At the risk of a gratuitous self-plug, the use of these medicines in young children was one of the issues of concern that Ray Moynihan and I highlighted in our book, Ten Questions You Must Ask Your Doctor (Allen & Unwin, 2008). We came across several references raising concerns about these products’ use in children when researching the book back in 2007.

So the TGA is certainly not rushing the jump.

Nonetheless, the move will be such a challenge to accepted practices that it will need to be backed by a long-term educational campaign. So argues Ron Batagol, a Pharmacy and Drug Information Consultant.

He writes:

“In a move that is likely to provoke much spirited debate amongst doctors, pharmacists and, most importantly, the parents and carers who look after the day-to-day health issues of  young children in their care, the Therapeutic Goods Administration (TGA) has given notice that it is intending to  “upschedule” over-the-counter cold and cough products to Prescription Only for children under six years and Pharmacist Only for children aged between six and 12 years.

As part of the upscheduling exercise, the TGA has also recommended cough and cold medicines should not carry dosage instructions for children under six years old. The TGA says that this approach would bring the regulation of cough and cold preparations in Australia into line with measures in place in the UK and Canada.

After extensive  internal and external reviews of the evidence surrounding both  efficacy and safety in use, the proposed changes are stated by TGA to have been made ” in light of the current lack of evidence of efficacy and the historical profile of adverse drug reactions (ADRs) in Australia and overseas”.

It is certainly true, that the  consensus of informed opinion amongst paediatricians about the usefulness and propensity of side-effects of these products is in concurrence with the TGA assessment.

Now I must say that there is a whole fascinating social phenomenon associated with parents and carers buying cough ands cold products for children in their care.

This has, in fact,  been noted in the TGA External Review, where they raise the concept of  “social medication” which researchers have found is, in part, aimed at modifying child behaviour to more acceptable patterns, and in part a ‘coping strategy, and that cough and cold medicines were a common “social medication” in this respect’. Pharmacists at the “coal face” will be very familiar with this belief amongst their clients and the associated behaviour patterns.

Presumably, in recognition of  the social behavioural re-scheduling moves would certainly make them feel to some extent disenfranchised, turning on its head as it does, a long-held, even if erroneous, understanding that recommending a suitable cough and cold product for use by children served both a therapeutic and, as discussed, also a “social” function.

It seems to me that there will need to be long-term educational campaign on this issue, if the  proposed changes are adopted.

Indeed, TGA has said that the changes recommended would need to be widely promoted and explained to medical practitioners, pharmacists, parents and caregivers, and that particular efforts be directed towards educating consumers, medical practitioners and pharmacists that OTC cough and cold medicines have not been shown to be effective, and are potentially harmful in children under 6 years of age.

From recent discussions of this issue, when I raised it on our major pharmacy internet discussion website Auspharmlist, I have no doubt that at all that education and explanation will certainly be needed for many of my pharmacist colleagues, and their professional organizations!  This is, of course, quite understandable.

After all, on the face of it, the proposed issue is somewhat analogous to the lengthy but ultimately quite successful campaign over the past 5-10 years, to “educate” doctors and inform the broader community that antibiotics are not required to treat a whole range of common infections, and may ultimately promote bacterial resistance.

Five to ten years ago, of course, patients virtually demanded an antibiotic from their doctors in such situations.  These days, most patients are aware of this or, at least, do understand the situation when it is explained to them.

But, with TGA inviting responses from  stakeholder organisations, it is going to  require a huge effort to achieve the aims of broader community understanding of the rationale for the move by TGA to restrict availability of this group of widely-used, and generally well-regarded  infant and childrens’ medicines.”

It’s about how health reform advocate John Menadue was “disinvited” from speaking at an Australian College of Pharmacy meeting, after making a provocative speech to a pharmacy conference, as previously reported at Croakey.

I spoke to several senior pharmacists and others in the health sector when researching the story (the Australian College of Pharmacy did not return my calls but I will be happy to post follow-up comments from them, the Guild and others).

