Archive for the 'ADHD General Information' Category

Intuniv: One Step Closer To FDA Approval for ADHD

Monday, June 16th, 2008

Thirty percent of children with AD/ADHD cannot tolerate taking stimulant medications.

For these individuals, the recent news that Shire is one step closer to gaining FDA approval for its time-released non-stimulant INTUNIV is welcome news.

Intuniv provides a 24-hour evenly released dose of the medication guanfacine. Specifically, guanfacine improves the symptom of the inability to concentrate in children with ADD/ADHD.

When given in conjunction with stimulants, it may also help reduce the aggression and the insomnia normally associated with the use of these drugs.

In fact, some physicians already prescribe it – in an immediate release version and under various brands – to their patients with ADD/ADHD along with other medications. The most common brand used is Tenex. This medication, however, appears not to be very effective at alleviating either the attention deficit or the distractibility seen in children with ADD/ADHD.

Two advantages of INTUNIV

Manufactured and marketed as INTUNIV, though, this form of the medication would hold two distinct advantages over what is currently being used. First, it would be approved specifically for the treatment of ADD/ADHD. And secondly – and most importantly to those whose concentration is low – it would relieve the unevenness produced by the immediate-release version of guanfacine.

Guanfacine works well in improving concentration, but it only lasts several hours, and once the medication wears off attentiveness wanes again.

Recent clinical trials conducted as part of the FDA approval process show that INTUNIV is extremely effective at boosting concentration levels consistently for a 24-hour period

The data the FDA scrutinized included the pooled analysis of results from two double-blind trials. Both of these studies used the teacher based ADHD Rating scale as the criteria for improvement.

One group of children received INTUNIV for the other group received a placebo which contained no medication.

All groups which received the medication scored significantly better in the rating scale than those who received the placebo.

The studies also examined the length of time the medication was effective for these children. Assessments were made at 12, 14 and 24 hour periods following the administration of this drug. Again the data showed significant improvement in the concentration of the children at each of these points in time.

Mild and moderate side effects of INTUNIV

Between 75 and 80 percent of the children, did display mild adverse side effects while taking INTUNIV, most of which appeared within the first two weeks and eventually tapered off. These seemed to be dose-related and included: upper abdominal pain, constipation, dizziness, hypotension, sedation, dry mouth, and drowsiness.

The most common of these side effects were related to sedation.

The medical community has been examining guanfacine for its effectiveness since 2001. That year a study appeared in the American Journal of Psychiatry showing that guanfacine to be a safe and effective treatment for children with ADHD and those who suffer with tic disorders.

The medication, according to the journal article, produced a mean improvement of 37 percent in the total score on teacher-rated ADHD Rating Scale following eight weeks of treatment. This was compared to the eight percent improved for those who received the placebo.

INTUNIV is not a controlled substance — as stimulants are — and does not appear at this time to carry any risk for either potential for abuse or dependence.

The FDA has issued an “approval letter” for INTUNIV, which means that it is prepared to approve the new drug application as soon as certain conditions are met, such as any requests for additional information.

How guanfacine works

Guanfacine works, according to Shire, by acting indirectly on the prefrontal cortex of the brain. Located directly at the very front of the brain and directly below the forehead, the prefrontal cortex controls what are known as the executive functions. This includes the resolution of conflicting thoughts, the choices involved in “right or wrong” and “good and bad” decisions, as well as the prediction of future events.

This section of the brain also governs social control that is it is the area used when we suppress or emotional urges.

Guanfacine is a selective alpha-2A-agonist medication.

Admittedly, the treatment of ADD/ADHD is a highly individualized challenge. Discovering the most effective combination the proper medications and other forms of therapy may mean attempting to use several medications in various combinations as well as varying doses. What is appropriate for one child or adult, may not be either appropriate or effective for another.

Nearly 8 percent of all school-aged children have been diagnosed with ADD/ADHD, according to the U.S. Centers for Disease Control and Prevention. While not normally thought of as a disorder affecting adults, some 4.4 percent of all adults, ages 18 to 44 are affected.

The major characteristic of ADD/ADHD is an inattention or hyperactivity-impulsivity that exceeds those normally observed in most individuals. Official diagnosis of this disorder can not be made until the symptoms have been observed for at least six months.

