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Experts Weigh in on Medication Overuse Headache
Following the American Headache Society’s Scottsdale Headache Symposium in November 2018, MedPage Today posted an article which shared differing opinions from Drs. Hans-Christoph Diener and Elizabeth Loder on medication overuse headache (MOH). While Dr. Diener noted that “we can identify people with chronic migraine who are at risk to have medication overuse,” and that following successful withdrawal treatment “the majority of patients…revert to episodic migraine,” Dr. Loder pointed out that while MOH may exist and contribute to chronic migraine, “it is over-emphasized and the evidence in support of these concepts is weak.”
For this article, I’ve asked Drs. Marcelo Bigal, Rob Cowan, Jack Schim, and Stewart J. Tepper to share their perspectives on this topic. I also asked both Dr. Diener and Dr. Loder to expand on their comments. We will see Dr. Diener’s response to the article, but we did not hear back from Dr. Loder. Lastly, I will weigh in on the MOH discussion.
Marcelo Bigal, MD, PhD
Chief Medical Officer, Purdue Pharma
The issue of medication overuse headache (MOH) needs to be disentangled into a few separate but related issues. First, do excessive medications make migraine worse? Second, should MOH be considered a distinct form of headache? And how can evidence inform clinical practice?
Robust evidence supports the fact that excessive acute medication use is associated with increased headache frequency among migraineurs. In a large epidemiological study, we demonstrated that exposure (medication) precedes outcome (increased headache frequency).1 The risk was higher for barbiturates, followed by opioids and triptans, and was not increased by nonsteroidal anti-inflammatory drugs (NSAIDs). Dose response and critical exposure levels were identified. Based on this study and several others, we argued that criteria of causality had been demonstrated beyond reasonable doubt.2
However, since the effect is specific to migraine in that the exposure only increases the risk in migraineurs, not in individuals with other types of pain, we do not consider MOH a distinct entity. Instead, we believe that excessive medication is a risk factor for chronic migraine (CM). Therefore, we should be able to subdivide CM into 2 groups, one with and one without excessive medication use.
From a clinical perspective, physicians should monitor acute medication consumption in individuals with migraine and should be liberal in starting preventive therapy. In those with CM and excessive acute medication use we don’t advocate abrupt discontinuation of acute medications, since some preventive medications, especially the newer anti-calcitonin gene-related peptide (CGRP) antibodies, seem to work equally well in individuals with and without excessive use of medication,3 allowing more natural and gradual control of acute medication consumption without the need for detoxification.
Rob Cowan, MD, FAAN, FAHS
Higgins Professor of Neurology and Neurosciences
Chief, Division of Headache Medicine, Dept. of Neurology and Neurosciences
Director, Stanford University School of Medicine
As is often the case when 2 smart people take artificially imposed opposite positions, the truth will lie somewhere in the middle. I doubt either of the debaters would argue either extreme position: MOH does not exist, or MOH when present is solely responsible for chronic daily headache (CDH). The argument that the absence of controlled studies negates the proposition fails the common-sense test: Without a controlled study, we can’t be sure that wearing a helmet when bicycling is better than not. In such a case, observational data is sufficient. Could there be confounders (eg, helmet wearers are more inclined to ride safely)? Of course, but is that important? Similarly, does the fact that some MOH patients continue with CDH after cessation of medication overuse warrant a general de-emphasis? Certainly not for the third-to-half of patients who benefit from limiting medication use.
I suspect both Drs. Diener and Loder would agree that we would benefit from better markers of chronification and that earlier intervention with at-risk patients (eg, patients with increasing headache frequency, severity or duration but still in the episodic phase).
Jack Schim, MD
Co-Director, The Headache Center of Southern California
There has long been recognition that overuse of analgesic medications can be linked to progression of headache disorders. MOH was initially described by Dr. Lee Kudrow in 1982, in a chapter entitled, “Paradoxical effects of frequent analgesic use.”4 The most recent edition of the International Classification of Headache Disorders (ICHD-3) description does not entail features that imply causality. While there is epidemiologic observation of correlation between frequent analgesic use and progression of primary headache disorders, the causal relationship is often obscured by the facts. Overuse of acute medications is quite common in individuals with CM, but not all with CM overuse medications.
In the article being discussed, Drs. Diener and Loder reviewed facts and opinions. They helped clarify that while MOH is widely recognized, much of what is known is descriptive, and not based on solid science. From their presentations, we can conclude that we can recognize MOH based on ICHD-3 criteria, but we cannot tell an individual with chronic headache whether we can best help them by educating them, or by adjusting preventives, or both. The call to action is clear; we need to evaluate best therapeutic approaches in an empiric fashion. Our best new therapies for migraine prevention, CGRP mAbs, work for the majority of patients, with minimal side effects, even in the face of what has been considered MOH. Now, we need to strategize how best to approach these clinically challenged individuals. We need to avoid further stigmatizing our patients. Let’s recognize that our patients do not fail preventives, the prior preventives have failed our patients. Can the introduction of highly effective, well tolerated preventives at an earlier stage help avoid chronification that may drive medication overuse?
Stewart J. Tepper, MD, FAHS
Professor of Neurology, Geisel School of Medicine at Dartmouth
It is clear that overuse of some acute medication is detrimental to patient health. Examples of this include analgesic nephropathy or peptic ulcer disease, and exacerbation of depression with overuse of barbiturate compounds or benzodiazepines. Few doubt the health merits of reduction of acute medication overuse, regardless of whether the acute medications can be proven to transform episodic migraine (EM) to CM.
The good news is that the issues of the existence of true MOH and its proper management are rapidly becoming less important. OnabotulinumtoxinA use decreases triptan use in multiple randomized controlled trials for CM prevention.
Each of the anti-CGRP and anti-CGRP receptor monoclonal antibodies (mAbs) have been effective in preventing CM with medication overuse. All have lowered acute medication use, both triptans and analgesics. It is worth noting, however, that in both the OnabotulinumtoxinA and mAb trials, over-users of opioids and barbiturates were excluded. The mAbs converted patients from acute medication overuse to non-overuse, and from CM with medication overuse to EM without medication. These changes occurred without specific plans for weaning acute medication in place.
Accordingly, patients with CM with acute medication overuse should be treated with optimal prevention, and the evidence is strongest for use of the mAbs to both reduce mean monthly migraine days and all acute medication use, both triptans and analgesics. The new monoclonal antibody effectiveness may make the old arguments moot.
Hans-Christoph Diener, MD, PhD
University of Essen, Germany
I think no one doubts that MOH exists. The worldwide prevalence is between 1% and 2% (Table). The dilemma is that the diagnosis can only be made after the intake of acute medication has been reduced. There are confounders: migraine can improve irrespective of the reduction of acute medication and many physicians will implement migraine prevention at the time of withdrawal. No randomized trial compared the continuation of unchanged intake of medication to treat migraine attacks with reduction or withdrawal.
| Author (year) (reference) | Country | Age Group | Prevalence of MOH |
Castillo et al. (1999)7 | Spain | ≥ 14 | 1,2% |
Wang et al. (2000)8 | Taiwan | ≥ 65 | 1,0% |
Lu et al. (2001)9 | Taiwan | ≥ 15 | 1,1% |
Pascual et al. (2001)10 | Review |
| 1,0-1,9% |
Prencipe et al. (2001)11 | France | ≥ 65 | 1,7% |
Colas et al. (2004)12 | Spain | ≥ 14 | 1,5% |
Zwart et al. (2004)13 | Norway | ≥ 20 | 0,9-1,0% |
Dyb et al. (2006)14 | Norway | 13-18 | 0,2% |
Wang et al. (2006)15 | Taiwan | 12-14 | 0,3% |
Wiendels (2006)16 | Netherlands | 25-55 | 2,6% |
Stovner et al.(2007)17 | Review |
| 0,5-1,0% |
Aaseth et al. (2008, 2009)18,19 | Norway | 30-44 | 1,7% |
Rueda-Sanchez & Diaz-Martinez (2008)20 | Columbia | 18-65 | 4,5% |
Katsarava et al. (2009)21 | Georgia | ≥ 16 | 0,9% |
Da Silva et al. (2009)22 | Brazil | 10-93 | 1,6% |
Straube et al. (2010)23 | Germany | 18-88 | 1,0% |
Jonsson et al. (2011, 2012)24,25 | Sweden | ≥ 15 | 1,8% |
Linde et al. (2011)26 | Norway | ≥ 20 | 1,0% |
Lipton et al. (2011)27 | USA | 12-17 | 1,0% |
Ayzenberg et al. (2012)28 | Russia | 18-65 | 7,2% |
Ertas et al. (2012)29 | Turkey | 18-65 | 2,1% |
Hagen et al. (2012)30 | Norway | ≥ 20 | 0,8% |
Yu et al. (2012)31 | China | 18-65 | 0,9% |
Shahbeigi et al. (2013)32 | Iran | ≥ 10 | 4,9% |
Schramm et al. (2013)33 | Germany | 18-65 | 0,7% |
Park et al. (2014)34 | South Korea | 19-69 | 0,5% |
Kristoffersen & Lundqvist (2014)35 | Multinational summary |
| 1,0-2,0% |
Steiner (2014)36 | Multinational summary |
| 1,0-2,0% |
Westergaard et al. (2015)37 | Denmark |
| 0,5-7,2% |
Bravo (2015)38 | Multinational | Older | 1,0-7,1% |
Mbewe et al. (2015)39 | Zambia | 18-65 | 12,7% (adj. 7,1%) |
Kulkarni et al. (2015)40 | India | 18-65 | 1,2% |
Westergaard et al. (2016)41 | Denmark | ≥ 16 | 1,6% (adj. 1,8%) |
Manandhar et al. (2016)42 | Nepal | 18-65 | 2,2% |
Zebenigus et al. (2016)43 | Ethiopia | 18-65 | 0,8% (adj. 0,7%) |
Al-Hashel et al. (2017)44 | Kuwait | 18-65 | 2,4% |
Rastenyte et al. (2017)45 | Lithuania | 18-65 | 3,5% (adj. 3,2%) |
Henning et al. (2018)46 | Germany | 18-65 | 0,7% |
Global Burden of Disease 201747 | Global |
| 0,8% |
+++
Commentary by Alan M. Rapoport, MD
The above comments by my associates are very informative and help the reader to better understand the arguments about MOH. When Dr. Lee Kudrow taught me and my partner Dr. Fred Sheftell about the entity of analgesic and ergotamine overuse headaches in 1979, we set out to find those patients, observe and treat them. We did not have to wait long as so many patients with frequent and severe headaches came to see us with what we now term “medication overuse headache.” They told us that they had fewer headaches several years before and increased the use of acute care medications as their headaches increased in frequency. They were unaware of the probability that their headaches increased in frequency because their medication did. Some would argue that they increased their intake to feel better as the headache increased on their own.
Of course, we were not sure of the cause and effect, but we saw the result of tapering the acute care medications, whether or not we used preventives, hospitalized those patients or treated them with behavioral medicine approaches, etc. We observed that the combination of these treatments seemed to work better than just detox, but we did not do the proper studies to prove it. We also noticed that about 30% to 40% of patients did not improve as well as others, and daily or near-daily headaches continued, often of a lesser intensity. Almost all felt better in general and had fewer adverse events from the medication. The decrease in those medications was undoubtedly better for their brain function, livers and kidneys.
I do believe that medication overuse makes most patients with frequent EM or CM worse and we should educate patients to avoid it. I agree with Dr. Bigal that preventive medications may help some patients to improve despite the excessive use of acute care medication, but I am not sure that the older preventives work as well and certainly not as quickly as the newer ones. Recently I have seen the anti-CGRP mAbs work wonders with some of my patients who could not decrease their triptan intake. They just stop using the triptans as their headaches decrease on these therapies.
There is another interesting phenomenon that I have seen in practice—mostly with butalbital products, which I no longer prescribe. Forty years ago, patients would say that they only had 4 headaches per month lasting 1 to 2 days and I would prescribe 10 pills for them. They would call in 2 weeks and say they needed more. When queried they would invariably say it worked so well on the bad headaches and made them feel so much better, that they took 1 or 2 on days they thought they were going to get a headache and it prevented them from forming. They were soon taking it frequently and over time they were dependent on the medication, and then it stopped working and was difficult to withdraw.
Dr. Loder’s point that the studies on MOH have not proven that medication overuse causes it may be technically true; but it would be unethical to start patients on too much medication and randomize some to stay on and some to taper off. Dr. Kudrow came the closest by taking existing MOH patients and treating half with withdrawal and half of each with preventives. His breakthrough study in 1982 “proved” the existence of analgesic rebound and directed us to the best treatment at that time.4 This was the first study to examine the effect of stopping the overuse of medication to see the results.
Finally, I am unhappy that ICHD-3 has defined MOH only by number of days of medication use, not at all considering whether or not the patient develops a new type of headache, a worse type or more frequent headache (the way it was in previous versions). We have all seen patients taking 3 triptans per day on their own or with our suggestion, and many actually do better with no headache, for a period of time. This is medication overuse by definition, but not MOH, as they have little headache. But we do not recognize this entity.
The good news is, with education and anti-CGRP therapies, we will probably see less MOH in the future, or at least know better how to treat it.
+++
References
1. Bigal ME, Serrano D, Buse D, et al. Acute migraine medications and evolution from episodic to chronic migraine: a longitudinal population-based study. Headache. 2008;48(8):1157-68. doi: 10.1111/j.1526-4610.2008.01217.x. PubMed PMID: 18808500.
2. Bigal ME, Lipton RB. Overuse of acute migraine medications and migraine chronification. Curr Pain Headache Rep. 2009;13(4):301-7. PubMed PMID: 19586594.
3. Bigal ME, Edvinsson L, Rapoport AM, et al. Safety, tolerability, and efficacy of TEV-48125 for preventive treatment of chronic migraine: a multicentre, randomised, double-blind, placebo-controlled, phase 2b study. Lancet Neurol. 2015;14(11):1091-100. doi: 10.1016/S1474-4422(15)00245-8. PubMed PMID: 26432181.
4. Kudrow L. Paradoxical Effects of Frequent Analgesic Use. Advances in Neurology. 1982;33:335-341.
5. Diener HC, Holle D, Dresler T, Gaul C. Chronic Headache Due to Overuse of Analgesics and Anti-Migraine Agents. Dtsch Arztebl Int. 2018;115(22):365-370.
6. Westergaard ML, Glumer C, Hansen EH, Jensen RH. Prevalence of chronic headache with and without medication overuse: associations with socioeconomic position and physical and mental health status. Pain. 2014;155(10):2005-2013.
7. Castillo J, Munoz P, Guitera V, Pascual J. Epidemiology of chronic daily headache in the general population. Headache. 1999;39:190-196.
8. Wang SJ, Fuh JL, Lu SR, et al. Chronic daily headache in chinese elderly - prevalence, risk factors, and biannual follow-up. Neurology. 2000;54:314-319.
9. Lu SR, Fuh JL, Chen WT, Juang KD, Wang SJ. Chronic daily headache in Taipei, Taiwan: prevalence, follow-up and outcome predictors. Cephalalgia. 2001;21:980-986.
10. Pascual J, Colas R, Castillo J. Epidemiology of chronic daily headache. Curr Pain Headache Rep. 2001;5(6):529-536.
11. Prencipe M, Casini AR, Ferretti C, et al. Prevalence of headache in an elderly population: attack frequency, disability, and use of medication. J Neurol Neurosurg Psychiatry. 2001;70(3):377-381.
12. Colas R, Munoz P, Temprano R, Gomez C, Pascual J. Chronic daily headache with analgesic overuse: epidemiology and impact on quality of life. Neurology. 2004;62:1338-1342.
13. Zwart J, Dyb G, Hagen K, Svebak S, Stovner L, Holmen J. Analgesic overuse among subjects with headache, neck, and low back pain. Neurology. 2004;62:1540-1544.
14. Dyb G, Holmen TL, Zwart JA. Analgesic overuse among adolescents with headache: the Head-HUNT-Youth Study. Neurology. 2006;66(2):198-201.
15. Wang SJ, Fuh JL, Lu SR, Juang KD. Chronic daily headache in adolescents: prevalence, impact, and medication overuse. Neurology. 2006;66(2):193-197.
16. Wiendels NJ, Knuistingh NA, Rosendaal FR, et al. Chronic frequent headache in the general population: prevalence and associated factors. Cephalalgia. 2006;26(12):1434-1442.
17. Stovner L, Hagen K, Jensen R, et al. The global burden of headache: a documentation of headache prevalence and disability worldwide. Cephalalgia. 2007;27(3):193-210.
18. Aaseth K, Grande RB, Kvaerner KJ, Gulbrandsen P, Lundqvist C, Russell MB. Prevalence of secondary chronic headaches in a population-based sample of 30-44-year-old persons. The Akershus study of chronic headache. Cephalalgia. 2008;28(7):705-713.
19. Aaseth K, Grande RB, Lundqvist C, Russell MB. What is chronic headache in the general population? The Akershus study of chronic headache. Acta Neurol Scand Suppl. 2009;(189):30-32.
20. Rueda-Sanchez M, Diaz-Martinez LA. Prevalence and associated factors for episodic and chronic daily headache in the Colombian population. Cephalalgia. 2008;28(3):216-225.
21. Katsarava Z, Dzagnidze A, Kukava M, et al. Primary headache disorders in the Republic of Georgia: prevalence and risk factors. Neurology. 2009;73(21):1796-1803.
22. da Silva A, Jr., Costa EC, Gomes JB, et al. Chronic headache and comorbidities: a two-phase, population-based, cross-sectional study. Headache. 2010;50(8):1306-1312.
23. Straube A, Pfaffenrath V, Ladwig KH, et al. Prevalence of chronic migraine and medication overuse headache in Germany--the German DMKG headache study. Cephalalgia. 2010;30(2):207-213.
24. Jonsson P, Hedenrud T, Linde M. Epidemiology of medication overuse headache in the general Swedish population. Cephalalgia. 2011;31(9):1015-1022.
