Pharmaceutical Makers Urged To Publish Unredacted Clinical Studies
Meanwhile, reports say Latinos are under-represented in U.S. clinical trials for Alzheimer's drugs; more at-home tests for covid will go on sale; and health officials testify in the ongoing opioid trial in West Virginia.
Stat:
WHO, Global Regulatory Group Urge Pharma To Publish Clinical Study Reports
In a significant step toward greater transparency, the World Health Organization and the International Coalition of Medicines Regulatory Authorities are urging drug makers to publish clinical study reports for new medicines and vaccines without redacting any confidential information. The agencies released a joint statement in which they explained their goal is to ensure research results are publicly accessible so that decision makers — notably, health authorities and physicians — have greater understanding about drugs and vaccines. The agencies also argued releasing trial information that is not redacted would boost public confidence in medical products. (Silverman, 5/7)
Noticias Telemundo:
U.S. Latinos Under-Enrolled In Clinical Trials For Alzheimer's Drugs
Alzheimer’s among U.S. Latinos is forecast to grow almost 600% in the next 25 years, but they’re chronically under-enrolled in clinical trials of drugs to treat the disease, according to the National Institutes of Health. U.S. Latinos are more likely to have Alzheimer’s or other forms of dementia than white non-Hispanics, according to the organization UsAgainstAlzheimer’s. (Franco, 5/8)
In other pharmaceutical industry news —
The Baltimore Sun:
More At-Home COVID Tests Coming To The Market, And Made In Maryland
An Australian company that recently began selling a rapid at-home COVID-19 test plans to open its first U.S. production plant in Maryland later this year. Ellume plans to announce today that it will make the test kits in Ballenger Creek, just south of Frederick, and eventually employ 1,500 people to make up to 19 million test kits a month. (Cohn, 5/10)
Axios:
Oklahoma Secures $2.6 Million Refund For Hydroxychloroquine Purchase
Oklahoma has secured a $2.6 million refund for a malaria drug purchase once touted by former President Trump as a treatment for COVID-19, the state's attorney general announced Friday. Trump repeatedly promoted hydroxychloroquine last year despite health officials warning that the drug should not be prescribed for treating COVID-19 outside of research or hospital settings due to serious side effects. Oklahoma purchased 1.2 million hydroxychloroquine pills in April 2020, per AP. (Chen, 5/7)
Houston Chronicle:
River Oaks Clinic Field Trip Health Brings Ketamine-Based Therapy To Depression Treatment
Field Trip Health is not an ordinary clinic. Opening on May 10, the River Oaks facility will house Houston’s next ketamine-enhanced psychotherapy clinic. Here, patients can take psychedelic therapy in a space designed just for it. It’s located at 4310 Westheimer Road, Suite 220. While Ketamine is currently a schedule III drug under the Controlled Substances Act and is approved for use in hospitals and other medical settings as an anesthetic, FTH administers a ketamine-derived nasal spray drug called Esketamine that recently earned FDA-approval for those with treatment-resistant depression. (Nickerson, 5/8)
Stat:
Two Drug Makers, Two Commercial Launches — With Divergent Results
Biocryst Pharma did it. Aurinia Pharma did not. The “it” is a successful, commercial drug launch. Biocryst reported a better-than-expected $10.9 million in sales for its drug Orladeyo in the March quarter — the first public assessment of the medicine’s marketing progress since it was approved last December. (Feuerstein, 5/7)
In updates on the opioid trial in West Virginia —
Charleston Gazette-Mail:
Local First Responders, Health Officials Testify In First Week Of Opioid Trial
Accusers in a lawsuit alleging opioid wholesalers have fault in the Cabell County and Huntington drug crisis used a “heroine,” scientist, historian, social worker and health expert to stitch together pieces of a quilt they say will eventually explain how the area was left in carnage. Huntington Fire Chief Jan Rader, who rose to fame for her role in the 2017 Oscar-nominated documentary “Heroine;” Dr. Corey Waller, an addiction medicine specialist; historian David Courtwright; Connie Priddy, program coordinator for Huntington’s Quick Response Team; and West Virginia’s former chief health officer, Dr. Rahul Gupta, testified about what they saw before, during and after 80 million pills were shipped to the area over an eight-year period starting in 2006. (Hessler, 5/9)
