Dr. Joe Biederman and ADHD

Posted by on March 15th, 2008 | Comments off

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.

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States sue over costly ADHD drug program

Posted by on January 29th, 2008 | Comments off

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.

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ADHD Medications and Neurofeedback

Posted by on December 17th, 2007 | Comments off

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.”

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How much improvement can ADHD students make with brainwave-powered video games?

Posted by on November 8th, 2007 | Comments off

From Delta Sky Magazine, November 2007

Attention, not Detention

THE DOORBELL RINGS and Stacey Morrison greets the arrival: Bobby, the seventh-grade son of family friends. She offers him an after-school snack, which he declines, and they both head to the small sunroom of the Morrisons’ house in the central New Jersey town of Metuchen. As Bobby takes a seat in front of a computer, Morrison (at her request, the family name has been changed) reaches for a red bicycle helmet and a spray bottle containing a saline solution. Both bear the words “Play Attention.”

Three contact pads in the helmet receive a quick, enabling spritz. Bobby dons the helmet, which is wired through a Play Attention control unit to the computer. He’s now ready for another half-hour session of computer games and mental exercises that its creator calls a revolutionary breakthrough in treating a widespread disorder. It’s not the games themselves that are so unusual, but the way that Bobby and other players control much of the activity. For instance, players make a frog hop on a lily pad, keep a bird aloft or build a tower using only their brainwaves, by focusing intently on the task at hand. That is to say, they’re paying attention—a problem for Bobby and, according to various estimates, anywhere from 1.4 million to 3.5 million school-age children who struggle with ADHD (Attention Deficient Hyperactivity Disorder).

After a short procedure to establish a baseline attention level, Bobby selects Mind Maze for the first of his five-minute challenges. “Remember,” says Morrison, who has taken a seat beside him to serve as his Play Attention coach, “you want to get less than two errors.” Responding to brainwave patterns indicating that he’s focused, the software empowering this short-term memory challenge—something like the 1980s game Simon—sets four colored blocks in a circle blinking in a sequence. Bobby repeats each sequence, in this case using the up, down and sideways arrows on the keyboard. In his 35 hours of Play Attention sessions to date, he has gone from three-block sequences to recalling the order of as many as seven blinking boxes. He has NASA, a boy named John and a former teacher named Peter Freer to thank for his progress.

Freer, founder of a company called Unique Logic + Technology, located in Asheville, North Carolina, invented Play Attention out of frustration. In the early 1990s, teaching fourth grade in a pod-style open classroom, he was assigned a notorious student named John. John’s problems stemmed from ADHD and parents with an eighth-grade education who were even less able to cope with his behavior than the schools were. “I felt for John,” says Freer. “He was not intentionally trying to act out or misbehave. He was just not wired the same as his peers.”

Freer sat John at a desk right next to his own. Simplified instructions for him. Used behavioral shaping rewards. John made incremental progress at school, but not at home. “The parents are frustrated. Dad’s hitting him. They medicate him. Some days he comes in so sleepy he just lays his head on the desk,” Freer recalls. “Some days he’s fairly normal. But it disturbed me—disturbed me that I was totally underequipped to help him.”

Freer, whose graduate work included writing educational software programs, began what he now terms his “crusade” to devise a way to teach children with ADHD how to pay attention to classroom lessons, take tests and do homework. Also driving his quest: indications that as many as 60 percent of children with ADHD carry their condition into adulthood. Freer discovered that NASA, eager to keep pilots and astronauts focused on eye-glazing, low-stimulation control panels, had devised a brainwave biofeedback training system. So he hired an engineer and programmer, and the team made some enhancements to the apparatus to create Play Attention.

The noninvasive sensors in the helmet, he explains, “listen to what the brain is doing in real time. It’s a physiological monitor, like grabbing a bar on a treadmill at the gym that displays your heart rate. When the neurons fire in the brain, they produce small electrical bursts. That’s what’s picked up.”

