American Heart Association recommends Heart Exam (EKG) Before Getting ADHD Drugs

In the wake of the deaths of 20+ children taking ADHD stimulant medication, the American Heart Association (AHA) cautioned this week that children should be screened for heart problems with an electrocardiogram(EKG) before getting drugs like Ritalin to treat hyperactivity and attention-deficit disorder.

The National Institute of Mental Health estimates that between 5% and 7% of children have ADHD. They speculate that about 2.5 million American children and 1.5 million adults take medication for ADHD to control behavior and increase focus.

Stimulant drugs like Concerta, Adderall, Ritalin, etc. are classified as schedule II drugs –the same category as cocaine. They can increase blood pressure and heart rate which is problematic for children with heart conditions. It could result in vulnerability to sudden cardiac arrest — an erratic heartbeat that causes the heart to stop pumping blood through the body — and other heart problems.

After review of these implications by the FDA, the FDA mandated that these medications carry warnings of possible heart risks in those with heart defects or other heart problems.

The AHA is now recommending children receive a thorough exam, including a family history and an EKG, before children are put on the ADHD drugs to insure that they don’t have any undiagnosed heart issues.

“We don’t want to keep children who have this from being treated. We want to do it as safely as possible.” said Dr. Victoria Vetter, a pediatric cardiologist at the University of Pennsylvania School of Medicine and head of the committee making the recommendation.

American Heart Association

AHA recommendations: http://www.americanheart.org/presenter.jhtml?identifier=3055953
http://www.americanheart.org/presenter.jhtml?identifier=3055974

Hospital Begins Screening for Heart Conditions in ADHD Children

The American Heart Association’s (AHA) recent recommendation that children be screened for possible heart problems before taking ADHD stimulant medication has spurred great anxiety among parents and professionals. The recommendation was given as a response to a number of deaths due to heart failure associated with ADHD stimulant medication.

In response to the AHA’s recommendation, the Pediatric Cardiology Division at the University of Virginia Children’s Hospital will begin offering electrocardiograms (ECG or EKG) for ADHD children taking stimulant medications for the disorder.

According to Dr. George McDaniel, director of the Pediatric Electrophysiology Program at UVA Children’s Hospital, this exam is important because not all children show obvious signs of a heart condition or abnormality.

The AHA also recommends that ADHD children receive a thorough family history and an EKG by their healthcare providers to screen for problems before they may arise.

Experts at UVA Children’s Hospital say the recommendations are conservative but the information is worth knowing.

Families should be reassured that there is no real urgency for a patient who is not having any difficulties,” said Dr. Paul Matherne, director of the Division of Pediatric Cardiology at UVA Children’s Hospital. “According to the guidelines parents should not stop their child’s medication and can have this screening done by their medical care provider at their next appointment.”

Student Use of Stimulant Meds

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.

Dr. Joe Biederman and ADHD

Massachusetts General Hospital (MGH) issued a press release regarding a study performed by Joseph Biederman, MD and colleagues. Biederman is a professor of Psychiatry at Harvard Medical School.  The study finds that the use of stimulant drugs to treat children with ADHD has no effect on their future risk of substance abuse.

This study directly contradicts previous studies which indicate stimulant treatment could increase substance abuse risk.  The authors of the current study (Biederman, et al) maintain that previous studies produced conflicting results because they had several limitations; some only looked at adolescents, although young adults are at the highest risk of substance abuse. The authors argue that other studies did not control for conditions such as conduct disorder that are known to be associated with substance abuse. This is commonly referred to as co-morbidity and is truly the norm for ADHD as ADHD virtually never presents by itself. It is commonly associated with conduct disorder, learning disabilities, dyslexia, etc. The authors also maintain that other studies may have examined the impact on use of only a particular substance.

Biederman, like Russell Barkley, seems to get substantial funding from the pharmaceutical industry. That being disclosed, Biederman’s previous research tended to promote the use of stimulant medication [from www.Sciencedaily.com]:

“Earlier studies under the MGH Psychopharmacology group had suggested that stimulant treatment might actually reduce the risk of substance abuse in ADHD patients, who are at elevated risk to begin with…”

Imagine that! Taking stimulant medication in the same class as cocaine or speed in my early years would prevent me from desiring to use addictive drugs in my later years! Now that’s impressive, Joe. Obviously that was an untenable position, but Joe got the next best result with his try-again research methodology; it may not prevent substance abuse later on, but at least, Dr. Joe maintains, it doesn’t cause it.

“Because stimulants are controlled drugs, there has been a concern that using them to treat children would promote future drug-seeking behavior,” says Dr. Joe, the study’s lead author.

