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• Authors’ Response to Dr. Pomeroy’s Concerns
  Thomas J. Moore
  Published on: 16 May 2023
• Misleading information of no value
  David P Pomeroy
  Published on: 3 May 2023

• Published on: 16 May 2023

  Authors’ Response to Dr. Pomeroy’s Concerns

  • Thomas J. Moore, Corresponding author Johns Hopkins University

  Dr. Pomeroy’s rapid response does not dispute our study methods, data, or primary conclusion: That
  nearly half the adult use of Schedule II stimulants occurs in combination therapy with other potent
  psychoactive drugs, notably antidepressants and anti-anxiety drugs. However, we disagree with his
  statements about safety, appropriate clinical use, and characterization of FDA approval status.
  Specifically:
   We know of no antidepressants that are FDA-approved (or “on label”) for combination therapy
  with stimulants such as the amphetamines or methylphenidate. In fact, not one of the six most
  commonly prescribed SSRI antidepressants has an FDA-approved indication for treating ADHD in
  monotherapy, let alone with combination therapy. (1)
   His contention that combined use of stimulants with antidepressants “is basically safe” ignores
  the well-documented risks of both drug classes. The U.S. Drug Enforcement Administration
  declares that the Schedule II stimulants are “dangerous,” and the drug prescribing information
  contains a boxed warning about the high risk of addiction and misuse as well as warnings about
  psychiatric side effects, serious cardiovascular reactions, long-term suppression of growth, and
  tics and other persistent involuntary movements.(2) SSRI antidepressants contain warnings
  about suicidality, and adverse effects include sexual dysfunction, weight loss, tremor, insomnia
  ...

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  Dr. Pomeroy’s rapid response does not dispute our study methods, data, or primary conclusion: That
  nearly half the adult use of Schedule II stimulants occurs in combination therapy with other potent
  psychoactive drugs, notably antidepressants and anti-anxiety drugs. However, we disagree with his
  statements about safety, appropriate clinical use, and characterization of FDA approval status.
  Specifically:
   We know of no antidepressants that are FDA-approved (or “on label”) for combination therapy
  with stimulants such as the amphetamines or methylphenidate. In fact, not one of the six most
  commonly prescribed SSRI antidepressants has an FDA-approved indication for treating ADHD in
  monotherapy, let alone with combination therapy. (1)
   His contention that combined use of stimulants with antidepressants “is basically safe” ignores
  the well-documented risks of both drug classes. The U.S. Drug Enforcement Administration
  declares that the Schedule II stimulants are “dangerous,” and the drug prescribing information
  contains a boxed warning about the high risk of addiction and misuse as well as warnings about
  psychiatric side effects, serious cardiovascular reactions, long-term suppression of growth, and
  tics and other persistent involuntary movements.(2) SSRI antidepressants contain warnings
  about suicidality, and adverse effects include sexual dysfunction, weight loss, tremor, insomnia
  and anxiety. (1) Because of lack of clinical testing we don’t know the extent to which the
  combinations make these substantial risks worse, better, or trigger new kinds of risks.
   Contrary to Dr. Pomeroy’s speculation that no co-author had clinical experience, the senior
  author, G. Caleb Alexander MD, is a practicing internist in the Johns Hopkins University health
  system, as well as co-founder of the Johns Hopkins Center for Drug Safety and Effectiveness.
  Our study is also explicitly clear about issues which we could not evaluate. For example, our data do not
  include information on the clinical basis for concomitant use. We agree with Dr. Pomeroy that ADHD
  and depression frequently occur together and may explain some combination therapy. Another pattern
  is a prescribing cascade in which an antidepressant causes unwanted sedation, which leads to the
  addition of a stimulant, which in turn causes insomnia, which leads to the prescription of sleep
  medication.
  References
  1. US prescribing information [package insert] for sertraline, escitalopram, fluoxetine, duloxetine,
  citalopram, and paroxetine.
  2. US prescribing information [package insert] for Adderall, Adderall XR, Vyvanse, and Concerta
  (combination salts, esters, and isomers of amphetamine and methylphenidate).
  Prescribing information available at the National Library of Medicine DailyMed web site:
  https://dailymed.nlm.nih.gov/dailymed/

  Thomas J. Moore
  Corresponding Author

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  Conflict of Interest:
  None declared.

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• Published on: 3 May 2023

  Misleading information of no value

  • David P Pomeroy, Physician n/a

  Combination drug therapy for ADHD and one or more of the common co-occurring disorders experienced by 50-60% of patients with ADHD is appropriate on-label use of stimulant plus anti-depressant for instance. 40% of patients with appropriately diagnosed ADHD have clinically significant anxiety as well, 30% have depression. SSRIs have FDA-approved Indications for treating both of these conditions. Stimulants and SSRIs are basically safe when taken together; rare instances of serotonin syndrome are seen. I do not see any evidence that any professional with experience diagnosing and managing patients with these conditions had any input into this "study"; if there had been then the negative value of the report would have been evident. Without correlating diagnoses with the data cited, as noted in the "limitations" section, the data is of no significance whatsoever. As a physician with 18 years of specialty practice in the field of ADHD and 26 years of general Family Medicine prior to that I can attest to the inaccuracy of the biased conclusions reached in this paper. I have no financial interests or benefit from any manufacturer of pharmaceuticals or any other purported treatments for ADHD. I do have a passion for exposing the "myth-information" surrounding ADHD diagnosis and treatment which abounds in the popular press and unfortunately in professional publications as well.

  Conflict of Interest:
  None declared.

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