without the disorder. The study found many genes were more expressed in people with panic disorder than in people without the condition. Similarly, the study found many genes were less expressed in people with panic disorder."

The entire 2007 article is here: http://psychcentral.com/news/2007/03/06/blood-test-for-panic-disorder/66...

Other blood tests focus on thyroid functioning and adrenal levels, both of which, if not functioning correctly, can cause anxiety related symptoms.

It will be interesting to see what 2009 will bring in the development of improved technologies to diagnose and treat anxiety disorders, as it will be interesting to follow the career of Dontrelle Willis. We wish him well.

Task-Specific Hypoactivation in Prefrontal and Temporoparietal Brain Regions During Motor Inhibition and Task Switching in Medication-Naive Children and Adolescents With Attention Deficit Hyperactivity Disorder

Anna B. Smith, Ph.D., Eric Taylor, M.D., Ph.D., Mick Brammer, Ph.D., Brian Toone, M.D. and Katya Rubia, Ph.D.

OBJECTIVE: A relatively small number of functional imaging studies of attention deficit hyperactivity disorder (ADHD) have shown abnormal prefrontal and striatal brain activation during tasks of motor response inhibition.

However, the potential confound of previous medication exposure has not yet been addressed, and no functional imaging study exists to date on medication-naive children and adolescents with ADHD.

The aim of this study was to investigate the neural substrates of a range of motor and cognitive inhibitory functions in a relatively large group of children and adolescents with ADHD who had never previously been exposed to medication.

METHOD: Nineteen boys with ADHD and 27 healthy age- and IQ-matched boys underwent functional MRI to compare brain activation during performance of tasks that assessed motor response inhibition (go/no go task), cognitive interference inhibition (motor Stroop task), and cognitive flexibility (switch task).

RESULTS: Boys with ADHD showed decreased activation in the left rostral mesial frontal cortex during the go/no go task and decreased activation in the bilateral prefrontal and temporal lobes and right parietal lobe during the switch task. No significant group differences were observed during motor Stroop task performance.

CONCLUSION: Abnormal brain activation was observed in medication-naive children and adolescents with ADHD during tasks involving motor inhibition and task switching, suggesting that hypoactivation in this patient group is unrelated to long-term stimulant exposure.

Furthermore, functional abnormalities are task-specific and extend from frontostriatal to parietal and temporal cortices.

ADHD Medication Study

Treatment Services for Children With ADHD: A National Perspective

Author/s: Kimberly Hoagwood
Issue: Feb, 2000

ABSTRACT

Objective: To summarize knowledge on treatment services for children and adolescents with attention-deficit hyperactivity disorder (ADHD), trends in services from 1989 to 1996, types of services provided, service mix, and barriers to care.

Method: A review of the literature and analyses from 2 national surveys of physician practices are presented.

Results: Major shifts have occurred in stimulant prescriptions since 1989, with prescriptions now comprising three fourths of all visits to physicians by children with ADHD.

Between 1989 and 1996, related services, such as health counseling, for children with ADHD increased 10-fold, and diagnostic services increased 3-fold. Provision of psychotherapy, however, decreased from 40% of pediatric visits to only 25% in the same time frame. Follow-up care also decreased from more than 90% of visits to only 75%.

Family practitioners were more likely than either pediatricians or psychiatrists to prescribe stimulants and less likely to use diagnostic services, provide mental health counseling, or recommend follow-up care.

About 50% of children with identified ADHD seen in real-world practice settings receive care that corresponds to guidelines of the American Academy of Child and Adolescent Psychiatry.

Physicians reported significant barriers to service provision for these children, including lack of pediatric specialists, insurance obstacles, and lengthy waiting lists.

Conclusions: The trends in treatment services and physician variations in service delivery point to major gaps between the research base and clinical practice.

Clinical variations may reflect training differences, unevenness in the availability of specialists and location of services, and changes in health care incentives.

J. Am. Acad. Child Adolesc. Psychiatry 2000, 39(2):198-206. Key Words: services, treatments, attention-deficit hyperactivity disorder.

http://www.findarticles.com/

Comparing Attend to Ritalin and EEG Biofeedback

We came across Rossiter and La Vaque's article on the EEG Spectrum site.

They used the same research tools as we had, namely the TOVA test, and they also used the same time frames (30 days). They had two groups, and compared the TOVA test improvements on a group using Ritalin for 30 days to a group using EEG Biofeedback training for 30 days.

One thing to note about these studies is that the TOVA test has no "placebo effect." That means that a researcher does not need a control group using a placebo for comparison. No one makes improvements on the computerized TOVA test scores unless there are some real neurological improvements.

A Comparison of EEG Biofeedback and Psychostimulants in Treating Attention Deficit/Hyperactivity Disorders. Thomas P. Rossiter, and Theodore J. La Vaque. Journal of Neurotherapy, 1, Summer 1995

When we put our information side to side with theirs, we have an apples to apples comparison for you to evaluate.

What should be obvious at first glance is that all three treatment interventions work. Each makes significant improvements on the TOVA.

Each intervention is helpful at reducing the symptoms of ADHD and improving performance.

Discussion of Presented Data on ADD ADHD

On close study is appears that the stimulant medication (Ritalin) performed slightly better overall than "Attend" or EEG Biofeedback training.

However, we believe that both the EEG Biofeedback group and the "Attend" group would continue to make gains beyond their gains measured at 30 days, whereas the Ritalin group would not make any further gains.

The Comparison Data shows that each treatment option is beneficial.

Why We Like ATTEND More Than Neurofeedback

Here's why we like the "Attend" more than EEG Biofeedback Training:

• "Attend" can give better results than the EEG Biofeedback training, at least as shown in our 30 day trials.
• The typical course of EEG training is 40 sessions over a 120 day period of time.
• The typical cost for EEG training is between $2,500 to $4,000.

Yes EEG Biofeedback training works, but "Attend" can deliver slightly better results for about $300 over the same 120 day period of time.

If you are doing the EEG Biofeedback training, consider using the "Attend" product while doing the training. We feel that using both can enhance the EEG training, and speed up the process (and lower the over-all cost of the EEG training).

Why We Like ATTEND More Than Ritalin

• "Attend" works almost as well, and does not have the potential serious side-effects of Stimulant Medications. See our articles on FDA Black Box Warnings.

