James Roguski

The Department of INjustice

James Roguski — Tue, 26 May 2026 21:34:40 GMT

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If you are concerned about the Federal government’s never-ending quest for control over your health and its ongoing destruction of the relationship between you and your chosen health care provider, then please take the time to comprehend what the Department of Justice has done in their attempt to destroy the career of one of America’s top surgeons: Dr. Sanjeev Kumar.

“For physicians, hospital administrators, and compliance professionals nationwide, the case raises an unsettling question: whether medical care will continue to be judged by established standards, regulatory guidance, and real patient outcomes, or by hypothetical harms imagined after prosecutors have already decided whom to charge.”

“Medical necessity should not be such a nebulous concept that it exists in the brain of a government charge reviewer, only.”

“No patient contracted an infection. No disease outbreak occurred. No evidence showed that any device was reused on a patient.”

“If a physician is receiving a criminal punishment for accepting the will of a patient, then we have real big problems in this country. We have a very serious problem with the criminalization of health care in this country and this case absolutely proves it.”

Please watch the video interview below:

Part I: Background

Part II: Court case (begins at 53 minutes)

YouTube: https://www.youtube.com/watch?v=CnZ9bX3MaDQ

Rumble: https://rumble.com/v7af8pc-interview-with-dr.-sanjeev-kumar.html

Important Questions:

1. Were medically unnecessary procedures performed at the clinic?

No. The medical board found no medically unnecessary procedures. Multiple insurance audits including medicaid found care to be medically necessary. Jury disputed 12 procedure out of more than 10,000. Even these 12 procedures have well documented medical indications in the chart (see table of indications documented in the medical chart). Anywhere in the world, these indications qualify for hysteroscopy. All 12 procedures disputed by the jury belonged to covid-19 pandemic (11 in 2021 and 1 in 2020). Most likely, the jury did not understand the case and the complex care received by the very sick patients.

2. Were medical devices reused at the clinic?

Yes. Multiuse devices were reused at the clinic after proper disinfection or sterilization. The clinic had numerous types of multiuse devices and single use devices. Even the single use devices had multiuse components. The allegations for reuse of single use devices stem from the misunderstanding between the single use and multiuse devices. If a witness did not have comprehensive knowledge of the devices, they can easily misunderstand the difference between single use vs multiuse devices. The medical board found no evidence of reuse of single use devices in their investigation. The clinic had one of the largest collections of the multiuse devices in the country.

3. Was ANY single use device proven to be reused on ANY single patient for ANY specific procedure?

No. No single use device was proven to be reused on any specific patient for any specific procedure. Defense team asked repeatedly and were not provided any specific information.

4. Were devices presented at the trial functional?

No. Devices presented at the trial were not functional-they did not work and could not be used or reused on any patients. They were broken, retrieved from biohazard trash cans and remained in the FBI possession for several months under unsanitary conditions.

5. Did any clinic employees testify on Dr. Kumar’s support?

Multiple clinic employees testified that no unnecessary procedures were performed and they never saw any reuse of any single use devices. Several brought their family members to be treated by Dr. Kumar and many were themselves receiving care by Dr. Kumar with the same devices.

6. Why are there so many counts (46)?

The government seized many devices from the clinic. Each device was broken down into two charges, one count for adulteration and one count on misbranding. A doctors office can literally have 100s of devices. So 16 devices seized by the government were the basis for 32 counts. Additional 4 counts were added for the multiuse devices just based on pictures without any actual testing of the device. All these devices were non functional, broken and several were seized from clearly labelled biohazard trash cans. None of these devices were connected to any specific patient. The government was not required to prove use or reuse of any of the specific device. In Addition, there were 10 counts of medical necessity labelled as healthcare fraud, all of which had well documented necessity indications in the chart.

7. Was any patient hurt?

No. Quite the opposite. Patients received excellent care and appreciated the convenience of weekend hours at the clinic. No evidence of any patient harm was presented at the trial. Numerous patients testified that they liked their care at the clinic. One said-I loved it. Another said Dr. Kumar was kind. Still another said -I stopped going to the clinic due to traffic. Main government witness testified that she learned a lot from Dr. Kumar and his patients loved him. No patient’s had any infections per the trial data.

8. Did Dr. Kumar sexually assault patients?

No. Government engaged in creative prosecution and called hysteroscopy as sexual assault as its a gynecologic procedure. These charges had no basis and were eventually dismissed by the court. They charged Dr. Kumar for sexual assault when when the procedure was actually performed by his physician assistant (a female) and he was physically not present in the clinic. Dr. Kumar enjoyed excellent reputation as a top surgeon in the region and had no sexual misconduct allegations before the government malicious prosecution leveled false charges.

9. Did Dr. Kumar receive a fair trail?

No. Pretrial propaganda with baseless sexual assault charges. During the trial, there were multiple Brady and Jenks violations. Lead FDA reviewer mislead the court under oath and now no longer with the FDA. Post trial Remmer hearing is ongoing and remains under seal.

10. How does this trial impact the practice of medicine?

Medical care can be charged as sexual assault by twisted application of the statue by a totally immunized prosecutor with no accountability. Government can call care dispensed by a clinic unnecessary based on a spurious chart review. This case demonstrated severe form of government overreach to restrict medical care by scaring the physician community.

January 12, 2026

The mixed verdict returned in United States v. Sanjeev Kumar bore little resemblance to the case that the public was first told it was witnessing. What began as a sensational prosecution framed around false, exaggerated and ultimately dismissed allegations of sexual misconduct and human trafficking ultimately narrowed into a dispute over medical judgment, regulatory enforcement, and the expanding criminalization of healthcare under statutes that were never designed for that purpose.

Please watch the video below:

Prosecutors selected 26 patients with the highest number of biopsies—a slanted, non-random sample— and had an expert review those cases. The expert agreed with many of Dr. Kumarʼs clinical findings. The government then narrowed the group to eight patients. Only then did the expert testify that repeating a biopsy within six months was inappropriate and that an insufficient biopsy sample should be repeated in a hospital setting at a cost exceeding $20,000.
Under oath, the expert could not identify a single medical standard, peer-reviewed study, or professional guideline supporting those opinions. No literature from the American College of Obstetricians and Gynecologists – ACOG – articulated such a rule, nor did any published standard require that insufficient biopsy samples be repeated exclusively in hospital settings. The standards applied at trial reflected one expert’s subjective views, imposed retrospectively on a selectively chosen patient group.
Perhaps most consequential was what the prosecution did not dispute. Dr. Kumarʼs cleaning protocols and standards of care had been reviewed and approved by the Tennessee Medical Board, which inspected his practice and found it appropriate. That approval was unrebutted. Nevertheless, a government expert was permitted to substitute personal judgment for CDC guidance, Medical Board oversight, and widely accepted medical practice.
One referring physician testified that he had sent hundreds of patients to Dr. Kumar and that those patients consistently received exceptional care. That physician was prevented from discussing the extent of free and reduced-cost care Dr. Kumar provided to underserved members of the community, limiting the juryʼs understanding of the practice as a whole. Patient witnesses faced similar constraints. Several were barred from fully describing their treatment experiences, including why procedures were recommended and how decisions were made, resulting in testimony that critics say presented an incomplete picture of the clinicʼs operations.
As the trial progressed, concerns also emerged about witness handling. Defense filings alleged that witnesses whose early statements conflicted with the Department of Justice’s theory were re-interviewed repeatedly by investigators. In several instances, those witnesses later offered testimony that differed materially from their earlier accounts, raising questions about whether investigative pressure contributed to evolving narratives rather than newly discovered facts.
The FDAʼs core theory—that Dr. Kumar reused “adulteratedˮ devices—also weakened under scrutiny. Evidence at trial showed that actual reuse of many seized devices was physically impossible. Certain cannulas were designed with safety mechanisms that prevent reuse altogether. One device highlighted by investigators was found in a cupboard without a battery and could not function. Forceps and graspers cited by the FDA did not fit the scopes they were allegedly associated with. Many items had been staged for disposal, not use.
Dr. Kumar conducted a live demonstration in court, showing that the devices collected by investigators were inoperable and could not be “held for saleˮ or used on patients. Other devices were shown to be sitting in CDC-approved high-level disinfectant solutions, consistent with federal guidance on medical device reprocessing and sterilization. Investigators, however, collected select items set for disposal while ignoring hundreds of sterile, packaged devices, documented cleaning logs, and protocols consistent with published Centers for Disease Control and Prevention sterilization guidance.
While prosecutors argued that Dr. Kumar violated complex FDA protocols, the defense documented that the lead FDA agent, Special Agent Brian Kriplean, violated basic evidence-preservation standards. According to motions filed during trial, Kriplean deleted the contents of his phone and failed to disclose key investigative materials until after witnesses had testified. Those actions formed the basis of motions alleging violations of Brady v. Maryland, Giglio v. United States, the Jencks Act -18 U.S.C. § 3500-, and Federal Rules of Criminal Procedure 16 and 26.2.
The contrast was striking. A physician was prosecuted criminally for alleged regulatory violations, while the investigating agency failed to preserve evidence and disclose exculpatory material in a timely manner. Observers noted that this dynamic sits at the heart of growing concerns about the overcriminalization of healthcare.
No patient contracted an infection. No disease outbreak occurred. No evidence showed that any device was reused on a patient.
Yet under the jury instructions permitted by the court, prosecutors were not required to prove actual use on a patient.
Under this interpretation of FDA adulteration statutes, criminal liability can attach if a device is merely present in a medical office, even if it is inoperable, never reused, and never touches a patient.
Taken together, the case illustrates a broader shift in federal enforcement strategy: the transformation of regulatory disputes into criminal prosecutions, the reliance on subjective expert opinion untethered from published standards, and the expanding criminal prosecution of physicians for compliance issues traditionally addressed through professional discipline or administrative review.
For hospitals and clinics that rely on trained staff to clean, stage, and dispose of equipment in accordance with CDC guidance, the implications are far-reaching and place unprecedented pressure on compliance operations.
https://whitecollarcriminaldefense.com/insight/after-dismissal-remaining-fda-charges-dr-sanjeev-kumar/

A Remmer hearing is currently underway in Dr. Sanjeev Kumar’s case.

A Remmer hearing is a court proceeding used to investigate allegations of jury misconduct or improper outside influence during a trial. Stemming from the landmark Supreme Court case Remmer v. United States, it requires the judge to hold a hearing with all parties present to determine if the jury was exposed to prejudicial information and if a new trial is warranted.

If an unauthorized “private communication, contact, or tampering” occurs with a juror, or if a juror is exposed to external information (like social media or outside research) there may be reason to convene a Remmer hearing. Attempts by third parties to influence a juror’s decision, inappropriate remarks made to jurors by court staff, bailiffs, or witnesses, or jurors doing their own research, looking up defendants online, or discussing the case on social networks are possible reasons to convene a Remmer hearing.

“What actually transpired” and whether the contact was harmful or harmless to the defendant is investigated. Both the defense and prosecution are allowed to participate, present evidence, and examine the jurors involved.

Once improper contact is proven, the law presumes the jury was prejudiced. The burden then shifts “heavily” to the prosecution to prove the contact was entirely harmless and did not affect the verdict.

If the judge finds that the outside influence likely impacted the jury’s verdict, the court must declare a mistrial or order a new trial.

Who is Dr. Sanjeev Kumar?

Dr. Kumar removes a large tumor at surgery during a life saving operation.

The above information is from the 2017 Baptist Cancer Center Annual Report

2017 Baptist Cancer Center Annual Report

2.58MB ∙ PDF file

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Sanjeev Kumar Found Right Place to Put Laparoscopy, Robotics into Practice

When Dr. Sanjeev Kumar came to Memphis in 2013 after a fellowship in gynecology/oncology at the Mayo Clinic, he found a patient population of heavyweights.
With Dr. Kumar’s expertise in robotic and laparoscopic surgery, the Baptist Medical Group Gynecology Surgical Center soon became ground zero for obese patients, a group that poses a greater degree of difficulty in surgical procedures.
“When I came to Memphis, we started getting these challenging patients and it was like ‘Let the new guy in town have these difficult cases that nobody else wants,’” Dr. Kumar recalled.
“Gradually we started developing methods and I started training my staff and operating team, and we started getting excellent results in very obese patients.
“Now in my practice, 80 to 90 percent of my patient population is obese. A lot of other physicians do not feel comfortable dealing with very obese patients, but with the surgery we’re offering we have seen the dramatic impact this makes in the patients’ lives.”
https://memphismedicalnews.com/article/762/taking-on-tough-task-of-obesity-surgery

https://www.actionnews5.com/2019/02/07/breakthrough-medical-procedure-can-help-prevent-miscarriage/

Visit Dr. Sanjeev’s website to learn more: DrSanjeevKumarSurgeon.com

In Dr. Sanjeev Kumar’s trial, the FDA claimed that they had “never cleared any hysteroscopes for high-level disinfection” and stated that hysteroscopes entering the uterus required sterilization.

Dr. Poulomi Nandy claimed: “It’s important to make sure that I communicate that FDA has not cleared any hysteroscopes with high-level disinfection.

However, the FDA’s claims are in direct conflict with the official instructions provided by the manufacturer.

A hysteroscopy is a minimally invasive procedure that allows a doctor to examine the inside of the cervix and uterus. It uses a hysteroscope—a thin, lighted telescope with a camera—inserted through the vagina, avoiding any skin incisions. It is used for both diagnosing and treating gynecological conditions.

Common Reasons for the Procedure:

Diagnosing abnormal bleeding: Investigating unusually heavy, long, or irregular periods, bleeding between periods, or postmenopausal bleeding.
Removing growths: Safely excising benign growths like uterine fibroids, polyps, or adhesions (scar tissue).
Fertility and pregnancy: Evaluating the uterine cavity to determine the cause of recurrent miscarriages or difficulty getting pregnant.
Device removal: Locating and removing displaced intrauterine devices (IUDs) or other foreign objects.
Tissue sampling: Performing a biopsy or a dilation and curettage (D&C) to check for precancerous or cancerous cells.

Below is a picture of Uro-V cannulas:

https://uroviu.com/products/uro-v-cystoscope/

The Feds seized cystoscope’s and treated them as hysteroscopes.

One is a hysteroscope and one is a cystoscope. Can you tell the difference?

A supplemental motion for a new trial filed last month in federal court raises questions about testimony presented during the criminal trial of Memphis gynecologic surgeon Dr. Sanjeev Kumar, with the defense arguing that Olympus physician reprocessing documentation conflicts with statements made to the court regarding accepted hysteroscope reprocessing methods.
The motion, filed in the United States District Court for the Western District of Tennessee, focuses on testimony from FDA employee Dr. Poulomi Nandy regarding the Olympus HYF-XP hysteroscope and whether the device could be reprocessed using high-level disinfection methods in outpatient clinical settings.
According to the filing, Dr. Nandy testified that the FDA had “never cleared any hysteroscopes for high-level disinfection” and stated that hysteroscopes entering the uterus required sterilization.
The defense filing cites testimony from Dr. Nandy stating:
“It’s important to make sure that I communicate that FDA has not cleared any hysteroscopes with high-level disinfection. All hysteroscopes, including this very old device from Olympus, was cleared with sterilization.”
However, the defense argues that FDA guidance directs physicians to follow manufacturer Instructions for Use (IFU) and reprocessing guidance for medical devices.
Olympus physician reprocessing documentation for the HYF-XP hysteroscope repeatedly references devices being “high-level disinfected or sterilized” during reprocessing cycles.
“The issue is whether the court received a complete and accurate explanation of hysteroscope reprocessing guidance and accepted outpatient medical practice,” said Dr. Kumar.
“These procedures are commonly performed in physician offices throughout the United States because they can improve access to care, reduce costs, and allow women to receive minimally invasive treatment outside hospital settings.
Inaccurate interpretations of accepted outpatient hysteroscopy practices could ultimately have broader implications for healthcare access and costs nationwide.”
https://www.globenewswire.com/news-release/2026/05/15/3295921/0/en/federal-court-motion-raises-questions-about-testimony-and-outpatient-hysteroscopy-practices-in-case-against-memphis-gynecologic-surgeon-dr-sanjeev-kumar.html

Flexible Endoscope Wall Chart

2.79MB ∙ PDF file

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When you learn what has been done to Dr. Kumar, you will wonder why the Department of Justice has failed to seek to recover some of the trillions of dollars received by those who caused so much harm during COVID-19:

https://www.law.cornell.edu/uscode/text/18/1347

Dr. Sanjeev Kumar was NOT permitted to enter the following CDC guidelines as evidence.

The government was able to argue that since the device was in the clinic, “it was potentially available to be used on a patient.”

Regulated medical waste disposal describes how devices need to be decontaminated before being discarded. The devices were in Cidex in the clinic.

Screenshot from page 81:

Guideline For Disinfection And Sterilization In Healthcare Facilities 2008 Update June 2024

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https://www.cdc.gov/infection-control/media/pdfs/Guideline-Disinfection-H.pdf

https://www.cdc.gov/infection-control/hcp/disinfection-sterilization/reuse-single-use-devices.html

Reuse Of Single Use Medical Devices Infection Control Cdc

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https://www.cdc.gov/infection-control/hcp/environmental-control/regulated-medical-waste.html

Cdc Regulated Medical Waste Infection Control

215KB ∙ PDF file

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Dr. Sanjeev Kumar was NOT permitted to enter as evidence the following documentation that the complaint was investigated by the Tennessee medical board and was dismissed by them.

Medical Board Clearance Letter Redacted

84.5KB ∙ PDF file

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October 27, 2019

Dr. Sanjeev Kumar was NOT permitted to enter the following document as evidence.

My instruction to the office manager--lays out clearly at the beginning of the clinic-”clinic housekeeping”. I had dictated that on my iphone so it has all the original typos but it instructs the staff to use flexible scopes, to disinfect them and to sterlize them, AND then to “elegently remove them from the room at the finish of the procedure”

this is a key email coz if you read the DOJ release, they say that I told staff to reuse equipment; the fact is quite the opposite-see this clear written email

Again, I was not allowed to introduce it to the trial evidence

Gmail Clinic Housekeeping Flexible Scope Hld Sterlization Redacted

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Documents from Dr. Sanjeev Kumar’s Court Case:

February 27, 2025

Sanjeev Kumar Indictment 1

302KB ∙ PDF file

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February 28, 2025

The FBI greatly inflamed public sentiment against Dr. Kumar by posting the following on the FBI.gov website:

Seeking Patient Information in Dr. Sanjeev Kumar Investigation

https://www.fbi.gov/how-we-can-help-you/victim-services/seeking-victim-information/seeking-patient-information-in-dr-sanjeev-kumar-investigation

March 10, 2025

DOJ Manipulates Malpractice Allegations to Fit Human Trafficking Narrative Against Mayo-Trained Gynecologic Oncologist

Despite Pam Bondi's explicit policy against "careerism," and “overcharging” Acting United States Attorney for the Western District of Tennessee, Reagan Taylor Fondren, appears to have done exactly that. Transforming what is essentially a malpractice allegation into a sensationalized sex trafficking indictment, AAG Fondren pursued gynecologist Dr. Sanjeev Kumar through an extensive multi-year investigation. Instead of bringing concrete allegations in a factually accurate indictment, she elected to use it as an instrument to inflame the passions of a vulnerable patient population.
Dr. Kumar faces an indictment primarily related to allegations of improperly sterilized instruments and billing disputes with insurance companies. However, the statements made by AAG Fondren to the media—intentionally portraying a respected physician as a predator—do not align with the actual charges outlined in the indictment. The allegations are also rebutted squarely by the Tennessee Medical board that cleared Dr. Kumar of wrongdoing in a September 17, 2024 letter. They are also rebutted by a Medicaid pre-payment audit that reviewed claims submissions prior to reimbursement.
The press release issued by the DOJ, laden with vague yet inflammatory allegation was deliberately designed to instill fear and distress in Dr. Kumar’s patient community. Dr. Kumar’s legal team, comprising Ronald W. Chapman II, former Assistant United States Attorney Maritsa Flahrety, and former United States Attorney Lawrence Laurenzi, issued a formal letter notifying the Department of Justice and AAG Fondren of the false nature of the allegations. In response, AAG Fondren removed all comments and quotations from the original press release but did not notify media outlets.
The DOJ employs such tactics because they are effective. Merely implying that a male gynecologist may be predatory is enough to traumatize and anger nearly all of his patients. AAG Fondren exploited this fear, issuing a press release in violation of DOJ ethical standards, labeling Dr. Kumar as “a predator in a white coat” and accusing him of abusing women. These allegations immediately captured widespread media attention, including coverage by the New York Times and virtually all Memphis news outlets.
The consequences of AAG Fondren’s actions were profound, causing unnecessary emotional trauma among vulnerable women by suggesting—without supporting evidence—that routine medical treatmentsconstituted abuse by a predatory physician. The provocative press release encouraged patients to come forward, leading over 200 women within 48 hours to contact a law firm advertising compensation for victims, thus creating an environment of panic and suspicion.
Notably, Dr. Kumar’s professional record remains impeccable. In fact, the Tennessee Department of Health (“TDOH”) launched a state investigation following the government’s execution of a search warrant at Dr. Kumar’s clinic in which the TDOH found insufficient evidence to support any allegations that Dr. Kumar was adulterating or misbranding hysteroscopes.
Dr. Sanjeev Kumar is one of only 300 specialists nationwide in gynecologic oncology and pelvic surgery. His clinical expertise covers critical conditions such as cervical cancer, endometrial cancer, ovarian cancer, pelvic masses and tumors, and vulvar and vaginal cancers. A highly regarded surgeon at the local hospitals, prior associate professor at the University of Tennessee and a Mayo Clinic-trained surgeon, Dr. Kumar has co-authored over 40 peer-reviewed publications and received numerous awards.
Despite his distinguished career and strong professional endorsements, the U.S. Attorney’s Office has alleged that Dr. Kumar sexually assaulted women through supposedly unnecessary medical tests. Such claims regarding medical necessity typically require expert medical opinion, which the prosecution notably lacks. The indictment does not cite any expert medical testimony backing the DOJ’s claims.
The specific procedures in question, such as hysteroscopy, are commonly performed for numerous medically justified reasons, including fertility issues, abnormal pap smears, uterine bleeding, endometriosis, miscarriages, removal of scar tissue, fibroids, polyps, and biopsies. Dr. Kumar’s treatments were consistently supported by appropriate medical diagnostics and referrals from respected primary care physicians nationwide.
Crucially, the indictment itself contains no allegations of sexual assault. Instead, it amounts to a payment disagreement between Dr. Kumar’s billing practices and what Medicare, Medicaid, and insurance providers agreed to reimburse.
https://www.chapmanlawgroup.com/wp-content/uploads/2025/03/Dr.-Sanjeev-Kumar-Case-Update-03.10.2025.pdf