25. Jonsson P, Linde M, Hensing G, Hedenrud T. Sociodemographic differences in medication use, health-care contacts and sickness absence among individuals with medication-overuse headache. J Headache Pain. 2012;13(4):281-290.
26. Linde M, Stovner LJ, Zwart JA, Hagen K. Time trends in the prevalence of headache disorders. The Nord-Trondelag Health Studies (HUNT 2 and HUNT 3). Cephalalgia. 2011;31(5):585-596.
27. Lipton RB, Manack A, Ricci JA, Chee E, Turkel CC, Winner P. Prevalence and burden of chronic migraine in adolescents: results of the chronic daily headache in adolescents study (C-dAS). Headache. 2011;51(5):693-706.
28. Ayzenberg I, Katsarava Z, Sborowski A, et al. The prevalence of primary headache disorders in Russia: a countrywide survey. Cephalalgia. 2012;32(5):373-381.
29. Ertas M, Baykan B, Orhan EK, et al. One-year prevalence and the impact of migraine and tension-type headache in Turkey: a nationwide home-based study in adults. J Headache Pain. 2012;13(2):147-157.
30. Hagen K, Linde M, Steiner TJ, Stovner LJ, Zwart JA. Risk factors for medication-overuse headache: an 11-year follow-up study. The Nord-Trondelag Health Studies. Pain. 2012;153(1):56-61.
31. Yu S, Liu R, Zhao G, et al. The prevalence and burden of primary headaches in China: a population-based door-to-door survey. Headache. 2012;52(4):582-591.
32. Shahbeigi S, Fereshtehnejad SM, Mohammadi N, et al. Epidemiology of headaches in Tehran urban area: a population-based cross-sectional study in district 8, year 2010. Neurol Sci. 2013;34(7):1157-66.
33. Schramm SH, Obermann M, Katsarava Z, Diener HC, Moebus S, Yoon MS. Epidemiological profiles of patients with chronic migraine and chronic tension-type headache. J Headache Pain. 2013;14:40.
34. Park JW, Moon HS, Kim JM, Lee KS, Chu MK. Chronic daily headache in Korea: prevalence, clinical characteristics, medical consultation and management. J Clin Neurol. 2014;10(3):236-243.
35. Kristoffersen ES, Lundqvist C. Medication-overuse headache: epidemiology, diagnosis and treatment. Ther Adv Drug Saf. 2014;5(2):87-99.
36. Steiner TJ, Stovner LJ, Katsarava Z, et al. The impact of headache in Europe: principal results of the Eurolight project. J Headache Pain. 2014;15:31.
37. Westergaard ML, Hansen EH, Glumer C, Jensen RH. Prescription pain medications and chronic headache in Denmark: implications for preventing medication overuse. Eur J Clin Pharmacol. 2015;71(7):851-860.
38. Bravo TP. Headaches of the elderly. Curr Neurol Neurosci Rep. 2015;15(6):30.
39. Mbewe E, Zairemthiama P, Yeh HH, Paul R, Birbeck GL, Steiner TJ. The epidemiology of primary headache disorders in Zambia: a population-based door-to-door survey. J Headache Pain. 2015;16:515.
40. Kulkarni GB, Rao GN, Gururaj G, Stovner LJ, Steiner TJ. Headache disorders and public ill-health in India: prevalence estimates in Karnataka State. J Headache Pain. 2015;16:67.
41. Westergaard ML, Glumer C, Hansen EH, Jensen RH. Medication overuse, healthy lifestyle behaviour and stress in chronic headache: Results from a population-based representative survey. Cephalalgia. 2016;36(1):15-28.
42. Manandhar K, Risal A, Linde M, Steiner TJ. The burden of headache disorders in Nepal: estimates from a population-based survey. J Headache Pain. 2015;17:3.
43. Zebenigus M, Tekle-Haimanot R, Worku DK, Thomas H, Steiner TJ. The prevalence of primary headache disorders in Ethiopia. J Headache Pain. 2016;17(1):110.
44. Al-Hashel JY, Ahmed SF, Alroughani R. Prevalence of Primary Headache Disorders in Kuwait. Neuroepidemiology. 2017;48(3-4):138-146.
45. Rastenyte D, Mickeviciene D, Stovner LJ, Thomas H, Andree C, Steiner TJ. Prevalence and burden of headache disorders in Lithuania and their public-health and policy implications: a population-based study within the Eurolight Project. J Headache Pain. 2017;18(1):53.
46. Henning V, Katsarava Z, Obermann M, Moebus S, Schramm S. Remission of chronic headache: Rates, potential predictors and the role of medication, follow-up results of the German Headache Consortium (GHC) Study. Cephalalgia. 2018;38(3):551-560.
47. Global Burden of Disease Neurological Disorders Collaborator Group. Global, regional, and national burden of neurological disorders during 1990-2015: a systematic analysis for the Global Burden of Disease Study 2015. Lancet Neurol. 2017;16(11):877-897.
Following the American Headache Society’s Scottsdale Headache Symposium in November 2018, MedPage Today posted an article which shared differing opinions from Drs. Hans-Christoph Diener and Elizabeth Loder on medication overuse headache (MOH). While Dr. Diener noted that “we can identify people with chronic migraine who are at risk to have medication overuse,” and that following successful withdrawal treatment “the majority of patients…revert to episodic migraine,” Dr. Loder pointed out that while MOH may exist and contribute to chronic migraine, “it is over-emphasized and the evidence in support of these concepts is weak.”
For this article, I’ve asked Drs. Marcelo Bigal, Rob Cowan, Jack Schim, and Stewart J. Tepper to share their perspectives on this topic. I also asked both Dr. Diener and Dr. Loder to expand on their comments. We will see Dr. Diener’s response to the article, but we did not hear back from Dr. Loder. Lastly, I will weigh in on the MOH discussion.
Marcelo Bigal, MD, PhD
Chief Medical Officer, Purdue Pharma
The issue of medication overuse headache (MOH) needs to be disentangled into a few separate but related issues. First, do excessive medications make migraine worse? Second, should MOH be considered a distinct form of headache? And how can evidence inform clinical practice?
Robust evidence supports the fact that excessive acute medication use is associated with increased headache frequency among migraineurs. In a large epidemiological study, we demonstrated that exposure (medication) precedes outcome (increased headache frequency).1 The risk was higher for barbiturates, followed by opioids and triptans, and was not increased by nonsteroidal anti-inflammatory drugs (NSAIDs). Dose response and critical exposure levels were identified. Based on this study and several others, we argued that criteria of causality had been demonstrated beyond reasonable doubt.2
However, since the effect is specific to migraine in that the exposure only increases the risk in migraineurs, not in individuals with other types of pain, we do not consider MOH a distinct entity. Instead, we believe that excessive medication is a risk factor for chronic migraine (CM). Therefore, we should be able to subdivide CM into 2 groups, one with and one without excessive medication use.
From a clinical perspective, physicians should monitor acute medication consumption in individuals with migraine and should be liberal in starting preventive therapy. In those with CM and excessive acute medication use we don’t advocate abrupt discontinuation of acute medications, since some preventive medications, especially the newer anti-calcitonin gene-related peptide (CGRP) antibodies, seem to work equally well in individuals with and without excessive use of medication,3 allowing more natural and gradual control of acute medication consumption without the need for detoxification.
Rob Cowan, MD, FAAN, FAHS
Higgins Professor of Neurology and Neurosciences
Chief, Division of Headache Medicine, Dept. of Neurology and Neurosciences
Director, Stanford University School of Medicine
As is often the case when 2 smart people take artificially imposed opposite positions, the truth will lie somewhere in the middle. I doubt either of the debaters would argue either extreme position: MOH does not exist, or MOH when present is solely responsible for chronic daily headache (CDH). The argument that the absence of controlled studies negates the proposition fails the common-sense test: Without a controlled study, we can’t be sure that wearing a helmet when bicycling is better than not. In such a case, observational data is sufficient. Could there be confounders (eg, helmet wearers are more inclined to ride safely)? Of course, but is that important? Similarly, does the fact that some MOH patients continue with CDH after cessation of medication overuse warrant a general de-emphasis? Certainly not for the third-to-half of patients who benefit from limiting medication use.
I suspect both Drs. Diener and Loder would agree that we would benefit from better markers of chronification and that earlier intervention with at-risk patients (eg, patients with increasing headache frequency, severity or duration but still in the episodic phase).
Jack Schim, MD
Co-Director, The Headache Center of Southern California
There has long been recognition that overuse of analgesic medications can be linked to progression of headache disorders. MOH was initially described by Dr. Lee Kudrow in 1982, in a chapter entitled, “Paradoxical effects of frequent analgesic use.”4 The most recent edition of the International Classification of Headache Disorders (ICHD-3) description does not entail features that imply causality. While there is epidemiologic observation of correlation between frequent analgesic use and progression of primary headache disorders, the causal relationship is often obscured by the facts. Overuse of acute medications is quite common in individuals with CM, but not all with CM overuse medications.
In the article being discussed, Drs. Diener and Loder reviewed facts and opinions. They helped clarify that while MOH is widely recognized, much of what is known is descriptive, and not based on solid science. From their presentations, we can conclude that we can recognize MOH based on ICHD-3 criteria, but we cannot tell an individual with chronic headache whether we can best help them by educating them, or by adjusting preventives, or both. The call to action is clear; we need to evaluate best therapeutic approaches in an empiric fashion. Our best new therapies for migraine prevention, CGRP mAbs, work for the majority of patients, with minimal side effects, even in the face of what has been considered MOH. Now, we need to strategize how best to approach these clinically challenged individuals. We need to avoid further stigmatizing our patients. Let’s recognize that our patients do not fail preventives, the prior preventives have failed our patients. Can the introduction of highly effective, well tolerated preventives at an earlier stage help avoid chronification that may drive medication overuse?
Stewart J. Tepper, MD, FAHS
Professor of Neurology, Geisel School of Medicine at Dartmouth
It is clear that overuse of some acute medication is detrimental to patient health. Examples of this include analgesic nephropathy or peptic ulcer disease, and exacerbation of depression with overuse of barbiturate compounds or benzodiazepines. Few doubt the health merits of reduction of acute medication overuse, regardless of whether the acute medications can be proven to transform episodic migraine (EM) to CM.
The good news is that the issues of the existence of true MOH and its proper management are rapidly becoming less important. OnabotulinumtoxinA use decreases triptan use in multiple randomized controlled trials for CM prevention.
Each of the anti-CGRP and anti-CGRP receptor monoclonal antibodies (mAbs) have been effective in preventing CM with medication overuse. All have lowered acute medication use, both triptans and analgesics. It is worth noting, however, that in both the OnabotulinumtoxinA and mAb trials, over-users of opioids and barbiturates were excluded. The mAbs converted patients from acute medication overuse to non-overuse, and from CM with medication overuse to EM without medication. These changes occurred without specific plans for weaning acute medication in place.
Accordingly, patients with CM with acute medication overuse should be treated with optimal prevention, and the evidence is strongest for use of the mAbs to both reduce mean monthly migraine days and all acute medication use, both triptans and analgesics. The new monoclonal antibody effectiveness may make the old arguments moot.
Hans-Christoph Diener, MD, PhD
University of Essen, Germany
I think no one doubts that MOH exists. The worldwide prevalence is between 1% and 2% (Table). The dilemma is that the diagnosis can only be made after the intake of acute medication has been reduced. There are confounders: migraine can improve irrespective of the reduction of acute medication and many physicians will implement migraine prevention at the time of withdrawal. No randomized trial compared the continuation of unchanged intake of medication to treat migraine attacks with reduction or withdrawal.
| Author (year) (reference) | Country | Age Group | Prevalence of MOH |
Castillo et al. (1999)7 | Spain | ≥ 14 | 1,2% |
Wang et al. (2000)8 | Taiwan | ≥ 65 | 1,0% |
Lu et al. (2001)9 | Taiwan | ≥ 15 | 1,1% |
Pascual et al. (2001)10 | Review |
| 1,0-1,9% |
Prencipe et al. (2001)11 | France | ≥ 65 | 1,7% |
Colas et al. (2004)12 | Spain | ≥ 14 | 1,5% |
Zwart et al. (2004)13 | Norway | ≥ 20 | 0,9-1,0% |
Dyb et al. (2006)14 | Norway | 13-18 | 0,2% |
Wang et al. (2006)15 | Taiwan | 12-14 | 0,3% |
Wiendels (2006)16 | Netherlands | 25-55 | 2,6% |
Stovner et al.(2007)17 | Review |
| 0,5-1,0% |
Aaseth et al. (2008, 2009)18,19 | Norway | 30-44 | 1,7% |
Rueda-Sanchez & Diaz-Martinez (2008)20 | Columbia | 18-65 | 4,5% |
Katsarava et al. (2009)21 | Georgia | ≥ 16 | 0,9% |
Da Silva et al. (2009)22 | Brazil | 10-93 | 1,6% |
Straube et al. (2010)23 | Germany | 18-88 | 1,0% |
Jonsson et al. (2011, 2012)24,25 | Sweden | ≥ 15 | 1,8% |
Linde et al. (2011)26 | Norway | ≥ 20 | 1,0% |
Lipton et al. (2011)27 | USA | 12-17 | 1,0% |
Ayzenberg et al. (2012)28 | Russia | 18-65 | 7,2% |
Ertas et al. (2012)29 | Turkey | 18-65 | 2,1% |
Hagen et al. (2012)30 | Norway | ≥ 20 | 0,8% |
Yu et al. (2012)31 | China | 18-65 | 0,9% |
Shahbeigi et al. (2013)32 | Iran | ≥ 10 | 4,9% |
Schramm et al. (2013)33 | Germany | 18-65 | 0,7% |
Park et al. (2014)34 | South Korea | 19-69 | 0,5% |
Kristoffersen & Lundqvist (2014)35 | Multinational summary |
| 1,0-2,0% |
Steiner (2014)36 | Multinational summary |
| 1,0-2,0% |
Westergaard et al. (2015)37 | Denmark |
| 0,5-7,2% |
Bravo (2015)38 | Multinational | Older | 1,0-7,1% |
Mbewe et al. (2015)39 | Zambia | 18-65 | 12,7% (adj. 7,1%) |
Kulkarni et al. (2015)40 | India | 18-65 | 1,2% |
Westergaard et al. (2016)41 | Denmark | ≥ 16 | 1,6% (adj. 1,8%) |
Manandhar et al. (2016)42 | Nepal | 18-65 | 2,2% |
Zebenigus et al. (2016)43 | Ethiopia | 18-65 | 0,8% (adj. 0,7%) |
Al-Hashel et al. (2017)44 | Kuwait | 18-65 | 2,4% |
Rastenyte et al. (2017)45 | Lithuania | 18-65 | 3,5% (adj. 3,2%) |
Henning et al. (2018)46 | Germany | 18-65 | 0,7% |
Global Burden of Disease 201747 | Global |
| 0,8% |
+++
Commentary by Alan M. Rapoport, MD
The above comments by my associates are very informative and help the reader to better understand the arguments about MOH. When Dr. Lee Kudrow taught me and my partner Dr. Fred Sheftell about the entity of analgesic and ergotamine overuse headaches in 1979, we set out to find those patients, observe and treat them. We did not have to wait long as so many patients with frequent and severe headaches came to see us with what we now term “medication overuse headache.” They told us that they had fewer headaches several years before and increased the use of acute care medications as their headaches increased in frequency. They were unaware of the probability that their headaches increased in frequency because their medication did. Some would argue that they increased their intake to feel better as the headache increased on their own.
Of course, we were not sure of the cause and effect, but we saw the result of tapering the acute care medications, whether or not we used preventives, hospitalized those patients or treated them with behavioral medicine approaches, etc. We observed that the combination of these treatments seemed to work better than just detox, but we did not do the proper studies to prove it. We also noticed that about 30% to 40% of patients did not improve as well as others, and daily or near-daily headaches continued, often of a lesser intensity. Almost all felt better in general and had fewer adverse events from the medication. The decrease in those medications was undoubtedly better for their brain function, livers and kidneys.
I do believe that medication overuse makes most patients with frequent EM or CM worse and we should educate patients to avoid it. I agree with Dr. Bigal that preventive medications may help some patients to improve despite the excessive use of acute care medication, but I am not sure that the older preventives work as well and certainly not as quickly as the newer ones. Recently I have seen the anti-CGRP mAbs work wonders with some of my patients who could not decrease their triptan intake. They just stop using the triptans as their headaches decrease on these therapies.
There is another interesting phenomenon that I have seen in practice—mostly with butalbital products, which I no longer prescribe. Forty years ago, patients would say that they only had 4 headaches per month lasting 1 to 2 days and I would prescribe 10 pills for them. They would call in 2 weeks and say they needed more. When queried they would invariably say it worked so well on the bad headaches and made them feel so much better, that they took 1 or 2 on days they thought they were going to get a headache and it prevented them from forming. They were soon taking it frequently and over time they were dependent on the medication, and then it stopped working and was difficult to withdraw.
Dr. Loder’s point that the studies on MOH have not proven that medication overuse causes it may be technically true; but it would be unethical to start patients on too much medication and randomize some to stay on and some to taper off. Dr. Kudrow came the closest by taking existing MOH patients and treating half with withdrawal and half of each with preventives. His breakthrough study in 1982 “proved” the existence of analgesic rebound and directed us to the best treatment at that time.4 This was the first study to examine the effect of stopping the overuse of medication to see the results.
Finally, I am unhappy that ICHD-3 has defined MOH only by number of days of medication use, not at all considering whether or not the patient develops a new type of headache, a worse type or more frequent headache (the way it was in previous versions). We have all seen patients taking 3 triptans per day on their own or with our suggestion, and many actually do better with no headache, for a period of time. This is medication overuse by definition, but not MOH, as they have little headache. But we do not recognize this entity.
The good news is, with education and anti-CGRP therapies, we will probably see less MOH in the future, or at least know better how to treat it.
+++
References
1. Bigal ME, Serrano D, Buse D, et al. Acute migraine medications and evolution from episodic to chronic migraine: a longitudinal population-based study. Headache. 2008;48(8):1157-68. doi: 10.1111/j.1526-4610.2008.01217.x. PubMed PMID: 18808500.
