Category — ADHD: Adderall

A study published in the June 14 edition of the Journal of Developmental and Behavioral Pediatrics has sparked controversy regarding ADHD medication and the brain’s power to regulate itself.

The study was funded by the National Institutes of Health and conducted by Dr. Adrian Sandler, a developmental-behavioral pediatrician and medical director of the Olson Huff Center for Child Development at Mission Children’s Hospital in Asheville, North Carolina.  The research was performed over the course of eight years using 99 patients from Western North Carolina.

Sandler found that children with ADHD can do just as well on half their medication when the medication is combined with a placebo. They performed as well even when parents and children had full knowledge they were taking a placebo.

[Placebo --  A substance containing no medication and prescribed or given to reinforce a patient's expectation to get well. The placebo in this research was akin to a harmless inert pill].

Previous studies have shown that common stimulant medication causes side-effects like tics, weight loss, stunted growth, and even heart complications in some instances. This often causes trepidation in parents afraid of the possible side-effects on their children.

Sandler compared fully medicated children, children on reduced medication, and children on reduced medication with a known placebo. The results were quite intriguing.  Both the fully medicated and reduced medication groups had increased side-effects while the reduced medication with placebo demonstrated decreased side-effects. Furthermore, the reduced medication group reported decreased control of their ADHD symptoms. However, the control of ADHD symptoms was no different in the reduced medication with placebo group than in the full dose group, i.e. the reduced medication with placebo performed as well as the fully medicated group with less side-effects as well.

“I’ve been getting a lot of calls and e-mails,” said Sandler,, who conducted the research with James Bodfish, a professor in the departments of psychiatry and pediatrics at UNC Chapel Hill School of Medicine, and study coordinator Corrine Glesne.

“Medications work,” Bodfish said in a statement. “The question is whether we always need to use them at the highest dose. Many parents are concerned about placing their child on medication. Some choose not to treat their child because of concerns about side effects.”

While the research doesn’t address it, the obvious question is, Why? Parents and children in this study knew they were taking a placebo. Why then did they perform as well as their peers without the side-effects — at essentially half the dose as their peers? While the placebo effect has been studied widely, the exact mechanisms are unknown. We do know that the mechanism is governed by the brain. This clearly tells us that having ADHD or not, our brain is still a powerful weapon in our arsenal.

We also cannot exclude the influence of the parents during this research. Did they expect their child to do better? The authors suggest that this was so. This dynamic cannot be overlooked in your family either.

The bottom line is that we likely have far more control over our behaviors and cognitive processes than we are given credit for. Modern medicine, as this research suggests, is just beginning to understand the brain’s role in shaping our lives. We’ve known this for years at Play Attention. Cognitive training. Memory training. Motor skills. Attention training. Behavioral shaping. It’s time to take control over our lives. We’ve all got the power to do it. It lies right behind our eyes.

If I told you that women who received only basic education were 130 % more likely to have a child on ADHD medication than women with university degrees, you’d see a link, wouldn’t you? 

Well, that’s what a  study published this month in Acta Paediatrica found.  That implies that nearly half of the serious cases of ADHD  in children are closely tied to social factors. The study reveals that factors like single parenting and poor maternal education were directly tied to ADHD medication use.

While we know that a genetic propensity likely exists, the human brain develops based on a complex interplay between nature and nurture; between genetic endowment (nature) and environment/social factors (nurture). Epigenetic theory tries to explain this relationship.

Curiously, few large-scale studies have tried to determine the impact of social and family influences on ADHD. Researchers at the Karolinska Institute in Stockholm, Sweden assessed data on 1.16 million school children and examined the health histories of nearly 8,000 Swedish-born kids, aged six to 19, who had taken ADHD medication.

"We tracked their record through other registers … to determine a number of other factors," said lead author Anders Hjern.

Here’s what the researchers found:

• Living in a single parent family increased the chances of being on ADHD medication by more than 50 percent.
• A family on welfare upped the odds of medication use by 135%.
• Boys were three times more likely to be on medication than girls.
• Social dynamics affected both sexes equally.

"Almost half of the cases could be explained by the socioeconomic factors included in our analysis, clearly demonstrating that these are potent predictors of ADHD-medication in Swedish school children," Hjern said.

It’s clear that this study found a link between socioeconomic factors and ADHD medication use/diagnosis. Other US studies have found that minority children and children of low socioeconomic status were more likely to receive ADHD medication.

