Should pharmacists stock homeopathic products?

There has been recent debate in AusPharmList about this topic which has also involved a discussion of their regulation.

Currently, any homoeopathic preparation that is more dilute than a one thousand fold dilution of a mother tincture (i.e. 4x or greater), and is not required to be sterile, is exempt from TGA GMP requirements and also from listing on the Australian Register of Therapeutic Goods (ARTG).

The historical basis for these exemptions dates back to the development and implementation of the current Regulations, when it was considered that homoeopathic preparations did not present a significant health risk to the general public, and hence minimal regulation was appropriate. However, this has meant that homeopathic products are not subject to the same level of post-market scrutiny that applies to other low risk medicines.

Exemption from TGA regulation has seen the marketing of purported homeopathic products such as homeopathic somatropin and homeopathic melatonin and marketing claims that are inconsistent with TGA evidence guidelines (a homeopathic product may claim that it is in accord with the homeopathic tradition (if it is) but this cannot and should not be converted to a claim for efficacy).

Increased regulation of homeopathic products (and better public education) has been proposed by numerous expert committees since 2003. It has yet to eventuate despite a TGA paper recommending specific changes in 2008. Most recently, the TGA have said they are awaiting the final NHMRC report on homeopathy (the draft report was released for public consultation from 9 April to 2 June 2014).

The other regulatory problem is the TGA’s lack of effective penalties for advertising claims that breach the Therapeutic Goods Advertising Code.  Companies often refuse to comply with “requests” by the Complaint Resolution Panel (CRP) for removal of claims (and the publication of retractions) when complaints have been upheld. The CRP then refers these complaints to the TGA who conduct their own assessment of the complaint and, when upheld, “order” the company to comply.

The company can continue to not comply. Another approach by companies is to appeal, first to the Minister and then to the AAT, a process that can take several years. Meanwhile, the offending promotion continues. The final route for complainants is to convince the ACCC to take the offender to court which takes several more years.

For example, a complaint about the promotion of homeopathic immunisation first lodged in 2011 was referred to the TGA by the CRP later that year. The TGA then “ordered” a retraction (which was not complied with in 2012) where upon a complaint was sent to the ACCC who finally got a Federal Court judgement in late 2015. See: http://www.medreach.com.au/?p=1215.

Once again, this problem has been the subject of numerous reports over the last decade. The latest was in May 2013 in which specific recommendations were made to give the TGA more powers. Apparently this report is still being considered by government in light of their de-regulation agenda.

Meanwhile, consumers continue to get taken in by these products. I remain convinced  that an important role for pharmacists is to have the knowledge and the will to provide their customers with the facts about such products.

Whether they should stock them is an ethical decision for individual pharmacist owners and chains and I accept that opinion on this will vary. However, a recent poll (15/04/2014) in Auspharmlist (below) appeared to show that opinion is changing.

AusPharm poll on stocking homeopathic products

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Posted in Complementary medicine | Tagged , , , , | 1 Comment

ABC 7:30 report – Should alternative medicines have their government rebate cut?

http://www.abc.net.au/7.30/content/2015/s4161774.htm

Regrettably a typical TV short report that provided the opinions of all and could not deal with the key issues in any depth.

Clearly there is a difference between exercise modalities  such as Yoga, Pilates, Tia Chi and therapeutic modalities such as homeopathy and iridology!

The former are sensible (and recommended) preventative health modalities even if there was little evidence from the NHMRC review about their effectiveness in various diseases (which was a different question). See:

http://www.shapeup.gov.au/start-shaping-up/physical/getting-active

The latter have considerable evidence (over a long time) of their ineffectiveness. Hence my concern about lumping them all together with the statement that, “the absence of evidence does not mean that the therapies evaluated do or do not work”.

I go to the local council gym 2-3 times a week for preventative health reasons but there is no private health insurance rebate for that!

I agree with ADAM STANKEVICIUS (CHF): “I think the Government needs to as soon as possible release the report, so that we know exactly what we’re talking about and then we need a good public debate on exactly what it is that’s covered by private health insurance”.

