Big stick won't work with industry sponsorship

A LEADING Australian ethicist has dismissed any need for legislation forcing the pharmaceutical industry to report all payments to doctors down to a cup of coffee, saying the “big stick” approach usually does not work.

Professor Paul Komesaroff, director of the Monash Centre for Ethics in Medicine and Society, said Australia did not need an Act similar to the United States Physician Payments Sunshine Act, which requires companies to report all payments to doctors, from stock options and research grants down to small gifts.

It exempts payments under $10 unless the doctor receives $100 or more from one company in a year.

Professor Komesaroff, who is also the Royal Australasian College of Physicians’ ethics convener, said education and encouraging ethical reflection were much more likely to be effective in changing behaviour than legislation.

But the Consumers Health Forum of Australia (CHF) has warned that if self-regulation of pharmaceutical advertising and promotion was not working, consumers would expect the federal government to introduce legislation similar to the Sunshine Act.

CHF’s executive director, Carol Bennett, said the federal government had identified the need for stronger self-regulation of advertising and promotion of therapeutic goods, warning that if industry could not strengthen its self-regulation within 2 years, the government would legislate.

“Consumers are involved in this process and, if self-regulation fails, will expect legislation similar to the US Physicians Payment Sunshine Act,” she said.

Ms Bennett and Professor Komesaroff were commenting on a debate at the recent TCT (Transcatheter Cardiovascular Therapeutics) 2010 conference in the US, reported in heartwire, an online cardiology newsletter.

The debate concluded that the medical community needed to change its culture to make physician–pharmaceutical industry relationships more honest.

The Sunshine Act was introduced in the US earlier this year as part of a larger health reform package and has been criticised for compelling companies to keep track of “payments” as small as a cup of coffee to doctors.

According to heartwire, the session co-moderator Dr Richard Popp, Professor of Medicine at Stanford University, told the conference that doctors were mainly to blame for the handout culture and it was up them to change it.

“All of this ‘sunshine’ is good, because if you’re embarrassed by the relationship you have with industry, you shouldn’t be having it,” he said.

Professor Komesaroff said if a Sunshine Act was introduced in Australia, it was likely that ways would be found around it, such as by putting hospitality costs down as “education”.

“All you do really is breed a kind of deviousness or attempt to find loopholes,” he said.

However, he believed some doctors were very close to the industry and established procedures were needed to deal with that, including a need to declare any dual interests to ethics, departmental, college, university or other committees.

Professor Anthony Keech, Deputy Director of the NHMRC Clinical Trials Centre, said a little improvement of current systems in Australia would serve the community well, provided there were regular checks of possible conflicts of interest.

"In Australia, even though physician regulation about management of conflicts of interest is still patchy, both industry controls and journal controls are now much better," said Professor Keech, who is Professor of Medicine, Cardiology and Epidemiology at the University of Sydney.

Medicines Australia chief executive Dr Brendan Shaw said details of hospitality associated with educational events had been published on the Medicines Australia website for the past two-and-a-half years.

“Educational events provided or sponsored by Medicines Australia members are governed by strict regulations,” he said.

“Gifts are banned, entertainment is banned, lavish hospitality is banned and information must be balanced and consistent with the Product Information.”

Dr Shaw said the self-regulatory system in Australia was robust, transparent and independent ― and it worked.

Posted 11 October 2010