“Play Attention made sense to me,” says Morrison, who’d consulted with numerous doctors and tried various treatments and mental exercises for her own son Jack, who was the same age as Bobby and suffering from ADHD. (Bobby himself has not received a formal diagnosis of ADHD.) “It’s like having a weak muscle in your body and they send you to physical therapy and you gradually strengthen that muscle. Except, when you tell a kid, ‘Pay attention. Pay attention,’ what does that mean? Attention is not something you can hold in your hand and see.”

That, she stresses, is the beauty of Play Attention. It shows you instantly when your attention begins to waver. “You have to pay attention,” Morrison says. “You can’t just stare at what’s on the screen. It knows the difference. You really have to be concentrating on that bird [to make it fly]. If you stop concentrating, the bird starts to drop.”

Morrison started her son Jack on Play Attention at the very end of his fifth-grade year, continuing his twice-weekly sessions throughout the summer. (Full-featured, professionally supported home versions of the program start at $100 a month. Open-site licenses for schools and organizations are also available.) In early September, Jack’s sixth-grade math teacher, who’d taught him the year before, called Morrison. “He’s like a different kid,” said the teacher. “He’s participating. He’s taking notes. He’s paying attention.”

One strength of Play Attention, explains Morrison, is its ability to target unwanted behaviors. Sitting beside Jack, she noticed that his eyes wandered all over when he first started playing Play Attention. “There’s chair-tipping or, like we’re working with Bobby now, fiddling with things on the desk,” she says. Now, with visible manifestations of behavioral drags on performance appearing on-screen, and with cues from the coach as well, Play Attention users can more easily understand the roots of inattention and begin to rewire their brains. “I know I’m just a mom, and I sound like an infomercial,” says Morrison, “but I’d like to see Play Attention in the school system.”

According to Freer (whose small business received a badly needed $100,000 in 1998 from an “angel” investor who herself suffered from ADHD), Play Attention is being used by some 450 American school systems and in various learning centers in England, Saudi Arabia, China and other countries. It’s also being used to address attention issues beyond ADHD.

While looking on with interest, some professionals remain cautious about Play Attention’s claims. “I think the jury is still out,” says Dr. Andrew Adesman, chief of developmental and behavioral pediatrics at Schneider Children’s Hospital in New Hyde Park, New York, who notes that the promise of Play Attention still awaits the critical eye of scientifically designed studies.

One such study is being conducted under Dr. Ellen Perrin and Dr. Naomi Steiner at The Floating Hospital for Children at Tufts–New England Medical Center in Boston. “We’re intrigued that [Play Attention] could be a helpful treatment for children with ADHD, either by itself or in conjunction with medication,” says Perrin, director of the hospital’s Division of Developmental-Behavioral Pediatrics and The Center for Children with Special Needs. The pilot study, which followed about 50 Boston area middle-school students through the 2006-07 school year, randomly assigned each child to one of three groups: those attending Play Attention sessions in school, those using another computer-based program and those receiving no special in-school program. The data collected laid the groundwork for the second phase of the study, now in progress.

By the time you read this, Bobby will have been weaned off his twice-weekly sessions at the Morrison house. Stacey Morrison, who is not being paid to coach Bobby, describes him as a bright kid who was getting B’s in his accelerated math class when he could have earned A’s: “His mother told me whenever he’d take a test, he’d always get the first problem wrong even though it was invariably the easiest question. I said, ‘Aha!’ Because when he first sat down to do Play Attention, whatever game he chose to do, at first he would always have trouble. But once he got started, he was fine.

“When Bobby started with me and I asked him for his goals, he told me, ‘I don’t want to spend so much time doing homework and getting yelled at all the time.’ He’s now getting A’s in that math class, stopped getting those first problems wrong, and his mother tells me, ‘You know what, Bobby is doing his homework on his own. He’s getting it done, and he’s having more free time.’”

Bobby’s mother has noticed something else, too—something that would please Peter Freer just as much, and an added benefit of Play Attention. “Bobby now looks people in the eye when he talks to them,” Morrison says. “He never used to do that before.”

