Positive Health Online

Replies to Sunday Times Letter 05-06-16 Regarding CAM and Charitable Status 

The Sunday Times Newspaper of 5 June 2016 included a letter entitled Tackle Health Charities by Colquhoun, Ernst and a number of other medical professionals calling for the charitable status of CAM charities to be revoked on the basis that they do not operate to “benefit the public”.

Below are replies received by Positive Health PH Online by readers regarding the above Sunday Times:

“...Dear Editor,

“It is very disappointing to read the letter from eleven medical professionals in the Sunday Times on 5th June calling upon the Charity Commission to revoke charitable status of some CAM related charities citing that they, “… encourage vulnerable people to take treatments that are not efficacious and can cause harm if used in the place of effective remedies …”.

“Professors Ernst and Colquhoun are known for their attacks on the CAM community possibly because CAM comes from a more holistic rather than reductionist perspective of medicine where drugs are tested in clinical trials looking for individual bio-markers. Ernst is known to argue for the rigorous testing of CAM interventions because he knows that these trials are entirely inappropriate for reasons I won’t go into now. However, I would like to refer Professors Ernst and Colquhoun to the science of epidemiology (the medical science that looks at the statistics of morbidity (disease and illness) and mortality (reasons for death).  Gordis says, “Diseases do not arise in a vacuum, they result from an interaction of human beings with their environment,” (2009).  Perhaps this statement in itself gives reason to pause for thought for the Professors?

“However, may I just reflect upon the practices of conventional medicine and the veracity of clinical trials in cancer because this has been closely examined by Peter Gøtzsche (2013), who claims that cancer drugs are a “disaster area” (p269). Gøtzsche’s investigations showed that in clinical trials

• “In Europe there were small patient number (on average 238), the outcomes were very prone to biased assessment that often showed only complete or partial responses; and, that of those studies that reported on survival they found only an average difference of 1 month;
• “In the USA Gøtzsche reports that the FDA approves 68 percent of cancer drugs based on outcomes that did not include survival and that 35 percent of cancer drugs are approved without a clinical trial;

“Gøtzsche continues that, according to his calculations, after 33 years of randomized trials on solid tumours (and this is research sponsored by the UK’s Medical Research Council), there has been no progress against cancer, on average. Gøtzsche clarifies that in both the US and Europe drugs are actually the third leading cause of death.

“The rise in the popularity and interest in CAM is a consumer, or if you like, a patient-driven movement that is based on people’s realizations that medicine is very commercialized and is now largely led by ‘Big Pharma’ and its profits. The risk of death from pharmaceutical drugs in the UK is 62,000 times that of taking food supplements. With regard to efficacy, I believe that people would not be seeking CAM out and it would not be as successful as it is if people did not receive health-related benefits.  Don’t people vote with their feet?”

References

Gordis, L. Epidemiology, 4^th Edition. Philadelphia, PA: Saunders Elsevier. 2009.

Ernst E. Disentangling integrative medicine.  Mayo Clinic Proceedings, 79, 565– 566. 2004.

Gøtzsche P. Deadly Medicines & Organised Crime: How big pharma has corrupted healthcare.  London, UK: Radcliffe Publishing and from variety of UK Government and NGO databases, reports, officials and expert advisors from a report commissioned by: Alliance for Natural Health, July 2012 (risk of death from pharma drugs in UK). 2013.

Name and Address Supplied

...Dear Sir or Madam,

“To say that complementary health charities “do not operate to benefit the public and should have their charitable status revoked” (Tackle health charities, Letters 5th May) is to deny the facts. In an international Review published in 2008 by The Kings Fund, it was reported that, in 2007, about 10% of the UK population chose to receive "Traditional/ Complementary Medicine”. This percentage in likely to have increased in 2016. Patients receiving Complementary & Alternative Medicine (CAM) do so from a practitioner of their choice and at no cost to the taxpayer, which results in substantial financial and resource savings to the NHS and to the public Health and Social Care sectors. 

