About pharma
Today’s top story is the resignation of FDA Commissioner Scott Gottlieb, MD. Regardless of political affiliation, most healthcare experts agree he was a bright spot in the current administration. Dr. Gottlieb has been praised for, among other actions, promotion of expedited generic approvals and fighting tobacco use- especially flavored cigarettes. He has been commuting between the DC area and his family in Connecticut and cites family time as his reason for leaving. A replacement has not been named.
The Real Price of Medications- A survey of variations in prescription drug prices:This report by the U.S. PIRG Education Fund found huge variations in drug prices among pharmacies. (As examples, see the graphic in the article.) Patients should not assume that they are getting best prices if they are go to a pharmacy contracted with their health plan.
FDA Approves Esketamine Nasal Spray For Hard-To-Treat Depression: I previously reported that an FDA committee approved Esketamine for treatment of depression. Now the drug has been approved by the full FDA for use in very controlled circumstances under physician supervision. Its potential is to rapidly treat depression when other medications have failed or in addition to other medications.
The Orphan Drug Act Revisited: This opinion piece is a thoughtful review of why we have the Orphan Drug Act and why it needs to be changed. Briefly, rare diseases, which were the intended targets of the drugs developed under this law, were defined by organ system. With increasing knowledge of genetic and molecular mechanisms of disease, many commonalities are being identified- making rarity no longer a reliable criterion for granting orphan status.
Read the article (From JAMA but appears to be open access)
About the public’s health
Dietary Reference Intakes for Sodium and Potassium (2019)-National Academy of Sciences Engineering Medicine): Sodium intake guidelines have been controversial for many years. People sensitive to sodium can get or worsen high blood pressure and heart failure. So what is a reasonable intake if you do not know if you will be adversely harmed? This study recommends 2300 mg/day or less. To put this number into perspective, the average US consumption is 3400mg/day. The report also calls on commercial food companies to lower sodium content in their products; most dietary salt comes from prepared food not from added salt at home.
Read the full study (Free signup required)
Staph infections can kill-More prevention in healthcare & communities needed: The CDC issued this report noting that staph infections (particularly MRSA) are still the cause of significant mortality. Recommendations for control are cited.
Unconventional natural gas development and hospitalizations: evidence from Pennsylvania, United States, 2003–2014: This research found that long term exposure to fracking was associated with higher rates of genital and urinary problems ( like urinary tract infections, kidney infections, and kidney stones) and skin conditions( such as cellulitis and abscesses). The greater the density of drilling, the higher the incidence. Add these findings to other environmental concerns for this drilling technique.
About insurance
How Affordable are 2019 ACA Premiums for Middle-Income People?: Subsidies for ACA exchange premiums are for those who make up to 400% of the federal poverty level. But what about those above that figure? Premiums can vary dramatically by age group and location. Research by the Kaiser Family Foundation found that: “while there seems to be a consensus that individual market premiums are out of reach for some middle-class people ineligible for ACA subsidies, there is little consensus around what to do about it.”
Medicare Advantage insurers to CMS: Rethink expanding use of encounter data in risk adjustment: Among other factors, CMS adjusts Medicare Advantage payments based on the severity of illness of the beneficiaries. About 25% of this risk adjustment is based on claims data and CMS want to increase the contribution to 50%. Insurers are pushing back, citing inaccuracies and gaps in such sources.
One wonders how insurers are making accurate payments if the claims data is so poor.
About healthcare IT
UPMC files federal trademark registration for cloud solution: UPMC has developed what it calls its “healthcare operating system (hcOS).” It is described as a three layer cake: “We ingest the data out of clinical systems as the base layer and get it into the cloud…The middle layer is a set of tools or processing that can handle things like governance, security, identity management, privacy, harmonization and indexing on top of the data. And, the third layer is natural language processing and artificial intelligence.” It is built using the Health Level 7 Fast Healthcare Interoperability Resources (FHIR) standard. For those into IT terminology this product is a PaaS (platform as a service).