Doctor Groups Hold Slugfest Over ADHD Drugs
26 CommentsBy Ed Silverman // July 30th, 2008 // 12:43 pm
First, the American Heart Association says children taking ADHD pills should have electrocardiagrams to screen for heart problems. The move was after an FDA review found reports of 19 sudden deaths in children treated with ADHD drugs and 26 reports of other problems including strokes and fast heart rates between 1999 and 2003.
Now, though, the American Academy of Pediatrics says most children taking ADHD drugs don’t need an EKG, and the new policy is certain to inflame the debate over the safety of these pills, which are powerful stimulants. More than half of the 4 million kids in the US who are diagnosed with ADD or ADHD are being treated with these pills.
The issue is that, while ADHD drugs such as Ritalin, Adderall and Concerta can help children focus more and behave less impulsively, they also can increase blood pressure and heart rate -and carry warnings about risks for sudden deaths in patients with heart problems.
But the AAP say the AHA was overzealous in recommending EKGs, because such rare deaths are more common in the general population than among children on stimulants. According to the academy, sudden heart-related deaths occur in about four out of 2.5 million US children on stimulants each year, versus between 8 and 62 such deaths yearly among all US children. Here is the AAP policy.
The AHA policy subjects healthy children to unnecessary and costly heart work-ups, and it could limit access to effective ADHD treatments, which “could have serious implications,” according to the AAP.
Initially, the AHA policy caused confusion and criticism, so the organization clarified its stance in May, issuing a little-publicized statement saying docs should use their own judgment about EKG screening and that ADHD treatment should not be withheld if an EKG isn’t done. The AAP agreed, but decided a more forceful stance against routine EKGs made more sense. The new policy was quietly posted online that month, but is now being published in Pediatrics, the academy’s medical journal.
“We really were hearing from our members and parents that things were not at all clear,” Jim Perrin, a Massachusetts General Hospital pediatrician and co-author of the policy, tells the AP. The policy makes clear there’s no scientific evidence to support “this fairly dramatic practice change.”
Tim Gardner, AHA’s president, tells the AP his group’s stance is based partly on the fact that children with heart abnormalities have a higher incidence of ADHD. But he downplayed differences with the AAP, saying both groups emphasize the importance of careful evaluations for kids starting ADHD drugs.
But Steve Nissen, the Cleveland Clinic cardiologist, says the academy appears to be dismissing concerns that stimulants are used excessively in children with insufficient evidence about long-term risks. And he adds the group’s pro-drug stance is troubling, coming only a few weeks after it advocated cholesterol drug treatment for children as young as 8 years old, the AP notes.
Vince
The AAP recent advice on statins now this. Just how much funding from the drug industry does this group recieve.Who are they looking out for.
Health Guru
Interesting post. Seems that this debate about ADD and ADHD meds will be going on forever. The two sides it appears can’t come to understand that risk is undertaken in every medicine, and its purpose is to decrease the already inherent risk in the life of the patient; with the condition or without it.
Lisa Van S
Vince,
The AAP testified before the NJ Stae Assembly, Consumer Affairs Committee, in opposition of Parental Informed Consent for Psychotropic drugs that carry black box warnings.
AAP is Pro-Pharma and Anti-Parent, pretty sick if you ask me!!!
atlex
LVS and Vince,
For your hypothesis to be true, one would have ot believe that the AAP gets far more support form Pharma than does AHA. Trust me, AHA gets as much, if not, more financial support.
Back in April the WSJ published an article discussing this (http://online.wsj.com/public/article/SB120881594888832643-djXDWMuQTzQOWA_qIKLyNqUIhyE_20080522.html).
Here’s an interesting quote from that article:
“‘This is a $250 million recommendation,’ says Mike Ackerman, a pediatric cardiologist at the Mayo Clinic in Rochester, Minn., who estimates the total cost of an ECG at about $100. ‘We’re really trying to find a needle in a haystack, and we have no data yet to know that the screening program they’re recommending would capture’ those few at-risk individuals. Dr. Ackerman was a member of another American Heart Association panel that last year stopped short of recommending routine ECG screening for heart abnormalities in young competitive athletes.”
Clearly this is not about one group being anti-patient, but a legitimate medical controversy.
Atlex
M Helm, MD
To me it appears that the confusion and controversy arises because there is not a thorough, sober review of evidence prior to a recommendation being made. The controversy is inflammed when there is incomplete reporting of the recommendations.
Ed points out that the AHA rapidly backed off the interpretation of their recommendation as being for ‘universal’ screening. Additionally, as I understand this, the AHA and the AAP did not collaborate on their respective recommendations. To my knowledge also, no one has heard the AACAP (child and adolescent psychiatry), the AAFP, or the general psychiatrist chime in on this debate.
