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Del Bigtree

Del Matthew Bigtree is an American television and film producer recognized for his Emmy Award-winning work on health-related programming, who later became a prominent advocate for vaccine risk awareness and informed consent. He founded the Informed Consent Action Network (ICAN) in 2016, serving as its CEO to pursue legal accountability from federal health agencies on vaccine safety data and practices.^[1]^[2] Bigtree's early career spanned over a decade in broadcast media, including as a producer for CBS daytime shows such as The Doctors, earning a 2010 Daytime Emmy for Outstanding Talk Show/Informative, and contributions to The Dr. Phil Show. His focus pivoted following an investigation into allegations of data suppression by the Centers for Disease Control and Prevention (CDC) involving whistleblower Dr. William Thompson, culminating in his production of the 2016 documentary Vaxxed: From Cover-Up to Catastrophe, directed by Andrew Wakefield, which examined purported MMR vaccine-autism research discrepancies.^[3]^[1]^[4] As host of the independent web series The HighWire, launched in 2017, Bigtree addresses topics including pharmaceutical industry influence, government health policy, and medical freedoms, accumulating over 33 million views. Under his leadership, ICAN has secured multiple court victories, including against the Department of Health and Human Services for failing to submit congressionally mandated vaccine injury reports and against the CDC and FDA for vaccine testing documentation, thereby exposing gaps in post-market surveillance and promoting empirical scrutiny of public health interventions.^[1]^[2]

Early Life and Career

Background and Education

Del Bigtree, whose full name is Del Matthew Bigtree, is an American television and film producer with limited publicly available details on his early personal life.^[5] He lacks formal medical or scientific training, having entered media production without advanced degrees in health-related fields.^[6] Bigtree attended the Vancouver Film School, graduating with training focused on film and production techniques.^[6] Early in his career, he directed independent short films such as Bitter Sweet (2005) and Sex and Sensuality (2007), as well as theatrical productions including a 2007 staging of David Mamet's Oleanna at the Hollywood Fight Club Theater.^[5] These efforts marked his initial foray into creative media, emphasizing narrative storytelling over technical expertise in medicine or science.^[6]

Television Production Achievements

Del Bigtree began his television production career in the early 2000s, contributing to independent films before transitioning to daytime talk shows. He served as a producer on the CBS syndicated medical talk show The Doctors, which debuted on September 8, 2008, and featured panels of physicians discussing health topics across more than 3,600 episodes until its conclusion in 2022.^[7] As part of the production team, Bigtree focused on field production and investigative segments, including those probing medical controversies and patient stories, which aligned with the show's emphasis on accessible health information.^[6] Under Bigtree's contributions, The Doctors received multiple Daytime Emmy Award nominations for Outstanding Talk Show/Informative, including in 2011 and 2013, shared among producers such as Jay McGraw and Carla Pennington.^[3] The program secured a Daytime Emmy win in 2010 for the same category, recognizing its innovative format in daytime television.^[8] Bigtree's six-year tenure on the show, from approximately 2008 to 2014, involved crafting segments that drew high viewership by blending expert analysis with real-world medical narratives, establishing his reputation for compelling health-related storytelling.^[9] Prior to The Doctors, Bigtree produced Bitter Sweet (2005), a TV movie exploring dramatic personal themes, and Sex and Sensuality (2007), a short film, which demonstrated his early versatility in narrative production.^[5] These works, along with his later Emmy-associated credits, underscored his ability to manage production logistics and editorial focus in competitive broadcast environments, skills he later applied to documentary filmmaking.^[10]

Vaccine Safety Advocacy

Del Bigtree founded the Informed Consent Action Network (ICAN) in 2016 as a 501(c)(3) nonprofit organization headquartered in Austin, Texas.^[11] The group was established to investigate the safety of vaccines, pharmaceutical drugs, and medical procedures, while advocating for individuals' legal right to informed consent prior to such interventions.^[2]^[11] Bigtree, a former Emmy-nominated television producer, initiated ICAN amid his growing focus on vaccine risk awareness, prompted by his role in producing the 2016 documentary Vaxxed: From Cover-Up to Catastrophe. This film centered on allegations from CDC whistleblower William Thompson that the agency had withheld data from a 2004 study suggesting a link between the MMR vaccine and autism in certain subgroups.^[1] Thompson reportedly provided over 10,000 pages of documents supporting these claims, which Bigtree cited as a catalyst for leaving mainstream television to pursue advocacy full-time.^[1] From inception, ICAN differentiated itself through a legal-first approach, emphasizing Freedom of Information Act (FOIA) requests and litigation to extract data from federal agencies like the Centers for Disease Control and Prevention (CDC) and the Department of Health and Human Services (HHS).^[2] An early action was a October 2017 notice to HHS under the National Childhood Vaccine Injury Act (42 U.S.C. § 300aa-31), asserting that the department had failed to submit required biennial reports on vaccine safety research since 1986 and demanding compliance.^[12] This strategy aimed to expose perceived gaps in regulatory oversight and empower public scrutiny, with Bigtree serving as CEO and guiding the organization's direction.^[11] ICAN received tax-exempt status in March 2017, enabling expanded operations funded primarily through donations.