Factors like low income and diminished quality time are more common in single-parent families. These typically lead to stressors like family conflict and a lack of social support, Hjern said.

While more research must be done, one has to ask, is medication the answer to social stressors like lack of time and money? Sounds too silly to ask, but it seems that our answer, ridiculously, is a resounding, YES!

We are the masters of our lives. We can make significant personal changes, but we must have the tools to do so. That’s why I began Play Attention (www.playattention.com) years ago.

A Nottingham University research team in the United Kingdom found that the brains of children with ADHD appear to respond to immediate rewards in the same way as they do to medication. Their research was published in the journal Biological Psychiatry.

“Our study suggests that both types of intervention [medicine and immediate reward/reinforcement] may have much in common in terms of their effect on the brain,” said Professor Chris Hollis, the lead investigator of  the study.

The research team used an EEG (electroencephalograph) to measure the brain activity of children as they played a computer game that provided extra points for less impulsive behavior.

The researchers devised a computer space game which rewarded the ADHD children when they caught aliens of specific colors  while avoiding aliens of designated colors. The game design actually tested the children’s ability to resist the impulse to grab the wrong colored aliens.

To test whether immediate reward/reinforcement made a difference, one iteration of the game rewarded the children fivefold for catching the right alien and penalized them fivefold for catching the wrong one.  All of this was done while activity in different parts of their brains was monitored with an EEG.

Hollis found that the immediate rewards helped the children perform better at the game. This was verified by the EEG which  revealed that both medication and immediate reward/reinforcement were "normalizing" brain activity in the same regions.

Many parents of ADHD children are aware that giving a reward to an ADHD child a week after their good behavior is insignificant to that child. ADHD children respond better to immediate reward, not delayed reward.

"Although medication and behavior therapy appear to be two very different approaches of treating ADHD, our study suggests that both types of intervention may have much in common in terms of their effect on the brain. Both help normalize similar components of brain function and improve performance,"  said Hollis.

"We know that children with ADHD respond disproportionately less well to delayed rewards – this could mean that in the ‘real world’ of the classroom or home, the neural effects of behavioral approaches using reinforcement and rewards may be less effective."

It’s obvious that providing immediate rewards/reinforcement 24 hours a day and 7 days a week would be impractical and impossible. But what does this research tell us? It tells us that if we are to train an ADHD student, feedback, reward, and reinforcement need to be immediate if we are to get their brain to rewire.

We at Play Attention have known this for many years. This is why we integrated immediate feedback/reinforcement for attention training, cognitive training, memory training, and behavioral shaping by using feedback technology. We patented this method years ago because of its inherent strength. While we knew this was the best way to achieve success, we feel research like this rather reinforces our approach. It’s about time the world caught up!

Generics don’t produce income for the pharma giants. Giant pharma’s manipulation of pricing affects users – perhaps more now that the economy is a mess. It also affects health and health related decisions. Ethically, this is wrong.

Shire hikes Adderall price as rumors fly

Amid new speculation that Pfizer might snag Shire in a buyout deal, the specialty pharma is following through on its strategy to switch patients to its newest ADHD med Vyvanse as blockbuster Adderall XR nears the end of its patent. Shire is hiking the price of Adderall by 20 percent, a boost that confounded analysts expecting a smaller increase.

The idea, of course, is that by making Adderall more expensive, Shire will shine the spotlight on Vyvanse, whose price is rising by a mere 7 percent. Cost-conscious patients will then switch to the cheaper brand, or so the theory goes. Then, firmly entrenched as Vyvanse users, the patients won’t move to generic Adderall when it hits the market.

Analysts apparently expect the switching to stick; Citigroup upgraded Shire stock on the prospect. But with insurers increasingly vigilant about drug prices, generic Adderall might woo away more Vyvanse users than Shire wants to lose. We’ll have to wait and see how that plays out.

In the meantime, though, investors are bidding up Shire stock on fresh rumors that Pfizer is kicking tires there. The U.K. company surfaces as a rumored Pfizer target from time to time, however, so it’s tough to know whether Pfizer is actually looking, or whether the habitual talk simply got stirred up when Pfizer chief Jeff Kindler made his “open to big deals” statement earlier this week.