“In this, both CAM practitioners and their patients are supported and informed, again at no cost other than through donation, by natural health charities. Generally, these charities exist to campaign, develop and provide access to information and good quality research for the benefit of practitioners, their patients and members of the public who are interested in supporting diversity in medical approaches. This accords with the relevant charities legislation which defines “public benefit” as including “the advancement of health (including the relief of sickness, disease or human suffering)", “the advancement of education” and “the relief of those in need by reason of youth, age, ill-health, disability, financial hardship or other disadvantage” (Charities Act 2006, Section 2).

“If, as I suspect, the purpose of the letter is also to aim a broad, sweeping criticism at CAM generally, then I suggest that its signatories research the proven benefit to the public of Integrated Healthcare or Medicine, which can combine the best of conventional and CAM to provide a comprehensive treatment plan that is in the best interests of a patient. This is especially the case in the treatment of cancer, which is why information about CAM is available from the charities Macmillan Cancer Support and Cancer Research UK and why it is also provided, often on a voluntary basis, in the oncology departments of many leading NHS hospitals, including The Royal Marsden NHS Foundation Trust in London.

“As regards the evidence-base for CAM, the signatories and your readers could start by researching the websites of the Research Council for Complementary Medicine (a charity), NHS Choices (which links to numerous research databases and journals) and the research pages of Positive Health Online. They could also review The World Health Organisation Traditional Medicine Strategy 2014 - 2023  and the informative website of The Alliance for Natural Health.

Yours faithfully,

Richard Eaton LLB  mail@richardeaton.co.uk

References

The Charities Act 2006, Section 2: www.legislation.gov.uk/ukpga/2006/50/section/2

Cancer Research UK: www.cancerresearchuk.org/about-cancer/cancers-in-general/treatment/complementary-alternative/

Macmillan Cancer Support: https://be.macmillan.org.uk/be/p-265-cancer-and-complementary-therapies.aspx

Research Council for Complementary Medicine: http://www.rccm.org.uk/

NHS Choices: http://www.nhs.uk/Livewell/complementary-alternative-medicine/Pages/complementary-alternative-medicines.aspx

The Alliance for Natural Health: http://anhinternational.org/about-us_2/

World Health Organisation Traditional Medicine Strategy 2014 - 2023: http://apps.who.int/iris/bitstream/10665/92455/1/9789241506090_eng.pdf?ua=1

The Royal Marsden NHS Foundation Trust: https://www.royalmarsden.nhs.uk/your-care/supportive-therapies

Positive Health Online: http://www.positivehealth.com/researches

The Kings Fund: https://www.kingsfund.org.uk/sites/files/kf/Research%20summary1.pdf

Twenty Years of Progress: Nutrition Emerging as a ‘Hard Science’ In Human Health

by Anne Glausser

A much better understanding of the role of diet and supplements in maintaining optimum health well into old age has emerged over the past 20 years, according to one expert, and today is helping to address chronic diseases that kill most people in the developed world - heart disease, stroke, diabetes and cancer.

As he retires this month after leading the Linus Pauling Institute at Oregon State University since 1997, Balz Frei, director and distinguished professor of biochemistry and biophysics in the College of Science, has outlined some of the key advances of that period, and the steps still needed for nutrition researchers to work more closely and successfully with the medical community.

In the recent past, Frei said, nutritional research was rife with inconclusive studies that showed  associations but no firm cause-effect relationships of disease prevention. Long-term trials with humans to study disease prevention are difficult and often cost prohibitive, and laboratory animal tests that showed effects - such as the effect of a certain food on cancer incidence - often lacked an explanation of “why.”

In the past two decades, a period of extraordinary growth for the Linus Pauling Institute, researchers have worked to answer that question of ‘why’ with considerable success.

“What I wanted to achieve with the institute was to put science behind nutrition,” Frei said. “We’re helping to lead the field of nutrition into more science and mechanism-based research that can have a real impact on promoting human health and preventing disease.”

In this research, an underlying cause of ageing and chronic disease has now emerged - chronic inflammation. Inflammation and its accompanying surge of ‘free radicals’ are tied to several major killers, including cardiovascular disease and certain cancers.  Scientists are honing in on the mechanisms of inflammation and the antioxidants that can prevent free radical damage. Important discoveries have been made with vitamin E, in particular, in understanding why this nutrient is required by the body and the role it plays in protecting critical fats, especially during brain development and in the ageing brain. Research on vitamin C showed that it helps arteries relax and lowers high blood pressure, a chief cause of stroke.

