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The Baker, the NHMRC and conflicts of interest

Following the recent post about the Baker IDI Heart and Diabetes Institute’s latest foray into pharmaceutical marketing, Croakey asked both the Baker and the NHMRC for comment.

No word yet from the Baker, but Professor Warwick Anderson, ceo of the NHMRC, sent this comment:

“The Australian Code for the Responsible Conduct of Research (issued jointly by NHMRC, the Australian Research Council and Universities Australia) applies to all institutions receiving NHMRC funding, and includes a chapter on conflict of interest, aimed at all disciplines (not just health research).

As far as relationships between clinical researchers and the biotech and pharmaceutical industries are concerned, NHMRC Council’s advice will be sought in September on the ideas that arose at the NHMRC workshop on conflicts of interest, held in June. This will include advice on the need for national principles to help guide ethical relationships between clinical researchers and private sector organisations, such as biotech and pharmaceutical companies.”

For those interested in knowing more about the NHMRC workshop, held in Canberra last month, here is a short report I filed for the British Medical Journal about it.

Australian researchers, universities and other research institutions are likely to face new measures aimed at ensuring conflicts of interest are managed more effectively.

The National Health and Medical Research Council (NHMRC) will consider recommendations that it require researchers to publicly declare conflicts of interest on university and other institutional websites.

The Council has also been asked 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 suggestions were made by senior researchers and NHMRC members attending a “transparency and conflict of interest” workshop convened by the Council in Canberra on June 3.

“The ideas that came up are all worth consideration and we will take those ideas to our Council over the next six months, “ the NHMRC CEO Professor Warwick Anderson told the BMJ after the workshop.

The Council is also developing new standards for management of competing interests in clinical practice guideline development, and has evidence these are poorly managed at present.

A broad-ranging survey of clinical practice guidelines, involving 313 produced in Australia between 2003 and 2007, 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.

Dr Heather Buchan, an NHMRC advisor who conducted the survey, said a US study had found most guideline authors had competing interests, and that the new standard was likely to require documentation of how conflicts were declared and managed.

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.

“Today’s meeting is an example of NHMRC’s commitment to good practice in this area,” he said.

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 Skepticism, 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 follows recent controversies in Australia 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.

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