MAHA Clinical File
Rx Only

Department of Health and Human Services | Investigational New Policy

IND Application

CLINICAL
TRIAL
Protocol

Open-Label, Uncontrolled Trial of Deregulated Peptides and Wellness Policy in the General Population

Application No.IND-MAHA-2026-001
PhasePre-Phase I
SponsorDept. of Health & Human Services
Evidence CollectionDeferred
Clinical trial protocol infographic showing an empty form with NO DATA watermark and a peptide molecular chain

1Principal Investigator

Investigator Credentials

NameRobert F. Kennedy Jr.
TitleSecretary, Health and Human Services
Medical DegreeNone
Scientific TrainingNone
Prior Research ExperienceEnvironmental law
Relevant Clinical Trial ExperienceNone
Conflicts of InterestFounded Children's Health Defense (anti-vaccine advocacy group)

2Co-Investigator / Proposed Surgeon General

Investigator Credentials

NameCasey Means, MD
Nominated ForSurgeon General of the United States
Confirmation StatusStalled in Senate (as of March 2026)
Prior ExperienceWellness influencer
Notable PositionsHas criticized the birth control pill, fearmongered about vaccines, touted supplements with weak evidence
SourceGizmodo, March 2026
Peer-Reviewed Publications Relevant to Role[left blank]
Confirmation StalledPublications: None Relevant

3Study Design

Protocol Design Form

DesignNone
RandomizationNo
BlindingNo
Control GroupThe American public (unblinded, non-consenting)
Sample Size330,000,000 (entire U.S. population)
Sample Size JustificationNot calculated. Not requested.
Statistical Analysis PlanPending. Indefinitely.
Data Safety Monitoring BoardNot established
Informed ConsentNot obtained
IRB ApprovalNot sought

Open-label by necessity; the principal investigator announces all interventions on the Joe Rogan Experience.

4Investigational Product: Peptides

Product Description

Product14 previously banned peptides
Regulatory StatusBanned by FDA (2023), to be unbanned by Kennedy
Total Trials Conducted5

Evidence Assessment

Kennedy, Joe Rogan Experience, March 2026

“[The evidence] hasn't been fully gathered.”

Largest Supporting Trial

Retracted. A journal yanked a positive trial after outside researchers discovered numerous “errors” and “concerns” with the data.

Gizmodo, March 2026

FDA's Own Assessment, March 2026

“We don't have sufficient data to say that we could establish efficacy.”

“My hope is that they're going to get moved to a place where people have access from ethical suppliers.”

-- Kennedy, March 2026

5Secondary Investigational Product

Product: Leucovorin for Autism

Kennedy's ClaimWould help "large numbers of children who suffer from autism"
Current Approved IndicationCerebral folate deficiency only
Largest Supporting Trial77 children
Trial StatusRetracted for data errors

Gap Analysis

Claim

“Large numbers of children”

Gap

Evidence

77 children (retracted)

FDA Briefing, March 2026

“We don't have sufficient data to establish efficacy for autism more broadly.”

6Enrollment Criteria

Inclusion / Exclusion

Inclusion CriteriaLives in the United States
Exclusion CriteriaNone
Informed ConsentNot obtained
Withdrawal CriteriaEmigration
Compensation for ParticipationNone. Participants also fund the study (U.S. taxpayers, non-consenting).

7Endpoints

Outcome Measures

Primary EndpointTBD
Secondary EndpointTBD
Safety Endpoint[left blank]
Duration of Follow-UpUnknown. The study has no defined end date.
Interim AnalysisNot planned. The principal investigator prefers to announce results on podcasts.

Safety Monitoring Note

Safety monitoring was described by the principal investigator as:

[this field was left blank]
No Safety Monitoring

8Funding Source

Financial Disclosure

Funding SourceU.S. taxpayers (non-consenting)
BudgetThe Department of Health and Human Services annual budget
Budget JustificationNot provided

Conflict of Interest Disclosure

The principal investigator founded an advocacy group (Children's Health Defense) that fundraises on vaccine skepticism.

The co-investigator has a wellness brand.

Neither has disclosed revenue from these activities in relation to policy decisions.

In a clinical trial, you need evidence before you start. In public health policy, apparently, you do not.

This page is satire formatted as a pharmaceutical document. It is not medical advice. The pharmacology, however, is real.