It is Time to Equip Patients Part 5
No One is Truly Objective
As the winter approaches here in New England, the picture above caught my eye. What do you see? Is the sun setting… or rising? What’s up? What’s down? Where was the picture taken? When? How can you be sure? Did my opening line influence you?
There seems to be a consensus from all the stakeholders that increased patient involvement would enhance the development of new medicines and devices. There also seems to be a consensus that this promise is not being realized. Why?
The purpose of this series is to identify and characterize some of the barriers to effective collaboration between patients and the innovative pharmaceutical industry.
Understanding the Problem
There are several factors that make it difficult to achieve the type of deep patient involvement in the drug development process and the shaping of the future of medicine. In this series, we will explore five of these barriers and look for common elements that may provide a course of action.
- Patients Don’t Speak the Language of Drug Development
- Professional Researchers can be Intimidating
- Patients and Researchers See the Journey Differently
- Many Stakeholders, Many Stakes
- Biopharma May Be Missing What is Most Important to Patients
In this installment, we get a glimpse of all the people who can influence decision-making in the development of new medicines in Biopharma R&D.
Many Stakeholders, Many Stakes
There is a perception that patients are too personally involved to be objective contributors to medicines development. The truth is, no one at the table is truly objective. If the goal is to have patients and researchers collaborating directly on drug development strategies and clinical trials, then it needs to be recognized that they have many different stakeholders with many different needs. Stakeholders can have a very vocal and visible influence or can work quietly in the background. Stakeholders can provide motivation when times are tough or may create pressure and stress when their varying needs are not aligned.
The importance of meeting the needs of these stakeholders cannot be underestimated or ignored. In fact, explicitly discussing the differing stakeholders’ needs may help the patient and researchers work more effectively together.
As stated earlier, patients have the biggest stake in this process. However, they also may have caregivers, family members, their health care professionals, and maybe even insurers in mind as they pursue the best possible treatment. Patients involved in research may also be considering their future children and grandchildren as they make decisions. In fact, this drive to make the world better for future generations can be a very powerful motivator.
Patient Advocate Groups (PAGs) may have similar stakeholders with slightly different needs. From the beginning of the patient involvement movement with the HIV/AIDS crisis in the 1980s and ’90s, PAGs have had a few distinct missions: to generate funds, to raise awareness, to protect against injury, and to gain access to new medicines earlier. Depending on their primary orientation, these groups can be seen as either collaborators or adversaries in medicines development. They also have a variety of donors to consider; some donors can be pretty vocal with their agendas.
Researchers hold very high standards of scientific objectivity in medicines development and clinical research. However, even the most principled scientist is influenced in their decision-making by forces beyond the data.
There is no doubt that researchers themselves see patients as hugely important stakeholders. However, they have another broad set of people that are driving their behavior. These stakeholders include, but are not limited to, regulators, management, private and government payers, customers (i.e. physicians), pharmacists, manufacturing partners, investors, and lawyers. Most large companies also work globally, so these researchers are trying to meet the needs of these same types of stakeholders in many diverse countries. Drug development is done in teams, and even these team members have different views on what is most important. Thus, while ‘patients come first’, there is a crowd of others seeking the attention of the researchers. It can be hard for that patient’s voice to come through the noise.
All the various stakeholders have an important role to play in this complex ecosystem, but it takes time and effort to learn them well enough to influence. Both patients and researchers need to develop the skills to have honest, effective conversations around the sensitive topic of stakeholders so that the sensitivity itself does not become a barrier to progress. Fortunately, this is a skill set that can be learned and practiced.
Within the industry, researchers are accustomed to weighing these many influences in their decisions and actions. Even then, there is a need to make these influences transparent so that the team can function well. When the patient voice is added to the discussion, the need to make stakeholder influences explicit increases dramatically. Researchers need to remember that patients are personally involved and they care about succeeding. Patients need to understand that researchers may not be, but they care about succeeding too.
Companies spend a lot of money training (and retraining) their colleagues about these stakeholders and the skills needed to work with them. Patients who want to be heard deserve a chance to learn and practice these same skills. The key is developing interactive education that provides the opportunity to learn about the skills, test them in a safe space, and receive constructive feedback.
Practice will build confidence.
Confidence will lead to progress.
 Lowe MM, Blaser DA, Cone L, Arcona S, Ko J, Sasane R, Wicks P. Increasing Patient Involvement in Drug Development. Value in Health 2016:19:869-878
 Britten N, Denford S, Harris-Golesworthy F, Jibson S, Pyart N, Stein K. Patient involvement in drug licensing: A case study Social Science & Medicine, 2014 Link