June 26, 2025

Sanjeev Kumar Indictment 2

288KB ∙ PDF file

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October 17, 2025

The Ruling in Plain English
Prosecutors charged Dr. Kumar under a federal “Travel Act” theory that accused him of enticing patients to travel for “illegal sexual activity.” The Court held that “sexual activity” in this context means conduct done for sexual gratification—and the indictment didn’t even allege that. In the Court’s words, prosecutors cannot “stretch the law to fit the evil.”
Result: Counts 1–4 dismissed.
The government failed to specifically allege a date. The Court said that’s not allowed. On multiple FDA counts, prosecutors tried to roll thousands of patient procedures—into single counts. That’s called duplicity, and it risks a non‑unanimous verdict because different jurors might convict for different underlying acts.
Result: Counts 5–9, 12–13, 16–18, 21–22, and 25 dismissed as duplicitous.
About that pre‑trial publicity
From day one, the government’s press messaging put the focus on lurid allegations. In its February 28, 2025 press release, the DOJ announced salacious charges; later, DOJ retracted the comments and quotations it originally published on that page—without the splashy do‑over that accompanied the first round of publicity.
The FBI simultaneously published a “Seeking Victim Information” page—an investigative tool, yes, but also a public signal that can amplify fear and encourage pile‑on litigation. Federal Bureau of Investigation
On March 10, 2025, Dr. Kumar’s defense team put it in writing: the case had been “sensationalized,” transforming alleged sterilization/billing disputes into a sex‑trafficking narrative designed to inflame a vulnerable patient population.
Three weeks later, national reporting confirmed that Acting U.S. Attorney Reagan Taylor Fondren was fired by the White House, an unusual move for a career DOJ lawyer. The timing is noteworthy; the reason was never officially tied to this case. Correlation isn’t causation—but the sequence can’t be ignored. AP News
Today’s ruling strips away the most incendiary narrative. The Court’s analysis is careful, methodical, and rooted in strict construction of criminal statutes—not in press releases.
Bottom line: The Court agreed that prosecutors pushed the law too far on the most sensational charges and on the “mega‑count” FDA theories.
https://whitecollarcriminaldefense.com/insight/kumar-memphis-obgyn-federal-dismissal/

October 30, 2025

Sanjeev Kumar Indictment 3

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November 3, 2025

Amended Report Of Amy Garcia, M

788KB ∙ PDF file

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December 29, 2025

Jury Instructions Sanjeev Kumar Case 12

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12 procedures disputed by jury well documented indications in medical chart

12 Procedures Disputed By Jury Well Documented Indications In Medical Chart Redacted

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January 12, 2026

When the Department of Justice first announced charges against Dr. Sanjeev Kumar, a Mayo Clinic–trained gynecologic oncologist, government press releases implied predatory behavior, sexual abuse, and human trafficking. Those allegations dominated headlines and generated widespread fear among patients. Yet none of those accusations ever reached the jury. Months before trial, the court dismissed the Travel Act charges brought under 18 U.S.C. § 1952, finding them legally deficient. Still, the narrative they created endured long after the charges themselves disappeared.
By the time jurors were seated, the case had transformed into something far more technical and far more consequential for the medical community. The prosecution centered on allegations of healthcare fraud under 18 U.S.C. § 1347 and criminal enforcement of FDA adulteration and misbranding provisions under the Federal Food, Drug, and Cosmetic Act, specifically 21 U.S.C. §§ 331, 351, and 352. These statutes are historically enforced through civil or administrative processes, not felony prosecutions carrying the weight of prison sentences. The case thus became a defining example of an FDA adulteration criminal case pursued in the absence of patient injury.
https://whitecollarcriminaldefense.com/insight/after-dismissal-remaining-fda-charges-dr-sanjeev-kumar/

January 28, 2026

Consolidated Motion For Judgment Of Acquittal And Motion For New Trial With Incorporated Memorandum Of Law In Support

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March 9, 2026

Motion To Continue Sentencing Of Sanjeev Kumar

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March 26, 2026

Sanjeev Kumar granted Remmer Hearing

https://www.localmemphis.com/article/news/local/sanjeev-kumar-granted-remmer-hearing/522-4114c2ee-bf3e-4347-864a-27a0b8172ae9

Sanjeev Kumar Granted Remmer Hearing

Chief Judge Sheryl H. Lipman granted the Remmer Hearing — a hearing to determine whether a jury, or juror, was influenced by external sources — following a post-trial evidentiary hearing to determine whether there was sufficient evidence to warrant one. ABC24 is working to determine the context under which the Remmer Hearing was granted.
According to a motion to continue sentencing submitted on March 9 in a U.S. District Court for the Western District of Tennessee, “On Thursday, March 5, 2026, pursuant to the court’s order, the parties interviewed a juror concerning outside contacts with the jury during their deliberations. Based on the interview of the juror, Defendant intends to file a motion requesting a ‘Reemer’ hearing.”
https://www.yahoo.com/news/articles/sanjeev-kumar-granted-remmer-hearing-225755734.html

April 21, 2026

James Roguski

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COVER YOUR ASS

James Roguski — Sat, 23 May 2026 16:46:12 GMT

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Please read my article from over a year ago:

This document is scheduled to be published in the Federal Register on 2026-05-27 and available online at

https://www.federalregister.gov/d/2026-10539

https://public-inspection.federalregister.gov/2026-10539.pdf

Read the document, spread the word and comment below:

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I added the bold and large font emphases below.

[BILLING CODE: 4150-37-P]

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Office of the Secretary

Notice of Declaration Under the Public Readiness and Emergency Preparedness Act for Medical Countermeasures Against Andes Virus

AGENCY: Office of the Secretary, Department of Health and Human Services.

ACTION: Notice of declaration.

SUMMARY: The Secretary is issuing a Declaration pursuant to section 319F-3 of the Public Health Service Act (42 U.S.C. 247d-6d) to provide liability protection for activities related to medical countermeasures against Andes virus consistent with the terms of the Declaration.

DATES: This declaration is effective as of the date of signature.

FOR FURTHER INFORMATION CONTACT:

L. Paige Ezernack, Administration for Strategic Preparedness and Response, U.S. Department of Health and Human Services, 400 7th St SW, Washington, DC 20024; 202-260-0365, paige.ezernack@hhs.gov.

SUPPLEMENTARY INFORMATION: The Public Readiness and Emergency Preparedness (PREP) Act authorizes the Secretary of Health and Human Services (the Secretary) to issue a Declaration to provide liability immunity to certain individuals and entities (Covered Persons) against any claim of loss caused by, arising out of, relating to, or resulting from the manufacture, distribution, administration, or use of medical countermeasures (Covered Countermeasures), except for claims involving "willful misconduct" as defined in the PREP Act. Under the PREP Act, a Declaration may be amended as circumstances warrant. The PREP Act also creates a compensation program. Liability immunity is addressed in section 319F-3 of the Public Health Service (PHS) Act, 42 U.S.C. 247d-6d, and the compensation program is addressed in section 319F-4 of the PHS Act, 42 U.S.C. 247d-6e.

Andes virus is a type of hantavirus spread by rodents in South America and, less commonly, by other infected people. The rodents that carry Andes virus have not been found in the United States. It can cause a severe respiratory disease in people, called Hantavirus Pulmonary Syndrome (HPS). Andes virus is the only type of hantavirus that is known to spread person-to-person. This spread is usually limited to people who have close contact with a sick person. This includes direct physical contact, prolonged time spent in close or enclosed spaces, and exposure to the sick person's body fluids. HPS is a severe and potentially deadly disease that affects the lungs. HPS can be life threatening. Among patients who have severe respiratory symptoms, the case fatality rate has been estimated at approximately 38%. Symptoms of HPS caused by Andes virus usually appear within 4-42 days after exposure. Early symptoms can include fever, fatigue, and muscle aches, especially in large muscle groups like the thighs, hips, back, or shoulders. Early symptoms such as fever, headache, muscle aches, nausea, and fatigue can be easily confused with influenza or other viral illnesses. About half of all HPS patients have experienced headaches, dizziness, chills, and gastrointestinal symptoms, including nausea, vomiting, diarrhea, and abdominal pain. Late symptoms of HPS appear approximately 4-10 days after the initial phase of illness and can include coughing, shortness of breath, and chest tightness. Individuals are generally only infectious while symptomatic.

Currently, there are no available antiviral treatments or vaccines for HPS that are FDA approved, or authorized by FDA for investigational or emergency use.

On May 2, 2026, the World Health Organization (WHO) was notified of a cluster of severe acute respiratory illness (SARI) among passengers and crew of a cruise ship (the M/V Hondius) in the Atlantic Ocean. The cluster included two deaths and one critically ill passenger, whose laboratory tests confirmed hantavirus. On May 6, 2026, WHO confirmed that the type of hantavirus responsible for this outbreak is the Andes virus.

As of May 8, 2026, WHO has reported eight cases (six confirmed and two suspected), including three deaths. The cruise ship departed from Ushuaia, Argentina, on April 1, 2026, and traveled across the South Atlantic Ocean, stopping at several remote locations, including Antarctica, South Georgia Island, Tristan da Cunha, Saint Helena, and Ascension Island. It carried 147 people (86 passengers and 61 crew) from 23 different countries. The United States government repatriated 18 passengers from the cruise ship to the United States on May 10 and 11, 2026.

Section I, Determination of Public Health Emergency or Credible Risk of Future Public Health Emergency

Before issuing a Declaration under the PREP Act, the Secretary is required to determine that a disease or other health condition or threat to health constitutes a public health emergency or that there is a credible risk that the disease, condition, or threat may constitute such an emergency.

Accordingly, in Section I, the Secretary determines that the spread of Andes virus and the resulting disease HPS constitutes a credible risk of a public health emergency for purposes of this Declaration.

Section II, Factors Considered

In deciding whether and under what circumstances to issue a Declaration with respect to a Covered Countermeasure, the Secretary must consider the desirability of encouraging the design, development, clinical testing or investigation, manufacture, labeling, distribution, formulation, packaging, marketing, promotion, sale, purchase, donation, dispensing, prescribing, administration, licensing, and use of the countermeasure.

In Section II, the Secretary states that he has considered these factors.

Section III, Recommended Activities

The Secretary must recommend the activities for which the PREP Act's liability immunity is in effect.

These activities may include, under conditions as the Secretary may specify, the manufacture, testing, development, distribution, administration, or use of one or more Covered Countermeasures (Recommended Activities).

In Section III, the Secretary recommends activities for which the immunity is in effect.

Section IV, Liability Immunity

The Secretary must also state that liability protections available under the PREP Act are in effect with respect to the Recommended Activities. These liability protections provide that, "[s]ubject to other provisions of [the PREP Act], a covered person shall be immune from suit and liability under federal and state law with respect to all claims for loss caused by, arising out of, relating to, or resulting from the administration to or use by an individual of a covered countermeasure if a Declaration has been issued with respect to such countermeasure."

In Section IV, the Secretary states that liability protections are in effect with respect to the Recommended Activities.

Section V, Covered Persons

The PREP Act's liability immunity applies to "Covered Persons" with respect to administration or use of a Covered Countermeasure. The term "Covered Persons" has a specific meaning and is defined in the PREP Act to include manufacturers, distributors, program planners, and qualified persons, and their officials, agents, and employees, and the United States.

The PREP Act further defines the terms "manufacturer," "distributor," "program planner," and "qualified person" as described below.

A manufacturer includes a contractor or subcontractor of a manufacturer; a supplier or licenser of any product, intellectual property, service, research tool or component or other article used in the design, development, clinical testing, investigation or manufacturing of a Covered Countermeasure; and any or all the parents, subsidiaries, affiliates, successors, and assigns of a manufacturer.

A distributor means a person or entity engaged in the distribution of drugs, biologics, or devices, including but not limited to: manufacturers; re-packers; common carriers; contract carriers; air carriers; own-label distributors; private-label distributors; jobbers; brokers; warehouses and wholesale drug warehouses; independent wholesale drug traders; and retail pharmacies.

A program planner means a state or local government, including an Indian tribe; a person employed by the state or local government; or other person who supervises or administers a program with respect to the administration, dispensing, distribution, provision, or use of a Covered Countermeasure, including a person who establishes requirements, provides policy guidance, or supplies technical or scientific advice or assistance or provides a facility to administer or use a Covered Countermeasure in accordance with the Secretary's Declaration.

Under this definition, a private sector employer or community group or other "person" can be a program planner when it carries out the described activities.

A qualified person means a licensed health professional or other individual authorized to prescribe, administer, or dispense Covered Countermeasures under the law of the state in which the Covered Countermeasure was prescribed, administered, or dispensed; or a person within a category of persons identified as qualified in the Secretary's Declaration.

Under this definition, the Secretary can describe in the Declaration other qualified persons, such as volunteers, who are Covered Persons.

Section V describes other qualified persons covered by this Declaration.

The PREP Act also defines the word "person" as used in the Act:

A person includes an individual, partnership, corporation, association, entity, or public or private corporation, including a federal, state, or local government agency or department.

Section V describes Covered Persons under the Declaration, including Qualified Persons.

Section VI, Covered Countermeasures

As noted above, Section III describes the Secretary's Recommended Activities for which liability immunity is in effect. This section identifies the Covered Countermeasures for which the Secretary has recommended such activities.

The PREP Act states that a "Covered Countermeasure" must be: A "qualified pandemic or epidemic product," or a "security countermeasure," as described immediately below; or a drug, biological product or device authorized for emergency use in accordance with Sections 564, 564A, or 564B of the FD&C Act.

A qualified pandemic or epidemic product means a drug or device, as defined in the FD&C Act or a biological product, as defined in the PHS Act that is:

(i) Manufactured, used, designed, developed, modified, licensed or procured to diagnose, mitigate, prevent, treat, or cure a pandemic or epidemic or limit the harm such a pandemic or epidemic might otherwise cause;

(ii) manufactured, used, designed, developed, modified, licensed, or procured to diagnose, mitigate, prevent, treat, or cure a serious or life-threatening disease or condition caused by such a drug, biological product, or device;

(iii) or a product or technology intended to enhance the use or effect of such a drug, biological product, or device. A security countermeasure is a drug or device, as defined in the FD&C Act or a biological product, as defined in the PHS Act that:

(i)(a) The Secretary determines to be a priority to diagnose, mitigate, prevent, or treat harm from any biological, chemical, radiological, or nuclear agent identified as a material threat by the Secretary of Homeland Security, or

(b) to diagnose, mitigate, prevent, or treat harm from a condition that may result in adverse health consequences or death and may be caused by administering a drug, biological product, or device against such an agent; and

(ii) is determined by the Secretary of Health and Human Services to be a necessary countermeasure to protect public health.

To be a Covered Countermeasure, qualified pandemic or epidemic products or security countermeasures also must be approved or cleared under the FD&C Act; licensed under the PHS Act; or authorized for emergency use under Sections 564, 564A, or 564B of the FD&C Act.

A qualified pandemic or epidemic product also may be a Covered Countermeasure when it is subject to an exemption (that is, it is permitted to be used under an Investigational New Drug (IND) Application or an Investigational Device Exemption (IDE)) under the FD&C Act and is the object of research for possible use for diagnosis, mitigation, prevention, treatment, or cure, or to limit harm of a pandemic or epidemic or serious or life-threatening condition caused by such a drug or device.

A security countermeasure also may be a Covered Countermeasure if it may reasonably be determined to qualify for approval or licensing within 10 years after the Department's determination that procurement of the countermeasure is appropriate.

Section VI lists medical countermeasures against Andes virus and HPS that are Covered Countermeasures under this declaration.

Section VI also refers to the statutory definitions of Covered Countermeasures to make clear that these statutory definitions limit the scope of Covered Countermeasures. Specifically, the Declaration notes that Covered Countermeasures must be "qualified pandemic or epidemic products," or "security countermeasures," or drugs, biological products, or devices authorized for investigational or emergency use, as those terms are defined in the PREP Act, the FD&C Act, and the Public Health Service Act.

Section VII, Limitations on Distribution

The Secretary may specify that liability immunity is in effect only to Covered Countermeasures obtained through a particular means of distribution.

The Declaration states that liability immunity is afforded to Covered Persons for Recommended Activities related to Covered Countermeasures obtained for voluntary administration to individuals in accordance with an IND Application.

Section VIII, Category of Disease, Health Condition, or Threat

The Secretary must identify, for each Covered Countermeasure, the categories of diseases, health conditions, or threats to health for which the Secretary recommends the administration or use of the countermeasure.

In Section VIII, the Secretary states that the disease threat for which he recommends administration or use of the Covered Countermeasures is HPS caused by Andes virus.

Section IX, Administration of Covered Countermeasures

The PREP Act does not explicitly define the term "administration" but does assign the Secretary the responsibility to provide relevant conditions in the Declaration.

In Section IX, the Secretary defines "Administration of a Covered Countermeasure:" Administration of a Covered Countermeasure means physical provision of the countermeasures to recipients, or activities and decisions directly relating to public and private delivery, distribution, and dispensing of the countermeasures to recipients; management and operation of countermeasure programs; or management and operation of locations for purpose of distributing and dispensing countermeasures. The definition of "administration" extends only to physical provision of a countermeasure to a recipient, such as vaccination or handing drugs to patients, and to activities related to management and operation of programs and locations for providing countermeasures to recipients, such as decisions and actions involving security and queuing, but only insofar as those activities directly relate to the countermeasure activities.

Claims for which Covered Persons are provided immunity under the Act are losses caused by, arising out of, relating to, or resulting from the administration to or use by an individual of a Covered Countermeasure consistent with the terms of a Declaration issued under the Act.

Under the definition, these liability claims are precluded if they allege an injury caused by physical provision of a countermeasure to a recipient, or if the claims are directly due to conditions of delivery, distribution, dispensing, or management and operation of countermeasure programs at distribution and dispensing sites.

Thus, it is the Secretary's interpretation that, when a Declaration is in effect, the Act precludes, for example, liability claims alleging negligence by a manufacturer in creating a vaccine, or negligence by a health care provider in prescribing the wrong dose, absent willful misconduct.

Section X, Population

The Secretary must identify, for each Covered Countermeasure specified in a Declaration, the population or populations of individuals for which liability immunity is in effect with respect to administration or use of the countermeasure. This section explains which individuals should use the countermeasure or to whom the countermeasure should be administered--in short, those who should take a drug or other countermeasure.

Section X provides that the population includes "any individual who uses or who is administered a Covered Countermeasure in accordance with the Declaration."

In addition, the PREP Act specifies that liability immunity is afforded:

(1) To manufacturers and distributors without regard to whether the countermeasure is used by or administered to this population; and

(2) to program planners and qualified persons when the countermeasure is either used by or administered to this population or the program planner or qualified person reasonably could have believed the recipient was in this population. Section X includes these statutory conditions in the Declaration for clarity.

Section XI, Geographic Area

The Secretary must identify, for each Covered Countermeasure specified in the Declaration, the geographic area or areas for which liability immunity is in effect with respect to administration or use of the countermeasure, including, as appropriate, whether the Declaration applies only to individuals physically present in the area or, in addition, applies to individuals who have a described connection to the area.

Section XI provides that liability immunity is afforded for the administration or use of a Covered Countermeasure without geographic limitation.

This could include claims related to administration or use in countries outside the U.S. It is possible that claims may arise in regard to administration or use of the Covered Countermeasures outside the U.S. that may be resolved under U.S. law.

In addition, the PREP Act specifies that liability immunity is afforded:

(1) To manufacturers and distributors without regard to whether the countermeasure is used by or administered in the geographic areas; and

(2) to program planners and qualified persons when the countermeasure is either used or administered in the geographic areas or the program planner or qualified person reasonably could have believed the countermeasure was used or administered in the areas.

Section XI includes these statutory conditions in the Declaration for clarity.

Section XII, Effective Time Period

The Secretary must identify, for each Covered Countermeasure, the period or periods during which liability immunity is in effect, designated by dates, milestones, or other description of events, including factors specified in the PREP Act.

Section XII extends the effective period through July 18, 2026.

Section XIII, Additional Time Period of Coverage

The Secretary must specify a date after the ending date of the effective time period of the Declaration that is reasonable for manufacturers to arrange for disposition of the Covered Countermeasure, including return of the product to the manufacturer, and for other Covered Persons to take appropriate actions to limit administration or use of the Covered Countermeasure.

In addition, the PREP Act specifies that for Covered Countermeasures that are subject to a Declaration at the time they are obtained for the Strategic National Stockpile (SNS) under 42 U.S.C. 247d-6b(a), the effective period of the Declaration extends through the time the countermeasure is used or administered pursuant to a distribution or release from the stockpile. Liability immunity under the provisions of the PREP Act and the conditions of the Declaration continues during these additional time periods. Thus, liability immunity is afforded during the "Effective Time Period," described under XII of the Declaration, plus the "Additional Time Period" described under Section XIII of the Declaration.

Section XIII provides for one month as the additional time period of coverage after expiration of the Declaration.

Section XIII also explains the extended coverage that applies to any products obtained for the SNS during the effective period of the Declaration.

