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Drug Money

Ethical Triage For Doctors

New, stricter guidelines on how doctors should handle the potential conflicts of interest, when interacting with the medical and pharmaceutical industry are in the process of being finalised, but the ethics body that was debating the conundrums involved has been ditched.

Managed by the Royal Australasian College of Physicians (RACP), the group developing the fourth edition of the benchmark Guidelines for Ethical Relationships Between Health Professionals and Industry has recently undergone changes that caused a furore among college fellows. The controversial draft guidelines, three years in the making, urged doctors not to accept free drug samples, nor to enjoy free hospitality from medical industries courting influence with the physicians.

But just three days after the heavily revised guidelines were made public in draft form, they were removed from the RACP website, prompting The Global Mail to report on the turmoil behind-the-scenes.

Within 24 hours of the article’s publication, the president of the college, Associate Professor Les Bolitho, submitted a letter to The Global Mail taking issue with our report, saying the ethics group once charged with the job is being replaced by “time limited and purpose driven Working Parties”.

To the confusion of some members of the ethics group, Bolitho’s letter to the editor says the group will continue until the end of the year and complete its review of the guidelines.

“They’ve either disbanded these EAGs or they haven’t.”

The hair being split here is whether or not the Ethics Advisory Group (EAG) that would have finalised the guidelines still exists. The chair of the group, as evidenced by his protest letter on September 8, wrote that Bolitho told him it does not exist. Bolitho’s recent letter to The Global Mail says it does.

Bolitho has not responded to requests for an interview. The college and ethics group have been in dispute, circulating both open and private letters arguing that losing the group could “cause serious damage to the college and its national and international standing”.

Professor, physician, bioethicist and member of the ethics group, Dr Ian Kerridge, says, “There’s obviously an internal inconsistency in [Bolitho’s letter to the editor] … they’ve either disbanded these EAGs or they haven’t.”

The Global Mail spoke to several members of the ethics group; none had been informed of the changes outlined in the letter to the editor.

Kerridge argues the ethics advisory group — disbanded, as he understood it, or soon-to-be-disbanded, according to Bolitho’s letter — was far more suitable than the new model proposed by the college.

“I think the model that they’re pursuing deeply misunderstands the way that ethics work, both as a feature of medicine, as a social practice, and it misunderstands the idea that ethics are constantly about examining oneself.”

The college represents specialist physicians — the extremely influential doctors who inform health policy and prescribing. These opinion leaders are cultivated by pharmaceutical companies, who want the doctors on their advisory boards and supporting new medicines; and by medical-equipment manufacturers, who want their latest half-million dollar inventions in these physicians’ surgeries.

The guidelines not only inform the RACP fellows’ relationship with industry, but previous editions have served as a gold-standard template for other medical professional colleges in Australasia and around the world.

The new draft argued against the common practice of distributing free drug samples to patients, and against accepting industry hospitality. The Global Mail’s Drug Money series tracks data showing that pharmaceutical hospitality alone spends an average of $1 million a week duchessing doctors and other health professionals.

“Medicine is not simply a science and it’s not simply the domain of professionals. Health care is the domain of the entire community and all of these things are heavily value-laden.”

Bolitho’s letter says that the new working-parties approach would “allow a larger group of RACP Fellows and Trainee members to lead and contribute to policy work within the College”.

But Kerridge says the new model would potentially operate “according to the priorities of the organisation itself rather than a reflective group that may involve people from outside of the College”.

He says that, “Medicine is not simply a science and it’s not simply the domain of professionals. Health care is the domain of the entire community and all of these things are heavily value-laden... ethics involves recognising all the non-scientific and non-clinical aspects of what we do.”

The draft guidelines were posted on the RACP website on September 4, with a request for public comment, but within three days college administration had removed all trace of the document without explanation.

Bolitho did not deny this in his letter but wrote that, “Publication of draft policies and guidelines on the RACP website is not the standard consultation procedure practised by the College.”

According to members of the ethics group, previous editions of the guidelines have been publicly aired for a couple of months with invitation for comment.

Bolitho added that the guidelines have been circulated to almost 100 internal and external organisations and individuals for feedback and comment.

Members of the guidelines task force say that while it may not be a standard procedure for other drafts in the college, extensive public consultation was undertaken for the last complete edition in 2006, and was expected for the new one.

Furthermore, a letter from members of the group to Bolitho criticised the comparatively small number of responses to the draft received by the college in the equivalent time period — 140 responses were received by the college in the first month of public consultation of the 2006 edition, while the new edition had received just five responses in the same time. They blame the diminished feedback on the college’s removal of the guidelines from the website.

Sources have said the decision to disband the ethics group was taken by Bolitho. His letter says it was a decision of the college board, based on a college-wide review of committees. When Bolitho was unavailable for an interview last week we asked for a replacement spokesperson, but no other members of the board, executive or college fellows were proffered by the organisation’s communications unit.

