Tag: hhs

Children’s Health Defense Supports the Motion Against U.S. Department of Health and Human Services Alleging Fraud in Omnibus Autism Proceeding

Children’s Health Defense (CHD) Senior Staff Attorney Rolf Hazlehurst filed a motion in the U.S. Court of Federal Claims alleging that the U.S. Department of Justice (DOJ), representing the U.S. Department of Health and Human Services (HHS), committed fraud in its representation of HHS in the Omnibus Autism Proceeding (OAP) in the National Vaccine Injury Compensation Program (NVICP).

The OAP was established to consolidate and adjudicate the approximately 5,400 claims filed on behalf of children who regressed into autism following vaccination.

In 2003, Hazlehurst filed a claim in the program on behalf of his son Yates, diagnosed with autism after suffering adverse reactions following routine childhood vaccines. Hazlehurst’s claim was one of six original “test cases” in 2007 that would decide the fate of all the other claims in the OAP.

According to the newly filed motion, the DOJ attorneys engaged in a series of acts of fraud upon the courts, beginning in the NVICP and ultimately impacting the Supreme Court of the United States.

In the NVICP, DOJ attorneys concealed from the special masters and petitioners that the government’s top expert witness, a world-renowned pediatric neurologist, revised his opinion on whether vaccines can cause autism.

The expert explained to the DOJ attorneys that vaccines can cause autism in a subset of children. The witness had been scheduled to testify in the first test case in the OAP.

However, the DOJ abruptly dismissed him as a witness once they learned of his clarification. Without the witness’s knowledge, DOJ attorneys repeatedly misrepresented his prior case-specific written opinion in the OAP to argue there is no scientific basis that vaccines cause autism.

Ultimately, all of the 5,400 OAP claims were dismissed, leaving vaccine-injured children and their families with no recourse.

“The DOJ’s first act of fraud upon the court snowballed into a massive scheme of deception with far-reaching implications. Their fraudulent scheme denied justice to Yates and the thousands of other children in the OAP,” said Hazlehurst.

“By hiding that their own expert’s opinion had changed to favor Yates and other children in the OAP, the DOJ effectively closed the NVICP’s doors to the injured children with similar claims who have followed.”

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The Era of Informed Consent is Over

In a significant blow to patient autonomy, informed consent has been quietly revoked just 77 years after it was codified in the Nuremberg Code.

On the 21st of December 2023, as we were frantically preparing for the festive season, the Department of Health and Human Services (HHS) and the Food and Drug Administration (FDA) issued a final ruling to amend a provision of the 21st Century Cures Act. This allowed 

…an exception from the requirement to obtain informed consent when a clinical investigation poses no more than a minimal risk to the human subject…

This ruling went into effect on January 22nd, 2024, which means it’s already standard practice across America. 

So, what is the 21st Century Cures Act? It is a controversial Law enacted by the 114th United States Congress in January 2016 with strong support from the pharmaceutical industry. The Act was designed to

…accelerate the discovery, development, and delivery of 21st-century cures, and for other purposes [?]…[emphasis added]

Some of the provisions within this Act make for uncomfortable reading. For example, the Act supported: 

High-risk, high-reward research [Sec. 2036].

Novel clinical trial designs [Sec. 3021]

Encouraging vaccine innovation [Sec. 3093].

This Act granted the National Institutes of Health (NIH) legal protection to pursue high-risk, novel vaccine research. A strong case could be made that these provisions capture all the necessary architecture required for much of the evil that transpired over the past four years.

Overturning patient-informed consent was another stated goal of the original Act. Buried under Section 3024 was the provision to develop an

Informed consent waiver or alteration for clinical investigation.

Scholars of medical history understand that the concept of informed consent, something we all take for granted today, is a relatively new phenomenon codified in its modern understanding as one of the critical principles of the Nuremberg Code in 1947. It is inconceivable that just 77 years after Nuremberg, the door has once again opened for state-sanctioned medical experimentation on potentially uninformed and unwilling citizens.  

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The Newly Unveiled HHS Rationale for Rescheduling Marijuana Underlines Drug Warriors’ Dishonesty

Last week, in response to a Freedom of Information Act request by Houston lawyer Matthew Zorn, the Department of Health and Human Services (HHS) revealed the rationale for its August 2023 recommendation that the Drug Enforcement Administration (DEA) move marijuana from Schedule I to Schedule III of the Controlled Substances Act. The document not only contradicts the position that the DEA has long taken on this issue; it contradicts the position that HHS itself took in 2016, when the DEA rejected a 2011 rescheduling petition. The reversal shows that marijuana’s classification has always been a political question rather than a legal or scientific matter.

