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Vinay Prasad

Vinayak K. Prasad, MD, MPH, is an American hematologist-oncologist, researcher, and professor of , , and at the (UCSF), where he practices clinically at . Prasad's work emphasizes rigorous evaluation of medical evidence, highlighting medical reversals—practices once endorsed but later disproven—and advocating for higher standards in drug approvals, often questioning reliance on surrogate endpoints over overall survival data. He has co-authored Ending Medical Reversal: Improving Outcomes, Saving Lives (2015) with Adam Cifu, which examines how enthusiasm for new therapies leads to harmful adoptions later reversed by evidence, and penned Malignant: How Bad Policy and Bad Evidence Harm People with Cancer (2020), critiquing regulatory and policy failures in that prioritize incremental benefits at high costs. Prasad gained broader attention for his analyses of public health measures during the , arguing against interventions like widespread masking and school closures due to insufficient causal evidence of benefits relative to harms. His empirical approach has sparked debate, positioning him as a skeptic of institutional in and , with over 400 peer-reviewed publications advancing these themes. In May 2025, despite prior criticisms of the agency, he was appointed director of the FDA's Center for Biologics Evaluation and Research, overseeing vaccines and biologics, but resigned after two months amid reported internal conflicts over approval processes.

Personal Background

Early Life and Education

Vinay Prasad was born in the United States to parents who had immigrated from . His family resided in a suburb of , , before relocating to . Limited public information exists regarding his childhood, though his upbringing emphasized academic achievement, as evidenced by his later scholastic honors. Prasad pursued undergraduate studies at , earning a in from the of Natural Science and a degree in from the of Arts and Letters. He graduated summa cum laude in 2005. He then attended the Pritzker School of Medicine, receiving his in 2009 and the Chairman's Award in , bestowed upon the top student in that field. Following medical school, Prasad completed an internal medicine residency at in 2012, where he received the Gerald Grumet Award for excellence as a resident teacher. During this period, he began questioning clinical practices reliant on historical precedent over , fostering an early commitment to rigorous evaluation of medical interventions. In 2014, he obtained a Master of from Bloomberg School of Public Health, complementing his clinical training with epidemiological and policy perspectives.

Professional Career

Academic and Clinical Roles

Prasad joined the University of California, San Francisco (UCSF) in May 2020 as an associate professor in the Department of and . He advanced to full professor in June 2023, holding joint appointments in , , and . Prior to UCSF, he served as an assistant professor from 2015 to 2018 and associate professor from 2018 to 2020 at (OHSU). In his clinical practice, Prasad works as a hematologist-oncologist at , attending hematology-oncology clinics approximately half a day per week, along with rotations at the VA Hospital. His patient-facing role emphasizes applying rigorous evidence evaluation to care, including scrutiny of trial data for treatment decisions. Academically, Prasad's research at UCSF centers on clinical trials, meta-research, and analysis in , with his laboratory investigating cancer drug approvals, trial design flaws, and evidence biases such as reliance on surrogate endpoints lacking correlation to overall survival. He has authored over 500 peer-reviewed publications by 2025, many addressing methodological limitations in medical evidence. Prasad teaches medical students and residents at UCSF, including leading the Epi 212 course on clinical epidemiology and delivering lectures on interpreting trial results, recognizing biases, and evaluating financial conflicts in research. He received a teaching award for his contributions to clinical epidemiology instruction in the medical school curriculum. This work integrates empirical scrutiny into training, fostering skepticism toward unsubstantiated practices.

