Campaigning for awareness
pharmafile | October 23, 2003 | Feature | Medical Communications |Â Â disease awareness campaignsÂ
With the vast number of different stakeholders involved in the healthcare sector, trying to pin down a strict definition of what phrases used in industry parlance actually mean can be a thankless task. Take providing information to patients', for example.
The more traditional GP would say it's fine as long as it's only him or her doing the providing. A patient group would say that its an essential means of working towards having more informed and enlightened patients, providing, of course, the quality of the information is good.
The Consumers' Association would tell you that if a pharma company does it, it's thinly veiled advertising and shouldn't be allowed.
A pharma company would reiterate that it's a valid tool that can be used for the enhancement of patient-centred care. Ask someone involved with the European Commission and they would produce a lengthy document containing a string of new EU directives but it's unlikely that even after extensive scrutiny and reading between the lines you'd be any the wiser as to what the phrase actually stands for.
This lack of clarity has often meant that UK pharma companies have had to navigate murky waters when it comes to the dissemination of information. Of course, US-style direct-to-consumer advertising is banned outright, but the next best thing companies have at their disposal, the disease awareness campaign, has often been the subject of much contention. Up until now disease awareness campaigns have been governed by the industry's self-monitoring Prescription Code of Practice Authority.
However, several times in the past, campaigns have fallen foul of the code. The most recent example has been Pfizer's sponsorship of an Impotence Association campaign where, after a complaint by a consultant psychiatrist, the PCPA ruled that the prominence of the company's logo on the advert could encourage patients to ask doctors specifically for Viagra.
An under-used tool
Despite the fact that disease awareness campaigns in the UK hardly have a prolific history, there have been some high profile ones. Pfizer's campaign has been the most recent, while four year ago Pharmacia (then Pharmacia & Upjohn) teamed up with advertising firm Saatchi & Saatchi to raise awareness of urinary incontinence. There have also been industry-sponsored campaigns on multiple sclerosis and migraine. Inevitably, accusations of profiteering will abound, but are companies actually seeing a return on their investment if they set out on a disease awareness campaign?
Tom Kass, Head of Healthcare and Biotech Investment at EFG Private Bank, answers with a resounding 'Yes'. He says that disease awareness is all about growing the overall market and, if it does so, the product will inevitably benefit as well. "Companies see tremendous value in these campaigns because theyre a way of getting directly to the customer – the headache market has increased through them and the triptans are now a $5 billion market," he says.
Of course, companies will never shy away from the fact that they want to sell their treatments and make a profit but they also insist that awareness campaigns have a public health role as well. Neil Dugdale, Portfolio Manager, CNS & women's health, at Merck KGaA, was involved in the campaign for the alcohol dependence drug Campral. Merck was allowed to state in the adverts that there were two products available in the alcohol dependence market and that patients could talk to their doctor or healthcare professional for further information.
Neil says that while the public may have a natural scepticism about any campaign conducted by a pharma company, seeing it as profit oriented, it is those patients to whom it applies that really count.
"We organised a series of meetings with patient groups at Marchwood Priory Hospital in Southampton to find out what kind of advert would appeal to them," he explains. "The consensus of opinion was to tell it as it is the realism of alcohol dependency is nasty so the campaign was designed to make people sit up and take notice. We tested the advert before we launched it and it went down really well.
"As long as you do your research, remain ethical and involve all the customers relevant to the whole campaign then you won't encounter any negativity from them and that's the most important thing," he enthuses.
He adds that the main objective of a campaign is to raise awareness of the whole disease area and to get patients to go for treatment: "Obviously we'll benefit but hopefully thousands of patients will benefit as well."
Growing the product or the therapy area?
By embarking on a disease awareness campaign there is the danger that companies can also be boosting sales of rival products. Tom Kass says that GlaxoSmithKline's migraine campaign (designed to create pull for anti-migraine drug Imigran) in fact caused a "gigantic explosion" in the use of ergotamines. Despite this, he still says it is a risk well worth taking.
"There is a marketing precept here," he adds. "In the 1980s, Pepsi was introduced in Norway and their huge advertising campaign grew the market so much that Coca-Cola benefited as well. The upside is that you're widening the market so much that you will get your share."
While there are no strict criteria for products well suited to disease awareness campaigns, they are on the whole broken down into non-lethal conditions that people don't like to bother their GP about. Whereas erectile dysfunction in men, sexual dysfunction in women and incontinence are examples that patients may feel too embarrassed to discuss with their doctor, there are other conditions, such as high cholesterol/blood sugar levels and high blood pressure, which people simply don't know they could have tested and consequently remedied at their local surgery.
Where do they work?
In the UK, companies haven't exactly been falling over themselves to conduct the next big awareness campaign. While some industry commentators believe that pharma companies may be waiting to see what comes out of the European legislation treadmill before deciding to embark, there are other more tangible barriers and markers to consider. From a purely marketing point of view, Neil Dugdale says there are certain therapeutic areas where a company could never be successful with a disease awareness campaign: "It wouldn't be a good idea to do a major campaign if you have a low market share in an area where there are a number of products available – after all, you can't centre it on your product and you have to declare that other products are available."
