The fight for us to know more about the pharmaceutical industry’s payments to doctors requires dogged persistence, according to this insider’s account from Dr Justin Coleman, a GP, medical writer and Croakey’s Naked Doctor columnist.
For every few steps forward, there’s likely to be some ground lost as well, he says, putting the call out to hackers and other transparency champions to join the good fight.
Justin Coleman writes:
This is the story of how a suburban GP, tapping away on his home computer after the kids went to bed, took on the combined might of a trillion dollar industry.
And lost, of course…this ain’t Hollywood.
However, it is also the story of how one small victory was made. And hopefully there will be more to come.
The latest version of the Medicines Australia (MA) code of conduct – edition 18 – recently came into effect, containing a new section that deals with making payments to doctors visible, where previously they were hidden.
It has been billed as Australia’s response to the US 2010 Sunshine Act (letting the sun shine into the dark corners of pharmaceutical influence). However, the watered-down nature of the new transparency provision is testament to the almost unmatched lobbying powers of the industry.
MA’s member companies are among the richest on the planet, and owe it to shareholders to maximise profit, although one eye must also be kept on reputation. Thus, it is quite understandable that MA code-drafters resisted transparency where they felt they could (loopholes here, flat refusals there), yet also that the finished, undernourished product is being marketed as evidence of the industry’s enthusiasm for openness. Both make good business sense.
Don’t get me wrong: the new code is certainly better than nothing.
And ‘nothing’ is still the transparency requirement for companies who don’t sign up to the MA code – mainly generic-brand manufacturers that, MA rightly argue, now have an unfair advantage.
The code is a start, but a pale version of what it might become, which is why I still tap away, nocturnally.
The Transparency Working Group
He suggested I join as RACGP representative, which might even see me getting an honorarium for my time. It was fine advice, as the RACGP was fully supportive, and could add weight to my opinion. It couldn’t, however, add an honorarium.
I wondered if MA might pay airfares to meetings, but they quite reasonably pointed to the irony of a doctor receiving money from the pharmaceutical industry to expose other doctors doing the same thing!
I ended up teleconferencing, although I did attend once, via a 3-hour round trip during a family holiday. Memo to self: annoying big pharma also entails annoying your wife.
The back story was that the ACCC would only authorise the next MA code if it contained a transparency provision, developed in consultation with stakeholders. It cited the US Sunshine Act, whereby all ‘transfers of value’ from pharma to doctors are published on a central website.
In 2014, the US data reveals, pharmaceutical companies paid 600,000 health professionals and hospitals a total of US$6.4 billion. Common reasons for payment include providing hospitality at educational evenings for family physicians, or paying specialists to give medical update talks, perhaps using slides prepared by the company.
The TWG meetings ran surprisingly smoothly, largely due to the competence of the chair Dominic Barnes, a former GP. Nonetheless, I didn’t find them easy. In my experience running Australasian Medical Writers Association meetings, everyone had always been on the same side.
The TWG was a tug of war for polite grown-ups: the pharmaceutical suits versus medical and consumer representatives. I was never quite sure where the AMA lawyer sat.
To be fair to the AMA, I don’t pretend my side represented all doctors, some of whose sympathies lie very much at the other end of the rope; restricting transparency. Some are concerned that patients or other doctors will read too much into the payments listed, as it would imply their decisions are compromised.
Indeed, the Consumer Health Forum rep was probably the only one on our side with the full backing of her constituents, as transparency is almost inevitably in the interests of patients.
The truth is, neither the payer nor payee has much to gain from transparency, except perhaps a chance to bask in the sunshine of having nothing to hide.
All the gain goes elsewhere. To patients, above all; and to taxpayers, whose money doctors direct towards one drug or another; and to any doctors who place a high value on the independence of advice that influences their clinical decisions.
Doctors’ judgement is influenced by the recommendations of their peers, via educational evenings, medical articles and the advice of specialists to whom they refer. Until now, there has been no easy way of finding out whether those peers have been paid by the company profiting from the treatment they are recommending.
After months of background reading, emails and rope-tugging, the TWG came up with a balanced document, fairly negotiated by both sides. We agreed to ignore the smaller payments that had bogged down the US system, with options to either exclude all payments below $25, or else exclude annual payment totals below $100 per pharmaceutical company. As in the US system, payments would be collated on a single website, to enable searching.
I was soon taught a lesson in corporatocracy, however, because the document proved unacceptable to MA’s member companies – too much transparency.
Instead, they passed it through a ‘Code Panel Review’ consisting of 13 pharmaceutical members, one AMA rep and one consumer rep.
