Category — ADHD: Medications

When it involves ADHD, psychologist William Pelham is one of the most prolific researchers around. Pelham and his colleague Dr. Brain Wymbs published a longitudinally study (Journal of Consulting and Clinical Psychology. Vol 76(5), Oct 2008, 735-744.) that tracked 282 families with and 206 without ADHD children. They found that couples who have a child diagnosed as ADHD are almost twice as likely to divorce or become estranged compared to couples without an ADHD child. A simple dynamic is causal: ADHD children can be stressful for parents thus magnifying conflicts between spouses. ADHD children also have oppositional behaviors which increase stress at home.

“We have known for a long time that kids can be stressful for their parents. What we show is they can be really stressful and can lead to marital dissatisfaction and divorce,” said Pelham, who works at the State University of New York at Buffalo. “What it means is ADHD should not be treated without involving the parents in the treatment.”

The researchers found that parents with ADHD children tended to reach the point of divorce or separation faster than their peers.

Parents of ADHD children are distinctly aware that battles over homework, chores, discipline are key stressors that provide further conflict between spouses. It is understandable that 22.7 percent for parents of kids with ADHD were divorced by the time the children were 8 years old as opposed to only 12.6 percent of the parents of non-ADHD children.

“Parents of children with ADHD report less marital satisfaction, fight more often, and use fewer positive and more negative verbalizations during child-rearing discussions than do parents of children without ADHD especially if the child also has conduct or oppositional problems,” Pelham and Wymbs noted in their paper.

The researchers discovered that regardless of whether parents had manageable or difficult children, if parents had an ADHD child they were three times as likely to be negative toward each other as parents who did not. Stress was up and patience was thin.

Does medicine help? Medicines can alleviate ADHD symptoms, however the researchers found that most meds were given in the daytime to improve school performance and wore off by evening when the children were to do homework and chores.

The Brits have taken the polar opposite approach to children with ADHD. I find it highly logical and practical: except in extreme cases, they advise parents to learn new parenting strategies to change and cope with their ADHD child. This may well curb the incredible divorce rate among ADHD parents as well as greatly improve their child’s future.

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

Shire hikes Adderall price as rumors fly

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

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

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

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

The American Academy of Pediatrics has issued a new policy contradicting the American Heart Association’s: stance that children prescribed stimulant medication Schedule II drugs should get a heart screening or EKG prior to taking the drugs. The American Heart Association (AHA) cited the fact that approximately 2.5 million children taking these drugs are at risk of elevated blood pressure and increased heart rate.

The FDA recently insisted that a warning be placed on the medication’s labels indicating risks for sudden deaths in patients with heart problems. Approximately 20-30 sudden deaths have been reported related to stimulant medication in the US and Canada.

The longest study on families and their use of medication, the Multi-modal Treatment of ADHD Children (MTA) study also indicated other side-effects including decreased height and weight.

The American Academy of Pediatricians (AAP) has taken the stance that children taking stimulant medication do not need and ECG or EKG (electrocardiogram) tests because the rate of death is very small in respect of the overall number of children taking the medication. The AAP contends that EKGs are expensive [around $100] and could delay access to effective ADHD treatments which “could have serious implications.” The AAP does advocate careful physical examination, and a review of family history of heart problems including sudden death. It does not, however, advocate routine EKGs.

According to the Associated Press, policy co-author Dr. James Perrin, a Massachusetts General Hospital pediatrician said the academy’s policy makes clear that there’s no scientific evidence to support “this fairly dramatic practice change.”

This is a rather disconcerting stance for several reasons. The first reason is that there are no long-term data demonstrating the safety or risks of stimulant medication especially in conjunction with cardiovascular risk. Secondly, according to the AHA, children with heart abnormalities have a higher incidence of ADHD. Third, stimulant medications are known to decrease both height and weight in children.

It’s also perplexing that the APA advocated cholesterol drug treatment for children as young as 8 years old. Given this history, then it is not out of character for the APA to minimize heart risk.  

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

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

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

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

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

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.”

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.

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.

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.

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?