Yes Stimulant Medications work, and work quickly. But make sure that your physician knows what he or she is doing.

If you are going to use stimulant medications , also consider using small doses of the "Attend" nutraceutical product at the same time.

We have see many children and teens decrease their effective, or optimal dose of stimulants by 50% or more, ie. a child receiving great benefit from three 10mg doses of Ritalin might receive the same benefit from three 5mg doses of Ritalin plus the Attend. The Attend takes about 30 to 45 days to really take effect.

ALWAYS talk with your physician before making any changes to medications.

Stimulant medications are not toys. These drugs are powerful interventions for the treatment of attention deficit hyperactivity disorder. They can be a sharp two-edged sword, offering great benefit but with potential serious side-effects, so treat them with respect.

Note: These study results are the sole property of Dr Cowan and until they are published as a study for the public they are not to be quoted or referred to as fact without the express permission of Dr Cowan. This study was not an academic study, but was conducted as a "research and development" project for VAXA International, the manufacturer of Attend. It was conducted in 1996-97. All rights reserved.

Attend : Alternative ADHD Treatment - Learn All About Attend for ADHD Here

newideas.net Get the details about ATTEND for ADHD, a natural homeopathic treatment for attention problems, impulsivity, and hyperactivity in children, teens, and adults. Attend is an over-the-counter remedy that is useful with or without other medic...

Neurofeedback for ADHD - EEG Info Videos

EEG Feedback for attention deficit disorder

Comparison of Ritalin to Attend and EEG Biofeedback Training

AHRQ and FDA To Collaborate in Largest Study Ever of Possible Heart Risks with ADHD Medications

Press Release Date: September 17, 2007

Two U.S. Department of Health and Human Services agencies will collaborate in the most comprehensive study to date of prescription medications used to treat attention deficit hyperactivity disorder (ADHD) and the potential for increased risk of heart attack, stroke or other cardiovascular problems.

Researchers supported by the Agency for Healthcare Research and Quality (AHRQ) and the U.S. Food and Drug Administration (FDA) will examine the clinical data of about 500,000 children and adults who have taken medications used to treat ADHD to determine whether those drugs increase cardiovascular risks.

Because medications used to treat ADHD can increase heart rate and blood pressure, there are concerns about the drugs' potential to increase cardiac risks. It is also thought these risks may be different for adults and children, but more evidence is needed about the long-term effects of using ADHD medications.

The planned analysis follows an FDA-sponsored preliminary study that compiled information from large health care databases on prescription drug use, inpatient care, outpatient treatment, and health outcomes, including death. Based on that effort, researchers identified people who took ADHD drugs during a 7-year period ending in 2005. AHRQ, which sponsors research on clinical effectiveness and safety, will team with FDA to complete the analysis of the data.

"This study highlights one of AHRQ's most important missions: to collect and analyze scientific evidence that will help patients, policymakers, and clinicians make the best possible decisions," said AHRQ Director Carolyn M. Clancy, M.D. "This partnership with the FDA is a great way to move closer to answering important clinical questions that affect children and adults who have ADHD."

"Case reports have described adverse cardiovascular events in adult and pediatric patients with certain underlying risk factors who receive drug treatment for ADHD, but it is unknown whether or not these events are causally related to treatment," said Gerald Dal Pan, M.D., director of FDA's Office of Surveillance and Epidemiology. "The goal of this study is to develop better information on this question."

The study will be coordinated by Vanderbilt University researchers on contract through AHRQ's Effective Health Care program. Data analysis will be performed by researchers at Vanderbilt, Kaiser Permanente of California, the HMO Research Network and i3 Drug Safety, as well as from FDA and AHRQ. The analysis will include all drugs currently marketed for treating ADHD. The study will analyze the risks of all the drugs as a whole, and risks of the drugs grouped by class.

The analysis will take about 2 two years to complete. Results are expected to be important not only to patients, their families and health care providers, but also to government insurance programs. Medicaid, Medicare, and the State Children's Health Insurance Program provide reimbursement for drugs prescribed for ADHD. This information could also be used to inform product labeling, which is used by health care providers when making treatment decisions.

ADHD is a behavioral disorder that, in many patients, causes hyperactivity, and may have a significant impact on school performance and social functioning. According to the National Institute of Mental Health, ADHD affects approximately 3 percent to 5 percent of school-age children and about 4 percent of adults.

Use of ADHD drugs has increased in recent years among children and adults. A recent AHRQ analysis of medication expenditures found three ADHD drugs—Concerta, Strattera, and Adderall—ranked among the top five drugs prescribed for children ages 17 years and younger. About $1.3 billion was spent on those drugs in 2004, the study estimated. Adult use is also believed to be increasing.

In May 2006, based on a review of anecdotal reports of heart attack, stroke and sudden death among patients taking usual doses of ADHD medications, the FDA asked drug manufacturers to revise product labeling to reflect concerns about possible adverse events. Drug manufacturers have created patient Medication Guides for individual products to help patients understand risks.

FDA and AHRQ recommend that individuals using or being considered for treatment with ADHD drug products work with their physician or other health care professional to develop a treatment plan that includes a careful health history and evaluation of current health status, particularly for cardiovascular and psychiatric problems, including assessment for a family history of such problems.

Agency for Healthcare Research and Quality, Rockville, MD. http://www.ahrq.gov/news/press/pr2007/adhdmedpr.htm

The question is asked how many adults take ADHD drugs from coast-to-coast across the United States?

Well first let's put this in the context that somewhere between 3% and 5% of all adults in the United States would meet the diagnostic criteria for ADHD. It is part of their life and one of the problems that they have to deal with on a daily basis. That number is about double when we look at children or teenagers in the United States. It's estimated that somewhere between 6% and 11% of children and teenagers with me at the diagnostic criteria for ADHD.

So it is not surprising when the national survey on drug use and health in 2012 reported that about 4% of adults in the United States have at some point in their life used Ritalin or other methylphenidate products. It doesn't mean they use them as adults. But that at some point during their lifetime they had used a stimulant medication for ADHD.

Another study by a pharmaceutical benefits management company reported that the use of stimulant medication by adults for ADHD was on a rapid increase. The most commonly prescribed medication for ADHD among adults his Adderall, followed by Ritalin or other methylphenidate compounds, followed by Vyvanse.

