Conclusions and recommendations
The policy on NHS funding and provision of homeopathy
1. We
recommend that the Government determine the total amount of money
spent by the NHS on homeopathy annually over the past 10 years,
differentiating homeopathic products, patient referrals and maintenance
and refurbishment of homeopathic hospitals, and publish the figures.
(Paragraph 15)
Our expectations of the evidence base
2. We
consider that conclusions about the evidence on the efficacy of
homeopathy should be derived from well designed and rigorous randomised
controlled trials (RCTs). (Paragraph 20)
3. We expect the conclusions
on the evidence for the efficacy of homeopathy to give particular
weight to properly conducted meta-analyses and systematic reviews
of RCTs. (Paragraph 25)
4. We have set out
the issue of efficacy and effectiveness at some length to illustrate
that a non-efficacious medicine might, in some situations, be
effective (patients feel better) because of the placebo effect.
That is why we put more weight on evidence of efficacy than of
effectiveness. (Paragraph 39)
5. We would expect
the Government to have a proper understanding of the power and
complexities of the placebo effect and the ethical issues surrounding
its use in a clinical setting; otherwise it cannot hope to make
good decisions relating to patients and public health. (Paragraph
40)
6. Our expectations
of the evidence base relevant to government policies on the provision
of homeopathy are straightforward. We would expect the Government
to have a view on the efficacy of homeopathy so as to inform its
policy on the NHS funding and provision of homeopathy. Such a
view should be based on the best available evidence, that is,
rigorous randomised controlled trials and meta-analyses and systematic
reviews of RCTs. If the effects of homeopathy can be primarily
attributed to the placebo effect, we would expect the Government
to have a view on the ethics of prescribing placebos. (Paragraph
47)
The evidence check: NHS funding and provision
7. We
conclude that the principle of like-cures-like is theoretically
weak. It fails to provide a credible physiological mode of action
for homeopathic products. We note that this is the settled view
of medical science. (Paragraph 54)
8. We consider the
notion that ultra-dilutions can maintain an imprint of substances
previously dissolved in them to be scientifically implausible.
(Paragraph 61)
9. Research funding
is limited and highly competitive. The Government should continue
its policy of funding the highest quality applications for important
scientific research determined on the basis of peer review. (Paragraph
63)
10. We recommend that
the Government Chief Scientific Adviser and Professor Harper,
Chief Scientist at the DH, get together to see if they can reach
an agreed position on the question of whether there is any merit
in research funding being directed towards the claimed modes of
action of homeopathy. (Paragraph 64)
11. In our view, the
systematic reviews and meta-analyses conclusively demonstrate
that homeopathic products perform no better than placebos. (Paragraph
70)
12. We recommend that
the Government Chief Scientific Adviser and Professor Harper get
together to see if they can reach an agreed position on the question
of whether there is any good evidence for the efficacy of homeopathy
and whether there is a genuine scientific controversy over the
efficacy of homeopathy and publish this. (Paragraph 72)
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 placebothat is, homeopathymay
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 hospitalshospitals that specialise in the
administration of placebosshould 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)
The role of pharmacies
30. We
consider that the way to deal with the sale of homeopathic products
is to remove any medical claim and any implied endorsement of
efficacy by the MHRAother than where its evidential standards
used to assess conventional medicines have been metand
for the labelling to make it explicit that there is no scientific
evidence that homeopathic products work beyond the placebo effect.
(Paragraph 146)
31. Although it goes
wider than the scope of this Evidence Check inquiry we must put
on record our concern about the length of time the RPSGB appears
to be taking to investigate and reach conclusions on cases where
it has been alleged that its guidelines on the sale of homeopathic
products have been breached. We recommend that the Government
enquires into whether the RPSGB, and from the 2010 handover, the
General Pharmaceutical Council, is doing an adequate job in respect
of the time taken to pursue complaints. (Paragraph 151)
Conclusions on the licensing regimes
32. It
is unacceptable for the MHRA to license placebo productsin
this case sugar pillsconferring 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)
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