skeptics groups of victoria, la notte, sept€¦ · iridology, naturopathy, western herbalism and...

Skeptics Groups of Victoria, La Notte, Sept 1, 2013

Dr Ken Harvey

Health professions & therapeutic goods industry: Regulatory / ethical update

Dr Ken Harvey MB BS, FRCPA

http://www.medreach.com.au


Talk outline

• Medicines Australia Transparency Code revision.

• TGA Consultation Regulation Impact Statement: Regulating the advertising of therapeutic goods to the general public.

• Natural Therapy Review Advisory Committee.

• Single national Code of Conduct for unregistered health practitioners.

2

A fundamental change in the relationship between industry and medical professionals is needed.


Dr Ken Harvey

U.S. Justice Department Fines

3

Unethical conduct

• Trials manipulated; negative results suppressed.

• Journal articles “ghost‐written”.

• Off‐label promotion.

• Well paid, but undeclared, medical opinion leaders used to promote company products (educational mercenaries).

• Excessive hospitality, kickbacks, bribery.

• Consumer groups manipulated.• Spurious patents and legal challenges to

delay the entry of generics.4 4


Dr Ken Harvey

It takes two to tango

5

The need for disclosure

• A recent editorial in the British Medical Journal reported that a US Senate Finance Committee investigation has found the medical device company Medtronic was “heavily involved in drafting, editing, and shaping the content of medical journal articles authored by its physician consultants,” who were paid hundreds of millions of dollars by the company through royalties and consulting fees.

• The Committee Chairman, Senator Max Baucus, said Medtronic’s actions had “violated” patients’ trust.

• The president of the North American Spine Society, said, “If surgeons had known that the lead authors of the 13 original studies on InFuse (the Medtronic product) had received payments ranging from $1.7m to $64m from Medtronic and that its marketing employees were co‐authors and co‐editors, would they have been as eager to use this product on their patients?”

6http://www.bmj.com/content/345/bmj.e7299


Dr Ken Harvey

In the USA

• The Physician Payment Sunshine Act becomes operational this year.

• It requires pharmaceutical and device companies to report to the Centers for Medicare and Medicaid Services (CMS) all payments, or other transfers of value, made to individual doctors and teaching hospitals that total more than US$100 per year.

• Companies must begin to collect the information by August 1, 2013 and report it to the CMS by March 31, 2014.

• The information will be posted on a public website on 30 September 2014. 7

In Australia

• Many consumer and health professional groups argued for full disclosure of payments made to individual healthcare professionals in the 16th Edition (2009) Code revision and again in the 17th Edition (2012) Code revision.

• The 17th Code Edition incorporated aggregate disclosure of payments, not individual.

• MA set up a Transparency Working Group to advise how individual disclosure might be implemented.

• A report has now been produced but there was no agreement on the amount of money that would trigger individual disclosure.

• Consultation with MA members and other stakeholders will continue with (hopefully) the adoption of individual payment disclosure in new Code revision in late 2014 with possibly payments being recorded from Jan 1, 2015 and public reporting in 2016 (compared to 2014 in the U.S.).

8


Dr Ken Harvey

In Australia

• This bill proposed by Senator R Di Natale would have replaced Medicines Australia Code with legislation that set stringent restrictions on the interactions between pharmaceutical companies and physicians.

• In June 2013, the Finance and Public Administration Legislation Committee recommended that the bill not be passed. Unlike the U.S., self‐regulation was thought to be more appropriate in Australia.

9

8.11.4 Recognising that pharmaceutical and other medical marketing influences doctors, and being aware of ways in which your practice may be being influenced.

8.11.5 Recognising potential conflicts of interest in relation to medical devices and appropriately managing any conflict that arises in your practice.

8.11.6 Not asking for or accepting any inducement, gift or hospitality of more than trivial value, from companies that sell or market drugs or appliances that may affect, or be seen to affect, the way you prescribe for, treat or refer patients.

8.11.8 Not offering inducements to colleagues, or entering into arrangements that could be perceived to provide inducements.

10

A Code of Conduct for Doctors in Australia


Dr Ken Harvey

New transparency a huge burden?

• The number of individual HCP reports that companies will have to gather in order to comply with MA's new transparency regime could far exceed 500,000 a year, research by Pharma in Focus has shown.