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Posted in Complementary medicine, Natural Therapies | Leave a comment

Federal Court judgement: Homeopathy Plus

In response to a case brought by the ACCC the Federal Court declared (on Dec 22, 2014) that Homeopathy Plus! Australia Pty Ltd ACN 134 266 149 and Frances Mercia Sheffield have engaged in conduct that was misleading and deceptive, or was likely to mislead and deceive, in contravention of section 18 of the Australian Consumer Law.

The full judgement is now posted at:

https://www.comcourts.gov.au/file/Federal/P/NSD256/2013/actions

> Consumer protection > Court events and Orders > View judgement.

This complaint was first lodged with the Complaint Resolution Panel (CRP) in 2011 and referred to the TGA by the CRP later that year. After a new investigation, the TGA “ordered” a retraction (which was not complied with by 2012) where upon a complaint was sent to the ACCC who finally got a Federal Court judgement in late 2015.

My 2012 complaint to the ACCC can be found here.

See also:

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U3A Melbourne November Complementary Medicine Course

PDF files of the material presented are now available for download below:

Background reading:

Course material (2 slides per page)

Two Monash Summer Research Project students (Grace Jackel and Aaron Kovacs)  researched the questions that participants wanted answered in the 3rd session. They are shown below together with the U3A co-ordinator (Julie Nankervis) and myself.

U3A_November_course

 

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Australian docs who accept pharma money must be named – ACCC

Australia’s competition and consumer watchdog (ACCC) has demanded that drug companies publicly name any doctor who accepts consultancy or speaker fees or free travel and accommodation.

Unless this condition is complied with the ACCC will not authorise Medicines Australia’s latest Code of Conduct (edition 18).

In light of the U.S. Sunshine Act, the ACCC had previously limited authorisation of the 17th edition of Medicines Australia Code to two years (rather than the five years sought) in the expectation that this would allow the industry to improve transparency provisions.

The 18th edition of Medicines Australia code merely “encourages” health-care professionals to consent to disclosure, while allowing them to opt-out and retain financial and other benefits of their interaction with pharmaceutical companies.

Numerous submission to the ACCC from consumer groups and others argued that this was not good enough; those who failed to agree to voluntary disclosure were likely to be those we wanted to know most about.

The ACCC is seeking submissions in relation to this draft determination before making its final decision.

See also:

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N.Z. Pharmacy pulls homeopathy after Advertising Standards complaint upheld

See this report from science based pharmacy.

On 14 April 2014, I submitted a formal complaint about the promotion of the same product (called Jet-ease in Australia) to the Therapeutic Goods Advertising Complaint Resolution Panel  (TGACRP).

I alleged that the information provided on Jet-ease web site breached a number of sections of the Therapeutic Goods Advertising Code, especially the statement that it had, “been proven effective in a clinical trial”.

I also noted that this product was promoted and sold in a large number of airport pharmacies, health stores and other outlets: http://www.jetease.com.au/auretail.html.

On June 2, 2014 I was informed the complaint had been sent to the Therapeutic Goods Administration “because of the possible breach of section 42DL(1)(g) of the Act (the product may not be on the Australian Register of Therapeutic Goods)”.

On June 19, 2014 the TGA acknowledged receipt of this (and other complaints about homeopathic products) but subsequently I have heard no more.

Meanwhile, promotion in Australia continues unchanged.

It would seem that the N.Z. regulatory system is much more efficient than the Australian one!

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Posted in Complementary medicine, Pharmaceutical Promotion | Tagged , , , | 4 Comments

“No Advertising Please” NAP campaign (Prescribers need evidence, not marketing)

No Advertising PleaseA nice launch of this campaign helped by the responses from:

  • Medicines Australia (“the idea that you can ignore information from a pharmaceutical company that has conducted extensive research and development to help treat disease is laughable at best and negligent at worst”), and the
  • Australian Medical Association (“the campaign is a bit silly. It’s insulting to doctors. It’s also rather naive).

Good media coverage including ABC TV 7:30 report, The Guardian, Fairfax media, The Australian, The Conversation, Croaky, 6-minutes, OzDoc, the Medical Observer, MJA Insight, and more recently The Wall Street Journal.

