New ADHD Drug to Fix Your Child

McNeil Consumer & Specialty Pharmaceuticals, a division of Johnson & Johnson (“J&J”), announced that an agreement with  Cephalon, Inc. to Co-Promote Modafinil for Attention-Deficit/Hyperactivity Disorder (Thursday September 1). McNeil currently manufactures and distributes Concerta for AD/HD.

Modafinil (coated tablet) is a form of Provigil which is used to alleviate excessive sleepiness  (narcolepsy) and other sleep disorders. Cephalaon and McNeil are awaiting U.S. Food and Drug Administration (FDA) approval for the treatment of attention- deficit/hyperactivity disorder (ADHD) in children and adolescents.

By combining sales forces totaling more than 700 sales reps between the two companies and by marketing heavily, the agreement may produce heightened sales figures for both companies in a competitive multi-billion dollar market. Cephalon will pay McNeil commission fees calculated as a percentage of annual net sales of Modafinil during the term of the agreement according to their press release.

Look for Shire Pharmaceuticals to market a new drug ostensibly in the same manner as J&J to compete.

In J&J’s press release they say that “Our company has extensive experience with ADHD and the pediatric medical community,” said Colin F. Watts, president, McNeil Consumer & Specialty Pharmaceuticals, a subsidiary of Johnson & Johnson. “We are excited about the prospect of collaborating with Cephalon on this new ADHD therapy.”

The most frequently reported adverse events in clinical trials with PROVIGIL were headache, nausea, nervousness, stuffy nose, diarrhea, back pain, anxiety, trouble sleeping, dizziness and upset stomach.

It has always been a concern of mine that ventures like these will reap a large profit without addressing cognitive, behavioral, and social needs of the end user. The public’s current perception is that using these medications will indeed ‘fix’ their broken child. Unfortunately, and according to the National Institutes of Health, more than medication is needed to address the full needs of AD/HD children. So, as long as pharmaceutical companies keep marketing in a manner which encourages the public’s ‘fix’ perception, we’ll continue to have kids who historically remove themselves from medication whenever they can (usually upon emancipation) and carry their AD/HD into adulthood with no compensatory skills.

ADHD ADD Drug Adderall XR Back on the Market in Canada

Bloomberg reports  Shire Says Canada Allows Sale of Adderall XR Again  after appealing Health Canada’s decision to pull Adderall XR from Canadian shelves.

h Canada’s decision was based on Adderall XR’s link to 20 deaths.

Bloomberg cites that “Adderall XR, used to treat attention deficit hyperactivity disorder or ADHD, will return Aug. 26, the Basingstoke, England- based company said today in an e-mailed statement. The medicine was taken from the market Feb. 9 at the request of Health Canada.

Shares of Shire fell 10 percent the day after the removal in Canada, which only accounted for $10 million of the product’s $606.7 million in 2004 sales. Adderall XR, which has about 25 percent of the hyperactivity market, is also facing patent challenges from companies including Barr Pharmaceuticals Inc. and Impax Laboratories Inc.”

Shire is the UK’s third largest pharmaceutical company.

Adult ADD: Many Children Maintain their Disorder into Adulthood

ADHD haunts children into adulthood, study shows

Psychological Association published research from Dr. Mariellen Fischer, a psychologist with the Medical College of Wisconsin. Her study was co-authored by Dr. Russell Barkley. The results of her 13 year study show that if AD/HD is left untreated in childhood, children will carry their disorder into adulthood.

For thirteen years they monitored 147 children with ADHD by age 7, comparing them with 76 neighbor children who didn’t have the disorder. About one third dropped out of high school. This seemed significantly high as none of the neighbor children dropped out. Leaving school is quite likely due to the public school system’s inability to accommodate the needs of ADHD students as well as ADHD student inability to learn coping skills which are seldom taught in school or at home.