Section XIV, Countermeasures Injury Compensation Program

Section 319F-4 of the PHS Act, 42 U.S.C. 247d-6e, authorizes the Countermeasures Injury Compensation Program (CICP) to provide benefits to eligible individuals who sustain a serious physical injury or die as a direct result of the administration or use of a Covered Countermeasure.

Compensation under the CICP for an injury directly caused by a Covered Countermeasure is based on the requirements set forth in this Declaration, the administrative rules for the Program, and the statute.

To show direct causation between a Covered Countermeasure and a serious physical injury, the statute requires "compelling, reliable, valid, medical and scientific evidence." The administrative rules for the Program further explain the necessary requirements for eligibility under the CICP. Further, the administrative rules for the CICP specify that if countermeasures are administered or used outside the United States, only otherwise eligible individuals at United States embassies, military installations abroad (such as military bases, ships, and camps) or at North Atlantic Treaty Organization (NATO) installations (subject to the NATO Status of Forces Agreement) where American servicemen and servicewomen are stationed may be considered for CICP benefits. Other individuals outside the United States may not be eligible for CICP benefits.

Section XV, Amendments

The Secretary may amend any portion of this Declaration through publication in the Federal Register.

Declaration by the Secretary of Health and Human Services

I. Determination of Public Health Emergency or Credible Risk of Future Public Health Emergency 42 U.S.C. 247d-6d(b)(1) I have determined that the spread of Andes virus and the resulting disease, hantavirus pulmonary syndrome (HPS), constitutes a credible risk of a future public health emergency.

II. Factors Considered 42 U.S.C. 247d-6d(b)(6) I have considered the desirability of encouraging the design, development, clinical testing, or investigation, manufacture, labeling, distribution, formulation, packaging, marketing, promotion, sale, purchase, donation, dispensing, prescribing, administration, licensing, and use of the Covered Countermeasures.

III. Recommended Activities 42 U.S.C. 247d-6d(b)(1) I recommend, under the conditions stated in this Declaration, the manufacture, testing, development, distribution, and voluntary administration and use of the Covered Countermeasures in individuals possibly exposed to Andes virus on the M/V Hondius and in individuals who have had close contact with individuals possibly exposed to Andes virus on the M/V Hondius.

IV. Liability Protections 42 U.S.C. 247d-6d(a), 247d-6d(b)(1) Liability protections as prescribed in the PREP Act and conditions stated in this Declaration are in effect for the Recommended Activities described in Section III.

V. Covered Persons 42 U.S.C. 247d-6d(i)(2), (3), (4), (6), (8)(A) and (B) Covered Persons who are afforded liability immunity under this Declaration are "manufacturers," "distributors," "program planners," "qualified persons," and their officials, agents, and employees, as those terms are defined in the PREP Act, and the United States. "Qualified person" includes

(A) a licensed health professional or other individual who is authorized to prescribe, administer, or dispense such countermeasures under the law of the State in which the countermeasure was prescribed, administered, or dispensed; or

(B) "a person within a category of persons so identified in a Declaration by the Secretary" under subsection (b) of the PREP Act. 42 U.S.C. 247d-6d(i)(8)

VI. Covered Countermeasures 42 U.S.C. 247d-6b(c)(1)(B), 247d-6d(i)(1) and (7) Covered Countermeasures are favipiravir. [link added]

Covered Countermeasures must be "qualified pandemic or epidemic products," or "security countermeasures," or drugs, biological products, or devices authorized for investigational or emergency use, as those terms are defined in the PREP Act, the FD&C Act, and the PHS Act.

VII. Limitations on Distribution 42 U.S.C. 247d-6d(a)(5), 247d-6d(b)(2)(E) I have determined that liability protections are afforded to Covered Persons only for Recommended Activities involving: Covered Countermeasures that are obtained for voluntary administration to individuals in accordance with an approved IND application. I have also determined that, for governmental program planners only, liability protections are afforded only to the extent such program planners obtain Covered Countermeasures through voluntary means, such as (a) donation; (b) commercial sale; (c) deployment of Covered Countermeasures from federal stockpiles; or (d) deployment of donated, purchased, or otherwise voluntarily obtained Covered Countermeasures from state, local, or private stockpiles and perform emergency response functions in accordance with the PREP Act and this Declaration.

VIII. Category of Disease, Health Condition, or Threat 42 U.S.C. 247d-6d(b)(2)(A) The category of disease, health condition, or threat for which I recommend the administration or use of the Covered Countermeasures is HPS caused by the Andes virus.

IX. Administration of Covered Countermeasures 42 U.S.C. 247d-6d(a)(2)(B) Administration of the Covered Countermeasure means physical provision of the countermeasures to recipients, or activities and decisions directly relating to public and private delivery, distribution and dispensing of the countermeasures to recipients, management and operation of countermeasure programs, or management and operation of locations for the purpose of distributing and dispensing countermeasures.

X. Population 42 U.S.C. 247d-6d(a)(4), 247d-6d(b)(2)(C) The populations of individuals to whom the liability protections of this Declaration extend include any individual (regardless of age) who uses or is administered the Covered Countermeasures in accordance with this Declaration. Liability protections are afforded to manufacturers and distributors without regard to whether the countermeasure is used by or administered to this population; liability protections are afforded to program planners and qualified persons when the countermeasure is used by or administered to this population, or the program planner or qualified person reasonably could have believed the recipient was in this population.

XI. Geographic Area 42 U.S.C. 247d-6d(a)(4), 247d-6d(b)(2)(D) Liability protections are afforded for the administration or use of a Covered Countermeasure without geographic limitation. Liability protections are afforded to manufacturers and distributors without regard to whether the Covered Countermeasure is used by or administered in any designated geographic area; liability protections are afforded to program planners and qualified persons when the countermeasure is used by or administered in any designated geographic area, or the program planner or qualified person reasonably could have believed the recipient was in that geographic area.

XII. Effective Period 42 U.S.C. 247d-6d(b)(2)(B) Liability immunity for Covered Countermeasures extends through July 18, 2026.

XIII. Additional Period of Coverage 42 U.S.C. 247d-6d(b)(3)(B), 247d-6d(b)(3)(C) I have determined that an additional one month of liability protection is reasonable to allow for the manufacturer(s) to arrange for disposition of the Covered Countermeasure, including return of the Covered Countermeasures to the manufacturer, and for Covered Persons to take such other actions as are appropriate to limit the administration or use of the Covered Countermeasures. Covered Countermeasures obtained for the SNS during the effective period of this Declaration are covered through the date of administration or use pursuant to a distribution or release from the SNS.

XIV. Countermeasures Injury Compensation Program 42 U.S.C. 247d-6e The PREP Act authorizes the Countermeasures Injury Compensation Program (CICP) to provide benefits to certain individuals or estates of individuals who sustain a covered serious physical injury as a direct result of the administration or use of the Covered Countermeasures, and benefits to certain survivors of individuals who die as a direct result of the administration or use of the Covered Countermeasures. The causal connection between the countermeasure and the serious physical injury must be supported by compelling, reliable, valid, medical, and scientific evidence in order for the individual to be considered for compensation. The CICP is administered by the Health Resources and Services Administration, within the U.S. Department of Health and Human Services. Information about the CICP is available at the toll-free number 1-855- 266-2427 or http://www.hrsa.gov/cicp/.

XV. Amendments 42 U.S.C. 247d-6d(b)(4) Amendments to this Declaration will be published in the Federal Register, as needed. Authority: 42 U.S.C. 247d-6d. Robert F. Kennedy Jr., Secretary of Health and Human Services. [FR Doc. 2026-10539 Filed: 5/22/2026 4:15 pm; Publication Date: 5/27/2026]

Antiviral Efficacy of Favipiravir against Two Prominent Etiological Agents of Hantavirus Pulmonary Syndrome | Antimicrobial Agents and Chemotherapy

https://journals.asm.org/doi/10.1128/aac.00886-13

https://journals.asm.org/doi/pdf/10.1128/aac.00886-13

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The WHO Has Declared a New PHEIC

James Roguski — Sun, 17 May 2026 02:53:53 GMT

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The following statement was released by the World Health Organization:

Tedros Adhanom Ghebreyesus, the Director-General of the World Health Organization (WHO) has determined that the Ebola disease caused by Bundibugyo virus (Bundibugyo is a town in the Western Region of Uganda. It is the chief town of Bundibugyo District) in the Democratic Republic of the Congo and Uganda constitutes a public health emergency of international concern (PHEIC), but does not meet the criteria of pandemic emergency, as defined in the International Health Regulations.

As of 16 May 2026, eight laboratory-confirmed cases, 246 suspected cases and 80 suspected deaths have been reported in Ituri Province of the Democratic Republic of the Congo across at least three health zones, including Bunia, Rwampara and Mongbwalu.
In addition, two laboratory confirmed cases (including one death) with no apparent link to each other have been reported in Kampala, Uganda, within 24 hours of each other, on 15 and 16 May 2026, among two individuals travelling from the Democratic Republic of the Congo.
On 16 May, a laboratory confirmed case has also been reported in Kinshasa, the Democratic Republic of the Congo, among someone returning from Ituri.

Unusual clusters of community deaths with symptoms compatible with Bundibugyo virus disease (BVD) have been reported across several health zones in Ituri, and suspected cases have been reported across Ituri and North Kivu.
In addition, at least four deaths among healthcare workers in a clinical context suggestive of viral haemorrhagic fever have been reported from the affected area raising concerns regarding healthcare-associated transmission, gaps in infection prevention and control measures, and the potential for amplification within health facilities.

There are significant uncertainties to the true number of infected persons and geographic spread associated with this event at the present time. In addition, there is limited understanding of the epidemiological links with known or suspected cases.

However, the high positivity rate of the initial samples collected (with eight positives among 13 samples collected in various areas), the confirmation of cases in both Kampala and Kinshasa, the increasing trends in syndromic reporting of suspected cases and clusters of deaths across the province of Ituri all point towards a potentially much larger outbreak than what is currently being detected and reported, with significant local and regional risk of spread.
Moreover, the ongoing insecurity, humanitarian crisis, high population mobility, the urban or semi-urban nature of the current hotspot and the large network of informal healthcare facilities further compound the risk of spread, as was witnessed during the large Ebola virus disease epidemic in North Kivu and Ituri provinces in 2018-19.
However, unlike for Ebola-Zaire strains, there are currently no approved Bundibugyo virus-specific therapeutics or vaccines. As such, this event is considered extraordinary.

The event constitutes a public health risk to other States Parties through the international spread of disease. International spread has already been documented, with two confirmed cases reported in Kampala, Uganda on 15 and 16 May following travel from the Democratic Republic of the Congo. Both confirmed cases were admitted to intensive care units in Kampala. Neighboring countries sharing land borders with the Democratic Republic of the Congo are considered at high risk for further spread due to population mobility, trade and travel linkages, and ongoing epidemiological uncertainty.

The event requires international coordination and cooperation to understand the extent of the outbreak, to coordinate surveillance, prevention and response efforts, to scale up and strengthen operations and ensure ability to implement control measures.

The Director-General of WHO, under the provisions of the IHR, will be convening an Emergency Committee, as soon as possible to advise, inter alia, on the proposed temporary recommendation for States Parties to respond to the event.

SOURCE:

https://www.who.int/news/item/17-05-2026-epidemic-of-ebola-disease-in-the-democratic-republic-of-the-congo-and-uganda-determined-a-public-health-emergency-of-international-concern

I certainly do not mean to be insensitive in any way to those in the affected areas who are dealing with health challenges.

It’s just that the International Health Regulation’s definition of a “PHEIC” leaves a lot to be desired:

https://apps.who.int/gb/bd/pdf_files/IHR_2014-2022-2024-en.pdf (page 5)

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Blocking the Sun with Amorphous Silica

James Roguski — Sat, 16 May 2026 17:23:21 GMT

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Please watch the video below:

If you would like to have a respectful discussion regarding this issue, help work on possible solutions, and organize opposition against this insane proposal, then please feel free to contact me directly anytime at 310-619-3055 (phone, text, Signal, Telegram or WhatsApp) or James.Roguski@gmail.com

WARNING!

Every second that we spend thinking and talking about this obviously absurd proposal, and every ounce of energy that we exert attempting to prevent it from happening, and every dollar that anyone donates to grifters who tell you that they will fight to help prevent it from happening is time, energy and money that will be diverted away from actually addressing and solving the real problems that we need to solve.

By all means…

Fight this insane proposal with all your might.

Mock it. Shame it. Be absolutely merciless.

Turn it into the laughingstock that it deserves to be.

Meme it into submission.

DESTROY THIS INSANE IDEA

BUT DO IT HARD AND DO IT FAST

AND THEN MOVE ON ASAP

TO WHAT REALLY NEEDS TO BE DONE

We need to stop this latest insanity with the full knowledge that what they are really hoping to accomplish is DISTRACTION.

This is actually an opportunity to show these bastards just how powerful “We the People” truly are.

This is an opportunity for all of us to come together, unite our forces and work together as one.

This proposal is actually a very sophisticated false flag.

Yes, they might actually try to spray 22 billion pounds of “amorphous silica” into the stratosphere on an annual basis, but what they actually seek to do is to distract everyone from doing what really needs to be done.

StardustSRT’s proposal is designed to distract you from the truth.

Don’t fall for it.

Use it as THE opportunity to unite against our common enemy!

THIS PROPOSAL IS OBVIOUSLY INSANE

Stardust’s proposal to spray 22 billion pounds (10 million metric tons) of amorphous silica into the stratosphere on a yearly basis in order to cool the Earth by reflecting sunlight will OBVIOUSLY cause adverse side effects.

Because the climate system is deeply interconnected, this massive deployment would trigger major, often unpredictable, shifts in weather patterns globally.

The effects on weather and the environment could be expected to include:

Disrupted Rainfall and Monsoon Patterns

This proposal will obviously result in severe regional disruptions to the hydrological cycle.

The shifting of atmospheric circulation would trigger devastating droughts and excessive flooding in different parts of the world, jeopardizing agricultural output and food security.

Stratospheric Warming:

While reflecting sunlight cools the surface of the Earth, absorbing solar radiation can also locally heat the stratosphere, potentially changing global winds like the jet stream and polar vortexes.

Ozone Layer Risks:

Introducing foreign particulate matter into the stratosphere risks triggering chemical reactions that deplete the Earth’s vital ozone layer, similar to the effects caused by sulfur-based geoengineering.

The “Termination Effect”:

If an annual injection program were abruptly halted, the rapid rebound of trapped greenhouse gases could cause global temperatures and precipitation to spike violently, at rates 5 to 10 times faster than gradual climate change.

The text below is a collection of excerpts from the proposed feasibility study to spray up to 22 billion pounds of amorphous silica into the stratosphere to block 1% of the sun’s rays in an attempt to cool the planet.

A feasibility study is presented for scaling up manufacturing of Submicronic Engineered Amorphous Silica Particles.
The goal of this study is to evaluate the feasibility of large-scale manufacturing of engineered amorphous silica particles for Stratospheric Aerosol Injection deployment, encompassing cost, timeline, and identification of key risks and mitigation strategies.
It is assessed that scaling up manufacturing from the current specialty chemical scale of 0.1 kt/yr to a single module of 250 kt/yr [551,155,655 - half a billion pounds] is expected to be completed within approximately five years [approximately 2031].
Plant replication of the 250 kt/yr module to regional hub manufacturing at a climate-relevant scale of 1 Mt/yr [2.2 billion pounds], sufficient to offset a significant fraction of decadal warming, is expected to be completed within two additional years [approximately 2033].
An outlook is provided for further expansion toward climate-scale 10 Mt/yr [22 billion pounds/year] manufacturing capacity, required for approximately 1% solar-flux modification. This climate-scale capacity is expected to be based on replicating the regional 1 Mt/yr hubs.
Unit economics of approximately USD $5/kg [$2.27/pound], dominated primarily by raw-material costs, appear plausible, with further reductions possible through process optimization, solvent recycling, continuous operation, and precursor-route improvements.
The most widely discussed Solar Radiation Management approach is Stratospheric Aerosol Injection, in which aerosols or aerosol precursors are introduced into the stratosphere to increase the reflection of incoming solar radiation. By increasing Earth’s reflectivity, Stratospheric Aerosol Injection could in principle reduce near-term warming and some associated climate impacts.
Illustrative images of the produced particles and synthesis route are shown in Figure 1. These images, alongside the companion studies, illustrate the fact that the present work is focused on scaling up a viable particle-production route, rather than a purely conceptual material system.
A key question is whether submicronic [that means nanoparticles] engineered amorphous silica particles (SEASP) can be manufactured at scale.
The objective is not to introduce a new particle chemistry, but to assess how existing small-volume Stober sol-gel silica manufacturing capability, currently on theorder of 0.1 kt/yr, can be expanded to climate-relevant rates of 1 Mt/yr and ultimately to climate-scale manufacturing of 10 Mt/yr. The former corresponds to an annual deployment required to offset a significant fraction of decadal warming. The latter [22 billion pounds per year] corresponds approximately to the annual deployment required for 1% solar-flux modification, subject to particle efficacy, residence time, and deployment assumptions.

Amorphous silica:

This single-module scale may be replicated to establish the 1 Mt/yr level (“climate-relevant scale”). Reaching this manufacturing capacity is expected within approximately two additional years, and a total of approximately seven years from launching the project.
Once 1 Mt/yr [2.2 billion pounds/year] manufacturing capability has been demonstrated, this research provides an outlook in which ramping manufacturing toward full climate-scale capability of approximately 10 Mt/yr [22 billion pounds/year] would be primarily a matter of coordinated and gradual replication of 1 Mt/yr [2.2 billion pounds/year] regional hubs.
Construction of each of these additional 1 Mt/yr [2.2 billion pounds/year] regional hubs is expected to take two or three years, and the limiting factors at this stage are expected to be capital deployment, project execution, infrastructure, precursor-supply coordination, and industrial partnering, rather than unresolved technical barriers in the SEASP manufacturing process.
Particle manufacturing at the relevant scale is only one aspect of Stratospheric Aerosol Injection scale-up. Atmospheric testing and any potential future deployment would also require parallel scale-up of the aircraft fleet to the relevant capacity, as well as scale-up of dispersion hardware and operational logistics. The present work focuses solely on the SEASP particle manufacturing track.
Scope and limitations: This paper assesses whether SEASP can be manufactured at climate-scale SAI quantities using known chemistry and available raw materials.
The decisions about whether to deploy Stratospheric Aerosol Injection sit with governments and the international community; this paper supplies one input they will need.
Full validation of any Stratospheric Aerosol Injection system towards potential deployment - particle performance, atmospheric behavior, and safety aspects - lies outside the scope of this work.

Feasibility Study For Industrial Scale Submicronic Engineered Amorphous Silica Particle Manufacturing For Stratospheric Aerosol Injection

5.9MB ∙ PDF file

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Over the past few years, the company “Stardust” has referred to themselves by a number of different names and they have utilized a number of different domain names. Previously, they were “Stardust-Initiative” and “StardustSolutions.”

They are currently using the following domain name:

StardustSRT.com

SRT = Sunlight Reflection Technology

SHARE YOUR OPINION WITH THEM DIRECTLY:

https://StardustSRT.com/contact-us

or…

press@stardust-initiative.com

If you would like to have a respectful discussion regarding this issue, help work on possible solutions, and organize opposition against this insane proposal, then please feel free to contact me directly anytime at 310-619-3055 (phone, text, Signal, Telegram or WhatsApp) or James.Roguski@gmail.com

James Roguski

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Drop The Case

James Roguski — Thu, 14 May 2026 03:53:00 GMT

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PLEASE WATCH THE VIDEO BELOW (VERY IMPORTANT!)

The first half of the video below describes the heroic work that Dr. Elfenbein did during COVID-19. The second half of the video is a discussion of the ongoing court case filed against him by the federal government. Please watch the entire video.

Backup videos:

YouTube: https://www.youtube.com/watch?v=K-_2il2CjpM

Rumble: https://rumble.com/v79tphy-drop-the-case.html

SHARE THIS ARTICLE FAR AND WIDE:

This is a very comprehensive article. I encourage you to take the time to explore it thoroughly.

I believe that once you fully understand the details of what the Biden administration’s Justice Department did to Dr. Ron Elfenbein and what the Trump Administration’s Justice Department is currently doing to Dr. Ron Elfenbein, then you too will feel compelled to make sure that millions of Americans know what their government is capable of doing to each and every one of us.

This outrageous abuse of power by unelected government bureaucrats must stop, and IT MUST STOP NOW!

TELL EVERYONE YOU POSSIBLY CAN ABOUT THIS MISCARRIAGE OF JUSTICE

Your silence on this matter amounts to your consent.

Please share this information with every judge, every lawyer, every government official, every member of the media, every member of your family, all of your friends, all of your social media contacts and everyone else that you can possibly imagine.

Please share this article far and wide:

DropTheCase.com

X @RonElfenbeinMD | TruthSocial

CLICK HERE TO DONATE TO DR. ELFENBEIN’S LEGAL DEFENSE

Below is a brief summary of Dr. Ron Elfenbein’s case:

The United States federal government (The Trump Administration’s Department of Justice) is pursuing criminal charges against Dr. Ron Elfenbein (for a second time) based on a dispute over the COVID-19 related billing codes that his company submitted to the government in regards to the services provided to just 5 patients.

Dr. Ron Elfenbein did NOT personally interact with the 5 patients. Dr. Elfenbein worked at multiple emergency rooms throughout Maryland and Delaware during the pandemic. The patients were seen by appropriate health professionals that Dr. Elfenbein set up and managed during the COVID-19 pandemic.

Background: There are five levels at which the services provided could have been coded (1 through 5, with 1 being the least amount and 5 being the highest amount).

The services provided to the 5 patients were all coded at level 4. The government has suggested at various points that the services should have been billed at level 3 or level 2. It also argued during Dr. Elfenbein’s trial and again in a post trial briefing that level 1 may have been the proper code (even though Level one no longer exists and is automatically excluded once a medical provider sees the patient).

The Federal government filed charges without having actually seen the medical records associated with the 5 patients. They did not have any way of determining whether or not the services were properly coded.

