Today’s posting reflects news since the last post 2/27/20.
About the public’s health
Israeli scientists: 'In a few weeks, we will have coronavirus vaccine': The scientists had been working on a vaccine for a poultry virus before COVID-19 came along. There is a high degree of similarity between the two so they got a “jump” on a possible vaccine. It could be launched in 90 days instead of 18 months (at soonest) as predicted.
Loss of life expectancy [LLE] from air pollution compared to other risk factors: a worldwide perspective: “Our comparison of different global risk factors shows that ambient air pollution is a leading cause of excess mortality and LLE, in particular through CVDs. Globally, the LLE from air pollution surpasses that of HIV/AIDS, parasitic, vector-borne, and other infectious diseases by a large margin. It exceeds the LLE due to all forms of violence by an order of magnitude and that of smoking by a third.”
Eating breakfast may protect against cardiovascular disease: What your mom told you was true. Here is the science: “Adults who skip breakfast are more likely to develop cardiovascular disease and have greater rates of all-cause mortality than those who typically eat a morning meal.” The content of the meal was not investigated.
No Device Shortages from COVID-19 Outbreak, FDA Says: However, the “agency is aware of 63 manufacturers representing 72 facilities in China that produce ‘essential medical devices,’ that are at risk if there is a supply disruption.”
Drugmakers tell analyst ingredient prices are rising as FDA reports first supply hit tied to COVID-19: In a related article, “the FDA reports the first shortage of a drug due to the COVID-19 outbreak. With 20 other FDA approved drugs relying solely on China as the source of an API or finished product, more shortages may soon materialize.” The agency did not identify the drug,
Yes, there's now a code for coronavirus. Plus emergency doctors, nurses say more resources needed: “A new ICD-10 emergency code—U07.1, 2019-nCoV acute respiratory disease—was established by the World Health Organization (WHO)…”
House approves bill to ban the sale of flavored e-cigarettes: “The bill would place new restrictions on the marketing of e-cigarettes and ban flavors in tobacco products, including menthol cigarettes. It also would place a new excise tax on nicotine.
The House approved the bill, 213-195, sending it to the Senate, where approval is considered unlikely. The White House said in a statement that President Donald Trump’s administration opposes the bill.”
Neonatal Mortality in the United States is related to location of birth (hospital versus home) rather than the type of birth attendant: “The safety of birth in the United States varies by location and attendant. Compared to U.S. hospital births attended by a certified nurse-midwife, planned U.S. home births for all types of attendants are a less safe setting of birth, especially when recognized risk factors are taken into account. The type of midwife attending U.S. planned home birth appears to have no differential effect on decreasing the absolute and relative risk of neonatal mortality of planned home birth, because the difference in outcomes of U.S. planned home births attended by direct-entry midwives or by certified nurse-midwives is not statistically significant.” What is it about the location in the U.S. that differentiates it from other countries that have records of safe births at home?
After obesity surgery, more patients returning for another: “Last year, an estimated 15% of the 252,000 obesity surgeries in the U.S. came after a previous surgery. That compares to 6% of the 158,000 surgeries in 2011, according to a surgeons’ group.” Actuaries will need to revise their cost calculations for this procedure because it’s “still possible to overeat, restrictive devices can slip and stomachs can stretch back out and patients can regain weight over time.”
USPSTF Recommends Screening All Adults for Hepatitis C Virus: The headline is self-explanatory.
How 10 drugmakers have responded to the coronavirus outbreak: Responses range from donating antivirals to testing and vaccine development.
About health insurance
Supreme Court agrees to hear latest challenge to ACA: “The Supreme Court on Monday agreed to hear a challenge from red states that the Affordable Care Act is unconstitutional, with the case likely to be heard this fall.
The case led by Texas and 17 red states is the third time the Supreme Court will decide the fate of the ACA. The lawsuit focuses on whether the individual mandate is constitutional and if the rest of the law should be taken down if the mandate is not.”
CMS selects 205 applicants for new Emergency Triage, Treat and Transport Model: “The Centers for Medicare and Medicaid Services has announced the selection of 205 applicants to participate in the new Emergency Triage, Treat and Transport Model… The model will reimburse emergency services for Medicare fee-for-service beneficiaries when treatment is provided at a facility other than an emergency department… Currently, Medicare only pays for emergency ground ambulance services when beneficiaries are transported to specific types of facilities, most often a hospital emergency department. This creates an incentive to transport all beneficiaries to the hospital even when an alternative treatment option may be more appropriate, CMS said… A patient may always choose to be brought to the ER, CMS said”
Economic Burden Associated With Extended-Release vs Immediate-Release Drug Formulations Among Medicare Part D and Medicaid Beneficiaries: It has long been known that the convenience and supposed compliance benefits of extended release medications (once a day versus twice or more) come at a premium. This research puts a number on those benefits for Medicare Part D and Medicaid. “During the study period, the estimated spending reduction associated with switching all patients receiving extended-release formulations (brand name extended-release and generic extended-release) to generic immediate-release formulations was $13.7 billion ($8.5 billion from Medicare and $5.2 billion from Medicaid).”
About healthcare IT
37% Health Orgs Shirk Mobile Security for Efficiency, Increasing Risk: “Verizon recently released its third annual Mobile Security Index, which revealed 37 percent of healthcare organizations admit to sacrificing mobile security to ‘get the job done’ and have drastically increased the risk of compromise in the process… Overall, organizations use an average of 1,300 apps and cloud services, and nearly all (95 percent) of those are unmanaged without IT administration rights or visibility.”
Here are the top 5 things that will be generating buzz at HIMSS 2020: No surprise the top of the list is COVID-19. But voice technology and interoperability are also prominent.
15 things health systems do today that will become obsolete due to technology: Very thought-provoking list worth a discussion.
About pharma
FDA Compiles Drug Approval Data into Searchable Format: “The first edition of the compiled data includes drugs approved between Jan. 1, 1985 and Dec. 31, 2019. It will be updated periodically to include the latest drug approval data.”
FDA Publishes Details on Gene-Drug Interactions: “The FDA has released a new table listing certain gene-drug interactions backed by scientific evidence that appear on agency-approved drug labeling… The inclusion of a particular gene-drug interaction ‘does not necessarily mean FDA advocates using a pharmacogenetic test before prescribing the corresponding medication, unless the test is a companion diagnostic,’ the agency noted.”
Testing lab challenges FDA findings that carcinogens in metformin do not exceed acceptable levels: “As questions about suspected carcinogens in drugs continue to roil the supply chain, the FDA last month said its testing of metformin did not find any with unacceptably high levels of NDMA. But testing laboratory Valisure has challenged those findings in a new Public Citizen petition, saying it discovered problems in 42% of the batches it checked. It contends the situation is likely to get worse as the COVID-19 outbreaks wreak havoc on supply chains.” Metformin is the first line oral agent recommended for treatment of Type 2 diabetes.
FDA Issues Final Rule Expanding Availability of Insulin Products: “The FDA issued a final rule amending the definition of ‘biological product’ to include chemically synthesized polypeptides, a category of products that includes all insulins currently on the market.” This change will more easily allow biosimilars to enter the market at a lower cost.
Sandoz to pay $195M criminal penalty in price-fixing case: “Sandoz, which is the generic unit of Novartis, admitted to its role in four antitrust conspiracies that took place between 2013 and 2015, each with a competing generic drugmaker. It also entered into a deferred prosecution agreement with the Justice Department.”