Bolitho’s letter to the editor also claimed there were “factual inaccuracies” in The Global Mail’s coverage of the RACP’s new approach to the guidelines. TGM has sought further clarification from the RACP about any points of inaccuracy. We also asked for more information about the “College-wide review”. Neither the college nor Bolitho has answered our questions. Our offer to visit the College’s Sydney headquarters to read the review of committees was not accepted.

Bolitho’s letter has caused TGM to correct one fact in the story.

The Global Mail published that the RACP has 13,500 members, information sourced to the college’s website; the page “About the RACP” says it has 13,500 members.

However, Bolitho writes that there are “14,300 Fellows” and “6,500 Trainee members”. This has now been amended in the original story.

14 comments on this story
by Colleen

“Publication of draft policies and guidelines on the RACP website is not the standard consultation procedure practised by the College.” Really? It was certainly the standard consultation procedure when I worked there. It is also the standard way most organisations seek feedback on policy documents, be they public, private, small or large. In fact, they seem to be using the RACP website for consultation right here: http://www.racp.edu.au/index.cfm?objectid=EB4C75FE-D949-CFFC-D32DE62BD56110F3

October 15, 2013 @ 9:18pm
by Terry Wall

Well done Clare. Hang in there and let the sun shine in!!

October 16, 2013 @ 1:01pm
by Tom Kelly

It is goods that this College has even attempted to deal with this important issue. However, it is a voluntary organisation, comprised of a small minority of all Australian doctors and which has no resources to investigate breaches of any ethical code it may ever develope.
However, the Medical Board of Australia is the government authority that regulates all doctors throughout Australia and to whom doctors must all submit to annual registration. Has it ever defined and prohibited improper relationship between doctors and drug companies, the breaching of which would result in disciplinary charges and deregistration?

October 16, 2013 @ 1:49pm
by Colleen

Tom - the problem with the College is that it is not voluntary. If doctors do not pay their annual fees, they are unable to use the letters FRACP after their name, and therefore unable to bill Medicare under the schedule. It is this that gives them their monopoly. It's a mad system. I can't imagine my university charging me annually for my law degree and taking it away if I fail to pay them. I paid for it as I did the study and the uni declared I had met the standard and fit to go off into the world. If the College wants to continue their system, they must prove they have an ongoing roll in standards, competence, ethics and oversight after specialist training finishes.... AND be prepared to hold doctors to account.

October 17, 2013 @ 8:23am
by pharmabeaware

Dear Tom
As a consumer of health care I am very reassured that Physicians are being watched by the Medical Board of Australia, I haven't seen their policy on ethical interactions with the pharmaceutical industry. I would like to know more about how the Medical Board goes about regulating their physicians in terms of investigating breaches

October 17, 2013 @ 8:32am
by Tim

Colleen - the RACP is very different from a university that awards a medical degree. Universities awards medical degrees which then cannot be retracted, but do not in themselves qualify you to practice. Only medical specialists (cardiologists, neurologists etc, not GPs, surgeons or the like) are members of the RACP. It is appropriate that there is monopoly professional governance for this group - it would be very difficult for a non-neurologist to accredit the ongoing medical education of a neurologist for example, or assess the appropriateness of their practice. This kind of self-governance is more or less definitional for professions and is the same model followed by lawyers, accountants, etc. The RACP is the right body to govern the clinical practice and ethical conduct of medical professions, and should have a monopoly on that. The medical profession really compromises itself when it is slack about conflict of interest, and its disappointing to see the RACP apparently being so soft in this issue, and being so non-transparent about it's decisions and processes.

October 18, 2013 @ 11:56am
by Withheld

I am a Fellow of the college and frankly this is appalling behaviour. The fellows who work in these committees give their time and expertise for free. To have the board take over this work and discard these fellows is disrespectful and rude.

October 18, 2013 @ 7:14pm
by Colleen

Tim - the RACP do not assess ongoing competence of physicians, nor do they credential physicians to practise. They auspice an ongoing medical education web platform, sure - but they don't provide or assess any of the medical education activities claimed by its members on that platform - it is entirely a self report system. The burden of assessing ongoing assessment of ability and credentialling (and the responsibility for same) falls to hospitals and the Medical Board (AHPRA) - just like the Law Society controls the ongoing competence and licensing of lawyers. The training body (a uni or the College of Law - the equivalent practical training post law degree that allows you to be admitted as a solicitor) have no ongoing role in assessing your competence - neither does RACP for physicians. The unusual monopoly RACP have purely relates to its authority over the people chosen to train for and enter the profession (be they physicians they have trained locally or overseas trained doctors seeking to be recognised) and a physician's ability to charge fees once he or she 'is in'.