The MTA (Multimodal Treatment of ADHD) found that after three years of drug taking, they couldn’t find any difference in children medicated and children who had done nothing at all. The study’s authors said they witnessed no overall global academic improvement, behavioral improvement, or social improvement. They also found that children in their study had lower overall weight. Height was also less than peers.

What interests me greatly is the fact that when the authors of these studies have close ties to the pharmaceutical industry, their data tends to be skewed in favor of medicine. When there isn’t a close tie, we tend to get contradictory data, which is what one would expect.

I’m not an advocate of medicine, but I’m not an opponent either. It has its place and can help some children in the short-term. It must be supported with cognitive and behavioral interventions to maximize the opportunity for change. 

As far a research goes, all I want is the truth. Nothing skewed. No hidden agendas.

States sue over costly ADHD drug program

Florida undecided as states sue over costly drug program

By M.C. MOEWE, staff Writer

They’re powerful psychotic drugs, used to treat conditions like schizophrenia. No one knows what their effects are on children, especially infants, yet within seven years the number of children prescribed the drugs in Florida’s health insurance program for the poor has nearly doubled.

There’s no doubting one side effect, though — drug companies watched sales soar, aided by a Florida program they helped create.

Florida is far from unique. Several states also noted the costly boom of atypical antipsychotics — a new class of the drug that was touted to have fewer side effects. The states are suing drug makers, alleging the companies pushed newer, untested drugs that proved no more effective in treatments — but were far more costly.

In Florida, the taxpayers’ bill for the drugs jumped from $9 million seven years ago to nearly $30 million in 2006. Whether Florida will join states like Texas, Pennsylvania and South Carolina in trying to recoup some of those costs is unclear.

“Our office is aware of concerns with antipsychotics in Florida’s Medicaid program but we cannot acknowledge nor provide any information pertaining to ongoing criminal investigations,” said Sandi Copes, a spokeswoman with the Florida Attorney General’s office.

Florida Medicaid records show the number of children — some just months old — who were prescribed the drugs went from 9,364 seven years ago to 18,137 in 2006. No records for privately insured patients are available.

“The situation is out of control,” said David Cohen, a professor at Florida International University who has been studying the use of antipsychotics since 1983. While no long-term studies have been done on the effects the drugs have on children, there is evidence children on the drugs face greater risks of diabetes, hyperglycemia and extreme weight gain, Cohen said.

‘MOOD STABILIZERS’

Orange City child psychiatrist Manuel Mota-Castillo said age shouldn’t be a factor in determining whether the drug is needed. He has prescribed antipsychotics to children frequently, with the youngest being a 25-month-old child.

“I don’t want to use the name ‘antipsychotic.’ I use ‘mood stabilizer,’ ” said Mota-Castillo, who also worked for three years at Act Corp., the area’s main mental health facility.

The 25-month-old child had been kicked out of five day-care centers where complaints included punching other children, he said. “The child’s mother came to me in shorts so I could see the bruises and marks (on her),” he said.

Crystal Lamson of Sanford said Mota-Castillo has been treating her bipolar son for more than two years. Ryland, now 7, broke a Plexiglas window at a day-care center when he was 5.

“I get criticized all the time from family members,” Lamson said. “(But) there are some children out there who do need them.”

Another Sanford parent, Richard Davis, said he watched in horror as his daughter Ciara, then 6, gained 40 pounds, developed breasts and had uncontrollable tongue and facial movements.

“Those drugs were killing her,” Davis said.

Over his objections, he said Ciara was given antipsychotics by her mother and while in foster care. A court-appointed guardian also noted the effects in an August 2003 report, describing a visit in which Ciara “never once kept her tongue in her mouth.”

Ciara, now 11, was taken off the drugs after about a year, her father said, and she quickly dropped the added weight.

‘TAINTED’ MONEY

In Florida, even as drug makers were being told to issue warnings about risks, a Florida Legislature-directed program partly funded by pharmaceutical companies was recommending the drugs as treatment for attention deficit hyperactivity disorder (ADHD) with tics or intermittent explosive disorder, according to the program’s Web site that has since been shut down.

According to a study that looked at three years of data, about 40 percent of the antipsychotics prescribed to Florida Medicaid children were given to children diagnosed with ADHD — a use not approved by the Food and Drug Administration.

The Florida program was patterned after a Texas project that has spurred a whistle-blower lawsuit. The Florida Algorithm Project used some of the Texas-developed medical formulas that recommended drug treatments for mental diseases.