FDA Tenure

In May 2025, Vinay Prasad was appointed by FDA Commissioner as Director of for Biologics Evaluation and Research (CBER) and Chief Medical and Scientific Officer, roles focused on regulating biologics, , cell therapies, and gene therapies under a prioritizing rigorous for approvals. This appointment aligned with Prasad's prior advocacy for causal over surrogate endpoints in regulatory decisions, aiming to enhance scrutiny of high-risk biologics amid concerns over accelerated approvals lacking long-term data. During his tenure, Prasad oversaw initiatives to tighten standards for therapies and , including a July 18, 2025, FDA directive to to suspend distribution of Elevidys, an AAV-based for , following reports of patient deaths and insufficient evidence of sustained efficacy beyond surrogate biomarkers like micro-dystrophin levels. The agency cited safety risks and the need for data demonstrating clinical benefits, such as improved motor function or survival, rather than relying on platform technology designations that expedited prior approvals. This move extended to holds on related clinical trials for other therapies using similar vectors, reflecting Prasad's emphasis on to mitigate uncertainties in treatments. Prasad resigned on July 29, 2025, after approximately two months, following internal and external pressures including involvement. The departure coincided with a July 28 reversal allowing limited resumption of Elevidys shipments for patients, amid criticisms from biotech stakeholders and conservatives who argued the suspensions stifled innovation for unmet needs, while some advocates contended the policies risked eroding trust in vaccines and biologics. He briefly returned to a leadership capacity at CBER in early August 2025 before regaining his full titles as Chief Medical and Scientific Officer in September 2025, though the episode highlighted tensions between evidentiary rigor and regulatory speed.

Key Intellectual Contributions

Evidence-Based Medicine and Critiques of Medical Practice

Prasad has emphasized the importance of randomized controlled trials (RCTs) in establishing causal efficacy for medical interventions, critiquing the premature adoption of practices based on observational data, expert opinion, or surrogate endpoints. In meta-research, he analyzed high-impact RCTs to quantify medical reversals—established practices contradicted by subsequent evidence—and low-value care, defined as interventions that are ineffective or offer marginal benefits at high cost. A 2013 study by Prasad and colleagues reviewed 2767 medical practices highlighted in leading journals from 2001 to 2010, identifying 146 reversals, which occurred across specialties and underscored the frequency of adopting unproven therapies without rigorous testing. This work informed his broader advocacy for prioritizing RCTs over lower-evidence sources to avoid harms from ineffective or harmful practices. In the 2015 book Ending Medical Reversal: Improving Outcomes, Saving Lives, co-authored with Adam Cifu, Prasad documented numerous historical reversals, arguing that many standard-of-care treatments lack durable evidence and contribute to unnecessary costs and patient risks. The book cites examples such as for postmenopausal women, initially promoted based on observational studies suggesting cardiovascular benefits but reversed by the 2002 RCT, which revealed increased risks of , , and venous without longevity gains. Prasad and Cifu estimated that reversals represent a significant portion of medical practice, with analyses of top journal articles showing that up to 40% of highlighted interventions later faced contradiction, urging clinicians to demand RCT-level evidence before widespread implementation. Prasad has applied these principles to critique overuse of low-value diagnostics and screenings, advocating cost-benefit evaluations centered on hard patient outcomes like overall survival rather than process metrics or disease-specific reductions. For instance, he has opposed routine () screening in asymptomatic men, noting that major RCTs, including the Prostate, Lung, Colorectal, and Ovarian (PLCO) trial and the European Randomized Study of Screening for Prostate Cancer (ERSPC), demonstrate no reduction in all-cause mortality despite detecting early cancers, due to leading to unnecessary biopsies, treatments, and complications like incontinence and impotence. In a 2019 systematic review of RCTs from three leading journals (1966–2017), Prasad's team identified 396 reversals and low-value practices, predominantly in high-income settings and cardiovascular medicine, reinforcing the need to phase out interventions without proven net benefits. These efforts promote a where correlation from non-randomized data does not substitute for causal proof from trials, aiming to minimize iatrogenic harm and resource waste.