• The figure comes from a recently finalised analysis of Medicines Australia's complete data set of events staged between October 2012 and March 2013.

• The analysis shows that had individual HCP reporting with a trigger point of $10 or above for each benefit been in place during the six months to March 31, companies would have recorded more than 269,000 occurrences in total, covering 9685 events.

• The higher trigger point of $25, which was favoured by companies that presented to the MA transparency working group, would have cut the recording of individual benefits required for the most recent reporting period from 269,000 to 133,000 and the number of events requiring such recording from 9684 to 4100.

19 August 2013

http://www.pharmainfocus.com.au/news.asp?newsid=7067

MA Code review

12

• Comment of discussion paper requested;• Consumer Workshop, Melbourne, Friday 18th October 2013


Dr Ken Harvey

Rules under review?

13

Date Initiative

2002 Report of a Review of Advertising Therapeutic Products in Australia and New Zealand

2003 Report of Expert Committee on Complementary Medicines in the Health System

2005 Description of the joint (Trans‐Tasman) regulatory scheme for the advertising of therapeutic products

2006Consultation (Draft) Regulation Impact Statement on the proposed amendments to the current regulatory system for herbal and homoeopathic medicines in Australia

2007 Consultation ‐ draft (Trans‐Tasman) advertising rule

2008 Regulation of homoeopathic and anthroposophic medicines in Australia

2009Draft Guideline for Levels and Kinds of Evidence for Listed Medicines with Indications and Claims for Weight Loss

2010 TGA Consultation: Improving advertising arrangements for therapeutic goods

2011

Consultation and Report of the Working Group on Promotion of Therapeutic Products

Report of the Review to improve the transparency of the Therapeutic Goods Administration

ANAO Report. Therapeutic Goods Regulation: Complementary Medicines

TGA reforms: A blueprint for TGA's future

2012Delivering reforms ‐ Implementation plan for TGA Reforms

TGA Advertising regulatory framework: Options for reform

2013TGA Consultation Regulation Impact Statement: Regulating the advertising of therapeutic goods to the general public

A decade of procrastination

Culminating in the latest RIS

1. Alternatives to the pre‐approval scheme

2. The complaints handling process

3. Provision of advice in relation to advertising matters

4. Investigation and enforcement powers

5. Advertising of higher risk medical device

6. Advertising directed to health professionals

7. Advertising of Pharmacist‐Only medicines

8. The Price Information Code of Practice

14


Dr Ken Harvey

Comments on the RIS proposals

• Alternatives to the pre‐approval scheme– We support option 4 (c), modified by option 2. This

would mean that the TGA, not delegates from two industry associations, would undertake pre‐approval for an extended range of media (adding pay‐tv) and types of advertisements (adding medical devices that are promoted to the public).

• The complaints handling process– We support option 2 (a), all complaints to be handled by the TGA.

This eliminates concerns expressed about the CRP, removes duplication in the current system and would allow earlier identification of repeat and major offenders and advertisements posing a high risk to public health and safety.

– However, the TGA’s current performance on Regulation 9 referrals causes great concern. 15


• Investigation and enforcement powers– We support option 2, enhanced investigative and

enforcement powers.

– These have been long needed and long awaited. Progressing this reform is urgent.

• Advertising of higher risk medical device– We support option 2, prohibit the advertising of higher risk medical

devices including Class 4 in vitro diagnostic devices (those with a high public health risk).

– Naturopaths have expressed concern that this measure will reduce access to their tools of the trade because they will not be able to advertise various diagnostic and therapeutic techniques.

– However, many of the dubious devices used by naturopaths are Class I (low risk) devices, or they are not included on the ARTG such as the Hemaview® live blood analysis and QXCI machines. 16


Dr Ken Harvey

Live blood analysis

“Another gimmick to sell you something”

Stephen Barrett, M.D.17 17

QXCI (Quantum Xeroid Conscious Interface)

• When analysing the persons energy, it functions similar to those of a virus scan on a computer. They detect weaknesses such as viruses, nutritional deficiencies and allergies by calculating the biological reactivity and resonance in your body.

