The advertisement includes a sample from a consumer advertising campaign that advises readers to talk to their doctor about a combination heart pill if they’re taking mubliple medicines for their heart.

The consumer ad incudes a rip-out section to take to the doctor which carries a Pfizer logo and says “I’d like to discuss my treatment for high blood pressure or high cholesterol. Please advise me if a combination heart pill is suitable.”

Croakey readers may remember that earlier this year Michele Kosky, executive director of the Health Consumers’ Council in WA, asked the TGA and Medicines Australia to investigate whether the consumer advertisement breaches the ban on direct-to-consumer advertising of prescription medicines.

In June, Croakey reported back that Kosky had not had any response from the TGA, and that the Medicines Australia code of conduct committee did not consider the advertisement to be promoting a particular product and therefore was not in breach of the code (although this was not a unanimous decision).

It seems worth revisiting the issue, now that Pfizer has started plugging its consumer campaign into its marketing in the medical mags. It doesn’t take much effort to join the dots.

Step 1: Push the consumers into doctors’ surgeries with a reminder to ask about a “combination heart pill”.

Step 2: Back up the consumer advertising campaign with a website like this (with a helpful print out to take to the doctors)

Step 3: Prompt doctors to think of Pfizer when patients start arriving with notes about “a combination heart pill”…

And this doesn’t count as direct-to-consumer advertising???

For the record, Pfizer’s most recent annual review for US shareholders said its combination heart pill, (aka Caduet, aka a combo of its mega-selling cholesterol-lowering drug, Lipitor, and blood pressure pill Norvasc) was worth $589 million in 2008, up four per cent on the previous year.

For those who believe new drugs are all about improving patient care, this article in Pharma Focus explains the strategy behind the development and promotion of combination products like Caduet – as a strategy for defending the impending expiration of Lipitor’s patent in 2011.

Meanwhile, if you want some independent information, here’s the blurb on the combo pill from the National Prescribing Service.

I wonder if Michele Kosky ever heard back from the TGA about her complaint? I will check and let you know…

Dr Ken Harvey, a tireless campaigner for ethical marketing, outlined his concerns about the bilateral meeting in this recent Croakey post.

Now, Health Action International, “an independent, global network, working to increase access to essential medicines and improve their rational use through research excellence and evidence-based advocacy”, has written to the Minister, raising similar concerns and calling for more effective regulation of marketing.

Here’s the letter:

10  September 2009

Dear Sir,

Sustaining a strong national medicines policy in Australia calls for a committed partnership  between all of the stakeholders affected by the policy’s content. For this reason, Health Action International (HAI) is deeply concerned to learn that the country’s Therapeutics Goods Administration (TGA) plans to meet with various industry associations later this month to discuss their various codes of conduct and determine potential strategies for a way forward.

Such a bilateral approach to controlling pharmaceutical promotion—without expert input from civil society and health care professionals or any reference to the World Health Organization’s Ethical Criteria on the Promotion of Medicinal Products —does little to earn or retain public trust in the Australian government’s efforts to protect public health. Instead, it seems aimed at accommodating the industry’s need to create markets for its products.

As an organisation devoted to the rational use of medicines, we know that the evidence shows that self regulation of promotion by the pharmaceutical industry has been mostly ineffective. This is mainly due to the obvious conflict of interest between the business goals of pharmaceutical manufacturers and the need to protect public health and ensure that medicines are used in a acceptably safe and rational way.  Promotion is a key factor driving sales. When product sales are given priority over public health, promotion can lead to over-prescribing and poor quality prescribing and medicine use. This, in turn, leads to an increased risk of adverse effects and higher health care costs. Unethical  pharmaceutical promotion has led to numerous health disasters, including those caused by thalidomide, DES and more recently, rofecoxib (Vioxx).