Oncology Research and Policy Positions

In Malignant: How Bad Policy and Bad Evidence Harm People with Cancer (2020), Prasad critiques oncology's overreliance on surrogate endpoints like progression-free survival (PFS) as proxies for overall survival (OS), arguing that such measures often fail to predict meaningful clinical benefits while enabling accelerated approvals without confirmatory trials verifying OS improvements. He highlights pharmaceutical industry influences on pricing, noting that many approved drugs cost over $100,000 annually yet deliver marginal or uncertain gains, as evidenced by cases where PFS extensions of weeks do not extend life but drive widespread adoption and high expenditures. Prasad also examines flawed trial designs, such as single-arm studies for rare cancers, which prioritize speed over rigor and expose patients to therapies lacking randomized evidence of superiority. Prasad's empirical analyses of FDA oncology approvals reveal that from 2005 to 2022, most drugs (over 90%) were initially cleared on endpoints, but subsequent validation showed only weak or inconsistent correlations with OS, with just one FDA-assessed demonstrating strong linkage. Post-market confirmatory studies are often delayed, underpowered, or negative, failing to confirm benefits in 40-50% of cases, particularly for immunotherapies where like response rates exhibit low predictive value for . He contends this pattern stems from regulatory incentives favoring rapid access over causal proof, leading to approvals of ineffective agents while genuine advances are overshadowed. While skeptical of surrogates, Prasad endorses targeted therapies with clear causal efficacy, such as (Gleevec) for chronic myeloid leukemia (CML), which he describes as a paradigm-shifting breakthrough that achieved durable remissions and OS gains through randomized evidence, serving as a benchmark for . Recent work reaffirms 's frontline superiority over second-generation tyrosine kinase inhibitors for most CML patients, based on head-to-head trials showing equivalent efficacy at lower toxicity and cost. Prasad opposes over-treatment in low-risk cancers, advocating de-implementation of interventions like extensive screening or therapies where data show no OS benefit and net harms from or false positives, as in multi-cancer early detection tests that amplify without mortality reductions. He criticizes lax regulation permitting ineffective drugs to persist post-approval and the hype surrounding unproven immunotherapies, urging randomized trials to distinguish incremental from transformative gains rather than accepting surrogate-driven narratives. This balanced stance calls for policy reforms, including stricter confirmatory requirements and incentives for OS-focused trials, to prioritize patient-centered outcomes over industry expediency.

Public Health Perspectives

Prasad emphasizes empirical evaluation of interventions, prioritizing randomized controlled trials (RCTs) and net benefit analyses over observational data or models, to avoid policies driven by weak or unproven assumptions. He critiques 's tolerance for lower evidentiary standards than clinical , arguing that interventions like cloth masking lack RCT support despite claims of ; for instance, the cluster RCT demonstrated cloth masks' ineffectiveness in adults. In a analysis, he highlighted how agencies endorsed N95 masks based on lab filtration properties rather than real-world behavioral RCTs, which were not conducted during the pandemic. Regarding population-level measures, Prasad advocates targeted protections for vulnerable groups, such as the elderly, over restrictions, citing disproportionate excess deaths in high-risk cohorts and downstream costs like economic disruption and fatigue. He has questioned blanket booster recommendations for low-risk individuals, noting limited transmission-blocking efficacy in RCTs and risks including in young males, which could yield net harms; a modeling estimated 18.5 serious adverse events per hospitalization averted in healthy young adults. Broad policies, he contends, foster distrust by overpromising benefits without stratified . Prasad's scrutiny extends to school interventions, where he weighed low child-specific risks—such as zero deaths among nearly 2 million Swedish students from March to June 2020—against harms like learning losses documented in U.S. districts with closures exceeding one year from 2020 to 2022. Transmission data, including a study showing only 32 in-school cases amid community spread, supported his view that closures offered no net benefit and exacerbated educational inequities for at-risk children via virtual learning gaps and unreported . Unless healthcare neared , he argued in a January 12, 2021, , schools should stay open to prioritize developmental needs.