2. Bigal ME, Lipton RB. Overuse of acute migraine medications and migraine chronification. Curr Pain Headache Rep. 2009;13(4):301-7. PubMed PMID: 19586594.
3. Bigal ME, Edvinsson L, Rapoport AM, et al. Safety, tolerability, and efficacy of TEV-48125 for preventive treatment of chronic migraine: a multicentre, randomised, double-blind, placebo-controlled, phase 2b study. Lancet Neurol. 2015;14(11):1091-100. doi: 10.1016/S1474-4422(15)00245-8. PubMed PMID: 26432181.
4. Kudrow L. Paradoxical Effects of Frequent Analgesic Use. Advances in Neurology. 1982;33:335-341.
5. Diener HC, Holle D, Dresler T, Gaul C. Chronic Headache Due to Overuse of Analgesics and Anti-Migraine Agents. Dtsch Arztebl Int. 2018;115(22):365-370.
6. Westergaard ML, Glumer C, Hansen EH, Jensen RH. Prevalence of chronic headache with and without medication overuse: associations with socioeconomic position and physical and mental health status. Pain. 2014;155(10):2005-2013.
7. Castillo J, Munoz P, Guitera V, Pascual J. Epidemiology of chronic daily headache in the general population. Headache. 1999;39:190-196.
8. Wang SJ, Fuh JL, Lu SR, et al. Chronic daily headache in chinese elderly - prevalence, risk factors, and biannual follow-up. Neurology. 2000;54:314-319.
9. Lu SR, Fuh JL, Chen WT, Juang KD, Wang SJ. Chronic daily headache in Taipei, Taiwan: prevalence, follow-up and outcome predictors. Cephalalgia. 2001;21:980-986.
10. Pascual J, Colas R, Castillo J. Epidemiology of chronic daily headache. Curr Pain Headache Rep. 2001;5(6):529-536.
11. Prencipe M, Casini AR, Ferretti C, et al. Prevalence of headache in an elderly population: attack frequency, disability, and use of medication. J Neurol Neurosurg Psychiatry. 2001;70(3):377-381.
12. Colas R, Munoz P, Temprano R, Gomez C, Pascual J. Chronic daily headache with analgesic overuse: epidemiology and impact on quality of life. Neurology. 2004;62:1338-1342.
13. Zwart J, Dyb G, Hagen K, Svebak S, Stovner L, Holmen J. Analgesic overuse among subjects with headache, neck, and low back pain. Neurology. 2004;62:1540-1544.
14. Dyb G, Holmen TL, Zwart JA. Analgesic overuse among adolescents with headache: the Head-HUNT-Youth Study. Neurology. 2006;66(2):198-201.
15. Wang SJ, Fuh JL, Lu SR, Juang KD. Chronic daily headache in adolescents: prevalence, impact, and medication overuse. Neurology. 2006;66(2):193-197.
16. Wiendels NJ, Knuistingh NA, Rosendaal FR, et al. Chronic frequent headache in the general population: prevalence and associated factors. Cephalalgia. 2006;26(12):1434-1442.
17. Stovner L, Hagen K, Jensen R, et al. The global burden of headache: a documentation of headache prevalence and disability worldwide. Cephalalgia. 2007;27(3):193-210.
18. Aaseth K, Grande RB, Kvaerner KJ, Gulbrandsen P, Lundqvist C, Russell MB. Prevalence of secondary chronic headaches in a population-based sample of 30-44-year-old persons. The Akershus study of chronic headache. Cephalalgia. 2008;28(7):705-713.
19. Aaseth K, Grande RB, Lundqvist C, Russell MB. What is chronic headache in the general population? The Akershus study of chronic headache. Acta Neurol Scand Suppl. 2009;(189):30-32.
20. Rueda-Sanchez M, Diaz-Martinez LA. Prevalence and associated factors for episodic and chronic daily headache in the Colombian population. Cephalalgia. 2008;28(3):216-225.
21. Katsarava Z, Dzagnidze A, Kukava M, et al. Primary headache disorders in the Republic of Georgia: prevalence and risk factors. Neurology. 2009;73(21):1796-1803.
22. da Silva A, Jr., Costa EC, Gomes JB, et al. Chronic headache and comorbidities: a two-phase, population-based, cross-sectional study. Headache. 2010;50(8):1306-1312.
23. Straube A, Pfaffenrath V, Ladwig KH, et al. Prevalence of chronic migraine and medication overuse headache in Germany--the German DMKG headache study. Cephalalgia. 2010;30(2):207-213.
24. Jonsson P, Hedenrud T, Linde M. Epidemiology of medication overuse headache in the general Swedish population. Cephalalgia. 2011;31(9):1015-1022.
25. Jonsson P, Linde M, Hensing G, Hedenrud T. Sociodemographic differences in medication use, health-care contacts and sickness absence among individuals with medication-overuse headache. J Headache Pain. 2012;13(4):281-290.
26. Linde M, Stovner LJ, Zwart JA, Hagen K. Time trends in the prevalence of headache disorders. The Nord-Trondelag Health Studies (HUNT 2 and HUNT 3). Cephalalgia. 2011;31(5):585-596.
27. Lipton RB, Manack A, Ricci JA, Chee E, Turkel CC, Winner P. Prevalence and burden of chronic migraine in adolescents: results of the chronic daily headache in adolescents study (C-dAS). Headache. 2011;51(5):693-706.
28. Ayzenberg I, Katsarava Z, Sborowski A, et al. The prevalence of primary headache disorders in Russia: a countrywide survey. Cephalalgia. 2012;32(5):373-381.
29. Ertas M, Baykan B, Orhan EK, et al. One-year prevalence and the impact of migraine and tension-type headache in Turkey: a nationwide home-based study in adults. J Headache Pain. 2012;13(2):147-157.
30. Hagen K, Linde M, Steiner TJ, Stovner LJ, Zwart JA. Risk factors for medication-overuse headache: an 11-year follow-up study. The Nord-Trondelag Health Studies. Pain. 2012;153(1):56-61.
31. Yu S, Liu R, Zhao G, et al. The prevalence and burden of primary headaches in China: a population-based door-to-door survey. Headache. 2012;52(4):582-591.
32. Shahbeigi S, Fereshtehnejad SM, Mohammadi N, et al. Epidemiology of headaches in Tehran urban area: a population-based cross-sectional study in district 8, year 2010. Neurol Sci. 2013;34(7):1157-66.
33. Schramm SH, Obermann M, Katsarava Z, Diener HC, Moebus S, Yoon MS. Epidemiological profiles of patients with chronic migraine and chronic tension-type headache. J Headache Pain. 2013;14:40.
34. Park JW, Moon HS, Kim JM, Lee KS, Chu MK. Chronic daily headache in Korea: prevalence, clinical characteristics, medical consultation and management. J Clin Neurol. 2014;10(3):236-243.
35. Kristoffersen ES, Lundqvist C. Medication-overuse headache: epidemiology, diagnosis and treatment. Ther Adv Drug Saf. 2014;5(2):87-99.
36. Steiner TJ, Stovner LJ, Katsarava Z, et al. The impact of headache in Europe: principal results of the Eurolight project. J Headache Pain. 2014;15:31.
37. Westergaard ML, Hansen EH, Glumer C, Jensen RH. Prescription pain medications and chronic headache in Denmark: implications for preventing medication overuse. Eur J Clin Pharmacol. 2015;71(7):851-860.
38. Bravo TP. Headaches of the elderly. Curr Neurol Neurosci Rep. 2015;15(6):30.
39. Mbewe E, Zairemthiama P, Yeh HH, Paul R, Birbeck GL, Steiner TJ. The epidemiology of primary headache disorders in Zambia: a population-based door-to-door survey. J Headache Pain. 2015;16:515.
40. Kulkarni GB, Rao GN, Gururaj G, Stovner LJ, Steiner TJ. Headache disorders and public ill-health in India: prevalence estimates in Karnataka State. J Headache Pain. 2015;16:67.
41. Westergaard ML, Glumer C, Hansen EH, Jensen RH. Medication overuse, healthy lifestyle behaviour and stress in chronic headache: Results from a population-based representative survey. Cephalalgia. 2016;36(1):15-28.
42. Manandhar K, Risal A, Linde M, Steiner TJ. The burden of headache disorders in Nepal: estimates from a population-based survey. J Headache Pain. 2015;17:3.
43. Zebenigus M, Tekle-Haimanot R, Worku DK, Thomas H, Steiner TJ. The prevalence of primary headache disorders in Ethiopia. J Headache Pain. 2016;17(1):110.
44. Al-Hashel JY, Ahmed SF, Alroughani R. Prevalence of Primary Headache Disorders in Kuwait. Neuroepidemiology. 2017;48(3-4):138-146.
45. Rastenyte D, Mickeviciene D, Stovner LJ, Thomas H, Andree C, Steiner TJ. Prevalence and burden of headache disorders in Lithuania and their public-health and policy implications: a population-based study within the Eurolight Project. J Headache Pain. 2017;18(1):53.
46. Henning V, Katsarava Z, Obermann M, Moebus S, Schramm S. Remission of chronic headache: Rates, potential predictors and the role of medication, follow-up results of the German Headache Consortium (GHC) Study. Cephalalgia. 2018;38(3):551-560.
47. Global Burden of Disease Neurological Disorders Collaborator Group. Global, regional, and national burden of neurological disorders during 1990-2015: a systematic analysis for the Global Burden of Disease Study 2015. Lancet Neurol. 2017;16(11):877-897.
Following the American Headache Society’s Scottsdale Headache Symposium in November 2018, MedPage Today posted an article which shared differing opinions from Drs. Hans-Christoph Diener and Elizabeth Loder on medication overuse headache (MOH). While Dr. Diener noted that “we can identify people with chronic migraine who are at risk to have medication overuse,” and that following successful withdrawal treatment “the majority of patients…revert to episodic migraine,” Dr. Loder pointed out that while MOH may exist and contribute to chronic migraine, “it is over-emphasized and the evidence in support of these concepts is weak.”
For this article, I’ve asked Drs. Marcelo Bigal, Rob Cowan, Jack Schim, and Stewart J. Tepper to share their perspectives on this topic. I also asked both Dr. Diener and Dr. Loder to expand on their comments. We will see Dr. Diener’s response to the article, but we did not hear back from Dr. Loder. Lastly, I will weigh in on the MOH discussion.
Marcelo Bigal, MD, PhD
Chief Medical Officer, Purdue Pharma
The issue of medication overuse headache (MOH) needs to be disentangled into a few separate but related issues. First, do excessive medications make migraine worse? Second, should MOH be considered a distinct form of headache? And how can evidence inform clinical practice?
Robust evidence supports the fact that excessive acute medication use is associated with increased headache frequency among migraineurs. In a large epidemiological study, we demonstrated that exposure (medication) precedes outcome (increased headache frequency).1 The risk was higher for barbiturates, followed by opioids and triptans, and was not increased by nonsteroidal anti-inflammatory drugs (NSAIDs). Dose response and critical exposure levels were identified. Based on this study and several others, we argued that criteria of causality had been demonstrated beyond reasonable doubt.2
However, since the effect is specific to migraine in that the exposure only increases the risk in migraineurs, not in individuals with other types of pain, we do not consider MOH a distinct entity. Instead, we believe that excessive medication is a risk factor for chronic migraine (CM). Therefore, we should be able to subdivide CM into 2 groups, one with and one without excessive medication use.
From a clinical perspective, physicians should monitor acute medication consumption in individuals with migraine and should be liberal in starting preventive therapy. In those with CM and excessive acute medication use we don’t advocate abrupt discontinuation of acute medications, since some preventive medications, especially the newer anti-calcitonin gene-related peptide (CGRP) antibodies, seem to work equally well in individuals with and without excessive use of medication,3 allowing more natural and gradual control of acute medication consumption without the need for detoxification.
Rob Cowan, MD, FAAN, FAHS
Higgins Professor of Neurology and Neurosciences
Chief, Division of Headache Medicine, Dept. of Neurology and Neurosciences
Director, Stanford University School of Medicine
As is often the case when 2 smart people take artificially imposed opposite positions, the truth will lie somewhere in the middle. I doubt either of the debaters would argue either extreme position: MOH does not exist, or MOH when present is solely responsible for chronic daily headache (CDH). The argument that the absence of controlled studies negates the proposition fails the common-sense test: Without a controlled study, we can’t be sure that wearing a helmet when bicycling is better than not. In such a case, observational data is sufficient. Could there be confounders (eg, helmet wearers are more inclined to ride safely)? Of course, but is that important? Similarly, does the fact that some MOH patients continue with CDH after cessation of medication overuse warrant a general de-emphasis? Certainly not for the third-to-half of patients who benefit from limiting medication use.
I suspect both Drs. Diener and Loder would agree that we would benefit from better markers of chronification and that earlier intervention with at-risk patients (eg, patients with increasing headache frequency, severity or duration but still in the episodic phase).
Jack Schim, MD
Co-Director, The Headache Center of Southern California
There has long been recognition that overuse of analgesic medications can be linked to progression of headache disorders. MOH was initially described by Dr. Lee Kudrow in 1982, in a chapter entitled, “Paradoxical effects of frequent analgesic use.”4 The most recent edition of the International Classification of Headache Disorders (ICHD-3) description does not entail features that imply causality. While there is epidemiologic observation of correlation between frequent analgesic use and progression of primary headache disorders, the causal relationship is often obscured by the facts. Overuse of acute medications is quite common in individuals with CM, but not all with CM overuse medications.
In the article being discussed, Drs. Diener and Loder reviewed facts and opinions. They helped clarify that while MOH is widely recognized, much of what is known is descriptive, and not based on solid science. From their presentations, we can conclude that we can recognize MOH based on ICHD-3 criteria, but we cannot tell an individual with chronic headache whether we can best help them by educating them, or by adjusting preventives, or both. The call to action is clear; we need to evaluate best therapeutic approaches in an empiric fashion. Our best new therapies for migraine prevention, CGRP mAbs, work for the majority of patients, with minimal side effects, even in the face of what has been considered MOH. Now, we need to strategize how best to approach these clinically challenged individuals. We need to avoid further stigmatizing our patients. Let’s recognize that our patients do not fail preventives, the prior preventives have failed our patients. Can the introduction of highly effective, well tolerated preventives at an earlier stage help avoid chronification that may drive medication overuse?
Stewart J. Tepper, MD, FAHS
Professor of Neurology, Geisel School of Medicine at Dartmouth
It is clear that overuse of some acute medication is detrimental to patient health. Examples of this include analgesic nephropathy or peptic ulcer disease, and exacerbation of depression with overuse of barbiturate compounds or benzodiazepines. Few doubt the health merits of reduction of acute medication overuse, regardless of whether the acute medications can be proven to transform episodic migraine (EM) to CM.
The good news is that the issues of the existence of true MOH and its proper management are rapidly becoming less important. OnabotulinumtoxinA use decreases triptan use in multiple randomized controlled trials for CM prevention.
Each of the anti-CGRP and anti-CGRP receptor monoclonal antibodies (mAbs) have been effective in preventing CM with medication overuse. All have lowered acute medication use, both triptans and analgesics. It is worth noting, however, that in both the OnabotulinumtoxinA and mAb trials, over-users of opioids and barbiturates were excluded. The mAbs converted patients from acute medication overuse to non-overuse, and from CM with medication overuse to EM without medication. These changes occurred without specific plans for weaning acute medication in place.
Accordingly, patients with CM with acute medication overuse should be treated with optimal prevention, and the evidence is strongest for use of the mAbs to both reduce mean monthly migraine days and all acute medication use, both triptans and analgesics. The new monoclonal antibody effectiveness may make the old arguments moot.
Hans-Christoph Diener, MD, PhD
University of Essen, Germany
I think no one doubts that MOH exists. The worldwide prevalence is between 1% and 2% (Table). The dilemma is that the diagnosis can only be made after the intake of acute medication has been reduced. There are confounders: migraine can improve irrespective of the reduction of acute medication and many physicians will implement migraine prevention at the time of withdrawal. No randomized trial compared the continuation of unchanged intake of medication to treat migraine attacks with reduction or withdrawal.
| Author (year) (reference) | Country | Age Group | Prevalence of MOH |
Castillo et al. (1999)7 | Spain | ≥ 14 | 1,2% |
Wang et al. (2000)8 | Taiwan | ≥ 65 | 1,0% |
Lu et al. (2001)9 | Taiwan | ≥ 15 | 1,1% |
Pascual et al. (2001)10 | Review |
| 1,0-1,9% |
Prencipe et al. (2001)11 | France | ≥ 65 | 1,7% |
Colas et al. (2004)12 | Spain | ≥ 14 | 1,5% |
Zwart et al. (2004)13 | Norway | ≥ 20 | 0,9-1,0% |
Dyb et al. (2006)14 | Norway | 13-18 | 0,2% |
Wang et al. (2006)15 | Taiwan | 12-14 | 0,3% |
Wiendels (2006)16 | Netherlands | 25-55 | 2,6% |
Stovner et al.(2007)17 | Review |
| 0,5-1,0% |
Aaseth et al. (2008, 2009)18,19 | Norway | 30-44 | 1,7% |
Rueda-Sanchez & Diaz-Martinez (2008)20 | Columbia | 18-65 | 4,5% |
Katsarava et al. (2009)21 | Georgia | ≥ 16 | 0,9% |
Da Silva et al. (2009)22 | Brazil | 10-93 | 1,6% |
Straube et al. (2010)23 | Germany | 18-88 | 1,0% |
Jonsson et al. (2011, 2012)24,25 | Sweden | ≥ 15 | 1,8% |
Linde et al. (2011)26 | Norway | ≥ 20 | 1,0% |
Lipton et al. (2011)27 | USA | 12-17 | 1,0% |
Ayzenberg et al. (2012)28 | Russia | 18-65 | 7,2% |
Ertas et al. (2012)29 | Turkey | 18-65 | 2,1% |
Hagen et al. (2012)30 | Norway | ≥ 20 | 0,8% |
Yu et al. (2012)31 | China | 18-65 | 0,9% |
Shahbeigi et al. (2013)32 | Iran | ≥ 10 | 4,9% |
Schramm et al. (2013)33 | Germany | 18-65 | 0,7% |
Park et al. (2014)34 | South Korea | 19-69 | 0,5% |
Kristoffersen & Lundqvist (2014)35 | Multinational summary |
| 1,0-2,0% |
Steiner (2014)36 | Multinational summary |
| 1,0-2,0% |
Westergaard et al. (2015)37 | Denmark |
| 0,5-7,2% |
Bravo (2015)38 | Multinational | Older | 1,0-7,1% |
Mbewe et al. (2015)39 | Zambia | 18-65 | 12,7% (adj. 7,1%) |
Kulkarni et al. (2015)40 | India | 18-65 | 1,2% |
Westergaard et al. (2016)41 | Denmark | ≥ 16 | 1,6% (adj. 1,8%) |
Manandhar et al. (2016)42 | Nepal | 18-65 | 2,2% |
Zebenigus et al. (2016)43 | Ethiopia | 18-65 | 0,8% (adj. 0,7%) |
Al-Hashel et al. (2017)44 | Kuwait | 18-65 | 2,4% |
Rastenyte et al. (2017)45 | Lithuania | 18-65 | 3,5% (adj. 3,2%) |
Henning et al. (2018)46 | Germany | 18-65 | 0,7% |
Global Burden of Disease 201747 | Global |
| 0,8% |
+++
Commentary by Alan M. Rapoport, MD
The above comments by my associates are very informative and help the reader to better understand the arguments about MOH. When Dr. Lee Kudrow taught me and my partner Dr. Fred Sheftell about the entity of analgesic and ergotamine overuse headaches in 1979, we set out to find those patients, observe and treat them. We did not have to wait long as so many patients with frequent and severe headaches came to see us with what we now term “medication overuse headache.” They told us that they had fewer headaches several years before and increased the use of acute care medications as their headaches increased in frequency. They were unaware of the probability that their headaches increased in frequency because their medication did. Some would argue that they increased their intake to feel better as the headache increased on their own.