On October 7, 2022, the same day he announced a mass pardon for people convicted of simple marijuana possession under federal law, President Joe Biden instructed HHS and Attorney General Merrick Garland to “initiate the administrative process to review expeditiously how marijuana is scheduled under federal law.” Biden noted that Schedule I, which includes “heroin and LSD,” is “the classification meant for the most dangerous substances” and is “even higher than the classification of fentanyl and methamphetamine—the drugs that are driving our overdose epidemic.” On Twitter, he reiterated that “we classify marijuana at the same level as heroin” and treat it as “more serious than fentanyl,” which he said “makes no sense.”

In short, it was clear that Biden did not expect HHS to confirm its previous position that marijuana belongs in Schedule I. He expected HHS to recommend that marijuana be moved to a lower schedule, which is what it ultimately did. As the details of the HHS recommendation clarify, that decision was not based on new scientific evidence. It was based on a reinterpretation of the criteria for Schedule I that could have been implemented much sooner if HHS and the DEA had been open to it, or if a previous president had encouraged it.

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Top Biden Health Official In Touch With DEA About Marijuana Rescheduling Recommendation

The head of the U.S. Department of Health and Human Services (HHS) says his agency has “communicated” the agency’s “position” on marijuana rescheduling to the Drug Enforcement Administration (DEA) and has continued to offer additional information to assist with the final determination.

HHS for the first time confirmed that it had recommended moving cannabis from Schedule I to Schedule III under the Controlled Substances Act (CSA) on Friday, releasing a trove of documents it submitted to DEA last year amid a Freedom of Information Act (FOIA) lawsuit initiated by attorney Matt Zorn.

Xavier Becerra, secretary of HHS, told The New York Times in a new interview that his department “communicated to them our position” and “put it all out there for them,” referring to the comprehensive scientific review it conducted and submitted to DEA as part of a scheduling directive from President Joe Biden.

“We continue to offer them any follow up, technical information if they have any questions,” Becerra said.

The status of DEA’s review is currently unknown, though some suspect the release of the cannabis materials in the FOIA lawsuit may indicate the scheduling decision announcement is imminent. Marijuana Moment reached out to DEA for clarification on the timing, and a spokesperson referred the inquiry to the Justice Department, which has not responded to requests for comment.

Congressional lawmakers, meanwhile, have touted the HHS Schedule III recommendation following Friday’s disclosure of the review documents.

“I’m encouraged by this news & urge the DEA to follow this common-sense scientific recommendation to move cannabis to Schedule III,” Rep. Dwight Evans (D-PA) said on Friday. “I continue to support full legalization but this would be a positive action.”

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Feds Will Release Marijuana Rescheduling Memo And Related Documents ‘In Their Entirety’ In Response To Lawsuit

The Department of Health and Human Services (HHS) has agreed to release documents related to its recommendation to federally reschedule marijuana “in their entirety” amid litigation over a Freedom of Information Act (FOIA) request that was filed by a lawyer last year.

“Good afternoon and thank you for your patience,” a Department of Justice attorney handling the case said in an email to attorney Matt Zorn on Thursday. “The agency has advised that it will release the letter and its enclosures in their entirety.”

Zorn posted a screenshot of the email on his blog, noting that the release could mean that “rescheduling is imminent—or not.”

When the government announces a marijuana rescheduling through a Federal Register notice, he pointed out, it would “attach the letter and its enclosures” to that posting.

Zorn last month obtained more than 250 pages of the rescheduling advisory letter and supporting documents sent by HHS to the Drug Enforcement Administration (DEA) last year, though the vast majority were released only in highly redacted form.

In a phone interview with Marijuana Moment, Zorn said the new development comes after a “little scuffle” with the federal government over the timeline in his FOIA lawsuit. The Justice Department had filed a motion to vacate a deadline for summary judgement that was set for January 18, and while Zorn said he would typically accept such a request, he instead filed an opposing brief and the judge ultimately denied the government’s motion.

He added that, “realistically, the lawsuit could have accelerated” the timing of the government’s scheduling announcement, though it’s also possible that just the letter will be released without DEA immediately announcing a decision in the ongoing scheduling review.

In October, HHS released a highly redacted version of the one-page letter from the health agency to DEA in response to public records requests by news organizations such as Marijuana Moment and lawyers, including Zorn.

Shane Pennington, a lawyer who co-writes the On Drugs blog with Zorn, applauded his colleague’s work in pushing for the documents to be released.

“Matt has demonstrated once again that litigation is a powerful tool for unlocking doors, solving problems, and doing the ‘impossible,’” he told Marijuana Moment in an email. “I’m proud to work with him on On Drugs and so many other projects.”