Not Just for Kids

Other groups and individuals with interests beyond ADHD (Attention Deficient Hyperactivity Disorder) are also getting good results from Play Attention (800-788-6786 or 828-225-5522; www.playattention.com).

Harriet Eskildsen, director of the High Tech Center for the Disabled at the College of Marin, in Kentfield, California, has found it has helped adult stroke victims regain lost quality of life. “My students tell me it’s helped them remain focused for a longer period of time,” she says. “They can go to the movies again and follow a story line. They can return to reading books, and can again take part in conversations, which requires listening skills we take for granted.”

Among those looking to Play Attention for an edge in athletic performance is Bill Tavares, coach of the U.S. Women’s Olympic Bobsled Team. Not only is Tavares impressed by the early improvements made by some of his bobsled drivers, for whom focus on the proper line down the course is paramount, he’s also enthusiastic about what his own Play Attention sessions have done for his golf game—helping him lower his handicap from 9 to a 4 or 5.—J.G.

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Study finds divorce increases Ritalin use in children

Posted by on August 14th, 2007 | Comments off

ADHD does not seem to be a condition like pregnancy where one is either pregnant or one is not. Rather it is a matter of degree. Some children and adults range from mildly inattentive to profoundly inattentive. The degree seems to be directly affected by a variety of environmental factors including divorce, parenting skills, etc. More frequently than not, drugs are prescribed to allay the symptoms. Obviously, they do not affect core issues that affect the child like divorce, marital discord, or learning disabilities.

Study finds divorce increases Ritalin use in children

HELEN BRANSWELL
Canadian Press
June 4, 2007 at 8:46 PM EDT

TORONTO — Children whose parents divorce are nearly twice as likely to be prescribed Ritalin in the aftermath of the split, a Canadian study reports.

But the author, a sociologist from the University of Alberta, cautioned against concluding that children of divorce are over-prescribed the drug, which is used to treat Attention Deficit and Hyperactivity Disorder, or ADHD.

Lisa Strohschein said the data she used can only identify the phenomenon and cannot reveal why Ritalin use rates are double when children of divorced parents are compared to children whose parents stay married.

“I’ve got the what, but not the why,” Ms. Strohschein said from Edmonton.

Ms. Strohschein suggests there may be a variety of answers. Some kids may need the drug to cope with the stress of the split, some kids may have ADHD and some kids may be getting a drug they don’t really need.

“The problem is I can’t be clear about it,” she said.

“I mean, I would love to be able to say ‘Yes, it’s divorce. That’s the problem,’ But it’s not necessarily so. It could just be our perceptions about divorce — and that’s the thing that makes me really cautious here.”

“(But) I don’t want to come out on the other side, either and say ‘Ritalin is bad’ because I think it clearly does help some kids.”

The psychiatrist-in-chief of the Hospital for Sick Children in Toronto said the study should serve as a reminder to doctors to move cautiously when prescribing Ritalin or other methylphenidate-based drugs to children in these circumstances.

“What we need is a deeper understanding of this issue, at the level of the primary care practitioners,” said Dr. Abel Ickowicz.

“Because . . . if we are going too quick to prescribe medication, like Ritalin, like methylphenidate, we may not only be masking the normal process of adaptation to divorce, but we may be contributing to the degree of distress the children of divorce are experiencing.”

The study, published in the Canadian Medical Association Journal, used data gathered by Statistics Canada through its National Longitudinal Survey of Children and Youth. The survey, which was first conducted in 1994, is completed every two years; Ms. Strohschein used data collected between 1994 and 2000.

Previous researchers had identified the fact that children who live in a household with only one parent or with a parent-step-parent combination were more likely to be on Ritalin than children growing up in households with both parents.

But it wasn’t clear whether the increased use was among all children in a single-parent household — in other words, children whose parents had divorced, children who had lost a parent to death and children born to a single mother — or whether some subset of these children was more heavily prescribed the drug.