Codes of conduct, developed by industry associations or related groups, lack the strength of legislation and usually contain few or no provisions on enforcement and substantial sanctions. In addition, your belief that removing code inconsistencies and adopting a national, industry-wide approach will push companies to follow the highest possible ethical standards may instead result in the adoption of code provisions of the lowest common denominator.

Instead, HAI and a number of its public health contacts in Australia believe that a new approach to pharmaceutical regulation on promotion is required. There should be one code applicable to all therapeutic claims and promotional practices; one complaint (and appeal) process, one monitoring process and one set of effective sanctions, including corrective advertising orders and fines related to the sales income of the product and company involved.

Unlike your proposal, we believe this process should be overseen by government, funded by industry (through product registration fees), and carried out by an independent committee representative of all stakeholders. The system should have a legislative base in the TGA and/or regulations and have strong enforcement provisions. Such a new system would be in line with the 2007 World Health Assembly Resolution WHA 60.16.5 on the Rational Use of Medicines. This urged member states (including Australia) to:

“Enact new, or enforce existing, legislation to ban inaccurate, misleading or unethical promotion of medicines, to monitor promotion of medicines, and to develop and implement programmes that will provide independent, non-promotional information about medicines”.

Ensuring the rational use of medicines is too important a task to be left to the industry alone. For years, Australia’s Medicines Policy has been a model to countries in the Asia Pacific region. Allowing just the industry to advise the government on the best way to control inappropriate and unethical promotion goes against the spirit of the national policy and damages its independent, public health approach.  Instead of encouraging the country’s pharmaceutial industry to determine how its products can be marketed, Australia should make regulation of pharmaceutical promotion a higher priority. HAI urges the Australian government to take the lead in formulating
effective regulatory policies that enable companies to sell needed medicines and demand that they market them in a responsible way.

Yours faithfully

Dr. Tim Reed
Director
HAI Global

This week the Steering Committee for the Australian Register of Naturopaths and Herbalists has formally called for submissions as part of its process to set up an independent register for Australia’s largest complementary medicine professional group.

Chinese Medicine practitioners have recently been announced as one of the three new professions to be part of the National Registration and Accreditation Scheme for Health Professionals, joining Chiropractors and Osteopaths as registered complementary medicine professions.

However naturopaths are by far the largest complementary medicine profession in Australia and at this stage don’t look to be considered for this process until 2012 when currently unregistered practitioners are considered.

A report commissioned by the Victorian government in 2003 and published in 2005 strongly urged that these practitioners be statutorily regulated and moves were even made towards this goal before being delayed indefinitely due to the current National Registration and Accreditation Scheme.

Whilst the aim of this register is to eventually be subsumed by this process, it is being initiated now to ensure minimum standards and afford public safety in the interim.

Many may ask why this is even a health issue? It‚s easy to dismiss the registration of complementary medicine practitioners as a trivial pursuit and this attitude could possibly be a reason that the issue has failed to gain any traction for so long. But, like it or not, complementary medicine practitioners  now form a very real part of the Australian healthcare landscape and look set to remain so for the foreseeable future.

Australians now spend more out of pocket on complementary medicine practitioner consultations than they do on conventional practitioners, and nearly half – more than half in some areas – of all health consultations are with complementary therapists.

Less than half of those who do consult with complementary therapists discuss this use with their conventional medicine practitioners, and an astounding 1 in 6 Australians now rely on complementary therapists as their primary care practitioner.

Setting benchmarks and standards in these professions has moved from an issue of minor consequence even a decade or two ago to one of major public health importance. However, whilst most of the attention on improving standards in complementary medicine has focused on product issues, practitioner issues have very much fallen off the radar.

Naturopaths are now chosen by patients with a broad range of health conditions and need appropriate levels of health knowledge not just to treat but also to be aware of the limitations of their treatments.

A case report in the Australian Family Physician highlighted this perfectly – a man with a head wound was unsuccessfully treated by his naturopath for so long that by the time he eventually consulted with a medical professional the infection had reached the meninges of his brain.

