Sometimes it seems like the FDA spends more time and effort regulating peripheral health devices like smart watches than it does regulating the food and drugs that 1) it's named for, and 2) that people actually ingest.
The FDA is explicitly trying to avoid regulating things like smart watches. They're all but begging companies like Fitbit to be careful in their marketing to avoid forcing the FDA to act on the claims.
Perhaps I should have been more careful saying "like smart watches" then. I meant devices in general ranging the gamut from NiBP machines to SpO2 machines to smart watches. Most of these have far less impact on far fewer people than drugs or food, and yet the FDA spends a huge amount of resources regulating them, even trying to walk through software development methodologies. This is something I've seen first hand working at several sites that make such devices. So perhaps they're trying to scare a few particular vendors out of that specific arena, but on the whole they've got that industry tangled in a huge amount of bureaucracy.
Whenever my doctor says they have a new version of a prescription I always pass.
I've seen way to many ads on tv from law firms asking if I or a loved one has been injured by new drugs. (Call the 800 number and you're heirs might receive a $1.50 settlement check in 10 years.)
My favorite? Prilosec (Omeprazole, a proton pump inhibitor to reduce stomach acid) was running to the end of its useful life for (Then AstraZeneca) Pfizer. What to do? Nexium!
It's interesting to watch the dichotomy here, and how the FDA can't win for trying. When something slips by, the FDA is fast-tracking dangerous drugs. When Europe gets a new "miracle" drug before we do, the FDA is killing people.
Is there any future where we can imagine that this gets better and not worse? It seems like the pharma lobby has more and more power these days as it gets more and more money. There seems to be little incentive for it to be fixed as most people don't seem sufficiently outraged.
> If the original title begins with a number or number + gratuitous adjective, we'd appreciate it if you'd crop it. E.g. translate "10 Ways To Do X" to "How To Do X," and "14 Amazing Ys" to "Ys." Exception: when the number is meaningful, e.g. "The 5 Platonic Solids."
Some of the drugs on the list are very familiar to me. Meridia, Redux were developed for obesity treatment. Redux had the same liabilities as fenfluramine which back in the 90's was being very carelessly prescribed by inexperienced practitioners resulting in unnecessary fatal outcomes. OTOH fenfluramine had been on the market for decades without notable difficulties until overprescribed.
Similarly PPA was a very old drug but bad outcomes were noticed after it was used extensively without proper medical supervison.
Serzone was a different story. It was an unusual antidepressant drug insofar as it had many active and a great many inactive metabolites which made its effects less predictable. After millions of prescriptions worldwide, a handful of fatalities associated with hepatic toxicity slowly came to light. When a Canadian study reported 18 such cases the pattern became clear and ultimately Serzone use was discontinued.
However it's not unprecedented that drugs can be metabolized to compounds that are extremely toxic to the liver. It is a very rare phenomenon because having the exact genetically determined combination of liver enzymes to produce the toxic product is strictly a matter of chance. There's a huge number of cytochrome enzymes that are highly variable subject to random genetic variation. Once in a while a person is born with a particular set of unfavorable variants when in comes to a specific compound.
The issue is that very rare events, e.g., 1/100000 cases requires huge number of exposures before the adverse events can be correlated with use of the drug. The FDA tries to assure safety, but prior to marketing it's not possible to rule out the "one in a million" sort of event. That's the reason it's vitally important to report side-effects, especially serious or life-threatening incidents to the FDA.
No question that all drugs have side-effects and therefore should be used knowledgeably and conservatively. But we must remain vigilant, there is always a chance of unanticipated outcomes, often for the worse, though occasionally for the better.
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[ 1245 ms ] story [ 915 ms ] threadhttp://www.theverge.com/2015/6/24/8836049/fda-regulation-hea...
I've seen way to many ads on tv from law firms asking if I or a loved one has been injured by new drugs. (Call the 800 number and you're heirs might receive a $1.50 settlement check in 10 years.)
http://www.chemistry-blog.com/2010/10/18/nexiums-dirty-littl...
https://en.wikipedia.org/wiki/Thalidomide
> If the original title begins with a number or number + gratuitous adjective, we'd appreciate it if you'd crop it. E.g. translate "10 Ways To Do X" to "How To Do X," and "14 Amazing Ys" to "Ys." Exception: when the number is meaningful, e.g. "The 5 Platonic Solids."
Similarly PPA was a very old drug but bad outcomes were noticed after it was used extensively without proper medical supervison.
Serzone was a different story. It was an unusual antidepressant drug insofar as it had many active and a great many inactive metabolites which made its effects less predictable. After millions of prescriptions worldwide, a handful of fatalities associated with hepatic toxicity slowly came to light. When a Canadian study reported 18 such cases the pattern became clear and ultimately Serzone use was discontinued.
However it's not unprecedented that drugs can be metabolized to compounds that are extremely toxic to the liver. It is a very rare phenomenon because having the exact genetically determined combination of liver enzymes to produce the toxic product is strictly a matter of chance. There's a huge number of cytochrome enzymes that are highly variable subject to random genetic variation. Once in a while a person is born with a particular set of unfavorable variants when in comes to a specific compound.
The issue is that very rare events, e.g., 1/100000 cases requires huge number of exposures before the adverse events can be correlated with use of the drug. The FDA tries to assure safety, but prior to marketing it's not possible to rule out the "one in a million" sort of event. That's the reason it's vitally important to report side-effects, especially serious or life-threatening incidents to the FDA.
No question that all drugs have side-effects and therefore should be used knowledgeably and conservatively. But we must remain vigilant, there is always a chance of unanticipated outcomes, often for the worse, though occasionally for the better.