A year ago Texas joined the whistle-blower suit against Janssen Pharmaceutica and several other Johnson & Johnson subsidiaries. The suit alleges the program’s treatment guidelines — “improperly influenced” and paid for by the drug companies –increased sales of the antipsychotic Risperdal.

An official with Janssen said the company will defend its actions.

“We believe our participation in all aspects of our Texas Risperdal activities were in accordance with what the law required,” said Ambre Morley, a company spokeswoman.

Florida pilot programs using the Texas-developed guidelines began in 2001, according to state documents. Act Corp. in Volusia County was one of 15 sites that adopted the program until it was discontinued in September 2004.

James Bax, a former director of the Florida program, said the project began with funding from pharmaceutical companies.

“It did not take me long to realize that the money from the drug companies was tainted,” Bax said. “Once I got into it, I saw what I thought was very insidious.”

According to the program’s defunct Web site, Bax was director only a couple of months before a retired Johnson & Johnson employee took the title.

In 2002, the Florida Legislature permitted the Department of Children & Families to accept grants from pharmaceutical manufacturers to develop training for health care organizations serving public sector clients, according to a September 2003 Agency for Health Care letter about the Florida program.

When first interviewed, those familiar with the program said they did not recall any ADHD-related information. But archived pages from the program’s Internet site show the program had more guidelines on how to treat ADHD than any other ailment. A 2004 report about the program’s progress pointed to the development of an ADHD guideline as an accomplishment.

Rajive Tandon, chief psychiatrist for the Mental Health Program Office with Florida’s Department of Children & Families, said he’s not sure how much impact the Florida program had on the increased use of antipsychotics.

“It certainly was a contributing factor,” he said.

Doctors believed the new antipsychotics were better, Tandon said, citing “aggressive marketing.”

But the new antipsychotics proved no more effective than older drugs in two significant studies — one published in 2005 in the New England Journal of Medicine and another in the Journal of the American Medical Association published in 2003, said Cohen, the antipsychotics expert at Florida International.

Tandon said Florida should consider a lawsuit like other states.

“Should we at least look into it? Absolutely,” he said, calling for, at minimum, an investigation into the Florida program’s funding and impacts. “Then basically hold the appropriate people responsible.”

– News researcher Janice Cahill contributed to this report.

More Drugs

Atypical antipsychotics were touted to have fewer side effects than older antipsychotics, and their use increased among children in Florida’s Medicaid program under guidelines that drug companies helped create between 2000 and 2006.

ADHD Medications: Mayo Clinic Study Contradicts MTA Study

As I wrote earlier, the longest study actually performed while following live children was the MTA and its 3-Year Follow-up of the NIMH MTA (multi-modal treatment) recently published in the journal of the American Academy of Child and Adolescent Psychiatry.

Co-author, Professor William Pelham, of the University at Buffalo, says: “The children had a substantial decrease in their rate of growth so they weren’t growing as much as other kids both in terms of their height and in terms of their weight. And the second was that there were no beneficial effects – none.”

Pelham adds, “In the short run [medication] will help the child behave better, in the long run it won’t. And that information should be made very clear to parents.”

Here’s the most telling observation of the study: “I think that we exaggerated the beneficial impact of medication in the first study. We had thought that children medicated longer would have better outcomes. That didn’t happen to be the case. There’s no indication that medication’s better than nothing in the long run.”

It’s obvious that this information was not good for the pharmaceutical industry. As is now common practice, a study will be launched to counter this kind of negative press. So, it was no surprise that the respected Mayo Clinic released a study two months later that “…reveals that compared to children without AD/HD, children with ADHD are at risk for poor long-term school outcomes such as low achievement in reading, absenteeism, repeating a grade, and dropping out of school. Both studies appear in the current edition of the Journal of Development & Behavioral Pediatrics, (http://www.jrnldbp.com).”

“In this study, treatment with stimulant medication during childhood was associated with more favorable long-term school outcomes,” explains William Barbaresi, M.D., Mayo Clinic pediatrician and lead author of the reports.

The MTA study focused on real families in real-time. The researchers were able to observe family dynamics, environment, pharmacological interventions and their relationships to academic and behavioral outcomes. This, of course, takes a significant amount of time and field researchers.

According to the Mayo Clinic Press Release, “The two Mayo Clinic studies are the first population-based, long-term studies to investigate links between ADHD, school performance and factors that modify long-term school performance of children with ADHD.”

