17 Matching Annotations
  1. Dec 2015
    1. Promoting health and relieving sickness using alternative or complementary methods. The Commission’s approachThe Commission’s approach in considering whether or not any particular alternative or complementary method is capable of promoting health or relieving sickness for public benefit is based on the law. The law requires a link between the benefit claimed and the purpose and that the purpose be for public benefit. The law also requires that benefit be demonstrated by evidence. The Commission has taken notice of the importance the law has given to benefit being proved in this area because of the risk of harm from treatments that have not been rigorously tested before being available for use. It also noted that the law has recognised that people who are ill may be more willing to try (and to pay for) treatments or therapies in order to be cured and that harm may occur as a result.17 The Commission also noted that if it gives recognition to a treatment this may be seen by some as a “kite mark” for that treatment although this is clearly not its function in considering whether an organisation is a charity. The Commission’s functions include promoting public trust and confidence in charity, and there is a risk that this would be compromised should the Commission accept treatments as being capable of promoting health either where this benefit is not clearly proven or where the risk of harm is great and safeguards are not in place. The Commission therefore takes the view that clear evidence to support any benefits claimed is required before it can be satisfied that benefit is demonstrated and that any potential for harm should be minimised before it can be satisfied that the benefits outweigh the real risk of harm.

      This makes a good deal of sense, except that it doesn't define what evidence is. Indeed there is no such definition anywhere in the document. Bizarrely, it cites repeatedly the House of Lords report of 2000 on complementary and alternative medicine (CAM), issued 12 years before the Soteria report. Far more authoritative and timely assessments of CAM were available in 2012. The opening paragraph fails to identify which law governs the process. One might assume it is the Charities Act 2011, but I can't find where in that is this requirement for evidence, laudable as it is.

      This report repeats the well known fallacy that "not all forms of complementary or alternative treatment may lend themselves to conventional research methods". This is special pleading of a particularly egregious kind. The methods of science, of which the randomised controlled trial (RCT) is a foundational element, are designed to test any claim whatever its nature. There are numerous RCTs of individualised homeopathy for example, which use blinded third party assessors.

    1. F7  Is homeopathy still accepted as being able to deliver benefits related to an aim of promotion of health or the relief of sickness? Yes. The efficacy of homeopathy was called into question in 2010 when Parliamentary and media coverage suggested that the claimed health benefits are unfounded and that there is no evidence that its benefits exceed a placebo effect. However, there has been no subsequent Parliamentary or legislative determination which has changed recognition of its efficacy. Our current position is to regard homeopathy as a method for which we need little or no further supporting evidence of efficacy so long as the trustees' claims for it are in line with its recognised benefits. See Group 1 of the ready reference table which sets out the information we need from organisations using homeopathy to deliver their purposes.

      It is strange that this appears as a final section, singling out homeopathy. It looks like an afterthought. The wording is astoundingly slippery. No therapy would be subject to any "Parliamentary or legislative determination" regarding its efficacy. Determining the efficacy of medicines is not the province of the legislature but of science. This statement turns on its head all of OG304's definitions of what evidence is. It is transparently dishonest.

    2. B9    CAM ready reference table The following table is based on the findings of the House of Lords Select Committee on Science and Technology 1999-2000 and covers most recognised forms of CAM which proposed charities use. It is intended to help caseworkers identify quickly what information they need when assessing applications from organisations using CAM to achieve their aims. It is not determinative, and we should be prepared to consider any further medical and scientific evidence which may have emerged subsequently.

      For the reasons I have given above, basing the ready reference table on the House of Lords report 2000 is meaningless. It is only an ad hoc classification not an assessment of evidence for efficacy. There are some obvious errors here.

      Group 1: Why has the Commission not changed the position of homeopathy, when the Commons report 2010 is cited? The licensing regime for homeopathy is not mentioned (the NR and HR licences), yet the regime for herbal medicine is mentioned.

      Group 2: Bach and other flowers remedies are foods and now not allowed to make health claims. Maharashi Ayurvedic Medicine is not a CNHC ‘discipline’. Also, it may use medicinal products that are not MHRA registered.

      "May not be used to diagnose conditions". If they don’t ‘diagnose’ (conditions or otherwise), how do they decide whether a treatment is necessary, which treatment and what dose?

      "Naturopathy* NOTE: naturopathy practitioners can now register with CHNC. However, there are issues in relation to naturopathy because treatment entails using an individually tailored package of therapies, not all of which may be capable of demonstrating efficacy". So which have demonstrated efficacy?

    3. The practitioners they use to administer treatments are (where one exists) members of the professional standard-setting regulatory body applicable to the CAM method being used, and are bound by its codes of ethics, conduct and practice

      The Commission seems to think there is only one regulatory body for homeopaths. There are several, with varying ideas about homeopathy.

