Overcoming the DTC Fear Factor

FDA gets on the “Less is More” bandwagon

The “Less is More” approach is gaining traction in health care. Fear is what often causes people to gird themselves with potentially unnecessary health care interventions: fear of getting it wrong, of missing out, of being criticized, of dying. Atul Gwande details the bravery required to challenge the medical status quo in his recent book Being Mortal. Gwande does a great job of debunking the myth of “more care is better care” when it comes to end of life treatment.

Now “Less is More” is being applied to health care communication. The FDA is overcoming the DTC Fear Factor and casting aside unnecessary risk information with the intent to drive superior patient comprehension. The FDA has issued draft guidelines that require less, not more, risk information in the Consumer Brief Summary portion of DTC print ads. PharmaGuy provides a comprehensive (and as always, entertaining) review of the proposed guidelines in his February Newsletter.

But the FDA is not using the editing pen wily-nilly. Knowledge born of research, is taking the edge off of their DTC Fear Factor. Upcoming research includes a study on the risk information presented in television ads. The objective is to see whether listing only the most actionable risks leads to better comprehension than the usual mind-numbing laundry list.

Certainly the FDA has reason to fear getting the level of risk information wrong. As Daniel Carpenter, a Harvard professor who studies the FDA posits in a Health Affairs article, the FDA is driven by it’s “desire to safeguard its reputation for protecting the public’s health.” The FDA’s “Less is More” approach certainly has its critics. Public Citizen criticized the FDA for its proposed August ’14 guidelines on how pharmaceutical companies should present risk information to physicians

This new “Less is More” approach to risk information demonstrates that the FDA is willing to undergo reputational risk to do the right thing for patients by presenting the information in a way patients can understand and act on. There is substantive evidence that links lack of patient understanding with negative health outcomes.”

So what is the likelihood of pharmaceutical review committees embracing the “Less is More” philosophy regarding risk information? Certainly the new review FDA guidelines will help, but as anybody who has sat through a review committee meeting can tell you, there is wide latitude in how FDA guidelines are interpreted. Many opt for the most conservative approach.

My guess is that review committees won’t get over their DTC Fear Factor anytime soon. There is just too much reputational risk. And it is hard to blame them. The media’s knee-jerk reaction is to attribute any misstep to a nefarious motive on the part of Pharma.

Overcoming the DTC Fear Factor will require Marketing Departments to do the hard work of proving that using fewer and simpler words to describe a product or disease state results in better comprehension. Just as the FDA Researchers helped their Reviewers get over the DTC Fear Factor with data, Pharma marketers will need data to bolster the courage of their Review Committees with solid research.

However, conducting research brings along its own “Fear Factor.” What if the language causes consumers to overestimate the efficacy or underplay the risks of the product? So why bother? In the past, trying to boost outcomes by improving communication comprehension was a “nice-to-have,” despite the compelling health literacy case.

But now, the Affordable Care Act makes reimbursement dependent on outcomes and patient experience. So ensuring patient comprehension is critical to the financial viability of Pharma’s direct customers: physicians, hospital systems and health plans. So follow the dollar. Customers care, so pharma marketers should care too.

Complexity is easy in Pharma communication, just go to the label. Eliminating the DTC Fear Factor in Pharma will take hard work. However, in health care, the “Less is More” train has left the station. Time to put fear aside, join the FDA and jump on the “Less is More” bandwagon.

Purple Cow or Bull in a China Shop?

How to make change stick

A colleague once generously called me a Purple Cow.

I say “generously” because he used the phrase as Seth Godin did, to mean someone/something intrinsically different. As a Pharma marketer, I constantly pushed for new marketing approaches. However, much of the time I tried to drive change, I probably behaved more like a bull in a china shop than a remarkable purple cow.

In fact, the Pfizer Health Literacy principles were launched internally two times because I had not fully involved my marketing colleagues the first time. After the initial launch, less than 25% of the patient literature coming out of my own department adhered to the principles. When even the people you directly supervise refer to a pamphlet written according to health literacy principles as using “dog food language” you know you haven’t done a good job socializing the concept.

As the founding partner of extrovertic, a health care consulting firm focused on delivering innovative marketing solutions, I continue to seek out new marketing approaches. However, I now appreciate the importance of involving others and managing the change process. So extrovertic has enlisted the help of a former colleague of mine, Susan Domotor, an expert in change management, to help extrovertic clients to successfully implement the change they seek to build their businesses.

According to Susan, studies show that business initiatives rolled out with less than adequate focus on the employee aspects of the change have about a 30 – 40% success rate” (Blanchard, IBM). As I found out in rolling out the Health Literacy Principles, this translates into significant amounts of wasted time and money.

Here are Susan’s top three recommendations for getting your colleagues to embrace the change you seek:

1. Create a strong business case – A business case helps people understand the importance of the change, conveys a sense of urgency for what you are trying to achieve, and generates a sense of ownership for a successful transition. A strong business case answers three questions: Why is the change necessary? What is the change? How will we achieve the change?

2. Ensure that Leadership is visibly engaged and is driving the change – Visible leadership support is critical for success and it cannot be delegated because employees will only commit to efforts that are driven by their leaders.

3. Develop a focused Communication Plan – An effective communication plan is critical to influencing employee behavior. The plan must create understanding for the initiative; provide employees opportunities to question, digest, and internalize the change; and as the initiative progresses, celebrate successes, share best practices, and capitalize on opportunities to highlight the performance and behavior that are valued in the new way of doing business. It is important to build the communication plan before kicking off your initiative. You can modify it along the way.

Change is being continually foisted on the pharmaceutical industry. Chances are that no matter what your job function, it now involves change. Whether it is to instill a new patient-centric mindset into your organization or to get your colleagues to embrace multichannel marketing for physician outreach.

Lucky for me (and patients struggling to understand health care information), my colleagues gave me a second chance. After the re-launch, over 95% of the patient pieces produced met the Pfizer Health Literacy Guidelines. But with a strong change management plan, you don’t have to count on being lucky, just being prepared.