Here’s how research like this works: researchers are given access to school files and medical records. They select and review data from files to draw their conclusions. This is becoming more popular than live research because it is less expensive, doesn’t require a significant number of field researchers, and can be done in less time. Unlike real-time research like the MTA, the Mayo study’s limitations are significant; it doesn’t allow real-time access to families or teachers to gain information regarding environment, family issues, etc; to interpret information; or to clarify written information. So the researchers are fairly limited to test scores and medical records. While this makes it easy to prepare and select data, it falls far short the information gather by a real-time study.

The Mayo study press release summarizes the research:

Dr. Barbaresi believes that both studies provide the first solid evidence of the long-term negative academic performance associated with untreated ADHD – as well as evidence for the best way to manage this problem. Dr. Barbaresi says, “The finding that treatment with stimulant medications is associated with long-term improvement in school outcomes is significant. Previously, there was evidence that treatment with stimulant medications improved short-term academic performance, but there was no good evidence that long-term outcomes are better with stimulant treatment. Our data can guide clinicians in their efforts to help children with ADHD succeed in school.”

Note that no mention is made of height and weight loss of children in the Mayo Clinic study as was found by the MTA. Furthermore it also directly contradicts information released by the MTA. Here’s the rub, funding for the Mayo study was contributed by grants from the U.S. Public Health Service; National Institutes of Health; Mayo Clinic Foundation for Biomedical Research; and McNeil Consumer and Specialty Pharmaceuticals.

Obviously the one extraordinary contributor was McNeil Consumer and Specialty Pharmaceuticals. McNeil is the producer of Concerta, a stimulant medication for ADHD. Is it likely that McNeil would contribute to a study that would indicate weight loss and stunted growth from use of its product? Not likely.

Would McNeil contribute to a study whose researchers said, “I think that we exaggerated the beneficial impact of medication in the first study. We had thought that children medicated longer would have better outcomes. That didn’t happen to be the case. There’s no indication that medication’s better than nothing in the long run.” Not likely.

It is a direct conflict of interest for a pharmaceutical company to participate in research with universities, hospitals, or other entities. I’ve never seen negative information released from a study performed by a pharmaceutical company on their own drug. Strange, isn’t it?

ADHD Medications and Neurofeedback

The Multimodal Treatment Study of Children With ADHD has been one of the longest studies performed on a select group of ADHD children. Recently published in the journal of the American Academy of Child and Adolescent Psychiatry, the data are somewhat alarming.

Data from the study were used to evaluate whether stimulant medication effects physical growth in children. The data collected over three years indicates that both height and weight are decreased in children using stimulant medication.

Co-author, Professor William Pelham, of the University at Buffalo, says: “The children had a substantial decrease in their rate of growth so they weren’t growing as much as other kids both in terms of their height and in terms of their weight. And the second was that there were no beneficial effects – none.”

Pelham adds, “In the short run [medication] will help the child behave better, in the long run it won’t. And that information should be made very clear to parents.”

Here’s the most telling observation of the study: “I think that we exaggerated the beneficial impact of medication in the first study. We had thought that children medicated longer would have better outcomes. That didn’t happen to be the case. There’s no indication that medication’s better than nothing in the long run.”

Our good professor, Dr. Russell Barkley just spoke at a national conference citing that medication is by far the best and most trusted method. Unfortunately dinosaurs like Barkley do exist, are respected, and yet completely propagate information that has no substance in current research. Barkley is also a critic of neurofeedback.

On another front –

ADHD Drugs To Be Examined

“Two federal agencies will collaborate in the broadest study ever of prescription drugs for the treatment of attention deficit hyperactivity disorder (ADHD) and the potential for cardiovascular problems.

Over the next two years, the Agency for Healthcare Research and Quality and the Food and Drug Administration (FDA) will examine clinical data of some 500,000 adults and children who have taken such medications to determine whether they increase the risk of heart attack or stroke, the U.S. Department of Health and Human Services announced.

The FDA’s Gerald Del Pan, MD, said case reports describe “adverse cardiovascular events in adults and pediatric patients with certain underlying risk factors who receive drug treatment for ADHD, but it is unknown whether … these events are causally related to treatment.”

The study of all ADHD drugs by class will be coordinated by Vanderbilt University, with analysis by its researchers, Kaiser Permanente of California, the HMO Research Network and i3 Drug Safety, plus the FDA and AHRQ, the government said.”

Curiously, this study has already been done with results published by the University of Oregon. I’ve published the results of this study before, but it was not at all favorable for ADHD drugs. Real data on long term effects, safety, comparative analysis, and general efficacy are lacking. Let’s hope the new study treats the subject with the objectivity and professionalism of the University of Oregon.