Of course, we were not sure of the cause and effect, but we saw the result of tapering the acute care medications, whether or not we used preventives, hospitalized those patients or treated them with behavioral medicine approaches, etc. We observed that the combination of these treatments seemed to work better than just detox, but we did not do the proper studies to prove it. We also noticed that about 30% to 40% of patients did not improve as well as others, and daily or near-daily headaches continued, often of a lesser intensity. Almost all felt better in general and had fewer adverse events from the medication. The decrease in those medications was undoubtedly better for their brain function, livers and kidneys.
I do believe that medication overuse makes most patients with frequent EM or CM worse and we should educate patients to avoid it. I agree with Dr. Bigal that preventive medications may help some patients to improve despite the excessive use of acute care medication, but I am not sure that the older preventives work as well and certainly not as quickly as the newer ones. Recently I have seen the anti-CGRP mAbs work wonders with some of my patients who could not decrease their triptan intake. They just stop using the triptans as their headaches decrease on these therapies.
There is another interesting phenomenon that I have seen in practice—mostly with butalbital products, which I no longer prescribe. Forty years ago, patients would say that they only had 4 headaches per month lasting 1 to 2 days and I would prescribe 10 pills for them. They would call in 2 weeks and say they needed more. When queried they would invariably say it worked so well on the bad headaches and made them feel so much better, that they took 1 or 2 on days they thought they were going to get a headache and it prevented them from forming. They were soon taking it frequently and over time they were dependent on the medication, and then it stopped working and was difficult to withdraw.
Dr. Loder’s point that the studies on MOH have not proven that medication overuse causes it may be technically true; but it would be unethical to start patients on too much medication and randomize some to stay on and some to taper off. Dr. Kudrow came the closest by taking existing MOH patients and treating half with withdrawal and half of each with preventives. His breakthrough study in 1982 “proved” the existence of analgesic rebound and directed us to the best treatment at that time.4 This was the first study to examine the effect of stopping the overuse of medication to see the results.
Finally, I am unhappy that ICHD-3 has defined MOH only by number of days of medication use, not at all considering whether or not the patient develops a new type of headache, a worse type or more frequent headache (the way it was in previous versions). We have all seen patients taking 3 triptans per day on their own or with our suggestion, and many actually do better with no headache, for a period of time. This is medication overuse by definition, but not MOH, as they have little headache. But we do not recognize this entity.
The good news is, with education and anti-CGRP therapies, we will probably see less MOH in the future, or at least know better how to treat it.
+++
References
1. Bigal ME, Serrano D, Buse D, et al. Acute migraine medications and evolution from episodic to chronic migraine: a longitudinal population-based study. Headache. 2008;48(8):1157-68. doi: 10.1111/j.1526-4610.2008.01217.x. PubMed PMID: 18808500.
2. Bigal ME, Lipton RB. Overuse of acute migraine medications and migraine chronification. Curr Pain Headache Rep. 2009;13(4):301-7. PubMed PMID: 19586594.
3. Bigal ME, Edvinsson L, Rapoport AM, et al. Safety, tolerability, and efficacy of TEV-48125 for preventive treatment of chronic migraine: a multicentre, randomised, double-blind, placebo-controlled, phase 2b study. Lancet Neurol. 2015;14(11):1091-100. doi: 10.1016/S1474-4422(15)00245-8. PubMed PMID: 26432181.
4. Kudrow L. Paradoxical Effects of Frequent Analgesic Use. Advances in Neurology. 1982;33:335-341.
5. Diener HC, Holle D, Dresler T, Gaul C. Chronic Headache Due to Overuse of Analgesics and Anti-Migraine Agents. Dtsch Arztebl Int. 2018;115(22):365-370.
6. Westergaard ML, Glumer C, Hansen EH, Jensen RH. Prevalence of chronic headache with and without medication overuse: associations with socioeconomic position and physical and mental health status. Pain. 2014;155(10):2005-2013.
7. Castillo J, Munoz P, Guitera V, Pascual J. Epidemiology of chronic daily headache in the general population. Headache. 1999;39:190-196.
8. Wang SJ, Fuh JL, Lu SR, et al. Chronic daily headache in chinese elderly - prevalence, risk factors, and biannual follow-up. Neurology. 2000;54:314-319.
9. Lu SR, Fuh JL, Chen WT, Juang KD, Wang SJ. Chronic daily headache in Taipei, Taiwan: prevalence, follow-up and outcome predictors. Cephalalgia. 2001;21:980-986.
10. Pascual J, Colas R, Castillo J. Epidemiology of chronic daily headache. Curr Pain Headache Rep. 2001;5(6):529-536.
11. Prencipe M, Casini AR, Ferretti C, et al. Prevalence of headache in an elderly population: attack frequency, disability, and use of medication. J Neurol Neurosurg Psychiatry. 2001;70(3):377-381.
12. Colas R, Munoz P, Temprano R, Gomez C, Pascual J. Chronic daily headache with analgesic overuse: epidemiology and impact on quality of life. Neurology. 2004;62:1338-1342.
13. Zwart J, Dyb G, Hagen K, Svebak S, Stovner L, Holmen J. Analgesic overuse among subjects with headache, neck, and low back pain. Neurology. 2004;62:1540-1544.
14. Dyb G, Holmen TL, Zwart JA. Analgesic overuse among adolescents with headache: the Head-HUNT-Youth Study. Neurology. 2006;66(2):198-201.
15. Wang SJ, Fuh JL, Lu SR, Juang KD. Chronic daily headache in adolescents: prevalence, impact, and medication overuse. Neurology. 2006;66(2):193-197.
16. Wiendels NJ, Knuistingh NA, Rosendaal FR, et al. Chronic frequent headache in the general population: prevalence and associated factors. Cephalalgia. 2006;26(12):1434-1442.
17. Stovner L, Hagen K, Jensen R, et al. The global burden of headache: a documentation of headache prevalence and disability worldwide. Cephalalgia. 2007;27(3):193-210.
18. Aaseth K, Grande RB, Kvaerner KJ, Gulbrandsen P, Lundqvist C, Russell MB. Prevalence of secondary chronic headaches in a population-based sample of 30-44-year-old persons. The Akershus study of chronic headache. Cephalalgia. 2008;28(7):705-713.
19. Aaseth K, Grande RB, Lundqvist C, Russell MB. What is chronic headache in the general population? The Akershus study of chronic headache. Acta Neurol Scand Suppl. 2009;(189):30-32.
20. Rueda-Sanchez M, Diaz-Martinez LA. Prevalence and associated factors for episodic and chronic daily headache in the Colombian population. Cephalalgia. 2008;28(3):216-225.
21. Katsarava Z, Dzagnidze A, Kukava M, et al. Primary headache disorders in the Republic of Georgia: prevalence and risk factors. Neurology. 2009;73(21):1796-1803.
22. da Silva A, Jr., Costa EC, Gomes JB, et al. Chronic headache and comorbidities: a two-phase, population-based, cross-sectional study. Headache. 2010;50(8):1306-1312.
23. Straube A, Pfaffenrath V, Ladwig KH, et al. Prevalence of chronic migraine and medication overuse headache in Germany--the German DMKG headache study. Cephalalgia. 2010;30(2):207-213.
24. Jonsson P, Hedenrud T, Linde M. Epidemiology of medication overuse headache in the general Swedish population. Cephalalgia. 2011;31(9):1015-1022.
25. Jonsson P, Linde M, Hensing G, Hedenrud T. Sociodemographic differences in medication use, health-care contacts and sickness absence among individuals with medication-overuse headache. J Headache Pain. 2012;13(4):281-290.
26. Linde M, Stovner LJ, Zwart JA, Hagen K. Time trends in the prevalence of headache disorders. The Nord-Trondelag Health Studies (HUNT 2 and HUNT 3). Cephalalgia. 2011;31(5):585-596.
27. Lipton RB, Manack A, Ricci JA, Chee E, Turkel CC, Winner P. Prevalence and burden of chronic migraine in adolescents: results of the chronic daily headache in adolescents study (C-dAS). Headache. 2011;51(5):693-706.
28. Ayzenberg I, Katsarava Z, Sborowski A, et al. The prevalence of primary headache disorders in Russia: a countrywide survey. Cephalalgia. 2012;32(5):373-381.
29. Ertas M, Baykan B, Orhan EK, et al. One-year prevalence and the impact of migraine and tension-type headache in Turkey: a nationwide home-based study in adults. J Headache Pain. 2012;13(2):147-157.
30. Hagen K, Linde M, Steiner TJ, Stovner LJ, Zwart JA. Risk factors for medication-overuse headache: an 11-year follow-up study. The Nord-Trondelag Health Studies. Pain. 2012;153(1):56-61.
31. Yu S, Liu R, Zhao G, et al. The prevalence and burden of primary headaches in China: a population-based door-to-door survey. Headache. 2012;52(4):582-591.
32. Shahbeigi S, Fereshtehnejad SM, Mohammadi N, et al. Epidemiology of headaches in Tehran urban area: a population-based cross-sectional study in district 8, year 2010. Neurol Sci. 2013;34(7):1157-66.
33. Schramm SH, Obermann M, Katsarava Z, Diener HC, Moebus S, Yoon MS. Epidemiological profiles of patients with chronic migraine and chronic tension-type headache. J Headache Pain. 2013;14:40.
34. Park JW, Moon HS, Kim JM, Lee KS, Chu MK. Chronic daily headache in Korea: prevalence, clinical characteristics, medical consultation and management. J Clin Neurol. 2014;10(3):236-243.
35. Kristoffersen ES, Lundqvist C. Medication-overuse headache: epidemiology, diagnosis and treatment. Ther Adv Drug Saf. 2014;5(2):87-99.
36. Steiner TJ, Stovner LJ, Katsarava Z, et al. The impact of headache in Europe: principal results of the Eurolight project. J Headache Pain. 2014;15:31.
37. Westergaard ML, Hansen EH, Glumer C, Jensen RH. Prescription pain medications and chronic headache in Denmark: implications for preventing medication overuse. Eur J Clin Pharmacol. 2015;71(7):851-860.
38. Bravo TP. Headaches of the elderly. Curr Neurol Neurosci Rep. 2015;15(6):30.
39. Mbewe E, Zairemthiama P, Yeh HH, Paul R, Birbeck GL, Steiner TJ. The epidemiology of primary headache disorders in Zambia: a population-based door-to-door survey. J Headache Pain. 2015;16:515.
40. Kulkarni GB, Rao GN, Gururaj G, Stovner LJ, Steiner TJ. Headache disorders and public ill-health in India: prevalence estimates in Karnataka State. J Headache Pain. 2015;16:67.
41. Westergaard ML, Glumer C, Hansen EH, Jensen RH. Medication overuse, healthy lifestyle behaviour and stress in chronic headache: Results from a population-based representative survey. Cephalalgia. 2016;36(1):15-28.
42. Manandhar K, Risal A, Linde M, Steiner TJ. The burden of headache disorders in Nepal: estimates from a population-based survey. J Headache Pain. 2015;17:3.
43. Zebenigus M, Tekle-Haimanot R, Worku DK, Thomas H, Steiner TJ. The prevalence of primary headache disorders in Ethiopia. J Headache Pain. 2016;17(1):110.
44. Al-Hashel JY, Ahmed SF, Alroughani R. Prevalence of Primary Headache Disorders in Kuwait. Neuroepidemiology. 2017;48(3-4):138-146.
45. Rastenyte D, Mickeviciene D, Stovner LJ, Thomas H, Andree C, Steiner TJ. Prevalence and burden of headache disorders in Lithuania and their public-health and policy implications: a population-based study within the Eurolight Project. J Headache Pain. 2017;18(1):53.
46. Henning V, Katsarava Z, Obermann M, Moebus S, Schramm S. Remission of chronic headache: Rates, potential predictors and the role of medication, follow-up results of the German Headache Consortium (GHC) Study. Cephalalgia. 2018;38(3):551-560.
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FDA: More safety data needed for 12 sunscreen active ingredients
including some of those frequently used in over-the-counter products.
The ingredients requiring additional investigation are cinoxate, dioxybenzone, ensulizole, homosalate, meradimate, octinoxate, octisalate, octocrylene, padimate O, sulisobenzone, oxybenzone, and avobenzone. The FDA actions were announced during a press briefing Feb. 21 held to discuss the proposed rule to update regulatory requirements for most sunscreen products marketed in the United States.
There are no urgent safety matters associated with these ingredients. The rule is part of FDA’s charge to construct an over-the-counter (OTC) monograph detailing all available data on sunscreen ingredients, as required by the Sunscreen Innovation Act.
OTC monographs establish conditions under which ingredients may be marketed without approved new drug applications because they are generally recognized as safe and effective (GRASE) “and not misbranded,” according to the FDA. The proposed rule classifies active ingredients and other conditions as Category I (proposed to be GRASE and not misbranded), Category II (proposed to be not GRASE or to be misbranded), or Category III (additional data needed).
“We are proposing that these ingredients require additional data before a positive GRASE determination can be made,” FDA press officer Sandy Walsh said in an interview, referring to the 12 ingredients. “This proposed rule does not represent a conclusion by the FDA that the sunscreen active ingredients proposed as having insufficient data are unsafe for use in sunscreens. Rather, we are requesting additional information on these ingredients so that we can evaluate their GRASE status in light of changed conditions, including substantially increased sunscreen usage and evolving information about the potential risks associated with these products since they were originally evaluated.”
Among its provisions, the proposal addresses sunscreen active-ingredient safety, dosage forms, and sun protection factor (SPF) and broad-spectrum requirements. It also proposes updates to how products are labeled to make it easier for consumers to identify key product information
Thus far, the agency says that only two active ingredients – titanium dioxide and zinc oxide – can be marketed without approved new drug applications because they are GRASE.
However, two other ingredients – PABA and trolamine salicylate – are not GRASE for use in sunscreens because of safety issues, Theresa Michele, MD, director of the Division of Nonprescription Drug Products Division of Nonprescription Drug Products in the FDA’s Center for Drug Evaluation and Research. Products that combine sunscreen and insect repellent also not fit the criteria, she said
“There are 12 ingredients for which there are insufficient safety data to make a positive GRASE determination at this time. To address these 12 ingredients, the FDA is asking industry and other interested parties for additional data. The FDA is working closely with industry and has published several guidances to make sure companies understand what data the agency believes is necessary for the FDA to evaluate safety and effectiveness for sunscreen active ingredients, including the 12 ingredients for which the FDA is seeking more data,” she said.
In addition to seeking these additional data, the rule also proposes the following:
- Dosage forms that are GRASE for use as sunscreens should include sprays, oils, lotions, creams, gels, butters, pastes, ointments, and sticks. While powders are proposed to be eligible for inclusion in the monograph, more data are being requested before powders are included. “Wipes, towelettes, body washes, shampoos, and other dosage forms are proposed to be categorized as new drugs because the FDA has not received data showing they are eligible for inclusion in the monograph,” according to the FDA statement outlining the proposed regulation.
- The maximum proposed SPF value on sunscreen labels should be raised from SPF 50 or higher to SPF 60 or higher. “There are not enough data to suggest that consumers get any extra benefit from products with an SPF of more than 60,” Dr. Michele said.
- Sunscreens with an SPF value of 15 or higher should be required to also provide broad-spectrum protection, and for broad-spectrum products, as SPF increases, the magnitude of protection against UVA radiation should also increase. “These proposals are designed to ensure that these products provide consumers with the protections that they expect,” the statement said.
- New sunscreen product labels should be required to make it easier for consumers to identify important information, “including the addition of the active ingredients on the front of the package to bring sunscreen in line with other OTC drugs; a notification on the front label for consumers to read the skin cancer/skin aging alert for sunscreens that have not been shown to help prevent skin cancer; and revised formats for SPF, broad spectrum, and water resistance statements,” the statement said.
- Products that combine sunscreens with insect repellents are not GRASE.