The medical professional associations have not yet learned that it is much more effective to develop collaborative statements which are supported with good science/epidemiology. Than for one group to promote something which is outrageous to another. Additionally, good PR tactics (like selling new ideas internally to minimize sniping, and developing clear, consistent and easy to comprehend talking points) are helpful.
As for the statin recommendations made earlier - again this is a problem where the evidence is not their to support the opinion of the committee. However, when you read the whole statement, there is clearly an emphasis on diet/exercise/lifestyle modification. What got picked up in the media was the statin comment.
ECGs are not even routinely recommended for sports participation physicals - though there are reconized risk factors which indicate the need to do them. There are likely to be more “sudden cardiac deaths” of young athletes who may have be seen in screening ECGs than could be attributable to stimulants.
Atlex’ citation of the needle in a haystack analogy is highly relevant. There are costs and barriers associated with the concept of universal ecg screening. We also do not know the circumstances of the reported deaths/cv injuries in stimulant users. It would be much more relevant to understand if there are possibly some predictors which should trigger a more comprehensive assessment.
I can think of a number of situations which may be relevant - family history; personal history of cardiovascular, connective tissue, blood, or metabolic disorders; other medications; eating disorders; psychiatric problems; drug abuse (or risk factors). Certainly a recommendation for routine ECGs would appear silly if it were found that the majority of “adverse events” were associated with the high end of the normal dose range, “polypharmacy,” suicide attempts/psychiatric conditions, or abuse of the stimulant with or without other drugs of abuse, and only a very small percent (less than the rate in the population) were attributable to cardiovascular disease.
I hope that practitioners (pediatricians and otherwise) first identify and address all other possible causes of inattention and disruptive behaviors prior to considering a diagnosis of ADD/ADHD. I also hope that the recommendations for diagnosis, monitoring and treatment of ADD/ADHD made by the AAP and AACAP and (I believe endorsed by the AAFP) are followed. These include baseline and ongoing assessment of heart rate and blood pressure, and vigilance for medication related adverse effects.
Here’s my disclosure for those who don’t know, I’m a pediatrician and a member of the AAP - active in my state chapter, and now on a national committee.
Final comment/question to Lisa Van S. Wasn’t it only the state chapter that opposed the psyciatric informed consent bill in NJ. I do not believe that the AAP on a national level took a position, but please correct me if I’m wrong. In my state chapter, the bill would have been enthusiatically supported (and I would have helped to line up the testimony). I’m sorry that NJ was not able to take the lead on this.
The shame of the proposed law is that full informed consent - including when a medication is used “off-label” or for some purpose which is not well studied - should be the standard of care regardless of whether or not it is a psychiatric drug. There should be no need for this law - but we both know that standard of care is rarely if ever met.
M Helm, MD
Oh, I forgot. Atlex, I’m darn sure you are correct on the levels of industry support to the organizations. Pediatricians are notoriously low value prescribers for all but a small number of conditions. More than half of my sick visits leave without a single prescription. Someday’s it has been only one in 10 who end up with a prescription. I think this is not unusual in pediatrics, and the vast majority of parents and patients are happy with this.
I’ve had only one complaint for NOT prescribing more medication. I saw a child who clearly had allergic and non-allergic rhinitis, and snoring/obstructed breathing during sleep. In that case the mother had in her mind that the child (with no fever, or other signs of infection) needed Omnicef for the sixth or so time that year. She saw me only becasuse she knew the other doctor there that day would not prescribe an antibiotic without cause - she learned I won’t either.
I would venture to guess that the AAP receives more support than other organizations from infant formula makers, vaccine makers, and the maker of Synagis. However, I may be wrong there, I believe the AAFP is still bigger than the AAP.
Meg
Having seen Steve Nissen in action at the ADHD FDA Hearing; getting his committee to support placing black box warnings on all these drugs (only to be shot down subsequently by the Pediatric Advisory Committee), I say “Go Steve”.
And the commenter suggesting informed consent for all off-label uses would be a step in the right direction.
I remember a little boy at a school where I worked (who was on an ADHD drug originally recommended by the school - natch), fall down and foam at the mouth and be taken off by ambulance from the drug. Fortunately he lived, but his immigrant parents will never trust schools or doctors again.
Lisa Van S
Atlex and M Helm MD,
Maybe,.. Just Maybe, the Medical Decision for an EKG should be left up to the Parent?
Here is the link to the NJ State Assembly, Consumer Affairs Committee Hearing on Parental Informed Consent Bill A378, its the last Bill that was heard. There was a powerful exchange between Assemblywoman Cruz-Perez and Nancy Pinkett the lobbyist for AAP. Another fascinating exchange was that of Assemblyman Moriarty and the Pediatric Psychiatrist Dr. Gulak, a huge prescriber of antipsychotics in NJ’s Medicaid Program for Foster Care Children. If I remember correctly, Abilify was his drug of choice.
http://www.njleg.state.nj.us/media/archive_audio2.asp?key=ACO&Session=2008.