The worldwide adult ADHD market holds a potential for billions of dollars for the pharmaceutical industry. In a brilliant marketing effort guised as a benevolent informational/screening initiative, Shire pharmaceuticals, the makers of Adderall for ADHD, launched a “screening initiative” in Atlanta. Shire’s press release states that they “…expect up to 20,000 adults to self-screen for ADHD in 13 cities” over 90 days.

Shire’s press release further states that:

The screening initiative, launched in Atlanta, GA, is designed to help raise awareness that ADHD is not just a childhood disorder. Research shows it is estimated that up to 65 percent of children with ADHD will continue to exhibit symptoms into adulthood. Adults who think they may have ADHD can take the first step toward recognizing the symptoms of the disorder by answering the 6-question World Health Organization (W.H.O.) adult ADHD screener. The screening initiative, known as the "RoADHD Trip," is housed, transported and anchored by the RoADHD Trip Tractor Trailer which expands into a tented area housing eight self-screening stations.

“Shire developed this mobile screening initiative as a forum to educate the public about ADHD in adults and provide information and resources to individuals about this disorder," said Gerardo Torres, M.D., Vice President and Scientific Lead, of Shire’s ADHD Business Unit. "This program demonstrates Shire’s on-going commitment to providing information for those who may be struggling with the symptoms of ADHD."

In each of the 13 cities, Shire is partnering with the Attention Deficit Disorder Association (ADDA), a leading adult ADHD patient advocacy organization, in an effort to assist up to 20,000 adults to self-screen for this disorder. Volunteers from ADDA will also be on-site to answer questions about ADHD in adults and to provide information about their organization. The W.H.O. adult ADHD screener, a questionnaire that is used to help recognize the symptoms of ADHD, will be available via on-site computers to help facilitate self evaluations. The W.H.O. screener is not designed to provide a diagnosis of ADHD but may provide information to participants regarding the symptoms of ADHD. Participants should discuss any questions they have regarding the W.H.O. screener results and other concerns about ADHD with their physician.

"Seeking information and speaking to qualified health care professionals are critical steps to diagnosis and management of ADHD," further explained Dr. Torres. "This initiative is an important first step to encourage that dialogue between patients and their physicians."

This should leave Shire’s competitors slapping their foreheads saying, “Why didn’t I think of this!”

Decision Resources Pharmacor report reveals that the UK’s Shire may be the ADHD top earner by 2017.

Shire currently markets ADHD stimulant medication, Adderall. Adderall’s instant release formula is now available as a generic drug. The report states that Shire´s ADHD drugs will be dominate this market by 2017. The report attributes this, at least in part, to Shire’s launch of Vyvanse´s, a new ADHD drug which has been approved for both children and adults. Vyvanse may lower abuse potential compared with other psycho-stimulants on the market. The Pharmacor report predicts that Vyvanse will generate almost $ 1.2 billion dollars in sales in 2017.

Shire’s ability to take the lead, according to the report, will be because of Shire’s Vyvanse and its patch sold as Daytrana. Additionally, Shire is pursuing a non-stimulant medication called Intuniv that will compete with Lily’s Strattera and secure dominance in the burgeoning international ADHD market projected to be worth $4 billion.

To facilitate continued sales increases and increased market share, all major pharmaceutical companies are marketing heavily in countries that traditionally have not accepted ADHD as a neurobiological disorder or treated it with medication.

The Denver Post (www.denverpost.com) reports that Boulder police arrested three teens on felony charges of distribution and possession of a schedule II controlled substance. The incidence occurred on April 4 at Nevin Platt Middle School where the youth attended school.

Apparently one student had the drugs, gave one to another student who swallowed it and was taken ill. The sick student was then taken to the hospital and released. Other students were involved in the safekeeping of the drugs after they were brought to school.

The student that brought the drugs (Strattera and Concerta for treatment of ADHD) attempted to trade the drugs for alcohol.

The Denver Post says,

Two of the students have been charged with distribution and possession of a schedule II controlled substance and unlawful acts while the third was charged with possession of a controlled substance and unlawful act. Possession and distribution of a schedule II controlled substance is a felony, officials said.

While these students were apprehended, the incidence of ADHD drug sales and use is quite common among students at middle school, high school, and university.

The New York Times (www.nytimes.com) reported in 2005 in an article called The Adderall Advantage that:

At many colleges across the country, the ingredients for academic success now include a steady flow of analeptics, the class of prescription amphetamines that is used to treat attention deficit hyperactivity disorder [ADHD].

