Fall 2017 Issue


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Response to Budget Bill-HB1500

Joint Commission on Healthcare Study on ADHD medications

Virginia's General Assembly has directed the Joint Commission on Health Care to study the use of medications for ADHD (Click here to view mandate), and I am leading that study. Given the role that psychiatrists can play in both the diagnosis and management of ADHD, I would welcome any input that PSV might have on the issues raised in the study mandate.

Andrew Mitchell, ScD
Senior Heath Policy Analyst
[email protected]

Dr. John Shemo responded as a representative of  PSV, specifically to part A of bill HB1500.

By John P.D. Shemo, MD, DLFAPA
Medical Director, Psychiatric Alliance of the Blue Ridge

Associate Professor, University of Virginia

Just as a little background, I have been a physician for more than 42 years.  I did post-graduate residencies in both Psychiatry and Internal Medicine. I have been extensively involved over the years in both academia and private practice, including extensively in the areas of patient care, research, administration and patient advocacy.  I have served on, and at one time chaired, the Government Policy Committee of the Group for the Advancement of Psychiatry. I have been a liaison on the DSM-5 steering committee and the APA Practice Guidelines steering committee.  I have been honored with the "Exemplary Psychiatrist Award" from the National Alliance for the Mentally Ill (NAMI).  I am currently the longest tenured member of the Board of Directors of the Psychiatric Society of Virginia and I have served as a Virginia representative in the American Psychiatric Association Assembly since 1999.

Based on this experience, I would like to share some thoughts and even concerns about the above referenced study:

A.  I am concerned that some of what is there in contained is taken out of context.  It is emphasized in the Bill that there are concerns “related to the use of psychiatric medications that have dramatically increased over the last 25 years." As noted above, I have been involved with the practice of medicine/psychiatry for more than 17 years longer than the last 25 years.  The available options for the treatment of impairing disorders, and the quality of these options, has dramatically increased in almost all areas of medicine, not just psychiatry.  In this context, we are able to not only treat many conditions better, but we are able to treat many we once could not impact at all. The reality is that many people are on more medications now than they would have been 25 years ago for a wide array of disorders because the treatments that now exist. Also, because better treatments exist now, fortunately we are able to diagnose many conditions earlier and treat them more aggressively.  In consequence, more people are living longer with a better quality of life. When I was first in medicine, most people were "old" by the age of 65.  Now, if an individual has taken reasonable care of themselves and been reasonably "lucky" in terms of genetics and environmental exposures, they are not at all "geriatric" at 65. This is obviously good for Americans, but may be less so for Medicare and Social Security.

In regard to your specific concern about the treatment of ADD/ADHD, I do think that this needs to be thought about in the context of the (mandated) changes in the educational system, especially the public school system.  There is now an overarching emphasis on the SOL’s or their equivalent in other states.

As you are no doubt aware, the SOL's have a heavy emphasis on the acquisition of facts rather than the development of critical thinking. (Yes, I am well aware that advocates of the SOL's would dispute this. Virtually all the public school teachers I know would not).  An educational system so focused puts children with even lesser degrees of ADD/ADHD symptomatically at an ever increasing disadvantage. Thus, children with lesser impairment by ADD/ADHD symptoms are needing help. An analogy would be that a child with a given degree of asthma may not need treatment if living in Arizona, but the same child would need ongoing treatment if they were trying to live in Los Angeles with its bad air quality.

I would also point out that the actual data on addiction is not well represented in this bill. Yes, children with ADD/ADHD do have an increased incidence of drug addiction, but the actual epidemiological data on this supports that those who have effective treatment have a lesser incidence of the development of substance abuse. Children with ADD/ADHD do not do as well in school and therefore tend to get marginalized. As a result, they socialize with other children not doing well, among whom there is a clear increased incidence of substance abuse.  If a child with ADD/ADHD is appropriately treated, (they are more likely to be socializing with other children doing well in school) their risk for developing substance abuse actually decreases. Again, there is a good database addressing this.

Your concern about the use of "anti-psychotics" is also noted. I think that it is important that your study group has a good understanding about how medications are "labeled."  Often, a medication gets "grouped" by its first FDA-approved use.  This then confuses people when the medication is used for another purpose. As an example, Propranolol is listed as an anti-hypertensive drug, which is its first FDA-approved use. Propranolol, in some people, is also a very effective medication for the prophylaxis of migraine headaches. This does not mean that migraines are "caused" by hypertension, as patients will ask if they look up Propranolol on the internet. Remember, biology/evolution is inherently conservative.  It uses the same mechanism repeatedly in the body for different purposes.  For example, we are currently aware of at least 25 serotonin receptors in the body that do very different things.

Having said this, I agree that "D² blockers" (not "anti-psychotics") should not be used in the treatment of ADD/ADHD unless there are co-incident factors being addressed.  I also agree that if this were the case, the child should be seen by a specialist.

I think that it is important to also address your stated issue regarding "no FDA indication" for a medication use.

If you will refer to page one of the introduction to the "PDR" (Physicians’ Desk Reference) which lists all branded medications and their FDA labeling, you will see that the FDA clarifies that its role is not the regulation of physician prescribing, but the regulation of pharmaceutical company advertising and marketing.  It points out that physicians should utilize their clinical experience and the current medical literature in making prescriptive decisions.

Getting "FDA approval" for a given medical use for a given medication is not just a scientific judgement.  It also involves an economic judgement by a pharmaceutical company.  If a given compound was found to be the definitive cure for a disease that only 400 people a year contract, it would never get FDA approval. FDA approval for an indication costs a pharmaceutical company about 1.5 billion dollars to obtain. It will not be sought by the pharmaceutical company if they do not believe that its use for that indication will repay that investment. Thus, no matter how strong the evidence, pharmaceutical companies will not seek approval for a new indication if the number of people with the disorder is limited or if their patent on the medication is near expiration. Once a patent has expired and the medication is generically available by multiple companies, it will never be approved for anything again as no company will have an economic incentive to bare the expense.

B.  Briefly, on the issue of telemedicine, I do also have some concerns.  While I support its use to increase access to care, I do think that this needs to be done with some precautions.

The first is the need to recognize that the technology of telemedicine, and especially, telemental health services, is not equivalent to live, face-to-face treatment. Any practitioner who maintains that they get equivalent results from telemedicine vs. "live" treatment must be "really bad in person."  Thus, it should be seen as only an option to extend access and not be seen as equivalent in quality to face-to-face care.

Beyond this, I do have a significant concern that telemedicine may evolve into a system run by corporate entities using less and less experienced practitioners to provide more and more "packaged" evaluation and treatment protocols with less and less attention to the individualized needs of real patients in the real world.

I hope some of this may be helpful in your deliberations. I was send your request for input by Andrew Mann at the Psychiatric Society of Virginia only a few days ago with what seemed a tight schedule. To paraphrase Mark Twain, I would have sent a shorter letter but I didn't have time.

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