The institute has also helped change the world view of vitamins and other nutrients. Instead of seeing them simply as a way to correct or prevent a deficiency condition like scurvy, they are increasingly recognized as a way to help prevent chronic disease, counter toxins and contribute to healthier ageing.

One molecule in particular, lipoic acid, has shown promise in its ability to “bring cells back to a youthful state,” Frei said. This compound triggers a reaction in cells that makes them more capable of fending off free radicals and other toxic insults that cause inflammation and disease.

Other findings of importance during Frei’s tenure at the institute include:

• The discovery and mechanisms of action of several phytochemicals that may help prevent cancer, metabolic syndrome, and cardiovascular disease;
• Compounds of particular interest range from catechins in tea to quercetin in onions, sulforaphane in broccoli and xanthohumol in hops;
• Chlorophyll, a phytochemical that gives plants their green colour, can bind to a toxic mould compound called aflatoxin that causes liver cancer, and render it inactive;
• Omega-3 fatty acids found in fish or fish oil have been shown to have important health effects, including their role in halting progression of fatty liver disease;
• The role of vitamin D in boosting the body’s immune system is being viewed with significant future importance, with the advent of multi-drug resistant bacteria, including one recently confirmed strain that resists medicine’s last-ditch antibiotic.

“Vitamin D plays a crucial role in many functions of the body, not just bone health, and it’s now a public health challenge to raise the levels of it in the population worldwide, so that everyone has the best shot at fighting infections,” Frei said. “LPI works beyond the ivory tower to help people make the right decisions regarding the use of diet and dietary supplements.”

An important future goal, Frei said, would be a full outreach to the medical community.

“Communication between the nutrition science and medical communities is not happening at the scale it needs to right now,” he said. “We need a bridge, and Linus Pauling Institute (LPI), its Micronutrient Information Center and other public outreach services are well-suited to be that bridge. If we could bring about a change in how medical doctors are educated, I think that would be a major contribution to public health.”

There’s an urgency to change perceptions on diet and supplements among the medical community as well as the general public, Frei said, as rates of chronic, preventable diseases continue to increase.

“There’s so much misleading information out there, so many false promises when it comes to dietary supplements,” Frei said. “We’re trying to counter these claims with evidence-based health information about vitamins, minerals, and phytochemicals. It has been, and to some extent continues to be an uphill battle for nutrition science to establish itself as a ‘hard’ science. But there’s also a realization now of how critical the field is to human health.”

During Frei’s tenure as director, LPI has grown from one principal investigator to 12, focused on the study of healthy ageing, cardio-metabolic disease prevention, and cancer prevention and intervention. More than 650 published research papers and review articles have been cited by peers over 26,000 times, and more than $55 million in funding came from the National Institutes of Health and other agencies. The Institute’s endowment has quadrupled since its inception at OSU, and during the university’s recent capital campaign LPI raised $48 million, $15 million of which went toward the construction of the Linus Pauling Science Center, a state-of-the-art research and education facility.

Further Information

Anne Glausser: 541-737-5881; anne.glausser@oregonstate.edu

Balz Frei may be contacted on Tel: +1 541-737-5078; balz.frei@oregonstate.edu

This story is available online: http://bit.ly/1Zym4iu

Regulation and Accountability of the Advertising Standards Authority Ltd - Discussion Document Concerning Complementary and Alternative Medicine

by Richard Eaton  LL.B (Hons)

This document is intended to stimulate discussion by practitioners of Complementary and Alternative medicine (CAM) and by their professional and regulatory organisations regarding the activities of the Advertising Standards Authority Ltd (ASA)[1] and the extent to which these challenge:

1. The freedom of practitioners to practise and regulate CAM;
2. The freedom of their patients to choose a CAM practitioner and to receive CAM;
3. The status of CAM within the Health and Social care sectors.

