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.

The Orphan Impact: Small drugs drive big changes

Seems everybody’s talking orphan drugs these days. No wonder, according to EvaluatePharma’s 2013 Orphan Drug Report, orphan drugs are estimated to reach 15.9% of total worldwide prescription sales by 2018. But the orphan drug impact goes beyond sales numbers. I believe that the patient centricity blossoming in the rare disease divisions will eventually spill over into the primary care divisions of pharmaceutical companies.

With the big blockbuster primary care drugs, development success lay primarily with company research departments. The halls of Pharma echo with stories of researcher heroics—how the lone scientist kept a molecule from hitting the drug dustbin only to become the next blockbuster.

But in orphan drugs, the heroes are as likely to be individual patient family members as researchers. In some cases the drug literally starts with patient families. Thanks to advances in digital technology and social media, orphan drug patient families play a major role in every aspect of bringing a drug to market, going far beyond traditional advocacy roles. Now individuals are able to leap tall barriers with a click of a mouse to accomplish superhero feats formerly reserved for massive organizations like the NIH and pharmaceutical companies.

Consider the role of patients, families and organizations in:

Disease discovery: Matt Might, a father whose son had a disease entirely unknown to science, leapt over barriers of scientific self-interest to find other patients and give his son’s illness a name.

A well-known blogger in his field, Matt’s post about his quest helped identify patients like his son across the globe. In the New Yorker article, which describes Matt’s disease naming odyssey, a Duke geneticist, who worked with Matt, sums up the new patient paradigm with this quote:

“It’s kind of a shift in the scientific world that we have to recognize—that, in this day of social media, dedicated, educated, and well-informed families have the ability to make a huge impact…Gone are the days when we could just say, ‘We’re a cloistered community of researchers, and we alone know how to do this.’ ”

Research direction: John Crowley funded individual scientists to fill the treatment void when he learned his daughter had Pompe disease. Ultimately John ended up partnering with one scientist to form a company that eventually was folded into Genzyme. And while his story is certainly one of the most dramatic (to the point of being the subject of a major motion picture starring Harrison Ford), John’s ability to drive the course of scientific discovery is becoming more commonplace in the rare disease space.

Product approval parameters: In June 2014, the Parent Project Muscular Dystrophy (PPMD) patient group, submitted the first ever-patient advocacy-initiated draft guidance for a rare disease to the FDA for Duchenne muscular dystrophy. Patients, through organizations like the PPMD, are now directly driving how Pharma should be conducting their research.
Because of the outsized role patients and their families play in bringing a drug to market, building strong patient relationships is a key marketing investment for orphan drug marketers. For example, Biogen Idec, deployed over 15 community managers to support people with living with hemophilia even before they had an approved product.
There are already signs of an “orphan drug spillover effect” on primary care marketing. Consider Sanofi’s community manager position in their Diabetes franchise. Or more recently, that Sanofi appointed a Chief Patient Officer. And this I believe, is just the start of the orphan drug effect.

Soon the patient centric tactics of Rare Disease marketers will be highlighted in “marketing excellence” meetings all over Pharma. Then questions will come during marketing plan presentations about “why can’t primary care teams start building patient relationships like their rare disease counter parts?” And before you know it, the small seeds of patient centricity will finally blossom throughout Pharma.

Patient Shopping in Our Lifetime?

This was the one of the final questions asked at a recent Elsevier conference where I was a speaker. The panel charged with answering this question was largely pessimistic. Panelists felt that the byzantine system of setting prices for both medical procedures and pharmaceuticals made it unlikely that consumers would ever get the cost data required for effective shopping behavior. They couldn’t imagine that anyone in the industry would step up to the challenge of making prices more transparent.

There is certainly reason for their negative outlook. For example, a recent study by Verilogue and Duke Medical Center found that when oncologists discussed  breast cancer treatment options with patients, costs were only discussed in 20% of the cases. If patients can’t get information on the costs and outcomes of various medical and drug treatments, then they can’t make the appropriate trade-offs.

In my opinion, the Elsevier panel was right and wrong.

Right because strides towards increased pricing transparency won’t come from within the industry. But wrong because change will be instigated from outside the industry—by government, non-profit organizations and entrepreneurs unencumbered by the war wounds of fighting vested health care interests.