If the government is still unsure of, and cannot articulate, the proper level at which the services should have been coded, what justification could they possibly have for charging Dr. Elfenbein with a crime? At the very worst, this is a billing dispute that could (and should) have easily been settled via negotiation. This case barely qualifies to be heard in small claims court.

The financial dispute amounts to a total of approximately $250 (~50 for each of the five patients). In the first trial, the United States government sought up to 50 years imprisonment and millions of dollars in penalties.

Dr. Elfenbein performed over 5,000 infusions of monoclonal antibodies at the request of federal health officials and saved hundreds of lives and millions of dollars.

On December 29, 2021, Dr. Elfenbein publicly criticized the Biden administration’s decision to pull monoclonal antibodies.

Dr. Elfenbein was indicted on April 19, 2022 .

On December 1, 2023, the trial judge entered a judgment of acquittal in a 93-page opinion.

CLICK HERE to read the judge’s decision.

The Federal government appealed the decision made by Judge Bredar and won, so Judge Bredar’s acquittal was overturned.

In late 2024, the Biden Administration Department of Justice appealed the ruling and a new trial is set for August 2026.

Download the PDF below which is an executive summary as well as a letter to President Donald Trump:

Executive Summary

58.2KB ∙ PDF file

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YOU CAN HELP!

Please watch the video below:

Copy the text of the letter below and send it via email, or print the PDF and send the letter via CERTIFIED MAIL to the government officials listed below the letter:

Everything is digital these days. You can check online to see when the certified mail that you send has been received.

SEND THIS LETTER/EMAIL (See customized PDFs below):

I am writing to respectfully urge the Department of Justice to dismiss the case against Dr. Ron Elfenbein [United States v. Ron Elfenbein, No. 1:22-cr-00146/ JKB-22-0146] with prejudice in the interests of justice, fairness, proportionality, and public confidence in the integrity of the legal system.

This case represents an extraordinary miscarriage of justice arising from a highly technical medical coding dispute involving fewer than $500 in alleged overbilling related to five patient claims during the COVID-19 pandemic. Despite the relatively minor amount in dispute, Dr. Elfenbein has faced years of prosecution, financial devastation, reputational harm, and the possibility of 50 years in prison and millions of dollars in penalties.

Dr. Elfenbein is NOT accused of inventing fake patients, billing for services never rendered, or causing patient harm. The patients were real. The medical services were real and were administered in the context of a public health emergency and global pandemic. The dispute centers on whether one CPT billing level was appropriate during an unprecedented public health emergency in which coding guidance was rapidly evolving and widely acknowledged to be ambiguous (and in a lexicon of over 69,000 possible codes).

This whole case appears to be one of retaliation by a weaponized Biden-era Department of Justice plain and simple. Dr. Elfenbein publicly questioned the narrative and spoke ill of the Biden Administration’s handling of the pandemic response. It also appears that no other physician has been prosecuted for what he is being prosecuted for, making this appear as both vindictive and selective. In fact, the coding supposedly at issue in this case was used by a great many other clinics for the same encounter types and so-called “level 4” (at issue in this case) is the most common code used for established patients nationwide. Yet, the government chose to pursue criminal charges despite KNOWING the aforementioned relevant facts. The billing argument makes no sense; the selective and vindictive prosecution does.

Importantly, the presiding judge, former Chief Federal Judge James Bredar, issued a detailed 93-page opinion (see link below) acquitting Dr. Elfenbein and granting a new trial in case of appeal, and finding that the government failed to provide sufficient evidence to prove that the coding used was false or fraudulent. He even went so far as to state that “no reasonable jury” could have found guilt and that “the evidence weighs so heavily in favor of the defendant it would be unjust to enter judgment against him.” Even the appellate court characterized the case as “close”, classified Dr. Elfenbein’s reading of the relevant rules as “reasonable,” and classified the evidence against him as “thin”, while still allowing a retrial.

This prolonged prosecution has already imposed enormous punishment on Dr. Elfenbein and his family. Continued prosecution would not advance justice, protect patients, or preserve public trust. Instead, it risks reinforcing the perception that prosecutorial discretion has been exercised in a disproportionate and fundamentally unfair manner.

The following points raise serious concerns regarding fairness, due process, and proportionality:

Miscarriages of Justice:

Concerns abound that Dr. Elfenbein was targeted by the Biden DOJ after
publicly criticizing federal COVID policies and speaking on national media
outlets.
Charges were reportedly filed before prosecutors reviewed the relevant patient charts.
The 5 relevant charts were never reviewed by a professional coder
5 total charts were reviewed (again not by a professional with relevant billing and coding experience), out of over 100,000 seen during the time frame of the indictment
The alleged billing discrepancy amounted to approximately $50 per patient claim, or less than $500 total (the difference between a “level 4” and” level 3” is, on average, $50).
Dr. Elfenbein faces the possibility of up to 50 years in prison and millions of dollars in penalties over a highly technical coding dispute.
The government failed to clearly identify what the “correct” billing code should have been or why or how Dr. Elfenbein’s guidance was incorrect
The Government never made any attempt to reach out to Dr. Elfenbein for clarification/explanation PRIOR to indictment. The timing seems to imply the government sought headlines with the new Biden-appointed US attorney Erik Barron just taking office, and the Biden DOJ “Covid Task Force” making a big announcement/press release
Multiple qualified medical coding experts reportedly concluded that Dr. Elfenbein’s coding recommendations were reasonable and supported by applicable guidance.
The government’s own expert witness lacked familiarity with important CMS pandemic-era guidance and was heavily impeached during trial testimony. This witness also testified in direct opposition to a central tenet of the indictment regarding time as a factor in coding decisions.
The presiding Chief Judge granted a judgment of acquittal in a lengthy opinion, finding insufficient evidence to support a conviction.
The court criticized the prosecution as resembling a “shoot first and ask questions later” approach.
No evidence has been presented that services were not performed, that patients were fictitious, or that patient harm occurred.
The prosecution abandoned any claim that the medical services themselves were unnecessary (despite this being in the indictment) .
The American Medical Association filed an amicus brief in support of Dr. Elfenbein, and as the “writer of the rules” the government is accusing Dr. Elfenbein of breaking, their support for him is quite remarkable. Further, the AMA brief expressed concern that prosecutions of this nature could create a chilling effect on physicians.
This prosecution will make doctors not want to ever exercise autonomy
and question the “narrative” and will disincentivize them from ever
stepping up to do the right thing to help fight the next pandemic.
The case has been described by observers as highly unusual compared with traditional healthcare fraud prosecutions involving fabricated services, kickbacks, or medically unnecessary procedures.
The coding guidance at issue was given during the unprecedented COVID-19 emergency and has been widely described as ambiguous and constantly evolving (even by BOTH the district and appellate courts).
Dr. Elfenbein was a frontline physician who operated major COVID 19 testing and monoclonal antibody treatment programs in coordination with government agencies during the pandemic. His company partnered with HHS and the Maryland Dept of Health, at the request of the US gov’t, in the monoclonal treatment center in Landover, MD.
Dr. Elfenbein was named “Person of the Year” by the Maryland State Medical Society—even after being indicted!
The prosecution has already caused severe professional, financial, emotional, and reputational damage to Dr. Elfenbein and his family over the course of several years.

Dr. Elfenbein dedicated himself to public service during one of the most difficult public health emergencies in modern history. The available materials portray a physician who stepped forward during a national crisis, worked closely with public agencies, and attempted in good faith to navigate confusing and evolving billing guidance while treating large numbers of patients under extraordinary conditions.

Reasonable disagreements over technical coding interpretations should not become the basis for life-destroying criminal prosecutions absent clear evidence of intentional fraud. The interests of justice would be best served by bringing this matter to a close.

I respectfully urge the Department of Justice to dismiss the case against Dr. Ron Elfenbein and end this prolonged ordeal for him and his family.

Respectfully submitted,

Judge James K. Bredar’s 93 page decision:

https://www.govinfo.gov/content/pkg/USCOURTS-mdd-1_22-cr-00146/pdf/USCOURTS-mdd-1_22-cr-00146-0.pdf

President Donald J. Trump

https://trumpwhitehouse.archives.gov/get-involved/write-or-call/

The White House
1600 Pennsylvania Avenue NW
Washington, DC 20500

Please print out the PDF below, customize it if you wish (see text above), sign it and send it to the above address via certified mail:

Letter To President Donald Trump In Support Of Dr Ron Elfenbein

57.5KB ∙ PDF file

Download

Acting U.S. Attorney General Todd Blanche

Todd Blanche

Acting Attorney General

United States Department of Justice

950 Pennsylvania Avenue, NW

Washington, D.C. 20530

Please print out the PDF below, customize it if you wish (see text above), sign it and send it to the above address via certified mail:

Letter To Todd Blanche Acting Attorney General In Support Of Dr Ron Elfenbein

58.1KB ∙ PDF file

Download

Kelly Hayes

United States Attorney

District of Maryland

36 South Charles Street

Baltimore, Maryland 21201

Kelly.Hayes@usdoj.gov

Please print out the PDF below, customize it if you wish (see text above), sign it and send it to the above address via certified mail:

Letter To Kelly Hayes United States Attorney District Of Maryland In Support Of Dr Ron Elfenbein

57.9KB ∙ PDF file

Download

Lorinda Laryea

Permanent Chief Criminal Fraud Section

Department of Justice

950 Pennsylvania Avenue, NW

Washington, DC 20530

Lorinda.Laryea@usdoj.gov

Please print out the PDF below, customize it if you wish (see text above), sign it and send it to the above address via certified mail:

Letter To Lorinda Laryea Permanent Chief Of The Criminal Fraud Section Department Of Justice In Support Of Dr Ron Elfenbein

58.6KB ∙ PDF file

Download

Please also sign the petition below to ask U.S. Attorney General Todd Blanche (in the Trump Administration’s Department of Justice) to dismiss the Biden-era weaponized charges against Dr. Ron Elfenbein.

ALSO:

Call the Department of Justice at 202-514-2000 and ask to leave a message for the Office of the Attorney General (Tod Blanche) regarding [United States v. Ron Elfenbein, No. 1:22-cr-00146/ JKB-22-0146], urging dismissal of the case before the August 2026 trial.

https://www.votervoice.net/AUTISMACTION/Campaigns/136852/Respond

Share this article with family, friends, news media, INFLUENCERS, colleagues, physicians, clergy and your social networks.

My name is Dr. Ron Elfenbein, and I’m an emergency physician. My whole career has been about running toward crises, not away from them. When COVID-19 hit, I did what responsible doctors do: I built testing sites and set up monoclonal antibody clinics to get lifesaving treatment to people who had nowhere else to turn. The clinic we built at FedEx Field, in partnership with the federal and Maryland state governments, treated thousands of Marylanders who otherwise would have gone without care.
Then I made the mistake of telling the truth on television and in print media.
In December 2021 I spoke to Fox News and went on Newsmax and said what I believed: the Biden Administration’s decision to halt monoclonal antibody treatments was wrong, the reasoning was politically motivated, and people were going to die because of it. I said it because it was true and because I’m a doctor and staying silent felt like its own kind of malpractice.
Four months later, federal agents came for me with no phone call, no warning, and no conversation—just an indictmenton five felony counts of healthcare fraud. The entire case was built on the claim that my clinics had used the wrong billing code for COVID testing visits. Not that any patients were harmed. Not that services went unperformed. Just a billing code—the same one, it turns out, that other clinics all over the country were using for the exact same services. The government never even looked at our patient charts before they charged me. And to put it into perspective, there are over 69,000 ICD-10 billing codes. Even the judge said the prosecution looked like a “case of shoot first and ask questions later.”
What happened next is something I wouldn’t wish on anyone. I lost my ability to practice emergency medicine and I lost the ability to treat Medicare patients—the elderly, the vulnerable, the very people I went into medicine to serve. I lost my business and watched everything I had built, everything I had sacrificed for, get dismantled not because of any finding of wrongdoing but because of the sheer weight of a federal prosecution hanging over my name.
I watched my wife carry a burden no spouse should ever have to carry, and I watched my four children grow up in the shadow of one word—“indicted”—that they were too young to fully understand. There were nights I couldn’t sleep and mornings I wasn’t sure I could keep going. The mental and physical toll of these last four years is something I still struggle to put into words, and I’m a man who talks to patients about hard things for a living.
Despite the weakness of the government’s case, I was convicted at trial. But Chief Judge James Bredar, the trial judge who heard the evidence and an appointee of President Obama, subsequently acquitted me. He wrote a 93-page opinionexplaining why no reasonable jury should have convicted me, and he condemned the prosecution’s failures in plain, unsparing language. The American Medical Association—the same organization that wrote the coding rules the government accused me of misreading—filed a brief on my behalf. And according to a former Deputy Attorney General, the opinion was a “tour de force” and “sends a strong message to leaders of the U.S. Attorney’s Office and the Justice Department’s Criminal Division.”
And still it continues. The Biden DOJ appealed days before they left office, and the Fourth Circuit Court of Appeals remanded my case to the District Court level for a new trial this August. Strikingly, Judge Bredar just recused himself from adjudicating the new trial. My family and I have to brace ourselves for another round—more legal fees, more headlines, more painful conversations with my kids about why Daddy is still in trouble for something the chief federal judge of Maryland already said he didn’t do.
I’m not writing this for sympathy. I’m writing this because what happened to me can happen to any physician, any citizen, who steps forward in a national crisis and dares to publicly disagree with those in power. The chill this case has sent through the medical community is real. Doctors who watched what happened to me will think twice before going on television, before speaking at a town hall, before telling their patients something that contradicts the official line. That silence has a cost too—and patients end up paying it. More than that, this sends the message: DO NOT do the right thing. Stay home, don’t step up when the need arises and when society needs you most.
Weaponization Watch has stood with me and with others like me because they understand what is really at stake. This isn’t just my case. It’s a test of whether the federal government can use its prosecutorial power to punish dissent under the cover of regulatory enforcement—and whether the authorities have the courage and the integrity to say: enough.
I’m asking the White House and the Department of Justice to look at what was done in the people’s name and drop this case. Not because I want special treatment, but because justice requires it.
I just want my life back. I want to go back to work. I want to take my kids to school in the morning without this hanging over all of us.
That is all I have ever wanted.
Dr. Ron Elfenbein is a Maryland emergency physician and founder of one of the state’s largest COVID-19 testing and monoclonal antibody treatment networks. His case, United States v. Elfenbein, is scheduled for retrial in August 2026. Support him on GiveSendGo. Sign the petition here. For more on the case or to contact Dr. Elfenbein, visit dropthecase.com.
Weaponization Watch
I Spoke the Truth About COVID Treatment. Then I Got Arrested by the Feds.
This is a guest post from Dr. Ron Elfenbein, a Maryland emergency physician facing federal retrial this August…
Read more
a month ago · 12 likes

TIMELINE OF EVENTS:

March 2020

COVID-19 pandemic hits. DEC pivots from traditional urgent care to mass COVID-19 testing. The Government issues interim rules expanding telehealth flexibility and encouraging provider evaluations alongside testing.

April – December 2020

Coding guidance changes rapidly. CMS publishes multiple interim final rules, relaxing documentation requirements and encouraging E/M visits with COVID testing. The regulatory environment is described as “unprecedented.”

December 2020 – March 2021

Dr. Elfenbein opens a monoclonal antibody infusion center (providing a COVID-19 cure) and it very quickly becomes the busiest in the state of Maryland.

February – April 2021

Dr. Elfenbein is approached by the U.S. Department of Health and Human Services (HHS) to set up and run a monoclonal antibody infusion center at the City of Praise church near FedEx Field in Landover, MD. He opens it in April in partnership with HHS and the Maryland Department of Health. His visionary “test to treat” model — in which a patient who tests positive and meets criteria is immediately infused to be cured of COVID-19 — becomes the national model for monoclonal antibody infusion centers.

June 11, 2021

Dr. Elfenbein is awarded a personal citation from then Maryland Governor Larry Hogan for “Your outstanding services to the citizens of this state.”

August 10, 2021

Dr. Elfenbein is awarded an official citation from the Maryland State Legislature for: “Stepping up for your fellow Marylanders, being on the front line fighting this pandemic, and for your honor, integrity, compassion and vision. Your leadership and tireless efforts are appreciated.”

September 2021

The Biden administration federalizes the monoclonal antibody supply and its distribution, introducing “equity” as a criterion for allocation — a first in medical history. The policy creates immediate artificial shortages where none had previously existed. Dr. Elfenbein publicly challenges this decision on television and other media outlets, appearing as a weekly guest on CBS, Newsmax, Fox News, and Sky News, among others.

December 2021

The Biden administration halts all monoclonal antibody treatments, citing a claimed Omicron prevalence above 70% — when in reality, prevalence stands at only 20%. Thousands of infusions were canceled, leaving vulnerable patients without access to a treatment proven to reduce hospitalization and death. Dr. Elfenbein publicly rebukes the decision on Fox News and Newsmax (Fox News coverage), calling out what he describes as arrogance and carelessness on the part of the administration. Dr. Elfenbein stated,“People are definitely going to die because of this”.

December 29, 2021

A doctor in Maryland said he had to cancel potentially life-saving monoclonal antibody infusions for about 250 people over the last week after the federal government stopped distributing treatments made by Regeneron and Eli Lilly because they aren’t effective against omicron, even though the delta variant, which the drugs are effective at treating, was still dominant at the time.
The Office of the Assistant Secretary for Preparedness and Response halted the allocation of those two antibody treatments last Thursday amid the rise of omicron, which the CDC had said days earlier was responsible for 73.2% of all new cases.
But the CDC backtracked on that alarming estimate this week, revising it down to just 22.5% for the week ending Dec. 18, more than a 50-point drop.
The delta variant, which Regeneron and Eli Lilly’s treatments are effective against, was actually responsible for 77% of all new cases when the federal government stopped distributing those antibody drugs.
Now, one doctor says the government’s massive miscalculation cost lives.
“I am as angry as I possibly can be about this,” Dr. Ron Elfenbein, the medical director and CEO of FirstCall Medical Center in Gambrills, Maryland, told Fox News Digital on Wednesday.
“The fact that these people are so adamant that they’re right when they’re using faulty data and they’re using faulty logic and frankly statistical modeling that has never been correct, ever, throughout this entire pandemic, to look at this, is just beyond the pale…. People are definitely going to die because of this or need hospitalization because [health officials] misread the statistics.”
The FDA has authorized three different monoclonal antibody treatments, which are lab-made substitutes for antibodies that can help fight off viruses.
The two treatments made by Regeneron and Eli Lilly are ineffective against omicron, according to the U.S. Department of Health and Human Services, but a third treatment created by British drugmaker GlaxoSmithKline has shown promise at beating back the new variant.
When the federal government stopped the allocation of Regeneron and Eli Lilly’s drugs last week, the Maryland Department of Health sent a letter to doctors throughout the state that said “sites… have been directed to stop administering these therapeutics.”
“Maryland is experiencing a sharp rise in COVID-19 Omicron variant cases. It is now the most dominant variant in the state,” Maryland’s top health officials wrote to doctors in a Dec. 23 letter, which was obtained by Fox News Digital.
Now that the CDC has significantly lowered its estimate for how prevalent omicron was at the time, Dr. Elfenbein said the pause in treatments was clearly unnecessary and is “absolutely hurting people.”
“I don’t know how many people throughout the country are dead, dying, in the hospital, or about to be hospitalized because of the mistakes that they just made,” Dr. Elfenbein, who runs two monoclonal antibody clinics, said on Wednesday.
“It’s just the height of bureaucratic arrogance, and it’s just, it’s horrible. I had to turn friends away, family, people call me, ‘Oh, my uncle has cancer. Can he get an infusion?’ I’m like, ‘I cannot give you an infusion because I will lose my medical license.’”
https://www.foxnews.com/us/maryland-doctor-monoclonal-antibody-treatments

January – March 2022

The Biden administration removes the Emergency Use Authorization (EUA) from almost all of the remaining monoclonal antibodies

April 19, 2022

Without warning, the U.S. Government charges Dr. Elfenbein with five counts of healthcare fraud. Each count represents a single patient visit billed as a Level 4 encounter. (Note: this is four months after publicly speaking out about the catastrophic mistakes made by the administration over the monoclonal antibodies.)

Elfenbein Indictment

1.92MB ∙ PDF file

Download

May 1, 2022

Dr. Elfenbein is awarded the Maryland State Medical Society Distinguished Member Award — the society’s highest individual honor — for “Demonstrating a distinguished commitment to serving the physicians, patients and public health of Maryland.”

July 14, 2023

Amended Superseding Indictment

760KB ∙ PDF file

Download

August 4, 2023

A jury finds Dr. Elfenbein guilty on all five counts.

December 5, 2023

December 21, 2023

Judge James K. Bredar issues a 93-page opinion — unusual and unprecedented in scope — granting a judgment of acquittal on all five counts AND a new trial in case of appeal.

The Court finds the Government failed to prove its case and that the evidence supports Dr. Elfenbein’s interpretation of the coding guidelines.

Dr. Elfenbein is found not guilty and ordered discharged.

https://www.govinfo.gov/content/pkg/USCOURTS-mdd-1_22-cr-00146/pdf/USCOURTS-mdd-1_22-cr-00146-0.pdf

https://www2.mdd.uscourts.gov/Opinions/Opinions/22-0146%20Elfenbein%20Opinion.pdf

August 1, 2024

Government notifies of its desire to appeal the judge’s decision.

Opening Brief Of Appellant United States Of America

671KB ∙ PDF file

Download

October 1, 2024

Brief Of Appellee Ron Elfenbein

1.43MB ∙ PDF file

Download

October 7, 2024

The AMA and Maryland State Medical Society file an Amicus Brief (friend of Court) with the Appeals Court on behalf of Dr. Elfenbein. This is remarkable as the government is accusing Dr. Elfenbein of violating rules established by the AMA — the very organization coming to his defense.

