It took three years to complete. Professors, physicians and philosophers collaborated with Australian and New Zealand transparency and ethics compadres, labouring on the latest edition of Guidelines for ethical relationships between health professionals and industry.
This document serves predominantly as the ethical guidebook for fellows of the Royal Australasian College of Physicians (RACP), and in its 20-year history has been adopted as the benchmark template by comparable medical professional bodies in Australia and around the world. The 4th edition is stricter in its recommendations than that produced in 2006 and targets a kaleidoscope of new tactics that medical industries, including drug companies, use to influence doctors.
However, the guidelines themselves now pose an ethical dilemma for the college. The executive has intervened to prevent a draft of the latest edition from undergoing public scrutiny that is a time-honoured — and according to advocates — essential part of the process.
The draft guidelines were posted on the RACP website on September 4, with a request for public comment, but within three days college administration removed all trace of the document. For a group of ethicists and transparency advocates, undermining the public-consultation process was akin to a hog-tying — a hostile takeover.
At the same time, it emerged that the ethics committee responsible for the guidelines had been quietly disbanded, as part of a variety of measures aimed at replacing the painstakingly democratic process of old, following a corporate restructure in 2008 which made the board and executive the hub of power.
In the past month, three open letters have been sent to the board, which question its actions, specifically the board’s removal of the consultation draft from the RACP website, and the simultaneous disbanding of the ethics committee of the college, without notifying its members.
Insiders suggest that college president, Dr Les Bolitho, himself shut down the public-consultation process. Bolitho could not be reached for comment as he is on leave. However, a statement from the college says: “It is inappropriate to comment prematurely on the draft document until it is considered by the College Board and finalised. When this occurs, the document will be released to the public”. It also says that the draft had been sent to “college bodies” and to “external individuals” for consultation. It does not say whose decision it was to remove the guidelines from the college website and change the review process without consulting with the ethics committee.
A spokesman for the RACP told The Global Mail that the college no longer intends to have a public-consultation process, but will instead release the guidelines after an internal consultation. “The College will always adopt and advocate for an ethical approach and has robust structures and processes to ensure it lives up to this commitment,” says the college executive spokesman.
As a continuation of our series Drug Money, which shines a light on the relationship between medical professionals and industry, The Global Mail is publishing the draft guidelines, in the belief that the agency of the final guidelines relies on transparent exchange and community debate.
Keep in mind, the guidelines are not rules or laws; rather, they’re like the Jiminy Cricket on a doctor’s shoulder, guiding the complex interactions that doctors have with medical industry.
College members are specialist physicians — the extremely influential doctors who inform health policy and prescribing from the top down. As such, pharmaceutical companies want these opinion leaders on their advisory boards, supporting new medicines; and medical-equipment manufacturers 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.
Read the guidelines below and leave a comment on this story. Or send your feedback to the college.
One of the major changes evident in the updated guidelines, is that they label doctors’ use of free drug samples as “inappropriate”, and declare that by accepting the samples they’re taking part in what is “primarily a marketing exercise — intended to create a relationship of reciprocity between the clinician and industry representative, or to establish a cohort of patients on long-term treatment with a particular drug”.
The guidelines also expand their definition of the medical industry to include complementary medicines companies (vitamins and supplements), not-for-profit sectors of the industry (community groups and charities) and sectors not previously captured.
It offers a new section addressing “E-health and the use of medical software containing advertising”, and warns that companies are inserting covert advertising into such programs. (Direct-to-consumer advertising of prescription medicine is banned in Australia.)
One organisation that has been consulted about the guidelines is the The Royal Australasian College of Surgeons (RACS), which has given the new edition its nod of approval. President of the RACS, Associate Professor Michael Hollands, pledged his college’s support of the guidelines in a letter to Dr Bolitho. “Should you wish,” he writes, “we would be happy to co-badge your document if you consider that helpful”.
Dr Ken Harvey, a transparency advocate who contributed to the guidelines says: “It’s clearly much stronger than the last one. It's really saying you shouldn't accept hospitality, you shouldn’t accept free samples ... but it’s nothing that’s not in the mainstream of public debate.”
However, Dr Ian Kerridge, a bioethicist, who had been on the RACP’s Ethics Expert Advisory Group, and is author of one of the open letters to the college board, worries that the way in which the RACP went about changing the process of updating the guidelines has damaged the reputation of the college itself.
Kerridge heard that the ethics committee was to be disbanded "on the grapevine...I hadn't heard anything from the college at all telling me that my services were no longer required."
In his letter to Dr Bolitho, on September 18, Kerridge wrote: “This came as an enormous shock, given that there has been no correspondence from the college to me or, as far as I am aware, to any other members of the Ethics Expert Advisory Group.”
Kerridge’s rather poetically expressed letter addresses the fundamental necessity of self-scrutiny by medical professionals, medical industries and everyone involved in health care. He writes, “Health care is ultimately a moral exercise and not simply a scientific or political one – and reflection upon the ethics of medicine is as old as medicine itself.”
All of the college’s Expert Advisory Groups were abruptly disbanded in August and, as yet, few members have been informed. In fact, as far as The Global Mail can ascertain, the larger community of 14,300 physicians has not been notified of any such changes.
Professor Paul Komesaroff is one interested party who did receive such notification. Komesaroff, an endocrinologist, had had an unbroken association with the different manifestations of ethics committees of the college since 1991, and had run them for 20 years until he received a letter from Dr Bolitho telling him that the ethics group was to be disbanded and that an “ethics working party” was instead being created to finish the 4th edition of the guidelines.
In a personal open letter to the college board, Komesaroff asks the board to reconsider the decision, “on the basis that it has the capacity to cause serious damage to the college and its national and international standing”.
Another letter, written by Komesaroff and signed by 11 other members of the ethics group and guidelines working party, despairs at the sudden change in the public-consultation process: “Public consultation is now regarded as critical in the development of important policy documents, but certain conditions are required to ensure that the consultation process is valid,” writes Komesaroff. “We seek your assurances that the integrity of the public-onsultation process will be protected.”
He has had no response to either letter but could not speak about the issue, having been told by the college that all media interaction about the guidelines should go through Dr Bolitho.
Dr Peter Brooks, rheumatologist and professor at the University of Melbourne, is a signatory to Komesaroff’s second letter and former secretary of the college.
He says the guidelines are, “something that medical groups need to get right because the relationship we have with the pharmaceutical industry is a very important one, but it’s one that has enormous potential for possible harm to patients”.