Ms. Strohschein compared prescription rates among 4,151 children whose parents hadn’t divorced and 633 children who had. She found that 3.3 per cent of children in the two-parent families were prescribed Ritalin; among the children whose parents had divorced, that figure rose to 6.1 per cent.

The study notes a number of potential explanations for the doubling of the usage rate.

One possibility is that the stress of the divorce aggravated a child’s existing behavioural problems to the point where Ritalin would actually be helpful, she hypothesized.

It is known that ADHD can run in families. In addition to passing on the condition to their children, parents with ADHD-type behaviour might be more likely to divorce — a theory that points towards appropriate use of the drug.

Another possibility is that in divorce, the natural emotions children experience — anxiety, sadness, anger — may manifest themselves in behaviour that is mislabeled as ADHD-like, or that parents and doctors may be anticipating problematic behaviour because of the stress of divorce. The study suggested this type of rationale would reflect inappropriate use.

Dr. Anton Miller, a developmental pediatrician and child health researcher at the University of British Columbia’s Centre for Community Child Health Research, said it’s possible no single answer applies across the board for these children.

“None of them is an outlandish kind of suggestion. They probably all have some validity,” he said.

“It’s certainly possible in some instances that ADHD might have been prematurely diagnosed…. But I would caution anybody (against) saying ‘Well that’s why all these children are getting medication.’ “

“But there is a possibility that in a proportion of the cases we need to try and figure out how much that does happen in the real world and try and advocate … for children to have thorough and really in-depth assessments for these kinds of behaviour and emotional problems.”

Ms. Strohschein agreed: “I think the take-home message is just to be careful not to make that broad assumption that kids must necessarily be doing poorly when their parents divorce. Some kids will do better, some kids will do worse.”

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The Last Normal Child and ADHD

Posted by on August 13th, 2007 | Comments off

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.

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The Global Market For ADHD Medications

Posted by on April 22nd, 2007 | Comments off

The Global Market For ADHD Medications

The University of California, Berkeley reports that ADHD has more than tripled worldwide since 1993. Researchers at UC, Berkeley found that the United States, Canada, and Australia “presented higher-than-expected rates of ADHD medication use between 1993 and 2003 – based on predictions from per-capita GDP indicators – a country-by-country analysis showed increases in ADHD drug consumption in countries ranging from France and Sweden, to Korea and Japan.” The US still leads the world in dollars spent on ADHD medication at $2.7 billion in 2006.

The University of California at Berkeley study was published in the journal, Health Affairs.  Researchers reviewed data on ADHD medication use among 5-19 year-olds in countries belonging to the Organization for Economic Cooperation and Development (OECD), whose members are largely economically fit North American, European and Northeast Asian nations.

The researchers stated that one in twenty-five children is taking medication for ADHD in the US. However, their research also suggests that the diagnosis of ADHD and subsequent use of medications to control it is now spreading worldwide.

Dr. Richard Scheffler, a UC Berkeley distinguished professor of health economics and public policy Overall thinks the study reflects global trends. “Given the global diffusion of ADHD medications, as well as the prevalence of this condition, ADHD could become the leading childhood disorder treated with medications across the globe,” Scheffler said. “We can expect that the already burgeoning global costs for medication treatment for ADHD will rise even more sharply over the next decade.”

The Berkeley researchers also cite that “Growth trends indicate that other countries are following in its tracks. For example, global spending on ADHD medications increased nine-fold among OECD countries during the time period studied. This increase is largely due to the advent and availability of more costly and long-acting medications such as Concerta™, Strattera™ and Adderral XR™”.

The use of medications outside of the US is still primarily short acting amphetamines. However, the pharmaceutical industry is well aware that they cannot reach the estimated $3.4bn by 2015, unless it is led by the launch of drugs with novel delivery mechanisms such as improved durations of action and anti-abuse profiles as media are raising the abuse flag significantly. These custom drugs will help differentiate these pipeline drugs from the current established ADHD therapies and increase market share.

It is important to note that although ADHD drugs have demonstrated efficacy in improving the three main symptoms of ADHD – inattention, hyperactivity and impulsivity – none have shown efficacy in treating the cognitive deficits of ADHD.