Here is some of what they had to say, both about the specifics of the Menadue case and the pharmacy profession in general:

A senior pharmacist who did not want to be named:
“I am absolutely ashamed… my profession at the moment is under a cloud of censorship being perpetrated by people who don’t control most of us.”

Another senior pharmacist who did not want to be named:
“We need to listen to people who have in the past shaped government policy. When they express a view of pharmacy, we need to listen to that view.  Some of the things John said (at the Sydney conference) were a little bit off the mark but a lot of what he said was right, that we do have a perception problem about how we conduct ourselves.”

Warwick Plunkett, president of the Pharmaceutical Society of Australia:
“The Guild in these matters are oversensitive, albeit it’s an important time in their negotiations of the community pharmacy agreement and I can understand they don’t want that in any way upset. But I think it’s healthy to have statements being made out there and an opportunity to either defend or take note of them in improving the eventual outcome for the profession.”

Professor Andrew Gilbert, Director, Quality Use of Medicines and Pharmacy Research Centre, Sansom Institute: University of South Australia:
“I was astounded by the decision, as many pharmacists had been enthusiastic about Menadue’s speech to the Sydney conference. Why would you, having got someone of the quality of John Menadue as a speaker, not use his intelligence and his knowledge of government workings and policy issues?”

Consultant clinical pharmacist Debbie Rigby:
“I think John Menadue’s talk at the Pharmacy Australia Congress expressed the thoughts and opinions of many pharmacists throughout Australia but also the wider health care environment and their perception of the pharmacy profession and industry. It’s always beneficial to hear the outsider looking in. John has a lot of experience in health policy. Whilst we may not agree with his comments, I think it’s an opportune time to reflect on the pharmacy profession’s role and perceptions in the whole health care environment.”

Professor Lloyd Sansom, Emeritus Professor, Uni SA:
“If someone of Menadue’s stature makes a statement, you’d want to listen to it and have a discussion with him. Rather than isolate him I would have thought it very prudent and sensible to engage in a dialogue with someone of his eminence and experience. He’s got something to say, you don’t have to agree with him, you can challenge him, why would you want to not listen to him? Don’t be scared of debate.”

Dr Lisa Nissen. Senior lecturer in the pharmacy school at the University of Queensland:
“We don’t always like what we hear but you’ve got to try and take onboard the lessons that you can learn from people who have different perspectives. We need to be challenged because there are indicators that the current practice model is not robust enough to take us where we want to go in the future. Taking on different perspectives and thinking about how we can integrate them is a good idea; that’s what smart people do.”

Carol Bennett, Consumers Health Forum:
“These issues are not new. For years some of the more progressive sections of the pharmacy sector have been discussing the need for pharmacy to embrace its role as a health provider and move away from being seen as retailers. If this is seen as controversial, I would be concerned about the extent to which the pharmacy profession and the Guild in particular maintain such a monopoly over the Community Pharmacy Agreement. I would like to think that the fear of open debate and discussion about pharmacy’s role is a thing of the past and that the profession understands its place as a health provider and, in doing that, all the accountability and transparency that go with it.”

No doubt there will be others, whether in pharmacy or the health sector more broadly, who have strong views on these issues. Croakey is happy to post your comments.

The Wall Street Journal reports that Merck has just released its list of payments to doctors for giving talks at promotional events. The list also includes some nurses, pharmacists and scientists.

The payments range from $150 to more than $20,000.

The paper reports that many drug companies are moving to do likewise, and that Eli Lilly published its own list earlier this year.  There is also a political push to require drug companies to report the payments.

It seems that Australia really is dragging the chain in this area.

For the sake of time-pressed Croakey readers, I’ve compressed the speech into several dot points. But it is worth reading in full, and you can do so here.

Here is a summary:

• There is quite a contrast between the community’s need for pharmacists to do more in their professional capacity and the unwillingness of the profession to change.

