Tuesday, November 18, 2014

Important Information on Generic Versions of Concerta

by Ruth Hughes, PhD

 
If you, or those under your care, are taking a generic version of Concerta (methylphenidate hydrochloride extended release tablets), be aware that the Food and Drug Administration has some concerns about their bioequivalency—their effectiveness. After receiving numerous complaints about the generic versions made by Mallinckrodt Pharmaceuticals and Kudco Ireland Ltd., the FDA has given both companies six months to demonstrate their products’ bioequivalency to Concerta or withdraw them from the market.

The FDA has not identified any serious safety concerns with these generic brands. They are not suggesting you make changes to your treatment (or your child’s treatment) unless you consult with your health care provider. The FDA has not expressed concerns regarding the generic brands (methylphenidate hydrochloride EX) manufactured by Actavis or Janssen.

So what does this mean for you? If someone in your family is currently taking a generic version of Concerta, CHADD recommends that you:

1.    Check with your pharmacist and find out what company is manufacturing your medication.
2.    Share the FDA alert with your pharmacist.
3.    Consult with your health care provider if you are concerned about the effectiveness of your medication, or have any other concerns about its use.
4.    If you and your health care provider determine that it would be best for you to change your prescription for name brand Concerta, be certain to ask if your insurance plan covers this cost.
5.    If it doesn’t, ask your health care provider to contact your insurance company and request an exception from any restrictions requiring generic medications for ADHD.

We will keep you informed on this issue.


Ruth Hughes, PhD, is the former CEO of CHADD. A clinical psychologist by training, she has an adult son with ADHD who is thriving. A former member of CHADD's national board of directors, she served as both Deputy CEO and Chief Program Officer before becoming CEO, and now serves as a special advisor.

Friday, March 21, 2014

Acetaminophen, Pregnancy, and ADHD

Guest blog by Max Wiznitzer, MD

Newly published in JAMA Pediatrics, this is a study of mothers’ use of acetaminophen during pregnancy and the subsequent development of ADHD-like behavioral problems in their children. The data were taken from the Danish National Birth Cohort, which recorded information for sixty percent of pregnant women during the years 1996-2002, during and six months after pregnancy. Later, information was obtained about the mothers’ and fathers’ behavioral problems during childhood and about their children’s behavior, presence of hyperkinetic disorder (a form of ADHD), and stimulant prescriptions. The group of children numbered more than 40,000. The study found an association (a relationship) between the mother’s use of acetaminophen during pregnancy and the presence of ADHD-like behaviors, the diagnosis of hyperkinetic disorder and the use of stimulant medication, especially if the acetaminophen was used for more than one trimester or at least once weekly for many weeks.

What is the significance of this study? It tells us that, in this Danish population, there is an association or connection between use of acetaminophen during pregnancy and ADHD features in the children. It does not tell us why this relationship exists—does one cause the other, is there another factor that affects both, or is this just a coincidental result? The large number of mothers in this study makes it likely that the results are real and not coincidental. However, while many reasons that could explain the relationship were examined, others were not, such as ADHD in the family or the reason for acetaminophen use.

What does this mean for the pregnant woman? Experts do not recommend changing the usual habit of using acetominophen for fever or significant discomfort during pregnancy. However, pregnant women should be aware of the reason for the acetaminophen use and, as for any other medication, strongly consider whether it is needed. If necessary, they should discuss any concerns with their obstetrician or family doctor. Lastly, they should realize that more research is needed to confirm or refute this finding and, if real, to determine the reason for the relationship between acetaminophen and ADHD-like behavior problems in the children.


Max Wiznitzer, MD, is the director of the Rainbow Autism Center at Rainbow Babies and Children's Hospital in Cleveland. He is also associate professor of pediatrics and neurology at the Case Western Reserve University School of Medicine. He is a member of CHADD’s professional advisory board.

Friday, March 7, 2014

The Myth That "ADHD Doesn't Exist"

guest post by Mary V. Solanto, PhD

Recently, there has been much attention paid to an article entitled “ADHD Doesn’t Exist” that appeared in a number of major U.S. publications, based on a book of the same name just published by Richard Saul, MD. Dr. Saul, who describes himself as a behavioral neurologist, makes his point by describing cases of children who came to him exhibiting signs suggestive of ADHD (difficulty concentrating, poor academic work etc), but who turned out upon closer examination to instead have a learning disorder, anxiety, impaired vision, or even bipolar disorder. His implication is that all children who are referred for attention or behavior problems will be found instead to have another condition that accounts for their symptoms. Abundant evidence indicates otherwise.