References:

Pro-drug gets attention,
http://www.sciam.com/article.cfm?id=pro-drug-gets-attention, accessed 11 Jun08

Guanfacine, http://www.depression-guide.com/guanfacine.htm, accessed, 7 Jun 08

Intuniv reduces ADHD symptoms, http://www.realmentalhealth.com/adhd/adhd_toc.asp, accessed 6 Jun 08

Shire Investigational Nonstimulant INTUNIV Showed Significant Efficacy In Reducing ADHD Symptoms, http://www.medicalnewstoday.com/articles/106801.php, accessed 10 Jun 08.

What is prefrontal cortex?, http://www.wisegeek.com/what-is-the-prefrontal-cortex.htm, accessed, 11 June 08

Larry Scahill, M.S.N., Ph.D., Phillip B. Chappell, M.D., Young S. Kim, M.D., Robert T. Schultz, Ph.D., Lily Katsovich, M.S., Elizabeth Shepherd, M.A., Amy F.T. Arnsten, Ph.D., Donald J. Cohen, M.D., and James F. Leckman, M.D. A Placebo-Controlled Study of Guanfacine in the Treatment of Children With Tic Disorders and Attention Deficit Hyperactivity Disorder, http://ajp.psychiatryonline.org/cgi/content/abstract/158/7/1067, accessed 11Jun08

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St John’s Wort for ADHD: Who Cares?

Friday, June 13th, 2008

This past week, a study was released in the prestigious Journal of the American Medical Association, which documented that St. John’s Wort has no benefit in ADHD or ADD.

You can access the original article here.

While I’m glad to see a natural treatment receive such rigorous research, and publication in such a leading journal, the question is: who cares?

The main concern that I have with this study is: Who even thought that St. John’s Wort worked for ADHD?

In the introduction of the research paper, the authors assert that St. John’s Wort is one of the top 3 botanical/herbal remedies used for ADHD. This statistic is referenced from a survey published in 2003 (you can read the abstract of this study here). There is a problem with taking this as a conclusion from this survey. This study surveyed pediatric patients treated for depression and ADHD, and reported on the most common herbal treatments used in the past year. The top 3 herbal preparations used included: gingko biloba, echinacea, and St. John’s Wort. However, the authors did not correlate the herbal medicine’s use with the condition - in other words, if an ADHD patient had taken echinacea, this study does not tell us that he/she took it for ADHD or for the common cold. In other words, the St. John’s Wort could have been taken for the depression (which was also tracked in the study) and not for the ADHD. Furthermore, there were very few patients who had taken herbal preparations in the past year (i.e. 18), bringing into question if this study was representative of the wider use of herbal preparations in ADHD.

As a physician in the field of ADHD - talking to my patients who try alternatives, and reading about it as well - I have never heard of using St. John’s Wort for ADHD. Referencing the book:ADHD Alternatives: A Natural Approach To Treating ADHD, By: Aviva Romm and Tracy Romm - they document that St. John’s Wort is effective for depression, but they do not even consider it a treatment for ADHD.

The American Herbal Products Association (AHPA) responded to the study, documenting two main concerns:

  • That the survey documenting that St. John’s Wort’s use for ADHD was flawed
  • That the strength of the St. John’s Wort in this clinical trial was degraded by the end of the study. They document that the authors even admit this.

Click here to read the AHPA’s response to this study.

In summary, I like seeing a major clinical trial on an alternative treatment for ADHD. I believe that we need a lot more of those. In future, my hope is that the researchers will choose compounds which are both widely used and considered to be effective before running the whole trial.

Please share your comments below - and if you do have any experience with St. John’s Wort - or more importantly - an herbal treatment which actually worked for ADHD - please share it below (in the comments).

All the best,

Dr. Kenny

p.s. to read more on St. John’s Wort - here is the wikipedia article.

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Brain Steroids

Friday, June 6th, 2008

We know that medications for ADD or ADHD help to improve concentration in those who have ADD and ADHD.
Some people - even if they don’t have the condition, take these medications to help to improve their focus and productivity (so called: ‘brain steroids’).
Each year, the press comes out with one or two stories (usually during exam time) talking about college students taking adderall to get through exams.
I must admit that the reason that I watched an episode of ‘Desperate Housewives’, was because a patient told me that one of the mothers on the show took her kid’s ritalin (I think that was in the first season).

