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The NEW ENGLA ND JOURNAL of MEDICINE

Perspective January 21, 2016

His tory of Medicine

Regulating Homeopathic Products A Century of Dilute Interest


ScottH. Podolsky, M.D., and AaronS. Kesselheim, M.D., J.D., M.P.H.

H
omeopathic drugs made several regulation- of artful misrepresentation, while
related headlines in 2015. First, in March, noting the potential therapeutic
effect on patients of the strong
the Food and Drug Administration (FDA) impression made upon their minds
filed a request for public comments to learn what the by this novel and marvelous meth-
od of treatment. But Holmes
public and physicians think about the turn of the 19th century and similarly criticized the orthodox
homeopathic drugs and whether introduced into the United States heroic medicine of his day
its limited regulatory oversight of shortly thereafter, homeopathy (which was grounded in bleeding
these products was appropriate to was predicated on such notions and emetics), and homeopathy
protect and promote public health.1 as like cures like and the law of continued to attract adherents,
The agency then held a 2-day infinitesimals, whereby extraordi- including some conventional phy-
public hearing featuring homeo- narily diluted products that in sicians.
pathic care providers and repre- their original form might have Throughout the 19th century,
sentatives of the homeopathic drug caused symptoms resembling those homeopaths founded hospitals,
industry, as well as drug-safety of the illness in question are ad- societies, and medical schools and
experts. Then in September, the ministered to patients in a highly developed a complicated relation-
Federal Trade Commission (FTC) individualized fashion. ship with orthodox medicine:
held its own public workshop on In the competitive U.S. medi- conventional physicians (whom
the advertising of homeopathic cal marketplace of the 1830s and homeopaths dubbed allopaths
products and whether it might 1840s, orthodox physicians took because of their emphasis on treat-
violate section 5 of the FTC Act, notice and drew attention to the ing or suppressing symptoms)
which prohibits deceptive acts or biologic implausibility of homeo- could incorporate homeopathic
practices affecting commerce. pathic remedies. The most caus- remedies into their practice, and
These actions came after more tic critique was voiced by Oliver homeopaths could perform cer-
than a century of missed oppor- Wendell Holmes, who declared tain procedures, such as surgeries,
tunities to regulate homeopathic homeopathy a mingled mass of normally performed by conven-
medicines. Founded by Samuel perverse ingenuity, of tinsel eru- tional physicians.
Hahnemann in Germany around dition, or imbecile credulity, and In the aftermath of the 1910

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PERS PE C T IV E regulating homeopathic products