Since Ritalin abuse first hit the radar screen several years ago, the reliance on prescription stimulants to enhance performance has risen, becoming almost as commonplace as No-Doz, Red Bull and maybe even caffeine. As many as 20 percent of college students have used Ritalin or Adderall to study, write papers and take exams, according to recent surveys focused on individual campuses. A study released this month by the National Center on Addiction and Substance Abuse at Columbia found that the number of teenagers who admit to abusing prescription medications tripled from 1992 to 2003, while in the general population such abuse had doubled.

Dr. Robert A. Winfield, director of University Health Service at the University of Michigan, Ann Arbor, sees a growing number of students who falsely claim to be A.D.H.D. so they can get a prescription. At least once a week, a jittery, frightened, sleep-deprived student who has taken too many tablets for too many days shows up at his office. “Things have really gotten out of hand in the last four to five years,” he said. “Students have become convinced that this will help them achieve academic success.”

On campus, the drugs are either sold or given away by people with prescriptions, or they are procured by students who have learned to navigate the psychiatric exams offered by campus health centers, which usually provide the drugs at a discount. Unlike Ritalin, two newer members of the family of analeptics – Adderall and Concerta – come in time-release forms and can keep a patient medicated an entire day.

Louisiana State’s The Daily Reveille (www. media.www.lsureveille.com) reported that a survey documented in the journal Nature cites that one in five students used Adderall & Ritalin for a study booster.

Final exams traditionally have students studying long hours to cram for their final exams. But some students are now using a quick-fix for brain retention.

One in five respondents of adult professionals said they have used drugs to enhance brain power, according to a January survey in Nature journal. The online survey polled 1,400 people in 60 countries.

Ritalin and Adderall were the two drugs participants said they took.

Ritalin and Adderall are commonly used to treat attention-deficit hyperactivity disorder. They are also used to treat symptoms of narcolepsy and chronic fatigue syndrome. The stimulants are supposed to reduce impulsive behavior and facilitate concentration.

But people diagnosed with ADHD are not the only ones who can benefit from the drugs.

“It does work [for anyone]. We know that from lab studies,” said Martha Farah, director of the Center for Cognitive Neuroscience at the University of Pennsylvania, according to CNN.com

This is an international phenomenon. The reason is that low-dose stimulant medication is not a targeted approach to fixing ADHD. Instead, low-dose stimulant medication works the same for non-ADHD students. Here’s an example: if we have 50 ADHD students and 50 high functioning non-ADHD students, give them both a boring task, the both will perform better on that task.

Students know this and it helps the cram for exams. Will it help to prosecute all these students under felony charges? Not likely.

The University of Virginia wished to test whether ADHD medication helps young adults while facing driving distractions.

Research suggests that ADHD drivers have a greater likelihood of having or causing an accident. Obviously, hallmarks of the ‘disorder’ are inattention, distractibility, and sometimes hyperactivity. So, when their cell phone rings and they answer, bad things tend to happen.

According to Daniel Cox, Ph.D., professor of psychiatry and neurosciences at the University of Virginia Health System, as a group young ADHD drivers are two to four times more likely to have a car accident than non-ADHD drivers. Cox’ research will examine the effects of methylphenidate (MPH), a controlled-release stimulant worn as a patch, on young ADHD drivers facing real-life distractions.

This is rather clever marketing as the research is funded by Shire Pharmaceuticals, the pharmaceutical mega-giant who makes Adderall and the MPH patch. As I’ve stated before, it’s always questionable when a pharmaceutical giant funds a university study on its own medications. In this instance, it will make great marketing if the good Dr. Cox finds that young adults drive better while on meds! But, heck, since stimulant medication has the same effect on non-ADHD people, shouldn’t we all take it prior to driving? Regardless of that fact, if young ADHD people can wear a patch and drive better, that’ll sell millions of dollars worth of medicine!

The study would likely be significantly more impressive if Dr. Cox used unmedicated non-ADHD young adults and medicated non-ADHD young adults as control groups. I’d be more than eager to see those results.

Or maybe, just maybe, ADHD or not, we should put our cell phones away, put out our cigarettes, not eat in the car, put our pet in a pet carrier, and focus on driving. Shouldn’t we demand that of our ADHD teens before placing a stimulant patch on their arms? 