• The field of prevention beckons pharmacists. But it does not seem that pharmacists are fully responsive to needs and opportunities.

• Do pharmacists really want to collaborate with other health professionals or remain individual business entrepreneurs? Some are dissatisfied that their professional skills are not fully utilised and extended. It is not surprising that many find dispensing medications and running what sometimes seem like gift shops, to be mind-numbing.

• Unfortunately, the Pharmacy Guild of Australia opposes pharmacists working as consultant pharmacists within the GP super clinics. It insists instead that the only pharmacy participation must be via the establishment of a community pharmacy within the clinic.

• The evidence is compelling that the highly protected pharmacy business model which is comfortable and financially rewarding for owners up to this point is going to come under challenge. The history of protection in Australia is that protected sectors are very vulnerable and risk not fully appreciating their vulnerability until it is too late. Why is it that so much effort goes into political lobbying in Canberra and comparatively little effort into utilising more effectively the enormous professional talents within pharmacy?

• Discussion of business prospects and protection is relevant to extending the role of pharmacists in healthcare. An extended role of pharmacists will be essential, as future business prospects of pharmacists will be significantly influenced by contracting margins and increased competition.

• Features of pharmacies today which will come under challenge include the geographical restrictions, impending pressures on pharmacists’ margins, and the barring of pharmacies from supermarkets. Australians don’t have great love for the Coles/Woolworths oligopoly but they would love to see more competition. This lack of competition may explain why paracetamol can vary in price from $10.95 for 100 Panadol to $3.95 for almost the same produce sold under the Chemmart brand.

•    It seems inevitable that the highly protected pharmacy sector is going to face major changes.  The lesson of protection in Australia is that if you want to have a seat at the table when protection is being reduced, you must accept the need to change.

• Perhaps pharmacists might consider two categories of registered pharmacists. One would compose many of the long-established pharmacists who are reluctant to move away from the distribution model. The second category could be younger and differently trained pharmacists who will respond to a new model of professional practice which substantially extends their role into disease prevention and enhanced therapies. It would seem a possible way to overcome the environment which new and highly motivated pharmacy graduates apparently find so discouraging and dampening.

• It is quite remarkable that the PGA has consistently opposed direct relationships developing between GPs and accredited pharmacists. It insists that the relationship must be with the patient’s nominated community pharmacy. This is quite contrary to normal health referral practices.

• How can the disconnect between how pharmacists are trained and how most of them work, be remedied?

Menadue concluded: “Despite the rhetoric about prevention, are governments, their bureaucracies and the professions ready to implement prevention policies? The answer to me seems to be ‘not yet’. Some hard thinking is required all round.”

• You can read more about John Menadue’s arguments for reform of both the demand and supply of health services here.

That’s the question on health consultant Simon Burrow’s mind as he jetsets across the world. He’s picked up a few ideas from South Africa and the United States that he suggests might be useful/relevant for health reform in Oz.

He writes:

“The recent primary healthcare debate and financial arm-wrestling going on between the Government and the Pharmacy Guild could have some interestingly different results if only the powers-to-be would bury their self-interests and look elsewhere in the world.

A recent consulting trip to South Africa and the USA has revealed some activity which could be used in Australia.

Many of the restrictions on privatising and widening the scope of pharmacy and making healthcare more accessible to the wider community had their origin in South Africa in the late 1960s.

Driven by necessity with the need to accelerate the provision of basic health care to all people, the ANC government has embarked on a progressive dropping of the regulations allowing corporate ownership, but with strict pharmacological controls.

Despite the bruising of the SAMA (South African Medical Association) egos, two major chains (think Priceline and Terry White) have emerged along with a number of banner groups (think Soul Pattinson and Amcal).

Working closely with private medical insurance companies, the Health Department have imposed strict pricing and dispensing fees and a proliferation of Clinics, staffed by qualified nurses, in many of the pharmacies.