In particular, it aims to promote discussion about:

(a) Implementing a process through which practitioners who are, or have been, in dispute with the ASA can be identified;

(b) Discovering whether or not such practitioners desire assistance from their professional organisations and, if so, in what way;

(c) Exploring the possibility of practitioners and CAM organisations (both professional and regulatory) combining to form a ‘CAM Pressure Group’ with the objective of bringing pressure to bear on the ASA, the statutory and other regulators with which the ASA works (see below), The Department for Business, Innovation and Skills and other relevant Government departments to reform and enhance the regulation and accountability of the ASA.

Pressure Groups have a proven role to play to bring about changes in the law within a democratic society, particularly in the health sector:

“…Pressure groups may be better able to focus on specialized issues, whereas political parties tend to address a wide range of issues…”

(http://www.encyclopedia.com/topic/pressure_group.aspx). 

Generally, this document is a call to all practitioners and CAM organisations to unite and state the case for CAM with regard to the challenges presented by the ASA.

The ASA and CAM: Brief Summary

The relationship between the CAM professions and the ASA has reached what has been described by the Alliance for Natural Health as “an all-time low”, particularly since the extension of the ASA’s remit to make ‘rulings’ (‘adjudications’) upon online marketing and media material;[2]

CAM Practitioners and institutions are making their views known. Campaigns are already in progress, including those by Freedom4health[3] and by the holistic hormone health specialist Dr Alyssa Burns-Hill.[4] Updates are available on the Alliance for Natural Health website.[5]

The basis of the dispute is the allegation that the ASA adjudication process is flawed and unfair in that it fails to properly take account of representations made and evidence provided by CAM Practitioners or to fully comply with Human Rights and the principles of Natural Justice.

In an article published in the January 2014 edition of CAM Magazine,[6] Dr Alyssa Burns-Hill is quoted as saying that the ASA is “overstepping the mark in terms of their remit” and that it has an “inability to stand back and look at their own procedures and how out of control they are”.

“Freedom4health” is also quoted, as follows:

“The UK Advertising Standards Authority has shown bias and disregard for evidence when investigating the advertising of complementary, holistic and integrative medicine. It acts as prosecutor, judge and jury in one….and publishes highly questionable ‘adjudications’…”

H:MC21 (“Homeopathy: Medicine for the 21^st Century”)[7] is a charity established, amongst other things, to inform the public of the facts about homeopathy and its historical and scientific relationship to orthodox medicine. It aims to do this through research, publication and campaigning. The ASA has adjudicated on complaints about H:MC21.[8] In response to an ASA adjudication, H:MC21 posted the following statement on its website:

“The process of fighting this complaint has given H:MC21 the impression that the ASA does not consider it sufficient for Homeopaths to state facts and supply evidence to support those facts. It would appear that if those facts support homeopathy, the ASA considers them to be unacceptable in an advertisement. We consider that an independent investigation into the ASA’s handling of this case and of other cases against homeopaths is urgently required”.

An extract taken from a press release issued by H:MC21 and posted on its website, reads as follows:

“The adjudication is not about consumers; it is about suppressing the charity’s ability to inform the public of the demonstrated facts that set out a clear argument for homeopathy as a legitimate, cost effective and safe alternative to conventional medicine.”

The jurisdiction and power of the ASA should not be underestimated. On its website,[1] the ASA has stated as follows:

“As the UK’s independent regulator for advertising across all media, our work includes acting on complaints and proactively checking the media to take action against misleading, harmful or offensive advertisements, sales promotions and direct marketing….if we judge an ad (sic) to be in breach of the UK Advertising Codes, it must be withdrawn or amended and the advertiser must not use the approach again.”

Elsewhere on its website it states:

“The professional and brand damage from getting your advertisement banned by the Advertising Standards Authority can be devastating”

and:

“We have a range of effective sanctions at our disposal to act against the few who do not and ensure they comply with the rules.”

The High Court of South Africa (Johannesburg) has not been reluctant to intervene with regard to the SA Advertising Standards Authority. In the case of Herbex (Pty) Ltd v The Advertising Standards Authority [2016] (14/45714) (25th April 2016) (ZAGPJHC) the court made declaratory orders relating to the status and powers of the SA ASA to determine complaints and issue rulings and also held that the Applicant’s constitutional rights of association and freedom of expression had been infringed. The court declared that all rulings issued by the SA ASA against the applicant were void. Arguably, elements of this judgment might be admissible as a persuasive (but not binding) precedent in court proceedings in this country.

