The report “Homeopathy in healthcare: effectiveness, appropriateness, safety, costs” is not a “Swiss report”

Felix Gurtner

Counterstatement to Shaw DM. The Swiss Report on homoeopathy: a case study of research misconduct. Swiss Med Wkly. 2012;142:w13594 http://www.smw.ch/content/smw-2012-13594/

In his recent editorial [1] David M. Shaw drew attention to a book on the effectiveness, appropriateness, safety and costs of homeopathy that had recently been published in English [2]. He pointed out several shortcomings regarding good research practice. Unfortunately, several statements in the editorial, concerning the role the Swiss government had in publishing the report, as well as the influence the book supposedly had on the latest decision on coverage of homeopathy by the mandatory Swiss health insurance, are not correct. Since the editorial is supposed to contribute to improving standards of conducting and publishing systematic reviews and Health Technology Assessments (HTAs), we feel that it is important that this obviously erroneous piece of information is rectified. In order to do this adequately, a short summary of the history preceding the latest decision concerning coverage is necessary:

Mandatory health insurance in Switzerland offers coverage only for services that are in accordance with the Swiss health insurance law. The following criteria must be fulfilled: “Wirksamkeit” (efficacy/effectiveness), “Zweckmässigkeit” (appropriateness / comparative effectiveness / risk-benefit-ratio), and “Wirtschaftlichkeit” (price level / cost impact / cost-effectiveness). In 1998, the former minister of the department of Home Affairs (health matters and health insurance are regulated in this department) decided that homeopathy and four other methods of complementary and alternative medicine (CAM) can be covered under two conditions, the first condition being that services are covered only if provided by physicians licensed for independent practice and who have undertaken postgraduate training in the respective method approved by the Swiss Medical Association. The second condition was that efficacy, effectiveness, appropriateness and cost impact had to be evaluated within 6 years. Similar “coverage under evaluation” schemes have been applied since 1996 in Switzerland for promising technologies when it was yet unclear if they fulfilled the criteria mentioned above. Later this concept was described and discussed under the term “coverage with evidence development” or CED in the international scientific literature [3].

The Swiss government financed an evaluation programm (Programm Evaluation Komplementärmedizin PEK) consisting of literature reviews, descriptive studies of CAM practice in Switzerland, and an analysis of the Swiss Health Surveys 1997 and 2002 on the utilisation of CAM. In May 2005, the main results of the evaluation were made available and presented to the commission that advised the ministry concerning coverage decisions. In June 2005 the minister made the decision to end any existing coverage of the five CAM methods [4] and on the same day, the final report was made available as an e-publication. Further publications or abstracts produced within PEK as well as critical comments of the international scientific review board to the final phase of PEK were added to the website at a later point [5].

As far as homeopathy is concerned, two literature reviews were commissioned: A meta-analysis on homeopathy trials and of matched trials in conventional medicine [6], and a broad analysis of the literature incorporating publications and unpublished reports on studies of various methodologies (randomised and non-randomised trials, case series, experimental studies). This review was declared to be an HTA by the authors (the final PEK [5] report does not classify the literature reviews as HTA reports) and published later as a book [7] under their responsibility without any consent of the Swiss government or administration. The book by Bonhöft and Matthiessen was later translated into English and published in 2012 [2].

The decision to end coverage for homeopathy and other CAM methods in 2005 was strongly criticised by large parts of the population even beyond the (according to the Swiss Health Survey 2002 [5]) 11% CAM users, and by many politicians. The decision also led to a referendum aiming at promoting CAM in general. The intention behind the referendum was to reinstall coverage by the mandatory health insurance. A moderate form of the referendum was accepted by three-quarters of the population during a popular vote in 2009. As a result, the medical associations in 5 CAM methods submitted documented requests for re-installing coverage again in 2010, using the systematic application forms introduced by the Federal Office of Public Health in 2008 [8]. The book on homeopathy mentioned above was part of the submission on homeopathy.

In December 2010 the advisory commission again came to the conclusion that for all five CAM methods, the proof of efficacy, effectiveness, appropriateness and cost impact was not convincing enough [9]. One month later, the minister of home affairs made the decision to re-install coverage from 2012 onwards under roughly the same conditions as during the period from 1999 to 2005 (physicians certified in CAM methods, coverage in evaluation) [10]. This decision took both the negative verdict of the advising commission as well as the will of the population, expressed in the popular vote in 2009, into account. However, one main difference must be taken notice of: During the first evaluation period all evaluation projects were conducted in one single evaluation programme under a mixed steering committee; the responsibility in future for evaluation will be divided between the providers (focus on utilisation and cost impact) and the administration (HTAs to be commissioned internationally). This approach should lead to methodologically correct evaluation projects.

This summary of the history around evaluations and decisions concerning the coverage of homeopathy and other CAM methods, illustrates the challenge of making decisions on the coverage of popular methods for which efficacy etc. has not been proven by standards applied for evaluating all other services.

As now has been demonstrated, Shaw is wrong in claiming that a) the report on homeopathy [2] was published or commissioned by the Swiss government, b) the report had an influence on the 2011 decision on re-installing coverage, and c) the Swiss government wanted homeopathy and other CAM methods to be evaluated at lower than usual standards in order to receive a certain result. In reality only an earlier, shorter version of the report was produced with funding by the Swiss government; the decision was made despite the contrary recommendations of the advisory commission, but took into account the will of the population expressed in the 2009 referendum. The advisory commission also based its recommendation on the other review produced with federal funding [6], as well as (in 2010) on study results published after 2005.

References

1 David M. Shaw. The Swiss report on homeopathy: a case study of research misconduct. Swiss Med Wkly;142:w13594 http://www.smw.ch/content/smw-2012-13594/ .

2 Gudrun Bonhöft, Peter Matthiessen (eds.) Homeopathy in healthcare: effectiveness, appropriateness, safety, costs. Springer, 2012.

3 Hutton J, Trueman P, Henshall C. Coverage with Evidence Development: An examination of conceptual and policy issues. International Journal of Technology Assessment in Health Care. 2007;23:425–32.

5 Final report and further publications or abstracts: http://www.bag.admin.ch/themen/

6 Schang A, Huwiler-Müntener K, Nartey L, et al. Are the clinical effects of homeopathy placebo effects? Comparative study of placebo-controlled trials of homeopathy and allopathy. Lancet. 2005;366:726–32.

7 Bonhöft G, Matthiessen P (Hrsg.) Homöopathie in der Krankenversicherung – Wirksamkeit, Nutzen, Sicherheit und Wirtschaftlichkeit. VAS – Verlag für Akademische Schriften, 2006.