Any reputable, knowledgeable mental health practitioner will take care to rule out these alternative conditions as the exclusive or primary cause of a child’s attention or behavior problems before diagnosing ADHD. But after other possible disorders are ruled out, a significant number of children meet the formal criteria for ADHD, as described in the Diagnostic and Statistical Manual. These are: (1) symptoms of inattention and/or hyperactivity-impulsivity that are extreme for the child’s age; (2) that occur both at home and at school; (3) with clear evidence that the symptoms reduce the quality of the child’s social, academic, or occupational functioning; (4) that are chronic, starting before age 12 and lasting at least 6 months; and (5) are not explained by another disorder.

Evidence that ADHD is a real disorder—and specifically a brain disorder—comes from several major sources. Neuroimaging has demonstrated that children with ADHD show (a) structural size differences in relevant brain areas and (b) less activation of brain regions that control attention, impulses and motor activity, organization, and planning, and that many of these differences persist to adulthood as well. Finally, family studies indicate that the condition is highly heritable and point to a genetic predisposition in the great majority of cases.

The unfortunate impact of this and other publications that are not fact-based is that they add to the stigma of ADHD and hinder the diagnosis and treatment of thousands of people who do have ADHD, and whose lives would be significantly improved with treatment.


Mary V. Solanto, PhD, is associate professor of psychiatry and director of the ADHD Center in the Division of Child and Adolescent Psychiatry at Mount Sinai School of Medicine. She is a member of the advisory board of the Journal of Child Psychology and Psychiatry and of the editorial boards of the Journal of Attention Disorders and The ADHD Report. Dr. Solanto serves on the professional advisory boards of Children and Adults with ADHD (CHADD) and the American Professional Society of ADHD and Related Disorders (APSARD). She is the author of Cognitive-Behavioral Therapy for Adult ADHD: Targeting Executive Dysfunction (Guilford Press, 2011).

Monday, July 22, 2013

A Brain Wave Diagnostic Test for ADHD?


Last week there was a lot of media buzz about a new product that uses brain waves to help diagnose ADHD. While the FDA press release was very carefully worded, the media was not always so careful. Below is a guest blog by Martijn Arns, PhD, a biological psychologist and researcher affiliated with Utrecht University in the Netherlands, to give all our CHADD members more information about this assessment device. This statement has been approved and adopted by CHADD’s Professional Advisory Board, the group of leading researchers and clinicians who help CHADD stay grounded in the science. - Ruth Hughes, PhD

A comment on: FDA permits marketing of first brain wave test to help assess children and teens for ADHD


guest blog by Martijn Arns, PhD
Utrecht University, Department of Experimental Psychology, Utrecht, The Netherlands
Research Institute Brainclinics, Nijmegen, The Netherlands
 

 
 In July 2013, the US Food and Drug Administration issued a press release with the above title, which quickly became very popular and attracted worldwide coverage with sources referring to it as a first brain test to diagnose children with ADHD. The test is commercialized by NEBA. The brain wave test referred to by the FDA consists of an EEG test (a technique which measures the electrical activity of the brain) whereby specifically the theta and beta waves are quantified and expressed in a so-called Theta/Beta ratio. Indeed, this measure has often been reported in scientific literature to deviate in children with ADHD. However, a recent meta-analysis which included all literature published on this measure to date – including a study from authors affiliated with NEBA – concluded that Theta/Beta ratio is not a reliable diagnostic marker for ADHD.* In a minority of ADHD patients (~25-30%), this measure is consistently found to deviate; however, such a percentage is too low to be used as a standalone diagnostic test. 


According to the FDA release, this brain wave test is also not approved as a standalone diagnostic test, but rather: “When used as part of a complete medical and psychological examination, the device can help confirm an ADHD diagnosis or a clinician’s decision that further diagnostic testing should focus on ADHD or other medical or behavioral conditions….” Therefore, this new device can simply be seen as one test in the whole spectrum of tests already used by clinicians to come to a diagnosis, similar to neuropsychological tests, IQ tests, ADHD rating scales, etc. This EEG test is not intended as a standalone diagnostic test.

Finally, also note that the FDA does not decide or rule on which treatments and tests are evidence-based or not. As stated in the title of their news release above, the FDA “permits marketing” of the device, and this decision is based on data submitted by the manufacturer that the device is safe to use. Scientific research and professional associations such as the American Psychological Association have guidelines to evaluate which tests and treatments can be considered evidence-based, and the EEG Theta/Beta measure is not recommended for making a diagnosis of ADHD.


