Why pharma needs proper patient engagement

Exubera was going to mark the end of an era. Diabetic patients would no longer need to inject themselves daily with insulin: it was all going to be easy and pain-free with Exubera, which delivered insulin by inhalation. One breath and it would be done, after years and years of needles. It was going to be the next big thing. Except it wasn’t. 

Production of Exubera ceased in late 2007, a little over a year after it had been approved. The flop caused Pfizer the loss of an estimated $2.8 billion.

The reasons behind the failure were multiple, ranging from adverse effects on lung function to the coincidental release of new and improved needles that were less painful to use. But a major reason was that patients simply did not take to it. The device was large (the size of a can of tennis balls) and impractical; it was also difficult to adjust the dose from injection to inhalation. In summary, it was not patient-friendly and so diabetics stuck to their needles.

It is hard to believe that any of this would have happened if patients had been involved before or even during the development of the drug. It is becoming more and more clear that proper understanding of patient needs should be the first step in the development of drugs and medical devices. And the added value of patient engagement - true engagement, meaning active participation in the planning and development of healthcare interventions - is quickly becoming essential.

The advantages of patient engagement in pharmaceutical research are clear, particularly in clinical research. Patients can be involved in preparing information for prospective participants and assisting in recruitment for clinical trials; they can even have a hand at helping with the design of study protocols, making sure that the endpoints tested are relevant for them. Basic research has been slower to take up patient contribution, but many grant evaluation panels now include patient advocates who ensure alignment of funded projects with the interests of people affected by disease. The FDA and the European Medicines Agency have also incorporated patients into their boards to provide advice during their decision-making process. If the pharmaceutical industry does not follow this lead, it runs the risk of losing touch with patients’ needs, which means running into challenges when their new drugs and devices reach the market. 

Patients are ready and eager to be involved in making decisions that affect their health. This, of course, means that the communication between patients and the industry needs to be closer than ever, and needs to happen across user-friendly channels. This is where digital tools can make a real difference, finding the patients that need help, establishing what their unmet needs are and using this two-way engagement to shape healthcare interventions that will improve their lives. 

The use of digital tools generates a wealth of data that nicely complements that obtained by conventional clinical trials: these data come from people whose characteristics are not limited by clinical trial eligibility. What’s more, wearable devices can collect information more frequently, generating more data. Also, sophisticated wearable devices have advanced sensors that can help detect digital, more patient-centric endpoints, for example movement tracking. As a result, that information is much more valuable. 

Digital can be smoothly incorporated into the clinical trial process. Acorda Therapeutics is now using digital marketing tools to recruit patients for their clinical trials: they can be deployed to find the people who are affected by different conditions and use the same channels to offer trial information and the possibility to participate. The strategy has resulted in hundreds of patients recruiting to their clinical trials.

These results suggest that patients are more than willing to use these new technologies for the management of their health. A King’s Fund report issued in 2018 to mark the NHS’ 70th birthday also found that patients are heartily embracing technology-supported health management, including video consultations with their GP for minor ailments. This can help free up overwhelmed health services.

The pharmaceutical industry has started to see the usefulness of digital approaches. Just this month, Sanofi announced a partnership with Google that will allow it to use technology and analytics to improve understanding of diseases and find out what specific treatments work best for patients. Verily, a spin out company from the Google X division, created Project Baseline in 2017: this began as an observational study following 10,000 people for at least four years, collecting all sorts of health data. It has now grown to carry its own trials, testing new technologies and devices, and matching prospective participants according to their interests.  

It’s not going to be easy: putting digital tools in every patients’ hands will certainly improve the understanding of their needs, but it’ll also generate a demand for tailored healthcare management. The “one-size-fits-all” approach has been the preferred one in healthcare since the beginning, but personalised medicine is gaining ground and has already demonstrated its value, for example in targeted cancer therapies developed to counteract the effects of specific genetic mutations. 

Did Pfizer learn from their Exubera lesson? They did. In 2015 they launched a campaign in association with patient advocacy groups using social media to share stories about chronic pain. This approach was not designed to promote specific products but rather as a way to listen to patients and their needs through channels that they already use, highlighting the importance of getting patients’ perspectives. In short, putting patients at the centre of the development of new medical interventions will guarantee their relevance and help improve healthcare for all.