Production and Impact of Vaxxed

Vaxxed: From Cover-Up to Catastrophe is a 2016 documentary directed by Andrew Wakefield and produced by Del Bigtree, focusing on allegations of data manipulation in a 2004 Centers for Disease Control and Prevention (CDC) study regarding the measles-mumps-rubella (MMR) vaccine and autism risk, particularly in African American boys.^[13] Bigtree, a former Emmy-winning television producer for The Doctors, spearheaded production after becoming involved in vaccine safety advocacy, framing the film around CDC scientist William Thompson's 2014 public statement that significant findings from the study were omitted from publication.^[14] The film features interviews with Thompson's colleagues, including Brian Hooker, and argues for greater transparency in vaccine research data.^[15] Originally scheduled for screening at the Tribeca Film Festival in March 2016, the film was withdrawn following backlash from medical organizations and scientists who labeled its claims as misleading and potentially harmful to public health.^[16] Festival co-founder Robert De Niro, who initially supported its inclusion to foster discussion on his son's autism diagnosis, reversed the decision after consultations emphasizing scientific consensus against a vaccine-autism link.^[17] Producers, including Bigtree, responded by organizing independent screenings, premiering the film on April 1, 2016, at New York City's Angelika Film Center, where it sold out multiple showings despite the controversy.^[18]^[19] Theatrical release expanded to limited U.S. theaters, grossing $1,163,265 domestically with an opening weekend of $28,339. Critical reception was polarized; mainstream outlets dismissed it as one-sided propaganda rehashing debunked theories, while supporters praised it for highlighting unaddressed CDC data discrepancies.^[20]^[15] Bigtree promoted the film through grassroots efforts, including Q&A sessions, which amplified its reach beyond theaters via streaming and DVDs.^[21] The film's release intensified public discourse on vaccine safety, drawing attention to Thompson's claims and prompting calls for congressional review of CDC practices, though no formal cover-up was substantiated by subsequent investigations.^[22] It bolstered vaccine skepticism communities, contributing to heightened parental hesitancy amid ongoing measles outbreaks, while critics from academia and media—often aligned with public health institutions—argued it misrepresented statistical subgroups without causal evidence.^[23] Bigtree's visibility as producer elevated his profile in advocacy circles, leading to expanded platforms for critiquing vaccine policy.^[24]

Key Legal and Empirical Challenges to Vaccine Mandates

Through the Informed Consent Action Network (ICAN), founded by Del Bigtree in 2016, significant legal efforts have targeted vaccine mandates by leveraging Freedom of Information Act (FOIA) requests to expose gaps in regulatory data supporting compulsory vaccination policies. In March 2020, ICAN secured a concession from the Centers for Disease Control and Prevention (CDC) in federal court, where the agency admitted it lacked studies demonstrating that the amount of thimerosal—a mercury-containing preservative—in infant vaccines was safe, undermining claims of comprehensive pre-licensure safety testing for routine childhood immunizations.^[25] Similarly, a 2019 FOIA response from the Food and Drug Administration (FDA) revealed no clinical trials had been conducted to support the safety of influenza vaccines for pregnant women, despite recommendations for their use, highlighting regulatory reliance on post-marketing surveillance rather than prospective controlled studies.^[26] These disclosures have fueled lawsuits challenging mandates on constitutional grounds, including violations of informed consent and bodily autonomy. ICAN-supported litigation, often led by attorney Aaron Siri, has contested school and employer requirements, arguing that absent rigorous, placebo-controlled trials—such as those conceded missing for vaccines like DTaP and MMR—mandates infringe on due process under the 14th Amendment and exceed the scope of Jacobson v. Massachusetts (1905), which permitted compulsion only with narrow exceptions for public health necessity backed by evidence.^[27] In June 2025, ICAN attorneys filed a suit against California officials enforcing SB 277's elimination of non-medical exemptions, asserting that unproven long-term safety profiles render such policies arbitrary and coercive.^[28] During the COVID-19 era, ICAN's FOIA victories compelled the release of over 7 million V-safe app records by December 2022, documenting that 7.7% of users reported seeking medical attention after doses, with higher rates for severe symptoms like hospitalization (among subsets), data the CDC had withheld despite mandate justifications citing vaccine efficacy.^[29] Empirically, these efforts underscore systemic challenges to mandate rationales, as revealed data indicate most vaccines lack inert placebo-controlled trials, relying instead on active comparators or observational methods prone to confounding factors like healthy user bias. ICAN's analyses of Vaccine Adverse Event Reporting System (VAERS) and Vaccine Safety Datalink data, corroborated by agency admissions, show underreporting of serious events—estimated at 1-10% capture—and no pre-licensure studies isolating causal links to outcomes like autoimmune disorders or neurological issues in mandated populations.^[30] For COVID-19 mandates, FOIA-obtained Pfizer trial documents exposed that relative risk reductions (e.g., 95% for symptomatic infection) masked absolute reductions under 1% in low-risk groups, with follow-up data indicating waning efficacy against transmission within months, questioning the proportionality of job loss penalties for non-compliance.^[31] Critics from regulatory bodies counter that herd immunity thresholds justify mandates despite imperfections, but ICAN's documented evidentiary voids—such as the FDA's 2024 stipulation on absent Boostrix trial protocols—persist as barriers to claims of unequivocal net benefit for universal enforcement.^[32]

Response to COVID-19 Pandemic

Public Statements and Campaigns

Del Bigtree used his platform, The HighWire, to regularly critique COVID-19 policies, asserting that government and pharmaceutical entities misrepresented virus risks and vaccine safety data to justify restrictions on civil liberties.^[33] In episodes aired throughout 2020 and 2021, he highlighted alleged inconsistencies in official narratives, such as early claims of asymptomatic spread lacking empirical support and the use of the pandemic to expand surveillance and control measures.^[33] For instance, on June 15, 2020, Bigtree interviewed physician Zach Bush, who framed the virus's emergence as an evolutionary signal rather than a solely pathogenic threat requiring mass vaccination.^[34] A key campaign involved a citizen petition filed by Bigtree and the Informed Consent Action Network (ICAN) on June 18, 2020, demanding that the FDA require placebo-controlled groups in all Phase II and III trials of SARS-CoV-2 vaccines to ensure verifiable safety and efficacy data, arguing that saline placebos were essential for causal assessment absent from ongoing trials.^[35] The petition emphasized that deviations from standard trial protocols risked undetected adverse effects, particularly given the novel mRNA technology.^[36] The FDA did not grant the request, proceeding with authorizations based on active comparators in some trials.^[35] Bigtree participated in public rallies opposing vaccine mandates, including a January 23, 2022, event in Washington, D.C., where thousands marched from the Washington Monument to the Lincoln Memorial, and a New York City protest against mandates that drew significant anti-vaccination crowds.^[37]^[38] Following the FDA's October 29, 2021, authorization of COVID-19 vaccines for children aged 5-11, he aired an episode decrying the move due to emerging safety signals from pharmacovigilance data and the low baseline risk of severe outcomes in that demographic.^[39] These efforts aligned with ICAN's broader advocacy, which saw revenue increases tied to heightened public scrutiny of pandemic responses.^[40]

