“Research is subordinated (not to a long-term social benefit) but to an immediate commercial profit. Currently, disease (not health) is one of the major sources of profit for the pharmaceutical industry, and the doctors are willing agents of those profits.”
Dr Pierre Bosquet, Nouvelle Critique, France, May 1961

As The Lancet prepares to publish another issue on homeopathy, this seems a suitable moment to republish a blog entry from 18 months ago which described the highly irregular context forming the backdrop to the publication of the seriously flawed study (Shang et al. ‘Are the clinical effects of homeopathy placebo effects? Comparative study of placebo controlled trials of homeopathy and allopathy’ The Lancet 2005;366 (9487):726-733) which claimed to support the conclusion that the effects of homeopathy are no more than placebo.

Further details on the study itself, analyses of it’s principal failings, and the reaction it provoked among serious researchers can be found on the Myths and Misconceptions page.

The Shang et al meta-analysis was an offshoot from a Swiss government study, the Programm Evaluation Komplementärmedizin (PEK), which was designed to allow politicians to assess whether or not five complementary therapies – anthroposophical medicine, homeopathy, neural therapy, phytotherapy and traditional Chinese herbal therapy – should be included in the list of services covered by the Swiss compulsory health insurance scheme (KLV). The cost of complementary therapies were, until 1998, reimbursed under the basic national scheme, but a change in the regulations in 1998 put the decision over which therapies were or were not valid for reimbursement in the hands of the Swiss Department of Internal Affairs (EDI). Public outcry forced the government to back-peddle and the five most popular therapies were reinstated in the KLV scheme from 1999 to 2005, on condition that each therapy was provided by FMH-certified physicians only, and that a simultaneous study in each therapy’s effectiveness was carried out (the PEK study). The decision on whether the therapies were retained within the basic health insurance scheme after 2005 would depend on the demonstration of their efficacy, appropriateness and cost effectiveness.

The study was set up under the Federal Office of Social Insurance (BSV) with a well-defined management structure and review board of internationally-acknowledged experts. It received widespread praise for the quality of its design and the degree of cooperation and transparency amongst its participants. As each area of the study began publishing their findings, the project was cited as an exemplar for future CAM research.

But as the extent of the findings in favour of the five therapies began to become clear, in 2004 PEK’s management structure was abruptly changed and the control of the study was passed to the Federal Office of Health (BAG). From that point onward, many attempts were made to interfere with and derail its emerging conclusions. Transparency was immediately compromised. Economic data showing the cost benefits of CAM were suppressed. The economist preparing to present the results of his work was dismissed without reason and placed under a gagging order. Other departments were prevented from publishing their work.

One member of the PEK steering committee, Dr med Peter Heusser, was so disgusted by what he witnessed that he has written an account of what happened, Medizin und Macht am Beispiel des Programms Evaluation Komplementärmedizin PEK (currently only available in German, but machine-translated here), and this brief summary is drawn largely from his account.

The Swiss authorities – both the government and the Federal Office of Health (BAG) – tried to sweep the PEK study under the carpet. A conference scheduled for April 2005 to present and discuss its results had to be cancelled because the Federal Office of Health prevented the publication of the study data. Some collaborators were even coerced into deleting all PEK-related data from their computers. The final meeting of the PEK international review board (six professors from Switzerland, Germany, Denmark and the UK responsible for the scientific quality of the study), scheduled for June 2005 for a final assessment of the project, was cancelled. (The review board eventually produced a summary report in September, which is highly critical of the political interference in the study.) Many contributors had their contracts terminated before their work could be completed. The recommendation in the final draft that homeopathy, anthroposophical medicine and herbal medicine should stay in the compulsory health insurance scheme was deleted in the final publication.

The Swiss government pre-emptively decided to exclude all CAM therapies from the compulsory health insurance scheme as of 30 June 2005, effectively ignoring not just the weight of scientific findings and economic benefits (which could save SFr millions on the health budget) which were emerging from the still-to-be-completed PEK study, but also the weight of Swiss public opinion.

In this context, the appearance of the Shang et al meta-analysis in The Lancet two months later – notably pre-empting the final report from the PEK international review board – can do little else but appear even more biased and reverse-engineered than it does already in its own right (see Myths and Misconceptions). A letter to The Lancet from the Swiss Association of Homeopathic Physicians raising objections to the study was not even granted publication.

None of this – aside from the initial frenzy surrounding the announcement of the conclusions of the meta-analysis on homeopathy – appears to have raised so much as a whisper from the English-speaking international media. Even in Switzerland it was only reported piecemeal so the full extent of what happened was not readily apparent.

Perhaps it’s worth noting that Switzerland is ranked as 8th most competitive nation in the 2005 World Competitiveness Yearbook. (In comparison, the UK came 22nd.) And it’s also ranked 8th in terms of the major exporting countries of chemical and pharmaceutical products. Around 5% of current global pharmaceutical R&D is attributable to Swiss companies. Just one of these companies, Roche Holding AG, parent company of Roche Pharmaceuticals, the manufacturers of the anti-viral drug Tamiflu, reported 2006 net income which was greater than the entire gross domestic product – that is, the value of all final goods and services produced within a nation in a given year – of the bottom 119 nations of the World Bank’s 183-nation rankings in 2005.

Since many university medical research laboratories would cease to exist without the support of the pharmaceutical industry, it’s perhaps no surprise that “at the end of 2004, professors of the medical faculties had expressed the intention at a meeting of the Swiss Academy of Medical Sciences … to do everything in their power to prevent complementary medicine remaining in the basic insurance. A dean voiced the prevailing opinion: “We must provide hand grenades [literal quotation, personal communication of a participant of that conference] against complementary medicine.”” (Dr med Peter Heusser).

Against the backdrop of more and more high-quality studies demonstrating the clinical effectiveness of homeopathy in practice, it will be interesting to see if The Lancet can recover its scientific credibility this time around, or whether this will turn out to be yet another ill-conceived attempt at a hatchet job jumping on the Colquhoun-Goldacre bandwagon.

“The prerequisite for today’s medical policy is naturally the currently predominant system of medicine. The sick are the source of income, therefore it is necessary for sick people to be there, yes, it proves advantageous if one makes the people artificially sick.”
Dr med Steintl: ‘International Medical Policy’, 1938, Berlin