Media and Public Engagement

Books and Publications

Prasad co-authored Ending Medical Reversal: Improving Outcomes, Saving Lives with Adam S. Cifu, published in 2015 by Johns Hopkins University Press, which documents numerous cases of medical practices initially adopted based on observational data or expert consensus but later overturned by randomized controlled trials, arguing for greater emphasis on such trials to prioritize effective interventions and reduce patient harm from ineffective or harmful treatments. The book analyzes reversals across specialties, including examples like the abandonment of routine hormone replacement therapy post-menopause after trials showed increased cardiovascular risks, and recommends policy shifts toward funding superiority trials over non-inferiority designs. In 2020, Prasad published Malignant: How Bad Policy and Bad Evidence Harm People with Cancer through the same press, critiquing oncology drug approvals reliant on surrogate endpoints like rather than overall survival or quality-of-life metrics, drawing on analyses of data to highlight how such practices lead to widespread adoption of marginally beneficial or ineffective therapies. The work examines regulatory and evidentiary shortcomings, such as accelerated approvals without confirmatory evidence of clinical benefit, using specific trial outcomes to advocate for stricter standards prioritizing patient-centered endpoints. Prasad has authored or co-authored over 200 peer-reviewed articles in high-impact journals, including the New England Journal of Medicine (NEJM) and (JAMA), often challenging prevailing medical assumptions with data from randomized trials and meta-analyses. For instance, a 2011 JAMA Internal Medicine study co-led by Prasad quantified medical reversals in NEJM publications, finding that 40% of original research articles recommending practices were later contradicted. More recently, in a May 20, 2025, NEJM perspective co-authored with Martin A. Makary, he proposed evidence-based refinements to vaccination policies, favoring risk-stratified recommendations over universal boosters based on trial data showing diminished absolute benefits in low-risk populations.

Podcast and Online Platforms

Prasad hosts the Plenary Session , launched in 2018, which examines , , and through interviews with experts and solo analyses. Episodes frequently address evidence deficiencies in clinical trials, ethical issues in , and shortcomings in regulatory frameworks, including accelerated approvals that prioritize endpoints over overall benefits. The , which produced over 390 episodes before becoming inactive during his FDA service, appeals to audiences seeking detailed scrutiny of decisions that lower evidentiary thresholds for market entry. Beyond audio, Prasad engages digital audiences via YouTube, Substack, and X (formerly Twitter). His YouTube channel, Vinay Prasad MD MPH, features video breakdowns of trial data and regulatory critiques, amassing over 100,000 subscribers by 2025. On Substack's Vinay Prasad's Observations and Thoughts, with more than 62,000 subscribers, he publishes essays prioritizing randomized trial outcomes over promotional narratives in oncology and public health. These platforms enable Prasad to deploy data visualizations, such as curves and endpoint comparisons, to challenge overstated claims for treatments; for instance, in 2022 analyses, he highlighted therapies hyped as breakthroughs yet failing primary endpoints in subsequent data. On X (@VPrasadMDMPH), he shared concise, evidence-based rebuttals to narrative-driven , building a following exceeding 100,000 across s by emphasizing empirical trial verification over institutional consensus. This online dissemination extends his influence to non-academic stakeholders, fostering discourse on causal mechanisms in medical innovation grounded in verifiable metrics rather than expedited approvals.

Controversies and Reception

COVID-19 Related Debates

Prasad opposed widespread lockdowns and mandates during the COVID-19 pandemic from 2020 to 2022, contending that they inflicted disproportionate harms on youth and low-income groups through economic disruption, educational setbacks, and increased non-COVID mortality, without achieving proportional reductions in viral transmission or overall deaths. He referenced Sweden's less restrictive approach, which avoided strict school closures and business shutdowns, as yielding comparable or superior excess mortality rates relative to more stringent Nordic neighbors and parts of Europe, based on data showing Sweden's all-cause mortality per capita aligned closely with infection fatality estimates while preserving societal functions. U.S. excess mortality analyses he invoked highlighted surges in deaths from drug overdoses, suicides, and deferred care among younger populations, outweighing direct COVID impacts in those cohorts. Regarding vaccination policies, Prasad questioned universal mandates and booster campaigns, particularly for low-risk groups like healthy young adults, arguing in 2021 that such measures risked eroding akin to authoritarian overreach without sufficient of net . He advocated randomized controlled (RCTs) to assess boosters' and safety in these populations, citing absent demonstrating reduction or long-term protection against variants. Empirical support for his stance emerged in studies showing prior conferred immunity equivalent to or more durable than against severe outcomes, with variant evolution enabling immune escape that diminished vaccine effectiveness over time. Prasad faced accusations of downplaying risks, particularly from proponents of pediatric , who labeled his positions as contrarian or harmful. He countered with causal analyses emphasizing opportunity costs, such as pandemic-era delays in cancer screenings and treatments that elevated non-COVID oncologic mortality, drawing from his expertise to quantify how resource diversion and fear-driven avoidance reduced diagnostic yields and worsened prognoses. By 2025, validations of targeted strategies he endorsed appeared in his co-authored New England Journal of Medicine , shifting approvals toward high-risk adults over dosing amid declining hospitalization rates, widespread hybrid immunity, and immunogenicity data favoring over blanket recommendations.

