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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
I was in medical practice from 1968 and in private specialist practice from 1975. I saw reps frequently as they were first to deliver information about both their new products and about neuro-physiological publications overseas. I attended dinner meetings at nice restaurants, and accepted being invited to speak at meetings for GPs when first in private practice and periodically thereafter. I even had my only ever gliding lesson paid for by a pharmaceutical company as part of a small group function.
In all the talks I gave to GPs I was careful to only mention the sponsor’s product by its generic name and to not to convey the impression it was better than other products in my opinion. I honestly believe that I did not allow the hospitality, and occasional gifts of minor medical equipment, to bias my prescribing, nor to influence my advice to other doctors.
I am sure most doctors behave the same way, and that a lot of fuss is being made about a very few who do allow themselves to be bought. Those few are easily recognised by their peers and given appropriate regard.
Governments, bureaucracies, and the media, have a vested interest in making a bigger thing of this issue than it deserves.
Ethics is a concept, and rarely practiced by big pharma unless it is a pragmatic part of its corporate positive profile and has a negative dollar cost.
The industry needs regulation as ethics cannot be imposed.
Sadly the practice of ethics, morality and professionalism amongst medicos reflects – as one would expect – the broader practise of these in the community.
Is there any difference in carrots to the industry and pens to doctors?
The big stick approach is an insult to the integrity of the great majority of doctors, but I do understand that the community would feel more comfortable if they knew that there were external checks and balances in place to guard against roguery.
Nevertheless, I would prefer that the profession sort out its renegades and rather than adopt the strategy where the “medical community needed to change its culture to make physician–pharmaceutical industry relationships more honest”, I would replace “honest” with “transparent”.
Roguery or nay, we must acknowledge the power of perceptions. After all, the patient sees all sorts of drug-company paraphernalia decorating a doctor’s office; and of course conspiracy theorists spin a pretty yarn.
Declaration: I had a cup of coffee (provided by me) with pharma reps this morning (and explained to them why I am reluctant to prescribe their product).
Declaration: Another pharma rep brought sandwiches for lunch today (which I did not eat) to discuss another product (which I never prescribe.)
Declaration: I serve with Komesaroff on the RACP ethics advisory panel (and have various other ethics roles the details of which I will spare you the tedium of reading).
I agree with Komesaroff et al. Trouble with the ‘Sunshine’ concept is that declaring huge numbers of trivial ‘competing interests’ along with the occasional ethically worrying ones will mean that consumers, regulators and others will find it difficult to see the wood for the trees, and the whole process will become devalued. This is already happening with conference presentations.
The CHF is about to be totally revamped with the incumbent structure not meeting or reflecting the needs and views of the CHF constituents. At present, the CHF stands for free everything and no responsibility for patients and is very anti-corporate and to some extent anti-doctor in my humble opinion, which I, of course, am happy to change if shown evidence to the contrary.