Brief Of Amici Curiae American Medical Association And Maryland State Medical Society In Support Of Defendant Appellee Ron K Elfenbein

568KB ∙ PDF file

Download

January/February 2025

President Trump declares “Ending the Weaponization of the Federal Government” a major initiative, and Attorney General Bondi issues a memo establishing a Weaponization Working Group and outlining cases of particular interest. Elfenbein’s case aligns directly with the memo’s focus on the retaliatory targeting and criminal prosecution of legitimate whistleblowers. https://www.justice.gov/ag/media/1388506/dl?inline

July 31, 2025

Appellee Ron Elfenbein’s Petition For Panel Rehearing And Rehearing En Banc

596KB ∙ PDF file

Download

August 17, 2025

Elfenbein Opinion

380KB ∙ PDF file

Download

November 10, 2025

Petition For A Writ Of Certiorari

2.02MB ∙ PDF file

Download

December 9, 2025

Brief Of Amici Curiae Eagle Forum Education And Legal Defense Fund And Association Of American Physicians And Surgeons In Support Of Petitioner

187KB ∙ PDF file

Download

December 17, 2025

TIME STAMPED: https://www.youtube.com/watch?v=rR_smBDSXeM&t=1440s

January 23, 2026

The fallout from former President Joe Biden’s weaponized Department of Justice (DOJ) continues to wreak havoc on the lives of those it attempted to crush, even with a new administration calling the shots.
“They did this before Trump was inaugurated. The wheels are in motion. It’s very hard to stop that,” Dr. Ron Elfenbein told Just The News.
Elfenbein is an emergency medicine physician in Maryland who gained national recognition during the early COVID-19 pandemic. He worked to serve patients and his community, donating substantial personal protective equipment (PPE) and supplies at a critical time to states including Maryland, Delaware, New York and Connecticut.
Elfenbein, who trained at Johns Hopkins and contracted for the United States Secret Service (USSS), earned widespread media attention for his contributions to the medical community during the pandemic, with appearances on outlets like CNN and CBS News. Prior to the government’s turn against him, mainstream journalists frequently consulted him for updates and to reinforce the prevailing narrative. He received a personal commendation from Maryland’s Governor and was named Person of the Year by the state medical society. He also received a grant from NASA (National Aeronautics and Space Administration) to help develop protocols for airway management in space.
Throughout his career, Elfenbein says he consistently chose principle over conformity, even when it required challenging “the science” during COVID-19 and against the administration’s preferences, which would ultimately put the DOJ’s crosshairs on his back.
The turn came when he publicly opposed the Biden administration’s policy in late 2021 to pause monoclonal antibody treatment (asserting that it would undermine Big Pharma funding), and after appearing on Fox News, he faced what he believes was retaliation from what he describes as a weaponized Department of Justice.
Four months later, he was indicted on what he asserts are baseless healthcare fraud charges related to “upcoding,” with prosecutors allegedly failing to review the medical charts that form the basis of all coding decisions.
According to Elfenbein, the counts, which stem from five coding instances, pertained to patients he never even saw; they were attended by physicians’ assistants and nurse practitioners. He was the medical director at the time.
Furthermore, Elfenbein was not the person at the practice who dealt with coding and submission of those charts and codes; it was his business partner. Elfenbein’s partner just happened to be a sitting Republican state delegate in Maryland, and was never even contacted by the federal government’s investigators.
Elfenbein told Just The News that the government’s assertion was that the medical events were coded incorrectly, and even if that were the case, the difference in billing for each case was $30, totaling $150 over the five cases, for which Biden’s DOJ was seeking 50 years in prison.
After a grueling trial, Chief U.S. District Judge James Bredar acquitted him in a detailed 90-page opinion, ruling that the evidence was insufficient to prove Elfenbein’s coding interpretation unreasonable and that some evidence actually supported his understanding of the requirements.
Relentless prosecution drains his finances
Unfortunately, the Biden DOJ wasn’t done with the punishing process. They appealed and the Fourth Circuit Court of Appeals overturned the acquittal, ordering a new trial in August.
Elfenbein has been drained financially, and warns that this could happen to anyone. “I’m nobody, right? I’m just a guy and I’m trying to do the right thing and I tried to step up. But this could be you. It’s not just the Donald Trumps of the world that they go after.”
In addition to financial destruction, Elfenbein has endured other forms of punishment. He says he was debanked by American Express, removed from his USAA policy, his TSA pre-check was revoked, and he lost his ability to own a firearm.
“The process is designed that way and they are relentless. They want to bankrupt you, and they know that they have more money than you do, so they will keep coming and coming and coming until you either plea or go to jail.”
https://justthenews.com/politics-policy/covid-hero-turned-target-maryland-doc-endures-biden-lawfare-trump-vows-end

Early 2026

Chief Judge James Bredar recuses himself from Dr. Elfenbein’s re-trial.

January 15, 2026

February 3, 2026

TIME STAMPED: https://www.youtube.com/live/57KbY5XvjdM?t=123s

February 18, 2026

TIME STAMPED: https://www.youtube.com/watch?v=GqMGQSxqd5k&t=179s

February 2026

https://rumble.com/v74dhio-dr.-ron-elfenbein-tells-his-story-from-covid-lifesaver-to-federal-indictmen.html

February 2026

TIME STAMPED: https://rumble.com/v74dh54-a-dirty-secret-the-weaponization-of-government-against-americans-continues-.html?start=165s

March 3, 2026

https://www.youtube.com/watch?v=dwq6m_OxmvM

March 6, 2026

TIME STAMPED: https://www.youtube.com/watch?v=o15VJyU1gWc&t=98s

March 11, 2026

TIME STAMPED: https://rumble.com/v76zg86-rogue-targeted-prosecution.html?start=848s

April 2, 2026

TIME STAMPED: https://www.youtube.com/live/fnh6KsoTR-A?t=2962s

April 6, 2026

https://www.youtube.com/watch?v=W8EDiotrYl8

April 9, 2026

TIME STAMPED: https://www.youtube.com/watch?v=wRTWw2Fc3Z0&t=63s

April 11, 2026

April 2026

TIME STAMPED: https://rumble.com/v77p05s-the-power-of-propaganda-covid-era-hero-fighting-to-clear-his-name.html?start=2025s

April 22, 2026

TIME STAMPED: https://rumble.com/v78uqp0-truth-be-told-roundtable.html?start=815s

April 25, 2026

TIME STAMPED: https://www.youtube.com/watch?v=LLJGGDxgKl0&t=399s

May 1, 2026

TIME STAMPED: https://www.youtube.com/watch?v=MuTH4HMtA3Q&t=42s

May 4, 2026

Weaponization Watch

I Spoke the Truth About COVID Treatment. Then I Got Arrested by the Feds.

This is a guest post from Dr. Ron Elfenbein, a Maryland emergency physician facing federal retrial this August…

a month ago · 12 likes

May 10, 2026

@RonElfenbeinmd is asking the Trump administration ","username":"StellaEscoTV","name":"Stella Escobedo","profile_image_url":"https://pbs.substack.com/profile_images/1905426355640303620/otjQPSTR_normal.jpg","date":"2026-05-10T15:14:02.000Z","photos":[{"img_url":"https://substackcdn.com/image/upload/w_1028,c_limit,q_auto:best/l_twitter_play_button_rvaygk,w_88/hzdtkglir3n3gv72u43i","link_url":"https://t.co/5CgvjNVZuf"}],"quoted_tweet":{},"reply_count":3,"retweet_count":27,"like_count":64,"impression_count":1333,"expanded_url":null,"video_url":"https://video.twimg.com/amplify_video/2053493710781071360/vid/avc1/720x1280/CYIb0jApNpzRQQoM.mp4","belowTheFold":true}" data-component-name="Twitter2ToDOM">

August 2026

Dr. Ron Elfenbein will face a second trial.

If you would like to have a respectful discussion regarding this issue and help work on possible solutions, then please feel free to contact me directly anytime at 310-619-3055 (phone, text, Signal, Telegram or WhatsApp) or James.Roguski@gmail.com

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What Causes The White Lines In The Sky?

James Roguski — Sun, 03 May 2026 13:59:53 GMT

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STEP #1: WATCH THE VIDEO:

STEP #2: Participate in the one-question opinion poll below…

Which option (A or B below) do you believe causes the white lines in the sky that can be seen from time to time behind jet aircraft?

A. Sprayed Particulate Dispersions:

The white lines in the sky ARE NOT condensation trails and ARE NOT caused by jet fuel exhaust. They ARE “sprayed, particulate dispersions” of compounds such as strontium, aluminum and barium or coal fly ash that are being sprayed on purpose.

B. Jet Engine Exhaust Pollution in Ice Super-Saturated Regions ISSRs:

The white lines in the sky ARE NOT something that is purposefully being “sprayed.” They ARE caused by jet engine exhaust pollution that contains large amounts of particulate matter, water vapor and many other pollutants, which are typically invisible. When jet engine exhaust is deposited in Ice Super-Saturated Regions (ISSRs), ice crystals can form on the particulate matter which then makes the jet engine exhaust pollution visible.

Leave a comment

STEP #3: PLEASE SHARE YOUR OPINIONS, BELIEFS AND THEORIES REGARDING WHAT YOU THINK IS CAUSING THE WHITE LINES IN THE SKY IN THE COMMENT SECTION BELOW:

Leave a comment

If you would like to have a respectful discussion regarding this issue and help work on possible solutions, then please feel free to contact me directly anytime at 310-619-3055 (phone, text, Signal, Telegram or WhatsApp) or James.Roguski@gmail.com

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The WHO Negotiations Have Been Extended

James Roguski — Fri, 01 May 2026 16:40:29 GMT

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The WHO Intergovernmental Working Group (IGWG) has FAILED to reach agreement on the PABS Annex to the Pandemic Agreement.

A vote on the PABS Annex to the Pandemic Agreement will NOT occur during the 79th World Health Assembly to be held from May 18-23, 2026.

The negotiations will continue after the World Health Assembly.

The next meeting of the IGWG is scheduled for July 6-17, 2026

Full details and video of the closing session are available here:

https://www.who.int/news/item/01-05-2026-who-member-states-agree-to-extend-negotiations-on-pathogen-access-and-benefit-sharing-annex

https://apps.who.int/gb/IGWG/e/e_igwg6-resumed-session.html

Below are screenshots of the Draft final report of the meeting:

FOR ADDITIONAL DETAILS, READ THE ARTICLE BELOW

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Methylsiloxanes

James Roguski — Sun, 19 Apr 2026 21:00:46 GMT

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There is an increasing awareness of, and a growing concern about, the environmental and health hazards associated with methylsiloxanes.

Methylsiloxanes are a class of synthetic chemicals used to produce silicone polymers – materials that are found in an EXTREMELY wide range of products. Methylsiloxanes are silicon-oxygen compounds. Silicone itself is polydimethylsiloxane (PDMS), and low-molecular-weight cyclic siloxanes (D4, D5, D6) exist within this material.

Methylsiloxanes are widespread synthetic pollutants found in the atmosphere, water, and soil, originating from personal care products, industrial processes, and notably, engine exhaust. Recent studies indicate high-concentration, omnipresent contamination (including urban and rural areas), with potential daily inhalation doses that are higher than PFAS and plastics, creating urgent needs for health risk evaluations. In many products, PolyFluoroAlkyl Substances (PFAS) have been replaced by methylsiloxanes. That may not have been an improvement!

Methylsiloxanes, commonly known as silicones, are polymeric compounds made up of silicon and oxygen atoms bonded together. Due to their versatility, high production volume, stability, and local presence in the environment and in biological fluids such as breast milk, fat, and plasma, siloxanes are considered to be persistent organic pollutants that represent a public health problem of which public awareness is just beginning to emerge.

Methylsiloxanes are associated with multiple adverse health effects. The cyclic volatile methylsiloxanes commonly referred to as D4, D5 and D6 are linked to cancer, developmental and reproductive toxicity, endocrine disruption, and liver toxicity. The European Union has classified D4 as an endocrine disruptor and evidence suggests D4 may impair human fertility. High doses of D5 in laboratory tests have shown potential to affect the immune system and cause uterine tumors.

https://www2.mst.dk/udgiv/publications/2005/87-7614-756-8/pdf/87-7614-757-6.pdf

Siloxanes Consumption, Toxicity And Alternatives

501KB ∙ PDF file

Download

On any given day, people around the world may inhale 1000s of times more methylsiloxanes than microplastics.

Global annual production of methylsiloxanes is estimated to be between 8,000,000 and 10,000,000 tons. China is the largest manufacturer and consumer of methylsiloxanes, producing over 4.5 million tons in 2019, which accounted for roughly two-thirds of global production.
Global annual emissions of methylsiloxanes in vehicle-emitted aerosols are estimated to range from 7-13 million pounds, underscoring the significant yet largely unknown potential for health and climate impacts.
Exposure to methylsiloxanes is common because of their widespread use in industry and across sectors, resulting in their presence in industrial applications as well as consumer and professional products.
Methylsiloxanes—specifically cyclic siloxanes such as D4, D5, and D6—are present in silicone gel-filled breast implants. They are components of the silicone elastomer shell and the filler gel, and they can bleed or diffuse through the shell into surrounding body tissues and blood, even if the implant is intact.
Methylsiloxanes, specifically large molecular polydimethylsiloxanes (PDMS), are emerging as a significant, previously overlooked component of engine exhaust, including those from vehicles and ships, and likely aircraft, as they are present as antifoam additives in lubricants. These compounds can survive high-temperature combustion and are emitted in the particle phase of exhaust.
Methylsiloxanes have been found in primary aerosol particles emitted by ship engines, accounting for up to 1.2% of organic aerosol mass during stable operation and rising to 28.2–59.3% under transient conditions (acceleration, deceleration, idle).
Methylsiloxanes are used as antifoam additives in engine lubricants and fuel oils. During engine operation, particularly during inefficient combustion, lubricating oil enters the combustion chamber, leading to the emission of unburned or partially decomposed compounds in the exhaust.
Methylsiloxanes are commonly present in the atmosphere, with urban areas showing the highest concentrations, often making up 2% to 4.3% of the total organic aerosol mass. Unlike other exhaust components, methylsiloxanes are chemically stable and can be transported over long distances, contributing to their presence in remote areas.
Methylsiloxanes in atmospheric aerosols likely impact rainfall by altering cloud formation and precipitation patterns. Methylsiloxanes are efficient surfactants. As a persistent, hydrophobic pollutant, these large molecular compounds can modify the surface tension of aerosol particles, affecting their role as cloud condensation nuclei (CCN), impact cloud formation, and interfering with ice nucleation, which dictates cloud evolution and rainfall efficiency. Similar to other aerosol types that alter droplet size, these compounds could lead to increased cloud droplet number but smaller droplet sizes, potentially suppressing light rain (cloud lifetime effect). Methylsiloxanes do not degrade quickly, allowing them to remain in the atmosphere as persistent organic aerosols that alter aerosol-cloud interactions over longer periods.

What are Siloxanes?

Siloxanes are often grouped based on properties like molecular structure (cyclic, circular in shape or linear, straight and chain-like), molecular weight, and volatility. Despite these differences, they all share a similar chemical backbone and many common characteristics.
Common cyclic VMS (cVMS) include compounds known as D4, D5, and D6. Common linear VMS include compounds known as L3, L4, and L5.
PDMS
PolyDiMethylSiloxane (PDMS) is used in numerous consumer products and industrial materials, including silicone cookware.
Due to concerns around their persistence, tendency to bioaccumulate, and toxicity, the European Union has adopted a broad restriction on certain cyclic siloxanes, including restricting their use in personal care products and cosmetics.
However, in the U.S., siloxanes continue to be produced at high volumes, and global production is estimated to be over 10 million tons annually. The U.S. Environmental Protection Agency (EPA) reported 2019 domestic production volume for D4, D5, and D6 as between 250 to 500 million pounds, 100 to 250 million pounds, and 1 to 10 million pounds, respectively.
Concerns over siloxanes are not limited to human health hazards. When cosmetics and personal care products containing siloxanes are washed off, they contribute to environmental contamination. A primary concern is related to the chemical stability and persistence of these chemicals in the environment and their ability to bioaccumulate.
The European Union’s chemical regulatory agency, ECHA, has designated multiple siloxanes as substances of very high concern, including VMS compounds L3 and L4 due to their designations as very persistent and very bioaccumulative substances.
As restrictions grow on the use of hazardous per- and polyfluoroalkyl substances (PFAS), siloxanes have been used as replacements in applications like textile treatments and in non-stick cookware.
This results in regrettable substitutions where one class of hazardous chemicals is replaced with another, rather than with safer alternatives.
https://toxicfreefuture.org/toxic-chemicals/siloxanes/

Millions of people use methylsiloxane-containing skin “moisturizers” even though methylsiloxanes damage even deep layers of the skin. If you use any products that contain methylsiloxanes, or if you know anyone who does, be sure to read: “Evidence of Skin Barrier Damage by Cyclic Siloxanes (Silicones)—Using Digital Holographic Microscopy” below.

Sources include:

breast implants
personal care products (PCPs)
cosmetics
foundations
makeup
brow liners
masks
setting powders/sprays
styling gels/lotions
creams
lotions
moisturizers
shampoos
conditioners
hair styling aids
hair treatment/serums
hair sprays
shaving products
antiperspirants
deodorants
sunscreens
personal lubricants
excipients in topical medicines
children’s products
pacifiers
baby bottle nipples
diaper creams
silicone cookware
baking utensils
dry cleaning solvents
detergents
fabric softeners
adhesives
cleaning products
glass and specialty cleaners
fuel additives
antifoaming agents
lubricants
sealants
polishes
waxes
waterproof coatings
paints
defoaming agents
penetrating oils

Cyclomethicone

Cyclomethicone is a general term used for several types of cyclic siloxanes, but the most common ones in cosmetic formulations include:

cyclotetrasiloxane (D4)
cyclopentasiloxane (D5)
cyclohexasiloxane (D6)

Other names:

amodimethicone
antifoam FD 62
cetearyl methicone
DC 35A
DC 360
DIME, DI-ME
dimethicone
dimethicone copolyol
dimethiconol
dimethyl siloxane
dimethylpolysiloxane
dimethylpolysiloxane hydrolyzate
Dow Corning 200
Dow Corning 561
KO 08
methicone
nylon
phenyl trimethicone
PMS 1.5, PMS 154A, PMS 200A, PMS 300
PNS 25
polydimethylsiloxane
polydimethyl silicone oil
S DC 200
silane
silicones
siloxane
SI-O-SIL SS-101-350
triethoxycaprylylsilane
triethoxycaprylylsilane crosspolymer
trimethicone
trimethylsilylamodimethicone

REFERENCES:

April 18, 2026

Scientists Raise Concerns Over Newly Recognized Pollutant Found Everywhere in the Air

“The findings also suggest that concentrations of methylsiloxane in the atmosphere are much higher than expected,” says Rupert Holzinger, associate professor at Utrecht University who co-supervised the study
These compounds account for about 2 to 4.3 percent of the total mass of organic aerosols, making them among the most abundant synthetic substances in the air. By comparison, PFAS levels in the atmosphere are typically more than a thousand times lower.
https://scitechdaily.com/scientists-raise-concerns-over-newly-recognized-pollutant-found-everywhere-in-the-air/

April 16, 2026

Newly recognized pollutant widely present in atmosphere

https://www.uu.nl/en/news/newly-recognized-pollutant-widely-present-in-atmosphere

Widespread occurrence of large molecular methylsiloxanes in ambient aerosols

Large molecular methylsiloxanes are widely present in atmospheric particulate matter across diverse environments, including urban, coastal, rural, and forest sites in the Netherlands, Lithuania, and Brazil.
These findings highlight the ubiquity of this emerging pollutant and underscore the urgent need for systematic evaluation of its environmental and human health impacts.
https://acp.copernicus.org/articles/26/5005/2026/

December 2025

In-depth insight into cyclic methyl-siloxanes in waste tires pyrolysis oil (WTPO), high silicon content gasoline, and high silicon content diesel

This study emphasizes that the potential threats posed by silicon-containing molecules in Waste Tire Pyrolysis Oil (WTPO) to the environment, organisms, and industrial equipment should be evaluated in advance of large-scale commercialization.
https://www.sciencedirect.com/science/article/abs/pii/S1743967125003514

October 2025

Silicone bakeware as a source of human exposure to cyclic siloxanes via inhalation and baked food consumption

Silicone-based bakeware is widely used due to its heat resistance, flexibility, and non-stick properties. However, concerns have emerged regarding the potential migration and release of siloxanes from these products into food and indoor air during baking.
https://www.sciencedirect.com/science/article/pii/S0304389425025105

June 2025

Toxicokinetic Profiles and Potential Endocrine Disruption Effects at the Reproductive Level Promoted by Siloxanes Used in Consumer Products

Siloxanes, commonly known as silicones, are polymeric compounds made up of silicon and oxygen atoms bonded together alternately. Due to their versatility, high production volume, stability, and local presence in environmental matrices and biological fluids such as breast milk, fat, and plasma, siloxanes have been considered persistent organic pollutants, representing a public health problem.
The toxicological effects of siloxanes, particularly D4, D5, and D6 included significant endocrine disruption, reproductive toxicity, and liver toxicity.
https://pubmed.ncbi.nlm.nih.gov/39375180/

May 6, 2025

A Review of Contamination Status and Health Risk Assessment of Volatile Methylsiloxanes in Environmental Matrices

https://pubs.acs.org/doi/10.1021/envhealth.4c00245

April 1, 2025

Volatile methylsiloxane levels of settled dust in hair salons: Spatial and occupational exposure trends

https://pubmed.ncbi.nlm.nih.gov/39900275/

September 12, 2023

Methylsiloxanes from Vehicle Emissions Detected in Aerosol Particles

Methylsiloxanes can be found in primary aerosol particles emitted by vehicles based on aerosol samples collected in two tunnels in São Paulo, Brazil.
The concentrations of methylsiloxanes exhibited a significant correlation with both unburned lubricating oils and organic aerosol mass.
https://pubs.acs.org/doi/10.1021/acs.est.3c03797

[ THIS IS VERY TROUBLING!]