Interesting data about adults with AD/HD in this study:

  • They are more likely than their peers to get fired
  • They are more likely to shun birth control and become parents by age 21
  • They are more likely to have higher credit card debt and fewer saving
  • They took medication for AD/HD as children, but few were being treated by their early 20s
  • They are more likely to start having sex a year earlier than classmates
  • 1 out of 3 had become parents by their early 20s vs. 1 in 25 of the classmates
  • They had less than half the savings of young adults they had grown up with and more debt

Dr. Fischer indicated that many children maintain their disorder into adulthood. The article is not clear whether this data was relevant to treated or untreated ADHD. However, clinical data suggests that perhaps 60% of ADHD children will carry their disorder into adulthood. This may be a conservative estimate.

While the data are compelling, the study is too small to conclude that ADHD alone causes these ill effects.

9/8/2005 Adults with Attention Deficit Hyperactivity Disorder Do Well on Deadline and Love a Challenge?

From the Kansas City Star by DIANE STAFFORD:

ADHD SUFFERERS FIND THEIR NICHE: Adults with Attention Deficit Hyperactivity Disorder Do Well on Deadline and Love a Challenge?

Can you say clueless? Stafford interviews Dr. William Dodson, MD who spoke to about 50 Hallmark Cards employees. His recommendation? If you want an employee who performs best on deadline, hire someone who has trouble staying on task. Dodson apparently specializes in treating with AD/HD. He said that adults with the neuropsychiatric condition generally respond well to urgency and fast pace. This seems true, meeting deadlines? That’s one of the greatest problems for adult AD/HD people.

“Workers with ADD need to be challenged or feel competitive,’’ Dodson generalized. “They like the new, the novel, the fleeting. They need ADD-friendly jobs – not accounting.’’

Sure they do. They are great in marketing. But don’t rely on them to get a job done on time. I’ve worked with many AD/HD adults. They’ll accept 20 jobs and finish none of them. Dodson truly seems clueless here.

Stafford also cites Blythe Gross, who has a doctoral degree in organizational psychology, also specializes in ADD treatment. After working with or interviewing hundreds of adult ADD patients, Gross wrote Making ADD Work: On-the-Job Strategies for Coping with Attention Deficit Disorder. Gross has been in the trenches with hundreds of AD/HD adults. She’s much more realistic in her perspective. She indicates that adult AD/HD “symptoms can range from an inability to get started on a task, to an inability to follow through on a task, to perfectionism that makes a project drag on forever because it’s never good enough.” This statement is the antithesis of Dodson’s.

I’d go with Gross and recommend her book, Making ADD Work: On-the-Job Strategies for Coping with Attention Deficit Disorder. With so many ‘experts’ on this subject, someone has to cry ‘baloney’ when nonsense like Dodson’s is put to press.

Training the Brain: Cognitive Therapy As An Alternative To ADHD Drugs

I have written for years that only by redefining ADHD can we address the problem through education and training. Finally, the movement is approaching mainstream as indicated in the article from Scientific American entitled, Training the Brain, Cognitive Therapy As An Alternative To ADHD Drugs.

It is interesting to note that the techniques mentioned in the article have been incorporated in the Play Attention cognitive tools for about ten years.

“Recent studies support the notion that many children with ADHD have cognitive deficits, specifically in working memory–the ability to hold in mind information that guides behavior. The cognitive problem manifests behaviorally as inattention and contributes to poor academic performance. Such research not only questions the value of medicating ADHD children, it also is redefining the disorder and leading to more meaningful treatment that includes cognitive training.”

Salient issues raised by the author include:

1. The difficult decision by parents “To medicate or not? Millions of parents must decide when their child is diagnosed with attention-deficit hyperactivity disorder (ADHD)–a decision made tougher by controversy.”
2. While medication may calm a student’s outward behavior, research shows that it does not increase cognitive ability manifesting in improved academic performance, social relationships, or defiant behavior over the long-term.
3. This has led scientists to research effective means of cognitive training as a substitute.

This is really a shift in our understanding of this disorder from behavioral to biological,” states Rosemary Tannock, professor of psychiatry at the University of Toronto. Tannock has shown that although stimulant medication improves working memory, the effect is small, she says, “suggesting that medication isn’t going to be sufficient.” So she and others, such as Susan Gathercole of the University of Durham in England, now work with schools to introduce teaching methods that train working memory. In fact, working-memory deficits may underlie several disabilities, not just ADHD, highlighting the heterogeneity of the disorder.”