*Arns, M., Conners, C. K., & Kraemer, H. C. (2012). A decade of EEG theta/beta ratio research in ADHD: A meta-analysis. Journal of Attention Disorders. doi:10.1177/1087054712460087



Monday, July 1, 2013

Drug Shortage Appears to be Growing

by Ruth Hughes, PhD

In just the few short weeks since my last blog, we have seen the shifting demand for methylphenidate generic products (Ritalin) grow from a shortage in two companies to six companies today. Pharmacists are finding it harder to order and it is taking longer to fill orders. The number of complaints coming to CHADD and to the American Academy of Child and Adolescent Psychiatry is also growing.

But most telling are the early responses to our survey asking patients, parents, and physicians to tell us if they are experiencing shortage problems in their area. Forty-four percent of the respondents are experiencing problems getting prescriptions filled for generic versions of Ritalin or other stimulant medications.

But we still need your help to define the scope of the shortage. We need to increase the overall number of respondents before taking this information to the federal government. Please fill out this short survey immediately and tell us about your experience. If you are a parent, please answer the patient questions. We need to hear from you even if you are having no problems, so we can gauge how serious any growing shortage might be. The survey will only take a few minutes to fill out and can help us ensure that there is an adequate supply of stimulant medication available.

CHADD and AACAP are poised to take action. Due to our concerns on this issue in 2012, the FDASIA law now contains a mechanism for addressing shortages that of medications that come under the purview of the Drug Enforcement Agency. The Secretary of Health and Human Services (FDA’s mother agency) can request the Attorney General of the Justice Department (DEA’s mother agency) to consider what actions the DEA should take to address the shortage and respond in 30 days. We already have a meeting scheduled with the FDA and will be asking for a meeting with Secretary Sebelius once we have a large enough response rate to the survey.

In the meantime, what can you do? You may have to call several pharmacies to find one in your area that has medication available. Report your shortage to the Food and Drug Administration by emailing drugshortages@fda.hhs.gov with the specific name of the medication, the dosage and where you are located. And most importantly, please click HERE to complete this short survey by July 8. We will keep you updated on the scope of the shortage and our actions to address it.


Ruth Hughes, PhD, is CEO of CHADD.

Monday, June 10, 2013

Another Drug Shortage? Help Us Find Out!


by Ruth Hughes, PhD

Your help is needed to prevent another medication shortage. Recently, CHADD has been getting complaints from people experiencing difficulty in getting generic versions of methylphenidate (Ritalin). We want to be very sure to identify any drug shortage before it gets as serious as the problems we had in 2011 and 2012. We do know that two pharmaceutical companies (Mallinckrodt and Shionogi) have reported shortages to the Food and Drug Administration for versions of methylphenidate.

Tell us about your experience by answering a small number of questions in our drug shortage survey. We need to hear from you even if you are having no problems, so we can gauge how serious any growing shortage might be. The survey will only take a few minutes to fill out and can help us ensure that there is an adequate supply of stimulant medication available.

Once again CHADD and the American Academy of Child and Adolescent Psychiatry are working together to address this problem. If the survey results indicate we do have a shortage, we will approach the Secretary of Health and Human Services to ask the Drug Enforcement Agency to address this issue immediately. But your input is absolutely needed if we are to identify the scope of the problems.

Please click HERE to complete this short survey by June 12.  We will share the results with you at the end of the month.
  
Thank you for your feedback.


Ruth Hughes, PhD, is CEO of CHADD.

Friday, May 3, 2013

College Health Centers and ADHD

by Ruth Hughes, PhD



This week we have seen yet another story from New York Times journalist Alan Schwarz about ADHD and stimulant abuse linked with a story of suicide. Like many of the recent media articles on this serious issue, there is a more complex and I think more compelling story. Unfortunately, too many readers, clinicians, and institutions are ending up fearful of treatment for legitimately diagnosed ADHD while the issue of reducing stimulant abuse and diagnosing ADHD accurately often goes by the wayside.
 
While stimulant abuse is a very serious and out-of-control problem, the consistent link to suicide in many of these stories is highly misleading. When there is suicidal behavior there are always serious mental health problems and often substance abuse as well. Appropriate use of stimulants is not causally related to suicide. But reading the spate of media on this topic, you would easily be convinced that they are related. Creating an atmosphere of fear does not help us to rationally and effectively address the problem of stimulant abuse.

