The positives of PR for pharma

The pharmaceutical industry today is feeling squeezed on many fronts: fewer blockbuster drugs being launched, more me-too drugs vying for attention, patent expirations and the resulting generic threat. Plus, the list of challenges goes on: safety issues and subsequent recalls, greater Medicare and managed care restrictions and attacks on the industry's integrity. Regulatory scrutiny, oversight and enforcement from both the US Food and Drug Administration (FDA) and the Office of Inspector General (OIG) continue to grow. 

In this environment, public relations (PR) is an invaluable communications tool. It has the ability to deliver fairly balanced and objective information to enhance scientific exchange, and can be cost-effectively utilised throughout a product's life cycle, even for mature brands and those going off patent.

Scientific exchange
The term 'scientific exchange' comes from an FDA regulation enshrined in the Code of Federal Regulations as Section 312.7(a). It says a drug company 'shall not represent in a promotional context that an investigational new drug is safe or effective'. However, as the regulation goes on to state: 'this provision is not intended to restrict the full exchange of scientific information concerning the drug', including in the lay media.

Balanced risk information
This means that scientific data on investigational drugs can be included in press releases intended for physicians, patients and the public. The FDA requires these releases to include a fair balance, that is to say, the presentation of balanced risk information. In addition, companies conducting medical research can also meet with patient groups to update them on scientific developments with regard to both investigational and marketed drugs, as such information potentially may have value for their audience. These interactions, typically driven by the PR function, can take the form of educational information packs and personal meetings.

KOLs and patient advocates
Key opinion leaders (KOLs) provide companies with strategic feedback through appropriate consulting relationships. Their involvement in disease education can increase the level of attention paid to a particular unmet medical need.

One of the challenges faced by companies in seeking to educate physicians, patients and consumers about marketed products is securing KOLs to help with these educational efforts. 

KOLs not only have to be experts in their medical field; they must also have superior communication skills. In addition, in many crowded therapeutic areas, there are not many KOLs without conflicts of interest. Indeed, the crème de la crème of the KOL population is nearly exhausted, given the number of marketed drugs already available and new drugs being developed. 

PR can help overcome this scarcity challenge. The identification of up-and-coming thought leaders has long been a key requirement for PR practitioners. News media demand credible local medical spokespeople who can address the burning issues related to a disease state or drug in a specific market. Working with local community groups and third-party patient associations, PR can involve experts from the Latino and black communities, for example, whose members have a higher prevalence of hypertension and diabetes. Therefore, either younger physicians nominated by the current KOLs, or local experts identified through patient advocacy recommendations, constitute another respected base of credible advocates who might, in fact, become future KOLs.

Indeed, companies cannot rely solely on prior relationships, clinical research track records, reputation or number of publications for the accurate selection of a KOL. Smarter companies are involving younger physicians considered 'on the rise', given their availability, their enthusiasm and their growing credibility among their peers.

Wayne Pines, former FDA official, points out that the PhRMA Code dictates that firms hire only the number of KOLs needed to achieve their objectives, that the KOLs be given well-defined roles documented in a written agreement and that they receive payments at fair market value. Plus, KOLs need to be educated about their roles and restrictions.

Relationship marketing initiatives
PR directed towards consumers is proficient at patient engagement, specifically driving people into databases, where questions are asked, information is dispatched and names are captured. At some point in the dialogue, an opt-in query is made and, if the patient consents, the company has the chance to communicate fairly balanced product messages that meet regulatory guidelines.

Direct-to-consumer (DTC) PR efforts boost corporate value and return on investment for disease-awareness advertising with minimal investment. A $4-6m PR campaign delivers a significant level of disease-state media relations and educational events in partnership with advocacy groups, complete with direct response mechanisms such as website address, freephone number, PO box.

By communicating through independent and trusted sources – media and third-party organisations – DTC PR cost-effectively helps build patient interest in learning more about a disease. Furthermore, multicultural populations do not receive medical information through traditional channels, but rather from pastors and other community-based sources. PR can deliver disease-state messages more effectively to this audience.

Innovative communication links
Some of the most innovative patient education programmes have been conceived when PR professionals are included in the discussion.

PR programmes have long been designed to educate patients on their conditions and treatment options to help them take a more active role in managing their health. A number of pharmacy and medical directors view patient education as one of the more important contributions that pharmaceutical companies can make when interacting with managed health plans. These programmes help to reduce unnecessary office visits, which is especially important in a capitated payment system. Value-added patient education programmes also help insurers to be more competitive, enabling them to hold on to patients for longer.

"We've seen excellent communications from companies like Cigna in educating the public about effective collaborations between payers and pharmacy partners. For example, in 2009, Cigna announced that it had teamed up with Merck in the industry's first outcomes-based contract. In 2011, this outcomes-based approach to pharmacy contracting was recognised with an award for innovation by the Pharmacy Benefit Management Institute (PBMI)," said Eve Dryer, a veteran healthcare communications expert who works extensively in creating partnerships between players across the healthcare spectrum.

The Cigna-Merck contract was designed both to improve adherence to medication and improve blood sugar levels for Cigna customers with type 2 diabetes. A year after the contract was implemented, results showed that there was, in fact, improved blood sugar control and blood sugar testing during the contract period. Medication adherence was 87 per cent.

"It is up to professional communicators to ensure that these types of innovative programmes are utilised even more extensively and are known to patients, physicians and all stakeholders in the healthcare system," Dryer commented.

Enhanced patient adherence
There are proven examples of the value of PR in enhancing compliance using local community educational events. There is a correlation between compliance and the amount of information patients receive about their condition and the role their prescription medicine plays in improving their health state. For example, compliance is higher when patients with hypercholesterolaemia understand the role of high-density lipoprotein versus low-density lipoprotein, how a prescription can affect those measures, when medicines start to work (long versus short half-lives) and how long they will need to be on them until the problem is under control.

PR community events reach patients who have been diagnosed with the specific condition and are taking a prescription medicine or who, depending on the disease state, buy an over-the-counter (OTC) medication. These highly trusted forums – for example, at senior citizen centres – enable physicians to teach patients in layman's terms about the importance of taking a prescription medication. They allow doctors to answer patients' questions, explaining:

• Why it is critical to ask the doctor and/or pharmacist questions about prescription instructions if they do not understand them
• Why medicines come with specific instructions in the first place
• Why they need to refill a prescription once it has run out
• The dangers of altering medication, such as breaking pills in half
• What happens if they substitute an OTC medication for their prescribed medication.

Surveys can be conducted prior to and following the event to quantify its role in increasing compliance understanding. Best practices can then be applied for a national roll-out of these events.

PR is a strategic communications tool with wide utility. At the same time, there are rules and regulations that companies and their PR experts must be fully versed in to avoid negative repercussions. Regulatory compliance training and testing helps to lower the risk of violations and decrease costs by reducing rewrites of violative materials under promotional review.

The Author
Ilyssa Levins is president, Center for Communication Compliance