Today's News and Commentary

About pharma

The medications that are thrown away: “Last year, Medicare paid for $725 million worth of expensive medications administered in outpatient clinics — things like chemotherapy drugs — that ended up being discarded, according to new data released by the federal government.” See the chart for the most costly wasted drugs.

Internal Deadlines, Drug Approvals, and Safety Problems: Quicker drug approvals have always been a doubled edged sword- the ability to get medications to those in need versus potential harm from overlooked side effects. This important research article quantifies this issue.
“ In the United States, the number of December drug approvals is roughly 80% larger than in any other month…Similar approval spikes occur at the end of each calendar month. Additionally, approvals spike before holidays, such as before Thanksgiving in the United States and the Chinese New Year in China (but not vice versa). Drugs approved in December and at month-ends are associated with significantly more adverse effects, including more hospitalizations, life-threatening incidents, and deaths. This pattern is consistent with a model in which regulators rush to meet internal production benchmarks associated with salient calendar periods: this type of ‘desk-clearing’ behavior results in more lax review, which leads both to increased output and increased safety issues.”

FDA Approves First-of-its-Kind Migraine Treatment: “Allergan’s Ubrelvy (ubrogepant) tablets received the FDA’s approval for the immediate treatment of migraine with or without aura, a visual disturbance or sensory phenomenon caused by the condition.
The novel drug, which is not indicated for preventive treatment, is the first drug in the class of oral calcitonin gene-related peptide receptor antagonists the FDA has approved for acute migraine treatment.”

Lawsuit accuses Pfizer of concealing cancer-causing chemical in Zantac: It was bound to happen: “A proposed class-action lawsuit was filed Jan. 2 accusing Pfizer of hiding the fact that Zantac, which it made from 2000 to 2006…Pfizer never listed N-nitrosodimethylamine, or NDMA, a human carcinogen, as an ingredient in Zantac, the lawsuit alleges.”

About health insurance

House, blue states ask Supreme Court to immediately review ObamaCare case: Rather than wait for the slow wheels of justice, the House and blue state attorneys general asked the Supreme Court to decide the fate of the ACA before the election. Recall where things now stand: the Appellate Court said the insurance mandate was now unconstitutional because there was no longer a penalty (oops…tax) for non compliance. That Court sent the case back to the lower court to decide if the whole ACA is now invalid.

About the public’s health

US on track for one of the worst flu seasons in decades: “Dr. Anthony Fauci, director of the National Institute of Allergies and Infectious Diseases, said while it's impossible to predict how the flu will play out, the season so far is on track to be as severe as the 2017-2018 flu season, which was the deadliest in more than four decades, according to the US Centers for Disease Control and Prevention.”

Best and worst diets for 2020, ranked by experts, with a popular one near last: Bottom line: Mediterranean diet is best. But read the article for where the others weigh in.

Social inequalities in multimorbidity, frailty, disability, and transitions to mortality: a 24-year follow-up of the Whitehall II cohort study: Read the article for the particulars of the study population and data gathering. The indicators of socioeconomic status considered were education, occupational position, and literacy. The findings showed that: “Socioeconomic status affects the risk of multimorbidity, frailty, and disability, but does not affect the risk of mortality after the onset of these adverse health conditions. Therefore, primary prevention is key to reducing social inequalities in mortality. Of the three adverse health conditions, multimorbidity had the strongest association with mortality, making it a central target for improving population health.”

FDA clears PhotoniCare's handheld OCT scanner for checking ear infections: This article is under The public’s health section because of the high prevalence of ear infections in children. ”PhotoniCare received FDA 510(k) clearance for its hand-held, noninvasive imaging scope that allows physicians to check for fluids deep behind the eardrum—one of the main signs of childhood ear infections, According to PhotoniCare, middle ear infections affect more than 80% of children, though they can be misdiagnosed up to half of the time following examination with a traditional otoscope.” If this device proves a better diagnostic tool, it will replace otoscopic assessment of middle ear infections and hopefully reduce prescription of unneeded antibiotics.

About healthcare quality and safety

Psychological safety and infection prevention practices: Results from a national survey: “High psychological safety was reported in approximately 38% of responding hospitals, and was associated with increased odds of regularly using urinary catheter reminders or stop-orders and/or nurse-initiated urinary catheter discontinuation (odds ratio, 2.37; P = .002) for catheter-associated urinary tract infection prevention, and regularly using sedation vacation (odds ratio, 1.93; P = .04) for ventilator-associated pneumonia prevention…A culture of psychological safety should be considered an integral part of HAI [hospital acquired infection] prevention efforts.”

Prevalence of Potentially Unnecessary Bimanual Pelvic Examinations and Papanicolaou Tests Among Adolescent Girls and Young Women Aged 15-20 Years in the United States: “In this population-based, cross-sectional study using data from 2011 to 2017, an estimated 2.6 million women aged 15 to 20 years in the United States (22.9%) received a bimanual pelvic examination in the past year, and 54.4% of these examinations were potentially unnecessary. An estimated 2.2 million young women (19.2%) received a Papanicolaou test in the past year, and 71.9% of these tests were potentially unnecessary.”

An accompanying editorial comments and rebuts reasons usually given for these unnecessary exams: “Some have suggested that the benefit of requiring an annual pelvic examination is that it prompts women to visit a clinician for their annual examination. There is no evidence to support this hypothesis.”