Healthy Skepticism Library item: 20166

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

Law J
Preparing to advertise directly to the European consumer
Scrip 1999 Nov6

Full text:

It is widely believed that one day pharmaceutical companies will be able to advertise their products directly to the European public. No-one knows exactly when this will happen, nor the kind of restrictions that will replace the outright ban that exists at the moment. But the idea has been steadily gaining in credibility as companies reflect on their communication strategies in a healthcare environment that increasingly sees the consumer, rather than the prescriber as king. This way of thinking makes the legal obstacles these companies face even more galling, especially given the amount of unregulated information about their products that is now widely available on the Internet.

Of course, obstacles also exist in the US where the rules are much more relaxed. Micheal Bigelow, manager of public policy planning and development at Eli Lilly, told a recent IIR conference entitled, ‘Successfully promoting pharmaceuticals to the informed patient’, that the actions of the FDA’s enforcement arm, the Division of Drug Marketing, Advertising and Communications (DDMAC), can be deeply frustrating. This, he went on is largely because there is little understanding of what constitutes ‘the proper public health message’ that the DDMAC is charged with upholding.

He cited example of example of advertisements that had attracted enforcement action, at considerable expense for the company involved, for reasons that are not instantly comphrensible. An ad for the allergy medication Claritin, for instance, was said to be “too busy”. And one for the smoking cessation treatment, Zyban, that included visual images (falling matches, lighter and cigarettes in the side-effects presentation) “interfered with the viewers’ ability to listen and process information”.

So, although the FDA guidance on broadcast advertising, introduced in draft form in August 1997 and ratified two years later, is generally felt to have had a positive impact on the US healthcare scene (see ‘DTC advertising encourages consumers to talk about drugs’ on page 9), the move has not been entirely problem-free.

And the essence of the problem – what is a proper public healthcare message and how can this be put across fairly to consumers – is no different in Europe. Indeed, when the EU pharmaceutical committee agreed, on September 29, 1999, to set up a working group to review the issues to involved in the light of developments in communications and e-commerce, this was expected to be a large part of, if not the actual framework for, the discussions.

The group will consist of one representative from the European Parliament, one from the EU economics and social committee ECOSOC, five representatives from regulatory authorities in member states, two from patient groups, two from patient groups, two from physician associations, two from industry associations and one from pharmacist’s associations. And their thinking will be met with interest not because anyone thinks the ban on advertising will be lifted overnight but because, as a policy advisory group, it can’t help but send out signals as to how things might change in the future and more importantly, the timing of those changes. Although industry wants a more liberal approach, it is also understood that much work has to be done before that is possible, or even desirable. As industry consultant Brian Lovatt says, it is not easy to make the sudden switch to consumers after communicating with professionals for years.

He believes industry’s greatest challenge before the communication rules are relaxed is to find out what patients want to know rather than what companies think they want to know. “This is critical”, he says. “Patients want assistance in understanding how medicines fit into their overall treatment. They want to know what the alternatives are and what happens if they don’t take the medicine. It is very important to talk to these patients and it is not difficult. Any patient association will tell you what you need to know”.

Industry view
This is no more than common sense, dovetailing neatly with the industry line. “What is important is to be able to give more information to patients”, says Frances Charlesworth, director of commercial and international affairs at the Association of the British Pharmaceutical Industry (ABPI).

To that end, the ABPI has set up a task force known as ‘The Informed Patient Initiative’ to research and assess the views of key stakeholders and promote the idea that companies can be trusted to communicate responsibly with consumers about their products. It would like to see quality standards applied to company information, for example, to ensure that the commercial and public health objectives of advertising can be seen to be not unduly balanced in the company’s favour.

Charlesworth cites the fact that consumers are already getting an abundance of unregulated information about pharmaceuticals via the Internet and that there is no way they can tell if this information is accurate. Moreover, ignorance of what medicines do and how they work is thought to be largely responsible for the fact that 50-70% of medicines are not taken as directed. There is also the US experience which shows that rules can exist to protect against the extremes of commercial practice while also allowing companies to communicate with end-user.

Charlesworth believes there is much companies can do in terms of education in the area of public health that can have a positive effect on the regulatory environment. “As healthcare professionals see that this kind of communication is not threatening and as patient compliance improves because they are better informed, we believe the regulations will change to reflect the new situation”, she says.

The kind of activity the ABPI is encouraging is well illustrated by Pharmacia & Upjohn’s £1 million campaign to raise public awareness or urinary incontinence. This began on January 4th this year with prominent full-page advertisements in the national press. In August, the message that there are various things that can be done for a weak bladder was taken to billboards and magazines. One month later, it was broadcast on TV. The results have been so encouraging, says Roy Sutherwood, director of public affairs at Pharmacia & Upjohn, that similar campaigns have since been started in both Sweden and Ireland.