The article focuses on Dr. Torkel Klingberg of the Karolinska Institute in Sweden who trained around 40 kids with ADHD with a software program that addressed “working memory.” After more than 20 days of training parents reported that their children had greatly improved attention and lessened hyperactivity.

Klingberg essentially proved that cognitive retraining improved neurobiological function. This work has been underway with Play Attention since 1994. It’s good to see the paradigm shift beginning to happen.

The Cost of ADHD Drugs Limits Use

The Impact of 3-Tier Formularies on Drug Treatment of Attention-Deficit/Hyperactivity Disorder in Children, a study published in the April 2005 issue of the Archives of General Psychiatry, concludes that number of health plans that limit the cost of ADHD drugs has been increasing in recent years.

Lead researcher, Haiden A. Huskamp, Ph.D. is an Associate Professor of
Health Economics in the Department of Health Care Policy at Harvard Medical
School.

The study concludes that in an effort to save money, many health plans encourage physicians and parents to select drugs that are ‘preferred’ by the health plan. Drugs selected that are not on the preferred list mean higher out of pocket expenses or co-payments. This reduces the likelihood parents will buy ADHD medication for a child.
 
The study found for one health plan, three-tier formularies resulted in a 17 percent decrease in the probability that parents would purchase an ADHD medication for their child. In addition, with the three-tier adoption, the plan’s spending decreased 43 percent and enrollee spending increased 46 percent.”

It seems that the health of the individual should take precedence over money saving strategies. Health plans should encourage, not discourage appropriate drug use.

ADHD: Biofeedback and Neurofeedback: An Introduction

What are Biofeedback and Neurofeedback?

Feedback is an process which reflexively changes itself using its own forceful flow. The classic feedback device is the steam valve. As the steam causes a rotor to turn the centrifugal force of the rotation causes levers to rise, or strings to fly out, in the same way that if you rapidly turn yourself, your arms fly outward.

The levers on a steam device control the flow of steam, the faster the rotation the smaller the steam vent, the smaller the vent the slower the rotation. The size of the vent, the speed of rotation and the force of the arms closing the valve can all be adjusted so that the rotating axle maintains a consistent speed, so long as the supply of steam is constant.

Over one hundred years ago, French physiologist, Claude Bernard, who was characterized by Louis Pasteur “Physiology Itself” noted that most all of the human body’s systems are feedback regulated. In fact, they remain quite constant regardless of changes in the external environment. In 1932, Walter Cannon coined the term homeostasis to describe internal dynamic constancy.

A man eats food, his mouth fills, juices flow, his stomach fills, and his sensors send a signal, “satisfied.” He stops eating. A woman trots upstairs a bit too fast, her oxygen sensors are starved, and she starts breathing more deeply and quickly.

I glance out the window, the sun has moved to bounce off the white wall of the bank next door, my pupils contract, and I turn back toward the darkest wall of the room, or dash into my dark room. My pupils dilate.

Generally, body systems regulate through positive and negative feedback loops. The body has sensors that detect deviation from its normal internal range. This deviation activates effectors that essentially reverse the condition.

Such ordinary biological feedback of daily living can be enhanced by using mechanical transducers (devices which measure energies). I can press a piece of plastic against my palm which turns color depending on my temperature. Quickly I learn to make the color redder and redder (the color is arbitrary, it could be bluer and bluer). If I am prone to headaches I can prevent, inhibit, or relieve a headache by warming my hand. I may measure the way my skin conducts electricity and can learn to make my own skin less conductive which tends to relax me. The plastic has fed the information back to my conscious mind and my brain has learned consciously to warm my hand. My body is responding to a feedback loop. According to Merriam Webster, biofeedback is: “the technique of making unconscious or involuntary bodily processes (as heartbeats or brain waves) perceptible to the senses (as by the use of an oscilloscope) in order to manipulate them by conscious mental control.”

