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FDA Worried Drug Was Risky; Now Reports of Deaths Spark Concern (cnn.com)
Blake Ellis and Melanie Hicken, writing for CNN: Two years ago, Brendan Tyne pleaded with the Food and Drug Administration to approve a drug that he was hopeful could finally bring his mother some peace. She could no longer move without assistance and had fallen victim to the debilitating and frightening psychosis that haunts many people with Parkinson's disease. "She thinks there are people in the house and animals are trying to get her," he told an FDA advisory committee. He believed that a new medication called Nuplazid, made by San Diego-based Acadia Pharmaceuticals, was the answer.
Nuplazid's review was being expedited because it had been designated a "breakthrough therapy" -- meaning that it demonstrated "substantial improvement" in patients with serious or life-threatening diseases compared to treatments already on the market. Congress created this designation in 2012 in an effort to speed up the FDA's approval process, which has long been criticized for being too slow. Around 200 drugs have been granted this designation since its creation. [...] The committee voted 12-2 and recommended that the FDA approve Nuplazid for the treatment of Parkinson's disease psychosis based on a six-week study of about 200 patients. It hit the market in June 2016. As caregivers and family members rushed to get their loved ones on it, sales climbed to roughly $125 million in 2017
[...] In November, an analysis released by a nonprofit health care organization, the Institute for Safe Medication Practices, warned that 244 deaths had been reported to the FDA between the drug's launch and March 2017. [...] Since the institute released its analysis, FDA data shows that the number of reported deaths has risen to more than 700. As of last June, Nuplazid was the only medication listed as "suspect" in at least 500 of the death reports.
Nuplazid's review was being expedited because it had been designated a "breakthrough therapy" -- meaning that it demonstrated "substantial improvement" in patients with serious or life-threatening diseases compared to treatments already on the market. Congress created this designation in 2012 in an effort to speed up the FDA's approval process, which has long been criticized for being too slow. Around 200 drugs have been granted this designation since its creation. [...] The committee voted 12-2 and recommended that the FDA approve Nuplazid for the treatment of Parkinson's disease psychosis based on a six-week study of about 200 patients. It hit the market in June 2016. As caregivers and family members rushed to get their loved ones on it, sales climbed to roughly $125 million in 2017
[...] In November, an analysis released by a nonprofit health care organization, the Institute for Safe Medication Practices, warned that 244 deaths had been reported to the FDA between the drug's launch and March 2017. [...] Since the institute released its analysis, FDA data shows that the number of reported deaths has risen to more than 700. As of last June, Nuplazid was the only medication listed as "suspect" in at least 500 of the death reports.
More comprehensive analysis of results, more comprehensive analysis of the pathways, more comprehensive analysis of what is going on in live patients and more comprehensive analysis of any deaths should improve things, but you can't do everything to the hilt. You need to balance any increase in these so as to get the best payoff (best outcomes for survivors, fewest deaths) for the same budget.
Unfortunately, experts are considered heretics at the moment, and science is held as blasphemy by some. Added to that, corporations have no particular incentive to invest more because, by definition, they'll get less return. Why would anyone willingly spend more in order to get less? It's not even legal in America to take action that could hurt shareholders, so pharmaceuticals cannot legally improve the science behind their work even if it would be the CEO's ultimate dream.
It's a small world and it smells funny; I'd buy another if it wasn't for the money; Take back what I paid (SoM)
You still believe that lie. How cute. It's been well documented for decades that most of the "incarcerated for marijuana usage" were violent criminals, and also were carrying marijuana when they were arrested. Much easier to make the neighborhood better by prosecuting the easy one than to spend the manpower and money to drag the victims through the crime again to convict for the violent crime. But keep on believing the propaganda that it's white cops fault that black people are killing each other.
I remember seeing an article somewhere about converting meth back into a decongestant. The allure is that it's far easier to get meth than it is to get the decongestant. I used to work in the pharm industry, and the regulations are laughable as to their inconsistencies. Did you know that dispensing pharmacies don't have to keep an exact pill count on controlled substances? They are allowed to estimate what's there. Distributors are REQUIRED to keep an exact pill count of any open bottles returned, but since the pharmacy was just guessing the paperwork doesn't match up. Imagine how a DEA investigator doing an audit feels about that.
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The Pharma companies created the system, as they're the only ones interested in the legislation. The public who are interested are simply a couple of determined individuals with no money and the huge emotional burden of a personal loss. They are ineffective.
Here's a secret: Every IRB is required to have a board of medical professionals, and a lay person. The lay person must come from outside the medical profession.
YOU can be on an ethical review board.
Also, it pays quite well.
Quackery is indeed a real thing. However, I don't see the FDA playing much of a role in that, their testing revolves around safety not efficacy. For example, phenylephrine is approved and sold as a decongestant, yet is no more effective than placebo. Quite safe, though.
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