The matter here was not an issue of inefficacy of the naturopath’s treatments, but rather the opportunity costs borne by the naturopath not referring for more appropriate treatment sooner, and it could have been easily averted through adequate training.

The education situation has undoubtedly improved since the days when Australian Skeptics  members’ dogs could get a government accredited complementary training organisation registered but complementary medicine qualifications are still extremely variable.

Anyone can currently call themselves a naturopath, and practise as one, without any qualifications, and whilst four-year Bachelor degrees do exist in naturopathy there also exists a cacophony of other courses of varying quality, and numerous professional associations that are more than willing to accredit their graduates.

The board of at least one professional association that accredits practitioners is composed of representatives of various private training colleges and therefore exhibits clear conflict of interest in setting educational benchmarks. This situation has left little incentive for improving standards and earlier this year Australia’s largest complementary medicine provider cut assessment of its students by between a third and one half to better compete financially with other providers.

Accreditation of naturopaths and herbalists is currently  carried out through professional associations. However the standard to which this is done is variable due to the large number of associations in Australia. Qualifications for entry, continuing professional education requirements and practice standards all vary considerably, as do complaints handling processes. Sometimes this can have drastic consequences.

One naturopath was allowed to remain a member of his professional association due to fear of legal action even after it had become apparent that he had falsified qualifications and had a history of fraud and violent crime. And even when removed from professional associations unethical practitioners may continue to practice as naturopaths.

Another naturopath was allowed to continue practising whilst under investigation for sexual crimes – eventually being found guilty of 34 counts – as there was no mechanism to bar him from practise.

Notwithstanding these examples it is patently obvious an organisation can’t promote the public’s interest and the interests of the profession it represents without clear conflict of interest. Whilst this arrangement hasn’t been legally tested in Australian it has in other jurisdictions, and is part of the reason that naturopaths are now statutorily registered in South Africa.

It should be acknowledged that the vast majority of practitioners are well qualified, behave ethically and support the initiatives to clean up the industry more generally.

However, given the emerging role that the public is choosing for naturopaths to play in healthcare it is essential that minimum benchmarks and standards are put in place by a body independent of the profession. The health and safety of a large swathe of the population is dependent on it.

• The Steering Committee for the establishment of the Australian Register of  Naturopaths and Herbalists is calling for submissions on the registration of these professions. Submissions are due in by close of business Monday, 31 August 2009. More details are here.

“The Australian has reported my complaints to authorities over the promotion of complementary medicines on “liverdoctor.com” by Dr Sandra Cabot; real name Dr Sandra McRae, a NSW registered medical practitioner.

Dr McRae responded that the complaint had been rejected by Australian authorities as being outside their jurisdiction because the website on which they appeared was subject to US rather than Australian regulations.

The domain history of “liverdoctor.com” shows that Dr McRae was listed as the administrative and technical contact for this web site until she changed this to US personnel after receiving my first complaint. She remains a medical practitioner registered in NSW, she continues to promote herself and her products using her Australian credentials and her web server and name servers remain in Australia.

The same complaint was sent to two different bodies: the industry Complaint Resolution Committee (CRC) of the Complementary HealthCare Council of Australia and the independent Complaint Resolution Panel (CRP) who administer the Therapeutic Goods Advertising Code. Both bodies were involved because the complaint involved both the web site and information on product labels.

The CRC dismissed the complaint because they believed the matter was now the responsibility of US authorities. The CRP referred the matter to the Regulatory Compliance Unit of the Therapeutic Goods Administration (TGA). I have yet to hear if they have accepted jurisdiction over this
complaint.

Regardless, the different response received from two complaint bodies dealing with the same issue highlights the current uncertainty over who has jurisdiction over information on web sites that are alleged to breach national laws.
Is it the country where the web site is based, the country where the domain is registered, or the country of the person actively promoting themselves and their products?

Can anyone cast more light on these matters?”