In the meantime, though, consumers should continue to use sunscreens regularly as part of a comprehensive sun protection program, FDA Commissioner Scott Gottlieb, MD, said during the briefing. “Broad spectrum sunscreens with SPF values of at least 15 are critical to the arsenal of tools for preventing skin cancer and protecting the skin from damage caused by the sun’s rays,” he continued. “Given the recognized public health benefits of sunscreen use, Americans should continue to use sunscreens in conjunction with other sun protective measures (such as protective clothing) as this important rule-making effort moves forward.”
To submit comments on this proposed rule, go to https://www.regulations.gov and follow instructions for submitting comments.
including some of those frequently used in over-the-counter products.
The ingredients requiring additional investigation are cinoxate, dioxybenzone, ensulizole, homosalate, meradimate, octinoxate, octisalate, octocrylene, padimate O, sulisobenzone, oxybenzone, and avobenzone. The FDA actions were announced during a press briefing Feb. 21 held to discuss the proposed rule to update regulatory requirements for most sunscreen products marketed in the United States.
There are no urgent safety matters associated with these ingredients. The rule is part of FDA’s charge to construct an over-the-counter (OTC) monograph detailing all available data on sunscreen ingredients, as required by the Sunscreen Innovation Act.
OTC monographs establish conditions under which ingredients may be marketed without approved new drug applications because they are generally recognized as safe and effective (GRASE) “and not misbranded,” according to the FDA. The proposed rule classifies active ingredients and other conditions as Category I (proposed to be GRASE and not misbranded), Category II (proposed to be not GRASE or to be misbranded), or Category III (additional data needed).
“We are proposing that these ingredients require additional data before a positive GRASE determination can be made,” FDA press officer Sandy Walsh said in an interview, referring to the 12 ingredients. “This proposed rule does not represent a conclusion by the FDA that the sunscreen active ingredients proposed as having insufficient data are unsafe for use in sunscreens. Rather, we are requesting additional information on these ingredients so that we can evaluate their GRASE status in light of changed conditions, including substantially increased sunscreen usage and evolving information about the potential risks associated with these products since they were originally evaluated.”
Among its provisions, the proposal addresses sunscreen active-ingredient safety, dosage forms, and sun protection factor (SPF) and broad-spectrum requirements. It also proposes updates to how products are labeled to make it easier for consumers to identify key product information
Thus far, the agency says that only two active ingredients – titanium dioxide and zinc oxide – can be marketed without approved new drug applications because they are GRASE.
However, two other ingredients – PABA and trolamine salicylate – are not GRASE for use in sunscreens because of safety issues, Theresa Michele, MD, director of the Division of Nonprescription Drug Products Division of Nonprescription Drug Products in the FDA’s Center for Drug Evaluation and Research. Products that combine sunscreen and insect repellent also not fit the criteria, she said
“There are 12 ingredients for which there are insufficient safety data to make a positive GRASE determination at this time. To address these 12 ingredients, the FDA is asking industry and other interested parties for additional data. The FDA is working closely with industry and has published several guidances to make sure companies understand what data the agency believes is necessary for the FDA to evaluate safety and effectiveness for sunscreen active ingredients, including the 12 ingredients for which the FDA is seeking more data,” she said.
In addition to seeking these additional data, the rule also proposes the following:
- Dosage forms that are GRASE for use as sunscreens should include sprays, oils, lotions, creams, gels, butters, pastes, ointments, and sticks. While powders are proposed to be eligible for inclusion in the monograph, more data are being requested before powders are included. “Wipes, towelettes, body washes, shampoos, and other dosage forms are proposed to be categorized as new drugs because the FDA has not received data showing they are eligible for inclusion in the monograph,” according to the FDA statement outlining the proposed regulation.
- The maximum proposed SPF value on sunscreen labels should be raised from SPF 50 or higher to SPF 60 or higher. “There are not enough data to suggest that consumers get any extra benefit from products with an SPF of more than 60,” Dr. Michele said.
- Sunscreens with an SPF value of 15 or higher should be required to also provide broad-spectrum protection, and for broad-spectrum products, as SPF increases, the magnitude of protection against UVA radiation should also increase. “These proposals are designed to ensure that these products provide consumers with the protections that they expect,” the statement said.
- New sunscreen product labels should be required to make it easier for consumers to identify important information, “including the addition of the active ingredients on the front of the package to bring sunscreen in line with other OTC drugs; a notification on the front label for consumers to read the skin cancer/skin aging alert for sunscreens that have not been shown to help prevent skin cancer; and revised formats for SPF, broad spectrum, and water resistance statements,” the statement said.
- Products that combine sunscreens with insect repellents are not GRASE.
In the meantime, though, consumers should continue to use sunscreens regularly as part of a comprehensive sun protection program, FDA Commissioner Scott Gottlieb, MD, said during the briefing. “Broad spectrum sunscreens with SPF values of at least 15 are critical to the arsenal of tools for preventing skin cancer and protecting the skin from damage caused by the sun’s rays,” he continued. “Given the recognized public health benefits of sunscreen use, Americans should continue to use sunscreens in conjunction with other sun protective measures (such as protective clothing) as this important rule-making effort moves forward.”
To submit comments on this proposed rule, go to https://www.regulations.gov and follow instructions for submitting comments.
including some of those frequently used in over-the-counter products.
The ingredients requiring additional investigation are cinoxate, dioxybenzone, ensulizole, homosalate, meradimate, octinoxate, octisalate, octocrylene, padimate O, sulisobenzone, oxybenzone, and avobenzone. The FDA actions were announced during a press briefing Feb. 21 held to discuss the proposed rule to update regulatory requirements for most sunscreen products marketed in the United States.
There are no urgent safety matters associated with these ingredients. The rule is part of FDA’s charge to construct an over-the-counter (OTC) monograph detailing all available data on sunscreen ingredients, as required by the Sunscreen Innovation Act.
OTC monographs establish conditions under which ingredients may be marketed without approved new drug applications because they are generally recognized as safe and effective (GRASE) “and not misbranded,” according to the FDA. The proposed rule classifies active ingredients and other conditions as Category I (proposed to be GRASE and not misbranded), Category II (proposed to be not GRASE or to be misbranded), or Category III (additional data needed).
“We are proposing that these ingredients require additional data before a positive GRASE determination can be made,” FDA press officer Sandy Walsh said in an interview, referring to the 12 ingredients. “This proposed rule does not represent a conclusion by the FDA that the sunscreen active ingredients proposed as having insufficient data are unsafe for use in sunscreens. Rather, we are requesting additional information on these ingredients so that we can evaluate their GRASE status in light of changed conditions, including substantially increased sunscreen usage and evolving information about the potential risks associated with these products since they were originally evaluated.”
Among its provisions, the proposal addresses sunscreen active-ingredient safety, dosage forms, and sun protection factor (SPF) and broad-spectrum requirements. It also proposes updates to how products are labeled to make it easier for consumers to identify key product information
Thus far, the agency says that only two active ingredients – titanium dioxide and zinc oxide – can be marketed without approved new drug applications because they are GRASE.
However, two other ingredients – PABA and trolamine salicylate – are not GRASE for use in sunscreens because of safety issues, Theresa Michele, MD, director of the Division of Nonprescription Drug Products Division of Nonprescription Drug Products in the FDA’s Center for Drug Evaluation and Research. Products that combine sunscreen and insect repellent also not fit the criteria, she said
“There are 12 ingredients for which there are insufficient safety data to make a positive GRASE determination at this time. To address these 12 ingredients, the FDA is asking industry and other interested parties for additional data. The FDA is working closely with industry and has published several guidances to make sure companies understand what data the agency believes is necessary for the FDA to evaluate safety and effectiveness for sunscreen active ingredients, including the 12 ingredients for which the FDA is seeking more data,” she said.
In addition to seeking these additional data, the rule also proposes the following:
- Dosage forms that are GRASE for use as sunscreens should include sprays, oils, lotions, creams, gels, butters, pastes, ointments, and sticks. While powders are proposed to be eligible for inclusion in the monograph, more data are being requested before powders are included. “Wipes, towelettes, body washes, shampoos, and other dosage forms are proposed to be categorized as new drugs because the FDA has not received data showing they are eligible for inclusion in the monograph,” according to the FDA statement outlining the proposed regulation.
- The maximum proposed SPF value on sunscreen labels should be raised from SPF 50 or higher to SPF 60 or higher. “There are not enough data to suggest that consumers get any extra benefit from products with an SPF of more than 60,” Dr. Michele said.
- Sunscreens with an SPF value of 15 or higher should be required to also provide broad-spectrum protection, and for broad-spectrum products, as SPF increases, the magnitude of protection against UVA radiation should also increase. “These proposals are designed to ensure that these products provide consumers with the protections that they expect,” the statement said.
- New sunscreen product labels should be required to make it easier for consumers to identify important information, “including the addition of the active ingredients on the front of the package to bring sunscreen in line with other OTC drugs; a notification on the front label for consumers to read the skin cancer/skin aging alert for sunscreens that have not been shown to help prevent skin cancer; and revised formats for SPF, broad spectrum, and water resistance statements,” the statement said.
- Products that combine sunscreens with insect repellents are not GRASE.
In the meantime, though, consumers should continue to use sunscreens regularly as part of a comprehensive sun protection program, FDA Commissioner Scott Gottlieb, MD, said during the briefing. “Broad spectrum sunscreens with SPF values of at least 15 are critical to the arsenal of tools for preventing skin cancer and protecting the skin from damage caused by the sun’s rays,” he continued. “Given the recognized public health benefits of sunscreen use, Americans should continue to use sunscreens in conjunction with other sun protective measures (such as protective clothing) as this important rule-making effort moves forward.”
To submit comments on this proposed rule, go to https://www.regulations.gov and follow instructions for submitting comments.
Who is least adherent to statins, and more
This week in MDedge Cardiocast: Silent strokes are pretty common after noncardiac surgery, troubling news about nonadherence to statins, what cardiologists need to know about ARVC, and how gender inequality in medicine affects the health of ALL women.
This week in MDedge Cardiocast: Silent strokes are pretty common after noncardiac surgery, troubling news about nonadherence to statins, what cardiologists need to know about ARVC, and how gender inequality in medicine affects the health of ALL women.
This week in MDedge Cardiocast: Silent strokes are pretty common after noncardiac surgery, troubling news about nonadherence to statins, what cardiologists need to know about ARVC, and how gender inequality in medicine affects the health of ALL women.
A.I. and U
There is a good chance that your car is equipped with a backup camera. It also may have sensors that alert you when there is another vehicle in one of your blind spots. These wonders of modern technology simply are vision enhancers much like an x-ray or an ultrasound. The sensors merely collect visual data, but the decision of what should be done with this additional information is up to you, just as you decide how to respond to your patient’s lab work and imaging studies.
If you have more disposable income than I do, you may have a vehicle that not only gathers information but also makes decisions based on what it senses by slowing down, applying the brakes, or adjusting the steering. My friends who own these semi-autonomous cars generally have given these control systems positive grades once they have experienced a few events in which the vehicle took over in what it considered a dangerous situation. However, even my friends who are fans of their semi-autonomous cars are uncomfortable about the widespread introduction of fully autonomous vehicles.
The practice of medicine is riding the crest of this same wave of artificial intelligence that promises, or some might say threatens, to remove humans from the driver’s seat (“A.I. Shows Promise Assisting Physicians,” by Cade Metz, The New York Times, Feb. 11, 2019). As reported in the New York Times, a team of physicians has created a system capable of making diagnoses based on a “neural network” that uses complex computer algorithms to learn by analyzing extremely large amounts of data. Once this system had been “taught” to identify certain medical conditions in EMRs, the team tasked the system with analyzing the records of nearly 600,000 patients at a women and children’s hospital in southern China. The investigators claim that the system was able to diagnose asthma with more than 90% accuracy, while physicians can diagnose with an accuracy of 80%-94%, and the system diagnosed gastrointestinal disease with 87% accuracy, well within the physicians’ accuracy range of 82%-90%.
Does this apparent success for A.I. mean that not only will you be vacating your place behind the wheel of your car, but also taking down your shingle and hanging up your stethoscope? Before you rush out and sign up for a federally-funded retraining program, you should remember that this study was done in China, where the privacy laws are somewhat skimpy and the data more voluminous by several scales of magnitude than here. Replicating their results and However, this report should serve as wake-up call to those of you who believe that making diagnoses is at the core of what makes you a physician. If sorting through pages of data to arrive at an explanation for your patients’ complaints is the intellectual challenge that keeps the practice of medicine fresh and exciting, you may want to start looking for other sources of mental stimulation.
A.I. isn’t going to replace the primary care physician. There still will need to be someone available at the initial point of contact who can do a physical exam, take, or at least review, the patient’s history, and then order the lab work and imaging studies that the A.I. system will use to make the diagnosis. In other words, the physician will be primarily responsible for data collection. You may feel that you are almost there already.
Will there be new roles for primary care physicians once A.I. systems are making the diagnoses? It is hard to imagine a fully autonomous health care system in which physicians completely disappear. But, now is the time to think seriously about how we are going to reinvent ourselves to adapt to the inevitable changes and continue as an (or could be "the") essential human element in an increasingly automated system.
Dr. Wilkoff practiced primary care pediatrics in Brunswick, Maine for nearly 40 years. He has authored several books on behavioral pediatrics, including “How to Say No to Your Toddler.” Email him at pdnews@mdedge.com.
There is a good chance that your car is equipped with a backup camera. It also may have sensors that alert you when there is another vehicle in one of your blind spots. These wonders of modern technology simply are vision enhancers much like an x-ray or an ultrasound. The sensors merely collect visual data, but the decision of what should be done with this additional information is up to you, just as you decide how to respond to your patient’s lab work and imaging studies.
If you have more disposable income than I do, you may have a vehicle that not only gathers information but also makes decisions based on what it senses by slowing down, applying the brakes, or adjusting the steering. My friends who own these semi-autonomous cars generally have given these control systems positive grades once they have experienced a few events in which the vehicle took over in what it considered a dangerous situation. However, even my friends who are fans of their semi-autonomous cars are uncomfortable about the widespread introduction of fully autonomous vehicles.
The practice of medicine is riding the crest of this same wave of artificial intelligence that promises, or some might say threatens, to remove humans from the driver’s seat (“A.I. Shows Promise Assisting Physicians,” by Cade Metz, The New York Times, Feb. 11, 2019). As reported in the New York Times, a team of physicians has created a system capable of making diagnoses based on a “neural network” that uses complex computer algorithms to learn by analyzing extremely large amounts of data. Once this system had been “taught” to identify certain medical conditions in EMRs, the team tasked the system with analyzing the records of nearly 600,000 patients at a women and children’s hospital in southern China. The investigators claim that the system was able to diagnose asthma with more than 90% accuracy, while physicians can diagnose with an accuracy of 80%-94%, and the system diagnosed gastrointestinal disease with 87% accuracy, well within the physicians’ accuracy range of 82%-90%.
Does this apparent success for A.I. mean that not only will you be vacating your place behind the wheel of your car, but also taking down your shingle and hanging up your stethoscope? Before you rush out and sign up for a federally-funded retraining program, you should remember that this study was done in China, where the privacy laws are somewhat skimpy and the data more voluminous by several scales of magnitude than here. Replicating their results and However, this report should serve as wake-up call to those of you who believe that making diagnoses is at the core of what makes you a physician. If sorting through pages of data to arrive at an explanation for your patients’ complaints is the intellectual challenge that keeps the practice of medicine fresh and exciting, you may want to start looking for other sources of mental stimulation.
A.I. isn’t going to replace the primary care physician. There still will need to be someone available at the initial point of contact who can do a physical exam, take, or at least review, the patient’s history, and then order the lab work and imaging studies that the A.I. system will use to make the diagnosis. In other words, the physician will be primarily responsible for data collection. You may feel that you are almost there already.
Will there be new roles for primary care physicians once A.I. systems are making the diagnoses? It is hard to imagine a fully autonomous health care system in which physicians completely disappear. But, now is the time to think seriously about how we are going to reinvent ourselves to adapt to the inevitable changes and continue as an (or could be "the") essential human element in an increasingly automated system.
Dr. Wilkoff practiced primary care pediatrics in Brunswick, Maine for nearly 40 years. He has authored several books on behavioral pediatrics, including “How to Say No to Your Toddler.” Email him at pdnews@mdedge.com.
There is a good chance that your car is equipped with a backup camera. It also may have sensors that alert you when there is another vehicle in one of your blind spots. These wonders of modern technology simply are vision enhancers much like an x-ray or an ultrasound. The sensors merely collect visual data, but the decision of what should be done with this additional information is up to you, just as you decide how to respond to your patient’s lab work and imaging studies.
If you have more disposable income than I do, you may have a vehicle that not only gathers information but also makes decisions based on what it senses by slowing down, applying the brakes, or adjusting the steering. My friends who own these semi-autonomous cars generally have given these control systems positive grades once they have experienced a few events in which the vehicle took over in what it considered a dangerous situation. However, even my friends who are fans of their semi-autonomous cars are uncomfortable about the widespread introduction of fully autonomous vehicles.
The practice of medicine is riding the crest of this same wave of artificial intelligence that promises, or some might say threatens, to remove humans from the driver’s seat (“A.I. Shows Promise Assisting Physicians,” by Cade Metz, The New York Times, Feb. 11, 2019). As reported in the New York Times, a team of physicians has created a system capable of making diagnoses based on a “neural network” that uses complex computer algorithms to learn by analyzing extremely large amounts of data. Once this system had been “taught” to identify certain medical conditions in EMRs, the team tasked the system with analyzing the records of nearly 600,000 patients at a women and children’s hospital in southern China. The investigators claim that the system was able to diagnose asthma with more than 90% accuracy, while physicians can diagnose with an accuracy of 80%-94%, and the system diagnosed gastrointestinal disease with 87% accuracy, well within the physicians’ accuracy range of 82%-90%.
Does this apparent success for A.I. mean that not only will you be vacating your place behind the wheel of your car, but also taking down your shingle and hanging up your stethoscope? Before you rush out and sign up for a federally-funded retraining program, you should remember that this study was done in China, where the privacy laws are somewhat skimpy and the data more voluminous by several scales of magnitude than here. Replicating their results and However, this report should serve as wake-up call to those of you who believe that making diagnoses is at the core of what makes you a physician. If sorting through pages of data to arrive at an explanation for your patients’ complaints is the intellectual challenge that keeps the practice of medicine fresh and exciting, you may want to start looking for other sources of mental stimulation.