Over a four-year period of time this company found that there was a 35% increase in the use of ADHD medications among Americans to matter what their age. But the highest rise in the prescription rate was among young adults. Just under 3% of young adults (18-24) are filling a prescription for ADHD medications.

Association of the Dopamine Transporter Gene (DAT1) With Poor Methylphenidate Response

Author/s: Bertrand G. Winsberg
Issue: Dec, 1999

ABSTRACT

Objective: This study attempted to relate the alleles of the [D.sub.2] (DRD2), [D.sub.4] (DRD4), and dopamine transporter (DAT1) genes to the behavioral outcome of methylphenidate therapy.

Method: African-American children with attention-deficit hyperactivity disorder were treated with methylphenidate in doses not in excess of 60 mg/day.

The dosage was increased until behavioral change was achieved, using a decrement in scores of less than or equal to 1 on a commonly used rating scale or until the maximum tolerated dose was achieved.

Blood samples were obtained at that point, and genotypes for polymorphism at the respective genes were identified.

Results: Genotypes were then tested by [X.sup.2] to assess the significance of any association with drug response. Only the dopamine transporter gene was found to be significant.

Homozygosity of the 10-repeat allele was found to characterize nonresponse to methylphenidate therapy (p = .008).

Conclusions: While the results suggest that alleles of the dopamine transpor ter gene play a role in methyiphenidate response, replication in additional studies is needed.

J. Am. Acad. Child Adolesc. Psychiatry 1999, 38(12):1474-1 477. KeyWords: attention-deficit hyperactivity disorder, drug response, dopamine transporter, molecular genetics.

Spring Training has started for professional baseball, and college baseball teams have been at work since January. It is time to get in shape for the 2008 baseball season.

I love baseball - always have. I was an "All Conference" pitcher and Captain of my college baseball team. I coached at a University for four years and have coached at the High School level for four more. I was a "bird-dog" scout for the Cleveland Indians and the Texas Rangers for a few years, and I have coached Little League teams forever. My nephew is a pitcher in the Minnesota Twins organization, and a legitimate prospect. Really, I love baseball.

But there is a strange and perhaps disappointing story about ADHD and MLB that has come out since the release of the Mitchell Report.

It seems that in 2006 there were 28 major league players who had diagnoses for ADHD, and were receiving treatment with stimulant medication during the season. They were permitted to receive such treatment with stimulants through MLB's "Therapeutic Use Exemption" program. Now, there is no story here - at least not yet. There was no story until MLB placed the use of amphetamines on their "banned substances" list. Then things changed.

In 2007 the number of TUEs requested by major league players jumped from 28 to 103 for Attention Deficit Hyperactivity Disorder. This increase was so startling that even some sleeping Congressmen woke up and decided to make it an issue for the media as a part of the House Oversight and Government Reform Committee hearings on the abuse of performance enhancing drugs in Major League Baseball.

Other "experts" jumped into the media conversation as well. “This demands an explanation. There’s something fundamentally wrong them going from 28 to 103,” said Dr. Gary Wadler, chairman of committee that determines the World Anti-Doping Agency’s banned-substances list. “If we had this percentage increase in the general population, it would be on the evening news as a national epidemic. It’s an outrageous number.” Wadler said the ban on amphetamines in 2006 appears to be tied to the increase. No kidding. “I can’t prove anything. Certainly you put all the facts together, I think that’s a reasonable explanation,” he said. “Might there be others? I guess so. It could be an anomaly year of some sort.”

Even ADHD guru Russell Barkley, a well-known ADHD expert, was interviewed on the topic. He said that while children with ADHD are often drawn to sports, which could explain the relatively high number, the sharp increase in one year is more difficult to explain.

Note to Dr. Barkley: In the average baseball game there will be less then 18 minutes of "action" per 150 game. Baseball does not draw ADHD kids to it, except perhaps for pitchers and catchers. Most ADHD kids who play the outfield will quit by the age of 12. Try martial arts, swimming, tennis, soccer, basketball, or hockey instead.

There are 30 Major League teams. They each have a 40 man major league roster, and a 25 man roster for "active players" during most of the season. As players came and went off of major league rosters there were 1,354 athletes who were subject to random drug testing during the course of the 2007 major league baseball season. That means 8.2 percent received permission from their team physician and Dr. Bryan Smith, baseball’s independent program administrator, to use Ritalin and Adderall, stimulants better known as treatments for hyperactive kids.

Baseball already has made changes in the TUE process for 2008. Before a player will be allowed to use a drug, the team physician must send the prescription to the independent administrator for approval before the player uses the substance.

So should Ritalin, Adderall, or other stimulants be viewed as "performance enhancing drugs" as steroids and HGH now are?

No. Ritalin, Adderall, and other stimulants are treatments for a real medical condition called ADHD. If the condition exists with a player, and he has been diagnosed by a real medical doctor, and that player goes through the MLB exemption process, then he should be allowed to receive his prescribed treatment.

This is nothing like taking illegal or controlled substances, without a doctor's prescription, to make an athlete bigger, stronger, faster.

I have seen Ritalin improve reaction time in subjects, improve time on task, and improve focus. During the course of a long season these would be valuable to any professional athlete. But Ritalin and other stimulants also decrease appetite and may cause difficulty sleeping, two problems for any athlete. But the way, I have seen Attend improve reaction time in college athletes whose baseline reaction times were much better than the "middle of the bell curve" too. Perhaps these MLB players ought to look into Attend instead.

I have also seen major league players who certainly had ADHD. One player that I am thinking of pitched for me at the University that I coached at, and went on to play in the majors for several years. He was clearly ADHD, and I knew it before I ever heard of ADHD. Easily distracted, he couldn't focus for more than five innings without some kind of stimulation, like being yelled at. One baseball writer describes him this way, "(He) soon learned to harness his fastball, completing his array of pitches, but became known as somewhat of an underachiever. Despite winning 15 games for (his first team), just a year and a half after his debut, he never really achieved his full potential... He was also suspended for ten days in 1987 when he was caught using sandpaper to scuff the ball on the mound. Though the incident cost (him) some respect, it ended humorously three years later, when he called the commissioner's office to ask for his glove back."

If this player had known about ADHD, and legitimate treatment available for it, he would have been really good - perhaps even great. But instead he is described as an "under-achiever."

