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Call for a review of pharmaceutical regulation

The organisers of a forum on pharmaceutical regulation, to be held in Adelaide on Thursday, are promising a “robust discussion”.  I hope there are plans for a podcast as I’m sure there will be plenty of interest in the debate.

Healthy Skepticism is hosting the panel discussion, at the Women and Children’s Hospital, to examine questions such as:

• Do partnerships with industry (as set out in Australia’s National Medicines Policy) bring about better health  outcomes?

• What are the strengths and deficiencies of our current system of regulation?

• Do the Therapeutic Goods Administration and state regulatory authorities have the political support and resources necessary to maintain objectivity?

• Is public access to regulatory processes and decisions sufficient to properly evaluate the operation of the policy?

The panellists will be:

  • Hon Mark Butler MP, Parliamentary Secretary for Health
  • Emeritus Prof Lloyd Sansom, AO, Chair, Pharmaceutical Benefits Advisory Committee
  • Assoc/Prof Chris Doecke, Director of Pharmacy Services, Royal Adelaide Hospital
  • Emeritus Prof Peter McDonald, AM, retired Infectious Diseases physician
  • Dr Agnes Vitry, Senior Research Fellow, School of Pharmacy and Medical Sciences, Uni SA
  • Dr Ken Harvey, Senior Research Fellow, School of Public Health, La Trobe University
  • Dr Jon Jureidini, Head, Department of Psychological Medicine, Women’s & Children’s Hospital, and Chair, Healthy Skepticism
  • Dr Peter Mansfield, OAM, GP and Director, Healthy Skepticism

The session will be facilitated by Prof Anne Tonkin Director, Medicine Learning & Teaching Unit, Adelaide University.

And here is the statement announcing the forum:

Healthy Skepticism, the international campaign against misleading health marketing, today called for a major review of government controls of medicines in Australia.

“Vioxx killed more Australians than the Victorian bushfires. Just as we re-think bushfire preparedness, it’s time we re-examined how well the public is protected by pharmaceutical regulation,” said Dr Peter Mansfield, the organisation’s director.

Australian regulatory processes failed to prevent the Vioxx disaster a few years ago because of failure on several fronts: “Drug regulators did not warn prescribers appropriately about potential cardiovascular risks. The Pharmaceutical Benefits Scheme did not limit unjustified drug expenditures. … Drug companies ran intense and misleading promotional campaigns. … Independent drug information was insufficient to counter the effects of the millions of dollars spent on advertising.”1

Dr Agnes Vitry (School of Pharmacy and Medical Sciences, University of South Australia) says that although Australia has a strong National Medicines Policy compared to most other countries, there are concerns that Australian regulators’ dependence on fees paid by drug companies might create a situation where they are more focused on serving the industry rather than prioritising the interests of public health e.g. by fast-tracking assessments without appropriate data to assess safety issues. The medicines agency requires more power and resources to ensure that safety is actively monitored after drugs are approved.

There are also concerns about Australia’s reliance on industry “self-regulation” to control the advertising and promotion of medicines. As Dr Ken Harvey (School of Public Health, La Trobe University) says, “The focus on self-regulation has produced a plethora of industry codes and complaint systems which makes it difficult for complainants to know where to send a complaint. There are gross inconsistencies between various codes.”

Healthy Skepticism would like to see much more streamlined and effective system, capable of meaningful constraint of companies like Pfizer, whose inappropriate marketing recently prompted US courts to order payment of $2.3 billion.

By contrast, as Harvey says, “Pfizer Australia has had 17 complaints against Medicines Australia (MA) Code of Conduct upheld during 2005-09. Although one of these complaints received the maximum fine of $200,000, over this time the fines only averaged $50,000. There is no evidence that such modest fines have reduced Code violations by Pfizer or other member companies. “

1. Vitry A, Lexchin J, Mansfield PR. Is Australia’s national medicines policy failing? The case of COX-2 inhibitors.  Int J Health Serv. 2007;37:735-44.

More details are available here.

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