Warning sign

Life is filled with an element of risk. The key is to embrace it whether you are climbing K2 or communicating to various stakeholders some of the potential clinical downsides to your products.

But communicate you must. You only need to pick up the daily newspapers, or turn on CNBC or the BBC to learn that a pharmaceutical company somewhere is under fire for failing to communicate fully the risk of a product. With increased scrutiny by the Food and Drug Administration (FDA), as well as here in Europe, companies are having to cope with the inordinate strain of having to back pedal about something they knew of all along.

We live in a time of the vicious spiral. A company is forced to withdraw a product due to questions about drug safety. The FDA and other regulatory bodies are then questioned by respective governmental watchdogs. Hearings are called and the finger pointing begins. Some observers will say that the regulatory body did not do enough to meet deadlines on risk management, accusing it of conflicts of interest.

Others will blame the corporations, suggesting that they are not being forthcoming with information. New drug safety initiatives are subsequently put in place. It is at this point that confused and worried patients, the end users of these products, begin to ask questions. As a result, widespread distrust of both government and the pharmaceutical companies takes root.

It is time to stop this cycle and to face the new reality. Instead of a world where questions and answers are prepared in advance about the safety what ifs?, we need to provide solid information

from the start that communicates fully to doctors and patients the positives, and the negatives, about the products. Transparency on drug safety issues can be an unfamiliar, and uncomfortable, place for the industry but, in an age where we have instantaneous access to information, it is of paramount importance that pharmaceutical companies and their communication partners opt for full disclosure of pertinent information. Not just the truth, but the whole truth.

Branding to bonding
A recent Yankelovich study stated that 76 per cent of people believe individuals should take primary responsibility for their health and not rely so much on their doctors. In this new age of consumer enlightenment, with 62 per cent of people actively seeking out information about health, communicating risk can become a positive.

There are the obvious advantages of avoiding product withdrawals and warning letters from regulatory agencies, requesting what seems to be a relentless stream of additional information. In addition, full disclosure from the outset, when your product is still in development, can also put you at the forefront of advancing public health.

It is important to move the emphasis from branding to bonding. Branding is a one-way conversation about your product, while bonding is about building relationships with your customers through trust and engagement. By doing this, you will be able to effectively establish the brand through focused and integrated disease awareness campaigns.

Risk and DTC
In the late 1990s, with the advent of direct-to-consumer (DTC) advertising in the US, communicating the risk of a product was reduced to an approved 5 or 6 second sound bite sprinkled in the middle, or slammed in at the end, of a 30 second television advert. Today, the FDA is taking a closer look at the copy used in these ads and examining the most effective way to put the genie back in the bottle, as many critics of DTC have dubbed it.

In Europe, the draft amendment of EU pharmaceutical legislation (Directive 2001/83/EC) which was supposed to herald thebeginning of a trial period for DTC in certain disease categories, fell apart. Apparently, it was a poor translation from the French and now the EU has removed the draft legislation completely. A veritable fait accompli for DTC in Europe.

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Better disease awareness in the US
Many of the doomsayers believe this to be an omen, portending Europe's isolation from the giant US market and the share of the big marketing budgets. However, recent FDA guidance has called for consumer-friendly alternatives to the brief-summary that clearly communicates risk as well as for an increased focus on non-branded disease awareness programmes aimed at encouraging individuals to seek help from a medical professional.

Perhaps the prohibition we have lived with in Europe will help us provide a guiding light for our colleagues across the Atlantic. While it is time for our US counterparts to redress the balance between promotion and education, smart marketers in Europe have been spending their marketing budgets on disease awareness campaigns for some time.

They have spent time building relationships with third party advocacy groups to ensure consumer-friendly information gets to patients and encourages them to enter into a dialogue with their health professional.

The benefits of this approach are borne out by a recent study, the Edelman Trust Barometer, which stated that only 9 per cent of respondents believe that information from corporate communications departments is accurate and complete. The same study showed that 60 per cent believe that the best information comes from their doctor.

Communicating risk should be a central strategy in your disease awareness programme. In 1988, Ries & Ries said it succinctly: Advertising doesn't build brands, publicity does. However, they probably didn't have the kind of negative publicity that we see nowadays in mind: the kind of negative publicity which can sink a product brand and, in turn, can undermine consumer and shareholder confidence in the corporate brand as well.

