Big pharma and transparency.
As big pharma continues to wine and dine medical practitioners, and over-prescription is rife, the ACCC is still waiting for the industry’s peak body to undertake promised reforms in reporting payments.
The old truism has it that there is no such thing as a free lunch, but a lot of Australian medical professionals could be forgiven for not believing it.
They get free lunches all the time. And free dinners. And free drinks. Somewhere close to $100 million worth each year, according to newly collated data.
The largesse may come without cost to them, but someone has to pay. In the first instance, that someone is the pharmaceutical industry.
But the big pharmaceutical companies don’t really have to pay either. They operate according to another old truism, observed by all those in the influence-peddling game: that kickbacks must always exceed bribes, that you only spend a buck to make a bigger buck.
Ultimately the cost is borne, says the empirical evidence of public health experts, by those doctors’ patients and by Australian taxpayers in the form of more prescriptions, more expensive prescriptions and inappropriate prescriptions.
Exactly how big that cost is, no one can say for sure. But we do now know how much big pharma spends wining and dining those medical professionals while trying to influence their prescribing practices, thanks to the work led by researchers at the University of Sydney.
In the four years to September
2015, the 42 companies represented by Medicines Australia, the peak pharmaceutical body in this country, spent more than a quarter of a billion dollars on educational events for medical professionals, mostly for doctors, but also increasingly for pharmacists and nurses. To be precise, it was $286,117,928.
According to data released last week on the BMJ Open website, during that four-year period there were almost 117,000 industry-sponsored events, involving 3,481,750 “individual attendances”.
That’s a lot of free lunches.
Since 2007, in the interests of “transparency”, drug companies have been required to detail the number of events, number of attendees, venues and costs of these educational events for health professionals.
To call the process transparent, however, is to exaggerate wildly. The companies individually reported the numbers annually to Medicines Australia, in PDF format, providing varying degrees of detail. There was no single coherent data set until recently, when academic researchers collated the millions of shards of information into one database, providing the first complete, accessible picture of big pharma hospitality.
It could be the last, too. Medicines Australia has decided, in the 18th iteration of its code of conduct, to stop providing the data. As from September 30, 2015, it declared it would no longer report “member company initiated events where only food and beverages are provided to healthcare professionals (i.e. no travel or accommodation provided)”.
Instead, it would set an upper limit on the value of food and drink of $120 and adopt a new system of reporting the names of some “individual healthcare professionals” who receive other payments or other “transfers of value” for their services.
Which might be a good thing, except that almost two years down the track they have not got around to doing this, and appear unlikely to get around to it any time soon. So for the time being at least, we have significantly less transparency than we did before.
First, though, let’s go to the rationale for all this spending, and the mechanisms by which it takes place.
When The Saturday Paper contacted Medicines Australia this week, with questions about the industry’s spending on educational events, the reply suggested altruistic motives.
“Engagement with pharmaceutical companies is an essential part of a medical practitioner’s ongoing education; foremost, because patients want to be sure that their doctors know how to use the medicines they’re being prescribed,” came the emailed response, attributed to chief executive Milton Catelin.
“Healthcare professionals use this information to educate patients about medicines and their safe ongoing use – a bond of trust that members of Medicines Australia want to help make even stronger through transparency and accountability.”
That’s what Medicines Australia says. But Ken Harvey, associate professor at Monash University’s School of Public Health and Preventive Medicine and one of Australia’s foremost experts in the area, says something different.
“Crap” is how he describes it. In his view, it is about marketing, pure and simple.
“Primarily it’s about selling the latest, most expensive drugs, with the side effects less well worked out,” he says. “There is virtually no promotion of more cost-effective or generic drugs, even though the government would like those more prescribed. And there’s no promotion at all of non-drug interventions, like preventative health.
“There is absolutely no reason why health professionals should listen to the biased and distorted stuff that comes out of drug reps, except that they like the meals and gimmicks and samples and other freebies they get for doing it.
“It is very annoying for those of us who’ve never accepted that crap.”
There are other ways for doctors to educate themselves, Harvey says, through the many journals that run objective research on the efficacy and applicability of new drugs. But there is little appetite.
Surprisingly, the Medicines Australia records show most of these educational events – about 64 per cent – occurred in clinical settings, by which we mean hospitals or doctors’ practices. The median cost was only $263, and
90 per cent included food and drink.
There were examples of lavish international travel for highly paid specialists, well-lubricated meals in good restaurants and big conferences, but, says Harvey, the more common event is less ostentatious. “It’s the drug rep coming along to the GP’s rooms bearing sandwiches or the like and feeding the guys in return for a bit of palaver about the new product.”
That sounds pretty benign, but it shouldn’t, according to Dr Ray Moynihan, a senior research assistant at Bond University, who has written for this paper, and is one of the team that crunched the data on drug company spending.
It’s about the contact, not just the quantum, he argues, on the basis of some pretty firm evidence.
One big study in the United States about a year ago, involving almost
280,000 physicians, for example, showed an “association” between meals with a value of less than $20 and changes in prescribing patterns.
Another US investigation, by the non-profit journalism organisation ProPublica, compared 2014 payments data from pharmaceutical and medical device makers with doctors’ prescribing patterns, recorded through the Medicare prescription drug program.