The ASA: Working with Others

The ASA, which is a private limited liability Company and not a Government department, defines its “five strands of our strategy”  (https://www.asa.org.uk/About-ASA/Strategy.aspx) and states that its “shared values are to be”:

“Consistent and proportionate, reliable and ethical, fair and respectful to all, accessible and helpful, intelligent and thorough but also timely and proportionate, open and accountable and acting with integrity and never being afraid to admit when we’re wrong, an excellent team, inspiring excellence in each matter.”

On its website (https://www.asa.org.uk/About-ASA/Working-with-others.aspx), the ASA states as follows (note: italics and some web-links have been added):

“…The ASA regulates advertising across all sectors, so it is unsurprising that we work with independent experts and many other regulators who have responsibility for looking after particular sectors more broadly.

“Other Regulators 

“The ASA has two major formal relationships with statutory regulators: Ofcom, our co-regulatory partner for broadcast advertising and Trading Standards.

We liaise with other regulators, as appropriate, to ensure that regulation is joined-up and consistent. If you think that the ASA has acted in a way that is inconsistent with other regulators, please get in touch: https://www.asa.org.uk/Industry-advertisers/Good-regulation.aspx

“Other regulators we work with include:

Ofcom
Gambling Commission 
Financial Conduct Authority 
Food Standards Agency 
Medicines and Healthcare Products Regulatory Agency
Phonepay Plus
The Portman Group
Trading Standards
Competition and Markets Authority 

You can read copies of our agreements with various organisations: https://www.asa.org.uk/General/Transparency/ASA_1_0.aspx#4

“Our experts 

“From time to time we also make use of independent experts to help us interpret evidence that may have been provided to us. Sometimes the evidence can be highly technical, for example medical trials or technological tests, so we work with experts to help us interpret the evidence accurately.

Read more about our use of experts: https://www.asa.org.uk/Industry-advertisers/Our-experts.aspx …”

So it is clear that the ASA operates a regulatory function within a broad network.

Parliamentary Debates[9]

The House of Lords

Compare the above with the speeches made in the House of Lords debates held on 29^th June 2015 and 29^th October 2015, in which the Government was asked what plans it had to review the governance of the ASA. In particular, refer to the speech of Baroness Deech, who has extensive experience of regulatory matters not least as the former Chair of the Bar Standards Board (https://www.barstandardsboard.org.uk/), made on the 29.10.15 (please note: italics have been added):

“…The ASA suffers from all those defects: the control of the funders over appointment and setting standards. The ASA is not a government agency, not elected, and not overseen. It is funded by the advertising industry through the levy collected by the Advertising Standards Board of Finance (ASBOF). The chair of the ASA is appointed by ASBOF. The council members appear to be appointed by the chair alone, and the fact that the majority are not connected with the advertising industry does not make the ASA independent in the regulatory sense. The codes of practice are written by an industry committee, the Committee of Advertising Practice-CAP-which shares an executive with the ASA.

“Therefore the code-writing, administration, appointments and funding are entirely in the hands of the advertising industry. There is no external input at all, save for the very tiny consumer input, the Advertising Advisory Committee, which gives advice only to the Broadcasting Committee of Advertising Practice, and can be ignored after the advice is received. The chair and council members of the ASA double up as the company directors of the ASA with ‘oversight’. The ASA is not subject to freedom of information requests. Three industry panels advise the CAP and the ASA. It is not accountable to anyone outside the industry - indeed, it is hermetically sealed.

