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Incentivize preventive and pre-clinical interventions to "engineer resilience" against chronic disease.
Key Insight: Regulatory frameworks incentivize treating disease, not preventing it—leaving prophylactic interventions without clear pathways.
The FDA focuses on established disease, offering no fast tracks for prophylactic meds or early biomarker trials. Companion diagnostic markets face high costs, complex regulations, and low reimbursements. Biomarkers rarely gain traction without approved treatments.
Key Insight: 20th century environmental policies delivered 30:1 returns, but regulatory momentum has stalled since the 1990s.
Despite the mounting evidence of environmental factors contributing to disease in the past decades, there has been fairly little regulatory action against industrial chemicals in the U.S. In the triumphs of eliminating lead in gasoline or banning flame retardants, the phase-outs took years to fully implement. With 70,000+ chemicals already in circulation, we would require centuries of chemical testing to convince regulators with enough irrefutable evidence to act and enforce regulations. Meanwhile today's global population is vulnerable to environmental exposures that can increase risk of disease and adverse outcomes.
For much of the twentieth century, exposure science was tethered to policy, delivering enormous health and economic returns. The phase-out of leaded gasoline yielded a return of $17–$200 for every dollar invested [1]. The Clean Air Act amendments of 1970 and 1990 reduced pollutants and prevented hundreds of thousands of premature deaths each year, yielding a benefit–cost ratio above 30:1 [2]. The Montreal Protocol has averted hundreds of millions of skin cancer and cataract cases by repairing the ozone layer [3]. Environmental health research objectives motivated new regulations at more stringent threshold doses. With these post-industrial revolution policy measures and enforcements in place, industry began to slowly self-regulate to minimize risks of crippling lawsuits.
| Intervention / Policy | Key Outcome | Health Impact | Economic Return |
|---|---|---|---|
| Phaseout of PCBs & DDT (1970s) | Reduced body burdens of persistent organic pollutants | Human dietary intake of DDT declined from 13.8 mg/day in 1970 to 1.88 mg/day in 1973 | Broad societal gains through improved neurodevelopment; long-term healthcare cost savings |
| Phaseout of Leaded Gasoline | Dramatic drop in child blood lead levels | BLL decreased from 17.1 µg/dL (1970s) to 2.7 µg/dL (1990s) | ROI of $17–$200 per $1 invested; annual benefits of $192–$270 billion per year |
| Clean Air Act (1970 & 1990) | Dramatic reduction of PM, SO₂, NOₓ, ozone, and lead | 2.4M asthma exacerbations prevented, 135K hospital admissions avoided, 230K+ premature deaths prevented | Benefit–cost ratio exceeding 30:1; benefits of $22 trillion vs $523B cost |
| Montreal Protocol | Ozone layer protection and recovery | Prevention of ~443M U.S. skin cancer cases and 63M cataracts | Avoidance of over $1.1 trillion in skin cancer costs; ~2M lives saved annually by 2030 |
However, the past decades have shown an increasingly deregulatory domestic policy environment. Since the 1990s, fewer environmental laws have been passed, political polarization has deepened, and tens of thousands of untested chemicals remain in circulation.
Color = Expansion vs Rollback; Opacity = Durability (higher = more stable)
Hover over bars for details on each regulatory action
Moreover, recent regulations on environmental chemicals have had limited success. Phthalate regulation rode on the coattails of other enactments (lead) for consumer product safety almost 20 years ago, and then further regulations have stalled in FDA for food, despite mounting evidence of the hormone disrupting effects.
Given the current timeline for most policy overhauls, piecemeal bans cannot keep pace with the tens of thousands of chemicals in circulation and new product manufacturing, nor can they address the bioaccumulative pollutants already burdening ecosystems and humans.
Key Insight: Place-based investments, tort settlement reinvestment, and TERP translation pathways can create sustainable funding for prevention R&D.
Strategic policy measures can realign biotech innovation with the study of environmental health:
Targeting areas of high disease incidence and elevated exposure rates would accelerate causal discovery of mechanisms of action and improve risk stratification. This approach has been shown to reduce downstream healthcare costs and productivity losses associated with environmentally mediated chronic disease clusters.
Redirecting a portion of toxic-tort settlements and environmental fines into a dedicated research and development fund, modeled on the Tobacco Master Settlement Agreement and the Deepwater Horizon Natural Resource Damage Assessment, would sustain long-term research capital toward identifying health effects and developing treatments for exposure-based diseases. In addition, Superfund-style requirements could mandate responsible parties to fund longitudinal health research and early intervention efforts in exposed populations.
At the federal level, new public–private partnerships could subsidize biotechnology firms' translational research aimed at treating early risk factors or prodromal states in exposed populations. Pharmaceutical firms could integrate existing longitudinal exposure cohorts and biobanks (e.g., NIH Environmental Influences on Child Health Outcomes Program) into discovery pipelines, uncovering upstream disease mechanisms and prevention targets.
Incentives are needed to carry forward the outputs of the NIH Toxic Exposure Research Program (TERP) housed within the Congressionally Directed Medical Research Program, which has generated foundational data with over $100M in funding towards exposure–disease mechanisms. Deliberate pathways for translation could include:
Roadmap: A seven-year plan to create regulatory pathways and funding mechanisms for prevention therapeutics.