A.I. isn’t going to replace the primary care physician. There still will need to be someone available at the initial point of contact who can do a physical exam, take, or at least review, the patient’s history, and then order the lab work and imaging studies that the A.I. system will use to make the diagnosis. In other words, the physician will be primarily responsible for data collection. You may feel that you are almost there already.
Will there be new roles for primary care physicians once A.I. systems are making the diagnoses? It is hard to imagine a fully autonomous health care system in which physicians completely disappear. But, now is the time to think seriously about how we are going to reinvent ourselves to adapt to the inevitable changes and continue as an (or could be "the") essential human element in an increasingly automated system.
Dr. Wilkoff practiced primary care pediatrics in Brunswick, Maine for nearly 40 years. He has authored several books on behavioral pediatrics, including “How to Say No to Your Toddler.” Email him at pdnews@mdedge.com.
Pseudoscience redux
My most recent column discussed the problem of pseudoscience that pervades some corners of the Internet. Personally, I respond to pseudoscience primarily by trying to provide accurate and less-biased information. I recognize that not everyone approaches decision making by seeking more information. When dealing a diverse public, a medical professional needs to have other approaches in the armamentarium.1 When dealing with other physicians, I am less flexible. Either the profession of medicine believes in science or it doesn’t.
Since that column was published, there have been major developments. There are measles outbreaks in the states of Washington and New York, and more than 100 deaths from a measles epidemic in the Philippines. The World Health Organization has made vaccine hesitancy one of its ten threats to global health in 2019.
Facebook has indicated that it might demote the priority and frequency with which it recommends articles that promulgate anti-vax information and conspiracy theories.2 Facebook isn’t doing this because it has had an epiphany; it has come under pressure for its role in the spread of misinformation. Current legislation was written before the rise of social media, when Internet Service Providers were primarily conduits to transfer bits and bytes between computers. Those ISPs were not liable for the content of the transmitted Web pages. Facebook, by producing what it called a newsfeed and by making personalized suggestions for other websites to browse, doesn’t fit the passive model of an ISP.
For alleged violations of user’s privacy, Facebook might be subject to billion dollar fines, according to a Washington Post article.3 Still, for a company whose revenue is $4 billion per month and whose stock market value is $400 billion, paying a billion dollar fine for years of alleged misbehaviors that have enabled it to become a giant empire is, “in the scheme of things ... a speeding ticket” in the parlance of the penultimate scene of the movie The Social Network. The real financial risk is people deciding they can’t trust the platform and going elsewhere.
Authorities in the United Kingdom in February 2019 released a highly critical, 108-page report about fake news, which said, “Facebook should not be allowed to behave like ‘digital gangsters’ in the online world.”4 The U.K. report urges new regulations to deal with privacy breaches and with fake news. It endeavors to create a duty for social media companies to combat the spread of misinformation.
Then the Wall Street Journal reported that Pinterest has stopped returning results for searches related to vaccination.5 Pinterest realized that most of the shared images on its platform cautioned against vaccination, which contradicts the recommendations of medical experts. Unable to otherwise combat the flow of misinformation, the company apparently has decided to eliminate returning results, pro or con, for any search terms related to vaccines.
While lamenting the public’s inability to distinguish misinformation on the Internet, I’ve also been observing the factors that lead physicians astray. I expect physicians, as trained scientists and as professionals, to be able to assimilate new information and change their practices accordingly. Those who do research on the translation of technology find that, this doesn’t happen with any regularity.
The February 2019 issue of Hospital Pediatrics has four items on the topic of treating bronchiolitis, including two research articles, a brief report, and a commentary. That is obviously a relevant topic this time of year. The impression after reading those four items is that hospitalists don’t really know how to best treat the most common illness they encounter. And even when they “know” how to do it, many factors distort the science. Those factors are highlighted in the article on barriers to minimizing viral testing.6
Dr. Powell is a pediatric hospitalist and clinical ethics consultant living in St. Louis. Email him at pdnews@mdedge.com.
References
1. “Discussing immunization with vaccine-hesitant parents requires caring, individualized approach,” by Jeff Craven, Pediatric News, Nov. 7, 2018; “How do you get anti-vaxxers to vaccinate their kids? Talk to them – for hours,” by Nadine Gartner, Washington Post, Feb. 19, 2019.
2. “Facebook will consider removing or demoting anti-vaccination recommendations amid backlash,” by Taylor Telford, Washington Post, Feb. 15, 2019.
3. “U.S. regulators have met to discuss imposing a record-setting fine against Facebook for privacy violations,” by Tony Romm and Elizabeth Dwoskin, Washington Post, Jan. 18, 2019; “Report: Facebook, FTC discussing ‘multibillion dollar’ fine,” by Associated Press.
4. “Disinformation and ‘fake news’: Final Report,” House of Commons, Feb. 18, 2019, p. 42, item 139.
5. “Pinterest blocks vaccination searches in move to control the conversation,” by Robert McMillan and Daniela Hernandez, The Wall Street Journal, Feb. 20, 2019.
6. “Barriers to minimizing respiratory viral testing in bronchiolitis: Physician perceptions on testing practices,” by MZ Huang et al. Hospital Pediatrics 2019 Feb. doi: 10.1542/hpeds.2018-0108.
My most recent column discussed the problem of pseudoscience that pervades some corners of the Internet. Personally, I respond to pseudoscience primarily by trying to provide accurate and less-biased information. I recognize that not everyone approaches decision making by seeking more information. When dealing a diverse public, a medical professional needs to have other approaches in the armamentarium.1 When dealing with other physicians, I am less flexible. Either the profession of medicine believes in science or it doesn’t.
Since that column was published, there have been major developments. There are measles outbreaks in the states of Washington and New York, and more than 100 deaths from a measles epidemic in the Philippines. The World Health Organization has made vaccine hesitancy one of its ten threats to global health in 2019.
Facebook has indicated that it might demote the priority and frequency with which it recommends articles that promulgate anti-vax information and conspiracy theories.2 Facebook isn’t doing this because it has had an epiphany; it has come under pressure for its role in the spread of misinformation. Current legislation was written before the rise of social media, when Internet Service Providers were primarily conduits to transfer bits and bytes between computers. Those ISPs were not liable for the content of the transmitted Web pages. Facebook, by producing what it called a newsfeed and by making personalized suggestions for other websites to browse, doesn’t fit the passive model of an ISP.
For alleged violations of user’s privacy, Facebook might be subject to billion dollar fines, according to a Washington Post article.3 Still, for a company whose revenue is $4 billion per month and whose stock market value is $400 billion, paying a billion dollar fine for years of alleged misbehaviors that have enabled it to become a giant empire is, “in the scheme of things ... a speeding ticket” in the parlance of the penultimate scene of the movie The Social Network. The real financial risk is people deciding they can’t trust the platform and going elsewhere.
Authorities in the United Kingdom in February 2019 released a highly critical, 108-page report about fake news, which said, “Facebook should not be allowed to behave like ‘digital gangsters’ in the online world.”4 The U.K. report urges new regulations to deal with privacy breaches and with fake news. It endeavors to create a duty for social media companies to combat the spread of misinformation.
Then the Wall Street Journal reported that Pinterest has stopped returning results for searches related to vaccination.5 Pinterest realized that most of the shared images on its platform cautioned against vaccination, which contradicts the recommendations of medical experts. Unable to otherwise combat the flow of misinformation, the company apparently has decided to eliminate returning results, pro or con, for any search terms related to vaccines.
While lamenting the public’s inability to distinguish misinformation on the Internet, I’ve also been observing the factors that lead physicians astray. I expect physicians, as trained scientists and as professionals, to be able to assimilate new information and change their practices accordingly. Those who do research on the translation of technology find that, this doesn’t happen with any regularity.
The February 2019 issue of Hospital Pediatrics has four items on the topic of treating bronchiolitis, including two research articles, a brief report, and a commentary. That is obviously a relevant topic this time of year. The impression after reading those four items is that hospitalists don’t really know how to best treat the most common illness they encounter. And even when they “know” how to do it, many factors distort the science. Those factors are highlighted in the article on barriers to minimizing viral testing.6
Dr. Powell is a pediatric hospitalist and clinical ethics consultant living in St. Louis. Email him at pdnews@mdedge.com.
References
1. “Discussing immunization with vaccine-hesitant parents requires caring, individualized approach,” by Jeff Craven, Pediatric News, Nov. 7, 2018; “How do you get anti-vaxxers to vaccinate their kids? Talk to them – for hours,” by Nadine Gartner, Washington Post, Feb. 19, 2019.
2. “Facebook will consider removing or demoting anti-vaccination recommendations amid backlash,” by Taylor Telford, Washington Post, Feb. 15, 2019.
3. “U.S. regulators have met to discuss imposing a record-setting fine against Facebook for privacy violations,” by Tony Romm and Elizabeth Dwoskin, Washington Post, Jan. 18, 2019; “Report: Facebook, FTC discussing ‘multibillion dollar’ fine,” by Associated Press.
4. “Disinformation and ‘fake news’: Final Report,” House of Commons, Feb. 18, 2019, p. 42, item 139.
5. “Pinterest blocks vaccination searches in move to control the conversation,” by Robert McMillan and Daniela Hernandez, The Wall Street Journal, Feb. 20, 2019.
6. “Barriers to minimizing respiratory viral testing in bronchiolitis: Physician perceptions on testing practices,” by MZ Huang et al. Hospital Pediatrics 2019 Feb. doi: 10.1542/hpeds.2018-0108.
My most recent column discussed the problem of pseudoscience that pervades some corners of the Internet. Personally, I respond to pseudoscience primarily by trying to provide accurate and less-biased information. I recognize that not everyone approaches decision making by seeking more information. When dealing a diverse public, a medical professional needs to have other approaches in the armamentarium.1 When dealing with other physicians, I am less flexible. Either the profession of medicine believes in science or it doesn’t.
Since that column was published, there have been major developments. There are measles outbreaks in the states of Washington and New York, and more than 100 deaths from a measles epidemic in the Philippines. The World Health Organization has made vaccine hesitancy one of its ten threats to global health in 2019.
Facebook has indicated that it might demote the priority and frequency with which it recommends articles that promulgate anti-vax information and conspiracy theories.2 Facebook isn’t doing this because it has had an epiphany; it has come under pressure for its role in the spread of misinformation. Current legislation was written before the rise of social media, when Internet Service Providers were primarily conduits to transfer bits and bytes between computers. Those ISPs were not liable for the content of the transmitted Web pages. Facebook, by producing what it called a newsfeed and by making personalized suggestions for other websites to browse, doesn’t fit the passive model of an ISP.
For alleged violations of user’s privacy, Facebook might be subject to billion dollar fines, according to a Washington Post article.3 Still, for a company whose revenue is $4 billion per month and whose stock market value is $400 billion, paying a billion dollar fine for years of alleged misbehaviors that have enabled it to become a giant empire is, “in the scheme of things ... a speeding ticket” in the parlance of the penultimate scene of the movie The Social Network. The real financial risk is people deciding they can’t trust the platform and going elsewhere.
Authorities in the United Kingdom in February 2019 released a highly critical, 108-page report about fake news, which said, “Facebook should not be allowed to behave like ‘digital gangsters’ in the online world.”4 The U.K. report urges new regulations to deal with privacy breaches and with fake news. It endeavors to create a duty for social media companies to combat the spread of misinformation.
Then the Wall Street Journal reported that Pinterest has stopped returning results for searches related to vaccination.5 Pinterest realized that most of the shared images on its platform cautioned against vaccination, which contradicts the recommendations of medical experts. Unable to otherwise combat the flow of misinformation, the company apparently has decided to eliminate returning results, pro or con, for any search terms related to vaccines.
While lamenting the public’s inability to distinguish misinformation on the Internet, I’ve also been observing the factors that lead physicians astray. I expect physicians, as trained scientists and as professionals, to be able to assimilate new information and change their practices accordingly. Those who do research on the translation of technology find that, this doesn’t happen with any regularity.
The February 2019 issue of Hospital Pediatrics has four items on the topic of treating bronchiolitis, including two research articles, a brief report, and a commentary. That is obviously a relevant topic this time of year. The impression after reading those four items is that hospitalists don’t really know how to best treat the most common illness they encounter. And even when they “know” how to do it, many factors distort the science. Those factors are highlighted in the article on barriers to minimizing viral testing.6
Dr. Powell is a pediatric hospitalist and clinical ethics consultant living in St. Louis. Email him at pdnews@mdedge.com.
References
1. “Discussing immunization with vaccine-hesitant parents requires caring, individualized approach,” by Jeff Craven, Pediatric News, Nov. 7, 2018; “How do you get anti-vaxxers to vaccinate their kids? Talk to them – for hours,” by Nadine Gartner, Washington Post, Feb. 19, 2019.
2. “Facebook will consider removing or demoting anti-vaccination recommendations amid backlash,” by Taylor Telford, Washington Post, Feb. 15, 2019.
3. “U.S. regulators have met to discuss imposing a record-setting fine against Facebook for privacy violations,” by Tony Romm and Elizabeth Dwoskin, Washington Post, Jan. 18, 2019; “Report: Facebook, FTC discussing ‘multibillion dollar’ fine,” by Associated Press.
4. “Disinformation and ‘fake news’: Final Report,” House of Commons, Feb. 18, 2019, p. 42, item 139.
5. “Pinterest blocks vaccination searches in move to control the conversation,” by Robert McMillan and Daniela Hernandez, The Wall Street Journal, Feb. 20, 2019.
6. “Barriers to minimizing respiratory viral testing in bronchiolitis: Physician perceptions on testing practices,” by MZ Huang et al. Hospital Pediatrics 2019 Feb. doi: 10.1542/hpeds.2018-0108.
Experts: Consider enteral therapy in CD, with caveats
LAS VEGAS – Temporarily switching to an enteral diet – without solid food – has the potential to reverse Crohn’s disease (CD), especially in children, a panel of experts told gastroenterologists here.
They acknowledged the controversial treatment requires strict adherence and can be impossible for some patients to tolerate. But it can be successful too, said gastroenterologist Lindsey G. Albenberg, DO, of Children’s Hospital of Philadelphia, where enteral nutrition therapy (ENT) is commonly used in patients with CD.
“Parents are obviously thrilled that there’s no exposure to immunosuppressive medications,” she said in a discussion about ENT at the Crohn’s & Colitis Congress - a partnership of the Crohn’s & Colitis Foundation and the American Gastroenterological Association. “Typically, we provide 80%-90% of calorie needs through a polymeric formula by mouth. If we see clinical response at 4-6 weeks or even earlier, then we will pursue a course of about 8-12 weeks.”
Research into the best role for ENT therapy in CD is limited. A 2018 Cochrane Library review found there’s “very low quality evidence” suggesting that ENT is better than steroids to induce remission in children. It also found there’s “very low quality evidence” that steroids are better than ENT in adults with CD (Cochrane Database Syst Rev. 2018 Apr 1. doi: 10.1002/14651858.CD000542.pub3).
According to clinician-scientist James D. Lewis, MD, MSCE, of the University of Pennsylvania, Philadelphia, ENT “has gotten a bad name in some ways because of a meta-analysis showing it was inferior to corticosteroids to induce remission.” In fact, he said, studies “didn’t look at mucosal healing and pooled together adults and children.”
In children, he said, the treatment seems to clearly be effective. The picture is less promising in adults. “Presumably that’s because those of you who are parents probably have more control over your young children than your own behavior,” he said, referring to management of food intake.
In adults, “there’s no reason to think it wouldn’t work,” he said. “But trying to convince adults to give up food is really challenging.”
Children who try ENT are often required to use a nasogastric feeding tube, an approach that adults tend to avoid. In kids, “it’s a question of knowing your patient,” said gastroenterologist David Suskind, MD, of Seattle Children’s Hospital. “If the patient says, ‘There’s no way you’ll put a nasal gastric tube in, and no way I will drink it [the ENT supplement],’ this may not be the best therapy. If they’re interested, we push forward. We get much better efficacy because the patients will do what we’re asking.”
Several panelists recommended that patients use polymeric formulations instead of elemental formulations because they’re more palatable. It can be a struggle, however, to stick with the treatment.
Kelly Issokson, MS, RD, CNSC, a dietitian with Cedars-Sinai Medical Center in Los Angeles, tried an ENT therapy for 30 days in order to understand what patients experience and said it was “very challenging.”
“When you sit down to a meal, you anticipate it, you start to salivate. With shakes, it was a lot more clinical,” she said. “The other thing I struggled with was texture and having it be so sweet. I’d freeze [the shakes] into ice cube trays and popsicles. That helped break the monotony. It changes the flavor and cuts the sweetness.”
Ms. Issokson urges her patients to stick with ENT for the entire period of therapy. “Studies show when patients introduce real foods the efficacy of inducing remission goes down. We recommend 100% calories and proteins coming from the formula,” she said. That means “no coffee, no broth, no tea, no nothing but the formula. Most of our patients are able to do that exclusively.”
Toward the end of therapy, around week 8 or 11, some patients tell her they crave food like soup. “I say OK, have a tiny bit,” she said, “but remember, this is only temporary. We’re almost at the end. Try to be 100% exclusive.”
Dr. Albenberg and Dr. Suskind report no disclosures. Ms. Issokson reports consulting fees (speaking and teaching) from AGA, Crohn’s & Colitis Foundation, Academy of Nutrition and Dietetics, and United Ostomy Association. Dr. Lewis reports many relationships – including consulting fees, ownership interest, and grant/research support – with Eli Lilly, Bristol‐Myers Squibb, Gilead, and others.
Correction, 2/22/19: An earlier version of this article misidentified the person in the first photo above.
LAS VEGAS – Temporarily switching to an enteral diet – without solid food – has the potential to reverse Crohn’s disease (CD), especially in children, a panel of experts told gastroenterologists here.