The community now go to the Clinics for their flu injections, baby counselling, and other basic healthcare. It works. The good independent pharmacies are thriving. The tacky, inefficient ones have died.

Move across the big Atlantic pond and it has been impressive to see how the US Health Department have harnessed the distribution power of the large chains (CVS; Walgreens; Rite Aid) to make the H1N1 flu vaccine available. Pharmacists are giving the injections and streams of yellow school buses arrive at the pharmacies for the children to be innoculated.

All this is happening as President Obama takes on the BIG one of American politics – healthcare. Even the Republicans are saying that they realise that Americans will have to contribute more. It’s scary that 40 million citizens do not have medical insurance.

Some lessons for Australia? I think so.”

Dr Ken Harvey, Adjunct Senior Research Fellow in the School of Public Health at La Trobe University, is reliably quick off the mark on these matters.  He’s already submitted a complaint to the Medicines Australia Code of Conduct Committee and has also sent the letter below to Mark Butler, the Parliamentary Secretary for Health. The letter is reproduced with Harvey’s permission.

Dear Mr Butler,

Re: Sigma Mediterranean Conference for GPs and Pharmacists; TGA and Ethical Codes of Conduct

I have attached advertisements and appended media coverage about this event which appears to breach Section 6.2 (hospitality), 6.4 (sponsorship) and 6.6 (venue) of Medicines Australia Code of Conduct.

However, Sigma, not being a member of Medicines Australia, has argued in the past that they are not subject to the provisions of Medicines Australia Code regarding such matters. I have also been told that the Therapeutic Goods Administration (TGA) supports Sigma’s view.

TGA’s letter of marketing approval requires the promotion of all prescription products (whether member or non-member) to comply with the requirements of the Medicines Australia Code of Conduct. In addition, the Therapeutic Goods Act 1989 notes that advertisement, in relation to therapeutic goods, includes any statement, pictorial representation or design, however made, that is intended, whether directly or indirectly, to promote the use or supply of the goods.

Clearly, the purpose of Sigma organising and promoting a 10-day Mediterranean cruise for doctors and pharmacists (with only one and a half days educational content) is to promote the use and supply of their products.

It seems self-evident that Medicines Australia Code should apply to this event and I cannot understand why the TGA has adopted a contrary view.

I should be grateful if, on my behalf, you could ask the TGA for an explanation of their ruling.

This Sigma event is yet another example of inconsistencies and double standards of Australian co- regulatory systems aimed at controlling unethical promotional practices.

Currently, Australia has a variety of complex and convoluted co-regulatory systems to control unethical therapeutic claims and promotional practices depending upon the type of product (innovator and generic prescription, over-the-counter and complementary medicines, therapeutic devices, food and cosmetics) and the media in which claims are made.

There are different standards and gross inconsistencies between various Codes of Conduct, their complaint processes, timeliness, transparency, sanctions, monitoring and effectiveness (see also: Harvey K. A review of proposals to reform the regulation of complementary medicines. Aust Health Rev 2009: 33(2); 279-285. )

In addition, the different jurisdictions involved in therapeutic claims made for “nutraceuticals” (functional foods) and “cosmaceuticals” (cosmetics) create additional problems.

It is time that this mess was simplified and unified by creating one Code applicable to all therapeutic claims and promotional practice; 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. The process should be overseen by government, funded by industry (using a moiety of product registration fees), and administered by an independent committee representative of all stakeholders. The system should have a legislative base in the Therapeutic Goods Act &/or regulations and be capable of being enforced. South African legislation provides a model of such a broader system (involving all types of medicines).

In May 2007, Australia (and other member states) adopted World Health Assembly Resolution WHA 60.16.5 on Rational Use of Medicines. This urged member states 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”.

I have proposed (to the recent National Medicines Policy Forum) that the National Medicines Policy Committee set up a working party to consolidate the multiple existing Codes into a single Code and draft suitable enabling legislation.

I should be grateful for your response to this proposal which, I believe, would be a practical demonstration of Australian commitment to WHA Resolution 60.16.5.