FOIA Revelations and Data-Driven Critiques

Through Freedom of Information Act (FOIA) requests and subsequent litigation led by the Informed Consent Action Network (ICAN), under Del Bigtree's direction as CEO, significant volumes of data on COVID-19 vaccines were compelled from federal agencies, enabling critiques centered on adverse event reporting and trial transparency. In September 2021, ICAN's legal counsel filed a FOIA request with the Food and Drug Administration (FDA) for all documents supporting the emergency use authorization of Pfizer-BioNTech's COVID-19 vaccine, totaling over 450,000 pages.^[41] The FDA initially proposed releasing records at a rate of 500 pages per month, projecting completion in approximately 75 years, but U.S. District Judge Mark T. Pittman ruled in January 2022 that the agency must expedite disclosure to 55,000 pages per month due to public interest in vaccine safety data.^[42] The released documents included Pfizer's post-marketing reports documenting 1,223 deaths among recipients within the first 90 days following vaccine administration, alongside thousands of serious adverse events such as cardiac arrests, strokes, and miscarriages.^[41] Bigtree, via ICAN's platform The Highwire, highlighted these findings to argue that regulatory oversight failed to adequately address early safety signals, pointing to discrepancies like unreconciled death counts in Pfizer's clinical trial data—where initial reports listed six deaths but later analyses suggested higher figures potentially linked to vaccination.^[43] He critiqued the absence of inert placebo controls in booster trial designs, as revealed in petition responses, asserting this undermined causal assessments of vaccine efficacy and risks compared to natural immunity or prior infection.^[44] In parallel, ICAN pursued FOIA requests for data from the Centers for Disease Control and Prevention (CDC)'s V-safe surveillance system, a smartphone app for self-reporting post-vaccination health issues launched in December 2020. After the CDC withheld raw data despite multiple requests, ICAN filed lawsuits in December 2021 and May 2022, culminating in a court-ordered release of over 10 million records in October 2022.^[45] Analysis of the V-safe dataset, covering approximately 10.4 million users, indicated that 7.7% sought medical attention, 25% experienced health events impairing daily activities for at least one day, and specific cohorts reported elevated miscarriage rates (e.g., 81.9% of pregnancy-related inputs noted issues).^[45]^[46] Bigtree leveraged this data to challenge CDC assertions of minimal vaccine risks, contending that the high incidence of reported symptoms—far exceeding pre-pandemic baselines—evidenced systemic underreporting in official narratives and necessitated independent verification over reliance on agency summaries.^[45] These efforts, Bigtree maintained, exposed gaps in pre-authorization testing, such as limited pregnancy safety data, prompting calls for halting mandates absent comprehensive longitudinal studies.^[44] ICAN's FOIA successes thus formed the basis for data-driven arguments prioritizing empirical transparency over institutional assurances.

Political Engagement

Alliance with Robert F. Kennedy Jr.

Del Bigtree formed a close professional alliance with Robert F. Kennedy Jr. during the latter's 2024 independent presidential campaign, reflecting their overlapping advocacy for vaccine safety data transparency and opposition to certain public health mandates. On January 2, 2024, Kennedy appointed Bigtree, chief executive of the Informed Consent Action Network (ICAN), as the campaign's communications director.^[47]^[48] In this capacity, Bigtree managed media strategy and public messaging, emphasizing themes of corporate influence in health policy and the need for rigorous vaccine testing protocols, aligning with Kennedy's long-standing critiques via his organization, Children's Health Defense (CHD).^[47]^[49] The partnership built on prior synergies between ICAN and CHD, including coordinated legal efforts against vaccine approval processes and mandates, often involving shared attorneys like Aaron Siri, who has represented both groups in petitions to federal agencies such as the Food and Drug Administration (FDA).^[50] For instance, ICAN's Freedom of Information Act (FOIA) requests and CHD's litigation have mutually reinforced challenges to vaccine safety claims, such as demands for pre-licensure placebo-controlled trials.^[40] This collaboration amplified their influence in advocacy circles, with ICAN reporting $23 million in revenue for 2023 amid heightened visibility from Kennedy's campaign.^[40] Following Kennedy's campaign suspension on August 23, 2024, and his subsequent endorsement of Donald Trump, the alliance persisted into post-election health policy initiatives. Kennedy included associates tied to ICAN in his MAHA transition team vetting process for federal health roles, signaling continued coordination on reforming agencies like the Centers for Disease Control and Prevention (CDC) and FDA.^[51] Additionally, in early 2025, Kennedy transferred ownership of the "Make America Healthy Again" (MAHA) trademark application to an LLC managed by Bigtree, formalizing their joint branding for broader health reform efforts.^[52]^[53] These steps underscored a strategic partnership aimed at institutional changes, though mainstream outlets have critiqued it for potential risks to established vaccination programs.^[51]

Leadership in Make America Healthy Again (MAHA)

