Inflection 8: Redefining Drug Approval Standards for Chronic Disease
What if we re-framed chronic disease drug approval standards to
demonstrate prevention, slowing, and/or reversal of disease progression?
What if the U.S. transformed pharmaceutical approvals to demand better health outcomes—specifically prevention, slowing, or reversal of chronic disease—not just symptom control?
Imagine a future where new pharmaceuticals targeting diabetes, heart disease, or Alzheimer’s are evaluated against a lifestyle-based gold standard—like the Mediterranean diet combined with movement, community support, and functional medicine protocols.
This isn’t science fiction. It’s a serious policy, ethics, and evidence conversation we must have now if we aim to become the fourth healthiest nation in the world by 2035.
The Strategy: Modernize Chronic Disease Drug Approval Standards
Currently, FDA approval for chronic disease medications often hinges on short-term symptom control markers—such as lowering HbA1c in diabetes or LDL in cardiovascular disease—without showing prevention of progression or reversal of disease . Our proposal is to reframe approval standards with three mandates:
- Demonstrate Prevention, Slowing, or Reversal of disease progression.
- Compare against a proven non-pharmaceutical gold standard—like a Mediterranean diet and lifestyle protocol .
- Use patient-centered, functional outcome measures, such as improved quality of life, reduced medication dependence, or restored metabolic function.
Implementation: Five Steps to Systemic Change
Step 1: Define New Gold Standards of Care
Establish validated, evidence-backed “best case” protocols from lifestyle medicine (e.g., Mediterranean or plant-based diets + movement + sleep hygiene + social connection + stress reduction). Examples include:
- Dean Ornish’s Reversal Diet and Program
- Blue Zones protocols
- Esselstyn’s no-oil plant-based dietary reversal protocols for cardiovascular disease
These would serve as control conditions in comparative trials.
Step 2: Reform Clinical Trial Guidelines
Update FDA and NIH trial design requirements for chronic disease pharmaceuticals to include:
- Longer time horizons for disease progression outcomes
- Lifestyle-based comparator arms in addition to placebo
- Inclusion of functional medicine-style metrics, such as insulin sensitivity, CRP levels, or remission rates
Step 3: Align CMS and Insurer Reimbursement Models
Coordinate with CMS and private payers to reward pharmaceuticals and protocols that show measurable disease prevention or reversal, not just management. Include alternative protocols in value-based care arrangements .
Step 4: Incentivize Dual Pathway Research
Launch federal and academic partnerships that fund integrative trials—testing pharmaceutical + lifestyle combinations versus lifestyle-alone arms. Require data transparency for all outcomes, not just statistically significant findings.
Step 5: Public Education and Clinician Training
Educate physicians and patients on the limitations of current chronic disease medications and the power of evidence-informed lifestyle interventions. Expand CME pathways that certify MDs in functional and integrative medicine.
Real-World Models to Build On
- Virta Health: Demonstrates type 2 diabetes reversal using nutritional ketosis, behavioral coaching, and biometric tracking .
- Ornish Lifestyle Medicine: Reversed coronary artery disease and improved telomerase activity in prostate cancer patients through nutrition, exercise, meditation, and love/support .
- Blue Zones Projects: Local policy and cultural interventions improving longevity and healthspan in U.S. cities through community-based lifestyle shifts .
Key Resources and Partners
- NIH/NCCIH (National Center for Complementary and Integrative Health): Support for alternative trial frameworks
- American College of Lifestyle Medicine: Clinician training and certification
- Institute for Functional Medicine (IFM): Research standards and practitioner network
- CMS Innovation Center (CMMI): Value-based care pilots
- FDA/CDER: Guideline reform and trial oversight
Why This Works: This approach aligns the goals of:
- Patients: Who want better outcomes, not just lifelong prescriptions
- Payers: Who want lower long-term costs and fewer hospitalizations
- Practitioners: Who want tools to heal not just manage
- Pharma: Who are increasingly investing in targeted, gene-based, and anti-inflammatory compounds that might meet these higher standards
In short: It’s a challenge, yes. But a transformational one.
Our Take: Let’s Raise the Bar
The U.S. spends over $4 trillion on healthcare, with more than 75% of it going to chronic disease management . Yet outcomes remain dismal, with rising rates of obesity, metabolic syndrome, and prescription polypharmacy.
If we’re serious about becoming a healthier nation, we need honest standards of effectiveness. That means recognizing the hard truth: if a pharmaceutical can’t outperform a fork, a walk, and a night of good sleep, maybe it shouldn’t be approved for billions of dollars in coverage.
Let’s rewrite the rules—so success means healing.
Truth, Clarity, & the Fine Print
Life by Natural Causes (LBNC) is a Knowledge-to-Health Outcomes Learning System designed to engage users in behavior changes that will result in positive health outcomes, all under the guidance of their own health team. LBNC, currently in Beta development, has a launch target of 3QCY25.
Medical Disclaimer: Only licensed MDs are authorized to make medical claims. We connect you with professionals trained to support and optimize your health outcomes. Always consult your physician — ideally one trained in functional medicine — or another qualified provider regarding any medical concerns.
Editorial Disclaimer: Our Take is an opinion series from the Life by Natural Causes (LBNC) team, offering our perspective on health, wellness, and the systems that shape them. Grounded in research and real-world experience, these views reflect our mission to inspire healthier outcomes. We invite you to reflect—and share your take with us.
Sources
Institute of Medicine (US) Committee on Standards for Systematic Reviews of Comparative Effectiveness Research. Finding What Works in Health Care: Standards for Systematic Reviews. 2011.
Estruch R, et al. Primary Prevention of Cardiovascular Disease with a Mediterranean Diet. N Engl J Med. 2013;368(14):1279-90.
Davis C, Bryan J, Hodgson J, Murphy K. Definition of the Mediterranean Diet; a Literature Review. Nutrients. 2015;7(11):9139-53.
Ornish D, et al. Can Lifestyle Changes Reverse Coronary Heart Disease? Lancet. 1990;336(8708):129-133.
Buettner D. The Blue Zones: Lessons for Living Longer From the People Who’ve Lived the Longest. National Geographic, 2008.
Esselstyn CB. Updating a 12-Year Experience With Arrest and Reversal Therapy for Coronary Heart Disease. Am J Cardiol. 1999;84(3):339-341.
CMS Innovation Center. Alternative Payment Models Overview. www.innovation.cms.gov
Virta Health. Clinical Trial Data: Type 2 Diabetes Reversal. www.virtahealth.com
Hyman M. Food Fix: How to Save Our Health, Our Economy, Our Communities, and Our Planet. Little, Brown Spark, 2020.
CDC. National Center for Chronic Disease Prevention and Health Promotion. www.cdc.gov/chronicdisease