Trust Consumers and They Will Trust You in Return

Consumer trust in the pharmaceutical industry may be waning, but it’s not too late to repair this fragile relationship. Providing consumers with information and education so they can better understand their conditions and treatment options will help them regain trust in the industry and its products.
By Anita St. Clair

DESPITE ITS LAUDABLE MISSION TO SAVE LIVES AND improve health, the pharmaceutical industry is not as well regarded as it should be. In a PriceWaterhouseCoopers survey, Billy Tauzin, President and CEO of the Pharmaceutical Research and Manufacturers of America, said the industry faces a “great problem that seriously threatens (its) ability…to…develop new cures and treatments. In a word, it is trust.” A foundation for any relationship, trust is a two-way street, and this is true of the relationship between consumers and the pharmaceutical industry. Regaining the trust of consumers starts with a simple idea: Consumers will trust the industry more when the industry trusts consumers more. The industry can demonstrate its trust by providing consumers with information they can understand and act upon, presenting a full disclosure of the risks and benefits of treatment, and giving strategies for minimizing the risks that come with treatment. The industry and the agencies who serve it can do more to regain consumers’ trust; this article suggests how.

Why Do Consumers Mistrust?
Confronted by drug recalls, lawsuits, and misleading advertising, consumers have good reason to mistrust. Pharma is a crisis-prone industry. In fact, the Institute for Crisis Management noted that the pharmaceutical industry was the second most crisis-prone industry in 2007, surpassing the petroleum refining and banking industries and second only to software makers. Given the recent turmoil, the banking industry is sure to pull ahead in the future, but trust in the pharmaceutical industry seems to be waning. In a 2001 Harris Interactive survey, 48% of people responded that they trust pharmaceutical companies to “do the right thing if faced with a serious problem with one of their products,” whereas only 27% of those surveyed in 2007 said they somewhat or very strongly trust the pharmaceutical industry.

Lost Trust: The Implications
Consumers who mistrust the industry may be more reticent to enroll in clinical trials, which depend upon consumers’ willingness to take a leap of faith. Consumers may also be less likely to seek treatment, opting instead to ignore symptoms or to attempt to manage health conditions on their own. They may also ask their physicians to swap one brand for another if they lose faith in the manufacturer. Of those who initiate treatment, many patients—50%, according to the World Health Organization—will not take medications as prescribed, which is a complex issue only partly attributable to mistrust of the industry. Harris Interactive noted that of those who report having adherence problems, 45% cite concerns with the medication itself as the cause of their nonadherence. These concerns are consequential. Consumers who are worried about the dangers of a medication report that, among other behaviors, they:

• Stop using the medication
• Switch to another medication
• Reduce the dose of the medication

In addition to being costly to patients and the healthcare system, poor adherence is costly to the industry. The National Council on Patient Information and Education estimates that non-adherence costs the pharmaceutical industry 36% in sales losses for the average drug.

Clinical Outcomes Are at Stake
Consumer mistrust of the industry or of a particular brand can affect adherence, which, in turn, can affect clinical outcomes. Adherence, in fact, has been called an important mediator between medical practice and clinical outcomes. Poorer clinical outcomes, no matter the cause, influence patient and physician perceptions about the medication itself and, ultimately, the manufacturer and the industry as a whole. Because clinical outcomes affect every stakeholder, including patients, physicians, managed care organizations, and quality assurance and accreditation organizations, those outcomes necessarily matter to brand marketers as well. Organizations, such as the National Committee for Quality Assurance, scrutinize the clinical outcomes of healthcare organizations whose formulary decisions are critically important to brand marketers. Brand marketers are well served to do everything possible to improve clinical outcomes. This can include providing more information about treatment risks, information that consumers can understand, education, rather than information overload, and tips for managing side effects.

Consumers Want More Information About Treatment Risks
Regaining the trust of consumers will not be easy, but the industry may benefit from considering what consumers say they need:

• 86% of consumers surveyed by the Pharmaceutical
  Safety Institute want to be more knowledgeable about
  a medicine’s potential side effects, and 96% were
  concerned about adverse reactions
• 60% of respondents to a Harris Interactive survey
  reported being skeptical that pharmaceutical
  companies will publish in a timely manner information
  about a medication’s side effects
• A PriceWaterhouseCoopers study revealed 94% of
  respondents believe pharmaceutical advertising is not
  transparent about risks and benefits of a medication