Drug makers are likely to increase the costs of these novelty release (e.g. long acting) drugs globally as they become more prevalent outside the U.S. in order to reach the estimated $3.4bn target in 2015.

Back to Berkeley, using the IMS Health MIDAS™, an international pharmaceutical database, researchers looked at data and found that between 1993 and 2003, “the number of countries using ADHD medications rose from 31 to 55, with the U.S. share of global market decreasing from 86.8 percent to 83.1 percent. Meanwhile, countries with traditionally low and moderate consumption of ADHD drugs were showing steady upswings.”

Stephen Hinshaw, who is frequently approached by the media to comment on ADHD, is chair of UC Berkeley’s Department of Psychology was a co-author of the study. Commenting on this study, Hinshaw states, “The results temper some key criticisms of ADHD. A common misconception is that ADHD only exists in the U.S. and that the pharmaceutical firms are getting bigger sales because of the ‘creation’ of the disorder in the U.S. Yet cross-cultural research has shown that ADHD exists in nearly any culture that has compulsory education. Clearly, ADHD–which has a substantial genetic liability–is not just a figment of American doctors’ imaginations.”

In a nutshell, here’s Hinshaw’s argument: The use of stimulant
medication in wealthy member nations of the OECD outside of the U.S. is
growing, therefore, “ADHD is not just a figment of American doctors’
imaginations.” I’m not arguing that ADHD is real or not real. I am
simply citing that pharmaceutical marketing dollars greatly contribute
to the rise in use of stimulant medications in these nations. For
example, when adult ADHD medication was marketed heavily in the U.S.,
sales of the drug skyrocketed. Did the number of diagnosed cases
increase? Yes. Did that mean more people had the disorder? No. If this
poor logic and poor research is the best Berkeley and Hinshaw can
produce, then the students that are graduated from Berkeley are doomed!
But, wait, that’s also a non causa pro causa!

Hinshaw has essentially committed a non causa pro causa (false cause). He’s co-authored a study of data from a pharmaceutical database and citing that the number of persons outside the U.S. in the Organization for Economic Cooperation and Development (OECD), whose members are largely economically fit North American, European and Northeast Asian nations. The pharmaceutical industry has spent many millions of dollars over the past few years to increase their profit in these nations in an effort to obtain their estimated goal of $3.4bn by 2015.

What can be clearly gleaned is that the Berkeley study is meaningless. It might have some teeth if the researchers actually correlated the marketing dollars spent by the pharmaceutical manufacturers to the numbers of persons using their medications in the OECD. It would be interesting to see the data on usage in third world countries who cannot afford it. I’d wager that they have far fewer cases of ADHD and use far less medication.

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Brain Study May Shed Light on Attention Disorders

Posted by on April 16th, 2007 | Comments off

New research shows it takes one part of the brain to start concentrating and another to be distracted.

This discovery could help scientists develop better treatments for attention deficit disorder .

The study, Top-down versus bottom-up control of attention in the prefrontal and posterior parietal cortices, performed at Massachusetts Institute of Technology (MIT) and published in of the journal Science, reveals that attention may have two forms: willful and reflexive. While this information is not new – cognitive psychologists have written about this for many years – the study finds that these two types of attention are controlled by distinct areas of the brain. Willful attention seems to be controlled by the frontal region of the brain in the prefrontal cortex while reflexive attention seems to be activated by the parietal cortex toward the back of the brain.

Put simply, if one is reading a book, then likely the prefrontal cortex is engaged in commanding attention like the conductor of an orchestra. If, while reading, a firecracker explodes nearby, your reflexive attention will activate from the parietal cortex command center shifting control away from the prefrontal cortex.

“This ability to willfully focus your attention is physically separate in the brain from distracting things grabbing your attention,” said Earl Miller, a neuroscientist at the Massachusetts Institute of Technology. “Now we know these two things are separate, it raises the possibility that we can fix them independently,” Miller said.