April 2023

Are Si-C bonds cleaved by microorganisms? A critical review on biodegradation of methylsiloxanes

No convincing demonstration of Si–C cleavage by native environmental microorganisms has been found.
https://pubmed.ncbi.nlm.nih.gov/36642148/

February 2023

Cyclic volatile methyl siloxanes (D4, D5, and D6) as the emerging pollutants in environment: environmental distribution, fate, and toxicological assessments

https://www.researchgate.net/publication/368688304_Cyclic_volatile_methyl_siloxanes_D4_D5_and_D6_as_the_emerging_pollutants_in_environment_environmental_distribution_fate_and_toxicological_assessments

October 25, 2022

Occurrence and Behavior of Methylsiloxanes in Urban Environment in Four Cities of China

Methylsiloxanes were widely found in the air, water, soil and sediment of four cities in China. The concentrations of mkethylsiloxanes in all four environmental media of Zhangjiagang were higher than those in the other three cities (Beijing, Kunming and Lijiang), indicating that the siloxane production plant had a significant impact on the pollution level of methylsiloxanes in the surrounding environment.
https://pmc.ncbi.nlm.nih.gov/articles/PMC9658807/

July 2022

A large contribution of methylsiloxanes to particulate matter from ship emissions

The chemical and stable carbon isotopic composition of the organic aerosol particles (OA) emitted by a shuttle passenger ship between mainland Naples and island Capri in Italy were investigated. Particulate-phase methylsiloxanes were mainly emitted near the harbor under inefficient combustion conditions. Large contributions of methylsiloxanes were found under inefficient combustion conditions, and considerably lower methylsiloxane emissions were observed under cruise conditions.
https://www.sciencedirect.com/science/article/pii/S0160412022002513

July 2021

Methylsiloxanes in petroleum refinery facility: Their sources, emissions, environmental distributions and occupational exposure

High concentrations of methylsiloxanes, including D4, D5 and D6 and linear analogs with 3–14 silicon atoms (L3-L14), have been detected in crude oil, additives and petroleum products from one petroleum refinery facility in China.

Overall, methylsiloxanes in air and soil samples from this facility were up to four orders of magnitude greater than those from surrounding areas, and plasma concentrations of methylsiloxanes in current workers from this facility were up to two orders of magnitude larger than those from reference group.

https://www.sciencedirect.com/science/article/pii/S0160412021000969

The ultra-classic skin care product scam:

Promote products that trap moisture in the skin and leave a smooth feel on the surface of the skin while actually damaging the deeper layers of the skin itself.

August 13, 2020

Evidence of Skin Barrier Damage by Cyclic Siloxanes (Silicones)—Using Digital Holographic Microscopy

Cyclic siloxanes (D4, D5, D6) are widely used in skin products.
A new skin-imaging technique, digital holographic microscopy (DHM), was used for the first time to investigate the impact of D4, D5, and D6 on the skin barrier.
We observed irreversible damage of the stratum corneum due to the interaction with cyclic siloxanes.
These substances changed:
(a) the first level of the skin barrier through destabilization of the intercellular lipid lamellae and destruction of the corneocyte structure (measured with axial nanometer resolution),
(b) the second level by collapse of not only corneocytes but also of a significant part of the clusters, leading to the loss of the stratum corneum integrity and formation of the lacunae,
(c) the third level as an effect of the change in the surface geometrical topography of the stratum corneum and disruption of the integrity of this skin layer, measured with lateral micrometer resolution.
https://www.mdpi.com/1422-0067/21/17/6375

June 16, 2020

Cyclic Volatile Methyl Siloxanes: Environment Tier II Assessment

https://cdnservices.industrialchemicals.gov.au/statements/IMAP_48424%20-%20IMAP%20Assessment%20-%2016%20June%202020.pdf

Cyclic Volatile Methyl Siloxanes Environment Tier Ii Assessment

342KB ∙ PDF file

Download

August 17, 2015

Indoor Air Pollution by Methylsiloxane in Household and Automobile Settings

The comparatively high concentration of methylsiloxane in these three venues indicates that interior renovation and decoration work, and even travelling in cars, can involve exposure to more serious siloxane contamination during everyday activities.
https://pubmed.ncbi.nlm.nih.gov/26280831/

February 25, 2015

Siloxanes Unexpectedly Observed In Antarctic Soil And Marine Life

The presence of synthetic compounds in such remote ecosystems is always undesirable:
“If a compound is found there, it will be everywhere.”
https://cen.acs.org/articles/93/web/2015/02/Siloxanes-Unexpectedly-Observed-Antarctic-Soil.html

Toxic ingredient to avoid: Siloxanes

Many siloxanes are persistent in the environment. These are classified as “persistent-bioaccumulative-toxic,” i.e., they build up in the environment. One of the most used siloxane is polydimethylsiloxane, a.k.a. dimethicone and PDMS. This ingredient is likely to bioaccumulate in the tissues of organisms. It’s also likely to persist in the environment and be toxic to aquatic life.
Cyclopentasiloxane (D4) is a stable and nonreactive chemical, so can take years to decompose. It may evaporate into the air or enter waterways through drainage systems when rinsed off skin or hair. 
https://davidsuzuki.org/living-green/dirty-dozen-siloxanes/

If you would like to have a respectful discussion regarding this issue and help work on possible solutions, then please feel free to contact me directly anytime at 310-619-3055 (phone, text, Signal, Telegram or WhatsApp) or James.Roguski@gmail.com

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Artemis II

James Roguski — Thu, 02 Apr 2026 00:43:01 GMT

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CLICK HERE TO WATCH THE LAUNCH

NASA Propaganda/Trailer

How the Artemis II Mission Works

Below is the main video of the launch:

Postlaunch News Conference

Mission Coverage

Live Views from Orion

My previous article:

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Start the conversation by sending me a simple text message that says “LET’S CONNECT.”

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Knowledge Versus BeLIEf

James Roguski — Wed, 01 Apr 2026 16:35:43 GMT

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Today is April 1, 2026.

This is NOT an April Fools Day joke article.

This is exactly the opposite.

PLEASE take the time to watch ALL of the videos below.

If you resonate with the messages in these videos and you value evidence over empty claims, honesty over deception, truth over propaganda and kindness over conquest, and if you want to cooperate with others to build a better future for everyone, then let’s connect on a deeper level.

Email: James.Roguski@gmail.com

Phone, Text, Signal, Telegram or WhatsApp: 310-619-3055

Start the conversation by sending me a text message that says “LET’S CONNECT.”

To all of my readers:

If you are aware of any videos that you think are worthy of being added to the video collection in this article, please share them in the comment section below:

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Humans Will Believe Anything They Hear

On Being Wrong

Bob Newhart

https://rumble.com/v1qji9y-bob-newhart-stop-it.html

Ask Your Doctor

Pretendatrin

Pure Blooded

No Amount of Evidence

Corruption is Legal in America

The Government Can

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Propaganda

Great websites:

https://YourLogicalFallacyIs.com

https://YourBias.is

Additional videos:

Charles Eisenstein

Using An Ai Powered Street Epistemologist Chatbot And Reflection Tasks To Diminish Conspiracy Theory Beliefs

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The Dunning Kruger Effect

Branded

How to WIN the Game of Earth

Law of Diffusion of Innovation

Monopoly

Soylent Green

https://www.dailymotion.com/video/x9txga0

Idiocracy

https://rumble.com/v4evmnx-idiocracy-full-movie.html

The Matrix

THEY LIVE

https://archive.org/details/they-live-1989-vhs

https://www.fright-rags.com/products/they-live-sunglasses

I’ve No More F*s To Give!**

**P*ssing the right people off…**

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James Roguski

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Missouri's Clean Skies Act

James Roguski — Sat, 28 Mar 2026 01:28:34 GMT

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Regardless of where you live on Earth, RIGHT NOW would be a very good time to support Michael Hogan’s efforts to pass legislation to ban geoengineering and weather modification in Missouri.

Please watch all the videos below and help spread the word!

YOUTUBE: https://www.youtube.com/watch?v=S6tHZ7cZRdo

RUMBLE: https://rumble.com/v77pvjs-missouri-clean-skies.html

VISIT: MOCLEANSKIES.ORG

CONTACT: MICHAEL HOGAN

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https://www.mocleanskies.org/form-to-testify

CONTACT MISSOURI STATE REPRESENTATIVES:

DETAILS:

https://documents.house.mo.gov/billtracking/bills261/hlrbillspdf/5461H.01I.pdf

Missouri House Bill 2388

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SUBMIT YOUR TESTIMONY FOR MISSOURI HOUSE BILL 2388:

https://witness.house.mo.gov/Default.aspx?bill=HB2388¬iceid=11479

Missouri House Bill 2656

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SUBMIT YOUR TESTIOMONY FOR MISSOURI HOUSE BILL 2656:

https://witness.house.mo.gov/Default.aspx?bill=HB2656¬iceid=11479

VIDEOS

If you would like to have a respectful discussion regarding this issue and help work on possible solutions, then please feel free to contact me directly anytime at 310-619-3055 (phone, text, Signal, Telegram or WhatsApp) or James.Roguski@gmail.com

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AMOC

James Roguski — Mon, 23 Mar 2026 20:41:23 GMT

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It seems like some people believe that the solution to nearly every problem on Earth is yet another solar geoengineering project.

CLICK HERE TO REGISTER TO ATTEND THE ZOOM MEETING ON TUESDAY MARCH 24, 2026 (details below)

Srm360 Amoc Primer

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The Atlantic Meridional Overturning Circulation (AMOC) is a massive system of ocean currents—including the Gulf Stream—that transports warm water north, regulating climate in Europe and North America.

The Atlantic Meridional Overturning Circulation, or AMOC, current brings warm water from the tropics northward toward the Arctic, and the flow of warm water helps keep Europe’s winters mild.

This "conveyor belt" is said to be weakening due to “climate change.”

Iceland’s government has designated the potential collapse of the Atlantic Meridional Overturning Circulation system as a national security concern and an existential threat, and is strategizing its response to potential worst-case scenarios.

"It is a direct threat to our national resilience and security. [This] is the first time a specific climate-related phenomenon has been formally brought before the National Security Council as a potential existential threat."

Iceland Climate Minister Johann Pall Johannsson

Iceland and the AMOC: When Existence Is at Stake

https://srm360.org/perspective/iceland-amoc-existence-at-stake/

SRM & the AMOC

https://srm360.org/primers/amoc/

NOTE: A gyre is a large, circular system of rotating ocean currents (spiral or vortex) formed by global wind patterns and Earth’s rotation.

Recent and early 20th century destabilization of the subpolar North Atlantic recorded in bivalves

https://www.science.org/doi/10.1126/sciadv.adw3468

CLICK HERE TO REGISTER TO ATTEND THE ZOOM MEETING ON TUESDAY MARCH 24, 2026 (details below)

March 24, 2026

7am Pacific
8am Mountain
9am Central
10am Eastern
2pm UK
3pm Central Europe
4pm Eastern Europe
10pm Perth, Australia

In this live discussion, “experts” will explore how climate change is currently affecting the Atlantic Meridional Overturning Circulation, and whether warming temperatures could weaken or collapse this circulation system.

The conversation will consider whether solar geoengineering could play a role in stabilising the Atlantic Meridional Overturning Circulation, and what the potential impacts, risks, and uncertainties would be in that scenario.

Speakers:

David Thornalley

Professor of Ocean and Climate Science·University College London

David Thornalley is a Professor of Ocean and Climate Science at University College London (UCL), with over 20 years’ experience investigating the Atlantic Meridional Overturning Circulation (AMOC). He obtained his PhD in Earth Sciences from Cambridge University, followed by postdoctoral positions at Cardiff University and the Woods Hole Oceanographic Institution. At UCL, he leads a research group that studies the circulation of the Atlantic Ocean, its marine ecosystems and its role during climate change – past, present and future. He is currently contributing to the EU EPOC project (Evaluating and Predicting the Ocean Conveyor) and he co-Leads the ARIA funded VERIFY project, which is combining paleoclimate data and models to develop an early warning system for the future potential tipping of the Greenland Ice Sheet and subpolar North Atlantic circulation.

John Moore

Research Professor·University of Lapland

John Moore leads the University of the Arctic Thematic Network on Frozen Arctic Conservation. He is also a Research Professor at Arctic Centre, University of Lapland in Finland and Member of Finnish Academy of Science and Letters. He is a glaciologist, working mainly on ice sheet dynamics and sea level rise, but began his career on ice cores and paleoclimate and also written on topics including history, economics and statistics. He has been a member of 6 Antarctic, 5 Greenlandic and 20 Svalbard scientific expeditions.

Laurie Laybourn

Executive Director·Strategic Climate Risks Initiative

Laurie Laybourn is Executive Director of the Strategic Climate Risks Initiative (SCRI), a think-do tank that develops capabilities for securing a better world even as complex environmental-driven risks escalate. He also holds fellowships at Chatham House, the University of Exeter, and the Institute for Public Policy Research (IPPR).

If you would like to have a respectful discussion regarding this issue and help work on possible solutions, then please feel free to contact me directly anytime at 310-619-3055 (phone, text, Signal, Telegram or WhatsApp) or James.Roguski@gmail.com

James Roguski

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STOP THIS NOW!!!

James Roguski — Thu, 19 Mar 2026 23:20:56 GMT

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The draft, which promotes greater legal uncertainty, is weak in benefit-sharing, and effectively normalises biopiracy, should be of serious concern to developing countries.

Sangeeta Shashikant and Nithin Ramakrishnan

If you live in the United States or Argentina, and you somehow believe that these PABS negotiations no longer matter to you, you are sadly mistaken.

For those few people around the world who still care about this issue, there is a lot of information contained in this article. Feel free to contact me directly anytime via phone, text, Signal, Telegram or WhatsApp at 310-619-3055 if you have any questions.

Please watch the 3 minute video below:

The final round of scheduled negotiations for the PABS Annex to the WHO Pandemic Agreement are scheduled for March 23-28, 2026:

https://apps.who.int/gb/IGWG/e/e_igwg6.html

The 79th World Health Assembly is scheduled for May 18-23, 2026:

https://www.who.int/about/governance/world-health-assembly

Below is the most recent (March 9, 2026) draft of the PABS Annex:

DRAFT
Annex (IGWG Bureau 9 March 2026)
Per the report of IGWG5, the IGWG requested the Bureau to present proposals for sections of texts for the draft PABS Annex, in advance of the sixth meeting of the IGWG, building upon the on-screen text and discussions at the fifth meeting. Highlighting in the text follows the conventions used in the IGWG.
WHO Pathogen Access and Benefit-Sharing System (“PABS System”)
I. Scope, objectives and use of terms
A. Scope and objectives
Recognizing the sovereign right of States over their biological resources and the importance of collective action to mitigate public health risks, and underscoring the importance of promoting the rapid and timely sharing of “materials and sequence information on pathogens with pandemic potential” (hereinafter “PABS Materials and Sequence Information”) and, on an equal footing, the rapid, timely, fair and equitable sharing of benefits arising from the sharing and/or utilization of PABS Materials and Sequence Information for public health purposes, the Parties hereby operationalize the multilateral system for safe, transparent, and accountable access and benefit-sharing for PABS Materials and Sequence Information, the “WHO Pathogen Access and Benefit-Sharing System” (hereinafter the “PABS System”). This Annex sets out the provisions governing the PABS System established in Article 12 of the WHO Pandemic Agreement.
B. Use of terms
For the purposes of this Annex:
(a) “Pathogen with pandemic potential” means any pathogen that has both the potential for sustained transmission in humans and the capacity to cause a pandemic emergency as defined in Article 1(c) of the WHO Pandemic Agreement.
(b) “PABS Materials and Sequence Information” means respectively: (i) any biological material, including but not limited to DNA, RNA, proteins and metabolites when available, from a pathogen with pandemic potential; and (ii) genomic information generated from a pathogen with pandemic potential.
(c) “Participating Manufacturer” means an entity, including a developer, that manufactures vaccines, therapeutics and/or diagnostics, including by means of licensing agreements, and that has entered into a legally binding WHO PABS Contract.
II. Implementation of the PABS System
A. Operation of the PABS System
1. The operation of the PABS System rests on two pillars: the rapid and timely sharing of PABS Materials and Sequence Information, and, on an equal footing, the rapid, timely, fair and equitable sharing of benefits, both monetary and non-monetary, including annual monetary contributions, vaccines, therapeutics and diagnostics arising from the sharing and/or utilization of PABS Materials and Sequence Information for public health purposes.
2. All elements of the PABS System shall come into operation simultaneously, in accordance with this Annex.
3. Each Party, in the implementation of the PABS System, shall respect and comply with applicable international law, and with applicable national and/or domestic law, regulations and standards related to risk assessment, biosafety, biosecurity and export control of pathogens, and data protection.
4. In the implementation of the PABS System, the Parties shall recognize and respect the traditional knowledge of Indigenous Peoples and of local communities, including traditional medicine, with regard to PABS Materials and Sequence Information.
5. The participants of the PABS System include, inter alia:
(a) laboratories that have agreed to terms and conditions of the WHO Coordinated Laboratory Network for sharing of PABS Materials and Sequence Information (hereinafter WCLN);
(b) databases that have agreed to terms and conditions for WHO recognized sequence databases for sharing of PABS Sequence Information;
(c) entities utilizing PABS Materials and Sequence Information for commercial purposes that have entered into legally binding WHO PABS Contracts; and
(d) individuals or entities utilizing PABS Materials and Sequence Information for non-commercial purposes that have agreed to terms and conditions.
6. All participants of the PABS System shall:
(a) use PABS Materials and Sequence Information solely for the purpose of pandemic prevention, preparedness and response;
(b) comply with applicable benefit sharing obligations as described in Section C;
(c) comply with applicable provisions regarding onward transfer of PABS Materials and the sharing of PABS Sequence Information;
(d) handle PABS Materials and Sequence Information in accordance with applicable international law and with applicable national and/or domestic law, regulations and standards related to risk assessment, biosafety, biosecurity and export control of pathogens, and data protection;
(e) appropriately acknowledge:
(i) use of PABS Materials and Sequence Information in presentations and publications; and
(ii) the contributions of collaborators, including laboratories/countries providing PABS Materials and Sequence Information; and
(f) not claim any intellectual property rights over PABS Materials and Sequence Information, or their genetic parts or components, in the form received from the PABS System.
7. In accordance with Article 12, each Party shall review and, as it deems appropriate, align its national and/or regional access and benefit sharing measures applicable to PABS Materials and Sequence Information within the scope of this Annex, so that measures that are contrary to, or inconsistent with, or duplicative of, this Annex will not be applied upon entry into operation of all elements of the PABS System. Participating Manufacturers and other entities that comply with WHO PABS Contracts shall not be subject to additional benefit sharing measures with respect to matters covered by such contracts. Entities using PABS Materials and Sequence Information for purposes beyond the scope of the PABS System shall be subject to applicable law on access and benefit-sharing.
B. Access to PABS Materials and Sequence Information
1. Each Party, upon identification of a pathogen with pandemic potential and initial national risk assessment, shall:
(a) through a laboratory or laboratories authorized under relevant national or domestic procedures:
i. share PABS Materials, as soon as available, on a priority basis, with one or more WCLN laboratories of the Party’s choice, and notify WHO thereof;
ii. upload PABS Sequence Information, as soon as available, on a priority basis, to one or more WHO recognized sequence databases of the Party’s choice; and
iii. ensure that a unique persistent identifier is assigned and attached to each PABS Material and Sequence Information;
(b) agree to onward transfer and use of PABS Materials and Sequence Information, in line with the applicable terms and conditions;
(c) provide, as soon as available, accurate and sufficiently detailed public health information, clinical and epidemiological information, as well as metadata needed for risk assessment, and continue to share the aforesaid in the event additional information becomes available; and
(d) take appropriate measures, in accordance with national legislation and, where applicable, international obligations, to ensure that traditional knowledge of Indigenous Peoples and of local communities regarding PABS Materials and Sequence Information, including traditional medicine, shall be accessed with the prior and informed consent or approval and involvement of the concerned Indigenous Peoples and of local communities, and under mutually agreed terms.
2. The terms and conditions applicable to laboratories within the WCLN shall require those laboratories to, inter alia:
(a) have the necessary facilities, equipment and personnel, and meet required relevant international and national biosafety and biosecurity levels and standards necessary to safely handle pathogens with pandemic potential;
(b) ensure that a unique persistent identifier is retained for each PABS Material, and, where applicable, each PABS Sequence Information, including for purposes of onward transfers;
(c) ensure that, through the relevant material transfer agreement and/or notice of shipment, onward transfers of PABS Materials outside the WCLN are subject to the requirements in Section A.6 and the recipient’s commitment to enter into a WHO PABS Contract or agree to terms and conditions as described in Section C.1, C.2, or C.3, as applicable;
(d) notify WHO of onward transfers of PABS Materials, both within and outside the WCLN.
(e) upon request, engage scientists from originating laboratories, especially those from developing countries, in scientific projects associated with research on PABS Material and Sequence Information, and seek to ensure their co-authorship in the preparation of manuscripts for presentation and publication, according to best practices for scientific publications; and
(f) share relevant results and analyses with WHO and the Party providing PABS Materials and Sequence Information in a timely manner.
3. The terms and conditions applicable to WHO recognized sequence databases for sharing of PABS Sequence Information shall require those databases to, inter alia:
(a) ensure their governance practices and terms of use are transparent and publicly accessible, including for the participants of the PABS System;
(b) comply with their own policies regarding onward sharing of PABS Sequence Information;
(c) support the rapid upload and availability of PABS Sequence Information and provide access thereto free of charge;
(d) apply appropriate information security policies and practices and quality standards, including to enable reliable identification of PABS Sequence Information over time and to support interoperability;
(e) ensure that a unique persistent identifier is assigned, attached and retained for each PABS Sequence Information;
(f) enable the reporting of and preserve information on data provenance, including the country of origin and laboratory which generated the PABS Sequence Information;
(g) notify users of the requirements in Section A.6, and that utilization of PABS Sequence Information entails commitment to enter into a WHO PABS Contract or agree to terms and conditions as described in Section C.1, C.2, and C.3, as applicable;
(h) provide records of PABS Sequence Information to WHO, upon request, to be referenced in tools to support implementation of the PABS System; and
(i) notify users that failure to comply with the applicable terms and conditions and/or WHO PABS Contract may result in denial, suspension or termination of access to PABS Sequence Information, where applicable.
C. PABS System benefit-sharing
1. WHO PABS Contracts for Participating Manufacturers shall include, inter alia, the following obligations:
(a) In the event of a pandemic emergency, in accordance with Article 12.6, each Participating Manufacturer shall make available to WHO rapid access targeting twenty per cent (20%) of its real-time production of safe, quality and effective vaccines, therapeutics and diagnostics for the pathogen causing the pandemic emergency, provided that:
i. a minimum threshold of ten per cent (10%) of its real-time production is made available to WHO as a donation; and
ii. the remaining percentage, with flexibility based on the nature and capacity of each Participating Manufacturer, is reserved at affordable prices to WHO.
(b) In the event of a public health emergency of international concern, in accordance with Article 12.7, Participating Manufacturers shall implement benefit-sharing provisions, including options regarding access to safe, quality and effective vaccines, therapeutics, and diagnostics for the pathogen causing the public health emergency of international concern, such as agreeing to provide, where available, promptly and on a priority basis to WHO on its request, such products at affordable prices, based on needs assessed by WHO.
(c) In addition to the above benefits, Participating Manufacturers, in accordance with Articles 12.5 and 12.8, shall:
i. provide monetary benefits, including annual monetary contributions based on objective, transparent and measurable criteria, and taking into account their use of PABS Materials and Sequence Information as well as their nature and capacity;
ii. based on their nature, capacity and use of PABS Materials and Sequence Information, commit to at least two of the following options:
1. capacity-building and technical assistance;
2. research and development cooperation;
3. facilitating rapid access to available vaccines, therapeutics and diagnostics with a view to responding to public health risks and events in the context of Article 13.3 of the International Health Regulations (2005);
4. granting of non-exclusive licenses to manufacturers in developing countries for the effective production and delivery of vaccines, therapeutics and diagnostics;
5. other forms of technology transfer as mutually agreed, including the transfer of relevant knowledge, skills and technical expertise.
2. WHO PABS Contracts for other entities utilizing PABS Materials and Sequence Information for commercial purposes, including developers that do not manufacture vaccines, therapeutics or diagnostics, shall, in accordance with Articles 12.5 and 12.8, include, inter alia, obligations for such entities to:
(a) provide monetary benefits, including annual monetary contributions based on objective, transparent and measurable criteria, and taking into account their use of PABS Materials and Sequence Information, as well as their nature and capacity;
(b) based on their nature, capacity and use of PABS Materials and Sequence Information, commit to at least one of the following options:
i. capacity-building and technical assistance;
ii. research and development cooperation;
iii. facilitating rapid access to available pandemic-related health products with a view to responding to public health risks and events in the context of Article 13.3 of the International Health Regulations (2005);
iv. granting of non-exclusive licenses to manufacturers in developing countries for the effective production and delivery of vaccines, therapeutics and diagnostics; v. other forms of technology transfer as mutually agreed, including the transfer of relevant knowledge, skills and technical expertise.
3. Applicable terms and conditions for entities using PABS Materials and Sequence Information for noncommercial purposes shall include, inter alia, obligations to:
(a) engage scientists from originating labs, especially those from developing countries, in scientific projects associated with research and development on PABS Material and Sequence Information, and seek to ensure their co-authorship in preparation of manuscripts for presentation and publication, promoting broad and free access;
(b) based on their nature and capacity, consider options for:
i. conducting risk analysis and assessment and outbreak forecasting;
ii. capacity-building and technical assistance;
iii. research and development cooperation;
iv. monetary benefits; and
(c) inform WHO, and enter into a WHO PABS Contract as appropriate, in the event they intend to utilize PABS Materials and Sequence Information for commercial purposes.
III. Governance and review of the PABS System
A. Governance
1. The Conference of the Parties shall oversee implementation of the PABS System. In support of this function, a subsidiary body to be known as the PABS Advisory Group is hereby established and shall operate in a manner consistent with the WHO Regulations for expert Advisory Panels and Committees. The Conference of the Parties shall approve at its first session terms of reference for the PABS Advisory Group and modalities for its operationalization and governance.
2. The PABS Advisory Group shall, inter alia, provide technical guidance and evidence-based recommendations to facilitate the implementation and operation of the PABS System and report to the Conference of Parties, through the Director-General, on operational and technical matters related to the PABS Annex.
3. The Secretariat of the World Health Organization, as Secretariat of the WHO Pandemic Agreement pursuant to Article 22 thereof, shall, inter alia, for the purposes of implementation of this Annex:
(a) in accordance with all relevant provisions of the WHO Pandemic Agreement, administer and coordinate the PABS System under the guidance of the Conference of the Parties, and regularly report to the Conference of the Parties on the operations of the PABS System;
(b) for the purposes of the coordination and operation of the PABS System, collaborate with relevant international organizations and relevant stakeholders;
(c) operationalise the WCLN and the recognition of databases for sharing PABS Sequence Information according to the requirements set out in Section II.B of this Annex;
(d) enter into WHO PABS Contracts and agree terms and conditions according to the requirements set out in Section II.C of this Annex;
(e) mobilize and facilitate technical assistance to Parties, upon request, and collaborate to strengthen required capacities, especially in developing countries; and
(f) establish a platform to provide visibility on operational progress, including, inter alia, lists of laboratories authorized under relevant national or domestic procedures, laboratories that are part of the WCLN, WHO recognized databases for sharing PABS Sequence Information, concluded WHO PABS Contracts and terms and conditions, and the implementation of monetary and nonmonetary benefit sharing.
4. Any Party may bring any allegation of non-compliance by an institution or laboratory in the WCLN or a WHO recognized sequence database with the applicable terms and conditions to the attention of the WHO Director-General, who will review the circumstances and may discuss the matter with the PABS Advisory Group to determine appropriate action(s) to be taken, including where appropriate the consideration of suspending or revoking the WHO designation/recognition of that entity. Any allegation of noncompliance with, or breach of, WHO PABS Contracts shall be addressed in accordance with the relevant terms of those contracts, and the Director-General shall report to the Conference of the Parties regarding any such allegations.
B. Review of the PABS System
The Conference of the Parties shall review the PABS System, with a view to ensuring its effective implementation, operations and functioning, no later than five years after entry into force of the WHO Pandemic Agreement and thereafter every five years. In addition, the Conference of the Parties may also conduct extra-ordinary reviews of the PABS System, as it deems appropriate.
https://healthpolicy-watch.news/wp-content/uploads/2026/03/Draft-PABS-Annex-text-Bureau-version-of-9-March-20262.pdf