    4. Caseworkers should take advice from a mentor or legal officer if they are unsure whether the evidence provided demonstrates that the risk of harm does not outweigh the benefit.

      The Commission has repeatedly told me that it is not a body of medical or health experts. So why in this OG are caseworkers referred to internal advice and not to an external medical or scientific expert?

    5. Practitioners have compulsory insurance to protect those receiving the treatment

      Does the Commission imply that insurance is mandatory for all CAM charities?

    6. B7.1     Assessing the risk of harm When considering harm factors in relation to CAM, what we are looking for is evidence that any potential for harm is minimised or reduced so that the harm does not outweigh the benefit. The greater the risk, the more compelling the evidence will need to be that those risks will not outweigh the benefits.   The risk of harm will be greater where: methods claim to cure, or diagnose conditions treatment is offered as an alternative to conventional medicine the way the treatment is administered means those receiving it could be vulnerable to harm or abuse there is little or no formal regulation and/or supervision of practitioners carrying out the method to ensure it is delivered safely  

      All CAM practitioners do claim to cure or diagnose conditions. Otherwise they would not be employed. Society of Homeopaths members commonly do so. It is surprising that this section doesn't mention safety monitoring. I am not aware of any CAM professional body which does this effectively. They all assume that CAM is harmless.

    7. B7        The risk of harm and how this impacts on public benefit When considering whether the purpose of an organisation which uses CAM to achieve its purposes is for the public benefit our approach is based on the law.  The law recognises that treatments which have not been rigorously tested before being made available for use carry an increased risk of harm to those receiving them; and that people who are ill may be willing to try (and pay for) treatments in the hope of a cure and may experience harm as a result   Public benefit will be affected if the potential for people to experience harm from a CAM method outweighs the benefits that can be gained. To satisfy the public benefit requirement, therefore, an organisation using CAM to achieve its purposes must be able to show that any risk of harm has been minimised or reduced so that the harm does not outweigh the benefits.   The main risks associated with CAM are: poorly administered, a CAM method could cause physical or psychological harm CAM has the potential to exploit people who, because of their condition, are especially vulnerable    using CAM as an alternative to conventional medicine may mean that people who need a medical diagnosis and treatment do not get it  

      As virtually all CAM has no evidence of efficacy, the risk of harm, however low, must always outweigh it.

    8. B6.3     Methods whose benefits have been previously accepted on evidence We will not require detailed scientific evidence of efficacy where the method is one which we have previously accepted on the basis of evidence and law in respect of the particular benefits claimed. An example of this is the Decision of the Commission 15 August 2002 in respect of the application to register NFSH Charitable Trust Limited (1094702), where we recognised that spiritual healing is capable of giving palliative relief in a complementary setting.   In these cases the trustees will need to show how the method is regulated, and that practitioners are registered with, and meet all the requirements of, the regulatory body.  For information about regulation of CAM, see B8.

      Does this mean that, where the Commission has been shown to be in error by accepting unsound evidence, it will not change its mind even when new evidence is presented?

    9. B6.2     Beneficial methods not regulated by statute Organisations using methods not currently subject to statutory regulation, but which have gained wide recognition through clinical trials and scientific medical research as being capable of delivering health benefits  and are subject to voluntary self-regulation by a recognised body need not provide detailed scientific evidence of the CAM’s effectiveness.  Where a method is subject to voluntary self-regulation, we can accept this on the same basis as one that is regulated in law.

      Of course not, but that excludes virtually all of CAM. It definitely excludes homeopathy.

    10. B6.1     Beneficial methods regulated by statute The law has already accepted the efficacy of some treatments and, where this is the case, we will not require further evidence.   Methods regulated by statute include: osteopathy, regulated by the General Osteopathic Council  chiropractic, regulated by the General Chiropractic Council  For these CAM methods, we need to know that practitioners used to deliver treatments are registered with the statutory regulatory body and meet all the requirements of that body. See Group 1 of the ready reference table in B9 for more information about what the trustees need to confirm.

      Factually incorrect. The Chiropractors Act 1993 and The Osteopaths Act 1994 say absolutely nothing about efficacy. They are only concerned with protecting the title and the public.

    11. the website of The Complementary and Natural Healthcare Council, which provides information about the methods it regulates and the medical conditions they are recognised as addressing

      This is seriously misleading. The CNHC does not require any of its registrants to demonstrate evidence to support any of the therapies they provide. What does "recognised as addressing" mean? Recognised by whom? The CNHC is the last place to look for evidence.

