Cardiologist to lead FDA, again
The US Senate has narrowly confirmed cardiologist Dr Robert Califf, as the new Food and Drug Administration (FDA) commissioner.
The 50-to-46 decision in favour of President Joe Biden’s nominee comes despite objections to Dr Califf’s pharmaceutical industry ties and concerns he would not act aggressively enough against the opioid epidemic.
Dr Califf is a prominent cardiologist with extensive clinical research experience who served as FDA commissioner during President Barack Obama’s final year in office.
President Biden said Califf will bring a steady hand to the FDA as the drug regulator faces urgent decisions on COVID-19 vaccines, therapeutics and testing to fight the pandemic.
The FDA has been without a permanent chief for more than a year. The acting commissioner Dr Janet Woodcock will stay on as Principal Deputy Commissioner.
Most BP devices not validated for accuracy
The majority of blood pressure measuring devices do not have any published evidence of validation, Australian researchers have noted.
“Lack of validation may undermine optimal medical practice through increased potential for incorrect hypertension diagnosis and inappropriate care,” a Letter in JAMA from investigators led by Dr Dean Picone (PhD) a post-doctoral researcher at the Menzies Institute for Medical Research, University of Tasmania, Hobart, said.
Their analysis of 3,411 devices from 457 manufacturers found 76.3% of all devices had no validation. Wrist-based devices were more likely than upper-arm cuff devices to have no validation (85.0% v 73.0%).
“Global and national policy frameworks, including regulations with enforcement, are needed, with the goal that all devices meet minimum requirements for independent validation before premarket clearance,” the authors said.
The data came from the publicly available Medaval database.
De-risking of patients with low CAC possible
Absence of coronary artery calcification (CAC) even in people with severe hypercholesterolemia, is associated with a low risk of myocardial infarction, stroke, and deaths.
A Danish study of 23,143 adults referred for a cardiac intervention found the prevalence of calcified plaque had no clear association with LDL-C levels.
Overall, absence of plaque was associated with low event rates across all LDL-C levels.
“Taken together, our results support the use of CCTA results for risk stratification (including derisking) of symptomatic patients with high LDL-C levels,” it said.
“This is important because such individuals are universally considered to be at high risk with very low LDL-C goals that can only be achieved by treatment with statins in combination with novel therapies to lower lipid levels. Among the large proportion of patients with LDL-C levels of at least 190 mg/dL who have no atherosclerotic plaque, the net benefit of such intensive treatment is questionable.”
Read more in JAMA Network Open