Consumers Want Information They Can Understand
If consumers cannot understand the product information, then it does not matter how much information the pharmaceutical company provides. Almost half of all American adults read at or below an 8th-grade reading level. Yet a recent audit of more than 150 online and offline patient education tactics found that the content had an average reading level of 10th to 11th grade. Some tactics were as high as a 19th-grade reading level. Reading level is just one factor that affects comprehension.
Other factors include:

• Culture
• Age
• Socioeconomic status
• Health beliefs, such as beliefs about the nature and severity of illness or about the effectiveness of treatment

Even patients with high literacy levels benefit from information that is easy to understand. Illness engenders anxiety among consumers of all literacy levels. A recent study reported in The Washington Post found that most people who received a diagnosis of cancer remembered less than half of the information their doctors told them. Of all the product information communicated to a consumer, information about treatment risks may be most important. Simplifying information about risk can go too far, however. According to Frank Fazio, Esq. a principal of Porzio, Bromberg & Newman, a firm that specializes in pharmaceutical defense litigation and regulatory compliance, oversimplification of risk or perceived “overpromotion” of a prescription drug product through direct-to-consumer advertising “can give rise to claims by plaintiffs’ attorneys in civil litigation that the pharmaceutical company has diluted its warning to the prescribing physicians undermining the impact of the warning.” In the wake of recent lawsuits, companies may fear tort liability. Providing information consumers can understand and information they take seriously is a careful process.

Consumers Want Education, Not Information Overload
There is a difference between providing information to consumers and truly educating them. Information is simply the provision of data. It is, for example, the complete prescribing information, which contains everything a consumer needs to know and nothing he or she is likely to absorb. Education anticipates the audience’s needs, tailors information to meet those needs, and aims to change attitudes or behaviors. Changing behavior is a science in and of itself; a science guided by theoretical models, such as the Stages of Change or the Health Belief models. Education recognizes, for example, that intermittent arthralgia (occasional joint pain) is a side effect that is unfamiliar to consumers and that simply knowing about it is not enough for consumers. How likely is joint pain to happen? How severe is the pain likely to be? At what point should the joint pain be reported to the doctor? What should the consumer do to manage his or her joint pain? Patient education answers questions like these in a way that consumers can understand and act upon the information. Yet, according to Fazio, “pharmaceutical companies need to be cautious about rendering medical advice without information concerning the individual characteristics of the patient.” Only the physician as “a learned intermediary is in the best position to evaluate the risks and benefits a treatment offers a particular patient. For example, a treatment side effect may be annoyance in one patient and lifethreatening in another.” He continued, and noted that pharmaceutical companies should try to “facilitate and encourage dialogue between the patient and the physician” about the risk/benefit equation and the management of side effects.” That is not to say that pharmaceutical companies should say nothing about the management of side effects but that they should be careful to say that patients should “rely upon their doctors for specific advice on when to call or what to do if a side effect happens.” Done well, patient education is not just a matter of “simplifying the detail aid.” Patient education, particularly around treatment risk, is a highly nuanced skill.

Consumers are clearly clamoring for more information about treatment risks. They are not clamoring quietly either. Product managers are wise to peruse blogs and other social media forms to better understand what patients are saying about their products and the barriers patients may be facing. This insight can help product managers create patient education materials that mitigate false information and that address treatment initiation and adherence barriers proactively. Understandably, patients do not want to be surprised by adverse events, particularly those events that are more serious than the health condition itself. Yet in discussions about treatment risk, there is such a thing as “too much information.” Consumers do not simply want a list of every side effect that has ever been reported. Even in the spirit of full disclosure, it is not helpful to overwhelm consumers. Consumers need to know about adverse events that are likely to happen; however, listing side effects in order of incidence may not be the right approach for every product. Consumers must know, for example, if a side effect was reported with equal frequency among people taking placebo. Helping consumers to make sense of risk information is more important than drowning them in a sea of information.