“Successful judicial review is very difficult, as it is directed only to the lawfulness of the ultimate review by the independent reviewer - one person - and in general cannot look at the reasonableness of the ASA decision itself… If the ASA observed the rules of natural justice and gave adequate reasons, and treated both sides equally, there might be trust, but more often than not the reasoning of the rulings are guesswork and subjective. As I will show, there is a lack of consistency in judgments. Some take an impressionistic line; others are more objective with scientific input, but only a handful of experts are listed on the ASA’s website and there are no guidelines on whether an expert is going to be called in on the scientific or political matter under review…

“The time has come, after 50 years of lagging behind best practice in regulation, to bring the ASA into the 21st century…’

The House Of Commons

Review, also, the Adjournment Debate in the House of Commons tabled by John Glen MP on 23^rd May 2016 (Hansard, Volume 611),[10] during which the Minister for Culture and the Digital Economy (Mr Edward Vaizey) stated as follows:

“…I hope that the ASA will…take on practical suggestions as to how it can improve its process…”;

“…I hope that it will sit down…to talk through how it can increase transparency in order to embed greater trust…”;

“…my strong advice to the ASA is that…it should listen well…”;

“…as you can imagine, Mr Speaker, we therefore take the concerns raised by hon. Members in tonight’s debate very seriously indeed…”;

“…I hope that the ASA will take their points on board…and reflect on whether it can take forward some of the judiciously put critiques of how it has worked…”

These quotes are Ministerial challenges to the ASA.

CAM Practitioners and Organizations Working Together: The Need For A Strategy?

The contradictions described above suggest that CAM practitioners and organizations are vulnerable and that they need to adopt a strategy to respond to investigations and adjudications by the ASA.

The following action is proposed for discussion:

1. Practitioners should immediately liaise with their professional and regulatory organizations regarding the above;
2. Such organizations should identify and analyse which of their members are (or have been) in dispute with the ASA and why;
3. Initially, all CAM organizations should set up a combined working party (to which each organisation should appoint a leading member of its Board) to explore how they can unite to form a CAM Pressure Group (CPG);
4. When established, the CPG should define a strategy for challenging the ASA;
5. Practitioners should pro-actively support the CPG, if necessary by contributing to its cost possibly as a part of their annual subscription payments;
6. CAM patients should be made aware of the CPG so that they, too, can provide their support in order to preserve their continuing freedom to choose and to receive CAM treatments from a practitioner of their choice and, further, to enhance the status of CAM within the public and private Health and Social Care sectors;
7. The CPG should, with appropriate consent(s), liaise and share strategic information with lawyers representing a member;
8. Generally, negotiations should be concluded with professional indemnity insurers and their brokers in preparation for any future claim arising between CAM practitioners/organizations and the ASA;
9. If represented by a CPG, CAM practitioners and organizations will be united to effectively lobby their Members of Parliament, relevant Government departments, the ASA and the statutory and other organizations with which the ASA works (listed above) to secure the proper regulation and accountability of the ASA.

Practitioners who are in dispute with the ASA need help. They should expect their professional organisations and regulators to have an effective strategy in place that they can call upon for swift advice and assistance.

Richard Eaton LL.B (Hons)
mail@richardeaton.co.uk

References

1. http://www.asa.org.uk/

2. http://anh-europe.org/search/node/Advertising+Standards+authority

(See also: CAM Magazine, July 2012 at page 36: ‘Complementary and alternative therapies are under threat – this is your call to action!’ by Tony Farley)

3. http://www.freedom4health.com and letter 2 at:

http://www.positivehealth.com/article/letters-to-the-  editor/letters-to-the-editor-issue-   226

4. http://www.asa-the-truth.org.uk

5. http://anh-europe.org

6. http://www.cam-mag.com

7. http://www.hmc21.org

8. https://www.asa.org.uk/Rulings/Adjudications/2013/7/Homeopathy-Medicine-for-the-21st-Century/SHP_ADJ_139800.aspx#.Vz7wo5MrLzU and see also: http://www.hmc21.org/#/asa-adjudication/4556112259

9. http://myparliament.info/Debates/Lords/2015-06-29/10408

http://www.theyworkforyou.com/lords/?id=2015-10-29a.1376.0 

10.  https://hansard.parliament.uk/commons/2016-05-23/debates/16052325000002/AdvertisingStandardsAuthority

General sources

www.positivehealth.com/article/complementary-medicine/is-choice-of-healthcare-a-human-right

www.positivehealth.com/article/complementary-medicine/your-cam-practice-and-the-advertising-standards-authority-ltd-time-to-take-action

www.positivehealth.com/article/complementary-medicine/practitioners-must-state-the-case-for-complementary-and-alternative-medicine