Who Pathogen Access And Benefit Sharing (pabs) System March 9, 2026 Draft

325KB ∙ PDF file

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ADDITIONAL INFORMATION:

March 19, 2026

Latest WHO PABS Text: A Blueprint for Biopiracy?

March 18, 2026

Pressure Builds as Pandemic Agreement Talks Reach Final Week With Little Consensus

https://healthpolicy-watch.news/pressure-builds-as-pandemic-agreement-talks-reach-final-week-with-little-consensus/

March 16, 2026

PABS Explained

March 14, 2026

World Council for Health

The Geneva Gamble: Why the WHO’s PABS Power Grab is a Prescription for Disaster

In the sterile meeting rooms of Geneva, a coup is being plotted. It’s not a coup with tanks and soldiers, but with legal clauses, technocratic jargon, and a mountain of pharmaceutical money. The World Health Organization and its globalist backers are in a frantic, final push to erect a central command for global health. The vehicle for this power seizur…

3 months ago · 48 likes · World Council for Health

March 12, 2026

Anonymous Access to PABS Sequence Information: Open Access or Open Exploitation?

March 12, 2026

WHO: Bureau PABS Text Only Accommodates EU’s Unreasonable Demands, Promoting Biopiracy

The draft, which promotes greater legal uncertainty, is weak in benefit-sharing, and effectively normalises biopiracy, should be of serious concern to developing countries.
https://twn.my/title2/health.info/2026/hi260301.htm

March 11, 2026

Designing the PABS System: Contracts, IP and the Equity Test

March 10, 2026

“The Elders” urge progress on Pathogen Access and Benefit Sharing Annex to secure a fair pandemic deal

https://theelders.org/sites/default/files/newsarticaldocument/The%20Elders%20urge%20progress%20on%20PABS%20Annex%20to%20secure%20a%20fair%20pandemic%20deal%2010032026_0.pdf

March 2, 2026

The Battle for an Equitable and Accountable PABS System

February 24. 2026

EU & Allies in PABS Negotiation: Promoting Innovation or Undermining the Right to Science & Equity?

February 20, 2026

WHO: EU Backtracks on Pandemic Agreement commitments, Ignores Evidence & Precedents

https://twn.my/title2/health.info/2026/hi260204.htm

February 13, 2026

WHO: Document reveals questionable practices in pathogen-sharing arrangements in WHO-managed networks

https://twn.my/title2/health.info/2026/hi260203.htm

February 13, 2026

PABS: South seeks stronger text on contracts, data governance, benefit sharing

https://twn.my/title2/health.info/2026/hi260202.htm

February 9, 2026

Powerful WHO Members Hint at Delay in Pandemic Talks if No Legal Certainty on Pathogen Information

https://healthpolicy-watch.news/powerful-who-members-hint-at-delay-in-pandemic-talks-if-equity-demands-are-ignored/

January 30, 2026

PABS Negotiations at a Crossroads

January 12, 2026

December 1, 2025

November 3, 2025

PABS could enable biopiracy & promote inequity, alerts TWN

October 30, 2025

Centring Equity in the PABS Annex

October 15, 2026

https://rumble.com/v715b80-reggie-littlejohns-address-at-the-european-parliament-stop-pabs-and-gain-of.html

September 6, 2025

August 23, 2025

WHY THE WORLD SHOULD OPPOSE THE WHO PATHOGEN ACCESS AND BENEFIT SHARING SYSTEM

If you would like to have a respectful discussion regarding this issue and help work on possible solutions, then please feel free to contact me directly anytime at 310-619-3055 (phone, text, Signal, Telegram or WhatsApp) or James.Roguski@gmail.com

James Roguski

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Aerotoxic Syndrome

James Roguski — Fri, 13 Mar 2026 19:05:58 GMT

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Please watch the interview below with Dr. Kevin Stillwagon:

https://rumble.com/v772lao-discussing-aerotoxic-syndrome-with-dr.-kevin-stillwagon.html

Aerotoxic syndrome refers to a range of acute and chronic health issues, including neurological, respiratory, and cognitive symptoms caused by breathing airplane cabin air contaminated by engine oils and hydraulic fluids (bleed air).

Aerotoxic syndrome is linked to “fume events” and, in some cases, can lead to long-term, disabling conditions for frequent flyers and crew. Unfortunately, the existence of “Aerotoxic Syndrome” as a specific medical diagnosis is still debated by some in the scientific and aviation communities.

The syndrome is attributed to contaminated bleed air, which is UNFILTERED engine-compressed air used to pressurize the cabin. If engine seals are faulty, engine oil and hydraulic fluid can enter this air supply.

“Fume events” are acute incidents where visible smoke or haze, accompanied by a distinct smell, enters the cabin, often causing immediate symptoms in passengers and crew. Contaminants often mentioned in these cases include organophosphates (OPs) and volatile organic compounds.

“Fume events” smell like dirty sweatsocks because heated jet engine oil, containing toxic additives like triarylphosphates (TCP), leaks into the cabin air supply via faulty seals, creating a foul, musty, or oily odor. This odor is caused by the thermal degradation of these lubricants and hydraulic fluids, often described as smelling like dirty socks, wet dog, or strong chemicals.

Acute, short-term symptoms occurring during or immediately after a flight include dizziness, severe headaches (migraines), nausea, confusion, vertigo, and eye/respiratory irritation.

Long-term effects from repeated exposure include chronic fatigue, cognitive impairment (”brain fog”), memory loss, depression, anxiety, tremors, and muscle/joint pain.

Aircrew (pilots and cabin crew) and frequent flyers are at the highest risk due to repeated exposure. Regulatory bodies estimate that some form of cabin air contamination (”fume events”) may happen on 0.2%–0.5% of flights, though many go unreported.

Symptoms often appear immediately, or can develop chronically from long-term exposure. It is generally considered an occupational issue for pilots and cabin crew, who have higher exposure levels compared to passengers.

A Solution?

Aerotoxic syndrome: What is that?

Commercial jet aircraft use air from the engines not only for propulsion purposes, but also to refresh the aircraft’s cabin air. This air is unfiltered when vented into the cabin. A small amount of oil generally leaks past the oil seals of the aircraft’s turbine engines. Tricresyl phosphate (TCP), an organophosphate compound, is released from that oil and ends up, along with metal shavings from the turbine blades, via the high pressure compressor, in the air destined for the cabin’s air conditioning. The flight crew and passengers inhale those burnt oil fumes as well as the toxic substances they contain.
Occasionally, a so-called ‘fume event’ occurs on board an aircraft. That is when more oil than usual suddenly leaks into the air, potentially causing, as the name indicates, a thin smoke screen to develop. This phenomenon occurs in one in roughly every 2000 flights, particularly during take-off and landing when more engine power is required.
Exposure to cabin air, whether polluted or not, is associated with certain health risks. This phenomenon is known as the aerotoxic syndrome, as explained in a recent article published by neurologist Gerard Hageman. The symptoms are diverse, consisting predominantly of fatigue and mild cognitive impairment.
Aerotoxic syndrome: diverse symptoms
Not everyone has symptoms; depending on the severity of the pollution and on the individual, the health effects may become apparent after just one flight or they may develop after repeated exposure to the harmful substances.
Symptoms related to aerotoxic syndrome include:
Memory impairment
Headaches
Dizziness
Nausea
Disorientation
Balance problems
Tightness in the chest
Breathing problems
Vomiting
Burnout symptoms
Shortness of breath
Fatigue
Coughing
Reduced vision
Palpitations
Lung irritation
Diarrhoea
Tinnitus (ringing in the ears)
Cognitive problems
Irritated eyes
Trembling
Increased heart rate
Cardiac arrhythmias
Trouble walking
Changed personality
Feeling of unease
Strong emotions and crying spells
Aerotoxic syndrome: how to prevent it
1. If you suffer from serious jet lag symptoms, i.e., aerotoxic syndrome, travel by other means than by plane.
2. Book flights on a Boeing 787 Dreamliner. This is currently the only plane that does not emit any toxic substances from the engines into the cabin.
3. Wear a special mask (P3 A2) in flight. This mask filters 95% of toxic substances from the air. Given that more toxic substances are vented into the cabin during take-off and landing, those are the times to wear a mask.
4. Drink bottled water - The drinking water system on board the aircraft is pressurised with the same contaminated air and is often treated with chemicals. So think twice about drinking coffee, tea and water. Preferably drink soft drinks, fruit juice or bottled water instead.
5. Have your symptoms diagnosed as soon as possible
If you repeatedly experience symptoms attributed to the aerotoxic syndrome, have them diagnosed within the shortest possible time frame.
https://www.fninstitute.com/en/complaints/brain-trauma/aerotoxic-syndrome

February 13, 2026

Forget About Chemtrails... The Real Toxic Exposure Is Inside the Cabin

Every modern jetliner except the Boeing 787 [which is equipped with a dedicated air inlet] supplies its cabin air by tapping directly into its engine compressors. That’s called “bleed‑air.” Sounds harmless until you realize those same compressors are lubricated with organophosphate‑loaded synthetic oils designed for turbines, not lungs.
When those seals inevitably leak — and they do — the hot oil turns into a chemical mist: tricresyl phosphate, aldehydes, carbon nanoparticles, and other industrial neurotoxicants. You breathe it. The crew breathes it. Everyone pretends it’s fine.
It’s not.
Independent laboratories have found these compounds in air filters, crew blood samples, and even in urine after fume events. The symptoms are textbook organophosphate poisoning: headaches, dizziness, nerve pain, brain fog, heart palpitations. For decades, airlines and regulators dismissed them as “psychological.” Sound familiar?
The fix is simple, but inconveniently expensive:
Monitor cabin air for organophosphates in real time.
Use non‑toxic oil formulations and improved seals.
Stop lying to the public about “brief odor incidents” or “dirty sock smells.”
https://drkevinstillwagon.substack.com/p/forget-about-chemtrails

February 12, 2026

France is the first country to definitively recognize, through a final judicial decision, a chronic pathology linked to repeated exposure to cabin air contaminants.

The Toulon Judicial Court (France) – Social Division, in a judgment delivered on December 19, 2025, ordered the recognition and coverage under occupational risk legislation of a pathology attributable to chronic exposure to aircraft engine oil fumes.
The certificate of non-appeal issued on February 5, 2026 renders this decision final and binding. This constitutes the first final judicial recognition worldwide of aerotoxic syndrome linked to chronic exposure, in the absence of an identified acute “fume event.”
A Historic Judicial Decision
The Court recognized the existence of a direct and essential link between the professional activity of an airline pilot and:
“Central and peripheral autoimmune neuropathy with demyelinating syndrome.”
Despite two successive unfavorable opinions issued by Regional Committees for the Recognition of Occupational Diseases (CRRMP), the Court held that:
occupational exposure to organophosphate compounds derived from engine oils was established;
metallic and chemical particles were found in the claimant’s body;
the chronology of symptom onset was consistent with occupational exposure;
no convincing alternative cause had been demonstrated;
the absence of an international scientific consensus does not prevent recognition of a causal link in a properly substantiated individual case.

The Primary Health Insurance Fund (CPAM) of the Var was ordered to recognize and cover the pathology under occupational disease legislation.
Versions of the official decision can be downloaded in English, French, German, Italian, Portuguese, Spanish at the link below:
https://www.unfiltered.vip/avsa-court-ruling-as-is-occupational-disease.html

November 2015

Aircraft Cabin Bleed Air Contaminants: A Review

Quantification of the potential health risks associated with exposure to bleed-air contaminants in cabin air is not possible without broad identification and measurement of the representative hazardous constituents of bleed air during contaminated air events. Included in the 2012 mandate (Public Law 112-95) is the directive to the FAA to “assess bleed air quality on the full range of commercial aircraft operating in the United States.” Carrying out such a mandate requires adequate funding to support research activities.
https://www.faa.gov/sites/faa.gov/files/data_research/research/med_humanfacs/oamtechreports/201520.pdf

May 16, 2023

Health consequences of exposure to aircraft contaminated air and fume events: a narrative review and medical protocol for the investigation of exposed aircrew and passengers

Thermally degraded engine oil and hydraulic fluid fumes contaminating aircraft cabin air conditioning systems have been well documented since the 1950s. Whilst organophosphates have been the main subject of interest, oil and hydraulic fumes in the air supply also contain ultrafine particles, numerous volatile organic hydrocarbons and thermally degraded products.
Inhalation of these potentially toxic fumes is increasingly recognised to cause acute and long-term neurological, respiratory, cardiological and other symptoms. Cumulative exposure to regular small doses of toxic fumes is potentially damaging to health and may be exacerbated by a single higher-level exposure. Assessment is complex because of the limitations of considering the toxicity of individual substances in complex heated mixtures.
There is a need for a systematic and consistent approach to diagnosis and treatment of persons who have been exposed to toxic fumes in aircraft cabins. The medical protocol presented in this paper has been written by internationally recognised experts and presents a consensus approach to the recognition, investigation and management of persons suffering from the toxic effects of inhaling thermally degraded engine oil and other fluids contaminating the air conditioning systems in aircraft, and includes actions and investigations for in-flight, immediately post-flight and late subsequent follow up.
https://pmc.ncbi.nlm.nih.gov/articles/PMC10186727/

June 12, 2015

Cognitive impairment and associated loss in brain white microstructure in aircrew members exposed to engine oil fumes

In aircrew we found significantly more self-reported cognitive complaints and depressive symptoms, and a higher number of tests scored in the impaired range compared to the control group. We observed small clusters in the brain in which white matter microstructure was affected. Also, we observed higher cerebral perfusion values in the left occipital cortex, and reduced brain activation on a functional MRI executive function task. The extent of cognitive impairment was strongly associated with white matter integrity, but extent of estimated number of flight hours was not associated with cognitive impairment nor with reductions in white matter microstructure. Defects in brain white matter microstructure and cerebral perfusion are potential neurobiological substrates for cognitive impairments and mood deficits reported in aircrew.
https://pmc.ncbi.nlm.nih.gov/articles/PMC4908163/

https://www.facebook.com/afacwa/videos/exposure-to-toxic-air-on-aircraft/1293812328964847/

Aerotoxic Syndrome—Susceptibility and Recovery

Significant numbers of aircrew and jet airline passengers are affected by post-flight symptoms of ill health, usually nowadays labelled “aerotoxic syndrome”. It could be inferred from a large passenger survey carried out in the Netherlands that up to 50% of flights may engender malaise to varying degrees, and up to 50% of the population might be susceptible to suffering from actual intoxication from the contaminants known to occur in aircraft cabin air. In-flight measurements of its composition have revealed the presence of known neurotoxins, notably tricresyl phosphate and carbon monoxide, both of which can enter the cabin air as it is bled off the main engines.
The continuing exponential growth of air passenger traffic means that cabin air contamination will eventually become a major public health hazard if effective action is not taken
https://pmc.ncbi.nlm.nih.gov/articles/PMC12196834/

