BlessingBox Profile picture
Oct 16, 2022 21 tweets 10 min read Read on X
You can’t build public health policy upon 🍒 picked studies & call it “evidenced based, or best practices” by fudging data.
You can however, call it conflict of interest, agenda, propaganda, undermining of research/practice of medicine w/ outcomes directly impact patient’s lives. Image
It’s pertinent to demand disclosure regarding the content/ findings of omitted “unpublished studies,” why were they not published, who made those decisions & how many other agencies & what other studies under @OIGatHHS oversight have ongoing non-compliance?
See article 4 link ⬆️ ImageImageImage
🙏
@ciaagofficial
@CIAAG_Lauren
@Shasta_Rayne
@LeahLonebear
for demanding “National Institutes of Health (NIH) address failure to report results of NIH-funded intramural/extramural clinical trials, as required by federal law.”
#HoldThemAccountable

uploads.documents.cimpress.io/v1/uploads/32b… ImageImage
“OIG concluded NIH does not have adequate procedures for ensuring that responsible parties submit the results of clinical trials and that it “took limited enforcement action when there was noncompliance and continued to fund new research.”

centerwatch.com/articles/26238…
Read the OIG report here: bit.ly/3dEppij.
View the FDAAA Tracker website here: bit.ly/2HEaAaQ
“NIH did not have adequate internal policies and procedures in place to notify parties prior to non- compliance, and took limited enforcement actions after the fact.”

download-files.wixmp.com/ugd/01f35d_a8d…
“NIH Did Not Ensure That All Clinical Trial Results Were Reported in Accordance With Federal Requirements”

*Report in Brief

oig.hhs.gov/oas/reports/re…
“NIH Did Not Ensure That All Clinical Trial Results Were Reported in Accordance With Federal Requirements”

*Complete Report

oig.hhs.gov/oas/reports/re…
FDA should proactively implement additional measures to improve compliance … such as audits that are made public, notices of noncompliance and the potential imposition of civil monetary penalties,”

centerwatch.com/articles/25652…
“For the first time ever, FDA threatened enforcement and fines against a sponsor for failing to submit trial results to ClinicalTrials.gov by required deadlines”

centerwatch.com/articles/25592…
“Rep. Frank Pallone, Jr. (D-N.J.) is pressing FDA & NIH on their efforts to ensure ClinicalTrials.gov reporting requirements are followed, referencing recent findings in a letter to the agency chiefs that show significant sponsor compliance issues.”

centerwatch.com/articles/26417…
Read Representative Pallone’s letter addressed to
FDA’s Robert M. Califf, M.D.
& NIH’s Lawrence A. Tabak, D.D.S., Ph.D.

democrats-energycommerce.house.gov/sites/democrat…
@threadreaderapp please compile
Coinciding w/
Dr. J. Callin’s hasty NIH departure post Congress inquiries, NIH further stigmatize pts “creating” criteria for “pre-addiction diagnosis.”

NIH
(RFI): Inviting input on term “preaddiction” for early-stage substance use disorder.
NOT-DA-23-019
grants.nih.gov/grants/guide/n…
For the record.

July 6, 2022
Preaddiction—A Missing Concept for Treating Substance Use Disorders
A. Thomas McLellan, PhD1; George F. Koob, PhD2; Nora D. Volkow, MD3

jamanetwork.com/journals/jamap…

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More from @BlessingBox4u

Dec 23, 2023
Backstory on everything you did or didn’t want to know about FDA Overdose Prevention Framework Including FDA approval of #AvertD
Circa 2022-2023 ⤵️

Public Citizen weighs in on FDA approval AvertD with Kolodny’s collaboration essentially stating that AvertD is null & void because all opioids are addictive- regardless.

Image
FDA approves first DNA test for risk of opioid use disorder
Who knew FDA was going to tweak the requirements & quietly approve a little over one year after FDA advisory committee overwhelmingly voted against an earlier version of the test?

medtechdive.com/news/fda-appro…
Read 14 tweets
May 1, 2023
AI Accountability Policy Request for Comment
Federal Register
Agency/Docket No. 230407-0093
Comments Close:
06/12/2023

federalregister.gov/documents/2023…
The RFC seeks comment on artificial intelligence (AI) system accountability measures and policies.

jdsupra.com/legalnews/ntia… Image
Federal Register
Request for Comments Regarding Artificial Intelligence and Inventorship
Docket No. PTO-P-2022-0045
Comments Close:
05/15/2023

federalregister.gov/documents/2023…

Stanford & AI⤵️
Read 4 tweets
Oct 20, 2022
FDA's Clinical Chemistry and Clinical Toxicology Devices Advisory Committee will meet to discuss *AvertD, a prescription genetic risk assessment tool for opioid use disorder (OUD).”



FDA briefing documents ahead of the meeting.


fda.gov/media/162373/d…
FDA advisory committee on Thursday voted strongly against AvertD, a prescription genetic risk assessment tool for opioid use disorder (OUD).

medpagetoday.com/painmanagement…
Image
Evidently, Public Citizen also weighed in with significant concerns.

citizen.org/wp-content/upl…
Read 19 tweets
Apr 13, 2021
“Integrative Medicine Research Lecture/National Center Complementary & Integrative Health/ Univ Utah dev/ testing integrative nondrug treatment strategy, Mindfulness-Oriented Recovery Enhancement (MORE)➡️ bio-psychosocial NIH research
#NATIONALPAINSTRATEGY
nccih.nih.gov/news/events/he…
Integrative Medicine Research/ National Center Complementary/ Integrative Health/ Dr. Alicia Heapy/ Yale/ VA ➡️ non-drug intervention for pain—Cooperative Pain Education Self-Management (COPES), a form of cognitive behavioral therapy.
#NATIONALPAINSTRATEGY
nccih.nih.gov/news/events/co…
Multi-Disciplinary Working Group (MDWG) NIH/ HEAL Initiative projects/ specific HEAL research studies.
#NATIONALPAINSTRATEGY

heal.nih.gov/events/2021-03…
Read 15 tweets
Dec 14, 2020
“The American Medical Association is once again urging states, regulators and policymakers to waive limits and restrictions on prescriptions for opioid medication and other controlled substances during the COVID-19 pandemic.” PNN
Issue brief: Reports of increases in opioid- and other drug-related overdose and other concerns during COVID pandemic
*Updated December 9, 2020

ama-assn.org/system/files/2…
The AMA urged states to adopt new DEA guidance giving more flexibility to physicians treating patients with opioid use disorder (OUD).
deadiversion.usdoj.gov/GDP/(DEA-DC-02…
Read 5 tweets
Dec 11, 2020
The DEA published this notice of proposed rule on December 4, 2020 and there is a 60-day comment period thereafter.  Partial Filling of Prescriptions for Schedule II Controlled Substances, 85 Fed. Reg. 78,282 (proposed Dec. 4, 2020).
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
21 CFR Part 1306 [Docket No. DEA–469] RIN 1117–AB45
Partial Filling of Prescriptions for Schedule II Controlled Substances
AGENCY: Drug Enforcement Administration, Department of Justice. govinfo.gov/content/pkg/FR…
Federal Register Electronic comments must be submitted, and written comments must be postmarked, on or before February 2, 2021. ⤵️ federalregister.gov/documents/2020…
Read 5 tweets

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