Here are a couple of examples that provide me with hope:

  • On the non-profit side, there is the Minnesota Community Measure Up coalition. They created the Minnesota D5 program, which provides effectiveness scores for treating diabetes by individual clinics/HCP offices.
  • Newer health care services like Counsyl, a genetic testing company, have actually built cost transparency into their business model. Counsyl has developed a proprietary tool that allows patients to calculate their exact costs once their particular insurance policy is factored in before they sign up for the service.
  • Iodine, a newcomer in the cost and rating business for drugs, has developed a very easy interface to help consumers start evaluating the cost/quality trade-offs for different medications.

Information will drive true shopper behavior.  Contrary to popular belief, patients can make educated choices. Patients don’t reflexively opt for latest and the greatest medical solution. As reported in the New York Times, a recent study in the Annals of Surgery, found that parents actually made the cost effective choice regarding appendectomies for their children.

When parents were told that both conventional and laparoscopic surgery yielded the same results, but that conventional surgery was far less expensive, two-thirds of parents chose the less expensive conventional surgery. 31% said that the information they received was the primary driver in their decision and 90% liked having a choice.

Pharma companies are going to have to learn how to market to health care shoppers rather than patients. This means that not only will pharmaceutical companies have to include cost in their outcomes studies with payers, they will also have to convince health care shoppers that their drugs represent a good value for the money.

And much like restaurants and hotels, Pharma companies will have to regularly monitor the various patient quality and cost rating systems to make sure their medications are fairly portrayed. A bad rating will have a direct impact on revenues, as consumers fail to start or stop using a medication, based on a rating they saw.

Pharma companies will need to include these products ratings from patient sites in their analyses of sales results. I predict that these analyses will show a direct correlation between consumer ratings and revenue. And when that happens, it will be the dawn of the era of the true health care shopper!

Follow the Money to Patient Engagement

4 Reasons why Pharma will finally become patient-centric

Pharma Financial Stars Lie with Patient-Centricity

Pharmaceutical marketers have been talking about Empowered Patients ever since I joined Pfizer Pharmaceuticals in the mid-90’s as one of their first consumer marketing hires. But despite all the talk, most pharmaceutical companies are nowhere near being patient-focused.

Pharma marketers know things are changing but are holding onto the HCP-focused status quo for as long as possible. In fact, I was recently asked by a Pharma Exec charged with driving patient engagement, “When do we really have to get serious about patients?” They felt that their primary customer was still the physician.

But ever the optimist, I believe that the next 2-5 years will represent a seismic shift in pharmaceutical marketing. Away from a singular focus on the physician towards a more patient-centric way of being. And that’s because patient-centricity is increasingly critical to a pharmaceutical company’s growth and financial health. As Watergate’s Deep Throat said, “Follow the Money.”

To my mind, there are four market trends that are helping to realign Pharma’s financial stars towards patient-centricity:

1. The Dawn of Health Care Shoppers-Historically, consumers exhibited very little true shopping behavior, even as they became increasingly responsible for their health care costs. This lack of true shopping behavior was largely because consumers had little visibility into costs and quality data and therefore couldn’t make the necessary trade-offs.

But that is changing.

Health care reform, combined with private sector efforts, are increasing transparency around both costs and quality, allowing consumers to start making trade-offs with their health care expenditures, including medications. Patients will move from merely asking a physician for a particular drug they saw advertised on television to making a highly considered decision to pay for drug A or drug B.

With this true decision-making, patients will be able to move markets. As this market moving ability starts to show up in pharma company regression analyses, Pharma companies will be stumbling over each other to be the most patient-centric.

2. The shifting economics of their customers-HCPs, Hospitals and Integrated Delivery Systems won’t be rewarded on the quantity of services they deliver anymore, but rather on the quality of those services and the patient experience. The smart pharmaceutical companies are going to look for ways to help their customers deliver better patient outcomes and experiences. And that is going to require additional investment to prove their patient interventions actually deliver.

3. The exploding orphan drug opportunity-Specialty and orphan drugs now represent the path to financial growth for many Pharma companies. And along with the orphan drug opportunity comes the empowered patient. These patients play a significant role in which drugs get into clinical trials, get approved by the FDA and reimbursed by insurers. If a company is in the Orphan Drug space, then by default they have to be patient centric. I predict that this “patient centricity” will eventually work its way into larger, primary care marketing practices.

