3 Proactive Health Care Trends That Will Impact the World in 2019
As 2018 comes to a close and we reflect on Powering Precision Health 2018, we should also reflect on the progress made over the past year and the opportunities ahead for turning reactive “sick care” into proactive health care. In the coming year, watch for the acceleration of the following three trends:
- Use of Biomarkers in the Drug Approval Process
Under the direction of commissioner Scott Gottlieb, the U.S. Food & Drug Administration (FDA) embraced using biomarkers – biological, molecular proteins found in blood, tissue or bodily fluids – to measure the effectiveness of new drugs in clinical trials. In November, the FDA approved Vitraki, the second treatment to receive FDA clearance based on a common biomarker found in multiple cancers.
This is an earth-shattering moment for a drug approval process that is still too slow and cumbersome in getting life-saving drugs to market. Using biomarkers instead of signs of symptom reversal to determine a drug’s effectiveness results in a 300 percent increase in the likelihood of approval. As the FDA endorses and seeks to expand this new strategy, those of us in the PPH movement stand ready to work with the administration on vital research.
- NfL Will Increasingly be Used to Monitor Brain Health
There is currently no standard blood test for measuring the health of the brain. Research suggests serum neurofilament light protein (NfL) is the most effective way to detect a host of neurological diseases. I’ve worked with another NFL – the National Football League – on efforts to better protect players, and we’re seeing that this biomarker can be used to measure brain health after athletes suffer subtle brain injury.
As I explained in an editorial for Quartz this year (which was later republished on our PPH blog), CT scans can only detect about 10 percent of concussions or traumatic brain injuries (TBI). But recent studies have found that NfL is a highly sensitive biomarker for concussion, opening the door for a more accurate test. Dr. Gottlieb’s FDA has already greenlighted the marketing of the first blood test for evaluating mild TBI in 2018, and we can expect continued progress on the front of using biomarkers for concussion and TBI.
But NfL’s role as a biomarker goes beyond head trauma. At the end of 2017, PPH researchers made the groundbreaking discovery that a link exists between NfL and the debilitating neurological disease multiple sclerosis (MS), concluding that, “Repeated NFL determinations in peripheral blood for detecting axonal damage may represent new possibilities in MS monitoring.” My prediction is that NfL will become the “cholesterol of the brain,” serving as the measure of general brain health across the spectrum of known neurological illnesses. Just as Troponin levels are tested for risk of heart attack, I believe one day, we’ll use NfL to measure our risk for neurological diseases.
NfL will have an impact in the short term on our ability to test the effectiveness of new drugs, and in the long run on developing reliable diagnostics using biomarkers as a guide.
- The Next Proactive Health Care Breakthrough Will be in Cancer Research
In 2017, a clinical trial crucially determined that a blood test using biomarkers could detect the recurrence of lung cancer an average of six months earlier than CT scans and other imaging methods. This year, the FDA issued a draft guidance on using minimal residual disease (MRD) as a biomarker in clinical trials meant to treat specific blood cancers. For these reasons, I am confident that the same breakthroughs we have seen in neurology will soon be emulated in oncology. Given the tragic impact that cancer has had and continues to have on families throughout the world, such progress on developing biomarker-based tests for monitoring cancers can play a major role in alleviating suffering and death by catching cancer more quickly.
PPH’s Mission and Role
In all these exciting developments, those of us who comprise the PPH movement will continue to provide the research and support in transforming the precision health and proactive health care dream into reality. Most immediately we will be focusing on aiding the trend of using biomarkers to monitor the effectiveness of drug treatments, where so much progress has been made in 2018. Beyond that, we’re working to translate our research findings into concrete diagnostic methods that will change the way we think about disease and its treatment. So, let’s reflect on a successful year for our cause, and look forward to an even more fruitful 2019!