FDA Decision-Making Disputes

Prior to his FDA tenure, Prasad critiqued the agency's use of use authorizations for therapies lacking long-term, placebo-controlled data demonstrating causal benefits, arguing that such approvals prioritized speed over rigorous evidence and risked by endorsing interventions without sufficient substantiation of net gains. During his 2025 role as director of for Biologics and (CBER), he advocated blocking or restricting therapies absent clear links to survival or clinical outcomes, exemplified by the July 2025 FDA directive under his and Commissioner Marty Makary's leadership to suspend distribution of ' Elevidys for following multiple patient deaths and amid doubts over its efficacy beyond endpoints like micro-dystrophin expression. Supporters, including Prasad's allies in circles, defended these stances as essential safeguards against historical pitfalls like thalidomide-induced birth defects or the 2010 partial withdrawal of (Avandia) due to cardiovascular risks despite initial approvals on surrogate markers, emphasizing that caution prevents irreversible harms in vulnerable populations. He bolstered this position with data on accelerated approvals, noting that approximately 22% of indications granted via this pathway were later withdrawn for failing confirmatory trials verifying clinical benefit, underscoring the empirical rationale for demanding causal over preliminary signals. Critics from industry and advocacy groups accused Prasad of obstructionism that delayed patient access to potentially life-extending treatments, with Sarepta executives and biotech analysts arguing his interventions exacerbated shortages and eroded trust in FDA processes, potentially harming patients reliant on innovative biologics. Right-wing activist amplified these charges, labeling Prasad a "progressive saboteur" with an anti-innovation bias and past statements undermining Trump-era priorities, which contributed to his brief July 2025 resignation amid political pressure before a swift reinstatement. These disputes highlighted tensions between Prasad's insistence on randomized, outcome-linked data and demands for expedited approvals in high-stakes fields like , where surrogate endpoints often substitute for direct survival metrics due to ethical and logistical challenges in conducting traditional trials.

Broader Critiques and Defenses

Prasad's critiques of pharmaceutical influence on regulatory decisions and the prevalence of medical reversals—practices where established treatments are later contradicted by superior evidence—have garnered acclaim from proponents of for emphasizing empirical rigor over expediency. His analyses, such as those questioning accelerated approvals reliant on surrogate endpoints rather than overall survival, have informed broader debates on trial design, including FDA initiatives like Project Optimus launched in 2022 to optimize dosing and reduce post-approval uncertainties. Detractors, often from mainstream and left-leaning outlets, have portrayed Prasad as overly or ideologically driven, citing his rhetorical intensity—such as a 2021 analogy likening certain enforcement measures to fascist tactics—as evidence of over substance. These criticisms frequently label him "anti-science," particularly amid his toward broad mandates and rapid regulatory pathways, attributing his positions to political alignment rather than data scrutiny. Defenses of Prasad highlight his consistent advocacy for randomized controlled trials (RCTs) as the gold standard for causal inference, countering "anti-science" accusations by underscoring his empirical track record; for instance, his early warnings on booster efficacy waning within months were corroborated by subsequent studies showing protection against hospitalization dropping below 50% by 3–4 months during dominance, as evidenced in seroprevalence and effectiveness data from 2023 onward. While some right-leaning commentators endorse his calls for , Prasad tempers such support with insistence on confirmatory trials post-approval, rejecting approvals absent robust survival benefits—a stance validated by historical reversal rates exceeding 40% in interventions.

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