How to get full, meaningful disclosure

The world of medicine is about to take an extraordinary leap forward in transparency. In the United States, from 1 January 2012, by law, every pharmaceutical and medical device manufacturer will have to start recording every payment to every doctor. 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;1 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.1 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”. And to remove all doubt as to the lawmakers’ seriousness, companies that knowingly fail to disclose will face fines of up to US$1 million.

The Republicans and Democrats who drafted the Sunshine Act were responding to calls from groups like the National Academies of Science for much greater disclosure. After rigorously assessing a mountain of evidence, authors from the National Academies’ esteemed Institute of Medicine concluded that collaboration between industry and the profession brings the benefits of new treatments, but that financial ties “present the risk of undue influence” on doctors’ judgements, and potentially “jeopardise” patient care, public trust, scientific integrity and objective medical education. Its landmark 2009 report recommended an end to many of the financial ties, and full public disclosure of all of them.2

In Australia, there have been similar calls for some time,3 but little interest so far from the profession or government in legally mandated and meaningful disclosure. Yet the push for genuine openness appears to be mounting.

Already, the Australian Competition and Consumer Commission and the judiciary have forced pharmaceutical companies to disclose the details of all their hospitality for health professionals. As a result, the Australian public now knows, from the Medicines Australia member company reports (http://medicinesaustralia.com.au/code-of-conduct/education-events-reports/member-company-reports/), that there are something like 28 000 industry-funded events every year, with around a third of them in hotels, resorts and rather good restaurants — though, importantly, the names of the doctors who are dining remain confidential.

Just last month, a former pharmaceutical saleswoman who marketed medicines for four companies for more than a decade revealed that many of these dinners and lunches — far from being “educational” — were promotional opportunities where companies would pay specialists between $750 to $1500 to present, without the knowledge of their patients or the public.4

Dr Ken Harvey, Adjunct Senior Lecturer in Public Health at La Trobe University, says that a number of medical and consumer groups are calling for more Sunshine Act-style disclosure in Australia in submissions to the current Medicines Australia code of conduct review. And one global drug company has already broken ranks, flagging a willingness to disclose the names of all Australian doctors who receive speaking fees or attend sponsored dinners.5

Australian Medical Association president Dr Steve Hambleton, following the recent revelations, has initiated an internal review of disclosure policies — specifically looking at whether doctors who receive payments from drug companies should be ethically required to reveal them to their patients. When asked what mechanism might be used for disclosing speaking fees and free trips, whether wall-chart or website, he stated “It needs to be meaningful, it can’t just be token”.

The aim, of course, is not transparency for its own sake, but rather, to shine a light into some of the dark corners in order to start cleaning them up. Along with disclosure, the US Institute of Medicine report recommended a range of disentanglement strategies: an end to accepting all gifts and meals; education free of industry influence; and guideline panels free of individuals with conflicting interests.2

Tinkering with codes of ethics is a pusillanimous response in comparison with the legally mandated transparency that could flow from the equivalent of a Sunshine Act in Australia, providing valuable information that is standardised, searchable and easily aggregated.