Approving Aduhelm Diminished Trust In FDA, Califf Acknowledges
The controversial approval of the Alzheimer's drug Aduhelm generated much media discussion, but Dr. Robert Califf, the new head of the Food and Drug Administration, says it also hurt trust in the FDA among the expert community. Meanwhile, reports say drug, health supplies shortages are ongoing.
Stat:
Califf Admits Alzheimer’s Drug Decision Impacted Experts’ Trust In FDA
Robert Califf, the new head of the Food and Drug Administration, admitted Thursday that the agency’s controversial approval of the Alzheimer’s drug Aduhelm has diminished its standing with experts. “It’s pretty clear that the controversy around this has temporarily impacted the trust in the FDA by people who pay attention to these things,” Califf said during STAT’s Breakthrough Science Summit. He added, however, that he doesn’t feel the broader public has lost trust in the FDA. (Florko, 3/31)
In other pharmaceutical and biotech news —
Axios:
Shortages Stretch Across Health Care Supply Chain
Surgical supplies for chest drainage, fluids required for dialysis and even old-fashioned hot and cold packs are among a list of items in shortage across health care, group purchasing organization Premier told Axios. Sustained, high-level supply chain shortages have stretched across all areas of health care. And they are expected to continue through the end of 2022, David Hargraves, senior vice president of Premier said. While it's natural for supply chains to have backorders and shortages, about eight to 10 times as many items are in short supply at any given time compared to before the pandemic, he said. (Reed, 3/30)
CIDRAP:
Supply Map Created To Predict Drug Shortages, Find Solutions
Five years ago, US Pharmacopeia (USP) began building a generic drug supply chain dataset to inform its strategic planning. Then the COVID-19 pandemic began, and the organization began analyzing the frequency of orders for its physical reference standards to gauge how the initial outbreak in China was affecting the pharmaceutical supply chain worldwide. Seeing its potential, USP invested several million dollars into the dataset, morphing it into something much bigger: a tool that can be used to predict medicine shortages, identify the drivers behind them, and determine the most beneficial solutions. (Van Beusekom, 3/31)
Stat:
After Patent Decision, It’s Business As Usual For CRISPR Developers
Earlier this month, the U.S. Patent and Trademark Office ruled that CRISPR patents key to developing human therapies belong to the Broad Institute of MIT and Harvard, ending the latest chapter in a bitter seven-year battle between the Broad and the home institutions of Jennifer Doudna and Emmanuelle Charpentier — the two scientists who won the Nobel Prize for creating the revolutionary gene-editing technology. But for all the acrimony exchanged and millions of dollars of legal fees spent by the academic institutions where CRISPR was first invented, the companies that are actually turning the technology into medicines are plowing through the fallout of the decision with little more than a collective shrug. (Molteni, 3/31)
Axios:
The Power Of Massive Databases And Trials To Unlock Precision Medicine
The goal of reaching an era of individualized precision medicine will first require a closer look at the broader population. Large clinical trials and massive databases of de-identified genetic and other health information — sometimes from generations of populations — are offering scientists and doctors data to decipher why certain individuals have a higher risk of disease or different responses to treatments. Until the roles of genetics, ancestry, environment, diet, age and gender are better understood, precision medicine will remain an elusive goal. (O'Reilly, 3/31)
Also —
Stat:
Main Authors In Elite Medical Journals Remain Mostly White And Male
A new analysis of two of the nation’s most prestigious medical journals shows that women and people of color rarely served as lead or senior authors of research articles published during the past three decades, and that gains in authorship during that time have lagged behind the increasing presence of these groups within medicine. In fact, when looking just at the main authors of high-profile journal articles — a metric closely tied to career success — representation of women and people of color appears to have stagnated in recent years, despite an increased focus on racial, ethnic, and gender equity in medicine. (McFarling, 3/31)