Del Bigtree serves as the Chief Executive Officer of Make America Healthy Again (MAHA), a health policy initiative aligned with Robert F. Kennedy Jr.'s vision for reforming federal health agencies, emphasizing chronic disease prevention, food system overhaul, and scrutiny of pharmaceutical influences.^[54]^[55] In this capacity, Bigtree has overseen organizational efforts, including the management of an LLC to which Kennedy transferred the trademark application for "Make America Healthy Again" in early 2025, securing branding rights for advocacy campaigns.^[52]^[53] Under Bigtree's leadership, MAHA has coordinated transition activities for Kennedy's prospective role at the Department of Health and Human Services, including vetting candidates for senior positions through a dedicated team comprising individuals linked to vaccine safety organizations.^[51] This involved interviewing and recommending personnel focused on implementing MAHA priorities, such as reevaluating vaccine schedules and addressing environmental toxins.^[51] Bigtree has publicly advocated for these reforms via events, including a February 13, 2025, press conference hosted by MAHA Action to outline agenda advancements.^[56] Bigtree's role extends to promoting MAHA's policy framework through media and commissions, such as contributing to discussions on the MAHA Commission's recommendations for health overhauls, including enhanced vaccine injury tracking and regulatory changes to food and drug approvals.^[57] He has emphasized data-driven critiques of public health mandates, drawing from his prior work with the Informed Consent Action Network to support MAHA's empirical focus on causality in chronic illnesses.^[58] These efforts position MAHA as a counter to established health bureaucracies, with Bigtree coordinating alliances among wellness advocates and policymakers.^[59]

Post-2024 Election Roles and Initiatives

Following the 2024 U.S. presidential election, Del Bigtree continued his advocacy through leadership in organizations aligned with the Make America Healthy Again (MAHA) movement, spearheaded by Robert F. Kennedy Jr., who was confirmed as U.S. Secretary of Health and Human Services on February 13, 2025.^[60] As CEO and co-founder of MAHA Alliance and MAHA Action, Bigtree focused efforts on promoting legislative and civic initiatives to address chronic disease prevention, food safety, and environmental health factors.^[61] On February 13, 2025, MAHA Action, under Bigtree's direction, hosted a press conference to outline priorities for advancing the MAHA agenda, including policy recommendations for reducing chemical exposures and improving nutritional standards.^[56] This event coincided with Kennedy's swearing-in and emphasized data-driven reforms in public health practices.^[62] Bigtree also managed an LLC to which Kennedy transferred the trademark application for "Make America Healthy Again" in early 2025, facilitating branding for advocacy campaigns.^[52] Bigtree's role extended to public speaking and media appearances, such as a February 19, 2025, event documented by C-SPAN, where he represented MAHA's objectives in scrutinizing federal health data and promoting transparency in vaccine-related research.^[54] Through MAHA Alliance PAC, he supported political action to influence state and federal policies, prioritizing empirical reviews of health interventions over institutional consensus.^[63] These initiatives built on pre-election collaboration with Kennedy's campaign, shifting post-election to implementation-focused advocacy amid Kennedy's HHS leadership.^[64]

Controversies and Counterarguments

Mainstream Media and Scientific Community Criticisms

Mainstream media outlets and scientific organizations have frequently criticized Del Bigtree for producing and promoting content that allegedly disseminates misinformation about vaccine safety, particularly through the 2016 documentary Vaxxed: From Cover-Up to Catastrophe, which he produced and in which he appears prominently. The film alleges a Centers for Disease Control and Prevention (CDC) conspiracy to suppress data linking the measles-mumps-rubella (MMR) vaccine to autism in African American boys, drawing on CDC scientist William Thompson's preliminary concerns about unadjusted subgroup data from a 2004 study. Critics, including epidemiologists and public health experts, contend that the film's narrative misrepresents the data: the full, adjusted analysis found no overall association between MMR vaccination and autism risk across the study's 624 participants, and the subgroup finding was exploratory and not statistically robust enough to alter conclusions supported by larger epidemiological studies involving millions of children worldwide, which consistently refute a causal link.^[15]^[65] Directed by Andrew Wakefield, whose 1998 Lancet paper falsely implicating MMR in autism was retracted amid evidence of fraud and ethical violations, Vaxxed has been described by outlets like STAT News as a conspiracy-laden production relying on emotional parental testimonies and selective data presentation to erode trust in vaccines and pharmaceutical entities, without engaging countervailing evidence from rigorous trials demonstrating MMR's efficacy in preventing outbreaks, such as the 2014 U.S. measles resurgence tied to unvaccinated clusters. Bigtree has defended the film as not anti-vaccine but critical of specific practices like combined shots, advocating separate administration despite no peer-reviewed evidence supporting reduced risk from spacing; media reports note it garnered over $400,000 in funding from donors skeptical of mainstream science, amplifying its reach amid festival pullouts like Tribeca in 2016 due to backlash from pediatricians and virologists warning of public health risks.^[15]^[66]^[15] Scientific fact-checkers have rebutted specific claims Bigtree has amplified via his platform, The Highwire, and Informed Consent Action Network (ICAN). In October 2022, he cited a distorted analysis of CDC Vaccine Adverse Event Reporting System (VAERS) data to assert over 18 million severe injuries from COVID-19 vaccines; FactCheck.org clarified that VAERS reports are unverified signals requiring investigation, with post-authorization monitoring by systems like V-safe and Vaccine Safety Datalink confirming serious adverse events occur in fewer than 0.003% of doses, far outweighed by prevented hospitalizations per CDC analyses of over 600 million doses. Similarly, in November 2022, Bigtree linked a pediatric respiratory syncytial virus (RSV) surge to COVID-19 vaccination, but experts attribute it to an "immunity debt" from pandemic-era reduced exposures, not vaccine-induced suppression, as RSV patterns predate COVID shots and vaccination trials showed no such effect. On aluminum adjuvants, his April 2024 assertions of brain and bone damage lack support; peer-reviewed reviews affirm that vaccine aluminum doses (under 1 mg) are rapidly excreted and below toxicity thresholds established by the FDA and WHO, with hypersensitivity rare and not causally tied to widespread harm in adjuvant-containing vaccines used for decades.^[46]^[67]^[68] Broader critiques from scientific bodies and media portray Bigtree's advocacy, including ICAN's FOIA-driven lawsuits, as selectively interpreting raw data to imply causation where correlation exists, such as in VAERS or court-adjudicated claims, while downplaying denominator effects like billions of safe doses; a 2022 legal analysis argued ICAN reframes neutral or adverse rulings to bolster narratives like vaccines causing autism, despite courts like the Vaccine Court rejecting such links in over 5,000 petitions based on epidemiological standards. Outlets like NBC and PBS have linked his influence to politicized anti-science pushes, including post-2024 efforts under Make America Healthy Again (MAHA), warning that amplified distrust contributes to measurable declines in childhood vaccination rates—from 95% MMR coverage in 2019 to under 93% by 2023—correlating with measles cases rising from 1,200 in 2016-2019 to over 100 U.S. outbreaks by 2025, per CDC surveillance. These sources, often aligned with public health institutions, emphasize empirical vaccine benefits—like averting 154 million deaths globally from 1974-2014 per WHO estimates—over Bigtree's focus on rare events, though critics of mainstream narratives note potential underreporting in adverse event systems.^[27]^[40]^[69]