Wired magazine did a story on using ‘brain enhancing medications’ for people who don’t even have ADD or ADHD.

It is surprising to hear of how many people use these medications to help with focusing and being productive. (Many of these people are scientists and researchers!)
In the first part of the article, the authors discuss the issue.
In the second part, they share some of the medication ‘regimens’ that people are using. They are generally a combination of ADHD medications like: Concerta, Ritalin, Focalin, Adderall, as well as Modafinil (provigil).

This is a concerning development - and one which can be quite dangerous.
In the past two years, the FDA has issued several warnings about ADHD medications including risks of cardiovascular concerns, psychiatric side effects- including hallucinations, agitation and suicidal ideas.
Most of the people taking these medications as performance enhancers - are taking these medications without proper medical supervision.

My suggestion: if you need a pick me up - have a large Starbucks (or even a Red Bull), but stay away from ADHD medications unless you’ve been properly diagnosed with ADHD and you are being medically monitored.

Please share your thoughts on this topic.
Since I know that the vast majority of my blog readers have ADD/ADHD or support a loved one with ADD/ADHD, please share your experiences with this topic - maybe it’s friends trying to get some of your pills!

All the best,
Dr. Kenny

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Discrimination in School

Tuesday, May 27th, 2008

I just came across a news report which is frankly shocking to me.

It’s a combination of ‘Survivor’ and systematized bullying in a kindergarten class.

In Morningside, FLA, a 5 year old boy who is in the process of being diagnosed with Autism, was ‘voted out’ of class by his classmates.
How a Kindergarten teacher could allow this to happen (and actually facilitate this) is mind boggling.

According to a news report (click here to see the original news story), kindergarten classmates of Alex where given a chance to say what they didn’t like about Alex. After expressing their dislikes (apparently to Alex directly…), the teacher put Alex to a vote.

Unfortunately, Alex’s classmates voted 14-2 to kick him out of the class.

Alex’s mother picked him up - and won’t send him back to the school. She is reportedly considering legal action, and the school board is reportedly starting an investigation.

Although this story is about Autism/Asperger’s - I’ve written about it here on my ADD/ADHD blog for four reasons:

  1. Some of my readers are concerned about Autism Spectrum Disorders
  2. Often kids with ADD/ADHD are teased, bullied and isolated socially - so the same issues apply
  3. I am an advocate for all of child’s (and adult’s) mental health - so if I can help to bring awareness and stop ignorance in any way - I will use this blog to do so…
  4. If I don’t stand up against discrimination when it arises, then I feel that I am condoning it. There is no way I can do that with this one…

I just find this outrageous.
For all of the advocacy work that many of us do - for something like this to happen in 2008 (or any time!) is completely unacceptable.

I want to think that this is an anomaly.
I want to believe that there aren’t other teachers who are using the model developed by reality TV (i.e. vote a student ‘off the island’ like on Survivor) to allow their students to humiliate and bully the most vulnerable in their classes.

Beyond this, I’m finding myself at a loss for words…

What do you think?
Is this an isolated incident?
What can we do to prevent anything like this happening again?

Please enter your thoughts and comments in the space below.

Dr. Kenny

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ADDENDUM:
I’ve just found this video from CNN about this issue.
Here it is:

Food Additive Elimination: Becoming Mainstream?

Sunday, May 25th, 2008

The link between food additives (i.e. preservatives and food coloring) and Attention Deficit Hyperactivity Disorder (ADD or ADHD) has been speculated for a very long time. There has been research for decades on this. The Feingold Diet has been in existence for many years, and postulates that when you eliminate food additives, ADD or ADHD will improve.

The issue has been that mainstream medical treatment for ADD/ ADHD has generally discounted the role of food additives and diet in the role of treating ADHD.

The interesting fact is that estimates are that up to two thirds of people try some form of alternative treatments for ADD/ADHD - with diet modification as one of the main treatments.

In September 2007, The Lancet published an article about food additives causing hyperactivity. This was a very well designed study, which documented that food additives increased hyperactivity in children who did not have ADD/ADHD. This was irrefutable evidence regarding the connection between food additives and symptoms of ADD and ADHD.