As I’ve said in past entries, I’m not a proponent of clinical neurofeedback, and I find there are limitations to some of its research, much of the research, especially research performed over the last few years, demonstrates the possibility that the brain can and will make changes provided it is given the right stimulation. Unfortunately, clinical neurofeedback training doesn’t address other core issues like organization, memory, discriminatory processing, auditory processing, time on-task, and other cognitive skills. That’s exactly why I created Play Attention. It addresses far more than clinical neurofeedback.

Probably most importantly, neither neurofeedback or Play Attention cause any stunted growth, weight loss, tics, or any side effects like medication. From our follow-up with our clients over the last eleven years, positive training effects last as well. Far unlike medication which “In the short run will help the child behave better, in the long run it won’t. And that information should be made very clear to parents.”

Medication, ADHD and Heart Complications

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.

Neurofeedback, ADHD and Medication

In his Attention Research Update, September 2007, David Rabiner, Ph.D. Senior Research Scientist, Duke University, entitled his article, How Strong is the Research Support for Neurofeedback Treatment? The report is rather perfunctory and the staid course he’s followed for years. A fresh, candid review must be performed regarding research on multi-modal treatments, neurofeedback, and medication.

Therefore, my intent here is to examine multi-modal treatments, neurofeedback, medication, their accompanying controversy and myth, and research support. I’m certain you’ll find this examination both enlightening and substantially different perceptively.

I will use some of Dr. Rabiner’s statements and also attempt to make sense of the misinformation that is propagated intentionally or unintentionally through CHADD (Children and Adults with Attention Deficit /Hyperactivity Disorder).

For the purpose of full disclosure when writing this entry:

Play Attention

I should disclose that I developed Play Attention, a device that monitors brain activity. It is used educationally to teach cognitive skills, improve attention, and shape behavior. It is not clinical neurofeedback. To be candid, I’m not a proponent of clinical neurofeedback for reasons I’ll describe below.

Dr. David Rabiner

Furthermore, it should also be disclosed that the Dr. Rabiner’s newsletter is funded by CogMed, a group that sells memory games to address ADHD, and Shire pharmaceuticals, the makers of Adderall and other ADHD medications.

Play Attention has paid Dr. Rabiner in the past to advertise in his newsletter. Dr. Rabiner also sat on the advisory board for Play Attention for several years. Play Attention can no longer advertise in Dr. Rabiner’s newsletter due to his contractual obligations with CogMed. CogMed will no longer allow Dr. Rabiner to sit on Play Attention’s advisory board either.

CHADD & Neurofeedback

CHADD is listed as a nonprofit organization, but still receives significant financial support from the pharmaceutical industry. Historically, it has done little else other than offer tips and strategies and support the use of medicine as a primary treatment.

According to Dr. Rabiner’s newsletter, CHADD’s stance on neurofeedback is summarized in their fact sheet on alternative and complementary interventions, which includes the following statement about neurofeedback:

It is important to emphasize, however, that although several studies of neurofeedback have yielded promising results, this treatment has not yet been tested in the rigorous manner that is required to make a clear conclusion about its effectiveness for AD/HD. The aforementioned studies can not be considered to have produced persuasive scientific evidence concerning the effectiveness of EEG biofeedback for ADHD.”

Well, if we hold EEG biofeedback (neurofeedback) to this “rigorous manner that is required to make a clear conclusion about its effectiveness for AD/HD,” it is only fair to hold every intervention including medication and multi-modal interventions to it as well.

Quite frankly, you’ll be surprised that they do not live up to this standard either. The actual research about medication is really no stronger than that for neurofeedback. It seems we have double talk here by an organization that receives funding from the pharmaceutical industry. Perhaps, given the benefit of the doubt, they just aren’t aware of it.

ADHD Medication Research
While it received little press in 2005, the Drug Effectiveness Review Project, based at Oregon State University released a 731-page report which thoroughly analyzed 2,287 studies – virtually every investigation ever done on ADHD drugs anywhere in the world – to reach its conclusions. To date, it is the most thorough and comprehensive evaluation of all research performed on ADHD drugs.

The American Association of Retired Persons (AARP) and Consumers Union, the publisher of Consumer Reports report the data to their respective audiences. Fourteen states other than Oregon are the principal financiers the Drug Effectiveness Review Project.

The prestigious Oregon Evidence-based Practice Center, Oregon Health & Science University Drug Effectiveness Review Project’s primary purpose is to provide consumers and state insurance plans trustworthy information about pharmaceuticals. The Drug Effectiveness Review Project’s physicians and pharmacists don’t just analyze ADHD medications, so this was not an attempt to subvert or smear that industry. They analyze virtually every study on a given class of pharmaceuticals to determine the best drugs in that class and present their findings to the public and insurance industry. The Project examined 27 drugs which included Adderall, Concerta, Cylert, Focalin, Provigil, Ritalin, Strattera, and others.

