“the Government should not endorse the use of placebo treatments”

I’m still not aware of any response from the NI Health Minister to the report on Peter Hain’s alternative remedy clinical trial scam self-assessing pilot scheme administered by Get Well UK – that report sits frozen in time on the departmental website. Still no sign of embarrassment from the BBC about the propaganda they broadcast on behalf of that scheme either. But the Commons Science and Technology Committee has just published a report which “concludes that the NHS should cease funding homeopathy.” The report can also be read here. As Martin Robbins writes in The Guardian

The select committee report has brutally inflicted the 21st, 20th and 19th centuries on this 18th century magic ritual, and under inspection it has fallen apart.

And, as Edzard Ernst points out

But what about patients’ experience? What about my own experience as a patient and later as a clinician? In fact, tonnes of data shows that people get better after seeing a homeopath. This is why homeopaths are adamant that their treatments work. Can this wealth of experience be overruled by scientific evidence?

When one begins to analyse this contradiction rationally it very quickly dissolves into thin air. The empathic encounter with a homeopath, the expectation of the patient, the natural history of the disease and many other factors all provide ample explanation for the fact that patients can improve even when they receive placebos.

This leads to the vexatious question: what is wrong with giving placebos to patients as long as they help? The answer, I’m afraid, is a lot. This strategy would mean not telling the truth to patients and thus depriving them of fully informed consent. This paternalistic approach of years gone by is now considered unethical.

From the report’s Conclusions and Recommendations [some added emphasis throughout]

13. We regret that advocates of homeopathy, including in their submissions to our inquiry, choose to rely on, and promulgate, selective approaches to the treatment of the evidence base as this risks confusing or misleading the public, the media and policy-makers. (Paragraph 73)

14. There has been enough testing of homeopathy and plenty of evidence showing that it is not efficacious. Competition for research funding is fierce and we cannot see how further research on the efficacy of homeopathy is justified in the face of competing priorities. (Paragraph 77)

15. It is also unethical to enter patients into trials to answer questions that have been settled already. Given the different position on this important question between the Minister and his Chief Scientist, we recommend that the Government Chief Scientific Adviser, Professor John Beddington, investigate whether ministers are receiving effective advice and publish his own advice on this question. (Paragraph 78)

16. We do not doubt that homeopathy makes some patients feel better. However, patient satisfaction can occur through a placebo effect alone and therefore does not prove the efficacy of homeopathic interventions. (Paragraph 82)

17. We recommend that the Department of Health circulate NHS West Kent’s review of the commissioning of homeopathy to those PCTs with homeopathic hospitals within their areas. It should recommend that they also conduct reviews as a matter of urgency, to determine whether spending money on homeopathy is cost effective in the context of competing priorities. (Paragraph 86)

Should NICE evaluate homeopathy?

18. We accept that NICE has a large queue of drugs to evaluate and that it may have greater priorities than evaluating homeopathy. However, we cannot understand why the lack of an evidence base for homeopathy might prevent NICE evaluating it but not prevent the NHS spending money on it. This position is not logical. (Paragraph 90)

Homeopathy on the NHS

19. When doctors prescribe placebos, they risk damaging the trust that exists between them and their patients. (Paragraph 97)

20. For patient choice to be real choice, patients must be adequately informed to understand the implications of treatments. For homeopathy this would certainly require an explanation that homeopathy is a placebo. When this is not done, patient choice is meaningless. When it is done, the effectiveness of the placebo—that is, homeopathy—may be diminished. We argue that the provision of homeopathy on the NHS, in effect, diminishes, not increases, informed patient choice. (Paragraph 101)

21. We recommend that if personal health budgets proceed beyond the pilot stage the Government should not allow patients to buy non-evidence-based treatments such as homeopathy with public money. (Paragraph 104)

22. When the NHS funds homeopathy, it endorses it. Since the NHS Constitution explicitly gives people the right to expect that decisions on the funding of drugs and treatments are made “following a proper consideration of the evidence”, patients may reasonably form the view that homeopathy is an evidence-based treatment. (Paragraph 109)

23. The Government should stop allowing the funding of homeopathy on the NHS. (Paragraph 110)

24. We conclude that placebos should not be routinely prescribed on the NHS. The funding of homeopathic hospitals—hospitals that specialise in the administration of placebos—should not continue, and NHS doctors should not refer patients to homeopaths. (Paragraph 111)

Product Licences of Right

25. We are concerned that homeopathic products were, and continued to be, exempted from the requirement for evidence of efficacy and have been allowed to continue holding Product Licences of Right. We recommend that no PLRs for homeopathic products are renewed beyond 2013. (Paragraph 121)

The evidence check: licensing

26. We conclude that the MHRA should seek evidence of efficacy to the same standard for all the products examined for licensing which make medical claims and we recommend that the MHRA remove all references to homeopathic provings from its guidance other than to make it clear that they are not evidence of efficacy. (Paragraph 128)

27. We consider that the MHRA’s consultation, which led to the introduction of the NRS, was flawed and we remain unconvinced that the NRS was designed with a public health rationale. (Paragraph 135)

28. We fail to see why the label test design should be acceptable to the MHRA given that, first, it considers that homeopathic products have no effect beyond placebo and, second, Arnica Montana 30C contains no active ingredient and there is no scientific evidence that it has been demonstrated to be efficacious. We conclude that the user-testing of the Arnica Montana 30C label was poorly designed with parts of the test actively misleading participants. In our view the MHRA’s testing of the public’s understanding of the labelling of homeopathic products is defective. (Paragraph 140)

29. If the MHRA is to continue to regulate the labelling of homeopathic products, which we do not support, we recommend that the tests are redesigned to ensure and demonstrate through user testing that participants clearly understand that the products contain no active ingredients and are unsupported by evidence of efficacy, and the labelling should not mention symptoms, unless the same standard of evidence of efficacy used to assess conventional medicines has been met. (Paragraph 141)


Conclusions on the licensing regimes

32. It is unacceptable for the MHRA to license placebo products—in this case sugar pills—conferring upon them some of the status of medicines. Even if medical claims on labels are prohibited, the MHRA’s licensing itself lends direct credibility to a product. Licensing paves the way for retail in pharmacies and consequently the patient’s view of the credibility of homeopathy may be further enhanced. We conclude that it is time to break this chain and, as the licensing regimes operated by the MHRA fail the Evidence Check, the MHRA should withdraw its discrete licensing schemes for homeopathic products. (Paragraph 152)

Overall conclusion

33. By providing homeopathy on the NHS and allowing MHRA licensing of products which subsequently appear on pharmacy shelves, the Government runs the risk of endorsing homeopathy as an efficacious system of medicine. To maintain patient trust, choice and safety, the Government should not endorse the use of placebo treatments, including homeopathy. Homeopathy should not be funded on the NHS and the MHRA should stop licensing homeopathic products. (Paragraph 157) [added emphasis]

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