Early in the development of biofeedback attention was first focused on temperature (TEMP) change. Temperature is easily and cheaply monitored and learned change is markedly reliable. Muscle tension (EMG) soon came along. The techniques of measuring muscle tension are perhaps as easily done as temperature measurement; but the equipment is more costly. TEMP and EMG are the most widely practiced forms of biofeedback.

In 1970 Barry Sterman noted that he could readily train cats to strengthen the amplitude of signals at 13 pulses per second generated in the brain’s Fissure of Roland. Later he observed that cats trained to make stronger 13-14 Hz signals resisted epileptogenic drugs (specifically, injected hydrazine). D.A.Quirk, a Canadian penologist, and G.von Hilsheimer, a Florida neurofeedback specialist, applied Sterman’s 1970 method to 2776 felons imprisoned in the Ontario Correctional Institute near Toronto and to about 10,000 clients seen in hospital and in outpatient care. The recidivism in these prisoners (15% in 3 years after discharge, compared to 40 – 100% in typical prisons) reduced significantly.

Subsequently a professional movement has been created using EEG biofeedback in the treatment of ADHD (pioneered by Professor Lubar at the University of Tennessee). In Europe a significant network of practitioners has been organized by Prof. Dr. Jiri Tyl of Prague who has significantly contributed to the proof of the efficacy of EEG biofeedback (see EEG Biofeedback FAQ)

Neurofeedback is a specific type of biofeedback that makes brainwaves perceptible through the use of sensors attached to the head. The brain operates by sending minute electrical impulses to the many cells that comprise it. When the brain is excited it emits a specific frequency range of waves. The same is true if it is tired or focused. This process is similar to a radio tower that gives off radio waves. Brainwave sensors called electrodes monitor brainwaves emanating from the brain much the same way a radio receiver monitors different radio frequencies – if I change my car radio from 101.5 FM to 107 FM, I get to listen to a different station. So, the sensors pick up these signals like little radio antennae. A receiver, like a radio receiver, amplifies them and sends them to a computer where they are changed to sound and/or pictures on the computer monitor. The pictures and sounds make the current state of the brain perceptible because that information is displayed via sound and pictures on the computer screen. So, if a person is overly excited, she can see this on the screen in a graph or perhaps a screen character rapidly buzzing around. If she wishes to calm herself, she learns to slow the computer character which is reflecting the necessary relaxing brainwave pattern. By repeating this process many times, she can eventually learn to place her brain and body in a calm state without the neurofeedback equipment. This learning achieved by biofeedback is robust, stable, reliable, and readily acquired.

There is significant evidence that hyperactive boys tend to make high amplitude slow brain waves which are associated with inefficient faster brain waves. The child can be taught to reduce the amplitude of signals slower than 7 pulses per second (<7 Hz for Hertz) and to increase the strength of the signals running 13-14 Hertz. Such children tend to become more social, more effective at school work, and they perform more adroitly on IQ and other tests. One can think of this process as switching radio stations at will. Neurofeedback students learn to switch from inattentive (daydreaming) states to focused states at will.

See www.drbiofeedback.com, www.aapb.com, www.isnr.org, www.pocket-neurobics.com

George von Hilsheimer, Ph.D., F.R.S.H., and Peter Freer, MAEd

Drug Updates: ADHD Drug Methylphenidate Linked to Chromosomal Changes

In a small but startling preliminary new study, Texas researchers have found that after just three months, every one of a dozen children treated for attention deficit/hyperactivity disorder (ADHD) with the drug methylphenidate experienced a threefold increase in levels of chromosome abnormalities-occurrences associated with increased risks of cancer and other adverse health effects.

The researchers say that to their knowledge this is the first study addressing the potential chromosome-breaking effects associated with treatment of children with methylphenidate, the generic name for a group of drugs that includes Ritalin, Concerta, Metadate CD and others.

Methylphenidate is the most widely prescribed of a class of amphetamine-like drugs used to treat ADHD, with more than 10 million prescriptions written for it in 1996 alone. Between 1991 and 1999, United States sales of methylphenidate increased more than 500 percent.