Yours sincerely,
Dr Ken Harvey

• Croakey will keep you posted on any responses to Ken Harvey’s letters

I wish I’d read it before giving a talk to health policy students at the ANU yesterday about lobby groups in health. Of course, you always end up preparing for these things at the last moment, generally late at night when the brain is frying rather than firing. I’ve already thought of some groups I should have mentioned but didn’t.

But here’s a quick summary of the talk anyway. Please add your additions and suggestions.

Lobby groups: professional

• The AMA is often called “the nation’s most powerful lobby group”, most recently in the SMH’s recent article previewing the presidential elections. Whether or not that is actually true is incidental, perception being reality. It’s who many journalists ring for comment on just about any development in health, whether or not the AMA spokesman actually has expertise in that area.

• The Pharmacy Guild. Their lobbying style is quite different to the AMA’s, as they operate largely behind closed doors and build their efforts around putting proposals and submissions into government. The national president Kos Sclavos once told me “we have more health economists than any other health group in Australia”. As well as 250 staff. But the real force is the reach of community pharmacy; it’s hard to think of a health professional with easier access to the community if governments get up their noses.

• Other professional and industrial organisations, ANF etc etc.

• There are also medical research institutes, but again their interests do not necessarily align with the broader public interest – often they are so reliant on industry funding, they are reluctant to speak up if it rocks the apple cart.

Lobby groups: business

• Pharma is the most obvious. Generally they do a very good job of influencing media coverage of their products, but often this is through third parties, so may not be obvious to a casual observer. As an industry, their image has taken a big hit in recent years.

• Other medical industries, eg surgical and devices companies

• Complementary products sector is big business despite the general public often viewing them as the ‘goodies’ (for some strange reason)

• Private health insurance lobby has to be judged one of the most successful, given the level of government support they receive despite widespread doubts about the value and merits of their product. Private hospitals also seem to do pretty well.

There is often a convergence between many professional and commercial lobby groups’ interests; for example, pharmacists flogging“non evidence based products”, and eminent medical experts and institutions lending their names and authority to marketing campaigns (see the Crikey Register of Influence for specifics)

• The un-health lobby groups – tobacco, alcohol, and food industries, to name just a few. They arguably have more influence over the community’s health than those described above.

So who represents the public interest?

This is a much tougher question to answer, though many may claim they do.

• Disease-based lobbies. The problem is that they are often narrowly focused and encourage the silo mentality that plagues health. Such groups are sometimes unduly influenced by commercial or professional interests.

• Patient groups. Again they are often focused around single issues and some, eg breast cancer, get more attention than others. Even those umbrella groups such as the Consumers Health Forum are representing their members’ interests, ie patients and that is not necessarily the same as the broader public interest.

• Groups such as the Public Health Association and CHOICE are attempting to represent the public health interest, but do not necessarily represent the broader community’s views.

Who represents those in greatest need, whether underserved groups such as Indigenous Australians or underserved issues such as the social and economic determinants of health?

Groups working in this area tend to be over-stretched and under-resourced. They are minnows compared to some of the sharks above.

The conclusion from all this is that much lobbying serves to reinforce the status quo in which society’s institutions, including government, tend to operate for the benefit of the well to do. More and better advocates are needed to agitate on behalf of the public interest in health, and especially on behalf of those in greatest need.

But as I said, this was all thought through late at night and in a great rush – it would be nice to hear others’ thoughts on these issues.

.

“Agreements between not for profit research institutes and the pharmaceutical industry can be fraught with conflict, even if an iron clad contract is in place to ensure the independence of the parties involved.  The recent case of Sanofi-Aventis contributing 25cents per pack of Plavix sold in Australia to the Baker Institute is an interesting case in point.  Both parties are publically adamant that the funds are entirely ‘without strings’ and this is most probably true in the legal and contractual sense.  However, it speaks volumes that the 25 cents per pack is derived from the Plavix marketing budget.