Broadly, the documents are believed to discuss new scientific information that’s come to light in recent years, which HHS suggests might necessitate rescheduling marijuana.

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DEA Tells Congress It Has ‘Final Authority’ On Marijuana, Regardless Of Health Agency’s Schedule III Recommendation

The Drug Enforcement Administration (DEA) is telling lawmakers that it reserves “the final authority” to make any scheduling decision on marijuana following an ongoing review, regardless of what the U.S. Department of Health and Human Services (HHS) recommends.

In a letter sent to Congressional Cannabis Caucus co-chair Rep. Earl Blumenauer (D-OR), DEA Acting Chief of the Office of Congressional Affairs Michael Miller gave a general overview of the scheduling review process that was initiated under a directive from President Joe Biden in October 2022.

That started with a scientific assessment from HHS that reportedly advised DEA to move marijuana from Schedule I to Schedule III of the Controlled Substances Act (CSA). Once HHS made its recommendation in August, “DEA conducts its own review,” the letter, sent last month and first reported by Punchbowl News, says.

“DEA has the final authority to schedule, reschedule, or deschedule a drug under the Controlled Substances Act, after considering the relevant statutory and regulatory criteria and HHS’s scientific and medical evaluation,” it says. “DEA is now conducting its review.”

The agency’s statement came in response to an earlier letter from 31 bipartisan lawmakers, led by Blumenauer, that implored DEA to consider the “merits” of legalization as it carried out its review. That initial letter also criticized the limitations of simply placing cannabis in Schedule III, as opposed to fully removing the plant from CSA control.

“While Congress works to send the President comprehensive cannabis legislation, the urgency of full descheduling should inform DEA’s position on overall cannabis reform and appropriate enforcement centered on advancing public safety, not unjust criminalization,” the lawmakers’ letter said. “Marijuana’s continued inappropriate scheduling is both arcane and out-of-touch with the will of the American people.”

In that context, DEA’s response offered little insight, with the agency declining to address the lawmakers’ key arguments and instead simply outlining the procedural details of the scheduling review.

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Feds Release 250+ Pages Of Redacted Documents On Marijuana Rescheduling Recommendation, Detailing Cannabis’s Medical Value

More than three months after news leaked that the U.S. Health and Human Services Department (HHS) was recommending that marijuana be moved to Schedule III under the federal Controlled Substances Act (CSA), the agency has finally released a tranche of documents related to its recommendation and the detailed review it undertook on cannabis’s accepted medical value.

Among the materials newly made public are correspondence from HHS officials to Drug Enforcement Administration (DEA) Administrator Anne Milgram as well explanations of the health agency’s reasoning for the recommended change after conducting a required eight-factor analysis under the CSA. Most pages are heavily redacted, however, and some were withheld completely.

The documents were posted online Thursday by attorneys Shane Pennington and Matt Zorn, coauthors of the blog On Drugs. Zorn previously submitted a request under the Freedom of Information Act (FOIA) to obtain the records.

“We haven’t had a chance to wade through it all,” the two lawyers wrote, “but are putting it up here now and will follow up as soon as we’ve studied everything more deeply.”

In response to the FOIA request, HHS “reviewed 252 pages of records,” releasing just two pages in their entirety. Another 236 were redacted in part, while 14 pages were withheld completely. All the released documents are embedded at the end of this article.

Broadly, the documents outline new scientific information that’s come to light in recent years subsequent to an earlier denial of a rescheduling petition, which HHS suggests might now necessitate rescheduling marijuana.

“The current review is largely focused on modern scientific considerations on whether marijuana has a CAMU [currently accepted medical use] and on new epidemiological data related to the abuse of marijuana in the years since the 2015 HHS” evaluation of marijuana under the CSA’s eight-factor analysis.

HHS also notes that it “analyzed considerable data related to the abuse potential of marijuana,” but added that it’s a complicated consideration.

“Determining the abuse potential of a substance is complex with many dimensions,” HHS wrote, “and no single test or assessment provides a complete characterization. Thus, no single measure of abuse potential is ideal.”

Most subsequent pages of the document were withheld completely.

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46 Pages FOIAed Emails Between CDC Leaders, Dr. Fauci, Dr. Collins, and White House, NIH, HHS, Show They Knew About Vaccine-Induced Myocarditis and Thrombotic Thrombocytopenia, a Blood Clotting Disorder. Emails Over 80% Redacted.