Researchers at The University of Texas M.D. Anderson Cancer Center in Houston and the University of Texas Medical Branch at Galveston (UTMB) reported their detection of the chromosome abnormalities in the journal Cancer Letters. Their peer-reviewed paper is to be published several months hence, but the journal editors have made it available online in the journal’s “articles in press” section.

The authors said they undertook the study because, even though methylphenidate has been approved for human use for more than 50 years, “there are surprisingly few studies” in either animals or human beings “on the potential for serious side effects,” such as causing mutations and cancer. In 1996, a report discussing several two-year-long animal studies showed that the highest levels of methylphenidate tested caused liver tumors in male and female mice. However, similar studies in rats showed no such tumors.

The new Texas study involved researchers drawing blood from children diagnosed with ADHD before they began taking methylphenidate in order to get a baseline level of chromosomal abnormalities. Three months after the children had begun taking the drug, the researchers drew the children’s blood and tested it a second time. Chromosomes are the bodies within cells that carry the genes and genetic information. All 12 of the children whose before-and-after blood cells were studied were treated with normal therapeutic doses of methylphenidate.

Most of the abnormalities found in the studied blood cells consisted of chromosome breaks “and a higher frequency of aberrations is reported to be associated with an increased risk of cancer down the line,” said lead author Randa A. El-Zein, M.D., Ph.D., an assistant professor of epidemiology at M.D. Anderson who performed the blood studies using several techniques.

“It was pretty surprising that all of the children taking methylphenidate showed an increase in chromosome abnormalities in a relatively short period of time,” El-Zein said.

UTMB Professor of Environmental Toxicology Marvin Legator, the study’s principal investigator and senior author, cautioned, “This study doesn’t mean that these kids are going to get cancer, but it does mean they are exposed to an additional risk factor, assuming that this study holds up.” Of the 53 known human carcinogens, Legator said 48 could be detected using the chromosome analysis methods employed in this study.

El-Zein stressed that much larger studies at several medical centers are needed to confirm the results of this study and to answer other questions not addressed by it. One of these issues is the question of what happens when patients stop taking methylphenidate. “Do the levels of chromosome abnormalities go back to normal?” El-Zein said. “We don’t know.”

Adderall: Canadian Regulators Order ADD Drug Withdrawn

From a recent news story – Drug withdrawal weighs on Shire:

Shares in Shire Pharmaceuticals have fallen 10% after its best-selling drug was withdrawn from sale in Canada amid reports linking it to 20 sudden deaths.

Regulators said data showed 14 children and six adults had died after taking the usual recommended doses of hyperactivity treatment Adderall XR.

Shire said it disagreed with the findings and remained confident in the safety and effectiveness of the drug.

The Hampshire-based firm is the UK’s third largest pharmaceutical company.

Most sales of Adderall XR come from the US.

The US FDA has also issued a Public Health Advisory to notify healthcare professionals that Health Canada, the Canadian drug regulatory agency, has suspended the sale of Adderall XR in the Canadian market.

Adderall XR (amphetamine)
Audience: Neuropsychiatric and other healthcare professionals

FDA issued a Public Health Advisory to notify healthcare professionals that Health Canada, the Canadian drug regulatory agency, has suspended the sale of Adderall XR in the Canadian market. Adderall XR is a controlled release amphetamine used to treat patients with Attention Deficit Hyperactivity Disorder (ADHD). The Canadian action was based on U.S. post-marketing reports of sudden deaths in pediatric patients. FDA is continuing to evaluate these and other post-marketing reports of serious adverse events in children, adolescents, and adults being treated with Adderall and related products. Adderall XR is approved in the United States for the treatment of adults and pediatric patients 6-12 years old with ADHD, and Adderall, the immediate release formulation of the drug, is approved for pediatric patients with ADHD.

More information can be found on the FDA Adderall and Adderall XR Information page.

FDA ALERT [2/09/2005] – Sudden Deaths in Children

Health Canada has suspended marketing of Adderall XR products from the Canadian market due to concern about reports of sudden unexplained death (SUD) in children taking Adderall and Adderall XR.  SUD has been associated with amphetamine abuse and reported in children with underlying cardiac abnormalities taking recommended doses of amphetamines, including Adderall and Adderall XR.  In addition, a very small number of cases of SUD have been reported in children without structural cardiac abnormalities taking Adderall.  At this time, FDA cannot conclude that recommended doses of Adderall can cause SUD, but is continuing to carefully evaluate these data.

