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It’s pertinent to demand disclosure regarding the content/ findings of omitted “unpublished studies,” why were they not published, who made those decisions & how many other agencies & what other studies under @OIGatHHS oversight have ongoing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