JackH said...
Provide some sort of personal summary or opinion that adds at least the slightest bit of value to an otherwise random link, and maybe I'll come back and click on this.

When you just post a link without summary, opinion or comment, you sent the message that this is not really worthy of your time, and therefore DEFINITELY NOT worthy of my time either...

Post Edited (BillyBob@388) : 4/12/2017 2:56:42 PM (GMT-6)

JackH said...
Agreed, BillyBob...better to let this clunker die a quick death on it's own and fade away.

Take it under advisement for next time...

Somebody said...
Moreover, while there's widespread support for provisions in the bill offering states money to battle opioid abuse and for mental health research and treatment, what's overlooked is that the measure also cuts $3.5 billion, or about 30%, from Obamacare’s Prevention and Public Health Fund, which fosters work to prevent Alzheimer's disease, hospital-acquired infections and other conditions.

One would expect Congress to ask the drug industry for something in return for regulatory rollbacks like those in the Cures Act. Remarkably, nothing in the measure would address the main problem the public sees with the drug industry — excessive prices.....................................

The 21st Century Cures Act has been meandering through Congress since 2015. But it was only this year that its promoters hatched the idea of combining the rollback of FDA standards with funding for the National Institutes of Health, which long has been starved of resources. That prospect brought many Democrats on board.

It may also have clouded their vision, leaving unnoticed the extent to which the bill reduces regulations on drug- and medical-device makers.

The bill opens a path for the FDA to approve new uses, or indications, for existing drugs without demanding thorough clinical tests conducted along customary lines. These include randomized samples, to prove they’re safe and effective for the new indications. Instead, the FDA could rely on “real world evidence,” which includes observations, safety and side-effect claims, and other data not subject to rigorous analysis. “That’s a much lower level of evidence,” Carome says.

"A homeopath would love this provision, and, I’m sure, so would drug companies," writes David Gorski, an oncologist and prominent debunker of pseudoscience and medical nostrums. "Why bother with the time, bother and expense of those pesky clinical trials to get your drug approved for additional indications, when you can rely on clinical experiences?”

The bill also permits drug makers to promote off-label uses of their drugs to insurance companies. This is a green light for them to vastly expand the markets for these drugs while bypassing FDA scrutiny. And it creates what Public Citizen calls an “overly broad” category of “breakthrough devices” that the FDA will be pressured to approve hastily.

These rollbacks are premised on the notion that the FDA has been a bottleneck in drug and device approval......................

Bololidat said...
BillyBob himself is the hook...I clicked it based on that alone...

Pratoman said...
The FDA has, I believe, felt. Lot of pressure to speed the process, particularly with drugs that treat serious diseases, and orphan drugs. So I'm guessing this is a reaction to that. Not sure it's a good thing, but someone with stage 4 cancer that has no other options but a drug in phase 3 or4 trials would be at least given hope where there was none

Somebody said...
The bill opens a path for the FDA to approve new uses, or indications, for existing drugs without demanding thorough clinical tests conducted along customary lines. These include randomized samples, to prove they’re safe and effective for the new indications. Instead, the FDA could rely on “real world evidence,” which includes observations, safety and side-effect claims, and other data not subject to rigorous analysis. “That’s a much lower level of evidence,” Carome says...................."Why bother with the time, bother and expense of those pesky clinical trials to get your drug approved for additional indications, when you can rely on clinical experiences?”

Post Edited (BillyBob@388) : 4/13/2017 7:26:31 AM (GMT-6)

Bololidat said...
You are your own imprimatur...is what I was declaring...