4. Patient Reported Outcomes (PROs) in clinical trials will increasingly become commercial differentiators-In many categories, pharmaceutical researchers have already captured patient-reported outcomes, particularly on quality of life. However, these metrics have had little true commercial value since the FDA has been leery of approving claims based on patient reported outcomes. I believe that the FDA’s new focus on patient centricity, as witnessed by their “Patient Focused Drug Development” initiative may signal a growing acceptance of PRO claims. And as PROs become more important to the commercial success of a medication, so will the patients.

It is this alignment of Pharma’s financial stars around patient-centricity, that makes me believe that pharmaceutical companies will finally begin to truly embrace the empowered patient. Just follow the money. It never lies.

The most overlooked marketing investment

Investing in your customers. That’s what companies, like YouTube, who have their pulse on the consumer do according to a recent article in Digiday. YouTube is helping their customers develop the content that will help them realize their dream of becoming digital stars. But the concept of customer investment goes beyond the digital world. Investing in customers is a business strategy well described in “Who Do You Want Your Customers to Become?” an e-book by Michael Schrage being offered by the Harvard Business Review.

Schrage says businesses can keep growing by asking, “Who do our customers want to become?” and helping them get there by strategically investing in customer capabilities. Invest in customers, because, as Schrage puts it, “your future depends on their future.”

Health care is no exception.

Think of the demands placed on physicians by the Accountable Care Act. To be successful in the future, physicians will need to become:

• Customer service experts since patient experience will drive reimbursement
• Data analysts as the practice collects patient satisfaction data
• Healthcare systems thinkers as practice ratings are dependent on the entire office visit experience, not just the physician interaction

The demands on patients have also increased. Take the experience of Peter Drier who practically become a forensic accountant to track down an unexpected $117,000 in charges associated with his neck surgery as recently reported in the New York Times. Or Matt Might who, according to an article in the New Yorker, had to supersize his social media skills to assemble a group of patients across the globe to give his son’s illness a name.
With the advent of the health care exchanges, Payers who once operated in the B-to-B mode have now found themselves having to develop the type of direct-to-consumer marketing skills pharmaceutical marketers acquired in the 1990’s.

There is no shortage of investment needs when it comes to pharmaceutical customers. Of course there is all sorts of regulation against practice building and incentivizing use. However, by applying a little creativity and keeping the end game in mind—improved outcomes and a better patient experience—the smart pharmaceutical “investor” will be able to eke out a competitive advantage with some well placed customer bets!

“Orange is the new Black”: what prisoners and patients have in common

While binge watching the second season of Orange is the new Black I was reminded of an important parallel between patients and prisoners. Both are victims of a “3rd party decider economy” where “the person selecting a product or service is not the person who will actually use it.”

OITNB

In a New York Times article entitled, “Orange Is the New Green,” Adam Davidson, wrote about the plot line where poor Piper waits weeks to get her shower sandals from the prison commissary. In an economically rational world, prison commissaries would try to maximize sales to inmates and minimize out-of-stocks.

After extensive real life research, Davidson concluded that the prison system wasn’t focused on meeting the prisoner’s needs, but rather the prison’s needs. And it was this emphasis on the 3rd party rather than the end user that was thwarting rational economic behavior.

To a large extent, the US health care system has been designed to meet the needs of HCPs rather than patients. Pharmaceutical marketing perpetuates this 3rd party decider distortion by allocating the bulk of marketing budgets to HCPs rather than patients. According to the 2014 MM&M/Ogilvy Healthcare Marketers trend report, pharmaceutical marketers spend over 50% of their budget on physician marketing. This is on par with last years report. Despite all the patient centric talk, spending has not changed.

Like prison commissaries with out-of-stock situations, allocating more money to HCP marketing is not rational economic behavior. There is significant evidence that HCPs’ sway over prescribing decisions is waning. Patients and Payers are increasingly calling the shots. But old habits die hard. Most of pharmaceutical decision makers today have built successful careers on face-to-face selling to HCPs. It is hard to divert budget from a technique that has delivered so faithfully for so many years.

Perhaps the upcoming 2015 planning season will take on this HCP market distortion. The US health care system is slowly being reoriented around patient needs. For example, the government is driving more patient focus with the Affordable Care Act and the FDA has initiated hearings on patient focused drug development.

Pharmaceutical marketers could redesign the 2015 planning process around patient needs. For example, why not use the patient journey to guide investment across all customer groups, not just patients? What are the HCP initiatives that have the most impact on patients? Invest in those! Think of the 2015 planning process as a binge session on the needs of patients, a productive binge session you don’t even have to feel guilty about.

Thanks for letting us share!

Dorothy