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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“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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ABC1 The Checkout: Swisse Chlorophyll

See the advertisement for

As “evidence” for the claims made they cite: Food Standards Australia New Zealand (FSANZ, 2013). Nutrition, Health And Related Claims, Standard 1.2.7. 1–48.

Now view this segment of The Checkout (Episode 3, March 6, 2014).

See also this advertisement for BioGlan’s Chlorophyll, their statement and “The Checkout’s” response.

And Nature’s Sunshine Liquid Chlorophyll advertisement. Ironically, unlike the others this product is Listed on the TGA’s ARTG (No: 26033).

Yet more examples of food-medicine inconsistency (and outrageous claims)!

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Coming out of retirement

As reported today, I’ve been offered, and accepted, an adjunct Associate Professor position at a university that was also approached by Swisse with an offer of funding but which did not accept.

See: Ken Harvey cancels retirement as Swisse spat turns personal  and

Swisse complains of resignation ‘stunt’

 

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Latest Press Release from Swisse; my response

The Swisse press release is available here

I quote from it:

  • Our prerequisites were simple….

This list of prerequisites does not include the key concern of myself and others; that the research proposed was to specifically evaluate the efficacy of Swisse products.

 Do we really want University researchers to spend their time assessing the efficacy, for example, of Swisse Men’s Ultivite which contains 52 “premium quality vitamins, minerals, antioxidants and herbs” in a potpourri of ingredients many of which lack logic (and are present in non-standardised, sub-therapeutic amounts)? These ingredients are presumably included in the hope that “more is better” has marketing appeal.

What about Swisse “Liver detox” and “Ultiboost Hunger control” (the subject of a 2013 ABC Checkout program)? See: http://www.youtube.com/watch?v=12ww26sQF7E&feature=youtu.be

There are many worthwhile complementary medicine questions to be researched such as exploring the efficacy of certain traditional medicines (from which many useful active pharmaceuticals have been derived). However, that was not what the Swisse – La Trobe MOU (as announced) proposed.

  • The top 10 patent protected drugs that are prescribed by doctors in Australia all rely on efficacy from research that was industry funded. This is absolutely no different to what Swisse is aiming to do, with the support of additional industry players, government and other financial backers.

Not true! Most research on product efficacy by conventional pharmaceutical companies is undertaken prior to marketing and is used as part of an application for product registration where it is independently assessed by regulators such as the Australian Therapeutic Goods Administration (TGA).

Swisse products are listed by the TGA; a process that requires no pre-market evaluation of efficacy.  However, the sponsors of listed products are  meant to hold purity, safety and efficacy data for potential audit, compatible with the product labelling and advertising claims. So if a company needs to find this evidence after marketing it would seem that their listing claim must be dubious.

  • Given that Swisse does not hold patent protection for any products to be researched, it means that the entire nutraceuticals industry can benefit from the research findings. 

Swisse (and other supplement company) products usually contain a unique mix of ingredients, for example the Swisse Men’s Ultivite F1 contains “52 premium quality vitamins, minerals, antioxidants and herbs”. Results found from trials using Men’s Ultivite F1 cannot be extrapolated to other multivitamin, mineral and herb products (unless they had an identical formulation) and thus other supplement companies cannot benefit from such research.

  • The Australian Integrative Medicine Association (AIMA) has publically stated itself that the attacks from the Friends of Science are hypocritical.

Ironically, AIMA did not disclose their own relationship with Swisse in this press release. In addition, FSM have clearly pointed out their many concerns about the Swisse-La Trobe MOU which are in no way “hypocritical”; see: http://www.scienceinmedicine.org.au/images/pdf/swisselatrobepartnership.pdf

  •  Dr Harvey advised last September that he intended to retire from all “watchdog activities”, suggesting that his recent retirement announcement from La Trobe, citing concerns over the Complementary Medicine Evidence Centre (CMEC), could merely be seen as yet another publicity stunt for a final farewell.

While it’s true I had intended to retire later this year, following publicity about the Swisse-La Trobe MOU I’ve had had many requests to keep on keeping on. In addition I’ve also received also an offer of an Adjust Assoc Prof appointment at another university that refused the Swisse offer. Accordingly, I’ve accepted the latter and postponed my retirement.

Swisse will be pleased to know that I have more complaints about the promotion of complementary medicines (and the ineffectiveness of the regulators) currently in train.

  •  Professor Paul Glasziou of Bond University suggested that the CMEC research concept was bad because he incorrectly claimed that complaints were made about Swisse misleading the public through our advertising. The complaints that Professor Glasziou refers to were from one anonymous source, and were over semantics… Swisse have never been fined…

 Swisse have claimed that a number of their products were “proven”, “clinically proven”, “scientifically shown”, “clinically tested with proven results” and “proven in clinical trials”; claims that the independent Complaint Resolution Panel (CRP) found breached the Therapeutic Goods Advertising Code, see: http://www.tgacrp.com.au/uploaded/doc/Swisse_Products.pdf . In my view (and that of the CRP) these “semantics” are important and the Swisse distortion of previous research results for marketing purposes was another concern about the research proposed.

Regrettably, the CRP has not got the power to “fine” companies who breach the Therapeutic Goods Advertising Code.

  •  … let’s celebrate the success of an Australian company that is making millions more people happier and healthier around the globe.

 With some important exceptions, there is little evidence that the majority of people who consume complementary medicines are made happier and healthier as a result. Most consumption would appear to be driven by hype and celebrity endorsement; not by evidence.

In conclusion, the following poll was conducted by MJA Insight:

Poll

 

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La Trobe – Swisse update

This issue has attracted considerable media attention. For example:

More recently:

La Trobe University has published its defence of the deal:

Finally, last year, the Australian Broadcasting Corporation (ABC) targeted Swisse (and the regulator: Australian Therapeutic Goods Administration (TGA)) in its consumer  affairs program, “Checkout” see:

They reinforce their views in a new video aimed a promoting the 2014 series of the show:

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