I was very dismayed at the description of college health centers that have stopped diagnosing and treating ADHD because it takes too much time to do it right. Do we stop diagnosing cancer, depression, appendicitis, or any other medical problem because it takes too much time? Proper and thorough evaluation combined with multimodal treatment within a university setting is one of the important things that a university can do to control stimulant abuse on campus. It seems to me that some of the knee-jerk reaction is more out of concern about liability and reputation, than about good medical treatment.

When working on this story, Alan Schwarz contacted CHADD and asked for our take on this issue. I would like to share with all of you the written comments I gave to the New York Times in their entirety.
 
[Text of comments to NYT]

At CHADD we are very concerned about stimulant abuse for a series of reasons. First, no one should be using any prescription drug that has not been prescribed for them. There are the consequences of side effects, drug interactions and other problems that may place a person at risk. If an individual feels it’s okay to use a stimulant, it is too easy to then take an opiate that has not been prescribed and is then entering even more dangerous practices. Prescription abuse is never acceptable.

Second, stimulant abuse and the emotional reaction that it have engendered has many adverse consequences for people who need stimulant treatment for ADHD. It makes it more unacceptable to seek diagnosis and treatment and creates a culture of fear and stigma. Many of our members reported during the drug shortage last year that they were treated like drug addicts when they had to go to more than one pharmacy to find who had stimulant medications.

CHADD strongly advocates for a good diagnostic and evaluation process which entails spending extensive time with a patient, getting an in depth history of the patient and the family, asking for reports from family members, teachers, or employers, as well as observation of the patient directly and utilization of symptom checklist. This cannot be done in ten minutes. If a physician is unable or unwilling to do an in depth evaluation, then a patient should be referred to a specialist who will do this level of evaluation.

Looking at the information you provided about college response to this issue, it seems to me a very mixed group of interventions. Here are the questions I would urge a college to consider when making policy about stimulant abuse:
  1. Any policies related to stimulant abuse should be consistent for all controlled medications. So if a college health center asks a student to attend sign an agreement about abuse, it should also be used for a student prescribed a pain killer given for a sports injury. 
  2. Are the actions proposed going to both help the patient as well as reduce the possibility of stimulant misuse?
  3. Are there other disorders that have the same or higher level of risks, and are those disorders being treated in a similar fashion?
  4. And are the policies in the best interest of the student presenting with the symptoms?
  5. What other actions need to be taken to reduce stimulant misuse on campus?
 
Requiring students to sign a release to allow the physician to contact parents for a history is good medical practice and should always be happening. A proper evaluation for ADHD should ALWAYS include the reports of other key informants, a lifetime history of either treatment for ADHD or the symptoms of ADHD and an in-depth evaluation that cannot be done in ten minutes. For the same reason CHADD understands the requirement of monthly counseling sessions. This is always a component of good, multimodal treatment for ADHD. I hope these treatment sessions are designed to help the student with the challenges of college life and ADHD, and are not just centered on stimulant misuse.

I am very concerned about any university health center that refuses to diagnose students with ADHD or does not allow a clinician to prescribe stimulants. It appears to me that these schools are more concerned about liability issues than good medical treatment or controlling abuse of stimulants. And I would also suggest that this deviates significantly from the established standards of care and practice guidelines for physicians dealing with ADHD. It is also discriminatory if the health center does not do the same for all controlled medications. The abuse of pain medications is a much larger problem with much more serious consequences. Are they also refusing to treat pain related to injury, treatment, or illness? If a university is very concerned about stimulant abuse, I would think the worst thing they could do is to relinquish this responsibility to unknown community practitioners. Nonprescribed use of stimulant medications on campus is a serious problem that can’t just be punted to someone else outside the school grounds.

CHADD is deeply concerned about the misuse of stimulants. We work with our members and young adults to learn how to more safely manage the medications, and how to deal with peer pressure to share. We are also concerned that legitimate diagnosis and treatment of ADHD in young people in particular is endangered, because of concerns about stimulant misuse.

[End of comments to NYT]

I share my written comments to the New York Times here primarily to inform our members about CHADD’s take on the issue of health care on college campuses as well as to provide insight into CHADD’s outreach efforts with the media.

CHADD will continue to provide evidence-based information about ADHD. We will strive to increase understanding of the complex issues of ADHD diagnosis and treatment. The press doesn’t always get it right, and in the case of a medical condition like ADHD, may do unintentional harm by adding to the stigma and fear associated with the disorder or the treatment. For all of you who have ADHD or have a loved one with ADHD, it is imperative that we set the record straight, and help our communities understand that ADHD is a real neurological disorder that can be accurately diagnosed and effectively treated.


Ruth Hughes, PhD, is CEO of CHADD.