Attorney Edward Berkovich submitted a Freedom of Information Act (FOIA) request to the Centers for Disease Control and Prevention (CDC) stating, “I request emails sent by and received by Dr. Rochelle P. Walensky, Sherri A. Berger, and Kevin Griffis (all of whom are CDC personnel) on dates beginning February 1, 2021 through May 31, 2021, containing the word myocarditis.” DailyClout reported on the initial 472-page production from that FOIA on August 29, 2023.

Mr. Berkovich recently received 46 additional pages, over 80% of which were fully redacted, involving other government entities such as the White House and Executive Office of the President, as part of this production. Of the 46 pages, only two pages were released without any redactions. Seven pages were partially redacted pages, and 37 pages were fully redacted. The redactions were “pursuant to 5 U.S.C. §552 Exemptions 5 and 6.” According to the CDC cover letter accompanying this production:

  • “Exemption 5 protects inter-agency or intra-agency memorandums or letters which would not be available by law to a party other than an agency in litigation with the agency. Exemption 5 therefore incorporates the privileges that protect materials from discovery in litigation, including the deliberative process, attorney work-product, and attorney-client privileges. Information withheld under this exemption was protected under the deliberative process and presidential communications privileges.The deliberative process privilege protects the decision-making process of government agencies. The deliberative process privilege protects materials that are both predecisional and deliberative. The information that have been withheld under the deliberative process privilege of Exemption 5 are both predecisional and deliberative, and do not represent formal or informal agency policies or decisions. Examples of information withheld include recommendations, comments, opinions. The presidential communications privilege protects documents solicited and received by the President or his immediate White House advisers who have broad and significant responsibility for investigating and formulating the advice to be given to the President.“
  • “Exemption 6 protects information in personnel and medical files and similar files when disclosure would constitute a clearly unwarranted invasion of personal privacy. The information that has been withheld under Exemption 6 consists of personal information, such as a telephone number. We have determined that the individual(s) to whom this information pertains has a substantial privacy interest in withholding it.”

In this FOIA production, the first set of emails are dated May 24-25, 2021, with the subject “Draft WH [White House] Script and Slides.” Abbigail Tumpey, former Associate Director for Communication Science for CDC’s Public Health Infrastructure emailed Rochelle Walensky, MD, MPH, CDC Director and ATSDR Administrator, with Sherri Berger, Deputy Director for Policy, Communications, and Legislative Affairs/Chief Strategy Officer; Robert (“Robbie”) Goldstein, MD, Massachusetts’ Commissioner of the Department of Public Health (DPH), a former Senior Policy Advisor at the Centers for Disease Control and Prevention (CDC), an infectious disease physician at Massachusetts General Hospital (MGH), and a faculty member at Harvard Medical School; Paul Fulton, CDC Press Officer; and Jason McDonald, a CDC spokesperson and Public Affairs Specialist CCed. These emails had a “draft press conf script and slides for [Dr. Walensky’s] review” attached. However, the 10 pages of the script and slides are fully redacted.

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Top Federal Health Official Confirms At Exactly 4:20 That His Department Is Recommending Marijuana Rescheduling

The head of the top U.S. health agency is confirming news that his department is recommending marijuana rescheduling—posting about the development at exactly 4:20pm ET in an apparent wink to cannabis culture.

Amid a flurry of reactions to reports that the U.S. Department of Health and Human Services (HHS) is advising the Drug Enforcement Administration (DEA) to move cannabis from Schedule I to Schedule III, Secretary Xavier Becerra shared a post about it at the symbolic time on X (the social media site formerly known as Twitter).

If anyone thinks the timing is a coincidence, they probably haven’t been closely following Becerra’s account, as the Biden cabinet official has made a habit of talking about marijuana policy on social media at 4:20 on the dot.

On the day that President Joe Biden announced the scheduling review, for example, the secretary posted about his commitment to following through on the directive—at 4:20.

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HHS is Still Wasting Money Fighting Online Covid “Disinformation”

Apparently, Covid discussions are still a thing worth cracking down on. That’s at least according to The Biden administration, which is injecting $500,000 into Texas Woman’s University as part of a grant program aimed at curbing COVID-19 “misinformation” and “disinformation” allegedly aimed at Hispanics, according to funding records reviewed by the Washington Examiner. The grant aims “to expand research on mitigating the effect of misinformation and disinformation” regarding “COVID-19 prevention and treatment initiatives among Hispanics.”

Timeline: Kicking off on May 10 and set to wrap up in April 2024, this grant is part of the Department of Health and Human Services (HHS)’s Food and Drug Administration’s portfolio. It’s part of Biden’s broader push to censor alleged disinformation by joining forces with social media platforms on content moderation – a move likened to “censorship” by some Republicans.

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