RESEARCH

MIT’s research sheds a little more light on the subject of attention because until now researchers have examined only one region at a time. Studying both regions allows us to examine their collaborative interactions, functions, and purposes.

Miller used EEG electrodes connected to the heads of monkeys to examine the complex interplay between the prefrontal cortex and parietal regions during tests of attention and bursts of reflexive attention.

When the monkeys voluntarily concentrated, the so-called executive center in the front of the brain – the prefrontal cortex – was in charge. But when something distracting grabbed the monkeys’ attention, that signal originated in the parietal cortex, toward the back of the brain.

ADHD IMPLICATIONS

Miller concluded that once the prefrontal and parietal regions signaled each other (see my blogs on neural networks), the electrical activity in these two areas began vibrating in synchrony. However, as EEG specialists have known for quite some time, willful concentration involved lower-frequency neuron activity. Distraction occurred at higher frequencies. This again lends credence to EEG training to produce better attention.

While the study sheds a little more light on the subject of concentration, it examined only two portions of the brain. I contend that the entire brain is involved in concentration. The brain seems to work as an orchestra works. While the conductor is not in command, the players tune and rehearse each of their own will. When the conductor steps to the stage, taps his baton, all the individual players each snap to attention and begin to play in synchrony. It is a metaphor for brain function – our brains are formed of many different parts that perform jobs independently of each other. When necessary, a conductor taps his baton and attention is achieved as the individual parts work in synchrony.

For a person with an attention problem or AD/HD, the conductor is not controllable at-will unless the object of attention is highly stimulating like a three ring circus. A little attention may be sustained if the object of attention is only moderately stimulating, but the other conductor responsible for reflexive attention quickly takes command and distraction ensues.

ADHD persons don’t have at-will command over either conductor responsible for willful attention or reflexive attention. Do we know why this is so? No, it may be caused by a variety of factors. Can they be taught to control these conductors? Absolutely. The brain is very flexible and can compensate. All educational systems are built upon this foundation. So, let’s take this out of the realm of medical mystery and dysfunction. Let’s place it back in the realm where it is a skill that can be improved like any other.

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Insurers Question Studies of ADHD Drugs

Posted by on September 13th, 2005 | Comments off

WSJ Article Excerpts:

By ANNA WILDE MATHEWS
Staff Reporter of THE WALL STREET JOURNAL
August 24, 2005; Page A1

DOWNEY, Calif. – When Eli Lilly & Co. wanted to get the big California health-maintenance organization Kaiser Permanente to use its new antidepressant, it ran straight into Debbie Kubota.

As the cost of drugs in the U.S. approaches $250 billion a year, pharmaceutical companies are running up against a growing breed of detective trained to see through marketing spin. Working for insurers, state Medicaid programs and nonprofit bodies, these detectives cast a wary eye on published studies in medical journals, once considered an unimpeachable source. They search for subtle aspects of clinical-trial design that might show the drugs are not all they’re cracked up to be.

“You could be duped,” says Siri Childs, who oversees pharmacy policy for the Washington state Medicaid program. “We know now that just because it’s published in a medical journal, that doesn’t assure its quality.”

The Cochrane Collaboration, a nonprofit that analyzes the quality of studies and collects the ones it considers good into broader analyses, has a volunteer corps of about 7,500 reviewers, mostly doctors and academics. That’s up from about 2,800 five years ago. Another player is the Drug Effectiveness Review Project, an effort by an Oregon nonprofit. It issues reports summarizing all the studies in a particular treatment area and often criticizes individual studies for failings such as inadequate controls and high dropout rates.

Some journals are trying themselves to help readers discover marketing messages slipped in amid the scientific data. Last year BMJ, a British journal, published a piece called “Users’ guide to detecting misleading claims in clinical research reports,” which came with a picture of a reader dumping salt on a medical journal. One piece of advice: Beware when the authors break out one subgroup of patients and claim benefits from the treatment that weren’t evident in the whole group.

