Update 1 Dec: A response from the NHMRC has been added to the bottom of the post.
Note: If you want to comment on the NHMRC’s draft guidelines for identifying and managing conflicts of interest in clinical guideline development (and, as the post below suggests, they do need help) – the deadline is COB this Friday, Dec 2.
In mid-2009, the National Health and Medical Research Council (NHMRC) convened a “transparency and conflict of interest” workshop in Canberra, to hear suggestions for how researchers, universities and other research institutions might manage conflicts of interest more effectively.
Suggestions included requiring researchers to publicly declare conflicts of interest on university and other institutional websites, and for the Council to consider establishing its own conflict of interest committee to provide advice internally and to act as a reference for other bodies, and to require research institutions to establish similar committees.
The workshop also heard that the Council was developing new standards for management of competing interests in clinical practice guideline development, and that it had evidence these were being poorly managed.
I attended the workshop and wrote a short news story afterwards for the BMJ (subscriber only) quoting NHMRC CEO, Professor Warwick Anderson, who said: “The ideas that came up are all worth consideration and we will take those ideas to our Council over the next six months.”
More than two years later, there seems to be very little to show for the workshop’s discussions.
The Council recently released for public consultation a draft policy for those involved in guideline development, whether those internally developed by the Council or externally developed ones that seek NHMRC endorsement. Public comment on the draft policy closes at 5pm on Friday Dec 2.
Hopefully some useful submissions are being made. The draft seems to lack any strong sense of why this is an important issue (despite a survey presented at the 2009 workshop, involving 313 guidelines produced in Australia between 2003 and 2007, which found 79 per cent did not mention whether the authors had competing interests. None of those declaring conflicts gave information about how these were managed or the dollar-value of the financial relationship.)
It would also be useful for the document to have some comparison with the policies of similar agencies elsewhere.
On related themes, journalist and occasional Croakey contributor Ray Moynihan, writing in the Medical Journal of Australia, suggests that the Sunshine Act in the US may be a useful model for Australia.
It will require every pharmaceutical and medical device manufacturer to start recording every payment to every doctor in the US from next year and from the following year, the companies will have to hand over all that information to the government annually, and this will then be published in full.
The much heralded “Sunshine Act” provides a great model for meaningful disclosure at a time when Australian institutions are wrestling with bringing more openness to the financial relationships between doctors and drug companies. It encompasses everything: gifts, meals, entertainment, travel, consultancy, speaking fees, education, research and more; and it requires that companies publish the name and business address of any doctor (or teaching hospital) who receives a benefit from them, along with the cost. The information must be made available through a website that is “searchable and is in a format that is clear and understandable” and be “able to be easily aggregated and downloaded”.
Moynihan notes the landmark Institute of Medicine report recommending an end to many of the financial ties between industry and the profession, and full public disclosure. He says that despite similar calls in Australia, there has been “little interest so far from the profession or government in legally mandated and meaningful disclosure”.
That is certainly the impression one gets from the NHMRC’s activities in this area.
I have put the questions below to the NHMRC, and will post their response when it lands.
• Is the NHMRC still considering a more wide ranging effort to ensure COIS are managed more effectively by researchers? If so, what will this cover and when can we expect to hear more about it? Will these recommendations include the suggestion put to the workshop that researchers should publicly declare these on university websites etc?
• The proposed COI recommendations for guideline development don’t make a strong case for why this is an important issue that warrants tackling. Why not? Why is there no mention of the evidence, cited in the (BMJ) story, that COIs are not well managed now in guideline development? Why is there no summary of what other agencies around the world require?
Meanwhile, just to recap some of the comments from the June 2009 workshop:
Professor James Best, chair of the NHMRC research committee, said many of the arrangements binding researchers and industry – such as industry-funded trials, education, advisory boards and guidelines – were marketing tools.
Professor Bruce Neal, a Senior Director at The George Institute for International Health, which receives significant industry funding, said the issue was bigger than simply researchers’ previous conflicts of interest. Researchers’ chances of obtaining future industry funding could be influenced by how they reported the results of their independent, investigator-driven research, he said.
Professor John Hopper, of the University of Melbourne, said measures to address conflicts also needed to consider issues such as professional patch protection by authors and reviewers.
An independent nutritionist, Dr Rosemary Stanton, said effective management of conflicts of interest was essential for food and nutrition research and guidelines as this was an area rife with conflicts.
Dr Agnes Vitry, a Senior Research Fellow from the University of SA and a member of Healthy Scepticism, said she was concerned the NHMRC had not committed to implementing the recent Institute of Medicine’s report on conflicts of interest.“ Compared to the relevant IOM proposals for institutions such as NHMRC, we are far behind,” she said.
The workshop followed controversies over commercially-funded clinical practice guidelines for venous thromboembolism prevention, and a sponsorship deal between Sanofi-Aventis and the Baker IDI Heart and Diabetes Institute which was in breach of the Medicines Australia code of conduct.
In other NHMRC news, the Council has been celebrating its 75th anniversary this week, and the Chief Scientist Professor Ian Chubb told the event that researchers need to “take the care and the time to bring the community along with us”. This meant, he said, explaining scientific regulations and ethical arrangements…
Update, 1 Dec. Below is the NHMRC response to my questions
NHMRC has in place strong procedures for consideration of conflicts of interest in its processes for peer review of research applications. To strengthen COI processes, the NHMRC has also conducted a targeted consultation (in July and August 2011) for which we received 55 responses. The NHMRC is now considering broader issues arising from this consultation.
We are also awaiting responses to the full public consultation, which closes on 2 December 2011 before proceeding to the next stage of developing the advice on identifying and managing conflicts of interest.
The current consultation document clearly states that the “NHMRC views the identification and management of conflicts of interest as an issue of central importance in ensuring that there is no undue influence in decision making owing to a competing interest.”
The current consultation document also takes into account discussions taking place in other jurisdictions, and best practice as formulated and implemented by such organisations as the International Committee of Medical Journal Editors and the Institute of Medicine of the National Academies in the United States.
The opening paragraphs of the current consultation document states that:
“NHMRC views the identification and management of conflicts of interest as an issue of central importance in ensuring that there is no undue influence in decision making owing to a competing interest. Developing sound policies for the management of conflicts of interest is a prerequisite of ensuring public confidence in the integrity of guidelines and other advice issued by NHMRC.
In creating this document, NHMRC is cognizant of world-wide events such as failures to disclose interests and to publish negative results from industry-funded clinical trials; and of concerns that researchers and institutions may be compromised by undisclosed relationships with the private sector (for example, with drug and medical-device companies).”