Fireside chat between Dr. Califf and Sally Greenberg: Discussion highlights
Influences on Dr. Califf’s career
Dr. Califf explained how his Duke medical education, where students spend their 3rd year doing research, spurred his interest and career in clinical research. He also discussed how the transition to electronic health records enables clinicians to study whole populations.
Dr. Califf explained how his mother’s diagnosis of multiple myeloma at the age of 81 influenced his view of the need to rapidly develop medical products and treatments for the patients who need them. He discussed the important role of patients in advocacy and clinical trials, noting that patients can change the way things are done, from donating data and tissue samples to researchers, volunteering for clinical trials, raising money, and having a say over the questions asked to address the medical problem/issue.
Experience working at FDA
Dr. Califf noted that FDA’s mission is to protect the public health and promote innovation at the same time. He believes this is the dilemma that makes the FDA an exciting place to work.
Dr. Califf praised the dedication of FDA’s employees. Since FDA regulates about 25 percent of the economy, almost everyone is affected by the FDA’s actions. As a result, numerous constituents are concerned about the FDA.
Improving healthcare provider-patient communication
Highlighting NCL’s Script Your Future medication adherence campaign, Sally Greenberg asked Dr. Califf how healthcare provider–patient communication could be improved. Dr. Califf agreed that more work needs to be done in this area, because there is not a simple, ready solution. He believes that team-based care is the key, as well as better utilization of the Internet and personal devices.
Ensuring patient-centered care and access to medications
Dr. Califf stressed that although FDA is prohibited from regulating the practice of medicine, there are steps that FDA can take to ensure that drug and device development is more patient-centered, such as encouraging industry to consult with patient groups and bring patients to FDA meetings early in the development process. In addition, in conjunction with industry and the medical community, Dr. Califf stressed that patient information will be a focus over the next two years.
In discussing the cost of medication, Dr. Califf again stressed that FDA has to stay within the bounds of its mission. It has no legal authority to intervene in the case of drug prices or monopolies. However, FDA can prioritize generic drugs (which comprise 88 percent of prescriptions) and strike up competition within the innovator category.
The value of public–private partnerships
Dr. Califf stated that public-private partnerships such as the Clinical Trials Transformation Initiative were one of his areas of expertise before joining the FDA. He believes that establishing partnerships between FDA, industry, patient groups, and academia is the way business should be done. Rules of engagement are important, however, because at the end of the day, FDA has to make a decision without being influenced by the innovators.
Importance of ‘real world data’
Dr. Califf credited a mentor of his for helping him to understand the importance of real world data. He gave an example of an algorithm that predicts patients who are at high risk of suicide. Having this data helps primary care physicians intervene with their high-risk patients.
Dr. Califf discussed 3 areas to improve the research and development process:
- Patient-centeredness – Understanding patient preferences
- The use of biomarkers and surrogate endpoints
- Streamlining clinical trials to make them simpler
Robert Nauman, North Carolina Alliance for Healthy Communities – Robert Nauman praised the Health Advisory Council for facilitating dialogue and partnerships between Council members. For example, through connecting with the Consumer Healthcare Products Association (CHPA), Rob’s organization used the Up and Away campaign materials with seniors across North Carolina, urging them to safely store medications out of the reach of children.
Bradi Granger, Duke University – Bradi Granger said she appreciates the opportunity to work with NCL and its Script Your Future campaign. Duke’s Medication Adherence Alliance gives providers tools to improve medication adherence.
Michelle Oshman, Eli Lilly and Company – Michelle Oshman said she values participation in the Health Advisory Council because it enables Lilly to speak and partner with the consumer community.
Kimberly Rawlings, Office of Communications, Center for Drug Evaluation and Research, FDA – Kimberly Rawlings reported that CDER has plans to release a Biomarkers and Standards campaign in the spring of 2016. Rawlings also discussed the release of two new mobile apps since the Council’s previous meeting: the Orange bookExpress and another app on Drug Shortages.
Marsha Henderson, Office of Women’s Health, FDA – Marsha said how much she has appreciated working with NCL over the past 20 years. She announced FDA’s Diverse Women in Clinical Trials Awareness Campaign, which is co-sponsored with the NIH Office of Research on Women’s Health. FDA/OWH will also be releasing a new publication on Women and Heart Disease.
Ernie Boyd, Ohio Pharmacists Association – Ernie Boyd thanked NCL for allowing state associations to be a member of the Health Advisory Council. The Ohio Pharmacists Association is pleased to be a part of NCL’s Script Your Future campaign, and to have seven Ohio colleges working with SYF to improve medication adherence.
Bri Morris, National Community Pharmacists Association – Bri Morris announced that NCPA is preparing to roll out a large-scale smoking cessation program for community pharmacists in 2016. She also reported the results of NCPA’s year-long study which measured the collective impact of appointment-based medication synchronization (ABMS) services provided by 82 participating community pharmacies across Arkansas. The study found that patients who received ABMS services were more than 2.5 times more likely to stick with their medication as prescribed by their doctor.