More information can also be found on the FDA Patient Information Sheet: Adderall and Adderall XR Extended-Release Capsules and the Alert for Healthcare Professionals: Adderall and Adderall XR (amphetamine).

Re-wiring Your Brain, Meditation & ADHD, A Self-service Guide

In his January 3, 2005 Washington Post article, staff writer Marc Kaufman says, “Meditation Gives Brain a Charge, Study Finds

“Brain research is beginning to produce concrete evidence for something that Buddhist practitioners of meditation have maintained for centuries: Mental discipline and meditative practice can change the workings of the brain and allow people to achieve different levels of awareness.”

“What we found is that the longtime practitioners showed brain activation on a scale we have never seen before,” said Richard Davidson, a neuroscientist at the university’s new $10 million W.M. Keck Laboratory for Functional Brain Imaging and Behavior. ”Their mental practice is having an effect on the brain in the same way golf or tennis practice will enhance performance.” It demonstrates,” he said, “that the brain is capable of being trained and physically modified in ways few people can imagine.”

It seems that science is finally catching up to practices that are literally thousands of years old. It is always amazing and somewhat frustrating that for centuries, millions of people have realized they can rewire their brains; however, science is just now beginning to understand the process and accept that it can actually occur.

Biofeedback and neurofeedback practitioners use equipment to undergo the same changes that the Buddhist monks undergo through training in the process of meditation. The machines used in biofeedback and neurofeedback allow the user to move into the same states as Buddhist monks. Sensors are attached to the scalp which permit the neurofeedback practitioner to view what the brain is doing, called brainwave activity, as it immediately happens via the computer screen. Repeating the practice of neurofeedback can be very similar to meditation. The Keck Laboratory verifies that physical activities or training can actually rewire the brain and this has been demonstrated for feedback practitioners too.

“The brain uses an enormous amount of the body’s energy. Even under normal circumstances it uses about 20 percent of your body’s entire energy production. When you work your brain harder, [meditate, use neurofeedback or biofeedback] you use more. The blood flow goes to the brain and it’s really like working out,” says Duke University neurobiologist Dr. Lawrence Katz.

Executive Director of the Center for Brain Health and professor of behavioral and brain sciences at the University of Texas at Dallas, Dr. Sandra Chapman says she wants to dispel the myth that the brain is “an untouchable black box. The brain is highly modifiable by everything we do.” Everything we do includes physical exercise, social interaction, meditation, prayer, or playing. Chapman says, “Whatever you spend time doing is what part of your brain is going to strengthen. Don’t do random things. Ask yourself if that’s the part of your brain you want to build. We see people who lose a lot of their ability, but the first thing to come back is the thing that they did the most.”

From our new knowledge of the working brain, it is evident that the opportunity exists to rewire the circuits that are weakest in persons with ADHD, i.e., those circuits that don’t allow attention to low-level stimuli like balancing a checkbook, cleaning your room, finishing homework, staying organized, or finishing a project at work. The object is to practice mindfulness and work on the aforementioned specific tasks. I developed Play Attention for just this purpose and science is finally catching up to us.

In referring to rewiring and strengthening the brain, research psychiatrist, Jeffrey Schwartz, of UCLA’s Neuropsychiatric Institute says, “The key really is the refocusing. When you refocus you activate alternative brain machinery… [It] really is like going to the gym; you’re strengthening your brain. When you stop doing it, you have a stronger brain.”

So, to rewire the circuits that are weak and strengthen them, we must repeatedly practice. For people with ADHD, this practice is clear: we must practice attention and those subordinate skill sets that are conspicuously missing. That’s the foundation of Play Attention. It is the only feedback based learning system that incorporates attention training with cognitive skills training. Our patents guarantee that. The scientific community IS finally catching up.

Portions of this blog were derived from Sky Magazine’s Brain’s World by Sophia Dembling (Feb. 2005)