October 19, 2013 @ 9:17pm
by Tim

Not really correct Colleen - you cannot become a physician except by passing the exams and assessments of the RACP. To become a neurologist for example you have to complete an intern year, then 3 years of basic physician training under the auspices of the RACP, then pass some fantastically difficult exams administered by the RACP, and then complete 2-3 more years of specialist training also under the auspices of the RACP. It is not legal to claim to be a physician or to practice as a neurologist, cardiologist, etc except by going through this process and then maintaining accredited continuing medical education. As you say a lot of this CME is self reported and is very problematic; a lot is muddied by pharmaceutical industry interests. It is actually not at all difficult to enter physician training - places are available for the vast majority of most who finish their intern year and want to pursue physician training. The difficulty is getting through the training program, and passing the exams, which is appropriate. I can't really think of a group other than physicians who would be able to assess trainees on whether or not their performance in these examinations is satisfactory or not, so there is some merit in self-regulation to this extent. I don't think its very informative to talk about the monopoly at this level. This monopoly power is not really unusual, its true of all the other medical specialties including GPs, emergency physicians, radiologists, etc. AHPRA have a role in assessing one's right to practice medicine at all, but no role in adjudicating fitness to practice in any particular field. In each field that responsibility falls to the relevant college.

October 21, 2013 @ 3:40pm
by Colleen

Sorry Tim, I think you miss my point.

I don't dispute that to become a physician with RACP you have to pass through very difficult exams, both at BPT and in advanced training - not to mention the gruelling hours of the actual apprenticiship in the hospital. RACP set high standards for the getting of those qualifications, sure. I have no issue with the training and granting of the qualifications as a physician, for the purposes of this discussion.

I am trying to explain that after all that hard work and exams you can finally been given the post nominals FRACP - you are a Fellow - and you can work as a consultant physician (be it in cardiology or respiratory medicine or whatever your specialty). You register with the Medical Board as a specialist and continue to register with them every year. This is the regulator that is responsible to the public for ensuring the competence and safety of doctors. However, unusually, simply to keep the right to use those letters you earned (FRACP) after your name, you must also continue to be a paid up Fellow of the College, i.e. you have to pay RACP membership money every single year. For what purpose?

The only reason people have to keep paying that fee is to keep the letters. Why would you, you wonder? I'll tell you why. Because if you don't, you can't participate in standard medical practice through billing patients under the Medicare Benefit Schedule. If you're in private practice or having a MBS billing option under your public hospital specialist contract (which many, if not most, do), and you have not paid your RACP annual subscription, you don't have the right to use those letters, so you cannot bill as a consultant physician for any items in the MBS under the Health Insurance Act 1975. FRACP is listed as the requisite qualification in Schedule 4 of the Health Insurance Regulations 1975. What do they do for that money? The major incentive to pay (other than the joys of being involved in College life and serving on its Committees and Boards) is to keep your post nominals and therefore, your billing rights.

October 23, 2013 @ 11:52am
by Tim

Right, I see what you're getting at. I don't think the current arrangement is obviously problematic though. How else should we decide who can bill as a consultant physician if not with reference to fellowship of the college? And who cares how much physicians (ultimately) choose to charge one another to remain members of their own college? Don't see how it would improve things if this bar to accessing a billing schedule was removed.

October 24, 2013 @ 1:57pm
Show previous 11 comments
by Colleen

I would presume it should be those that are registered with the Medical Board in an appropriate category that can charge under the MBS. That is the industry practising certificate, after all. The College should be a membership organisation only after training - and yes, who cares what they charge. If people see value in being a member when it is not tied to their billing rights, they should be free to voluntarily pay their subscription. I just don't know if I would.

November 1, 2013 @ 11:09am
by LF Ng, FRCP

@ Clare, Colleen and Tim: Good ongoing discussion. Just come across this article. Well done! I must be one of the few Physicians in Oz who do not wish to have FrACP behind my name for several reasons - mentioned in a private overseas publication by a mate of mine: www.tiny.cc/PrimaryLink

FYI I can bill Medicare by virtue of my recognition under s3D of the Health Insurance Act 1973 and I successfully do. The Act has been amended several years ago (but not proclaimed - hence it is not law) to remove the FrACP as an exclusive qualification for this purpose.

The rACP is a private limited company, incorporated on 1 Apr 1938 in NSW. The 'royal' prefix is permission to use given by the British monarch, George VI and, strangely is managed by Buckingham Palace - not the GG's Office.

The implication is that give sufficient public complaints to Her Majesty, the permission to use this prefix may be rescinded - a Royal " excision" and thus the implied collapse of the company!

The bottom line is that the days of the rACP are numbered :-)

November 2, 2013 @ 10:57am
by ANON

Some years ago, whilst working (in professional exile) outside Oz, I was invited to chair a Pharma sponsored oncology symposium session (unrewarded apart from the flight and hotel like everyone else) when I met a previous Melbourne teaching hospital-based peer reviewer who was quite happy to admit publicly during his presentation that his trip with his wife was funded by a multinational for his wedding anniversary!

When he realised who I was and remembered that he had unfairly recommended to the rACP to extend my peer review period based on his own bias (rather than the ethical science), he made himself scarce from the rest of the meeting!

Others will tell stories from other Australian colleges.

November 2, 2013 @ 8:02pm
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