New lines of communication
pharmafile | October 21, 2003 | Feature | Medical Communications, Sales and Marketing | MHRA, disease awareness campaigns
New guidelines from the Medicines and Healthcare Products Regulatory Agency (MHRA) have placed disease awareness campaigns under the spotlight.
They spell out how disease awareness campaigns should be conducted and clarify existing legislation, which was previously open to varying interpretation and doubt. For the first time the pharmaceutical industry has a set of rules that clearly set out the 'do's and don'ts' when it comes to organising an awareness campaign.
MHRA guidance
The guidelines state that the primary purpose of a disease awareness campaign must be to increase awareness of a particular condition and that the use of a medicine must not be promoted. The guidelines recommend that seven key points (see end) must be applied to any campaign.
In addition to these points, the guidelines also state that the main objective of a disease awareness campaign must be to encourage people to take appropriate steps for gaining help and treatment.
The Association of the British Pharmaceutical Industry (ABPI) welcomed the regulations saying: "The MHRA guidelines finally remove areas of doubt so that pharmaceutical companies are quite clear what is permitted and what is not."
However, at first sight, such guidelines could make some pharmaceutical companies feel as though their hands are tied and their slightest step outside the regulations will incur the wrath of the MHRA and unfavourable press coverage for unsuspecting brand managers.
The key question therefore, is whether pharmaceutical companies have as much to gain from involvement in a disease awareness campaign in this post-guideline era. A recent disease awareness campaign, commissioned by Pennsylvania-headquartered bio-pharmaceutical company Cephalon to raise awareness of narcolepsy may shed some light on this. One of the company's marketed products is Provigil, a non-amphetamine wake promoter. Provigil is indicated for the treatment of excessive daytime sleepiness associated with narcolepsy.
Nap Attack a case in point
It takes an average of nine years for someone with narcolepsy to be diagnosed because the condition is so under-recognised. Symptoms can often be mistaken for other conditions, such as depression; other sufferers have been labelled as just being 'lazy'. As GPs spend only a mere 15 minutes on studying sleep disorders during their medical school training, they frequently did not recognise the symptoms.
However, research has shown that consumer media coverage which raises awareness of a disease is the most significant driver of patient self-referral. In addition, through patients recognising their condition and presenting themselves to their GP with some knowledge of narcolepsy, they are more likely to be referred to the correct specialist.
In conjunction with the patient groups in the sector and some leading clinicians, the concept of an awareness campaign focusing on the broadcast media was developed. The aim was to secure a primetime TV documentary on one of the leading terrestrial channels, which would then be used as a trigger for further broadcast, print and medical media coverage on narcolepsy.
The campaign was designed to raise awareness of narcolepsy and drive patients to see their GP for referral to specialist sleep centres, as well as communicate the symptoms of narcolepsy to consumers who may not be aware that they suffer from narcolepsy.
The first result was an hour-long documentary called Nap Attack shown on BBC1. This was followed a couple of months later by a 50-minute programme, called Living Nightmare, on BBC2's flagship science documentary series, Horizon.
Approaches to further broadcast media resulted in BBC1's Inside Out regional documentary series running a short feature on narcolepsy, as did Sky News, who ran a three-minute rolling news item on the impact of narcolepsy on patients. The ITV1 morning show, This Morning, also broadcast a feature about narcolepsy as did the London radio station, LBC, who dedicated their half-hour evening show to the topic, and BBC Southern Counties radio, who ran a feature piece.
The profusion of broadcast coverage stimulated interest from the print media. As a result, coverage in the national and regional newspapers, consumer magazines and on Internet sites was extensive. The consumer PR programme was complemented by a medical media programme designed to ensure that GPs and other healthcare professionals referred patients into specialist sleep units. Throughout, the key communications messages on narcolepsy were achieved. As a result, over 114 pieces of print coverage were generated as a direct result of the Nap Attack and Horizon documentaries.
The combined audience of the broadcast and print coverage was over 100 million – staggering considering the condition only affects about 20,000 people in the UK.
As a result, clinicians reported immediate referrals following the broadcasts and many noted a major increase in numbers of patients being referred where the GP had specifically queried narcolepsy (previously most GPs simply queried sleep problems). Dr John Shneerson, Director of Respiratory Support and Sleep Centre, one of the UKs leading sleep centres in Papworth Hospital clearly felt the awareness campaign achieved its objective. "The broadcast coverage was a significant contribution to increasing awareness of narcolepsy and its modern treatment across the country," he said. "For example, within days of the Nap Attack show referrals to our sleep centre increased."
Inevitably, an increase in numbers of patients being referred to sleep specialists would translate into potential new patients for campaign sponsor Cephalon's Provigil, one of the most widely prescribed products in this disease area.