It found, and we quote: “Doctors who got money from drug and device makers – even just a meal – prescribed a higher percentage of brand-name drugs overall than doctors who didn’t…
“Indeed, doctors who received industry payments were two to three times as likely to prescribe brand-name drugs at exceptionally high rates as others in their specialty.”
Moynihan can point to other studies, too, many of them from the US.
The reason for that is not only that America has better data on almost everything, but is due in significant measure to a piece of legislation called
the Physician Payments Sunshine Act of 2010, which enables anyone to see which doctors received what benefits from which pharmaceutical companies.
And this brings us back to edition 18 of Medicines Australia’s code of conduct, for at least some of those involved in its formulation saw the Sunshine Act as a model.
One of those people was Queensland GP Justin Coleman, who represented the Royal Australian College of General Practitioners on the Medicines Australia transparency working group.
“The story is that each new edition of the code gets run past the Australian Competition and Consumer Commission,” he says.
“They had previously said MA was not doing enough around payments to individual health professionals. So the working group was established and eventually we came up with a working paper proposing changes along the lines of the Sunshine Act, which requires that the industry should individually name healthcare providers to whom they gave money and lunches and so on.”
He personally favoured a regime exactly like that in the US, under which payments or “transfers of value”, such as free food worth more than $10, must be recorded but need not be reported unless the aggregate exceeds $100 in a calendar year. Others favoured a threshold of $25 for reporting. But while there were a couple of slightly different options, there was broad agreement among all in the working group that doctors should be identified.
“But the companies did not accept that and produced a modified document, which none of the rest of us had input to, which they then presented to the ACCC,” he says.
Instead of providing more detail on payments to doctors, it provided far less.
The companies agreed only to the publication of the names of those who took much more from them than meals – those who received speakers’ fees, consulting fees, sponsorships, airfares, accommodation and fees for sitting on industry advisory boards.
“MA then argued that because they were obligated to report names, they shouldn’t have to report any aggregated data on hospitality – the total amount spent on health professionals,” Coleman says.
He cites an example of what this might mean in practice.
“If, for example, they are spending $15,000 on an event, they might have to declare $1000 paid to the keynote speaker. But not the amount spent on hospitality,” he says.
“Now there’s no way a person will be able to look up where the events were, who attended them, how much was spent on them.”
That is to say, the relatively small cohort of influencers would be named, but not the much larger cohort of the influenced – the people who actually write the prescriptions.
It could have been worse. The industry wanted the naming regime to be opt-in, Coleman says, meaning those taking the big bucks would have the option of remaining anonymous.
He describes knocking off that idea as “the single biggest thing we achieved”.
The other thing MA wanted was to continue the system of separate reporting for each of its member companies. They even objected to a common format.
But the ACCC would not wear that. In its statement of April 24,
2015, authorising the new code to operate for the next five years, the commission stipulated the condition for “transparency reports compiled by Medicines Australia member companies to be published in a common accessible format and to be available for at least three years”.
It further stated that “Medicines Australia must also use reasonable endeavours to establish a central reporting system and provide six-monthly reports on its progress in doing so”.
This, it said, would ensure the collected data was accessible to patients, healthcare professionals, consumer and healthcare organisations, researchers, academics and the media. That was more than two years and four of those sixmonthly progress reports ago.
A spokesperson for Medicines Australia told The Saturday Paper they were “still exploring ” the feasibility of a central database. The most recent progress report, produced in May, makes excuses in much more detail, but the bottom line is that nothing much has happened, despite the urging of the nation’s competition regulator.
The public health advocates such as Coleman, Moynihan and Harvey have long ago lost patience with Medicines Australia and its attitude to transparency.
The code as it now exists amounts to “a weak effort to legitimise indefensible practices”, Moynihan says.
Leanne Wells, chief executive of the Consumers Health Forum, for example, notes the “clear evidence that direct promotion of drugs and medications to doctors can influence their prescribing”. She has some concern about the slow progress towards disclosure.
“We have consistently called for more and accelerated transparency,” she says. “We’d be very concerned at any attempt to obfuscate what the ACCC and others have been calling for.”
The ACCC itself, in its mild and bureaucratic way, appears less than happy with Medicines Australia’s slow progress towards that promised database.
In response to the industry’s report in May, the commission put out a statement saying it was “aware of a number of issues” around the implementation of Medicines Australia’s commitment and encouraging it “to continue its efforts to establish a central reporting system to ensure that the data collected is accessible to patients and other interested parties so that the full benefits of this new transparency regime are realised”.
One wonders, though, what good it will do.
The latest information from the US shows that despite the implementation of the Sunshine Act, big pharma is spending more than ever, and doctors are taking more than ever. Of what use then is transparency?
“That’s a very good question,” says Ray Moynihan. “And I and others who work in this area have never said transparency is the final answer. Transparency is vital but it’s not sufficient. You need transparency to understand how big this issue is.
“The Sunshine Act has not been a failure. It has brought forth a wealth of data that the US and the world is only starting to get its head around. It shows the real correlation between doctors accepting this money and inappropriate prescribing.”
The next step, he says, is to use that data to build momentum towards “more rational policy responses” that solve the problem.
In short, to go beyond reporting on the cost of the “free” lunches, and instead put an end to them.
“THE SUNSHINE ACT IN THE UNITED STATES HAS NOT BEEN A FAILURE … IT SHOWS THE REAL CORRELATION BETWEEN DOCTORS ACCEPTING THIS MONEY AND INAPPROPRIATE PRESCRIBING.”