Flexner report on medical educa- time, but regulators had been fo- In 1988, recognizing the in-
tion, however, medicines increas- cused on stemming the tide of creasing size of the homeopath-
ingly self-conscious grounding in truly dangerous quack products ic-drug market, the FDA issued a
laboratory science rendered ho- containing cocaine, heroin, and Compliance Policy Guide man-
meopathy academically suspect.2 chloroform, among other harm- dating conformity with good
Its base of support shifted in sub- ful substances.4 manufacturing practices and ap-
sequent decades, as lay practi- The next major piece of legis- propriate labeling regarding in-
tioners increasingly spoke for the lation that could have restricted gredients and directions for use.
field, and popular interest inten- homeopathic products was the Homeopathic drugs used for se-
sified from the 1960s onward in 1938 Food, Drug, and Cosmetic rious conditions were to be pre-
the context of counterculturalism, Act. That law, however, focused scribed by clinicians, whereas
antiauthoritarianism, and growing on the safety, rather than efficacy, those offered for self-limited
disillusionment with the reduc- of new drugs, and remedies list- conditions could be sold over the
tionism of conventional medicine. ed in the Homeopathic Pharma- counter. Thus, the FDA not only
By the 1990s, homeopathy was copeia were considered to have recused itself from evaluating the
well represented in the arma- met the new quality standards. efficacy of remedies prescribed
mentarium of alternative healers, The inclusion in the Act of a refer- by homeopathic clinicians but
whose appeal flummoxed mem- ence to the Homeopathic Pharma- also allowed over-the-counter ho-
bers of the medical establish- copoeia appears to have resulted meopathic drugs to be marketed
ment. For example, lamenting not only from the efforts of Sen- as therapeutic.
the consumption of enormous ator Royal Copeland (D-NY), a Homeopathic remedies have
quantities of alternative remedies, homeopathic practitioner and enjoyed continued popularity
Journal editors Marcia Angell and sponsor of the bill, to differenti- over the past three decades. Ac-
Jerome Kassirer noted, There ate homeopathy from quackery, cording to the 2012 National
cannot be two kinds of medicine but also from the belief among Health Interview Survey, about
conventional and alternative. such prominent leaders of aca- 5million U.S. adults and 1 mil-
There is only medicine that has demic medicine as Morris Fish- lion children had used a homeo-
been adequately tested and medi- bein (editor of JAMA) that the pathic treatment in the previous
cine that has not, medicine that distinctions between conventional year. Although homeopathic drugs
works and medicine that may or medicine and homeopathy would are generally considered to be
may not work.3 continue to dissolve in the cruci- safe they consist of prepara-
By testing, they explained, we ble of scientific investigation.4 tions so diluted that no trace of
mean the marshaling of rigorous When the 1962 KefauverHarris the original active ingredients
evidence of safety and efficacy as Amendments mandated that the may even remain some physi-
required by the . . . FDA for the efficacy of conventional drugs be cians worry that even inert ho-
approval of [conventional] drugs. proven through well-controlled meopathic remedies will redirect
This definition was ironic, how- investigations, homeopathic rem- patients away from effective con-
ever, given the FDAs historical edies remained under the regu- ventional remedies or clinicians.
accommodation of homeopathy. latory radar, protected by the In addition, dangerous examples
The Pure Food and Drug Act of amendments failure to change the have emerged; for instance, the
1906, which had endowed the status of products in the Homeo- purportedly homeopathic Zicam
agency with its initial regulatory pathic Pharmacopeia. Moreover, Cold Remedy actually contained
power and mandated that drug both the subsequent Drug Effi- high doses of zinc gluconate, and
products actually contain the in- cacy Study Implementation (DESI) in 2009 it was pulled from the
gredients on their labels, governed process, by which all drugs ap- market because its intranasal use
drugs recognized in the U.S. proved between 1938 and 1962 was linked to anosmia.
Pharmacopeia and the National were retrospectively evaluated, and Unlike dietary supplements,
Formulary, as well as any prod- the FDAs review of over-the- which were explicitly excluded
uct intended to cure, mitigate, or counter remedies, excluded ho- from rigorous FDA regulation in
prevent disease. This scope would meopathic products, in the latter 1994, homeopathic products can
clearly have covered homeopathic case with the intention that they actually be substantially regulat-
remedies, which were largely ad- would be reviewed at a later ed by the FDA, since the Food,
ministered by clinicians at the time (they werent).4 Drug, and Cosmetic Act allows

202 n engl j med 374;3 nejm.org January 21, 2016

The New England Journal of Medicine


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Copyright 2016 Massachusetts Medical Society. All rights reserved.
PE R S PE C T IV E regulating homeopathic products

