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Healthy Skepticism Announcements

Closer look at drug regulation needed: Meeting Adelaide 24 Sep 2009

The Hon Mark Butler (Parliamentary Secretary for Health, Commonwealth of Australia) and Prof Lloyd Sansom (Chair of the Pharmaceutical Benefits Advisory Committee) will participate in a public discussion of pharmaceutical regulatory systems, hosted by Healthy Skepticism, this Thursday 24 September 2009 at 4pm at the Women’s and Children’s Hospital, North Adelaide, Australia

 

Closer look at drug regulation needed, says Healthy Skepticism

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.

The Hon Mark Butler (Parliamentary Secretary for Health) and Prof Lloyd Sansom (Chair of the Pharmaceutical Benefits Advisory Committee) will participate in a public discussion of pharmaceutical regulatory systems, hosted by Healthy Skepticism, this Thursday 24 September 2009 at 4pm at the Women’s and Children’s Hospital, North Adelaide. Details are available at:
http://www.healthyskepticism.org/files/events/Regulating-pharmaceuticals.pdf

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.
http://www.ncbi.nlm.nih.gov/pubmed/18072318

Contacts:
General media enquiries for Healthy Skepticism: Dr Jon Jureidini, Chair .(JavaScript must be enabled to view this email address)   Mobile: 0418 897530
Dr Peter Mansfield: .(JavaScript must be enabled to view this email address)
Dr Agnes Vitry: .(JavaScript must be enabled to view this email address)
Dr Ken Harvey: .(JavaScript must be enabled to view this email address)
Enquiries re Sep 24 meeting: Robyn Clothier: .(JavaScript must be enabled to view this email address)

 

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What these howls of outrage and hurt amount to is that the medical profession is distressed to find its high opinion of itself not shared by writers of [prescription] drug advertising. It would be a great step forward if doctors stopped bemoaning this attack on their professional maturity and began recognizing how thoroughly justified it is.
- Pierre R. Garai (advertising executive) 1963