Long-Term Safety Questioned of Ritalin

In research published in Pediatrics, [December 2007; vol 120: pp 1494-1501], lead author, Almut G. Winterstein, PhD, assistant professor of pharmacy health care administration, University of Florida College of Pharmacy, Jacksonville, found that common stimulants used to treat attention deficit hyperactivity disorder (ADHD) don’t often cause serious heart complications in children. However, she warns that their safety is undetermined for prolonged use.

Winterstein found that stimulants such as Ritalin, Adderall, and Concerta frequently raise blood pressure and heart rate. The researchers analyzed health records from 55,000 children and teens newly diagnosed with ADHD from 1994 to 2004 with two significant findings:

1. Children who used stimulant medication had a 20% increase in visits to hospital ERs or doctors’ offices for heart palpitations and racing heartbeat, compared with children who didn’t use stimulant medication.
2. Stimulant medications did not appear to be associated with an increase in hospitalizations or deaths due to cardiac causes.

Last year the FDA took a special interest in the matter of heart safety when it announced a special Black Box advisory to be placed on stimulant medication. This was in part due to reports of the sudden deaths of 12 children who used ADHD Drug, Adderall.

The Canadian government quickly suspended sales of Adderall XR in Canada, but later permitted sales after further investigation.

Winterstein, PhD, in an interview with WebMD, notes:

… that because serious cardiac events are so rare among children and teens, a much larger study is needed to confirm the safety of these drugs.

“We can’t really say that there is no increase in risk (for serious cardiac events) among children who take these drugs,” she says. “What we can say is that if there is an increase in risk, it will not affect a large number of children.”

ADHD Drugs and Heart Risk

The CDC estimates that 4.4 million children between the ages of 4 and 17 have been diagnosed with ADHD, and as of 2003, 2.5 million were taking medication for it.

Children are increasingly taking the drugs for longer and longer periods, but little is known about their long-term cardiovascular impact, Winterstein says.

“The average exposure in our study was two years, but we see children who are on these drugs for five years, 10 years, and even longer,” she says.

She adds that it is also not clear if the drugs are safe for children with existing heart problems or with risk factors for heart disease.

Dr. Lawrence H. Diller’s book, The Last Normal Child: Essays on the Intersection of Kids, Culture, and Psychiatric Drugs, is a fascinating and provocative work. As an experienced developmental/behavioral pediatrician, Diller examines the current trend to quickly diagnose attention deficit hyperactivity disorder (ADHD) and the perfunctory prescription of stimulant drugs even when there is scarce evidence regarding academic improvement, social improvement, or long-term efficacy.

Diller’s perspective is quite evenly balanced; he prescribes stimulant medication for ADHD when indicated, but only as part of thorough assessment and comprehensive management program.

It is clear that Diller believes that ADHD is being over diagnosed. He states that over the last 15 years brand name stimulant production has increased by an astounding 1700% and generic stimulants by more than 3000%!

The number of U.S. children taking psychotropic drugs has doubled over the last ten years. We currently have more than 4.5 million children under 18 taking psychotropic drugs – mostly stimulants. Perhaps even more alarming are the percentages of ADHD children being reported by the Centers for Disease Control (CDC): typically common rates between 5% to 7% are reported in children in Colorado and 5.5% in California. However, as many as 10.5% of children in Louisiana are diagnosed with ADHD as are 11% of children in Alabama.

Diller suggests that the rampant diagnosis and pharmacological treatment of ADHD might be related to the fact that, “The drug industry hijacked American psychiatry in the 1990s….Insurance companies structure doctors’ reimbursement so as to reward short visits, ones in which a prescription brings the session to a definite conclusion.”

Diller also suggests that the Individuals with Disability Education Act of 1990, actually accelerated pharmacological treatment as well as the ADHD diagnosis because its amendment in 1991 now included ADHD as a diagnosis that makes a child eligible for special services and accommodations in public schools. As parents quickly learned, an ADHD diagnosis could gain their child special services and testing accommodations.

The pharmaceutical industry parleyed this trend by targeting parents with direct ADHD drug advertising. Parents, having diagnosed their child via the effects of the advertising campaign, could now approach their family practitioner to request stimulant drugs as a remedy. Diller suggests that many parents welcomed a brain-focused diagnosis that relieved them of responsibility for problem behavior.

The book encompasses far more than I’ve described here and is well worth reading. It is an excellent, balanced perspective that provides insight into the staggering $3 billion juggernaut known as ADHD.