Lisa Van S
Ooops forgot… Click on March 3rd 10 am
Laurie
M. Helm…it was Nancy Pinkum(not sure of the spelling) who was representing the American Academy of Pediatrics.She did not identify herself with any one chapter, but as the representative for the whole organization. I believe she is their lobbyist.
Thank you for your statement about informed consent and it importance. If more physicians acted as you recommend, the bill wouldn’t be necessary. Sadly it is.
Atlex
LVS,
Did I state anywhere that parents shouldn’t make the decision? Of course not. As usual, you make things up as you go along.
Atlex
Lisa Van S
H Helm MD
“I’m sorry that NJ was not able to take the lead on this”
The Bill isnt dead yet, and Senator Vitale should think twice before blocking it for a third time,. it then becomes an issue of “Ethics”.
Lisa Van S
Atlex,
“legitimate Medical Controversy”
No controversy, no making things up as I go along. Provide information to the Parent, and let them decide,.. its not that difficult.
M Helm, MD
For Laurie and Lisa Van S, I can’t find any name like Pinkett or Pinkham or Pinkum in the AAP staff directory or any of the state government affairs pages. I listened to the testimony before, but it was a while ago, so I listened again tonight. There were a number of statements made on both sides of the argument, including by your attorney, which were not accurate - but that’s typical for testimony to legislative committees. For future reference whatever her name is, she appears at around 1:15 minutes. She certainly sounds to my ears more like she is from central Jersey, than Chicago.
Typically, the AAP has concerns for parity of mental health services and access to care. There is also advocacy for provision of services in non-traditional/school-based programs.
My (off-topic) opinion - as pediatricians, we routinely obtain informed consent/provide fact sheets for vaccines. State medical boards have specific requirement for informed consent (and the elements the consent must include) for gastric bypass surgery. I think the NJ bill(which is restricted to only those with Black Box warnings) really doesn’t go far enough. There should ALWAYS be informed consent for psychiatric treatment. This should specify known and potential side effects, alternative treatments, potential consequences of treatment and non-treatment, nationally recognized diagnosis monitoring and treatment guidelines, and the research support/FDA approval status for treatment of the specific condition. It should definitely take more than 10 minutes, and it should be a covered benefit with a high level (well-paying) billing code for the physician.
I also think that in kids, all psychiatric treatment should be based on a foundation of counseling with a qualified psychologist or other provider with experience with children and adolescents.
I don’t believe the ‘atypical’/newer antipsychotics have a black box warning for pediatrics. The NJ law could create a theoretical barrier to an FDA approved treatment (fluoxetine - best used with counseling based on good research), but not require consent for giving a preverbal child Abilify. That was also a point made by Nancy P, and others.
Good luck with the bill, I’m sure that Ed will continue coverage.
Back to the topic… Lisa, we may differ slightly on parental autonomy relating to ECGs. If the test is of no proven medical value, it is hard to justify transfering the cost of a test with unknown value to the private or public payor. If there is a genuine medical concern based on the specific circumstances, the test should be a covered benefit. If the parent is willing to pay for the test even without the indication of any utility, that’s a different question. Similar considerations are relevant for cancer screenings, but there is better concensus on when and for whom the tests are appropriate and helpful.
There is a need for evidence to accurately assess risk/benefit and guide recommendations and policy. Physician opinion or even concensus, sensaltionalism and fear-driven, emotional “gut-reactions” are not helpful.
“In God we trust, all others must show proof.”
Laurie
“There should ALWAYS be informed consent for psychiatric treatment. This should specify known and potential side effects, alternative treatments, potential consequences of treatment and non-treatment, nationally recognized diagnosis monitoring and treatment guidelines, and the research support/FDA approval status for treatment of the specific condition. ”
Oh, if this was truly going on, I would be thrilled! I agree with you that the bill should go farther, but the fact that this group of drugs DOES have black box warnings and, with the exception of Prozac, are off label for most diagnosis’ makes it critical. If the bill attempted to get mandatory informed consent for all psychiatric drugs it wouldn’t have made it as far as it has. Psychiatry has been lobbying hard against even this small step. To attempt to make it even more encompassing would have resulted in a quick death of the bill.
It’s a small step, but one I feel is at least a start for complete education of parents prior to prescribing.
Laurie
I’ll try to get the lobbyist correct name. It’s very hard to hear it on the audio. This is the second time she has testified about the bill and the AAP’s opposition. She may be from Jersey since the Committee knew her well.