So, for what it is worth, let the players who have legitimate medical diagnoses for ADHD use whatever treatment they feel will benefit them the most during the course of their season and their career. Isn't that what any adult with ADHD wants? Doesn’t every adult with ADHD want to be able to choose the best treatment intervention for their particular type of ADHD?

But for the players who want to "get an edge" by using stimulants without legitimate medical reasons, let me suggest that you just use our ADHD eating program plus a cup of coffee before the game. You will get much the same benefit, but without giving a bad name to the players who actually need the treatment.

Is Ritalin Like Cocaine in the ADHD Brain

OK, I have to admit that I didn't see this coming.

Whenever I have heard people comparing Ritalin to Cocaine I have just turned them off as either over-reacting, or uninformed. Yes, both are psychostimulants. Yes, both impact the brain's performance. But other than that, why not compare caffeine to cocaine, as both are stimulants and impact the brain.

I had worked in a psychiatric hospital for a few years, and had seen people who had come because of their cocaine addiction, and they didn't look anything like the kids I saw with ADHD who were benefiting from the use of Ritalin or other stimulants (and I had worked with nearly 1,000 kids who had benefited from treatment with stimulants).

But eventually someone had to do some kind of comparison study between Methylphenidate and Cocaine. And though the study was done with mouse brains, what the researchers found should make us all a bit uneasy. According to one of the lead researchers, "Methylphenidate (Ritalin), which is thought to be a fairly innocuous compound, can have structural and biochemical effects in some regions of the brain that can be even greater than those of cocaine."

Press release dated February 2, 2009

NIDA Study Shows That Methylphenidate (Ritalin) Causes Neuronal Changes in Brain Reward Areas

Similarities and Differences Compared to Cocaine were Found

Investigators funded by the National Institute on Drug Abuse have shown that the medication methylphenidate (Ritalin), which is commonly prescribed to treat attention-deficit hyperactivity disorder (ADHD), can cause physical changes in neurons in reward regions of mouse brains—in some cases, these effects overlapped with those of cocaine. Both methylphenidate and cocaine are in the class of drugs known as psychostimulants. While methylphenidate is widely prescribed, this study highlights the need for more research into its long-term effects on the brain. These research findings will be published Feb. 3 in Proceedings of the National Academy of Sciences.

"Studies to date suggest that prescribed use of methylphenidate in patients with ADHD does not increase their risk for subsequent addiction. However non-medical use of methylphenidate and other stimulant medications, can lead to addiction as well as a variety of other health consequences," said NIDA Director Dr. Nora Volkow. "This study highlights the fact that we know very little about how methylphenidate affects the structure of and communication between brain cells."

The researchers exposed mice to two weeks of daily injections of cocaine or methylphenidate, after which reward areas of the brain were examined for changes in dendritic spine formation—related to the formation of synapses and the communication between nerve cells; and the expression of a protein (delta Fos B) which has been implicated in the long term actions of addictive drugs. Both drugs increased dendritic spine formation, and the expression of delta Fos B; however the precise pattern of their effects was distinct. It differed in the types of spines affected, the cells that were affected, and the brain regions. In some cases there was overlap between the two drugs, and in some cases, methylphenidate produced greater effects than cocaine—for example, on protein expression in certain regions.

"Methylphenidate, which is thought to be a fairly innocuous compound, can have structural and biochemical effects in some regions of the brain that can be even greater than those of cocaine," stated Dr.Yong Kim, lead author of the study. “Further studies are needed to determine the behavioral implications of these changes and to understand the mechanisms by which these drugs affect synapse formation” he added.

Previous studies, including two reported by NIDA on April 1, 2008 (NIH Research Suggests Stimulant Treatment for ADHD Does Not Contribute to Substance Abuse Later in Life) have shown that children treated with stimulants for ADHD early in life have no greater risk of drug addiction as adults.

The National Institute on Drug Abuse is a component of the National Institutes of Health, U.S. Department of Health and Human Services. NIDA supports most of the world’s research on the health aspects of drug abuse and addiction. The Institute carries out a large variety of programs to inform policy and improve practice. Fact sheets on the health effects of drugs of abuse and information on NIDA research and other activities can be found on the NIDA home page at www.drugabuse.gov. To order publications in English or Spanish, call NIDA’s new DrugPubs research dissemination center at 1-877-NIDA-NIH or 240-645-0228 (TDD) or fax or email requests to 240-645-0227 or drugpubs@nida.nih.gov.

The National Institutes of Health (NIH) — The Nation's Medical Research Agency — includes 27 Institutes and Centers and is a component of the U.S. Department of Health and Human Services. It is the primary federal agency for conducting and supporting basic, clinical and translational medical research, and it investigates the causes, treatments, and cures for both common and rare diseases. For more information about NIH and its programs, visit www.nih.gov.

Antidepressant Medication and Teenagers

A lot of teenagers, and even children, are prescribed antidepressants, somewhere from 1% to 1.5% of the population. At one point studies estimated that as many as 1.66% of children or adolescents were prescribed antidepressant medication, but after the FDA required a "black box" warning label for the medications in 2005, the prescription rate has dropped. The warning label states that the use of antidepressants among children and teenagers is associate with an increased risk of suicial thoughts, and suicial behaviors. So physicians have backed off of prescribing the medications.

However, the estimated suicide rate among American adolescents is about 16%.

Research indicates that as a result of fewer depressed teenagers receiving antidepressant treatment, the suicide rate among teenagers has gone up. See Hamilton B, et.al., Annual Summary of Vital Statistics: 2005. Pediatrics. Also see Greenhouse, J., et.al., Generalizing from Clinical Trial Data: A Case Study. The Risk of Suicidality Among Pediatric Antidepressant Users. Carnegie Mellon University.

Follow along with me here:

1. Antidepressants can increase suicidal thoughts and behaviors in children and adolescents who were not having any, or many, suicidal thoughts or behaviors, according to a study of 4,600 children and teens (and, by the way, no one in this group of 4,600 committed suicide). This was the basis of the FDA's black box warning label.