Pharmaceutical companies are past masters at managing and manipulating social obligations and reciprocity for their marketing benefit.  Gifts engender a feeling of indebtedness on the recipient and a social obligation to reciprocate in some way to the giver of the gift.  In this way, the phrase “much obliged” has become synonymous with “thank you”.  Marketing expenditure in any industry is always associated with a quid pro quo for the ‘investing’ organisation – increased sales, as Ken Harvey highlights in his response.

In the case of the Baker Institute, this arrangement provides a guaranteed income stream, so the Institute would be commercially ‘mad’ to conduct any research that could jeapordise this arrangement.  While the Institute, according to public statements, legally retains its right to research whatever it likes, conducting research that may be unpalatable to Sanofi may jeapordise renewal of this agreement or the development of future agreements (with Sanofi or other companies).  Sanofi is a large pharmaceutical company with many commercially successful drugs, so the agreement using a ‘royalty’ from Plavix could provide leverage to reduce research in other areas such as diabetes that may adversely affect other drugs in its current portfolio or development pipeline.

Accountability would also be more complex with a corporation than the more well studied individual practitioner.  A practitioner will face clients and may be asked awkward questions in a one to one situation which may reflect on the trust of a patient in their practitioner.

Corporations are faceless entities which are also charged with a different charter – looking after the corporate bottom line (and shareholders, if applicable).  Therefore there is a different sense of public accountability for their actions.

In this case, it can be argued (and probably will be) that the Baker Institute was doing the best deal it could to generate research funds to improve medical research for the greater good of society.  One wonders if the contract will be released publicly to demonstrate the transparent nature of the agreement?”

Vitry’s comments are well worth a read:

1. Should health departments, hospitals, safety and quality groups be reviewing their support for these particular guidelines in response to the concerns raised in the MJA and elsewhere? If so, are there any particular actions you would like the various agencies to take?

Alasdair Millar describes a well researched case-study of what may happen when appropriate development procedures for clinical guidelines are not followed.  Unfortunately, it’s not a rare situation.

In my research on the quality of Australian guidelines, we found that guidelines that followed the NHMRC processes scored significantly better than those not approved by the NHMRC in all domains except for editorial independence and clarity and presentation (the declaration of conflicts of interests was not a requirement for NHMRC-approved guidelines when we did our study). Low-quality scores in the rigour of development domain raise concern about guideline validity.

In contrast with Prof Chris Baggoley’s opinion, I don’t believe that guidelines that don’t follow appropriate processes are preferable to the absence of guidelines.  Promotion of invalid guidelines may result in ineffective or unsafe treatments, or inefficient use of resources and it is the point that Alasdair Millar is making.

First, we must make clear that Alasdair’s criticisms focus on the use of preventive treatment for medical patients. He is not dismissing the usefulness of preventive treatment in many surgical patients especially in high risk surgical procedures. There would be no issue if the guideline development process was as simple as implied by Prof Baggoley: you have a good look at the scientific evidence and other international guidelines to produce your own guidelines. Unfortunately, this is not the case.

First, the quality of the evidence and the uncertainty around the validity of the results  need to be reflected in the wording and grading of the recommendations. There are a lot of uncertainties around the evaluation of preventive treatment of medical patients for the reasons explained very well by Alasdair.

Clinical trials tend to use asymptomatic DVT as the main assessment outcome and the value of this surrogate has been questioned because of the discrepancy between high incidence of venographic DVT and low risk of clinical outcomes such as death, e.g. in elective hip and knee replacement surgery (see many references here).

Second, guideline developers have to make decisions about the generalisability of the results to sub-groups of patients different of the patients enrolled in the trials. There are two options here that guideline developers may consider: either you match your recommendations with the inclusion criteria of the trials (“evidence-based” option favoured by Alasdair).

Or you believe that the benefits shown for particular subgroups in the clinical trials  could be extrapolated to other groups at high risk of DVT as shown in epidemiological studies (option favoured by the Australian Working Party).