Advocacy Achievements and Empirical Defenses

Informed Consent Action Network (ICAN), led by Bigtree since its founding in 2016, has secured multiple legal outcomes exposing deficiencies in federal vaccine safety reporting. In July 2018, following ICAN's lawsuit, the Department of Health and Human Services (HHS) stipulated in federal court that it had submitted zero required biennial reports to Congress on vaccine injury prevention and safety monitoring since the 1986 National Childhood Vaccine Injury Act's enactment—a lapse exceeding 30 years.^[70]^[2] This disclosure revealed non-compliance with statutory mandates for documenting surveillance efforts, including those under the Vaccine Adverse Event Reporting System (VAERS) and Vaccine Injury Compensation Program.^[71] ICAN's strategy of over 1,800 Freedom of Information Act (FOIA) requests and ensuing litigation has produced more than one million pages of government records, enabling data-driven critiques of vaccine approvals and mandates. Notable releases include CDC V-safe data from over 10 million post-COVID-19 vaccination check-ins, where approximately 7.7% of respondents reported seeking medical care, and free-text fields captured over 7,800 entries describing emergency room visits, hospitalizations, or disabilities such as heart inflammation and seizures.^[72]^[71] Independent analyses of this raw data, unavailable in aggregated CDC summaries, have been presented as evidence of underemphasized risks in official narratives.^[73] Bigtree defends these positions empirically by citing agency admissions of evidentiary gaps, such as the CDC's failure in federal court to provide studies isolating vaccine effects from autism spectrum disorders despite repeated ICAN demands.^[74] He further argues, via The Highwire platform and legal filings, that routine childhood vaccines often lack pre-licensure randomized controlled trials using inert placebos over extended periods—unlike pharmaceutical standards—relying instead on comparisons to other vaccines or short-term endpoints, which confound causality assessments.^[75]^[76] These revelations, Bigtree contends, substantiate calls for rigorous, independent safety verification over reliance on manufacturer-submitted data. Such advocacy has influenced policy, culminating in HHS's August 2025 restoration of the Advisory Commission on Childhood Vaccines after ICAN's sustained challenges to monitoring lapses.^[77] Bigtree attributes this to FOIA-forced transparency revealing systemic oversights, positioning ICAN's work as a catalyst for accountability rather than opposition to vaccination itself.^[2]

Legacy and Ongoing Influence

Del Bigtree's legacy centers on his role in amplifying vaccine safety concerns through legal advocacy and media production, notably as CEO of the Informed Consent Action Network (ICAN), founded in 2016. ICAN has secured multiple court-ordered disclosures via Freedom of Information Act requests and lawsuits against federal agencies, including the Department of Health and Human Services and the Centers for Disease Control and Prevention, compelling the release of data on vaccine injury reporting and testing protocols previously withheld.^[2] These efforts, including a 2018 settlement requiring HHS to submit congressionally mandated vaccine safety reports, have provided raw datasets that skeptics cite as evidence of regulatory shortcomings, though mainstream scientific bodies maintain the data does not indicate systemic vaccine risks.^[2] Bigtree's production of the documentary Vaxxed (2016) and hosting of The HighWire, a weekly show launched in 2017, further disseminated such information to audiences questioning pharmaceutical and government oversight, fostering a network of health freedom advocates.^[75] ICAN's financial growth underscores Bigtree's organizational influence, with revenues nearly doubling to $23 million in 2023 amid heightened public scrutiny of COVID-19 vaccines, reflecting donor support for its mandate-driven critiques rather than broad anti-vaccination stances as characterized by outlets like NBC News.^[40] His Emmy-winning background in television production lent credibility to these platforms, enabling The HighWire to challenge narratives from institutions often accused of conflicts of interest due to industry funding.^[78] While critics in academia and media attribute rising vaccine hesitancy partly to such advocacy, empirical defenses highlight instances where ICAN's revelations aligned with later acknowledged issues, such as incomplete adverse event reporting in VAERS.^[33] Ongoing influence manifests in Bigtree's leadership within the Make America Healthy Again (MAHA) movement, where he serves as CEO and co-founder of MAHA Alliance and MAHA Action, organizations advancing policy reforms on vaccines, food safety, and chronic disease prevention post-2024 election.^[61] In early 2025, Robert F. Kennedy Jr., confirmed as HHS Secretary, transferred a trademark application for "Make America Healthy Again" to an LLC managed by Bigtree, signaling alignment in prioritizing transparency over expedited approvals.^[52] Bigtree participated in Kennedy's HHS transition team, vetting candidates and pushing initiatives like reevaluating vaccine schedules and fluoride regulations, amid over 420 state-level bills in 2025 echoing MAHA priorities.^[51]^[69] The launch of the MAHA Institute in May 2025 positions it as a policy counterweight to traditional health think tanks, with Bigtree's involvement driving empirical audits of federal health data to inform reforms.^[59] This trajectory extends his impact from grassroots skepticism to potential federal restructuring, though outcomes hinge on verifiable safety improvements over institutional resistance.