In its analysis of published and unpublished research data produced by six prominent ADHD medication producers, the group found that 2,107 studies were unreliable and were subsequently rejected. Now, this is telling in itself. Finding 2,107 funded yet critically poor or fundamentally flawed studies performed by universities and the pharmaceutical industry itself speaks volumes to the nature of that research and those people responsible for it.

The Project began its review of the remaining 180 studies which demonstrated good controls and methods. Its conclusions regarding ADHD medication were quite astounding.

Here, bulleted, are some incredible results with comments:

• “No evidence on long-term safety of drugs used to treat ADHD in young children” or adolescents. Now, if you ask any physician, or the pharmaceutical industry, they will tell you the drugs are completely safe for long-term use based on research. That research doesn’t exist.

• The research providing any evidence of safety is of “poor quality.” This includes research regarding the possibility that some ADHD drugs could cause heart or liver conditions, tics, or stunt growth.

• “Good quality evidence … is lacking” that ADHD drugs demonstrate improvement in “global academic performance, consequences of risky behaviors, social achievements,” and other measures. The common perception is that ADHD drugs do improve academic performance and social skills. Many drug makers use ads depicting this. However, evidence for long-term improvement in academics, social skills, or behavior is virtually non-existent.

• Drug makers have found that they can expand their market by inducing adults into the ADHD experience. However, the Project found that evidence “is not compelling” demonstrating that ADHD drugs actually help adults, nor is there evidence that one drug “is more tolerable than another.”

Furthermore, the Project found that the U.S. Food and Drug Administration doesn’t require pharmaceutical manufacturers to compare newly developed medications with medications currently on the shelf. Most companies simply use a placebo or sugar pill given instead of their medication as a control. Therefore the Project found that “good quality” studies are lacking that pit one drug against another to provide evidence of effectiveness. It also could not find comparative data which might help determine which ADHD medications are less likely to produce detrimental side effects like heart and liver problems, depression, decreased appetite, tics, or seizures.

The Project could not find research that clearly provided an understanding of way that ADHD drugs work. It is not well understood for most ADHD drugs.

Even the research on ADHD performed by the respected Dr. Russell Barkley, a critic of neurofeedback studies, ranked only “fair” in the Project’s analysis of research and he’s had significant funding from the pharmaceutical industry, federal government, and universities. Noting that he’s cited most neurofeedback research as lacking, wouldn’t we expect at least a “good” or even a “superior” on his report card?

So, if one chooses ADHD medication, how does one know which drug is safer? Works better? Has fewer side effects? The research isn’t there, so we don’t know. In light of this, the Project suggested that one may do just as well on methylphenidate (generic Ritalin) which is far less expensive than newer options such as Concerta or Adderall. Incidentally, when the Project reviewed research on Concerta, it concluded that Concerta “did not show overall difference in outcomes” compared to generic good old cheap generic methylphenidate. Is Adderall any better? The Project found evidence to be “lacking.”

Do ADHD drugs provide long-term improvement for academic performance? Social interaction? Better behavior? The research just isn’t there.

The Project made clear that its findings do not mean ADHD drugs are unsafe. They may be safe and sometimes useful, but the Project found scientific proof is lacking.

While I’m not a clinical neurofeedback proponent, I think it’s clear that if pundits like Dr. Rabiner and organizations like CHADD are going to talk about good research, then let’s level the playing field and have the same requirements for everyone.

Standards of Research, Dr. Rabiner, & CHADD

Let’s go back to CHADD for a moment and its warnings about neurofeedback.

“Controlled randomized trials are required before conclusions can be reached. Until then, buyers should beware of the limitations in the published science. Parents are advised to proceed cautiously as it can be expensive – a typical course of neurofeedback treatment may require 40 or more sessions – and because other AD/HD treatments (i.e., multi-modal treatment) currently enjoy substantially greater research support.

Now, let’s examine the 3-Year Follow-up of the NIMH MTA (multi-modal treatment) Study. CHADD states studies such as this most recent one and most thorough one “enjoy substantially greater research support.” :

According to Dr. Rabiner, neurofeedback studies, while often producing good results, often lack random assignment. Here’s what he states in his current newsletter:

    Random Assignment

    Imagine that you are testing a new medication treatment for ADHD with 50 children who have been carefully diagnosed. In a random assignment study, whether each child is assigned to the treatment or control condition is determined by chance – you could flip a coin and give the medicine to the ‘heads’ and nothing to the ‘tails’. This insures that any differences that might exist between children who get the medication and those who don’t are purely chance differences. At the end of the study, if those who received the medicine are doing better, you could feel confident that this is probably due to the medicine itself, and not to differences that may have been there before the treatment even started.