Dr. Kubota, a 26-year Kaiser veteran who holds a doctor of pharmacy degree from the University of Southern California, is based in the industrial city of Downey, southeast of Los Angeles, across the street from an abandoned movie set. Kaiser tries hard to keep her and her colleagues away from the influence of the companies whose products they evaluate. Before meeting with Dr. Kubota, a representative of a drug company must fill out a form indicating who will be coming, what they plan to discuss and why the information can’t be relayed in written form. No gift pens, mugs or other trinkets are allowed. Dr. Kubota’s business card doesn’t show her direct phone number.

When Dr. Kubota started her current job in 1997, she says she “would just read the abstract,” the summary at the beginning of a study. “I guess I was naive,” she says. “You kind of assume everything is there for you in the abstract.” Today, she quickly homes in on details that aren’t mentioned in the abstract and generates a 6-inch stack of papers studded with Post-it notes for each drug.

When she reviewed Adderall, a stimulant now marketed by Shire Pharmaceuticals Group PLC to treat attention deficit hyperactivity disorder, she noted that one of the major trials included only people who had responded well to Ritalin, another ADHD drug. She thought the move likely improved the results. Dr. Kubota recommended leaving Adderall off Kaiser’s formulary. The physician committees partially overruled her, putting Adderall on the Northern and Southern California formularies but only for patients who failed to respond to another stimulant. Adderall later was added to the preferred list as a first-line treatment after a once-daily formulation went on the market.

A spokesman for Shire, Matt Cabrey, said that the designers of the trial, which was conducted when Adderall belonged to another company, felt that for ethical reasons they should give the drug to people with a “reasonable anticipated reaction.” James Swanson, the lead author of the article that described the trial’s results, said the trial was designed to show whether Adderall works faster than Ritalin.

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Are ADHD drugs safe? Report finds little proof

Posted by on September 13th, 2005 | Comments off

M. ALEXANDER OTTO;
The News Tribune
September 13th, 2005

At a time when millions of children and adults are taking drugs for Attention Deficit Hyperactivity Disorder, the most comprehensive scientific analysis of the drugs to date has found little evidence that they are safe, that one drug is more effective than another or that they help school performance.

The 27 drugs studied included Adderall, Concerta, Strattera, Ritalin, Focalin, Cylert, Provigil, and others that, in some households, are well-known for their sometimes calming affects.

The 731-page report was done by the Drug Effectiveness Review Project, based at Oregon State University. The group analyzed 2,287 studies – virtually every investigation ever done on ADHD drugs anywhere in the world – to reach its conclusions

They found:

• “No evidence on long-term safety of drugs used to treat ADHD in young children” or adolescents.

• “Good quality evidence … is lacking” that ADHD drugs improve “global academic performance, consequences of risky behaviors, social achievements” and other measures.

• Safety evidence is of “poor quality,” including research into the possibility that some ADHD drugs could stunt growth, one of the greatest concerns of parents.

• Evidence that ADHD drugs help adults “is not compelling,” nor is evidence that one drug “is more tolerable than another.”

• The way the drugs work is, in most cases, not well understood.

The findings do not mean ADHD drugs are unsafe or unhelpful, just that sound scientific proof is lacking.

The Pharmaceutical Research and Manufacturers of America, the Washington, D.C.-based drug industry lobby group, had no comment on the report, but its senior vice president, Ken Johnson, said the benefits of most drugs “clearly outweigh the risks.”

ADHD is suspected when people have a harder time than others their ages paying attention, sitting still or controlling impulses. To be diagnosed, those tendencies must interfere with work, school or other activities.

Nationally, about 4.4 million kids between 4 and 17 fit the bill. Of those, more than 2.5 million take ADHD drugs. Up to 8 percent of kids in Washington state have been diagnosed with the condition.

The Drug Effectiveness Review Project was formed in 2003 to give consumers and state insurance plans trustworthy information about pharmaceuticals.

Industry studies, which researchers have shown sometimes are rigged for favorable outcomes, don’t give the confidence “many of us would like to decide whether or not we should be using a given medication,” said the project’s deputy director, Mark Gibson.