them to be sold as therapeutic. same standards of scientific proof tory framework after a quarter-century;
public hearing (http://www.gpo.gov/fdsys/
We believe that, at minimum, applied to conventional medi- pkg/FR-2015-03-27/pdf/2015-07018.pdf).
regulators should reconsider the cines. The recent actions by the 2. Haller JS. The history of American ho-
way homeopathic drugs are mar- FDA and FTC may finally signal meopathy: from rational medicine to holis-
tic health care. New Brunswick, NJ:Rutgers
keted, so that consumers who are the end of homeopathic drugs University Press, 2009.
seeking conventional medicines at century-long evasion of regulatory 3. Angell M, Kassirer JP. Alternative medi-
pharmacies dont become con- scrutiny. cine the risks of untested and unregulat-
ed remedies. N Engl J Med 1998;339:839-41.
fused. In August, Disclosure forms provided by the authors
4. Junod SW. An alternative perspective:
An audio interview are available with the full text of this article
with Dr. Podolsky the FTC submitted homeopathic drugs, Royal Copeland, and
at NEJM.org.
comments to the federal drug regulation. Food Drug Law J
is available at NEJM.org
2000;55:161-83.
FDA recommending From the Department of Global Health and 5. Staff of the Federal Trade Commission.
that the agencies better harmo- Social Medicine, Harvard Medical School In response to a request for comments re-
(S.H.P.), and the Program on Regulation, lated to its public hearing on homeopathic
nize their approaches to regulat- Therapeutics, and Law (PORTAL), Division product regulation: evaluating the Food and
ing homeopathic products and of Pharmacoepidemiology and Pharmaco- Drug Administrations regulatory framework
their advertising.5 Reconsidering economics, Department of Medicine, after a quarter-century. 21 August 2015
Brigham and Womens Hospital (A.S.K.) (https://w ww.ftc.gov/system/f iles/documents/
the over-the-counter sale of ho- both in Boston. advocacy_documents/ftc-staff-comment-food
meopathic remedies entirely would -drug-administration-regarding-current-use
be an even more drastic step and 1. Department of Health and Human Ser- -human-drug-biological-products/
would require the FDA to take on vices, Food and Drug Administration. 21 150821fdahomeopathic.pdf).
CFR Part 15 [docket no. FDA-2015-N-0540]:
the entire industry for propagat- homeopathic product regulation: evaluating DOI: 10.1056/NEJMp1513393
ing remedies that dont meet the the Food and Drug Administrations regula- Copyright 2016 Massachusetts Medical Society.

ACOs and High-Cost Patients


BrianW. Powers, A.B., and SreekanthK. Chaguturu, M.D.

M anaging the care of high-


cost patients is a key con-
cern of physicians and health sys-
programs requires targeting the
particular drivers of excess care
utilization by high-cost patients;
To further characterize this vari-
ation, we analyzed 2014 claims
data for the costliest 1% of pa-
tems that are forming accountable only programs that closely match tients in each payer category
care organizations (ACOs) and delivery interventions to specific whose care is managed by Part-
entering into alternative payment clinical needs have succeeded.3 ners HealthCare, a large integrat-
contracts tying reimbursement to Prevailing approaches for manag- ed delivery system in Massachu-
performance on cost trends and ing the care of high-cost patients setts (see table). Because of the
quality measures.1 The logic is focus on improving adherence structure of U.S. health care fi-
simple: given that a small per- and disease management for mul- nancing, these payer-defined pop-
centage of patients (often those tiple co-occurring conditions ulations are helpful surrogates
with complex or multiple medi- a strategy developed and tested for clinically distinct subgroups
cal conditions) account for the among Medicare patients.1 Can of patients and reflect the locus
majority of health care spend- tactics honed among the elderly at which alternative payment
ing,2 directing additional resourc- be successfully applied to other contracts are negotiated.
es and services toward patients high-cost populations? The costliest 1% of Medicare
who are likely to incur high costs Health services researchers patients had an average of eight
and experience poor outcomes have documented that across co-occurring chronic conditions.
a strategy known as high-risk populations covered by different Most had cardiovascular risk fac-
care management could sub- health care payers, small groups tors, and more than half had
stantially reduce costs and im- of patients are responsible for end-stage sequelae of ischemic
prove quality. Faith in this prop- outsized portions of health care heart disease, congestive heart
osition has led to widespread costs.2 Less is known, however, failure, or chronic kidney disease.
adoption of high-risk care-man- about variation in clinical charac- These patterns argue for the use
agement programs by ACOs.2 teristics and care-utilization pat- of disease management and care
Successfully structuring these terns among payer-defined groups. coordination to improve care and

n engl j med 374;3 nejm.org January 21, 2016 203


The New England Journal of Medicine
Downloaded from nejm.org on February 10, 2017. For personal use only. No other uses without permission.
Copyright 2016 Massachusetts Medical Society. All rights reserved.