    12. B5.1     Suitable forms of evidence All claims made for the efficacy of a method must be substantiated with evidence. We recognise that not all forms of alternative or complementary treatment may lend themselves to conventional research methods. However, the evidence must be evidence that a court can recognise.    Examples of suitable evidence include; peer-reviewed research (ie research scrutinised by fellow professionals) in recognised medical journals, for example The Lancet or BMJ   recognition by the Department of Health or other governmental health regulatory or health provision body.    Examples of evidence which is not sufficient to demonstrate efficacy include: testimonial or anecdotal evidence (see B5.5) articles or features of a non-scientific nature promoting the method, treatment or therapy   Deciding whether evidence is sufficient in relation to the claims made is not always straightforward. Factors that can help include:   the source of the evidence – is it sufficiently independent and authoritative? is the evidence accepted in academic or scientific circles?  If not, can any differences of expert opinion be rationally explained? does the evidence fully address the claims made for the method? is the method recognised and/or supported by the Department of Health or other governmental health provision body? what is the method’s relationship with conventional medicine?   We must be satisfied that, taken overall, the evidence is of the quality that would be accepted by a court or Tribunal as demonstrating benefit. For more guidance about how we evaluate evidence, see our decision in relation to the Soteria Network, which shows how our approach is applied in practice.

      Section 5.1 starts well, but immediately falls victim to the special pleading fallacy identified above. The definitions of acceptable and unacceptable evidence are generally clear, but lack detail. What is meant by `research'? It should not include single case reports, a mainstay of the CAM lobby. "Recognition by the Department of Health or other governmental health regulatory or health provision body" is too vague. If this includes CAM regulators, then it is not at all acceptable for the reasons given above. However note that the NHS as a body does not approve homeopathy, as you will see at NHS Choices. There remain two NHS homeopathy hospitals (from five a few years ago) and the practice is in terminal decline.

    13. When considering the potential for harm, this will be reduced where: the treatment or therapy is non-invasive people will not be at risk of abuse or exploitation (eg the treatment is not hands-on or does not require the removal of clothing) the treatment or therapy is subject to regulation, whether statutory or by voluntary agreement, meaning: practitioners must be professionally qualified and eligible to practice there is a supervisory and complaints regime compulsory insurance is required to protect those receiving the treatment  

      No CAM regulatory body currently requires that its registrants' claims are evidence based. The OG here does not define what `professionally qualified' means. For example, a homeopath might well be qualified by membership of the Faculty of Homeopathy, or even by gaining a BSc in homeopathy, but all either of those does is to demonstrate that the person is knowledgeable about nonsense. How a qualification in nonsense protects the user is impossible to understand. Similarly there is no defined standard in the OG for a complaints regime. The General Chiropractic Council famously received about 500 complaints about misleading claims by its registrants, and threw most of them out.

    14. what the benefits are - is it capable of fulfilling the health benefits claimed for it? The greater the claims made for the treatment or therapy being offered, the more convincing the evidence will need to be. See section B5 for more information about the evidence we need to consider an application any potential harm from use of the treatment or therapy and being satisfied that the harm does not outweigh the benefits. See Sections B5-B7 for more information on how we assess this.

      When advertisers are prosecuted for making misleading claims for health, the standard applied by the courts is that of the RCT. This is also of course applied by the Advertising Standards Authority (ASA). So the OG has clearly set out what the evidence should be. I do not think there is any room for inferring a lesser standard here.

  2. Jul 2015
    1. Homeopathy, on the other hand, uses highly diluted and succussed doses of natural substances - usually plants and minerals.  It is this dilution that makes homeopathy safer than allopathy and herbalism, and the succussion that allows remedies to retain their effectiveness, despite their high dilution.  This ‘minimum dose’ concept is one of the key principles of homeopathy, also developed in the late 1800's.

      Surprisingly this author does not even seem to know the real history of homeopathy. It was invented in the late 18th century not the `late 1800's' (sic - incorrect use of apostrophe).

    2. Allopathy (pharmaceutical medicine) uses extracts of active ingredients, often sourced from the same plants used by herbalists and homeopaths, that are then reproduced synthetically and highly concentrated in laboratories for use as drugs.  This process is then patented, and was developed in the late 1800's. 

      This paragraph displays amazing ignorance of drug development. Firstly,`allopathy' is a pejorative term invented by homeopaths. It has no meaning in science or medicine.

      Whereas modern pharmacy grew out of certain historical practices such as herbal medicine, most modern drugs are designed from a detailed knowledge of biochemical mechanisms. They are not extracts, are not necessarily highly concentrated, and are formulated as a result of rigorous dose-ranging studies in human subjects. It is untrue to claim that the drug development process used today is similar to that used in the late 1800s.