NIH Highlights Exacerbated COVID-19 Risks With SUDs

Researchers from the National Institute on Drug Abuse and Case Western Reserve University, including NIDA Director Nora Volkow, shared findings in Molecular Psychiatry that linked greater risk of COVID-19 diagnosis for individuals with substance use disorders. A review of 73 million national EHRs found that 10.3% of those surveyed had been diagnosed with an SUD while accounting for more than 15.5% of confirmed COVID-19 cases. From there, it was concluded that individuals with a recently diagnosed SUD were more likely to develop COVID-19 as compared to the non-SUD cohort. COVID-19 outcomes for those with SUDs were also worse as it relates to hospitalization and deaths for these patients. The findings indicate that hospitalization and death for those with SUDs were at 41% and 9.6% as compared to those without at 30.1% and 6.6%.

On the research findings and implications for future care, Dr. Volkow said, “The lungs and cardiovascular system are often compromised in people with SUD, which may partially explain their heightened susceptibility to COVID-19…Another contributing factor is the marginalization of people with addiction, which makes it harder for them to access health care services. It is incumbent upon clinicians to meet the unique challenges of caring for this vulnerable population, just as they would any other high-risk group.”

Articles & Resources

NIH Newsroom – Substance Use Disorders Linked to COVID-19 Susceptibility

New York State Sues J&J for Alleged Opioid Fraud

New York Governor Andrew Cuomo announced on Thursday civil charges brought against Johnson & Johnson around the fraudulent mischaracterization of the safety and efficacy of its opioid products. The state alleges that Johnson & Johnson used brochures and other third-party publications to specifically target elderly patients in need of pain control while downplaying the risks associated with misuse and addiction. According to the release, the state alleges that Johnson & Johnson had a “long-standing and multi-faceted leading role in originating, supplying, facilitating, and actively creating a dangerous market for opioids for chronic pain treatment.”

In announcing the charges, Governor Cuomo said, “The opioid crisis has taken too many lives and New York State will continue to take action against those who helped fuel this public health catastrophe and bring a measure of justice to families who have lost loved ones…Misrepresentation of opioids to consumers for profit is inexcusable and we will use every tool necessary to help ensure those responsible are held fully accountable.”

Articles & Resources

NY Governor’s Newsroom – Governor Cuomo Announces Insurance Fraud Action Against Johnson & Johnson for Leading Role in the Opioid Crisis

Washington Post – New York Files Civil Insurance Fraud Charges Against Johnson & Johnson in Opioid Case

CBS News – New York Files $2 Billion Lawsuit Against Johnson & Johnson for its Alleged Role in Opioid Epidemic

OMB Finishes Review of MAT Endpoints Guidance

On September 11th, the White House Office of Management and Budget finished its review of a guidance document for industry regarding “Opioid Use Disorder: Endpoints for Demonstrating Effectiveness of Drugs for Medication-Assisted Treatment.” While not much is known around the contents of the guidance beyond what is alluded to in the title, this document will follow on an August 2018 publication from the FDA in helping manufacturers (sponsors) develop medication-assisted treatment drugs for opioid use disorder. The updated guidance, which was first shared with OMB in May 2020, will be published in the Federal Register in the near future.

Articles & Resources

Link to OMB Regulatory Review Page

What We Read Last Week

Several articles were published last week pertaining to the opioid epidemic, covering a variety of different components of the issue. Links to relevant articles are provided below.

Articles & Resources

Journal of the American Medical Association – Assessment of Opioid Prescribing Patterns in a Large Network of US Community Health Centers, 2009 to 2018

American Journal of Preventive Medicine – Prevalence of Nonpharmacologic and Pharmacologic Therapies Among Noncancer Chronic Pain–Associated Ambulatory Care Visits, 2016

Rep. Trone Newsroom – Rep. David Trone Announces Bipartisan, Bicameral Effort to Raise Awareness for National Recovery Month Amid COVID-19 Pandemic

Rep. Trone Twitter – Congress Goes Purple

ABC News – Mexico Sees Fentanyl Seizures Up 465%, Denies Making Drug

Business Insider – How A Pioneering Brain Surgery Helped a Man Who’d Been Addicted to Opioids For 18 Years Find Sobriety

New York Times – Defying the Family Cycle of Addiction

Centers for Medicare & Medicaid Services – Federal Meta-Analysis Support: Section 1115 Substance Use Disorder Demonstrations, Evaluation Design Report

U.S. Attorney for the Eastern District of Pennsylvania – Chester County Doctor Agrees to Pay Over $1.2 Million to Settle Allegations of Fraudulent Billing and Unlawful Opioid Distribution

U.S. Attorney for the Western District of New York – Former Medical Practice Office Manager Sentenced For Stealing Controlled Substances

U.S. Attorney for the Middle District of Florida – Sarasota Pain Doctor And Former Insys Sales Representative Charged In Health Care Fraud Kickback Conspiracy

U.S. Attorney for the Eastern District of Pennsylvania – West Chester Drug Dealer Sentenced to 6 ½ Years for Selling Hundreds of Deadly Fentanyl Pills Disguised as Oxycodone

U.S. Attorney for the Middle District of Pennsylvania – Scranton Doctor Indicted For Receiving Healthcare Kickbacks And Unlawfully Distributing Controlled Substances Resulting In Two Deaths

U.S. Attorney for the Western District of Pennsylvania – Ex-Doctor’s Girlfriend Sentenced in Scheme to Illegally Distribute Oxycodone and Defraud Medicare and Medicaid

U.S. Attorney for the Western District of Missouri – Former Paramedic Pleads Guilty to Stealing, Diluting Ambulance Drugs

This Week’s Calendar

The House and Senate have no opioid-related hearings or events scheduled at this time as they return from their August recess and undertake a brief sprint before Members break for an October recess ahead of the November elections. In the instance that there are any changes to the schedule for this week, we will make additional information available.

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