2. But in children and teens who ARE having suicidal thoughts or behaviors prior to treatment with medications, antidpressants LOWER the risk of suicide. Simon and his group studied 65,000 medical records and found that the highest risk of suicide among the depressed was the month PRIOR to beginning treatment, and that the risks greatly diminished after beginning treatment with antidepressants (Simon GE, et.al., Suicide risk during antidepressant treatment. Am J Psychiatry. January, 2006)

3. Other studies have found that the more often antidepressants are prescribed to children and adolescents who could benefit from them, the lower the suicide rates (Gibbons RD, et.al., The relationship between antidepressant medication use and rate of suicide. Archives of General Psychiatry. 2005)

So the bottom line is, black box warning label or not, if your child or teenager is not depressed and is not having suicial thoughts or behaviors, they are probably better off not taking an antidepressant medication.

Teenagers and Depression: What Parents Need to Know

From newideas.net the ADD ADHD Information Library, and Doug Cowan, Psy.D., clinical editor. Many teenagers suffer from depression, and many diagnosed with ADHD also have depression. It is important for parents to understand depression in teenagers, ...

Adolescent Prescription ADHD Medication Abuse is Rising

ADHD is a neurological disorder that impacts between 5% and 9% of children, teens, and even adults. Over the years, as more pharmaceutical companies enter the market, and more medications are developed, there has been a signficiant increase int he use of ADHD medications - and a recent study suggests an increase in the misuse of such medications.

The study is titled "Adolescent Prescription ADHD Medication Abuse is Rising Along With Prescriptions for These Medications," and was published August 24, 2009 in the journal Pediatrics. The authors, Jennifer Setlik, MD, Randall Bond, MD, and Mona Ho, MS, looked at the information available from the American Association of Poison Control Center's National Poison Data System from 1998 to 2005 for all incidents involving teenagers who intentionally abused or misused ADHD medications, which are most commonly stimulants such as Ritalin.

ADHD Prescription Drug Abuse: Teens!

Teen Drug Abuse, or more specifically prescription drug abuse continues to rise. ADHD students in High School and College are selling or giving prescription drugs to their friends. The parents get the prescriptions filled and are unwittingly providin...

The Researchers found that incidents of reported and treated abuse rose 76 percent, from just over 300 incidents to 581 incidents. Estimated prescription rates for teens and preteens increased 133 percent for amphetamine products, 52 percent for methylphenidate products, and 80 percent for both together. The authors emphasized that the majority of adolescents use their ADHD medication appropriately. But doctors need to remember that the more medication is prescribed to teenagers, the more likely there are to be incidents of abuse, so the doctors need to monitor the medications closely.

The author's conclusion stated, "The sharp increase, out of proportion to other poison center calls, suggests a rising problem with teen ADHD stimulant medication abuse. Case severity increased over time. Sales data of ADHD medications suggest that the use and call-volume increase reflects availability, but the increase disproportionately involves amphetamines."

We believe that medications for ADHD can be highly effective, but the potential for significant side-effects and also now for mis-use and abuse is real. This is why we advocate alternative treatments as the first intervention whenever possible. We like EEG biofeedback traning, our ADHD Diet, and Attend by VAXA as an alternative to stimulant medications.

Update on Vyvanse as a New ADHD Medication

A couple of months ago we reported that Shire Pharmaceuticals was looking to receive approval on their third medication for the treatment of ADHD named VYVANSE, and now they are receiving it from the FDA.

This new ADHD medication will go along with Shire's two other products for ADHD, Daytrana, a methylphenadate patch worn by children on the hip, and the somewhat controversial ADDerall XR. All three products are once per day dosing.

The product is expected to be on the market by the summer of 2007, and is expected to generate a lot of money for Shire.

Shire Pays Huge Money for New River and Vyvanse

In fact, Shire is so fond of stimulants for the treatment of ADHD that they paid $2,600,000,000 (yes, that's 2.6 Billion dollars) for New River Pharmaceuticals, the company that actually developed Vyvanse. Read more in the press release below about the new medication, the money, and the companies.

Press Release - VYVANSE - February 23, 2007

FOR IMMEDIATE RELEASE
Shire and New River Pharmaceuticals Announce FDA Approval of the First and Only Stimulant Prodrug VYVANSE ™ (lisdexamfetamine dimesylate) as a Novel Treatment for ADHD

Basingstoke, U.K., Philadelphia, PA and Radford, VA – FEBRUARY 23, 2007 – Shire plc (LSE: SHP, NASDAQ: SHPGY, TSX: SHQ) and its collaborative partner New River Pharmaceuticals Inc. (NASDAQ: NRPH) announced today that the U.S. Food and Drug Administration (FDA) has granted marketing approval for VYVANSE (lisdexamfetamine dimesylate, formerly known as NRP104), for the treatment of Attention Deficit Hyperactivity Disorder (ADHD).

On February 20, 2007 Shire and New River announced an agreement whereby Shire will acquire New River for approximately $2.6 billion in an all cash transaction unanimously recommended by the Boards of both companies. The transaction is the subject of another press release issued February 20, 2007.

VYVANSE is a prodrug that is therapeutically inactive until metabolized in the body. In clinical studies designed to measure duration of effect, VYVANSE provided significant efficacy compared to placebo for a full treatment day, up through and including 6:00 pm. Furthermore, when VYVANSE was administered orally and intravenously in two clinical human drug abuse studies, VYVANSE produced subjective responses on a scale of “Drug Liking Effects” (DLE) that were less than d-amphetamine at equivalent doses. DLE is used in clinical abuse studies to measure relative preference among known substance abusers.

“The FDA approval of VYVANSE is exciting news for Shire as well as for patients, their families, and healthcare providers as it’s an important, novel approach for the treatment of ADHD,” said Matthew Emmens, Shire Chief Executive Officer. “The label we received with the approval letter includes information about the extended duration of effect and abuse-related drug liking characteristics of VYVANSE which illustrate benefits that differentiate this compound from other ADHD medicines. The addition of VYVANSE to our ADHD portfolio reaffirms Shire’s commitment to continue to address unmet medical needs and advance the science of ADHD treatment. Beginning with product launch in Q2 2007, Shire will make VYVANSE our top promotional priority within our ADHD portfolio.”

Randal J. Kirk, New River’s Chairman and Chief Executive Officer, remarked, “VYVANSE’s approval signals a new era in the treatment of ADHD. Upon product launch, patients will have a novel treatment option combining the effectiveness of a stimulant – long considered the gold standard in ADHD medicines – with other potential benefits.”

The FDA has proposed that VYVANSE be classified as a Schedule II controlled substance.

