Healthy Skepticism Library item: 16503

Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.

Publication type: Magazine

McIntosh E
New rules of engagement
Medical Observer 2009 Sep 18
http://www.medicalobserver.com.au/News/0,1734,5273,18200909.aspx

Abstract:

The rules governing the relationship between doctors and the pharma industry have been tightened yet again. Elizabeth McIntosh looks at the key changes.

Full text:

FIRST, lobster, caviar and fancy restaurants were given the flick.

Now, the ubiquitous brand-name pens, mugs and umbrellas have suffered a similar fate at the hands of the increasingly stringent Medicines Australia (MA) Code of Conduct.

As the relationship between doctors and pharma companies continues to occupy the spotlight, more eyes are turning to the code for guidance on the issue of transparency.

Writing in the MJA last week (2009; 191: 273-75), leading psychiatrist Professor Philip Mitchell said doctors must be more transparent about their relationships with industry if they wanted to address the public credibility problem they now faced.

His comments come as Parliamentary Secretary for Health Mark Butler announced plans to meet with industry players in order to stamp out prescribing inducements.

The MA code has just undergone its latest rewrite as part of a three-yearly editing cycle that sees doctors’ groups, industry stakeholders and patients have their say on what should stay and what should go.

And there are significant changes this time around.

Brand reminders that could be used outside the doctor’s surgery are banned, although pens and notepads will still be allowed at conferences. Educational brand reminders have been given a reprieve, but they mustn’t cost more than $20 each.

Advertising has been ejected from prescribing software, and funding of patient groups has come under scrutiny – companies must now disclose any financial or in-kind support they offer to these groups, but won’t be required to supply exact figures.

Fines for a breach of the code have been raised by $50,000, with moderate and severe breaches now attracting penalties of $150,000 and $250,000. The maximum fine for individual or cumulative breaches has been capped at $300,000.

And the code now extends its overarching ban on promoting prescription medicine to the general public to the burgeoning forums of Internet blogs and social media sites such as Facebook and YouTube.

While it still needs to be assessed by the Australian Competition and Consumer Commission (ACCC), it’s expected the code will be in force from January.

In the meantime, there is a backlog of brand-name merchandise that needs to be offloaded, and at least some surgeries are feeling the effect.

On Sydney’s north shore, Medical Observer’s medical editor Dr Libby Harris turned up to work one day to see a pharma rep emptying her car of brand-name booty that will be contraband by January.

So will GPs really miss the freebies?

Possibly not, although La Trobe University school of public health adjunct senior research fellow Dr Ken Harvey thinks doctors are more likely to be angry about the “political correctness” of the move.

“Clearly there’s some that think it’s political correctness gone too far, but there’s good evidence that small gifts do engender reciprocity – so you have to get rid of them,” he says.

Pfizer’s country medical director Dr Bill Ketelbey also supports their demise, but has a different perspective.

“Fundamentally, they’re beginning to detract and negate the professional interaction that we’re trying to have with the doctors,” he recently told SBS’s Insight program. “[They’ve] become a bit of a lightening rod for detractors of the industry.”

SUBLIMINAL EFFECTS

The influence of brand-name reminders has long been hotly debated among doctors and academics, with some believing they have little overt impact on prescribing habits, while others say the effect is subliminal.

RACGP president Dr Chris Mitchell says while GPs like to believe they are immune to the effects of advertising, there is strong evidence to show that they, like everyone, can be influenced.

“I’m sure the pharmaceutical companies wouldn’t be spending their money if they didn’t think it would work,” he says.

Inner-city Sydney GP Dr Winston Lo sympathises with the anti-gift campaigners, but believes doctors should be given more credit when it comes to their prescribing choices.

“We have to remember GPs are trained to prescribe based on best evidence,” he says.

“We’re not going to be so easily manipulated or swayed by promotional products or materials.”

One element of the new code that doctors may be more amenable to is the removal of pharma advertising from prescription software. This was announced earlier in the year and, in anticipation, market-leader Health Communications Network (HCN) began to progressively drop advertising from Medical Director.

Despite the ensuing rise in software costs, the ad-free move was widely welcomed by many doctors and academics, including Dr Harvey, who said after years of anti-ad campaigning that it was gratifying to finally see it occur.

Dr Mitchell is also glad to wave goodbye to software ads.

“GPs I talked to really hated the ads – that really in-your-face stuff we can do without,” he says, adding there is potential for this kind of advertising to interfere with the doctor-patient relationship.

NEW MEDIA REGULATION

Perhaps in anticipation of new marketing strategies, Medicines Australia now plans to regulate new social media technologies such as YouTube and Facebook – all will face the same rules as printed material.

And Medicines Australia’s chief executive Ian Chalmers says while his organisation recognises that the Internet can’t be censored and patients can independently access the foreign-based websites of member companies, it will still require member companies to be compliant.

Looking more closely at the funding arrangements between member companies and patient groups is another previously untapped area for the code, but Consumers Health Forum executive director Carol Bennett doesn’t anticipate any negative fallout.

Many groups have been disclosing that information themselves for years, she says.

And she doesn’t believe any further disclosure from pharma companies will hurt the reputations of patient groups either.

“It would be rare for consumer groups to be concerned about that being a problem,” she says. “There are a lot of disease-based groups that rely on funding from pharmaceutical groups to ensure that they can provide projects from their members. The groups that do enter into these agreements tend to do so with some very robust criteria.”

Osteoporosis Australia currently discloses all contributions on its website, and CEO Naseema Sparks believes other patient groups will welcome the disclosure.

“I think some patients who take certain medications are quite comfortable to see [pharma companies supporting] the consumer organisation for the disease that they have,” she says.

SAMPLE PACK REPRIEVE

While amendments to the code cover a wide range of activities, one area has been given a noticeable reprieve: the distribution of medication starter packs.

Views on these vary significantly. Many GPs see them as a valuable resource while others believe they serve only to steer patients towards expensive medications.

NSW GP Dr Michael Berger, whose practice includes elderly people and patients from lower socioeconomic brackets, uses sample packs with discretion.

“I know my patients. I will write a script for someone I know who can afford it, and if they’re struggling financially, I might give them a sample pack,” he says. “They’re useful for medicines which aren’t necessarily on the PBS.”

However, Dr Jon Jureidini, Adelaide psychiatrist and chair of Healthy Skepticism, says research shows many sample packs aren’t going to patients.

“If doctors start a patient on an expensive drug, it may actually end up costing [the patient] more,” he says. “If you only have a small range of samples, a patient may miss out on another drug which is available.”

Dr Jureidini believes the sample pack issue is a significant omission from the latest edition of the code and groups should be lobbying for its inclusion next time around.

And while he welcomes stricter rules on promotion in general, he isn’t willing to predict how the future face of pharma marketing will look.

In the US, plans to force companies to disclose on a database all payments made to doctors are likely to significantly change the landscape.

And some believe a similar more stringent system should be adopted here, particularly in light of recent media reports of medical device manufacturers offering specialist doctors highly paid consultancies and tickets for the soccer World Cup.

As for the increased fines applicable to member companies in Australia, Dr Harvey doesn’t think they go far enough, and has asked the ACCC to consider the issue before ratifying the code.

But Mr Chalmers says monetary deterrents aren’t always what scare companies most.

“The damage to their reputation can be far more significant,” he says.

“The potential requirement to publish an admission of guilt, or a requirement to write to all clinicians in a therapeutic area, or even for companies which are listed on the New York Stock Exchange, which must formally advise the exchange, creates a CEO who is mightily unhappy.”