References

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Del Bigtree - ICAN - Informed Consent Action Network
Del Bigtree is one of the preeminent voices of the vaccine risk awareness movement around the world. He is the founder of the non-profit, Informed Consent ...
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About Us - ICAN - Informed Consent Action Network
Using an unprecedented legal strategy, ICAN has successfully won lawsuits against Health and Human Services, the Centers for Disease Control, the National ...
[3]
Del Bigtree - Awards - IMDb
2010 Winner Daytime Emmy. Outstanding Talk Show/Informative. The Doctors. Shared with: Jay McGraw · Carla Pennington · Phil McGraw · Andrew Scher · Jeff Hudson ...
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Vaxxed: From Cover-Up to Catastrophe (2016) - Full cast & crew
Vaxxed: From Cover-Up to Catastrophe (2016) - Cast and crew credits, including actors, actresses, directors, writers and more.
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Del Bigtree - IMDb
Del Bigtree. Producer: Bitter Sweet. Del Bigtree is known for Bitter Sweet (2005), Sex and Sensuality (2007) and The Doctors (2008).
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https://www.thedailybeast.com/anti-vaxxer-del-bigtree-got-his-start-on-the-tv-show-the-doctors
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Sep 22, 2021 · The interview Dr. Patrick did with Del Big Tree was AMAZING! Del was producer for an American talk show and an Emmy award winner.Missing: production | Show results with:production
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Speaking at The WAVE, Del Bigtree is an Emmy Award-winning television and film producer and leading voice in the medical freedom movement.Missing: biography | Show results with:biography
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Oct 12, 2017 · § 300aa-31. Dear Secretary Hargan: Informed Consent Action Network hereby provides notice per 42 U.S.C. § 300aa-31(b). Americans, including ...
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'Vaxxed' Filmmakers Insist Not an Anti-Vaccine Movie - Time Magazine
Mar 31, 2016 · At a press conference held in Studio City on Wednesday, Vaxxed producers Del Bigtree and Polly Tommey, distributor Phillipe Diaz and director Dr ...Missing: production details<|control11|><|separator|>
[15]
We watched the movie 'Vaxxed' so you don't have to - STAT News
Apr 1, 2016 · The anti-vaccine documentary "Vaxxed" premiered to a delighted crowd, including many who harbor a deep distrust of the scientific ...
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Vaxxed: Tribeca festival withdraws MMR film - BBC News
Mar 27, 2016 · New York's Tribeca Film Festival will not show Vaxxed, a controversial film about the MMR vaccine, its founder Robert De Niro says.
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Robert De Niro pulls anti-vaccination film from Tribeca film festival
Mar 26, 2016 · Actor and co-founder of festival says he 'did not believe film contributes to or furthers the discussion I had hoped for'
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'Vaxxed,' Controversial Vaccine Documentary, Plots National Roll Out
Apr 3, 2016 · A week after it was pulled from the Tribeca Film Festival, “Vaxxed: From Cover-Up to Catastrophe" debuted at New York City's Angelika Film ...
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Apr 1, 2016 · Andrew Wakefield's controversial documentary, receiving a hurried theatrical release after being pulled from the Tribeca Film Festival, attempts to prove the ...
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Vaxxed: From Cover Up to Catastrophe (2016) - The Numbers
Financial analysis of Vaxxed: From Cover Up to Catastrophe (2016) including production budget, domestic and international box office gross, DVD and Blu-ray ...
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Mar 28, 2016 · Robert De Niro Pulls 'Vaxxed' From Tribeca Film FestivalThe Oscar-winning actor reversed his decision to show the anti-vaccine documentary at ...
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when given to children under age 2 — ...
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[25]
[PDF] CDC Concedes in Federal Court It Does Not Have Studies to ...
Mar 5, 2020 · The FDA, pursuant to a FOIA request from ICAN, eventually produced the clinical trials it relied upon to license the current MMR vaccine which ...<|control11|><|separator|>
[26]
Stipulated Order Showing FDA's Off-Label Use of Vaccines During ...
Nov 3, 2019 · Upon investigation, ICAN determined the FDA has not licensed any influenza vaccine as an indicated use for pregnant women, ...
[27]
[PDF] How Anti-Vaccine Groups Use the Law to Help Spin a False Narrative
Nov 23, 2022 · In this Article, we examine one influential anti-vaccine organization, the. Informed Consent Action Network (ICAN), that uses its far-reaching ...
[28]
BREAKING: Another California Lawsuit Filed As ICAN's Attorneys ...
Jun 27, 2025 · The lawsuit, filed on June 24, 2025, against California officials, challenges their enforcement of California's draconian compulsory vaccination ...
[29]
ICAN vs V-safe Covid Vaccine Data Legal Battle
Oct 21, 2022 · ICAN sued the CDC twice for v-safe data to be released to the public. These two court filings can be reviewed – the first was filed December 28, ...
[30]