Companies may be free to choose which disease areas to work on with these campaigns but when it comes to the tricky business of what is and isn't allowed, it is a different story. It may come as some relief to hear that the Medicines and Healthcare Regulatory Agency (formerly the MCA) has now issued new guidelines to tackle the grey area of where to draw the line between medical education and drug promotion.
The guidelines, which evolved from discussions within the industry-government collaboration, the Pharmaceutical Industry Competitiveness Taskforce (PICTF), have delighted the UK industry, which says that under the former rules, it was never really sure of what it could or couldn't do with disease awareness campaigns.
Association of the British Pharmaceutical Industry (ABPI) spokesman Ben Hayes says that the new legislation reflects a "general consensus" between the medicines regulators and the industry to set out in terms of guidelines their joint thinking.
"When we sat down to discuss this with the Government, we both realised that we had a lot in common in terms of how we saw the provision of information," he says. "The guidelines are beneficial to both sides as well as the public."
He is keen to point out that representatives from member companies of the ABPI were involved in the talks: "It has not just been theory from the trade association, its been practical advice and participation of our companies."
Campaign guidance
So what do the new guidelines lay down? Usually, when a new piece of legislation comes into effect, someone somewhere doesn't like something but it appears that everyone is happy with this particular document. The guidelines restate and clarify general accepted principles: disease awareness campaigns should not promote products and must concentrate on increasing awareness of a disease and its possible management.
Campaigns can make reference to the availability of treatment options but this "cannot be of such a nature that an individual would be encouraged to approach a prescriber to request a particular medicinal option." In the case of a certain disease having only one, one leading or few medicinal treatments available, companies are advised to be particularly careful. "It is particularly important that these campaigns focus on health and disease education, with details of where to get appropriate advice," state the guidelines.
Tom Kass is optimistic about the MHRA guidelines, describing them as nice and simple: "Basically they just say 'be good, be clean, be honest, be a boy scout and don't mention your product'." However, he admits that they still constitute something very important: "A country like Britain tends to go along with guidelines and principles so if you have them written down then at least you have something to push against. If in the Europe-frantic way, nothing is written down, then anything a company writes could potentially be held against it."
The mention of Europe has no little significance. With companies still waiting to see in what form the European Commission's review of pharmaceutical legislation will emerge after a lengthy and exhausting process through the European Parliament, the section on drug advertising has already hit the headlines. One of the initial proposals was to expand the definition of advertising to include the "awareness of the availability of medicines". Although this has now been dropped, Paul Woods, Global Promotional Consultant at AstraZeneca, admits that for a while the UK industry was concerned that this could mean a clampdown on disease awareness campaigns.
"I think one significant thing is that the title of the section in the Directive is Advertising and Information," he says. "That indicates that there could be a move towards information being regulated. While behind it all is a good rationale that information should be of high quality, at the end of the day we could see a huge bureaucracy that is going to cost a lot but ultimately be of little value to the patient."
One eye on Europe
Tom Kass is of the opinion that UK companies will not be too concerned about what the European legislation on information and advertising will throw up. He says that, almost as a rule, the UK industry gets its own legislation installed pretty well because the ABPI is one of the more assertive talking shops.
"One of the reasons they're so happy about the new guidelines is that they helped to write them!" he laughs. "Or should I say they had high input?"
However, Ben Hayes says that despite the industry's involvement, the new guidelines are ultimately a MHRA document. He also argues that the question of European central legislation cannot be ignored: The latest legislation has thrown up all kinds of questions about what is and isn't allowed, so it came to the point when we had to ask, 'What exactly are people getting at here?'"
When asked whether the ABPI is hopeful that the new disease awareness guidelines will eventually be adopted on a European scale, he replies cautiously that the Association feels it has some experience that is worth sharing: "I think it's fair to say that countries such as the UK and some Scandinavian states have a more liberal attitude than certain other member states in terms of health legislation. But having said that, nobody is slamming the document on the European table with a 'take it or leave it' approach."
While the ABPI is hopeful that the new guidelines will encourage the UK industry to consider sponsoring awareness campaigns again, only time will tell if marketing departments feel comfortable within the newly established parameters. As Paul Woods points out, the European push towards regulation of medicines information could eventually create the scenario where it is only the pharmaceutical industry on the receiving end of controls, with all the other 'providers of information' still given a free reign.
"Take a look at the vast amounts of really good patient information provided by the industry and then compare it to some of the awful and misleading stuff available on the Internet," he says. "I think the challenge is to make sure that whatever comes out of the future legislation process is governed by a determination to make sure that high quality information wins out over low quality information. That's not the same as saying the industry must be regulated and everybody else can do what they like."
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