The result, to quote the RACGP submission to the ACCC, was underwhelming:
The MA Transparency Model differs from the original TWG discussion paper so profoundly that the RACGP wonders if the TWG and subsequent public discussion had the primary aim of ‘being seen to consult’, rather than serving as any meaningful consultation process…
The Code Review Panel rejected or altered proposed new changes that would have promoted transparency. [Stakeholders] were not…made aware that multiple significant changes had occurred…any public consultation [was] based on a one-sided view reflecting the pharmaceutical industry’s preferred position, but was presented to stakeholders as being the view of the TWG.
Admittedly, I might have toned it down a little if I’d had more than a few days’ notice during a busy working week. But our tug of war had been just a sideshow, while the real powerbrokers sat next door in the big top.
In a neat reflection of our respective firepower, MA’s response to the ACCC was a 101-page document drawn up by a team of lawyers from Allens Linklaters. They probably even received an honorarium.
Of all the loopholes inserted into the proposal put to the ACCC, one stood out as fundamental. MA submitted that doctors should be allowed to veto having their name published. This ability to veto would have destroyed the entire concept.
I sent strong objections to all TWG members, labelling it an ‘opt-out’ clause—a phrase then adopted by other objectors and the media. At my behest, the RACGP requested the ACCC hold a pre-decision meeting for all parties concerned. Ken Harvey, I and others argued that an optional system would make a nonsense of transparency, while MA argued they were respecting doctors’ privacy.
The ACCC ultimately ruled in our favour, although conceded MA their opt-out clause for the first year.
As a result, since the beginning of last October, for the first time ever in Australia, some doctors have been receiving notices from pharmaceutical companies that the dollar figure they are about to accept might be published on the company’s website, unless the doctor prefers otherwise.
That ‘opt-out’ loophole for the doctor will close later this year, and publication will occur, regardless.
The small detail of the ‘opt-out’ loophole closing is, oddly enough, probably due to me.
Without that victory, I honestly think the entire transparency discussions would have been pointless.
On most other contested matters, MA succeeded. Our protracted debate during the TWG around $25 or $100 was swept aside by MA’s decision to not require reporting of any food or hospitality payments at all. A doctor attending a pharmaceutical dinner every night of the year need never be troubled by the code.
However, to its credit, the code should at least capture payments to those doctors whom the industry refers to as ‘Key Opinion Leaders’ – doctors whose messages align with the company’s and who are sent on the educational circuit.
Although it will hopefully still eventuate, we also lost the initial battle for a centralised database. Finding a doctor’s name will involve searching every pharma website individually. MA wanted the names to disappear after two years, and even objected to the ACCC requirement to list them in (readily searchable) standard Excel format.
Three final reflections
1. First, everyone I dealt with was polite, and probably just doing their job. There’s nothing fundamentally wrong with pharma acting to increase sales and profit. My concern is that, in the absence of fightback, the scale forever tips in favour of profits over patient benefit. Probably even with fightback, which will always be dwarfed by giant corporates. But happily, even a part-timer might push back the tide at least a little.
2. Second, given the unscaleable heights of corporate regulation, I decided to focus subsequent efforts on doctors.
Pharma has every right to try to influence prescribing habits with marketing, but doctors don’t have to listen. I firmly believe patients’ interests are better served if doctors reduce their marketing exposure. Doctors should resist the attractive option of receiving their education about pharmaceuticals from the mouths of those paid to market it.
Hence, for six months my nocturnal tappings changed focus, and in October 2014 I launched the No Advertising Please campaign, outlining the evidence as to why doctors should consider avoiding seeing drug reps, and should instead use more independent sources of medication advice.
For a zero-budget, private campaign, it gained a lot of interest, with 60 TV, radio and print features in its first month. Like most zero-budget campaigns, everyone involved then ran out of puff, and it has lain too quiet since.
3. Finally, where to next?
Pressure should be placed on Medicines Australia to move fast on a centralised, searchable database for all transparency information, certainly by the time the opt-out clause runs out in October 2016.
The whole point of transparency is to be able to see clearly – information scattered around 20 websites is obscuration. The US has a centralised database today; a decent data hacker could build one tomorrow, so there’s no reason for delay.
Regulatory pressure should press pharmaceutical and medical device companies who don’t sign up to the MA code to provide equivalent transparency. Marketing influences the choice of surgical devices, medical equipment, community pharmacy dispensing, and wound dressings—industry reps target nurses, even to the point of accompanying them inside operating theatres.
Why do I bother?
Given it’s no easy road, I guess I must get some kick out of trying to change systems where I see flaws. I fully accept that my efforts annoy not only pharma, but also some of my medical peers. Happily for both, there’s only so much a suburban GP can do in his spare time.
That’s why we need transparency champions in every institution – the public and private health sector, and government.
The role isn’t glamorous and takes a lot of effort, but health consumers depend on it.
• This is an edited version of an article first published in Australian Doctor in November 2015.
• Read more Naked Doctor columns here.
• Follow on Twitter: @drjustincoleman
(The image above is from the No Advertising Please campaign.)