Complicating efforts to get reliable information, the U.S. Food and Drug Administration doesn’t require companies to compare new drugs to ones on the market. Most times, firms instead compare their wares to sugar pills because it is easier to show benefit and get approved for sale.

The problems leave insurers and patients in the lurch when they need to know what drugs work best. That’s where the Drug Effectiveness Review Project comes in. Its physicians and pharmacists analyze virtually every study on a given class of pharmaceuticals to find the best drugs.

The American Association of Retired Persons and Consumers Union, the publisher of Consumer Reports, use the project’s findings to tell people what drugs give the most for the money. Fourteen states, including Washington, also use its services to decide what drugs to cover for beneficiaries. Those states are the project’s chief funders.

For ADHD, the project analyzed published studies as well as unpublished data from the six leading makers of ADHD drugs. The group rejected 2,107 investigations as unreliable, and reviewed the remaining 180 to find superior drugs.

Instead, it found that evidence to choose one drug over another for safety or effectiveness is “severely limited” by a lack of studies measuring “functional or long-term outcomes.”

The project could not find a “good quality” study that tested the drugs against each other. It also could not find comparative evidence to determine which ADHD drugs are less likely to cause tics, seizures and heart and liver problems.

That evidence is needed. Canadian authorities have recently warned against using Adderall Extended Release in patients with heart problems. Cylert and Strattera have been linked to liver damage, the report said.

Until better research is done, the findings mean that choosing the right ADHD drug is largely a matter of trial and error. They also suggest some people might do as well or better on cheap generic Ritalin, sold by its scientific name methylphenidate, instead of far more expensive, newer options such as Concerta and Adderall.

In fact, in the few instances where the Oregon group could draw conclusions, it found Concerta “did not show overall difference in outcomes” compared to generic Ritalin, and proof that Adderall is better “lacking.” What little evidence there is comparing another newer expensive drug, Strattera, to generic Ritalin “suggests a lack of difference in efficacy.”

Gibson cautioned that his project’s latest report is still open for public comment and possible fine-tuning. But the overall results did not surprise Libby Munn, a nurse practitioner at Greater Lakes Mental Healthcare in Lakewood.

“I’ve never been aware of any evidence of any one being better than another,” said Munn, who treats patients for ADHD and other conditions. “That’s true of antidepressants and antipsychotics, too. Once you compare meds for a given disorder, there are often no proven differences.”

Tacoma psychiatrist Dr. Fletcher Taylor, an expert in adult ADHD at Rainier Associates, works with drug companies to develop new products. He said he stands by the effectiveness and safety of the drugs.

Still, he said, Adderall and Concerta are largely equal in their effect, though some people do better on one than another. Their greatest advantage over generic Ritalin is that people take fewer pills during the day.

ADHD DRUG COSTS*

• Methylphenidate (generic Ritalin) $15.69

• Ritalin (brand name): $27.79

• Amphetamine/dextroamphetamine (generic Adderall): $47.09

• Adderall (brand name): $94.49

• Concerta: $103.99

• Strattera: $123.99

• Focalin: $25.99

*Comparisons based on the lowest dose for 30 days.

Source: Walgreens Pharmacy

FIND THE RIGHT DRUG

These Web sites offer help comparing drugs to find what works best:

• The American Association of Retired Persons lets you compare drugs at www.aarp.org/health/comparedrugs/

• Consumers Union, the publishers of Consumer Reports, gives tips on the best drug buys for safety and effect at www.crbestbuydrugs.org/

• The consumer-advocacy group Public Citizen has a solid record of spotting problem drugs, calling, for instance, for the removal of Vioxx in 2001, when few knew there were problems. The group is now worried about the cholesterol pill Crestor. Public Citizen’s drug information site is www.worstpills.org/

• The Oregon State University Drug Effectiveness Review Project is online at www.ohsu.edu/drugeffectiveness/

M. Alexander Otto: 253-597-8616 alex.otto@thenewstribune.com

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