It is hard to assess these results as there has never been such a bold campaign in the UK, or indeed Europe, to compare them with. But they look encouraging. The total number of calls to the helpline has passed 20,000 and is still rising. More importantly, more than three quarters of these calls have translated into concrete requests for more information. “We have good transcriptions of 15,576 calls which translates into a transcription rate of 76% which analysts at Saatchi & Saatchi say is remarkable”, says Sutherwood. Another 5,000 questionnaires, cut out from the press advertising, have also been returned. And there is no way of knowing how many people went to their doctor asking for treatment as a result of this campaign.

There have, of course, been other public health programmes initiated by companies with an interest in a particular disease area. But some of these have run into difficulties, illustrating just how important it is to get the tone of the message right. A recent public awareness campaign run by Yamanouchi Pharma, for example, attracted four independent complaints to the UK industry’s self-regulatory body, the Prescription Medicines Code of Practice Authority. They all concerned a leaflet, funded by the company, which outlined the symptoms of prostate problems and encouraged people who might be affected to contact their GP.

The complainants believed the regulations had been breached because although the leaflet did not mention a specific product, it created a potential demand for Yamanouchi’s Flomax MR. In the one case where a breach of the voluntary code was ruled, it was found that specific reference to the alpha 1A-adrenoceptor antagonists would encourage patients to ask their doctors to prescribe such a medicine. This would in effect lead to a prescription for Flomax MR.

Dr Susan Bews, medical director at Yamanouchi Pharma, said the leaflets have since been changed to take out the offending wording. “We were slightly surprised but there are always two sides to these things”, she says.

These two sides, that of the regulator upholding the interests of the public and that of the company upholding the interests of shareholders, are inevitably in conflict to some extent. But sometimes it is hard to ascertain precisely where the goalposts are, particularly when Pharmacia & Upjohn’s incontinence product, Detrusitol (tolterodine), also has a major share of the UK market (45%) and its campaign will undoubtedly increase sales.

It may just be a question of timing, as well as the fact that Pharmacia & Upjohn is said to have taken extensive clinical as well as legal advice. Incontinence is also an area that has long had strong patient and professional groups working hard to improve awareness of the condition.

“All surveys have shown that less than half the people who have a problem seek treatment. We reasoned that if there is unmet need in a disease area and no public health money available to run a campaign, then a coalition of patients, doctors and companies who all share an interest in that disease area was a good way forward”, says Sutherwood.

Lovatt believes the respect that Pharmacia & Upjohn demonstrated towards all the stakeholders in this disease area was crucial to the campaign’s success. “We have worked in several disease areas and our studies carried out on behalf of companies always focus on the four Ps. These are the payers, prescribers, providers and patients. We want to know how they think and what they want to know”.

With the payers, the idea is to find out the kind of priority assigned to a particular disease area in order to ascertain how much public money will be spent to get a specific amount of patient benefit. With providers, the aim is to find out how information should be presented to effect a change in the drug formulary. Similarly, with prescribers, Lovatt says it is important to know what their treatment goals are. With asthma, for example, he says it is not necessarily a change in how much breath is expelled but rather that the patient doesn’t return to the surgery. And with patients in this disease area, the aim is a good night’s sleep. “I don’t know of a single company working with asthmatics that has specifically addressed the question of sleep”, he says. “But this is what patients say they want. This is why it is important to talk to people. Only then can companies start to build their DTC materials”.

Finally, there is the question of tone. Complaints to the UK voluntary code show that a key issue seems to revolve around how information is presented, Glaxo Wellcome, for example, has been told to be rather less enthusiastic in its briefing of products to doctors.

A general practitioner had complained about the impartiality of a doctor he heard being interviewed on BBC Radio 4’s Today programme earlier this year, at the time of the launch of Seretide, Glaxo Wellcome’s combination inhaler containing salmeterol and fluticasone.

The panel agreed this was a breach of the Code, saying the physician had been “too positive and more suited to promoting Seretide than providing factual, balanced and non-promotional information”. The company’s argument, that it could have no influence on what a doctor said during a live interview, held little sway.

As the industry continues down the consumer road, the quality of information companies use will undoubtedly effect the process through which the regulations are finally relaxed. This is why the industry associations are calling for a responsible approach: and why the Pharmacia & Upjohn campaign is widely acknowledged as a success that has pushed DTC communications about as far as the regulations will allow. How much further they will be pushed before finally caving in to mounting consumer demand for more information and corporate demand to be able to to supply it remains to be seen.