They acknowledged the controversial treatment requires strict adherence and can be impossible for some patients to tolerate. But it can be successful too, said gastroenterologist Lindsey G. Albenberg, DO, of Children’s Hospital of Philadelphia, where enteral nutrition therapy (ENT) is commonly used in patients with CD.
“Parents are obviously thrilled that there’s no exposure to immunosuppressive medications,” she said in a discussion about ENT at the Crohn’s & Colitis Congress - a partnership of the Crohn’s & Colitis Foundation and the American Gastroenterological Association. “Typically, we provide 80%-90% of calorie needs through a polymeric formula by mouth. If we see clinical response at 4-6 weeks or even earlier, then we will pursue a course of about 8-12 weeks.”
Research into the best role for ENT therapy in CD is limited. A 2018 Cochrane Library review found there’s “very low quality evidence” suggesting that ENT is better than steroids to induce remission in children. It also found there’s “very low quality evidence” that steroids are better than ENT in adults with CD (Cochrane Database Syst Rev. 2018 Apr 1. doi: 10.1002/14651858.CD000542.pub3).
According to clinician-scientist James D. Lewis, MD, MSCE, of the University of Pennsylvania, Philadelphia, ENT “has gotten a bad name in some ways because of a meta-analysis showing it was inferior to corticosteroids to induce remission.” In fact, he said, studies “didn’t look at mucosal healing and pooled together adults and children.”
In children, he said, the treatment seems to clearly be effective. The picture is less promising in adults. “Presumably that’s because those of you who are parents probably have more control over your young children than your own behavior,” he said, referring to management of food intake.
In adults, “there’s no reason to think it wouldn’t work,” he said. “But trying to convince adults to give up food is really challenging.”
Children who try ENT are often required to use a nasogastric feeding tube, an approach that adults tend to avoid. In kids, “it’s a question of knowing your patient,” said gastroenterologist David Suskind, MD, of Seattle Children’s Hospital. “If the patient says, ‘There’s no way you’ll put a nasal gastric tube in, and no way I will drink it [the ENT supplement],’ this may not be the best therapy. If they’re interested, we push forward. We get much better efficacy because the patients will do what we’re asking.”
Several panelists recommended that patients use polymeric formulations instead of elemental formulations because they’re more palatable. It can be a struggle, however, to stick with the treatment.
Kelly Issokson, MS, RD, CNSC, a dietitian with Cedars-Sinai Medical Center in Los Angeles, tried an ENT therapy for 30 days in order to understand what patients experience and said it was “very challenging.”
“When you sit down to a meal, you anticipate it, you start to salivate. With shakes, it was a lot more clinical,” she said. “The other thing I struggled with was texture and having it be so sweet. I’d freeze [the shakes] into ice cube trays and popsicles. That helped break the monotony. It changes the flavor and cuts the sweetness.”
Ms. Issokson urges her patients to stick with ENT for the entire period of therapy. “Studies show when patients introduce real foods the efficacy of inducing remission goes down. We recommend 100% calories and proteins coming from the formula,” she said. That means “no coffee, no broth, no tea, no nothing but the formula. Most of our patients are able to do that exclusively.”
Toward the end of therapy, around week 8 or 11, some patients tell her they crave food like soup. “I say OK, have a tiny bit,” she said, “but remember, this is only temporary. We’re almost at the end. Try to be 100% exclusive.”
Dr. Albenberg and Dr. Suskind report no disclosures. Ms. Issokson reports consulting fees (speaking and teaching) from AGA, Crohn’s & Colitis Foundation, Academy of Nutrition and Dietetics, and United Ostomy Association. Dr. Lewis reports many relationships – including consulting fees, ownership interest, and grant/research support – with Eli Lilly, Bristol‐Myers Squibb, Gilead, and others.
Correction, 2/22/19: An earlier version of this article misidentified the person in the first photo above.
LAS VEGAS – Temporarily switching to an enteral diet – without solid food – has the potential to reverse Crohn’s disease (CD), especially in children, a panel of experts told gastroenterologists here.
They acknowledged the controversial treatment requires strict adherence and can be impossible for some patients to tolerate. But it can be successful too, said gastroenterologist Lindsey G. Albenberg, DO, of Children’s Hospital of Philadelphia, where enteral nutrition therapy (ENT) is commonly used in patients with CD.
“Parents are obviously thrilled that there’s no exposure to immunosuppressive medications,” she said in a discussion about ENT at the Crohn’s & Colitis Congress - a partnership of the Crohn’s & Colitis Foundation and the American Gastroenterological Association. “Typically, we provide 80%-90% of calorie needs through a polymeric formula by mouth. If we see clinical response at 4-6 weeks or even earlier, then we will pursue a course of about 8-12 weeks.”
Research into the best role for ENT therapy in CD is limited. A 2018 Cochrane Library review found there’s “very low quality evidence” suggesting that ENT is better than steroids to induce remission in children. It also found there’s “very low quality evidence” that steroids are better than ENT in adults with CD (Cochrane Database Syst Rev. 2018 Apr 1. doi: 10.1002/14651858.CD000542.pub3).
According to clinician-scientist James D. Lewis, MD, MSCE, of the University of Pennsylvania, Philadelphia, ENT “has gotten a bad name in some ways because of a meta-analysis showing it was inferior to corticosteroids to induce remission.” In fact, he said, studies “didn’t look at mucosal healing and pooled together adults and children.”
In children, he said, the treatment seems to clearly be effective. The picture is less promising in adults. “Presumably that’s because those of you who are parents probably have more control over your young children than your own behavior,” he said, referring to management of food intake.
In adults, “there’s no reason to think it wouldn’t work,” he said. “But trying to convince adults to give up food is really challenging.”
Children who try ENT are often required to use a nasogastric feeding tube, an approach that adults tend to avoid. In kids, “it’s a question of knowing your patient,” said gastroenterologist David Suskind, MD, of Seattle Children’s Hospital. “If the patient says, ‘There’s no way you’ll put a nasal gastric tube in, and no way I will drink it [the ENT supplement],’ this may not be the best therapy. If they’re interested, we push forward. We get much better efficacy because the patients will do what we’re asking.”
Several panelists recommended that patients use polymeric formulations instead of elemental formulations because they’re more palatable. It can be a struggle, however, to stick with the treatment.
Kelly Issokson, MS, RD, CNSC, a dietitian with Cedars-Sinai Medical Center in Los Angeles, tried an ENT therapy for 30 days in order to understand what patients experience and said it was “very challenging.”
“When you sit down to a meal, you anticipate it, you start to salivate. With shakes, it was a lot more clinical,” she said. “The other thing I struggled with was texture and having it be so sweet. I’d freeze [the shakes] into ice cube trays and popsicles. That helped break the monotony. It changes the flavor and cuts the sweetness.”
Ms. Issokson urges her patients to stick with ENT for the entire period of therapy. “Studies show when patients introduce real foods the efficacy of inducing remission goes down. We recommend 100% calories and proteins coming from the formula,” she said. That means “no coffee, no broth, no tea, no nothing but the formula. Most of our patients are able to do that exclusively.”
Toward the end of therapy, around week 8 or 11, some patients tell her they crave food like soup. “I say OK, have a tiny bit,” she said, “but remember, this is only temporary. We’re almost at the end. Try to be 100% exclusive.”
Dr. Albenberg and Dr. Suskind report no disclosures. Ms. Issokson reports consulting fees (speaking and teaching) from AGA, Crohn’s & Colitis Foundation, Academy of Nutrition and Dietetics, and United Ostomy Association. Dr. Lewis reports many relationships – including consulting fees, ownership interest, and grant/research support – with Eli Lilly, Bristol‐Myers Squibb, Gilead, and others.
Correction, 2/22/19: An earlier version of this article misidentified the person in the first photo above.
EXPERT ANALYSIS FROM THE CROHN’S & COLITIS CONGRESS
Lawsuit against ABIM draws $200,000 in donation support
More than $200,000 has been raised by doctors and their supporters nationwide through a GoFundMe campaign launched to pay for costs associated with the class-action lawsuit against the American Board of Internal Medicine over its maintenance of certification (MOC) program.
Chicago-based cardiologist Wes Fisher, MD, and fellow physicians with the Practicing Physicians of America (PPA), started the fundraising campaign in May 2018 with an initial $150,000 goal to pay for attorney and prelitigation costs, according to posts on Dr. Fisher’s blog. After reaching that goal in September 2018, four internists filed suit against ABIM over its MOC process in December 2018, alleging antitrust claims.
PPA has since raised the GoFundMe goal to $400,000 to help support the next phase of the litigation, according to the campaign page.
In an email to supporters, Dr. Fisher said donations will help “take down MOC and end the unproven and burdensome continuous certification requirements for all subspecialties nationwide.” Dr. Fisher declined to comment for this article.
Brian Dixon, MD, a pediatric psychiatrist and PPA board member based in Fort Worth, Tex., said the campaign page and its success speaks for itself.
“Physicians are hurting and want to restore physician autonomy,” Dr. Dixon said in an interview. “Most physicians are pretty fiscally thoughtful so their donations are a powerful statement that they want change to the MOC process.”
Richard J. Baron, MD, ABIM president declined to specifically address the GoFundMe campaign, but said in an interview that the board is proud of its credential and grateful to the many physicians that have helped inform changes ABIM has made to its programs.
“Valuable credentials with standards behind them gain market share because they are meaningful and say something important about the doctors who hold them,” Dr. Baron said in an interview. “There is evidence in peer-reviewed journals that doctors holding our credential are more likely to meet quality metrics throughout their careers [Ann Intern Med. 2018 Jul 17. doi: 10.7326/M16-2643], that they are more likely to order mammograms for women who need them [Womens Health Issues. 2018 Jan-Feb. doi: 10.1016/j.whi.2017.10.003], that they provide care of equivalent quality at lower total cost[JAMA. 2014 Dec 10. doi: 10.1001/jama.2014.12716], and that they actually earn higher salaries [Health Serv Res. 2013 Jun. doi: 10.1111/1475-6773.12011]. All doctors should be concerned if making evidence-based claims about our credential based on data published in peer-reviewed journals gives rise to litigation alleging fraud.”
The lawsuit against ABIM, filed Dec. 6, 2018, in Pennsylvania district court, claims that ABIM is charging inflated monopoly prices for maintaining certification, that the organization is forcing physicians to purchase MOC, and that ABIM is inducing employers and others to require ABIM certification. The four plaintiff-physicians are asking a judge to find ABIM in violation of federal antitrust law and to bar the board from continuing its MOC process. The suit is filed as a class action on behalf of all internists and subspecialists required by ABIM to purchase MOC to maintain their ABIM certifications.
On Jan. 23 of this year the legal challenge was amended to include racketeering and unjust enrichment claims. The suit alleges that in violation of the Racketeer Influenced and Corrupt Organization Act, ABIM has deceived the public, including hospitals and insurance companies, into believing that its MOC credential benefits physicians, patients, and the public and that it constitutes self-regulation by internists and subspecialists. The challenge also asserts that ABIM has charged inappropriate, unreasonable, and unlawful MOC-related fees that result in the board becoming unjustly enriched at the expense of plaintiffs and other class members. The plaintiffs seek damages and injunctive relief, plus lawsuit and attorney costs.
ABIM has not yet responded to the lawsuit. In an interview, Dr. Baron said that the board will “have an opportunity to respond fully and completely in court in March and to [share] our side of the story.”
The lawsuit’s GoFundMe campaign has garnered more than 750 donations with sums ranging from $15 to $7,400. The average contribution is $210, according to an update on the funding website by Dr. Fisher, who serves as treasurer for Practicing Physicians of America.
PPA, the group behind the lawsuit – although not a named plaintiff – started in 2017 and focuses on strengthening physician autonomy, improving patient safety, and decreasing physician burnout, according to its website.
“Our current focus is beating burnout and empowering physicians to reclaim the leadership mantle in medicine and health care,” Dr. Dixon said. “By sharing the PPA ‘Seal of Approval’, we are inspiring physicians of all backgrounds to speak up and be heard. Ultimately, PPA wants to be a stable ‘stage’ for every physician’s voice that supports patient safety and physician autonomy.”
The organization, which is free to join, does not yet have concrete membership numbers, according to PPA’s secretary, Niran Al-Agba, MD, a Silverdale, Wash.–based pediatrician. Dr. Al-Agba referred to PPA as a resistance movement that is still building its infrastructure and recruiting members.
“We’re a work in progress,” she said in an interview. “The more people that know about us, the more people will join us.”
A central focus of the organization is ending MOC, according to the PPA website. Dr. Al-Agba said the current MOC process for physicians is burdensome and does not better medical practice. Dr. Al-Agba said her own personal experience with MOC has been negative, particularly a test she took in 2012 as part of the American Board of Pediatrics’ Maintenance of Certification program.
At the time, Dr. Al-Agba was nursing her young baby and was denied a request to take the 6-hour test at a later date. She had to bring her pumping equipment with her to take the test and faced inconsideration and humiliation when she needed a private place to pump at the test facility, said Dr. Al-Agba, who ultimately passed the test.
Dr. Al-Agba who blogs about being a mother and a doctor, wrote an open letter to the American Board of Pediatrics about her experience in 2016. She called the experience “demoralizing.” In general, she believes MOC is more about memorization and regurgitation, rather than education for physicians.
“What I want to see is a system that makes sense,” she said. “I want to see my learning tied to benefiting patients, as opposed to [MOC] which is showing you can still pass tests in medicine about esoteric facts.”
As a direct care physician, Dr. Dixon does not contract with insurance companies so MOC has little impact on his practice, he said. However, within a few years, he stands to lose an assistant professorship because the university requires board certification to stay in the position.
“As a business award winner, I bring a unique perspective to mental health care, and it would be a shame to be blacklisted from teaching the next generation of physician entrepreneurs because of the MOC process,” he said. “MOC is redundant and unnecessary so my hope is that it completely disappears. In the event ABIM and [the American Board of Medical Specialties] aren’t interested in making the right choice and making MOC optional, I’d like for medical schools, hospitals, and insurance companies to voluntarily disregard this useless designation to evaluate physicians. Great physicians are automatically lifelong learners and we’re committed to our patients.”
ABIM has made a number of modifications to its MOC process in recent years in response to physician concerns. This includes an overhaul of the organization’s governance structure to include more than 200 practicing physicians and opening new avenues for physicians to engage in the creation of assessment content that more closely reflects what they see in practice, Dr. Baron said. In addition, ABIM now surveys all specialists to contribute to the exam blueprint review and the creation of the new Item Writing Task Force.
In a December 2018 blog post, ABIM leaders said the organization would vigorously defend itself against the legal challenge, and that the board’s focus will “remain on maintaining a standard of professional achievement that the public values, signaling that ABIM diplomates are well-trained and staying current in their fields to better serve their patients.”
More than $200,000 has been raised by doctors and their supporters nationwide through a GoFundMe campaign launched to pay for costs associated with the class-action lawsuit against the American Board of Internal Medicine over its maintenance of certification (MOC) program.
Chicago-based cardiologist Wes Fisher, MD, and fellow physicians with the Practicing Physicians of America (PPA), started the fundraising campaign in May 2018 with an initial $150,000 goal to pay for attorney and prelitigation costs, according to posts on Dr. Fisher’s blog. After reaching that goal in September 2018, four internists filed suit against ABIM over its MOC process in December 2018, alleging antitrust claims.
PPA has since raised the GoFundMe goal to $400,000 to help support the next phase of the litigation, according to the campaign page.
In an email to supporters, Dr. Fisher said donations will help “take down MOC and end the unproven and burdensome continuous certification requirements for all subspecialties nationwide.” Dr. Fisher declined to comment for this article.
Brian Dixon, MD, a pediatric psychiatrist and PPA board member based in Fort Worth, Tex., said the campaign page and its success speaks for itself.
“Physicians are hurting and want to restore physician autonomy,” Dr. Dixon said in an interview. “Most physicians are pretty fiscally thoughtful so their donations are a powerful statement that they want change to the MOC process.”
Richard J. Baron, MD, ABIM president declined to specifically address the GoFundMe campaign, but said in an interview that the board is proud of its credential and grateful to the many physicians that have helped inform changes ABIM has made to its programs.
“Valuable credentials with standards behind them gain market share because they are meaningful and say something important about the doctors who hold them,” Dr. Baron said in an interview. “There is evidence in peer-reviewed journals that doctors holding our credential are more likely to meet quality metrics throughout their careers [Ann Intern Med. 2018 Jul 17. doi: 10.7326/M16-2643], that they are more likely to order mammograms for women who need them [Womens Health Issues. 2018 Jan-Feb. doi: 10.1016/j.whi.2017.10.003], that they provide care of equivalent quality at lower total cost[JAMA. 2014 Dec 10. doi: 10.1001/jama.2014.12716], and that they actually earn higher salaries [Health Serv Res. 2013 Jun. doi: 10.1111/1475-6773.12011]. All doctors should be concerned if making evidence-based claims about our credential based on data published in peer-reviewed journals gives rise to litigation alleging fraud.”
The lawsuit against ABIM, filed Dec. 6, 2018, in Pennsylvania district court, claims that ABIM is charging inflated monopoly prices for maintaining certification, that the organization is forcing physicians to purchase MOC, and that ABIM is inducing employers and others to require ABIM certification. The four plaintiff-physicians are asking a judge to find ABIM in violation of federal antitrust law and to bar the board from continuing its MOC process. The suit is filed as a class action on behalf of all internists and subspecialists required by ABIM to purchase MOC to maintain their ABIM certifications.
On Jan. 23 of this year the legal challenge was amended to include racketeering and unjust enrichment claims. The suit alleges that in violation of the Racketeer Influenced and Corrupt Organization Act, ABIM has deceived the public, including hospitals and insurance companies, into believing that its MOC credential benefits physicians, patients, and the public and that it constitutes self-regulation by internists and subspecialists. The challenge also asserts that ABIM has charged inappropriate, unreasonable, and unlawful MOC-related fees that result in the board becoming unjustly enriched at the expense of plaintiffs and other class members. The plaintiffs seek damages and injunctive relief, plus lawsuit and attorney costs.