In February 2008, the American Academy of Pediatrics published an article which reviewed the issue and recommends that “a trial of preservative free, food coloring free diet is a reasonable intervention”. You can read more details of this here.

This week, an editorial was published in the British Medical Journal by Dr. Kemp, which suggests that removal of food additives from the diet should be a standard first approach when treating children with ADD/ADHD. This is based on his review of the research.

It seems that the pendulum is starting to swing.

Eliminating food additives and food coloring is on the brink of becoming a mainstream recommendation for the initial treatment of ADD and ADHD.

What Do I Suggest?

I suggest that you review all treatment options with your doctor.
In so far as diet modification, I am all for it as part of the treatment plan for ADD and ADHD. As far as treatments go - there is almost no risk or side effects to this treatment (apart from more time and possibly money to find food alternatives which are preservative free).
I suggest learning more about it - and giving it a try.

The one caution that I have is that elimination diets can be part of the treatment plan, but they may not be the whole answer. Research shows us that in general, treatment of ADD/ADHD needs a comprehensive, multimodal approach (i.e. including behavioral strategies, academic/occupational strategies, medication, therapy etc.). So while I encourage trying elimination diets, I don’t suggest that you then disregard all of the other treatment options which may be helpful.

Please share your thoughts and experiences in the comments below.

Dr. Kenny

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Patient Voices: ADHD

Saturday, May 24th, 2008

The New York Times put out a fantastic multimedia webpage this week - sharing people’s experiences with ADD/ADHD.
It’s called: Patient Voices: A.D.H.D.
There is a lot of great information there -
* to help parents to further understand their kids/teens
* For adults with ADD/ADHD to understand it better
* To further understand the role of medicine and other treatments

I suggest that you grab your favorite beverage, turn this on and listen for a while. You’ll learn a lot.

All the best,
Dr. Kenny

p.s. it is great to see such a high quality piece on ADHD in the mainstream media…

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Lines That Divide Us - Bullying Video

Thursday, May 22nd, 2008

A friend of mine, Michel Fortin, shared this video on his blog. It is very powerful, and has a significant implication for those with ADD or ADHD.

This video demonstrates the awful aspects of bullying, how many students it affects, and how difficult it can be emotionally.

The fascinating thing is that this video also shows a healing process which is going on for the students taking part in this exercise.

I encourage you to watch this video - and to share it with kids and teens who have experienced teasing and bullying. They will learn a lot.

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Adult ADD Roadtrip - Screen Yourself

Friday, May 16th, 2008

People are becoming more aware of the fact that adults often have ADD/ADHD as well as kids. A recent US based study found that 4.4% of American adults have ADD/ADHD, and many aren’t aware of it.

Shire, the company which produces Adderall and Vyvanse, has developed an awareness campaign which will help adults to ’self screen’ for the disorder. They have called it the ‘RoADHD Trip’, as they will be traveling to different US cities.

This initiative is including volunteers from the Attention Deficit Disorder Association, who will help to answer questions for the estimated 20,000 adults who will complete a screening questionnaire during this campaign - to try to figure out if they have adult ADD/ADHD.

The news release which describes the program states that they will be going to the following cities:

The events will take in Atlanta, GA; Alpharetta, GA; Raleigh, NC;
Simpsonville, SC; Albany, NY; Nashville, TN; York, PA; Boston, MA; Chicago,
IL; Milwaukee, WI; Taylor, MI; Ionia, MI; and Columbus, OH.

I wanted to let you know that I strongly support this initiative. There are so many adults with ADD or ADHD who don’t know they have it, or they suspect that they do and can’t get the resources or help that they need.

As I write this, I am in a hotel room in San Francisco just before a conference begins. When I was clearing US customs (i.e. entering the US from Canada), the customs officer asked me where I was going. When I mentioned a conference, and ADHD, he actually asked me how he could learn more about it - because he thinks he has adult ADHD and he doesn’t know where to find answers. I took a few minutes to talk to him about it (though not too long - people were waiting to clear customs!).

This is one small example - but there are many more out there. I support this initiative - as we need to help to educate and advocate for people out there who have ADD and ADHD. And as people self screen for the disorder, the volunteers from ADDA will help to educate everyone about this disorder.