This proposal was submitted to and accepted by the U.S. Drug Enforcement Administration (DEA). A final scheduling decision is expected from the DEA following a 30-day period for public comment. Once VYVANSE receives final scheduling designation, the label will be available. Pending final scheduling designation, product launch is anticipated in Q2 2007.

VYVANSE will be available in three dosage strengths: 30 mg, 50 mg and 70 mg, all indicated for once-daily dosing.

New River developed VYVANSE as a new ADHD medication designed to provide lower potential for abuse, in which d -amphetamine is covalently linked to l -lysine, a naturally occurring amino acid. The combination is rapidly absorbed from the gastrointestinal tract and converted to d -amphetamine, which is responsible for VYVANSE’s activity.

Joseph Biederman, MD, director of Pediatric Psychopharmacology at Massachusetts General Hospital, was lead investigator on the pivotal clinical studies testing lisdexamfetamine dimesylate for the treatment of ADHD.

These large multi-site studies showed that the drug significantly reduced ADHD symptoms throughout the day with a predictable tolerability profile. “Our studies showed that this next-generation stimulant medication's unique chemical profile offers an option for physicians and their patients in the treatment of ADHD, with outstanding efficacy and duration of action” said Dr. Biederman.

Once-Daily Vyvanse approved for the treatment of ADHD in children and adults, and now in adolescents

PHILADELPHIA – November 15, 2010 – Shire plc (LSE: SHP, NASDAQ: SHPGY), the global specialty biopharmaceutical company, today announced that the US Food and Drug Administration (FDA) approved the prescription medication Vyvanse® (lisdexamfetamine dimesylate) Capsules CII for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in adolescents ages 13 to 17. The approval is based on study data demonstrating that Vyvanse improved ADHD symptoms compared to placebo in adolescents with ADHD.1 Vyvanse is also indicated for the treatment of ADHD in children ages 6 to 12 years, and adults.1

“This adolescent indication for Vyvanse is good news for kids in this age group diagnosed with ADHD and their caregivers as it offers an additional treatment option to help them manage their symptoms,” said Mike Yasick, Senior Vice President of Shire’s ADHD Business. “The approval of Vyvanse for children and adults – and now for adolescents – underscores Shire’s commitment to helping ADHD patients and their families.”

The FDA's approval of Vyvanse in adolescents was based on results from a randomized, double-blind, placebo-controlled, four-week, forced-dose escalation study of adolescents who received one of three Vyvanse doses, 30, 50 and 70 mg/day, or a placebo.1 This study was conducted in 314 adolescents aged 13 to 17 who met DSM-IV-TR® criteria for ADHD.1 In this study, patients were randomized to a daily morning dose of Vyvanse (30 mg/day, 50 mg/day or 70 mg/day) or placebo for a total of four weeks of treatment.1 All subjects receiving Vyvanse were initiated on 30 mg for the first week of treatment.1 Subjects assigned to the 50 mg and 70 mg dose groups were escalated by 20 mg per week until they achieved their assigned dose.1 The primary efficacy outcome was change in Total Score from baseline to end point in investigator ratings on the ADHD Rating Scale (ADHD-RS).1 The ADHD-RS-IV rating scale is a measure of the core symptoms of ADHD.2 The core symptoms of ADHD are inattention, hyperactivity and impulsivity.3 All Vyvanse dose groups were superior to placebo in the primary efficacy outcome.1

The safety of Vyvanse was also evaluated during the study.1 The most frequently occurring treatment-emergent adverse events (greater than or equal to 5 percent and twice placebo) reported in patients treated with Vyvanse were decreased appetite, insomnia, and weight decrease.1 Safety results were generally consistent with previous Vyvanse studies in children and adults.4

Vyvanse is a federally controlled substance (CII) because it can be abused or lead to dependence. Keep Vyvanse in a safe place to prevent misuse and abuse. Selling or giving away Vyvanse may harm others, and is against the law. Vyvanse is a stimulant medication. Misuse of stimulants may cause sudden death and serious cardiovascular adverse events.

Shire Development Inc. supported this study.

Vyvanse: How It Works_

Read the text of this video at eveningpsychiatrist.blogspot.com Darvin Hege, MD, Atlanta, ADHD medication treatment specialist, board-certified psychiatrist exp.lains why and how Vyvanse works better than Adderall, Ritalin, Concerta, Dexedrine, Strat...

About Vyvanse
Vyvanse, which was introduced in the United States in July 2007 for the treatment of ADHD in children ages 6 to 12 years, approved in April 2008 to treat ADHD in adults, and approved in November 2010 to treat ADHD in adolescents ages 13 to 17, is currently available in six once-daily dosage strengths of 20 mg, 30 mg, 40 mg, 50 mg, 60 mg, and 70 mg.1

Additional information about Vyvanse and Full Prescribing Information and Medication Guide, including WARNING about Potential for Abuse, are available at http://www.vyvanse.com.

INDICATION
Vyvanse is a prescription medicine for the treatment of ADHD in children ages 6 to 17 and adults. Vyvanse should be used as part of a total treatment program that may include counseling or other therapies.

IMPORTANT SAFETY INFORMATION

Vyvanse is a federally controlled substance (CII) because it can be abused or lead to dependence. Keep Vyvanse in a safe place to prevent misuse and abuse. Selling or giving away Vyvanse may harm others, and is against the law. Vyvanse is a stimulant medication. Misuse of stimulants may cause sudden death and serious cardiovascular adverse events.

Vyvanse should not be taken by patients who have:
Heart disease or hardening of the arteries, moderate to severe high blood pressure, overactive thyroid gland (hyperthyroidism), glaucoma, agitated states, a history of drug abuse, taken an anti-depression medicine called a monoamine oxidase inhibitor (MAOI) within the last 14 days, or sensitivity to, are allergic to, or had a reaction to other stimulant medicines.
Vyvanse is a stimulant medicine. The following have been reported with use of stimulant medicines.
Heart-related problems:
Tell your doctor if you or your child have any heart problems, heart defects, high blood pressure, or a family history of these problems. Call your doctor right away if you or your child has any signs of heart problems such as chest pain, shortness of breath, or fainting while taking Vyvanse.
Mental (Psychiatric) problems:
Tell your doctor about any mental problems you or your child have, or about a family history of suicide, bipolar illness, or depression. Call your doctor right away if you or your child have any new or worsening mental symptoms or problems while taking Vyvanse, especially seeing or hearing things that are not real, believing things that are not real, or are suspicious.
Serious side effects have been reported with use of stimulant medicines such as Vyvanse, including:
seizures, mainly in patients with a history of seizures
eyesight changes or blurred vision
motion and verbal tics. Patients with tics or Tourette’s syndrome may experience a worsening of symptoms while taking Vyvanse.
slowing of growth. Your child should have his or her height and weight checked often while taking Vyvanse. The doctor may stop treatment if a problem is found during these check-ups.
The most common side effects reported in studies of Vyvanse were:
upper belly pain
nausea
dry mouth
dizziness
weight loss
trouble sleeping
irritability
decreased appetite
vomiting
Please see Full Prescribing Information and Medication Guide including WARNING about Potential for Abuse, and discuss with your doctor. For more information, please visit http://www.vyvanse.com.

