Thread by @BlessingBox4u

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.

It’s pertinent to demand disclosure regarding the content/ findings of omitted “unpublished studies,” why were they not published, who made those decisions & how many other agencies & what other studies under @OIGatHHS oversight have ongoing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 ⬆️

🙏
@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…

For the record.
#HoldThemAccountable

For the record.
#HoldThemAccountable

For the record.
#HoldThemAccountable

For the record.
#HoldThemAccountable

“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.

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…