ABIM has not yet responded to the lawsuit. In an interview, Dr. Baron said that the board will “have an opportunity to respond fully and completely in court in March and to [share] our side of the story.”
The lawsuit’s GoFundMe campaign has garnered more than 750 donations with sums ranging from $15 to $7,400. The average contribution is $210, according to an update on the funding website by Dr. Fisher, who serves as treasurer for Practicing Physicians of America.
PPA, the group behind the lawsuit – although not a named plaintiff – started in 2017 and focuses on strengthening physician autonomy, improving patient safety, and decreasing physician burnout, according to its website.
“Our current focus is beating burnout and empowering physicians to reclaim the leadership mantle in medicine and health care,” Dr. Dixon said. “By sharing the PPA ‘Seal of Approval’, we are inspiring physicians of all backgrounds to speak up and be heard. Ultimately, PPA wants to be a stable ‘stage’ for every physician’s voice that supports patient safety and physician autonomy.”
The organization, which is free to join, does not yet have concrete membership numbers, according to PPA’s secretary, Niran Al-Agba, MD, a Silverdale, Wash.–based pediatrician. Dr. Al-Agba referred to PPA as a resistance movement that is still building its infrastructure and recruiting members.
“We’re a work in progress,” she said in an interview. “The more people that know about us, the more people will join us.”
A central focus of the organization is ending MOC, according to the PPA website. Dr. Al-Agba said the current MOC process for physicians is burdensome and does not better medical practice. Dr. Al-Agba said her own personal experience with MOC has been negative, particularly a test she took in 2012 as part of the American Board of Pediatrics’ Maintenance of Certification program.
At the time, Dr. Al-Agba was nursing her young baby and was denied a request to take the 6-hour test at a later date. She had to bring her pumping equipment with her to take the test and faced inconsideration and humiliation when she needed a private place to pump at the test facility, said Dr. Al-Agba, who ultimately passed the test.
Dr. Al-Agba who blogs about being a mother and a doctor, wrote an open letter to the American Board of Pediatrics about her experience in 2016. She called the experience “demoralizing.” In general, she believes MOC is more about memorization and regurgitation, rather than education for physicians.
“What I want to see is a system that makes sense,” she said. “I want to see my learning tied to benefiting patients, as opposed to [MOC] which is showing you can still pass tests in medicine about esoteric facts.”
As a direct care physician, Dr. Dixon does not contract with insurance companies so MOC has little impact on his practice, he said. However, within a few years, he stands to lose an assistant professorship because the university requires board certification to stay in the position.
“As a business award winner, I bring a unique perspective to mental health care, and it would be a shame to be blacklisted from teaching the next generation of physician entrepreneurs because of the MOC process,” he said. “MOC is redundant and unnecessary so my hope is that it completely disappears. In the event ABIM and [the American Board of Medical Specialties] aren’t interested in making the right choice and making MOC optional, I’d like for medical schools, hospitals, and insurance companies to voluntarily disregard this useless designation to evaluate physicians. Great physicians are automatically lifelong learners and we’re committed to our patients.”
ABIM has made a number of modifications to its MOC process in recent years in response to physician concerns. This includes an overhaul of the organization’s governance structure to include more than 200 practicing physicians and opening new avenues for physicians to engage in the creation of assessment content that more closely reflects what they see in practice, Dr. Baron said. In addition, ABIM now surveys all specialists to contribute to the exam blueprint review and the creation of the new Item Writing Task Force.
In a December 2018 blog post, ABIM leaders said the organization would vigorously defend itself against the legal challenge, and that the board’s focus will “remain on maintaining a standard of professional achievement that the public values, signaling that ABIM diplomates are well-trained and staying current in their fields to better serve their patients.”
More than $200,000 has been raised by doctors and their supporters nationwide through a GoFundMe campaign launched to pay for costs associated with the class-action lawsuit against the American Board of Internal Medicine over its maintenance of certification (MOC) program.
Chicago-based cardiologist Wes Fisher, MD, and fellow physicians with the Practicing Physicians of America (PPA), started the fundraising campaign in May 2018 with an initial $150,000 goal to pay for attorney and prelitigation costs, according to posts on Dr. Fisher’s blog. After reaching that goal in September 2018, four internists filed suit against ABIM over its MOC process in December 2018, alleging antitrust claims.
PPA has since raised the GoFundMe goal to $400,000 to help support the next phase of the litigation, according to the campaign page.
In an email to supporters, Dr. Fisher said donations will help “take down MOC and end the unproven and burdensome continuous certification requirements for all subspecialties nationwide.” Dr. Fisher declined to comment for this article.
Brian Dixon, MD, a pediatric psychiatrist and PPA board member based in Fort Worth, Tex., said the campaign page and its success speaks for itself.
“Physicians are hurting and want to restore physician autonomy,” Dr. Dixon said in an interview. “Most physicians are pretty fiscally thoughtful so their donations are a powerful statement that they want change to the MOC process.”
Richard J. Baron, MD, ABIM president declined to specifically address the GoFundMe campaign, but said in an interview that the board is proud of its credential and grateful to the many physicians that have helped inform changes ABIM has made to its programs.
“Valuable credentials with standards behind them gain market share because they are meaningful and say something important about the doctors who hold them,” Dr. Baron said in an interview. “There is evidence in peer-reviewed journals that doctors holding our credential are more likely to meet quality metrics throughout their careers [Ann Intern Med. 2018 Jul 17. doi: 10.7326/M16-2643], that they are more likely to order mammograms for women who need them [Womens Health Issues. 2018 Jan-Feb. doi: 10.1016/j.whi.2017.10.003], that they provide care of equivalent quality at lower total cost[JAMA. 2014 Dec 10. doi: 10.1001/jama.2014.12716], and that they actually earn higher salaries [Health Serv Res. 2013 Jun. doi: 10.1111/1475-6773.12011]. All doctors should be concerned if making evidence-based claims about our credential based on data published in peer-reviewed journals gives rise to litigation alleging fraud.”
The lawsuit against ABIM, filed Dec. 6, 2018, in Pennsylvania district court, claims that ABIM is charging inflated monopoly prices for maintaining certification, that the organization is forcing physicians to purchase MOC, and that ABIM is inducing employers and others to require ABIM certification. The four plaintiff-physicians are asking a judge to find ABIM in violation of federal antitrust law and to bar the board from continuing its MOC process. The suit is filed as a class action on behalf of all internists and subspecialists required by ABIM to purchase MOC to maintain their ABIM certifications.
On Jan. 23 of this year the legal challenge was amended to include racketeering and unjust enrichment claims. The suit alleges that in violation of the Racketeer Influenced and Corrupt Organization Act, ABIM has deceived the public, including hospitals and insurance companies, into believing that its MOC credential benefits physicians, patients, and the public and that it constitutes self-regulation by internists and subspecialists. The challenge also asserts that ABIM has charged inappropriate, unreasonable, and unlawful MOC-related fees that result in the board becoming unjustly enriched at the expense of plaintiffs and other class members. The plaintiffs seek damages and injunctive relief, plus lawsuit and attorney costs.
ABIM has not yet responded to the lawsuit. In an interview, Dr. Baron said that the board will “have an opportunity to respond fully and completely in court in March and to [share] our side of the story.”
The lawsuit’s GoFundMe campaign has garnered more than 750 donations with sums ranging from $15 to $7,400. The average contribution is $210, according to an update on the funding website by Dr. Fisher, who serves as treasurer for Practicing Physicians of America.
PPA, the group behind the lawsuit – although not a named plaintiff – started in 2017 and focuses on strengthening physician autonomy, improving patient safety, and decreasing physician burnout, according to its website.
“Our current focus is beating burnout and empowering physicians to reclaim the leadership mantle in medicine and health care,” Dr. Dixon said. “By sharing the PPA ‘Seal of Approval’, we are inspiring physicians of all backgrounds to speak up and be heard. Ultimately, PPA wants to be a stable ‘stage’ for every physician’s voice that supports patient safety and physician autonomy.”
The organization, which is free to join, does not yet have concrete membership numbers, according to PPA’s secretary, Niran Al-Agba, MD, a Silverdale, Wash.–based pediatrician. Dr. Al-Agba referred to PPA as a resistance movement that is still building its infrastructure and recruiting members.
“We’re a work in progress,” she said in an interview. “The more people that know about us, the more people will join us.”
A central focus of the organization is ending MOC, according to the PPA website. Dr. Al-Agba said the current MOC process for physicians is burdensome and does not better medical practice. Dr. Al-Agba said her own personal experience with MOC has been negative, particularly a test she took in 2012 as part of the American Board of Pediatrics’ Maintenance of Certification program.
At the time, Dr. Al-Agba was nursing her young baby and was denied a request to take the 6-hour test at a later date. She had to bring her pumping equipment with her to take the test and faced inconsideration and humiliation when she needed a private place to pump at the test facility, said Dr. Al-Agba, who ultimately passed the test.
Dr. Al-Agba who blogs about being a mother and a doctor, wrote an open letter to the American Board of Pediatrics about her experience in 2016. She called the experience “demoralizing.” In general, she believes MOC is more about memorization and regurgitation, rather than education for physicians.
“What I want to see is a system that makes sense,” she said. “I want to see my learning tied to benefiting patients, as opposed to [MOC] which is showing you can still pass tests in medicine about esoteric facts.”
As a direct care physician, Dr. Dixon does not contract with insurance companies so MOC has little impact on his practice, he said. However, within a few years, he stands to lose an assistant professorship because the university requires board certification to stay in the position.
“As a business award winner, I bring a unique perspective to mental health care, and it would be a shame to be blacklisted from teaching the next generation of physician entrepreneurs because of the MOC process,” he said. “MOC is redundant and unnecessary so my hope is that it completely disappears. In the event ABIM and [the American Board of Medical Specialties] aren’t interested in making the right choice and making MOC optional, I’d like for medical schools, hospitals, and insurance companies to voluntarily disregard this useless designation to evaluate physicians. Great physicians are automatically lifelong learners and we’re committed to our patients.”
ABIM has made a number of modifications to its MOC process in recent years in response to physician concerns. This includes an overhaul of the organization’s governance structure to include more than 200 practicing physicians and opening new avenues for physicians to engage in the creation of assessment content that more closely reflects what they see in practice, Dr. Baron said. In addition, ABIM now surveys all specialists to contribute to the exam blueprint review and the creation of the new Item Writing Task Force.
In a December 2018 blog post, ABIM leaders said the organization would vigorously defend itself against the legal challenge, and that the board’s focus will “remain on maintaining a standard of professional achievement that the public values, signaling that ABIM diplomates are well-trained and staying current in their fields to better serve their patients.”
Dupilumab conjunctivitis does not always require an ophthalmologist referral
WAIKOLOA, HAWAII – Since its approval in 2017, dupilumab (Dupixent) has proven to be a solid addition to the atopic dermatitis (AD) armamentarium.
About 80% to 85% of patients treated with the biologic will achieve a 50% reduction in their Eczema Area and Severity Index score, and some will go on to a 90% reduction, according to Jonathan Silverberg, MD, PhD, of the department of dermatology, Northwestern University, Chicago.
But Dr. Silverberg has seen it in his own practice and said it can be hard to know whether or not to refer to ophthalmology. “We’re often left with this conundrum of ... ‘Is it a side effect of the medication, or is it just because they happen to have hay fever or keratoconjunctivitis or other ophthalmic comorbidities?’ And it’s not always easy to sort out.”
In an interview at the Hawaii Dermatology Seminar, provided by Global Academy for Medical Education/Skin Disease Education Foundation, he offered his advice on managing a patient who develops conjunctivitis during dupilumab treatment, including his treatment tips for when it is safe to handle in the dermatology clinic.
Dr. Silverberg, who was an investigator in the dupilumab phase 3 trials, said that, while dupilumab is the only systemic agent approved by the Food and Drug Administration for treating AD, and more are on the way for AD, there will always still be a role for traditional immunosuppressives. He explained why in the interview and why he favors methotrexate when old school options are in order.
This news organization and SDEF/Global Academy for Medical Education are owned by the same parent company.
WAIKOLOA, HAWAII – Since its approval in 2017, dupilumab (Dupixent) has proven to be a solid addition to the atopic dermatitis (AD) armamentarium.
About 80% to 85% of patients treated with the biologic will achieve a 50% reduction in their Eczema Area and Severity Index score, and some will go on to a 90% reduction, according to Jonathan Silverberg, MD, PhD, of the department of dermatology, Northwestern University, Chicago.
But Dr. Silverberg has seen it in his own practice and said it can be hard to know whether or not to refer to ophthalmology. “We’re often left with this conundrum of ... ‘Is it a side effect of the medication, or is it just because they happen to have hay fever or keratoconjunctivitis or other ophthalmic comorbidities?’ And it’s not always easy to sort out.”
In an interview at the Hawaii Dermatology Seminar, provided by Global Academy for Medical Education/Skin Disease Education Foundation, he offered his advice on managing a patient who develops conjunctivitis during dupilumab treatment, including his treatment tips for when it is safe to handle in the dermatology clinic.
Dr. Silverberg, who was an investigator in the dupilumab phase 3 trials, said that, while dupilumab is the only systemic agent approved by the Food and Drug Administration for treating AD, and more are on the way for AD, there will always still be a role for traditional immunosuppressives. He explained why in the interview and why he favors methotrexate when old school options are in order.
This news organization and SDEF/Global Academy for Medical Education are owned by the same parent company.
WAIKOLOA, HAWAII – Since its approval in 2017, dupilumab (Dupixent) has proven to be a solid addition to the atopic dermatitis (AD) armamentarium.
About 80% to 85% of patients treated with the biologic will achieve a 50% reduction in their Eczema Area and Severity Index score, and some will go on to a 90% reduction, according to Jonathan Silverberg, MD, PhD, of the department of dermatology, Northwestern University, Chicago.
But Dr. Silverberg has seen it in his own practice and said it can be hard to know whether or not to refer to ophthalmology. “We’re often left with this conundrum of ... ‘Is it a side effect of the medication, or is it just because they happen to have hay fever or keratoconjunctivitis or other ophthalmic comorbidities?’ And it’s not always easy to sort out.”
In an interview at the Hawaii Dermatology Seminar, provided by Global Academy for Medical Education/Skin Disease Education Foundation, he offered his advice on managing a patient who develops conjunctivitis during dupilumab treatment, including his treatment tips for when it is safe to handle in the dermatology clinic.
Dr. Silverberg, who was an investigator in the dupilumab phase 3 trials, said that, while dupilumab is the only systemic agent approved by the Food and Drug Administration for treating AD, and more are on the way for AD, there will always still be a role for traditional immunosuppressives. He explained why in the interview and why he favors methotrexate when old school options are in order.
This news organization and SDEF/Global Academy for Medical Education are owned by the same parent company.
EXPERT ANALYSIS FROM THE SDEF HAWAII DERMATOLOGY SEMINAR
FDA clears first-of-its-kind phone app for insulin management
The Food and Drug Administration has granted 501(k) clearance to a phone app for managing insulin in patients with type 2 diabetes.
The app will enhance Hygieia’s d-Nav Insulin Guidance Service, which uses Cloud-based technology and a small group of health care professionals to support physicians and help patients with diabetes achieve better glycemic control by providing personalized insulin adjustments. The system has been shown, in a 90-day clinical study, to reduce both costs and levels of glycosylated hemoglobin. Patients can use the app to enter glucose-event data and receive a recommended insulin dose.
“Insulin therapy is critical to the health of more than 8 million people in the United States, but it is often ineffective, largely because it requires a continual, personalized adjustment that is not practical for physicians and not manageable for patients. The d-Nav service, including the user-friendly phone app, makes insulin therapy more effective, less time intensive, and less costly for everyone involved,” Eran Bashan, CEO of Hygieia, said in a press release.
This is the first insulin-mangement app that can titrate individualized doses for all insulin regimens and the first that can connect to any glucose meter that shares information with the cloud. It is available for both Android and iOS.
Find the full press release on the Hygieia website.
The Food and Drug Administration has granted 501(k) clearance to a phone app for managing insulin in patients with type 2 diabetes.
The app will enhance Hygieia’s d-Nav Insulin Guidance Service, which uses Cloud-based technology and a small group of health care professionals to support physicians and help patients with diabetes achieve better glycemic control by providing personalized insulin adjustments. The system has been shown, in a 90-day clinical study, to reduce both costs and levels of glycosylated hemoglobin. Patients can use the app to enter glucose-event data and receive a recommended insulin dose.
“Insulin therapy is critical to the health of more than 8 million people in the United States, but it is often ineffective, largely because it requires a continual, personalized adjustment that is not practical for physicians and not manageable for patients. The d-Nav service, including the user-friendly phone app, makes insulin therapy more effective, less time intensive, and less costly for everyone involved,” Eran Bashan, CEO of Hygieia, said in a press release.
This is the first insulin-mangement app that can titrate individualized doses for all insulin regimens and the first that can connect to any glucose meter that shares information with the cloud. It is available for both Android and iOS.
Find the full press release on the Hygieia website.
The Food and Drug Administration has granted 501(k) clearance to a phone app for managing insulin in patients with type 2 diabetes.
The app will enhance Hygieia’s d-Nav Insulin Guidance Service, which uses Cloud-based technology and a small group of health care professionals to support physicians and help patients with diabetes achieve better glycemic control by providing personalized insulin adjustments. The system has been shown, in a 90-day clinical study, to reduce both costs and levels of glycosylated hemoglobin. Patients can use the app to enter glucose-event data and receive a recommended insulin dose.
“Insulin therapy is critical to the health of more than 8 million people in the United States, but it is often ineffective, largely because it requires a continual, personalized adjustment that is not practical for physicians and not manageable for patients. The d-Nav service, including the user-friendly phone app, makes insulin therapy more effective, less time intensive, and less costly for everyone involved,” Eran Bashan, CEO of Hygieia, said in a press release.
This is the first insulin-mangement app that can titrate individualized doses for all insulin regimens and the first that can connect to any glucose meter that shares information with the cloud. It is available for both Android and iOS.
Find the full press release on the Hygieia website.