    What if you didn’t use random assignment, but let each child’s parents choose whether their child is in the treatment or control group? In this case, it is possible that children in the 2 groups differed in important ways before the treatment began. If children who received the medication were doing better at the end of the study, it might be because of differences that were there to start with.

    For example, parents who chose the medicine might be more willing to pursue other ways to help their child than those who didn’t. The fact that children who received the medication were doing better at the end of the study might thus have nothing to do with the medicine itself, but reflect other things their parents were doing to help them. No matter how hard you might try to rule out these other possible explanations – and I’m sure you can think of many others – you could never do this with certainty. Thus, I might reasonably doubt that your new medication is really effective.

National Institutes of Mental Health Multi-Modal Treatment Study

But if Dr. Rabiner is correct that research without random assignment is ambiguous, possibly not valid, then let’s try to evaluate data from the 3-Year Follow-up of the NIMH MTA (Multi-Modal Treatment) Study. Let’s look at the researchers said about the 14th month:

    Indeed, once the delivery of randomly assigned treatments by MTA staff stopped at 14 months, the MTA became an observational study in which subjects and families were free to choose their own treatment but in the context of availability and barriers to care existing in their communities.

So what are we to gain from the long-term evaluation done in the MTA study? Does it enjoy substantially greater research support? According to Dr. Rabiner’s standards, not if it became an observational study.

CHADD also warns that neurofeedback is expensive. How expensive is it compared to ongoing medication for a lifetime? We’ll that’s relative isn’t it? How expensive is medication to a single mom with no insurance? Heck, to any parent with or without insurance? To grandparents raising their grandchild in mom’s absence? And by taking medication, which is expensive (Concerta, AdderallXR), etc, are we guaranteed anything more than what neurofeedback might offer? According to available research, No. CHADD’s arguments lack substance but have been their common response for a long time. I am asking that this nonsense ends.

Neurofeedback

Back to neurofeedback…The primary purpose of neurofeedback is to alter brainwave patterns that are presented in real-time feedback to clients. Clients [Rabiner] “…are trained to alter their brainwave activity and taught to alter their typical EEG pattern to one that is consistent with a focused and attentive state. According to neurofeedback proponents, when this occurs, improved attention and reduced hyperactive/impulsive behavior will result.”

Thus, the fundamental premise behind neurofeedback is that brainwaves are dysregulated, especially in certain areas of the brain, and training can regulate them. Furthermore, it is proposed that this regulation improves attention and behaviors. I find this to be rather facile. Neurofeedback’s premise is surprisingly similar to medication in essence; fix these brainwaves and the person is fixed whereas proponents of drug intervention insist that if one takes a pill ADHD is fixed! Unfortunately, neither of these therapies adequately fully addresses core issues of ADHD. Neither medication or neurofeedback, by themselves teach the skills one needs to survive and thrive in the workplace or classroom. Skills like organization, improved memory, discriminatory processing, auditory processing, time-on-task, etc. are not trained through either of these interventions. The only way to attain them is to train and learn them.

I’m not saying that neurofeedback doesn’t work. It’s been field tested as has been medication for years. Could it be a worthwhile tool to be used in a multi-modal plan? Yes. Again, let’s level the playing field.

Current Neuroscience & Neuroplasticity vs. Current ADHD Interventions

The reality about neurobehavioral problems is that they exist in a context, i.e. they exist because of the brain and because of that brain’s environment. The brain is directly affected by its environment. The brain is neuroplastic; it will and does adapt according to the stimulation it receives. That is conclusive fact. No doubt about it. So, if we are speaking about a human being, then attention problems are not just brain based. They may take root there, but they are also directly related to and affected by one’s environment. Therefore, appropriate environmental factors play a great role in the treatment of ADHD including behavior shaping, consistent reward/consequences, structure, etc.

The fact that our current system doesn’t address this fact is where we fall far short of correctly treating ADHD.

Let’s say that little Jimmy demonstrates some fidgeting and inattention at school. His teacher writes a note home telling Jimmy’s parents she suspects Jimmy may have ADHD. Jimmy’s parents take heed and bring him to the pediatrician where Jimmy gets a prescription for medication within 20 minutes. This is the norm.