Canadian Union of Public Employees - Onboard Fume Events

What are the hazards of “bleed” air?
Bleed air is supposed to be fresh, clean, air taken from the compressor section of the engine before it is mixed with fuel or exhaust gasses. However, it isn’t always “clean.”
Synthetic lubricants with special heat-resistant additives are used to keep moving parts in a jet engine at a cool operating temperature. If there is a malfunction, the lubricating oil or other chemicals such as de-icing fluid can be pulled into the bleed air and fed directly into the aircraft cabin. Even engines under the strictest of maintenance schedules can malfunction or break down. Additionally, the seals inside engines can lead to low doses of exposure because of the way many of them are designed.
At elevated temperatures, such as those found inside a jet turbine, the additives in these products can degrade and become converted into a fine mist or fumes that becomes part of the air in the cabin. There is no filtration equipment currently onboard standard commercial aircraft designed to remove these toxic fumes before or after they enter the cabin.
It has been known for more than 60 years that the malfunctioning of an engine can introduce unwanted chemicals into the cabin and result in acute exposure. This is commonly known as a “fume event.” A recent World Health Organization publication breaks down all the different chemicals that are in an engine before the combustion chamber.
“Turbine engines utilize synthetic lubricants that generally include an ester base stock (95%), a wide variety of triaryl phosphates (TAPs), organophosphate (OP) anti-wear additives (around 3%), amine antioxidants and proprietary ingredients (1–2%). The commercial formulation of the OP additive is generally cited as tricresol phosphate (TCP). Exposure of such substances to extreme temperatures generates a large number of pyrolyzed [decomposed through heating] compounds and hydrocarbons. Hydraulic fluids are made up primarily of tributyl phosphates (TBPs) and triphenyl phosphates, while de-icing fluids consist of ethylene and propyl glycols.”
https://cupe.ca/onboard-fume-events

September 26, 2017

Aerotoxic Syndrome – A Hazard of Airline Travel

Aerotoxic Syndrome is caused by the inhalation of contaminated airline cabin air that is caused by “bleed air” and other fumes entering the aircraft cabin air supply. Bleed air contamination has been recognized since the introduction of the bleed air system in the 1950s and is still a health hazard today. With the exception of the Boeing 787, today’s aircraft all use the bleed air system to provide cabin ventilation. Commercial airlines routinely pump or “bleed” compressed air from airline engines to cabins where crew members inhale this unfiltered air that is contaminated with pyrolized hydraulic fluids and synthetic jet engine fuels. The contamination includes a neurotoxic organophosphate by product. A small 2016 study by Reneman et al 2016 demonstrated that cognitive impairment in the participating aircrew was directly associated with the number of airline flights and the extent of compromised integrity of brain white matter.

https://naturalhealthresearch.org/aerotoxic-syndrome-a-hazard-of-airline-travel/

LEGAL ACTIONS

Aerotoxic Syndrome Lawsuit: Airplane Toxic Exposure

https://personalinjurylawcal.com/aerotoxic-syndrome/

Toxic cabin air

https://www.unitelegalservices.org/services/toxic-cabin-air

The following articles are only available to those who subscribe to the Wall Street Journal:

Wall Street Journal

September 13, 2025

Toxic Fumes Are Leaking Into Airplanes, Sickening Crews and Passengers

https://www.wsj.com/business/airlines/air-travel-toxic-fumes-64839d6e

September 14, 2025

What You Need to Know About Fume Events on Airplanes

https://www.wsj.com/business/airlines/what-you-need-to-know-about-fume-events-on-airplanes-e79138c6

September 23, 2025

The Airline Industry Has a Toxic Fume Problem

https://www.wsj.com/podcasts/the-journal/the-airline-industry-has-a-toxic-fume-problem/b0b96fa7-a88a-41d6-a154-cdbac36f4048

December 21, 2025

‘He Was Poisoned.’ Toxic Fumes on Planes Blamed for Deaths of Pilots and Crew

https://www.wsj.com/business/airlines/toxic-fumes-airplane-pilot-crew-death-739fa3bb

December 22, 2025

Why Toxic Fumes on Planes Are Being Blamed for Illnesses and Deaths

https://www.wsj.com/podcasts/whats-news/why-toxic-fumes-on-planes-are-being-blamed-for-illnesses-and-deaths/56829939-a179-4569-af9e-f432ad58edb6

December 22, 2025

I’m Worried About Toxic Fumes on My Upcoming Flight—What Can I Do?

https://www.wsj.com/business/airlines/im-worried-about-toxic-fumes-on-my-upcoming-flight-what-can-i-do-d436198f

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An Independent Alberta?

James Roguski — Fri, 06 Mar 2026 16:12:24 GMT

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Please watch the video below:

https://rumble.com/v76q45y-an-interview-with-bruce-pardy-about-independence-for-alberta.html

RightsProbe.org

https://x.com/PardyBruce

https://BrucePardy.substack.com/archive

Below is a timeline of events:

December 18, 2025

Alberta increases citizen initiative petition fee from $500 to $25,000

https://www.cbc.ca/news/canada/edmonton/citizen-petition-referendum-increase-9.7021761

December 23, 2025

Should Alberta Become An Independent State?

https://jamesroguski.substack.com/p/should-alberta-become-an-independent

January 2, 2026

Elections Alberta announced that the citizen petition had been issued and signatures could be collected beginning on January 3.

The deadline to submit signatures for the Alberta independence petition, led by the Alberta Prosperity Project, is May 2, 2026.

Proponents must gather 177,732 signatures—10% of the 2023 provincial election voters—between January 3 and May 2, 2026, to trigger a referendum.

The proposed independence question is clear:

“Do you agree that the province of Alberta should cease to be a part of Canada to become an independent state?”

February 20, 2026

Premier Danielle Smith says a referendum is to be held on October 19, 2026 to ask Albertans about how they want the province to deal with immigration as well as the Constitution.

She says it will include these nine questions:

On immigration
1. Do you support the Government of Alberta taking increased control over immigration for the purposes of decreasing immigration to more sustainable levels, prioritizing economic migration and giving Albertans first priority on new employment opportunities?
2. Do you support the Government of Alberta introducing a law mandating that only Canadian citizens, permanent residents and individuals with an Alberta-approved immigration status will be eligible for provincially funded programs, such as health care, education and other social services?
3. Assuming that all Canadian citizens and permanent residents continue to qualify for social support programs as they do now, do you support the Government of Alberta introducing a law requiring all individuals with a non-permanent legal immigration status to reside in Alberta for at least 12 months before qualifying for any provincially funded social support programs?
4. Assuming that all Canadian citizens and permanent residents continue to qualify for public health care and education as they do now, do you support the Government of Alberta charging a reasonable fee or premium to individuals with a non-permanent immigration status living in Alberta for their and their family’s use of the health care and education systems?
5. Do you support the Government of Alberta introducing a law requiring individuals to provide proof of citizenship, such as a passport, birth certificate, or citizenship card, to vote in an Alberta provincial election?
On the Canadian Constitution
Do you support the Government of Alberta working with the governments of other willing provinces to amend the Canadian Constitution in the following ways:
6. Have provincial governments, and not the federal government, select the justices appointed to provincial King’s Bench and Appeal courts?
7. Abolish the unelected federal Senate?
8. Allow provinces to opt out of federal programs that intrude on provincial jurisdiction such as health care, education, and social services, without a province losing any of the associated federal funding for use in its social programs?
9. Better protect provincial rights from federal interference by giving a province’s laws dealing with provincial or shared areas of constitutional jurisdiction priority over federal laws when the province’s laws and federal laws conflict?
https://www.ctvnews.ca/edmonton/article/increased-control-over-immigration-nine-questions-on-alberta-referendum-in-october/

March 3, 2026

The Fix Is in to Defeat Alberta Independence

Last week, Alberta Premier Danielle Smith announced a referendum for October 19. It will ask Albertans a slate of policy and constitutional questions. Independence, she said the next day, will be added to the ballot if the requisite number of signatures is met in the petition drive, which is likely. Albertans will get their chance to say if they want to leave Canada. But Canadian federalists can relax. The Alberta premier is one of them. The referendum is the fix to defeat Alberta independence. It will undermine the separatist cause and split the independence vote.
Smith has repeatedly said that her mandate is a sovereign Alberta inside a united Canada. But many of her fellow Albertans are fed up. They perceive that their province has long received a raw deal in Confederation. They tire of Ottawa throwing obstacles in the way of their primary industries. They resent having their wealth taxed and sent elsewhere around the country. A growing number of Albertans are determined to leave Canada. Recent polls peg it at about one in three.
https://brownstone.org/articles/the-fix-is-in-to-defeat-alberta-independence/

First Nations chiefs unanimously pass non-confidence vote in Alberta government

First Nations chiefs across Alberta unanimously passed a vote of non-confidence in the Alberta government this week, citing concerns around the separatist movement and a failure to meet their treaty responsibilities.
In a news release, the Assembly of Treaty Chiefs of Treaty No. 6, Treaty No. 7, Treaty No. 8 said the provincial government, governed by the United Conservative Party, has repeatedly shown a lack of understanding and respect for its treaty responsibilities, demonstrating its “inability to responsibly and respectfully govern the province of Alberta.”
“We have to put [the government] on notice that this is completely unacceptable,” Trevor Mercredi, grand Chief of Treaty 8 First Nations of Alberta, told CBC News.
https://www.cbc.ca/news/canada/edmonton/first-nations-chiefs-alberta-non-confidence-vote-9.7109712

If you would like to have a respectful discussion regarding this issue and help work on possible solutions, then please feel free to contact me directly anytime at 310-619-3055 (phone, text, Signal, Telegram or WhatsApp) or James.Roguski@gmail.com

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Brian McGinnis

James Roguski — Thu, 05 Mar 2026 22:05:47 GMT

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WARNING: GRAPHIC CONTENT

The videos below clearly shows Brian McGinnis’s arm being broken. Be brave. Watch the videos.

Marine Veteran Brian McGinnis Removed From Senate Hearing After Protest Over US Policy Toward Israel

Brian C. McGinnis, a Marine Corps veteran and Green Party candidate for U.S. Senate in North Carolina, was forcibly removed from a Senate Armed Services Committee hearing on March 4, 2026, after interrupting the proceedings with a protest over U.S. policy in the Middle East. During the hearing, McGinnis stood and began shouting objections to what he characterized as the U.S. movement toward war with Iran in support of Israel.
Video from inside the chamber shows Capitol Police moving quickly to restrain and escort him out after he refused to stop speaking. Officers later arrested McGinnis on charges including assault on a police officer, resisting arrest, and unlawful demonstration.
Footage of the removal shows multiple officers attempting to pull McGinnis away from a doorway as he held onto the frame. During the struggle, Senator Tim Sheehy of Montana, a Republican member of the committee and former Navy SEAL, left his seat and physically assisted officers in removing McGinnis. The video shows Sheehy grabbing McGinnis as officers attempted to free his arm from the doorway and carry him out.
Capitol Police later stated that McGinnis “got his own arm stuck in a door to resist our officers and force his way back into the hearing room,” and reported that officers sustained minor injuries during the encounter. McGinnis allegedly suffered a broken arm during the struggle.
The visual record confirms that security personnel were already engaged in removing McGinnis when Sheehy intervened physically. Whether that intervention was necessary or appropriate has become a point of debate.
What McGinnis Said About Israel
McGinnis framed his protest explicitly around U.S. support for Israel and the risk of American military escalation with Iran. According to accounts from inside the hearing, he shouted statements including that Americans did not want to “fight and die for Israel.” He positioned his protest as an anti-war stand and an effort to confront lawmakers about what he views as foreign policy driven by special interests rather than the will of American voters.
His comments reflect a broader political argument that U.S. military commitments in the region are shaped in part by long-standing strategic ties with Israel. That position remains controversial across party lines. Supporters of the U.S.-Israel relationship describe it as a cornerstone of American security policy, while critics argue that congressional alignment with Israeli policy can contribute to entanglement in regional conflicts.
Inside congressional hearings, however, outbursts are treated as procedural violations regardless of viewpoint. Senate rules permit the removal of individuals who disrupt official proceedings. McGinnis’s arrest followed that pattern.
The Senator’s Role in the Removal
Senator Sheehy later described his actions as an effort to assist law enforcement and de-escalate the situation. Video evidence shows him helping officers lift and remove McGinnis after police had already restrained him. Critics argue that an elected senator inserting himself into a physical removal raises concerns, particularly because trained Capitol Police were already present and engaged.
https://www.military.com/feature/2026/03/05/brian-mcginnis-removed-senate-hearing-after-protest-over-us-policy-toward-israel.html

Brian McGinnis is a Green Party candidate for U.S. Senate from North Carolina

About Brian McGinnis:

I have lived long enough to know that truth is simple. I have seen effective leadership in different parts of the world where public servants have actually served the public with healthcare, education and a hopeful future. Yet, here I have seen the complexity of lies that politicians use for why they cannot deliver for people, while always delivering for the donors who live at the people’s expense. I am a Green because I know capitalist parties will never actually serve working class people. The Democrats and Republicans may market to working class people but when push comes to shove they will both fail working class people time and time again. Because of all of these things I chose to do something by becoming a Green and running for US Senate.

I have worked for a living and I know what that is like.
I am a family man with a beloved wife and four wonderful kids.
As a veteran and firefighter putting everything on the line for others comes naturally to me and that will not change, if elected.
I value the truth, integrity and political courage as a matter of life and death.
I have also come to realize that the two capitalist parties, the Democrats and Republicans, are the problem, not the solution. That is why I am running as a Green.

https://BrianMcGinnis4ussenatenc.org/

Go Fund Me for Brian McGinnis

https://www.gofundme.com/f/help-brian-with-medical-and-legal-aid

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Regime Change War In Iran?

James Roguski — Sat, 28 Feb 2026 16:14:27 GMT

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Interview with Jeff Dornik, the CEO of Pickax

James Roguski — Fri, 27 Feb 2026 18:52:35 GMT

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Please watch the interview with Jeff Dornik, the CEO of Pickax:

https://rumble.com/v76d5ai-interview-with-jeff-dornik-the-ceo-of-pickax.html

CLICK HERE TO JOIN PICKAX FOR FREE

Click above to open your account and then download the app for Android or Apple.

The Top 10 Reasons to Join Pickax:

Pickax is truly a free speech social media platform. There are NO algorithms to manipulate your feed or “shadow ban” your posts. Everyone who follows you will see all of your posts in their feed and you will see all of the posts of everyone you follow in your feed.
Verified users are real people, not bots.
Rumble videos can be integrated directly into posts and articles.
You can become a content creator at no cost.
You own your content.
Advertising revenue will be shared with content creators.
There are no fees to get a “blue check”.
You can write long-form articles as well as simple posts.
You can work to build a true community of friends, followers and subscribers.
You will be able to share in the growth of Pickax instead of helping billionaires like Elon Musk and Mark Zuckerberg get even richer.

Previous interview:

https://www.youtube.com/watch?v=TClfN8GaFBw

https://rumble.com/v6y8xd0-discussing-pickax-with-jeff-dornik.html

Previous articles about Pickax:

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Petition to Stop Geoengineering

James Roguski — Thu, 26 Feb 2026 15:00:20 GMT

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I received this via email this morning.

I have signed this petition and I encourage you to also sign it.

CLICK HERE TO SIGN THE PETITON

Petition to President Donald J. Trump

Stop Geoengineering Experiments on the American people

Preamble: President Donald J. Trump, we respectfully urge you to take decisive action to prevent any geoengineering experimentation or deployment that could threaten the American people.

Whereas: If deployed at scale, geoengineering would have profound, unpredictable, and potentially irreversible consequences—including disrupted weather and rainfall patterns, extreme drought, risks to planetary food security and ecological diversity, unintended warming or excessive cooling, stratospheric ozone depletion, greater exposure to air pollutants and ultraviolet exposure with associated health risks, acid rain, diminution of solar power systems, and geopolitical conflict over control of the global thermostat. These impacts would harm biodiversity, agriculture, and human health on a global scale.

Whereas: Unlike traditional technologies, geoengineering cannot be meaningfully tested without large-scale deployment. In effect, it proposes turning the Earth into a laboratory—locking humanity into dangerous outcomes that may be impossible to reverse and could worsen the very problems they claim to solve. America should never consent to policies that treat its citizens—or the rest of the world—as test subjects.

Whereas: We cannot afford to be distracted by the false promise of speculative, high-risk technologies pushed by special interests and global bureaucracies. The United States must lead with prudence, humility, and respect for natural systems—not reckless experimentation.

___________________________________

Therefore: We respectfully call on you to:

1. Immediately prohibit federal funding, authorization, or participation in geoengineering research, testing, or deployment.

2. Require full transparency and investigation into any proposed geoengineering activities that could affect U.S. airspace, land, or waters.

3. Protect American sovereignty, public health, and environmental integrity by rejecting efforts by other nations to promote geoengineering.

CLICK HERE TO SIGN THE PETITION

This petition is a start.

There is MUCH, MUCH MORE that needs to be addressed..

Must read articles:

Project Inhumanity
Air Traffic Related Air Pollution
Get The Lead Out! (Deadline for comment is March 13, 2026)
The Air Quality Act
Strontium, Aluminum and Barium, Oh My!

Did you attend/watch this presentation this past Tuesday?

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Break The Feed

James Roguski — Tue, 24 Feb 2026 17:23:20 GMT

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Click on the link below to view the live stream:

The Pickax App will be going live in The Google Play Store at the beginning of the livestream, and iOS will be live any day now, could be as soon as today or tomorrow.

No censorship
No algorithms controlling reach
The ability to read and write full articles
Rumble videos are playable directly in the newsfeed
Monetization through revenue sharing, affiliate programs, and paywalled content
Eliminates bots and anonymous trolls

https://rumble.com/v7683kw-break-the-feed-pickax-app-launch-livestream.html

https://rumble.com/v767inm-break-the-feed-pickax-app-launch-livestream-feat.-silk-dr-pierre-kory-naomi.html

NOTE: There was a small glitch on Rumble regarding the time. The live stream BEGINS at 11am Pacific and will run all evening. Tune in whenever you can.

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FULL DISCLOSURE: I am a “Founding Member” with Pickax and I am proud to be Pickax’s first “Decentralizer.”

I fully support Jeff’s work to ensure free speech and his support of content creators.

Please read the article and watch the video below:

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James Roguski

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James Roguski

The Department of INjustice

“Medical necessity should not be such a nebulous concept that it exists in the brain of a government charge reviewer, only.”

“No patient contracted an infection. No disease outbreak occurred. No evidence showed that any device was reused on a patient.”

“If a physician is receiving a criminal punishment for accepting the will of a patient, then we have real big problems in this country. We have a very serious problem with the criminalization of health care in this country and this case absolutely proves it.”

Please watch the video interview below:

Part I: Background

Part II: Court case (begins at 53 minutes)

Important Questions:

1. Were medically unnecessary procedures performed at the clinic?

2. Were medical devices reused at the clinic?

3. Was ANY single use device proven to be reused on ANY single patient for ANY specific procedure?

4. Were devices presented at the trial functional?

5. Did any clinic employees testify on Dr. Kumar’s support?

6. Why are there so many counts (46)?

7. Was any patient hurt?

8. Did Dr. Kumar sexually assault patients?

9. Did Dr. Kumar receive a fair trail?

10. How does this trial impact the practice of medicine?

January 12, 2026

Please watch the video below:

A Remmer hearing is currently underway in Dr. Sanjeev Kumar’s case.

Who is Dr. Sanjeev Kumar?

Dr. Kumar removes a large tumor at surgery during a life saving operation.

Sanjeev Kumar Found Right Place to Put Laparoscopy, Robotics into Practice

Visit Dr. Sanjeev’s website to learn more: DrSanjeevKumarSurgeon.com

However, the FDA’s claims are in direct conflict with the official instructions provided by the manufacturer.

Below is a picture of Uro-V cannulas:

When you learn what has been done to Dr. Kumar, you will wonder why the Department of Justice has failed to seek to recover some of the trillions of dollars received by those who caused so much harm during COVID-19:

Dr. Sanjeev Kumar was NOT permitted to enter the following CDC guidelines as evidence.

Screenshot from page 81:

Dr. Sanjeev Kumar was NOT permitted to enter as evidence the following documentation that the complaint was investigated by the Tennessee medical board and was dismissed by them.

October 27, 2019

Dr. Sanjeev Kumar was NOT permitted to enter the following document as evidence.

Documents from Dr. Sanjeev Kumar’s Court Case:

February 27, 2025

February 28, 2025

Seeking Patient Information in Dr. Sanjeev Kumar Investigation

March 10, 2025

June 26, 2025

October 17, 2025

The Ruling in Plain English

About that pre‑trial publicity

October 30, 2025

November 3, 2025

December 29, 2025

12 procedures disputed by jury well documented indications in medical chart

January 12, 2026

January 28, 2026

March 9, 2026

March 26, 2026

Sanjeev Kumar granted Remmer Hearing

Sanjeev Kumar Granted Remmer Hearing

April 21, 2026

May 1, 2026

May 13, 2026

May 21, 2026

James Roguski

310-619-3055

All support is deeply appreciated.

COVER YOUR ASS

This document is scheduled to be published in the Federal Register on 2026-05-27 and available online at

Read the document, spread the word and comment below:

I added the bold and large font emphases below.

FOR FURTHER INFORMATION CONTACT:

L. Paige Ezernack, Administration for Strategic Preparedness and Response, U.S. Department of Health and Human Services, 400 7th St SW, Washington, DC 20024; 202-260-0365, paige.ezernack@hhs.gov.

Currently, there are no available antiviral treatments or vaccines for HPS that are FDA approved, or authorized by FDA for investigational or emergency use.

Section I, Determination of Public Health Emergency or Credible Risk of Future Public Health Emergency

Section II, Factors Considered

Section III, Recommended Activities

Section IV, Liability Immunity

Section V, Covered Persons

Section VI, Covered Countermeasures

Section VII, Limitations on Distribution

Section VIII, Category of Disease, Health Condition, or Threat

Section IX, Administration of Covered Countermeasures

Section X, Population

Section XI, Geographic Area

Section XII, Effective Time Period

Section XII extends the effective period through July 18, 2026.