FDA

FDA Commissioner Stephen Hahn indicated that his agency would be willing to grant emergency authorization to a coronavirus vaccine, even before it completes Phase 3 clinical trials. This is a reckless gamble and could cause an unmitigated public health disaster.
The FDA’s rigorous oversight – rather than a race to satisfy an aggressive agenda – is imperative during this pandemic.
Perhaps someday a ballad will be written about the tragic tale of hydroxychloroquine (HCQ) and its ugly cousin chloroquine (CQ). HCQ, a potential (and controversial) therapy for COVID-19 at one time, is no more. The FDA revoked the emergency authorization of both HCQ and CQ. This was an example of how NOT to develop a drug. A lesson learned -- or not.
As new breeding techniques create new ethical debates over food, we think the ethical toolbox needs updating. Talking about crossing species lines simply isn’t enough. If Darwin had known about gene editing, we think he would have agreed.
Virtually every day there's news about one or more clinical trials in progress or being planned. But most people don't fully understand what the different trials mean. ACSH advisor Dr. Katherine Seley-Radtke gives us a primer that clearly explains the entire process. Timely reading.
COVID-19 has spread across the media much faster than across the world. The uptick is seen in the articles we're bringing forward this week. But rather than concentrate on what to do -- which has already been amply covered -- we're sharing reflections on how we got here. And what we can do differently.
We are holobionts, those who thrive in a saline environment, crafting of at least two species living in close proximity with one another. The other species is our gut microbiome, those microbial communities residing in our bowels and providing us with nutrients and signals. There's no denying their importance. But not as much can be said for probiotics –- the live microorganisms marketed to us with claims to better our health.
We wrote a little over a month ago about the large number of institutions not reporting study results, as required on ClinicalTrials.gov. Now, Stat reports that a federal court has ruled that those reports must be filed, although the timeframe for compliance remains ambiguous.
If you're a government agency like the CDC, the best time to admit to a huge mistake is on Friday afternoon before a three-day weekend. And if you're a government agency like the FDA, there's never a good time to make a boneheaded decision.
The denial of prescription analgesic medication to chronic pain patients has caused unnecessary suffering. But it has also driven up the suicide rate, trapping those who cannot bear to live without the drugs that have kept them functioning for years. ACSH advisor Red Lawhern, Ph.D., discusses the tragedy of intolerable pain.
The rest of the world has not been out snoozing in the sun. But Americans have had access only to older generations of sunscreens that prevent sunburn — but not the deeper damage that can cause skin cancer.
While an investigation is underway into the exact nature of the problem, so far the likeliest explanation is that improper use of vaping devices has led to illness, or the death, of some users. But that sort of nuance isn't governing the thinking of the FDA or CDC officials, both of which are allowing myths and fearmongering to drive their policies and public statements.