What’s sorely missing is where Jimmy’s parents or Jimmy’s pediatrician write a note back asking to speak to the teacher to develop a plan of action regarding Jimmy’s behavior before beginning medication. This should be our standard practice regarding ADHD. We need to change the way we view ADHD and the way we address ADHD according to current neuroscience, not how we addressed it in 1980.

Unfortunately, most pediatricians or general practitioners are quite overwhelmed and not well equipped educationally to provide a full battery of tests taking up to four or five hours for an accurate diagnosis. So, a reverse diagnosis is made; the MD writes the prescription for medication and if it works, it was ADHD!

The problem is that stimulant medication works for everyone. If we have two groups of children, one group diagnosed with ADHD and one group of average children, both given boring tasks, both medicated, who will do better on the boring tasks? The answer is: Both! Medication is a shotgun approach that teaches nothing. Virtually no research demonstrates long-term efficacy in social improvement, academic improvement, or behavioral improvement.

Attention is a skill like any other skill. It can be considered a cognitive skill that is measured by behavioral or performance analysis. Should strategies, known to work to improve performance on ADHD students be attempted before medication or neurofeedback? Yes. Resoundingly yes! Should Jimmy’s parents adopt a structured, consistent schedule at home? Yes. Should Jimmy’s parents develop a behavioral plan for school and home working together with Jimmy’s teacher? Yes. Should all of this be employed before neurofeedback and medication? Yes. Could it be employed while using either medication or neurofeedback? Yes. Is it far less expensive than these other interventions? Yes.

Why don’t we do this first then? While a variety of factors relate to the answer, one of the most significant ones is: It is easier to take a pill or to ask someone else to solve your problem than it is to do the work to solve it yourself. Granted, many parents are not trained to work with ADHD children, but they can learn and need to – it’s part of being a parent.

I’ll quote the respected psychologist, Dr. Abraham Maslow –

If the only tool you have is a hammer, you tend to see every problem as a nail.

Here’s how this quote relates to our current dilemma: Many parents rely on their Doctor’s opinion alone believing the physician is almost all knowing. Doctors, pediatricians included, are sparsely trained to instruct parents or educators on how to facilitate a multi-modal management plan. Instead, as they are instructed from medical school and because medicals schools rely heavily on pharmaceutical money, they are given the only answer: drugs. It is only natural that parents believe this. Unfortunately, neither the medical industry, pundits, or CHADD are familiar with research regarding medication or either choose to ignore it.

Neurofeedback Controversy

Back to Dr. Rabiner’s newsletter, this segment entitled, Controversy Surrounding Neurofeedback Research.

Neurofeedback treatment for ADHD has been a source of substantial controversy in the field for many years and remains so today. Although there are a number of published studies in which positive results have been reported, many prominent ADHD researchers feel that given significant limitations to the design and implementation of these studies, neurofeedback should be considered a promising, but unproven treatment.

I think it’s quite reasonable to say that the ‘controversy’ surrounding neurofeedback is constantly stirred up by articles such as Dr. Rabiner’s. He also says that neurofeedback studies sometimes suffer from smaller populations, etc. It does make good press, but given significant limitations to the design and implementation of studies on multi-modal treatments and pharmaceuticals, they should all be considered promising, but unproven treatments. Neurofeedback research seems to suffer the same dilemma as that of multi-modal and pharmaceutical interventions – all could be far stronger. All have considerable weaknesses. All have some strengths because they’ve been field tested for many years. So, either they are all controversial, or none of them is controversial. It’s far past time to stop double talking.

Summary

Neither medication nor neurofeedback are solutions unto themselves.

Without hidden agendas or profit motives they are on the same playing field. Now, let’s play fair and develop strategies based on our knowledge of the ADHD problem. It’s in the best interest of our children and their outcomes to find workable, manageable solutions.

Obviously, no one intervention is best, proven, or more reliable even if marketing people would like to make it seem so. It takes a whole village to raise a child. It takes a group of interventions to raise an ADHD child. Let’s find the best interventions, based on honest available research, use them in concert, and see if it works. And understand this caveat clearly, just because research, no matter how high a grade it’s given, demonstrates efficacy, it doesn’t mean that it will work successfully for you or your child. That’s just because we’re human. We learn differently, respond differently, and are wired differently based on our years of exposure to the world and our genetic makeup. That’s not theory. That’s fact.

Given that no intervention is sufficient by itself, it will always be a matter of trail and error to determine what course of actions will succeed for the long-term. Even though we desire or wish it, none are guaranteed, but that’s life, isn’t it?

The Last Normal Child and ADHD

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.