This later option could be a huge gamble as demonstrated recently for other guidelines. The most recent example where this later option has been shown to be wrong was the recommendation in many guidelines to give low-dose aspirin to all type 2 diabetes patients based on the assumption that patients with type 2 diabetes will benefit from low-dose aspirin as type 2 diabetes is a very important risk factor for cardiovascular diseases but in the absence of good trial evidence showing that aspirin will benefit specifically patients with type 2 diabetes. Recent evidence has shown that it was not true.

Patients with type 2 diabetes without additional risk factors are more likely to be harmed than to be saved by aspirin. The point that Alasdair wants to make is that by widening the indications of preventive treatment for medical patients without good evidence you may end up harming people that you want to protect.

At the end of the day, making recommendations involve value judgements: is the expected benefit worth the potential risks? It is an area that the guideline developers must make much clearer than it is currently done. Health professionals need to be able to say clearly to their patients which are the risks of the different options.

It is where the conflict of interests (funding provided by the drug company who has a financial interest in the medicine recommended in the guideline, personal conflicts of interest of working party members) come into play.

How can health professionals and the public know whether the Australian Working Party made a “genuine” decision when they decided to widen the indications for preventive treatment of medical patients or whether they were consciously or unconsciously influenced by their ties with pharmaceutical industry?

Research has shown clearly that declaration of conflicts of interest will not be “the” answer. It is also the point made by Psaty for the interpretation of industry-funded clinical trials in his recent JAMA editorial.

I believe that in the case of guidelines, it is the same as for clinical trials: you need to have a critical look at the guidelines! It is what Alasdair did very nicely as a very concientious health professional. Also thanks to the MJA to have allowed the publication of his dissenting view. In my experience, it is not so easy to hold “dissenting” views in Australia as everybody knows everybody and you don’t want to hurt your friends/colleagues/employers…but healthy debates need to happen!

I would suggest that agencies that have endorsed the Working Group guidelines review as a matter of urgency their recommendation of treatment of medical patients over 60. These patients may be at high risk of DVT but also at high risk of bleed. What is the strength of the evidence for this group of patients?

2. Should such agencies also review their approach to endorsing and disseminating guidelines generally?

The issues for Australia are how to develop good guidelines with limited resources?

Professional organisations (including the Working Party) are given a hard time: they are criticised for the quality of their guidelines if they don’t follow the NHMRC processes but they cannot get appropriate funding for making guidelines in most cases. I am so admiring of organisations such as the Australian Cancer Network which try so hard to produce NHMRC-approved guidelines with so little financial (and emotional!) support!

So which are the ways forward? We proposed some in our article. Adaptation of international guidelines is an option (chosen by the Working Party) that avoids duplicating efforts when high-quality international guidelines are already available on similar topics.

However, this needs to be done well and there is no validated process for adapting guidelines produced in one cultural and organisational setting for use in another. NHMRC guidance in this area would be welcome to support the efforts of professional societies.

Second, a question that may need to be debated is whether the NHMRC methodological requirements for guideline developers have become too tough and too bureaucratic (see here for example) by comparison with so little attention devoted to the important issue of conflicts of interest?
Without appropriate public funding, guideline developers don’t have many other options other than relying on drug company funding with all the dangers that it involves.

In response to our article (and our criticisms of their guidelines), the Heart Foundation has called for a strong and robust national framework for the development and implementation of guidelines.

At the NHMRC, NICS will be in charge of the clinical guidelines from July this year. Will they have more resources than their predecessors? What are their plans? Do they plan to consult publicly the different stakeholders?

In the meantime, agencies need to be very careful before endorsing guidelines. The best advice I would give is to do what we do at the Australian Medicines Handbook, have a look around for other “good” independent (no industry funding) international guidelines. Some such as the ones produced by the UK organisations, NICE and SIGN, have very good development processes.