[PDF] AN INTRODUCTION TO VACCINE SAFETY
Immunity from Liability for Vaccine Harms. By the early. 1980s, pharmaceutical companies faced crippling liability for injuries to children caused by their ...
[31]
Informed Consent Action Network v. National Institutes of Health
Plaintiff, the Informed Consent Action Network (ICAN), requested COVID-19 vaccine data from the National Institute of Health (NIH) under the Freedom of ...
[32]
Informed Consent Action Network v. FDA, No. 24-1761, 2024 WL ...
Nov 20, 2024 · Request for records concerning clinical trial protocols related to the Boostrix vaccine against tetanus, diptheria, and pertussis.
[33]
Digging the rabbit hole, COVID-19 edition: anti-vaccine themes and ...
Nov 7, 2020 · The themes are the claim that “they” – government and pharma – are lying to you, claims that COVID-19 is an excuse to remove civil liberties, ...
[34]
Zach Bush MD: Highwire with Del Bigtree Interview 2020 - YouTube
Jun 15, 2020 · Triple board-certified M.D., Dr. Zach Bush, joins Del in an evolutionary discussion on why Coronavirus is here, what it's trying to tell us, ...<|separator|>
[35]
[PDF] FDA-Petition-COVID-19-Vaccine-Trials-Final-3.pdf
It is hereby requested that the Commissioner: a. Require all Phase II and III trials of vaccines against COVID-19 include a placebo control group (i.e., a ...
[36]
A Citizen Petition filed by Del Bigtree and ICAN demanding clinical ...
Jun 18, 2020 · A Citizen Petition filed by Del Bigtree and ICAN demanding clinical trials of vaccines for SARS-CoV-2 contain a placebo control group.
[37]
At D.C. rally, anti-vaccine activists protest covid mandates
Jan 24, 2022 · and Del Bigtree, founder of the anti-vaccine group Informed Consent Action Network. ... advocating, or promoting that others not get the COVID ...
[38]
Once struggling, anti-vaccination groups have enjoyed a pandemic ...
Feb 3, 2022 · Despite ICAN's claims in court filings, Bigtree contends that the pandemic has been good for business. In his speech at January's anti-vaccine ...
[39]
FDA HAS LOST ITS WAY-The Highwire with Del Bigtree
The FDA authorized Covid vaccines for 5-11 year- olds this week, via press release. With concerning safety signals and low risk from infection, experts are ...Missing: 19 key statements
[40]
Anti-vaccine group with ties to RFK Jr. saw another windfall last year ...
Dec 23, 2024 · Del Bigtree's Informed Consent Action Network, which advocates against polio, measles, hepatitis and Covid vaccines, brought in $23 million ...
[41]
Pfizer 12-15 & Moderna Documents - ICAN
Click below for court documents and for productions of Pfizer's 12-15 and Moderna's documents from the FDA.
[42]
Judge orders FDA to hasten release of Pfizer vaccine docs | Reuters
Jan 7, 2022 · A federal judge in Texas on Thursday ordered the Food and Drug Administration to make public the data it relied on to license Pfizer's ...
[43]
ICAN Demands Answers About Death Discrepancies in Pfizer's ...
Aug 29, 2022 · For the second time, the FDA has avoided answering very simple questions about discrepancies concerning the numbers of deaths in Pfizer's ...
[44]
ICAN Petitions to FDA Regarding COVID-19 Vaccines
Jun 3, 2021 · When clinical trials for the COVID-19 vaccines were released (and did not include an inert placebo), ICAN filed a forceful petition ...
[45]
V-Safe - ICAN - Informed Consent Action Network
Oct 18, 2022 · ICAN's legal team sued the CDC twice leading to a court order requiring release of the data. ICAN has taken the CDC's official raw data and ...Missing: results | Show results with:results
[46]
Posts Distort Misleading Analysis of COVID-19 Vaccine Safety Data
Oct 28, 2022 · ICAN sued the CDC in December 2021, and again in May 2022, following FOIA requests to obtain all data submitted to v-safe since Jan. 1, 2020.
[47]
RFK Jr. hires Del Bigtree, top anti-vaccine activist, as campaign ...
Jan 2, 2024 · Robert F. Kennedy Jr. hired Del Bigtree, who leads ICAN, a top anti-vaccine organization, as his presidential campaign's communications ...
[48]
Leading anti-vaccine activist joins RFK Jr. campaign as ... - The Hill
Jan 2, 2024 · Del Bigtree, a leading anti-vaccine activist, has joined Robert F. Kennedy Jr.'s presidential campaign as communications director.
[49]
Anti-Vaxxer All-Star Takes Charge of Kennedy Communications Shop
Jan 2, 2024 · The Kennedy campaign has hired anti-vaxxer and conspiracy theory spreader Del Bigtree to manage its communications shop.
[50]
Resistance to vaccine mandates is building. A powerful network is ...
May 26, 2021 · “If you or anyone you know is being required by an employer or school to receive a covid-19 vaccine, ICAN is offering to support legal action on ...
[51]
Kennedy's 'MAHA transition team' includes anti-vax activists - Politico
Nov 22, 2024 · Robert F. Kennedy Jr. is enlisting associates with close ties to anti-vaccine organizations to help vet and interview candidates for senior roles.
[52]
RFK Jr. sought to trademark 'Make America Healthy Again ...
MAHA — to an LLC managed by Del ...
[53]
RFK Jr sought 'Make America Healthy Again' trademark for vaccine ...
Jan 30, 2025 · Trump's health secretary pick transferred ownership of Maha slogan application to anti-vaccine ally Del Bigtree.Missing: alliance | Show results with:alliance
[54]
Del Bigtree | C-SPAN.org
Feb 19, 2025 · Del Bigtree is a Chief Executive Officer for the Make America Healthy Again (MAHA) with one video in the C-SPAN Video Library.