Lisa Van S
M Helm MD,
Abilify and Seroquel, as you know are antipsychotics. FDA has placed Black Box Warnings on these meds for increased risk of suicide/violence. May I suggest that you check your 2008 version of the PDR.
You stated that our Attorney was innacurate in his testimony, would you please point out the inaccuracy.
Lisa Van S
H Helm MD
“Parental Automany”,… Thank God for that, it saved my child’s life.
Lisa Van S
Laurie,
I believe Nancy is a Councilwoman somewhere in NJ. I tried to educate her on the Med Guides!!
Just A Thought
Amphetamines are a good enough cause to suggest cardiac testing in anyone.
Call them whatever you like. I have seen one child’s generic medication labeled ‘amphetamine’.
If yours is not speed, how closely related is it in chemical make-up?
I have doubts as to whether some parents would do anything that might suggest that the child should be taken off drugs. They have so much pressure from the schools, for one.
Is it true that schools get double the federal dollars for each disabled child? That ADHD is considered a disability under those federal guidelines?
If you can complain about the risk of kids being overweight and eating fatty foods, if you can suggest that they be treated for high cholesterol, then how can you not expect the safty net to protect them here?
Let’s not be onesided. Drugs always. Anything that might debunk them, never.
ATG
Actually, there is no credible substantiation that stimulants (or so-called “nonstimulant” ADHD drugs) improve academic performance. Since children with an LD, for which the diagnosis of ADHD is eligible, can take tests untimed and in many circumstances with the help of an aid, this tends to skew reports on academic performance. And as far as improvements in nonacademic performance, there’s a few tilts there as well. Just the idea alone that a child is on stimulants can often work as a placebo for teachers and therapists, causing more positive reviews of the child’s behavior regardless of whether the child is on actually taking the drugs.
Furthermore, according to the unheralded details of the MTA, even nonacademic behavioral improvements aren’t long lived and children in the non-drug groups (cb therapy) fared better over time as the drug group lost most or all their initial seeming gains.
And I don’t think anyone should believe the reports that cardiac deaths among children on stimulants are lower than in the general population any more than they should believe that cardiac deaths among recreational methamphetamine users are lower than in the general population. The least bit of digging through whichever epidemiological studies supposedly support this would no doubt come up with some major numbers-massaging. But I’m not up to it tonight. Had too much coffee and I’ve got an arrhythmia.
M Helm, MD
Lisa Van S. - The black box warnings on the atypicals relate to elderly patients with dementia. Only recently did Abilify and Risperdal get approval for “bipolar” and schizophrenia in adolescent. Zyprexa applied for these indications, but final approval hasn’t been granted. The current black box warning on Abilfy which does mention children reads as follows:
“Children, adolescents, and young adults taking antidepressants for Major Depressive Disorder (MDD) and other psychiatric disorders are at increased risk of suicidal thinking and behavior. (5.2)”
Problem is, Abilify is not an antidepressant. So how does this relate to the risks of a child receiving Abilify?
I haven’t the time to review and provide a critique of all the testimony. I’m supportive of full informed consent for all psyciatric/behavioral medications in children - wether or not there is a black box warning. I’m also supportive of behavioral and cognitive behavioral interventions for all patients with those conditions. MTA, TADS, TORDIA and a number of other studies - not to mention the professional society treatment guidelines validate that the non-medication treatments improve outcomes (and may be sufficient on their own).
As a society, we are far to eager for a “quick fix.” The question of “isn’t there a pill for this?” is too often the reason for a medical visit. Problem is all pills carry risks.
For the MD/DO/NP/PA to understand the risks and benefits, but not communicate them seems a poor way to establish a “therapeutic alliance.” Worse still, in my current job, it is fairly clear that a large number of prescribers really don’t understand the risks (or mechanisms of action, etc) of many of the medications they prescribe (or want to, but can’t due to payor decisions). This leads to some bad practice behaviors - examples of which are in the NJ Leg. testimony.
Lisa Van S
H Helm MD
FDA and Industry negotiated the language on Abilify and Seroquel. I am assuming the confusion in the language has to do with sales!
Lisa Van S
H Helm MD
Why is it that I cant find you listed as a Pediatrician,.. or a member of the AAP?
M Helm, MD
Lisa Van S
How should I know? You probably don’t have enough information to search for me based on just a last name. I’m not the only Dr. Helm in the country, and I’m not really looking to have my address published on Pharmalot. I’m sure you can understand that. However, I am as I say, a pediatrician, an AAP member, and an evidence-based pharmacy benefit program medical director. I also have an earlier graduate degree in business.
Lisa Van S
M Helm MD,
You may contact me privately,.. lvansyckel61@yahoo.com
I keep all conversations confidential.