Then, you need to have a closer look at the areas where there may be a lot of clinical uncertainty or conflicting recommendations between guidelines. It’s not to say that “international consensus” offers some guarantee as most guidelines could be wrong at the same time (see aspirin example above) and it may be so hard to be the “dissenting” voice and to be able to make your disagreement published in medical journals!

3. Should health and medical groups producing guidelines accept funding from interests with a commercial stake in the guidelines’ recommendations?

Health and medical groups producing guidelines should not accept funding from interests with a commercial stake in the guidelines’ recommendations. The risk of bias is much too high and there are two many examples of biased guidelines because of industry funding. It is already so difficult for independent experts to make an appropriate assessment of the scientific evidence because of the importance of publication bias. In my opinion, it is better not to do “Australian” guidelines (but critically assess independent international guidelines) than to rely on industry funding.

I could make a long list of recommendations in Australian non-NHMRC guidelines that don’t stand a critical look.

4. Would you like to make any other comments?

It is time for professional  and charity organisations in Australia and clinical experts involved in these organisations to review their policies with regards to industry funding.

Industry funding does not only increase dramatically the risk of bias but it increases the risk of suspicion from the public. It is not so easy to do in a country like in Australia where “partnership with industry” has been presented as the best way forward to deliver the best health and industry outcomes for the country (see the National Medicines Policy).

It’s time to have a good discussion on what is acceptable in partnership, what we cannot expect from partnership, etc.  I believe that this is an urgent issue to look at for the newly created National Medicines Policy Committee.

Personally, I don’t think that we can take the risk to have the pharmaceutical industry involved in the production of medicine imformation for consumers and health professionals.

Professional and charity organisations which accept and request such funding are at high risk of becoming compromised at one stage or another. They are at high risk of being dragged in a position (most often unconscientiously and that is the problem) where they would recommend harmful treatment or treatment to a much wider population than justified by medical evidence.

“It’s a well known fact that if you want to break a wall down quickly, place
a pharmacist on one side and a bag of money on another. Demolition will be
quick.

Yes, pharmacists should serve the community and it’s been a well-worn argument
by the Guild in their $15 billion negotiations with the sitting Government
every five years.

However, how do you reconcile the steady march of super-pharmacists
who sit in their offices in Melbourne, Sydney and Brisbane, hocked to the
eyeballs with debt owing to self-serving  wholesalers (in return they dispense
the favour of giving them their distribution business), and to the quasi-chains
(or buying groups as they are delicately named)?

These super-pharmacists employ young, usually Asian female, pharmacists as employees to push the pills and ensure that ‘turnover’ and ‘number of scripts filled’ is raised
each week. Often, the brand/banner owner (usually one of the wholesalers)
provides the ‘retail manager’ who ensures that everything runs smoothly and
profitably for the owner and brand owner.

But, is this community pharmacy? Is this why the Guild continues to hang
onto the last vestiges of regulations and not allow free market forces to
operate – to allow selected pharmacists and peripheral industry players to
pile more feathers on to their nests?

It’s an elitist and self-serving situation.  Surely, this is not what Australia is about?

In a recent visit to Singapore, I saw the free market system at
work. Dedicated pharmacists providing a high level of service and patient
care and well-run, clean and modern pharmacies. As an aside, they’re profitable
too!

Surely, Ms Roxon, we should be opening it up; allow the brands to flourish;
allow other entrants into the market BUT, concentrate on upping the ante
with regard to provision of information, proper patient counselling, take
some of the strain off the GPs and allow pharmacists to give ‘flu injections
and the like.

That way, the professionals will do what they are trained to do and the businessmen can ensure a robust PBS.”

• Simon Burrow trained as a schoolteacher and journalist before embarking on a career in health and beauty retailing for over twenty years. He is now consulting, predominantly in health and beauty, and works in Australia, India, Singapore, South Africa and France. He is best known as the brains behind both the Clicks (South Africa) and Priceline (Australia) customer loyalty schemes — ClubCard.