Remember, we are moving from branding to bonding. In a trusting relationship, the other party does not expect perfection, but they do expect honesty and openness. It is here where you can make a difference and stand out from the rest of the pack by communicating upfront the risk profile of a product within the key messages of a disease awareness campaign.

It's important to remember, however, the Medicines and Healthcare products Regulatory Agency (MHRA) guidelines on communication materials as you begin to formulate a strategic communications plan.

You should always be asking yourself if what you are saying is:

ï Accurate
ï Up to date
ï Substantial
ï Comprehensive
ï Balanced and fair
ï Readable
ï Accessible
ï Sourced

Make sure at this point that you build enough into the budget for some accurate awareness testing prior to launch. If your communications come under scrutiny and you need to substantiate your claims this will be invaluable.

Pfizer is a good example of a company that has presented evidence that DTC and disease awareness campaigns for its erectile dysfunction drug Viagra can lead to more people visiting the doctor and being properly diagnosed and treated.

While it clearly communicated the risks (ie that the drug is contraindicated in patients using any nitrate-based products, plus side effects such as dry mouth and temporary spots in the field of vision) it advanced public health. During the first two years of its ED campaign, for every one million men who visited their doctor prompted by the campaign, it was revealed that:

ï 30,000 had untreated diabetes
ï 140,000 had untreated high blood pressure
ï 50,000 had untreated heart disease.

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Often product directors and category managers feel that putting communications dollars behind a product which is second or third to market is money not well spent. Rather than worrying about not having the first to market advantage, they would be wise to concentrate on:

a) Tailoring communications towards a narrower group who would truly benefit
b) Including disease education and awareness
c) Looking for ways to balance benefit and risk clearly in all communications; and
d) Aiming to encourage a better health dialogue between patient and doctor for informed decision-making.

This leads us right back to the upsides of a potential downside. It could be termed as light emanating from the black box. Remember that consumers today are much more interested in products that help improve their quality of life. At the same time, they want complete information on the potential risks and complications that may accompany the benefits. It can be compared, on a lighter note, to buying a top of the range car but the company never telling you that the engine will fail at 100,000 miles. Consider showing the power of your brand, both the upside and the responsibility.

The core of communicating risk
While branded DTC is under scrutiny in the US and unlikely to happen in the UK and the EU in the foreseeable future, it's important to remember that Clause 20 of the Association of the British Pharmaceutical Industy guidelines in the UK states that, within the regulatory framework, there are only three potential channels for consumer marketing communications:

ï PR
ï Disease area advertising
ï Patient support programmes.

A PR-led disease awareness campaign can be a very effective tool in reaching your various stakeholders. The key that unlocks this treasure trove is not old school public relations. It's all about realising your full potential by building powerful relationships with health professionals, patient organisations and, most importantly, the individuals that use your products - the patients.

It also means solidifying a powerful relationship from the outset with your clinical, medical and legal affairs teams. You need to play hardball with them. Don't just let them know the many perils there are to be faced in not fully disclosing the risk and of failing to disclose any, and all, downsides of a product. Instead, coach them on the many advantages of being the company that really cares about its customers.

This is not about crisis planning or minimising potential risk. This is about prevention - about getting the message out clearly that this product may not be for everyone.

Cards on the table
The best way to avoid potential patient and shareholder panic with a prescription medication is to put all the cards you have on the table from the start. Of course, you can't predict the future in terms of long-term side effects but what you know now should go on all communication materials and not just the package inserts.

Overkill may be the best way to go here. Begin to think as directors in the food and drinks business did a few years ago, when standardised ingredient and nutrition labelling came into force. This is not such a daunting task and there are some simple things that can be done:

ï Standardise how risk is communicated in all communication materials
ï Keep the instructions user friendly for all audiences
ï Target communications to the relevant audiences; and
ï Be comprehensive and transparent.

This new way of communicating risk will cause a sea change within many pharma companies and supporting agencies. It is a change long overdue. You cannot predict where the FDA or other regulatory bodies may be heading. What you can do is proactively change the way you look at risk.

Communicate the risks and complications clearly and succinctly and let the positive attributes of the brand take over. Never underestimate the power of the health-active consumer to bond with products. The central point is to make certain you do tell them the potentially bad news.

The Author
Kate Triggs is executive vice president, managing director health Europe at Edelman