The following post is by Ken Savin, Advisor, Clinical Innovation at Eli Lilly and Company. Ken received his Ph.D. from the University of Utah in 1996 and came to Lilly in 1998 from the Memorial Sloan Kettering Cancer Research Center as a senior organic chemist. He worked on several projects as a medicinal chemist in the areas of anxiety, depression and inflammatory disorders, and he has been involved in many cross-functional Lilly research collaborations. Some of Ken's recent efforts include the NASA – Lilly collaboration, an outgrowth of the InnoCentive program and a recent Innovation Day event. Through these programs, he continues to reach out to other organizations internally and externally as part of a broader open innovation effort.
Every day we see some evidence that the culture of medicine is changing. Paternalistic approaches to providing healthcare are becoming less and less acceptable as patients have begun to make good use of the medical information and community support networks available on the Internet. If we, as drug developers, want to provide the best possible care and the best possible medicines, it just makes good sense for us to listen to people and carefully consider what works best from their standpoint.
Adherence, the idea of whether or not a patient is following a treatment regimen as directed, is one of many complex issues within drug development for which we could use more insights from patients and caregivers. It has been estimated that three out of four Americans do not take their medications as prescribed. Even in clinical trials, where adherence rates tend to be relatively high, investigators report average adherence rates of only 43 to 78 percent among patients receiving treatment for chronic conditions. This can lead to poor health outcomes for patients, and unreliable results in a clinical trial.
Listening for Solutions
Autonomy is true empowerment. It promotes patient responsibility and holds the promise to lead us to more engagement and better health. We must move beyond participatory medicine and focus on educating, enabling and equipping patients with the tools necessary to master autonomy and the art of self-care. ~Hugo Campos, ePatient advocate
The reasons that patients don't follow treatment recommendations are varied and complex. Oftentimes, it's due to factors that are completely outside of the patient's control. Reasons can include misunderstanding between the doctor and the patient, overly-complicated regimens, the costs associated with the medication and many more. Some people don't even realize that they aren't being adherent, due to misunderstanding of how their medicine is supposed to be taken. It's important for those of us who prescribe and develop drugs to understand where the friction occurs and come up with ways to ease it.
That's one of the reasons I hosted an Adherence Summit earlier this year at Lilly's corporate headquarters.
The idea for the summit came about after I had posted an Innocentive challenge to fellow Lilly employees. (Innocentive is an internal platform that we use to crowdsource ideas and solutions from the wide range of talent within the company.) Several people came forward to say that they were already working on projects around adherence within their departments. So, we thought it would be a good idea to bring everyone together to learn from each other.
We also felt it was important to have everyone who was working on adherence to learn from patients outside of Lilly, in an effort to understand how to develop realistic solutions that will fit patients' lives, rather than expecting patients to adjust their lives to fit one of our solutions. We were honored to have patient advocates and Hugo Campos and Britt Johnson attend and share their insights with us.
What Did We Learn?
When a patient talks face-to-face with an employee at a pharmaceutical company, they will often say something like, "Look, I don't want to "engage" with you, I just want to get better." These conversations are the key to truly shifting the focus to solving the real problems patients face every day when it comes to following their treatment regimens. Too often we develop strategies to address issues that we have assumed are most important to the patient. When we talk to patients, we learn that their priorities are sometimes not the same as ours at all.
One of the most important things we realized at the summit was that we were all trying to make important decisions about improving adherence without having enough information. We need to learn first hand about everything that happens along the patient journey, going beyond the basic steps they must go through to take their medicines or participate in a clinical trial, for example. We also have to understand what they feel along the way, what kinds of barriers they are exposed to and how they react to those barriers. Then, we can ask ourselves how we can help in overcoming those barriers. These ideas led to the suggestion of a new project that will allow Lilly employees to have more regular contact with patients and their immediate caregivers.
In order to improve adherence, we need to go beyond the traditional "How can we make the injectable device easier to hold?" types of problems. We need to also think about how to engage patients' loved ones and immediate caregivers. With clinical trials, for example, it's been shown that if the patient has a spouse, family member or partner assisting them through the process, they're much likely to adhere to the protocol. So, what kinds of things might we do to make their jobs easier? Send them a video that explains the protocol in detail ahead of time? Make sure they are invited to the first patient visit? How can we go beyond what we've typically done in order to ease the burden on both patients and their immediate caregivers?
One of our biggest breakthroughs at the summit came when a Lilly analytical chemist told the group about her experience as a caregiver for her mother who was living with both diabetes and cancer. Her mother had begun chemotherapy, and those medicines where somehow making her diabetes medications less effective. Because of her experience in pharma industry, the caregiver was able to find out that the steroid used in the chemotherapy affected her mother's metabolism. She then figured out that her Mom needed to adjust her insulin dosages to compensate for this fact. Obviously, most people don't have an analytical chemist at home to help them figure this out. In fact, this is something that many doctors might even have a difficult time recognizing right away. Could there be a solution in developing apps that allow patients to enter all of the important details about their health and lifestyle, and receive personalized dosages and schedules for their medications?
If, for example, a patient has been prescribed several medications, and he can't take one of the pills in the evening because the other medications he has to take at the time would interfere with it, the app could suggest a better time for him to take that medication and set up an alert.
Similar responsive technologies could help us measure adherence in clinical trials, as well. Can we make it easier for patients to report when they've taken the experimental medicine, by connecting an app to a chip or device on the packaging of the medicine, that would send information to the researchers wirelessly every time the patient opened the package? Would that help save the patient the time and inconvenience of having to write it down or type it out everytime?
There are many possibilities, and our hope is to be able to get more input from patients, so that we can choose those which will do the most good.
Moving from "Adherence" to "Concordance"
People are taking a much more active role in their healthcare, which I think is having a positive impact on healthcare overall. In general, we are all much more educated about our options, and will go to our doctors with ideas about what types of medications we should be taking or treatment regimens we should be following. As a result, maybe the idea of "adherence," which many patients feel has a paternalistic connotation, can be replaced with the idea of "concordance." In its most basic form, concordance requires good communication between the patient and his or her doctor, in an effort to determine what the patient hopes to achieve through treatment, and what his or her options might be for reaching that goal. But the idea of concordance needs to go beyond the doctor and patient relationship to also inform what we as drug developers are doing to bring new and better treatments to light.
Patients have told us that they want us to know them, not just their diseases. In order to do that, we have to go beyond statistics to understand not just their medical condition, but also their hopes, fears and motivations surrounding it. The more we are able to do that, the more we are able to offer treatments that allow more people to live healthier lives.
What are you ideas on how to make treatment regimens and clinical trial protocols easier to follow? Let me know in the comments below...