About ADHD

Attention Deficit Hyperactivity Disorder (ADHD) is a psychiatric behavioral disorder that manifests as a persistent pattern of inattention and/or hyperactivity-impulsivity that is more frequent and severe than is typically observed in individuals at a comparable level of development.3,5

ADHD is one of the most common childhood psychiatric disorders.6 In the United States, approximately 7.8 percent of all school-age children have been diagnosed with ADHD at some point in their lives, according to the Centers for Disease Control and Prevention (CDC).7 Although many people tend to think of ADHD as a childhood problem, up to 65 percent of children with ADHD may still exhibit symptoms in adulthood.8 The disorder is also estimated to affect 4.4 percent of US adults aged 18 to 44 based on results from the National Comorbidity Survey Replication.9 When this percentage is extrapolated to the full US population aged 18 and over, approximately 9.8 million adults are believed to have ADHD.10

The specific etiology of ADHD is unknown, and there is no single diagnostic test for this disorder.6 Adequate diagnosis requires the use of medical and special psychological, educational, and social resources, utilizing diagnostic criteria specified in the Diagnostic and Statistical Manual of Mental Disorders, 4th Edition, Text Revision (DSM-IV-TR®) or International Classification of Diseases, 10th revision (ICD-10).3,5,6

Although there is no cure for ADHD, there are accepted treatments that have been demonstrated to improve symptoms.6 Standard treatments include educational approaches, psychological therapies which may include behavioral modification, and/or medication.6

For further information please contact:

Media Matthew Cabrey
mcabrey@shire.com
+1 484 595 8248 +1 484 595 8248

Cori Blair (Porter Novelli for Shire)
Cori.Blair@porternovelli.com
+1 212 601 8248 +1 212 601 8248

SHIRE PLC

Shire’s strategic goal is to become the leading specialty biopharmaceutical company that focuses on meeting the needs of the specialist physician. Shire focuses its business on attention deficit hyperactivity disorder (ADHD), human genetic therapies (HGT) and gastrointestinal (GI) diseases as well as opportunities in other therapeutic areas to the extent they arise through acquisitions. Shire’s in-licensing, merger and acquisition efforts are focused on products in specialist markets with strong intellectual property protection and global rights. Shire believes that a carefully selected and balanced portfolio of products with strategically aligned and relatively small-scale sales forces will deliver strong results.

For further information on Shire, please visit the Company’s Web site: http://www.shire.com.

"SAFE HARBOR" STATEMENT UNDER THE PRIVATE SECURITIES LITIGATION REFORM ACT OF 1995

Statements included herein that are not historical facts are forward-looking statements. Such forward-looking statements involve a number of risks and uncertainties and are subject to change at any time. In the event such risks or uncertainties materialize, the Company’s results could be materially adversely affected. The risks and uncertainties include, but are not limited to, risks associated with: the inherent uncertainty of research, development, approval, reimbursement, manufacturing and commercialization of the Company’s Specialty Pharmaceutical and Human Genetic Therapies products, as well as the ability to secure and integrate new products for commercialization and/or development; government regulation of the Company’s products; the Company’s ability to manufacture its products in sufficient quantities to meet demand; the impact of competitive therapies on the Company’s products; the Company’s ability to register, maintain and enforce patents and other intellectual property rights relating to its products; the Company’s ability to obtain and maintain government and other third-party reimbursement for its products; and other risks and uncertainties detailed from time to time in the Company’s filings with the Securities and Exchange Commission.

References:

1. Vyvanse [package insert], Wayne, Pa: Shire US Inc., November 2010
2. Collett BR, Ohan JL, Meyers KM. Ten year review of rating scales. V: scales assessing attention-deficit/hyperactivity disorder. J Am Acad Child Adolesc Psychiatry. 2003;42(9):1015–1037.
3. Diagnostic and Statistical Manual of Mental Disorders. 4th ed., Text Revision (DSM-IV-TR®). Arlington, VA: American Psychiatric Publishing; 2000:85-93.
4. Double-Blind, Placebo-Controlled Efficacy and Safety Study of Lisdexamfetamine Dimesylate in Adolescents With Attention-Deficit/Hyperactivity Disorder. Poster Presentation #I.56. Presented at the New Clinical Drug Evaluation Unit Meeting; June 14-17,2010; Boca Raton, FL.
5. International Classification of Diseases, Tenth revision, (ICD-10). World Health Organization; 2007: Chapter 5, F90. http://www.who.int/classifications/apps/icd/icd10online/. Accessed September 29, 2010.
6. Pliszka S and the AACAP Work Group on Quality Issues. Practice parameter for the assessment and treatment of children and adolescents with attention-deficit/hyperactivity disorder. J Am Acad Child Adolesc Psychiatry. 2007;46(7):894-921.
7. Mental health in the United States: Prevalence of diagnosis and medication treatment for attention-deficit/hyperactivity disorder, United States, 2003. MMWR. 2005;54(34):842-847.
8. Dulcan, M and the AACAP Work Group on Quality Issues. Practice parameters for the assessment and treatment of children, adolescents, and adults with attention-deficit/hyperactivity disorder. J Am Acad Child Adolesc Psychiatry. 1997;36(10 Suppl):85S-121S.
9. Kessler RC, Adler L, Barkley R, et al. The prevalence and correlates of adult ADHD in the United States: results from the national comorbidity survey replication. Am J Psychiatry. 2006; 163:716-723.
10. Annual Estimates of the Population by Selected Age Groups and Sex for the United States: April 1, 2000 to July 1, 2005 (NC-EST2005-02). U.S. Census Bureau. http://www.census.gov/popest/national/asrh/NC-EST2005-sa.html. Accessed September 29, 2010.