Given this, how would such an awareness campaign now sit in light of the MHRA Guidelines?
Nap Attack in light of the MHRA Guidelines
Because the narcolepsy campaign was of an editorial rather than 'paid for' or advertorial nature, Cephalon had little control of what the producers and journalists would include in their programmes and features. However, as narcolepsy is a complicated condition, initial briefing meetings with producers and journalists were organised to ensure that the condition was fully understood and so that any questions about the disease could be answered at an early stage. Following the meetings, they were then supplied with generic information on narcolepsy approved both by Cephalon and a leading independent clinician. They were also directed towards the patient support groups, narcolepsy patients willing to share their experiences on camera as well as sleep specialists. This ensured that information fed into the campaign was accurate, up-to-date and balanced. From then on production control sat firmly with the journalists and producers.
To assist with the influx of postbroadcast enquiries, support materials were provided to the producers and journalists, which again had been approved by Cephalon and independent sleep experts. This ensured listeners and readers could benefit from information that would help them to recognise their disease and therefore, seek the most appropriate help. None of the support materials were product-focussed in any way, ensuring compliance with the MHRA's guideline on particular care in relation to conditions where few products are available. Media coverage was universally 'generic' and balanced, concentrating on the health and disease aspects of the condition.
Throughout, Cephalon's role in the campaign was made clear to all parties and all materials clearly identified Cephalon's involvement. Following the broadcasts, consumers were directed to either the BBCs website or the two patient groups for further information. The BBC had developed its own materials whilst the patient groups issued their own fact sheets.
Overall, the awareness campaign fulfilled the key criteria spelt out by the MHRA Guidelines, while still offering benefits for all those concerned with the campaign.
Single-Product or Market-Leader Issues
The guidelines specifically highlight the issue of diseases or conditions where there are few products, one leading or only one product available. Campaigns of this type will require particular care to ensure they focus on health and disease education, providing details of where to get appropriate advice, but they are not prohibited by the guidelines. This finally clarifies the issue for companies planning to run such a campaign.
Novartis Pharmaceuticals, whose long-running Stepwise campaign focuses on raising consumer understanding of fungal nail infections and athlete's foot, have frequently found themselves under scrutiny for running this campaign.
Indeed, in reporting the guidelines, the British Medical Journal (BMJ 2003;326:1219) implied that in a case like this, it could be construed as direct-to-consumer advertising by the back door. However, it is encouraging to note that the Department of Health, in responding to the BMJ, noted that as long as Novartis did not steer consumers towards a particular product, it would not be in breach of the MHRA's guidelines. As the Novartis campaign is a disease-only one, these guidelines now give them free rein to continue their campaign unabated.
So what is the verdict?
It is important to understand that although the MHRA Guidelines set out clear rules and regulations, most pharmaceutical companies running disease awareness campaigns have already adopted such an approach, without the benefit or existence of this guidance.
However, pharmaceutical companies must now ensure that the MHRA guidelines become an integral part of the planning process when proposing a disease awareness campaign and that companies and agencies they work alongside understand the guidelines too. It is reassuring to note that the MHRA is willing to offer guidance on whether a campaign falls within or outside these guidelines. Thus if you are unsure, it may be prudent to discuss it with them prior to committing time and resources on something that could ultimately fall foul of the guidelines.
Overall, the guidelines are to be welcomed as they clear up the ambiguity surrounding disease awareness campaigns that has dogged the industry in recent years and ensure patients, clinicians and the pharma industry continue to benefit from well orchestrated disease awareness campaigns.
Seven key points for disease awareness campaigns to cover
DACs should include information that is:
Accurate: The information in a DAC should be carefully checked for accuracy so that the public is not misled.
Up-to-date: Every effort should be made to ensure that information contained in a DAC is current. The date of publication should be clear.
Substantiable: The information in a DAC should be capable of substantiation by reference to the medical literature or other authoritative sources.
Comprehensive: DACs should cover the key characteristics of the disease.
Balanced and fair: DACs should ensure that the impact/implications of the disease are realistically conveyed without being alarmist. Management options should be presented in a balanced and fair manner that does not unduly emphasise particular options or the need to seek treatment.
Readable/accessible: The language used should be designed to convey key messages clearly, supported by appropriate design and formatting.
Source identified: The source(s) of the DAC should be clearly identified on the publication itself.
Source: MHRA Guidance Note 26, Disease Awareness Campaigns Guidelines
Vicky Amos is an Account Director and Kellie Delaney Isaacs a Senior Account Executive at Sant Communications.
To view the full MHRA Guidelines, please click here.
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