To find out more about this, you can visit Shire’s site: ADHD Support. And to see the schedule of their program, click here. To find out more about ADHD in adults, visit ADDA.

What if you can’t get to one of the tour’s sites?

If you suspect that you have adult ADD or ADHD, and you want to screen yourself for it, I suggest that you print this adult ADD screening questionnaire.

I suggest that you don’t read the questionnaire instructions, but rather go right to the questions and fill them out as best you can. (there are only 18 questions)

Then, go back and read the instructions on how to score it.

Whether you score highly or not (or even if you don’t even fill out this questionnaire), if you are concerned about adult ADD or ADHD, I strongly encourage you to talk to your primary care doctor about it and see if he or she can give you some help in finding the right local resources.

Please share your thoughts or comments below.

Dr. Kenny

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You Can Still Register For Unwrapping The Gift of ADD

Thursday, April 17th, 2008

Yesterday, the site for our new program, Unwrapping The Gift of ADD went live for registrations.

We knew that a lot of people were interested in our program, and the ‘buzz’ was building…
We had 479 spots for our program, but based on all of the feedback that was coming in, it was obvious that wouldn’t be enough…

And then, at 11:55 am eastern time (5 minutes before the site was supposed to go live!), the server went down.
Despite all of our planning - when the traffic started to hit the site hard, it crashed. It turned out that there was a problem with a ‘mysql database’.
Hmmm…. Thankfully, my webmaster ‘diagnosed this’, and got us going by 12:09 pm (i.e. 9 minutes late). [Thank you Mike!!!!].
It was a very long 9 minutes for us (And many of you too…)
Despite all of the planning, technology is technology…

Needless to say, I was inundated with emails - frustration, upset, anger…
People wanted to get into our program - Unwrapping The Gift of ADD.

I was tied to my computer (as was Dr. Hallowell’s list manager), answering questions and helping people sign up for hours.

As the day went on, I was able to arrange for more spots for our program. We will be using ‘webcast’ technology - meaning that you will be able to listen in via your internet connection. Because of all of the chaos yesterday, I didn’t email you again to let you know that we would have extra spots, we just kept the site live and taking registrations.
(Just as an aside - this webcast technology works on dial-up too…)

Many people emailed in saying: “I had to miss the signup at noon - will you run this program again?”

The answer is - ‘no’, we have no plans to run this program again…

BUT… You can still sign up now.

I am speaking with the president of the webcast company (when you need A LOT of lines, I guess you get to speak to the president…) this afternoon. At that point, I’ll be able to gauge how many spots our program will have.

In other words - if you want to make sure to secure a spot - go to our site now and sign up. If you get in before by this afternoon, then you will have a spot for sure.
(I really hope we’ll just be able to keep the site live for ongoing registrations, but I can’t be sure until later today…)

A final word: thank you to all of you who have been sending in your positive emails and comments. We really appreciate it!

We’re so excited (and humbled) to be able to share our ’strength based approach’ to ADD/ADHD with you.
Because at the core of it - we know that the information that our experts will share can literally change lives….

Looking forward to having you participate in the live event!

Dr. Kenny Handelman

p.s. if you skipped to the bottom - the short summary is: we can still take registrations today, so sign up now here.

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Visit The Hallowell Center With Me…

Sunday, April 13th, 2008

Dr. Hallowell and I just met at the Hallowell Center a few days ago - to put the final plans together for the ‘Unwrapping The Gift of ADD‘ program which will be launching in a few days (The website will go live on Wednesday April 16th at 12 pm EDT, 9 am PDT).

I flew down to Boston for the day (and then had to drive to Sudbury, MA to get to Dr. Hallowell’s office). I thought it would be fun to bring my camcorder - and let you join me for this journey. In this video, you’ll get to:

  • See Dr. Hallowell’s office
  • Listen in as I ask him some of the questions that have come up about ‘Unwrapping the Gift of ADD’
  • and hear more about this program

Even though you may not ever be able to visit the Hallowell Center - you can check it out with me on these videos…

This video runs about 15 minutes - so it had to be broken into two parts (Youtube only allows 10 minute videos…)

Enjoy!

…and as always, please leave your comments below.

Dr. Kenny

Video 1:

Video 2:

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