FULL disclosure of the relationship between therapeutic goods companies, doctors and other stakeholders is currently in the hands of the Australian Competition and Consumer Commission.
Amendments Medicines Australia has proposed to its Code include companies providing aggregate reports on any payments made to health care professionals to act on advisory boards and provide other consulting services, with the information to be made publicly available on the Medicines Australia website every 6 months, but without naming individual doctors.
At a pre-decision conference with the ACCC earlier this month, Associate Professor Ian Haines (senior medical oncologist and palliative care physician at Monash University), Bruce Arnold (law lecturer at the University of Canberra), Ray Moynihan (journalist, author and academic researcher), Carol Bennett (chief executive officer of the Consumers Health Forum) and I argued that it is vital this code includes full disclosure.
An example of why this is necessary comes from the US. There, a Senate Finance Committee investigation found the medical device company Medtronic was heavily involved in drafting, editing and shaping the content of medical journal articles authored by its physician consultants, who were paid more than US$200 million over 15 years by the company, through royalties and consulting fees.
Committee chairman Senator Max Baucus said Medtronic’s actions “violate the trust patients have in their medical care”.
In a response to the Senate report, representatives of the North American Spine Society asked: “If surgeons had known that the lead authors of the 13 original studies on InFuse [the Medtronic product] had received payments ranging from $1.7m to $64m from Medtronic and that its marketing employees were co-authors and co-editors, would they have been as eager to use this product on their patients?”
Hence the need for full disclosure of such arrangements.
This is just the latest in a series of scandals that has cost the US therapeutic goods industry more than US$20 billion in fines in the past few years.
A recent feature article in Scientific American also highlights the problem of scientific institutions and scientists themselves not policing financial ties with drug companies.
At the meeting with the ACCC, my colleagues and I pointed out that if no changes were made to its draft determination and the 17th edition of Medicines Australia Code is authorised for another 3 years, then Australia will fall behind the level of transparency that will come into force in the US next year as a consequence of the 2010 Physician Payment Sunshine Act.
This is unacceptable.
I tabled a petition that currently has more than 420 signatures and asked the ACCC to make the following changes to its draft determination:
- Reduce the period of authorisation of the Code of Conduct from three years to one year.
- Request Medicines Australia to submit a revised code to include arrangements covering transparency of relationships between the pharmaceutical industry and individual health professionals for authorisation at the end of 2013.
- Ensure that Medicines Australia increases the number of informed critics of their current Code regarding transparency matters on the transparency working group.
I pointed out that while most of the petition signatories are Australian health professionals or concerned consumers, the interest in changing the current Code goes beyond Australia’s boundaries, to include a number of international signatories.
This is because Australia’s medicines policy is regarded as an exemplar in our region and there is international support for the ACCC to strengthen the Medicines Australia Code along the lines requested.
If there are no changes to the draft determination, aggrieved petitioners will ask for a review of this determination by the Australian Competition Tribunal on the grounds that the limited public benefits do not, in our view and on expert advice, outweigh the anticompetitive detriments of the deal.
Medicines Australia argues that its members supported increased disclosure and its transparency working group was set up to explore various models whereby this might be achieved. However, they believe the issues are complex, the cost of compliance high, and the benefits unclear, and more time is needed to find the right way forward.
My response? Medicines Australia’s concerns reminded me of Saint Augustine’s prayer: “Oh Lord, give me chastity, but do not give it yet.”
The ACCC is expected to make a final determination on these matters before the end of the year. Let’s hope the outcome is a win for transparency.
Dr Ken Harvey is adjunct associate professor at the School of Public Health, La Trobe University. He can be contacted via www.medreach.com.au.
Posted 3 December 2012
POSTSCRIPT: The ACCC announced on 20 December 2012 that it had granted authorisation for edition 17 of Medicines Australia’s Code of Conduct for 2 years.