• After measuring the body's frequencies it feeds back its own frequencies to neutralise destructive wave patterns. Healing takes place through energetic intervention, giving the body the true healthy energy patterns which enhance wellness, facilitate recovery and tune up your inner healing intelligence's ability to manifest fully.

http://www.naturaltherapypages.com.au/connect/cellagenics/service/10805 18


Dr Ken Harvey

QXCI (Quantum Xeroid Conscious Interface)

• In the late 1980s, an out‐of‐work math instructor in Colorado built an electronic device he claimed could diagnose and destroy disease.

• The U.S. FDA, which regulates medical devices, ordered Nelson to quit selling his machine and making false claims.

• Nelson refused, was indicted on felony fraud charges. He fled the country, never to return.

• Today, Nelson, orchestrates health‐care frauds from a century‐old building in Budapest, Hungary.

• His latest machine “INDIGO” has now replacing QXCI/SCIO (Quantum Health) and is promoted and used by the Cellagenics (and other) Oz Naturopathic practices.

http://seattletimes.nwsource.com/html/localnews/2004020583_miracle18m2.html 19


• Advertising directed to health professionals– We support option 2, update the exemption for health

professionals in section 42AA of the Act to only recognise health practitioners regulated under the National Registration Accreditation Scheme (NRAS) administered by AHPRA.

– This proposal has created the greatest opposition from naturopaths, herbalists, homeopaths and Blackmores.

– The rationale for this option is that the TGA are not assured that non‐NRAS registered health practitioners are able to exercise specialist judgement when either treating patients with advertised therapeutic goods, or advising them about the use of advertised therapeutic goods. CM practitioners disagree.

– The reality is that naturopaths, herbalists and homeopaths are represented by a plethora of organisations with very varied educational and professional standards. 20


Dr Ken Harvey

CM organisations

21 21

Natural Therapy Review Advisory Committee

• The NHMRC is currently reviewing the evidence for the effectiveness of “natural therapies” such as aromatherapy, homeopathy, iridology, naturopathy, western herbalism and nutrition.

• This will comprise a systematic review of available evidence on their effectiveness in treating a variety of clinical conditions in humans and also assess evidence provided by stakeholders.

• The findings of this review will inform the government’s Natural Therapy Review Advisory Committee.

• The review’s purpose is to ensure that taxpayer funds that are paid through the rebate to subsidise natural therapies are underpinned by a credible evidence base that demonstrates their clinical efficacy, cost effectiveness and safety and quality.

• NRAS registered health practitioners such as Chinese Traditional Medicine, Chiropractic and Osteopathy practitioners will not be reviewed. 22


Dr Ken Harvey

Should NRAS registered practitioners be exempt?

23

Should NRAS registered practitioners be exempt?

24 24


Dr Ken Harvey

Options for unregistered practitioners

25

AHMAC Standing Council on Health, 1 August 2013

• Ministers agreed in principle to strengthen state and territory health complaints mechanisms via:

– a single national Code of Conduct for unregistered health practitioners to be made by regulation in each state and territory, and statutory powers to enforce the Code by investigating breaches and issuing prohibition orders;

– a nationally accessible web based register of prohibition orders; and

– mutual recognition of state and territory issued prohibition orders.

• Each State and Territory will be responsible for:– enacting new (or amending existing) legislation and regulations to give effect to the national Code

of Conduct, the national register of prohibition orders, and mutual recognition of prohibition orders across state boundaries;

– determining a suitable local body to receive and investigate breaches of the Code of Conduct and issue prohibition orders, noting that existing Health Complaints Entities (HCEs) already have statutory roles to investigate complaints about unregistered health practitioners but only NSW and South Australia have a code of conduct and prohibition order powers.

• AHMAC will undertake a public consultation on the terms of the first national Code of Conduct and proposed policy parameters to underpin nationally consistent implementation of the Code, for consideration by Ministers.

26


Dr Ken Harvey

In conclusion:

• The therapeutic goods industry (and health professionals) are increasingly being challenged by health activistgroups (with help from the media).

• We await with interest the advice the TGA will give the next government on the final advertising RIS and other consultations.

• Complaints, assessment of TGA performance and use of the media will be ramped up after the election.

• There are several forthcoming consultations with which Skeptics groups (or individuals) might like to engage.

Friends of Science in Medicine

skeptics groups of victoria, la notte, sept€¦ · iridology, naturopathy, western herbalism and...

Documents