[55]
63 - The Fight for Health Freedom: A Conversation with Del Bigtree
May 14, 2025 · In this episode of the Change Life Destiny podcast, guest host Dr. Chris Motley sits down with Del Bigtree, CEO of MAHA (Make America Healthy Again).<|separator|>
[56]
Make America Healthy Again to Host Press Conference
Feb 13, 2025 · On Thursday, February 13th at 4pm, MAHA Action will host a press conference to discuss the advancement of the MAHA agenda with Del Bigtree, ...
[57]
MAHA COMMISSION CALLS FOR HEALTH OVERHAUL
Sep 16, 2025 · MAHA COMMISSION CALLS FOR HEALTH OVERHAUL. Comments. logo ... Del Bigtree shares new details on the highly anticipated release of ...
[58]
'Riding a Wave Right Now': Mary Holland, Del Bigtree Discuss ...
Apr 1, 2025 · ... Del Bigtree ... 'We Will Do That Right Away': RFK Jr. Promises Better Vaccine Injury Tracking, as White House Launches MAHA Commission ...
[59]
MAHA has a new think tank. The Trump administration is listening
May 15, 2025 · The MAHA Institute, a policy center launched Thursday, is pushing to change the American health and food systems: from rethinking vaccine availability and ...
[60]
Senate Confirms RFK Jr., a Prominent Vaccine Skeptic, as Health ...
Feb 13, 2025 · The vote capped a remarkable rise for Robert F. Kennedy Jr., who was confirmed by a Republican Senate in a chamber where his father and ...
[61]
Del Bigtree - NPEW 2025
Del Bigtree is the CEO and co-founder of MAHA Alliance and MAHA Action, where he leads a team focused on advancing the “Make America Healthy Again” mission.
[62]
Let's Make America Healthy Again - Senator Ron Johnson
Mar 3, 2025 · I believe this is a watershed moment for America. The Make American Healthy Again movement held a press conference after RFK Jr's swearing-in.
[63]
A Data-Driven Wake-Up Call (Bigtree, Online 2025) | Continuing ...
Overview. Del Bigtree, television producer and founder of the Informed Consent Action Network (ICAN), shares his personal journey into health advocacy and ...
[64]
INSIDE THE 2024 ELECTION WITH DEL BIGTREE - The HighWire
Nov 7, 2024 · ... Robert F. Kennedy Jr. campaign. Del chronicles his experience behind RFK, Jr.'s historic run for President, his decision to run as an ...
[65]
Andrew Wakefield's Vaxxed: Scary Music and Specious Claims
Jun 21, 2016 · The documentary is rehashing a false narrative about the MMR vaccine having a causal role in autism development that has been countered time and again.
[66]
Vaxxed review – one-sided film leaves the elephant in the room
Apr 2, 2016 · The anti-vaccination documentary, pulled from the Tribeca film festival but screened in New York on Friday, offers a biased look at a controversial topic.
[67]
RSV Surge in Children Likely Caused by 'Immunity Gap,' Not COVID ...
Nov 18, 2022 · Hospitals across the country are seeing a spike of respiratory syncytial virus infections among children. Experts say the spike is most ...
[68]
Posts Raise Unfounded Concerns About Aluminum in Vaccines
Apr 5, 2024 · Halsey said that in very rare cases, people can develop a hypersensitivity to the aluminum adjuvants after receiving multiple vaccine doses, ...<|separator|>
[69]
https://www.pbs.org/newshour/health/anti-science-bills-hit-statehouses-attacking-longstanding-public-health-protections
[70]
ICAN vs. HHS: Key Legal Win Recasts Vaccine Debate - BioSpace
Sep 14, 2018 · The US Department of Health and Human Services (HHS) has admitted that, in direct violation of Federal law, it failed to provide a single vaccine safety report ...Missing: outcomes | Show results with:outcomes
[71]
ICAN's Novel FOIA Approach Produces Unprecedented Results
Jan 29, 2024 · ICAN's attorneys, led by Aaron Siri, have submitted close to 1,800 FOIA requests to date. Making the request is just the first step though. Siri ...Missing: successes | Show results with:successes
[72]
V-Safe Data - ICAN - Informed Consent Action Network
Find the interactive V-Safe dashboards below and click the DOWNLOAD buttons to obtain exclusive data obtained by ICAN.Missing: Del Bigtree
[73]
New data is out on COVID vaccine injury claims. What's to make of it?
Oct 12, 2022 · The U.S. Centers for Disease Control and Prevention, facing a Freedom of Information Act lawsuit seeking a vast trove of data about the ...
[74]
Get Informed - ICAN
CDC – CDC Cannot Support its Claim That “Vaccines Do Not Cause Autism”. In a federal lawsuit, filed by ICAN, the Center for Disease Control (CDC) has failed to.Missing: outcome | Show results with:outcome
[75]
[PDF] Informed Consent Action Network - Supreme Court
Feb 5, 2024 · Through The Highwire,. ICAN is able to shed light on governmental oversight in the area of vaccine and drug development, produce reports from ...
[76]
[PDF] The Subcommittee on the Administrative - Congress.gov
Jun 26, 2024 · While Covid-19 vaccine trials were robust as compared to trials for vaccines on the CDC childhood schedule, they were anemic as compared to ...
[77]
HHS Finally Restores Task Force on Safer Childhood Vaccines - ICAN
Aug 14, 2025 · As many of you know, ICAN previously sued HHS to obtain these reports that were supposed to be sent to Congress—and HHS, in response ...Missing: outcomes | Show results with:outcomes
[78]
[PDF] Who Is Del?
Jan 25, 2021 · Del Bigtree is one of the preeminent voices of the Vaccine Risk Awareness Movement. His career as an Emmy-winning producer of the CBS talk ...