Source: Shire PLC Press Release

ADHD Medication and Cough and Cold Medicines : A Warning for Parents

For those of you parents, especially those who have children taking ADHD medications, we want you to be aware of the following information.

The Center for Disease Control (CDC) just startled everyone by reporting on a study that estimates that each year cough and cold medicines send about 7,091 children to hospital emergency rooms, which accounts for 5.7% of all emergency room visits for medications in this age group.

Here is the study: Schaefer MK, Shehab N, Cohen AL, Budnitz DS. Adverse Events Attributable to Cough and Cold Medications in Children.* Pediatrics. Epub 28 Jan 2008. DOI: 10.1542/peds.2007-3638. You can read the PDF of the study here: http://pediatrics.aappublications.org/cgi/reprint/peds.2007-3638v2

The CDC does not know if there were any deaths as a result. The information was simply not available to the. But past studies have uncovered a number of deaths in very young children who were inadvertently given too much of the medicines.

For the children whose symptoms were reported, allergic reactions like hives and itching were most common, and neurological symptoms like drowsiness and unresponsiveness were next. Most of the medicines involved were liquid combinations of cough and cold treatments, CDC researchers said.

They report that about 4,600 children took the medicines unsupervised, and that about 3,500 of those children were ages 2 – 5. Another 1,500 were children under the age of 2 years old who were given over-the-counter cough and cold medicines that the FDA considers to be too dangerous for such young children.

The CDC offers this advice to parents:

• Don't leave medicines where your child might be able to reach them.
• Don't tell children that medicine is candy.
• Don't take adult medications in front of your child.
• Don't give children younger than age 2 medicines intended for older children.
• Throw away cold and cough medicines for children less than age 2.

There are two important warnings here for parents:

1. Cough and Cold medicines for children taste like candy, or better. I love the taste and so do you. And so do your children. It makes it all too easy for our children to take medication, even when we are not around;
2. These medicines are not candy. They are medicines that are not to be given to infants. That little warning on the label that says “for children 3 and under – consult your doctor” are NOT saying, “Oh, just go ahead and give it to them.”

Of even greater concern is the message that there were over 1,000 cases in which parents gave the proper dosage and an allergic reaction or some other problem developed.

We have to remember that Cough and Cold medicines can have an effect on the Central Nervous System, and sometimes that effect is unpredictable. We all know children who go to sleep when given Benadryl, and other children who spin up like a top. Parents, we have to be careful.

Parents must consider the drug interactions between Cough and Cold medicines and any other medication that the child might be taking, especially medications for ADHD, depression, or anxiety. Always consult your doctor. Or better yet, talk to the pharmacist. Parents, we have to be more careful.

Doug Cowan, Psy.D.
The ADHD Information Library

By Guest Author Rory Stern Psy.D.

There I was watching television one afternoon, and a commercial came on that reported, "X% of people who suffer from depression and take medication, continue to experience symptoms of depression."

I was on the edge of my seat... I couldn't believe it! Were they finally going to suggest other treatment besides medication? Was someone going to finally blow the lid on treatment and actually suggest the importance of therapy and better understanding the behaviors?

All that excitement was suddenly lost the moment I heard the commercial recommend the need and use of additional medications. I felt deflated. It just didn't make sense. "Treat ongoing symptoms of depression with more medication instead of going after the root cause," I asked myself? That was the last straw.

What does this mean for ADHD?

Like depression, ADHD is thought to be biologically based. Research has suggested, and theorists believe, that there are abnormalities with the absorption of chemicals and neurotransmitters in the brain that lead to behaviors like we see in ADHD and depression. This is one major reason why prescribing medication is often a first step for the individual diagnosed with ADHD.

Medications are specifically engineered and researched to target these specific chemicals and neurotransmitters in the brain to aide in the process. Yet, many people with ADHD still experience symptoms of the disorder even while taking their prescribed medications.

Ask yourself what else might be going on?

While I am no expert on medication and how the brain functions, I can tell you that if your medication is not addressing the symptoms you are struggling with, then you really owe it to yourself to ask what else might be going on.

Can medications make a difference? Yes, absolutely. But at the same time, disorders like ADHD and depression also have a very strong and powerful emotional or psychological component. And while there is no set standard for what might happening, there has been a theme to suggest that the events in our lives, and those immediately around us can contribute to how we behave and interact with the world.

This is particularly true in children and adolescents.

Does this account for ADHD? Maybe yes, maybe no. But, I can guarantee you that regardless of the presence or absence of a disorder, we are all affected by our environment and what we are experiencing.

Disclaimer: In any discussion of medication, I feel it is of critical importance to remind you that any and all medical and mental health decisions continue to be made with your or your child's physician, psychiatrist, or therapist who is an expert in ADHD.

To learn more about ADHD and what might really be impacting your child, I invite you to visit and sign up for your seven-part mini-course on the dirty little secrets behind ADHD. I would also like to invite you to ask your most pressing question about ADHD and how it could be affecting your family and your child.

Article Source: http://EzineArticles.com/?expert=Rory_Stern http://EzineArticles.com/?ADHD-Tip---Will-More-Medication-Always-Be-The-...

Dr. Rory Stern is a writer, therapist, coach, consultant, and speaker. In managing "The Truth Behind ADHD," he offers a unique style of providing parents of children with ADHD both information and insight into what their child is experiencing. In addition, he connects with parents on a level that allows them to understand their own struggles along with how their child is struggling. His main goal is to provide parents with the support, encouragement, and resources to take action now so they can start to experience change in their child's life, as well as their own.

Rory's unique style combines his rich experience and training as therapist, coach, consultant, mentor, adviser, and parent. He understands that there is more to each child's struggle than just symptoms of ADHD alone. For that matter, he also knows how a child's ADHD not only impacts himself, but also impacts the lives of his parents and siblings. While considering his approach, Dr. Stern takes into account not just the behaviors of the child, but also urges that parents consider all options and events that are impacting everyone's lives in the family.

Dr. Stern holds a doctorate in clinical psychology from the Massachusetts School of Professional Psychology. He also completed a graduate certificate in executive coaching. He lives in the greater-Boston area with his wife Lacie, and his two beautiful young children.