See also the following YouTube interviews with:

And a press release from the Consumer’s Health Forum supporting the campaign.

No Advertising Please

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Self-regulation or government regulation of transparency?

In 2012, when edition 17 of Medicines Australia Code was released, the Australian Competition and Consumer Commission (ACCC) limited its authorisation to 2 years, rather than the 5 years sought, to encourage Medicines Australia to improve transparency around payments to individual health care professionals.

This was in accord with international developments such as the US Open Payments (the Physicians Payment Sunshine Act), which mandated full public disclosure of these relationships.

Edition 18 of Medicines Australia Code has now been submitted to the ACCC for authorisation. It “encourages” healthcare professionals to consent to disclosure. However, it also allows them to opt-out of disclosure while retaining the financial and related benefits of their interaction with member companies. As Senator Richard Di Natale noted, “The voluntary nature of disclosure makes the Code next to meaningless. It’s like making a breathalyser voluntary for drink drivers”.

Medicines Australia Code is weak because other therapeutic goods industry associations have not adopted transparency provisions in their own self-regulatory Codes and many have also opted out of ACCC Code authorisation (and thus being subjected to ACCC persuasive powers). In addition, there are increasing numbers of non-members of therapeutic goods industry associations (for example, the Indian generic company Ranbaxy Australia) who are not bound by any self-regulatory Code. Furthermore, Australian health professional organisations have also failed to address &/or incorporate transparency provisions in their own Code.  It’s therefore not surprising that many members of Medicines Australia were worried that attempting to force full disclosure would put them at a competitive disadvantage with other therapeutic goods companies, especially generic companies.

Medicines Australia argue that disclosing transfers of value from those health professionals who consent (and lumping together the total value of benefits received and the numbers of those who do not) is an incremental improvement (and public benefit) on the previous Code and thus their latest Code should be authorised.

The alternative view is that it would be to the public detriment to authorise a Code that fails to deliver on the key principles agreed to by Medicines Australia Transparency Working Group, including the key outcome raised by many interested parties in deliberations about edition 17 of the  Code: transparency on individual payments made to healthcare professionals (consistent with developments in the U.S.).

My own view is that the ACCC should not provide a fig-leaf of respectability to edition 18 of Medicines Australia Code by authorising the flawed outcome achieved. Rather they should defer authorisation and refer this mess back to where the responsibility lies: the Regulatory Policy & Governance Division of the Australian Department of Health, the Therapeutic Goods Administration (TGA) and the government, all of whom have failed to address the limitations of self-regulation.

A number of counties such as France, Portugal and Turkey have now embraced government regulation of transparency in addition to the USA. I also believe that Australian legislation should also make transparency (and other ethical considerations) a condition of market authorisation by the TGA.

My full submission (and others) can be found here. A (much) shorter version has published by MJA Insight.

If others wish to engage in this debate the ACCC is accepting submissions until August 1, 2014.

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Recent activities (U3A Melbourne)

I’ve just delivered a short course on,  “Complementary medicines: Exploring the Issues” for U3A Melbourne.

The material presented is available (as PDF’s) here: Background reading I & Background reading II , Questionnaire and presentations (2 slides per page)  Session I, Session II & Session III.

As expected, when questioned at the start of the course, none of the course participants knew what AUST L or AUST R on the labels meant!

As part of the course I showed some recent TGA videos which participants felt were informative.

There was criticism of the static talking head format (boring); some would have preferred a more lively interview format such as the one I also showed presented by Norman Swan (ABC Tonic) for NPS Medicine Wise.

Regardless, many older participants appreciated that the TGA video had the spoken word duplicated by the text and also a transcript available to read at their leisure.

In addition, the information presented at , “Listed medicines: The role of Australia’s medicines regulator” is excellent, in particular the “Buyer – be aware” section.

This TGA material deserves wider publicity.

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Monash University appointment confirmed

My appointment as Adjunct Associate Professor, in the School of Public Health and Preventive Medicine, Monash University has now been confirmed.

I thank Prof John McNeil for offering me this position.

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