Consumers Want Tips to Manage Side Effects
Many side effects can be managed. Yet, too often, pharmaceutical companies do not provide side effect management tips, even though they know that poorly managed side effects can result in poor treatment adherence or, worse, treatment discontinuation, which is the ultimate act of non-adherence. The “well-managed side effect” should be a chief aim of any product’s patient education program; however, patients are often left to their own devices or are told vapidly to “talk with their doctors,” a phrase that is so overused that it likely holds no real meaning for consumers. The better strategy may be to help direct specific questioning around common side effects or to provide unbranded resources. Pharmaceutical companies need only look to the following examples for evidence that robust patient education works. Among patients taking nonsteroidal anti-inflammatory medications in one study reported in the British Journal of Clinical Pharmacology:1

• Patients who were not educated about the side effects were less likely to modify their doses in response to side effects than were educated patients
• Patients educated about modifying their dose if adverse events developed were less likely to have serious side effects than those who were not educated
• 96% of educated patients were compliant with therapy compared with 4% of uneducated patients

Providing written plans for patients that include tips for symptom management can be useful in chronic conditions, as reported in a study published in Chest.2 An interactive educational program developed for children with asthma helped:

• Decrease morbidity costs; in one year, these savings exceeded the cost of the program
• Increase patients’ quality of life
• Decrease school absenteeism
• Reduce the number of asthma-related emergencies

The pharmaceutical company may decide not to provide meaningful side-effect management strategies because of medical/legal concerns about dispensing “medical advice.” Erring on the side of caution, the company may end up saying a lot about what patients should know but little about what patients could do, which can leave patients feeling overwhelmed and ill- prepared to manage their treatments. Given that, according to Fazio, some patients are “reticent to ‘bother’ their doctors about side effects they are experiencing” the patient education materials provided by a pharmaceutical company may be especially important. Striking the balance between saying enough but not saying too much is the challenge for product managers. How can a product manager respect the cautious nature of the in-house medical/legal review process, yet still advocate for information that will ultimately help patients and the brand?

Key Strategies Within a Cautious Medical/Legal Review Process
Even a good patient education program may not see the light of day without a sound approval strategy. Medical/legal review meetings of promotional materials are critical moments for brand managers. Although medical/legal teams differ from company to company, many strategies for facilitating the approval process around the discussion of side effects and management tips exist, including:

Understanding the Nuances of the FDA Guidance to the Industry. This will help you to understand and respect the context in which your medical/legal team is operating.

Relying on Credible References. For side-effect management tips, consider relying on protocols developed in clinical trials, standards of care, and clinical guidelines.

Staying Close to the Intent of the References. It is not
simply a matter of using credible references, but also
of understanding those references well enough to craft
reliable content.

Having a Rationale. Be prepared to articulate the value of the program as a whole as well as the specific need to help patients manage their side effects. A well managed side effect is the goal for all stakeholders, including the brand (fewer adverse events reporting; improved treatment adherence and clinical outcomes).

Collecting Data to Support Your Case. Call center statistics can point to the need for patient education around, for example, the management of certain side effects. You can also gather insights into education needs from other brands within your company or from similar product categories outside of your company.

Qualifying the Language. Rather than saying, “Try the BRAT (Bananas, Rice, Applesauce, and Toast) diet to manage diarrhea,” say, “Talk with your doctor about how to manage diarrhea. He or she may suggest the BRAT diet.”

Facilitating the Conversation Between Physician and Patient. Providing a list of questions about side-effect management may allow you to suggest tips that the patient can then discuss with the doctor.

Having a Plan B and a Plan C. Anticipate the medical/ legal concerns that are likely to arise. Rely on your agency partner to have several options ready should Plan A suffer blows.

Including the Agency Writer in Your Meetings. Agency writers should be prepared to rework content on the fly so that wholesale chunks of your patient education program are not thrown out. Together with you and the agency account manager, the writer can do some creative problem solving to save important aspects of your program.

Providing Unbranded Materials. If side-effect management is a tricky area for your medical/legal team, consider providing unbranded education around, for example, “caring for sensitive skin” rather than caring for a treatment-specific rash.

Engendering Trust Starts With the Industry
It is incumbent upon the industry to earn consumers’ trust. By providing more information about the treatment risks, information that consumers can understand, education rather than information overload, and tips for managing side effects, the industry can help to regain consumers’ trust and to foster an open dialogue among patients, physicians, and the industry. Brand managers, working with their medical/legal teams, can influence the shift to a more positive image for the industry.

REFERENCES
1. Wynne HA, Long A: Patient awareness of the adverse effects of non-steroidal
anti-inflammatory drugs (NSAIDs). Br J Clin Pharmacol 1996;42:253-256.
2. Runge C, Lecheler J, Horn M, et al: Outcomes of a Web-based patient education
program for asthmatic children and adolescents. Chest 2006;129:581-593.

Anita St. Clair is Managing Director of HealthEd Encore (www.healthedencore.com). She can be reached at a.stclair@healthedencore.com.