It took 10 years for the first beta blockers to be approved in the US after they were in use in Europe. In that amount of time, thousands of Americans died for lack of the drugs. It's hard to distinguish this from mass murder, or at least mass manslaughter.
But that's not quite the issue in question, eh? My understanding is, you can't get the unapproved anti-venom even if you are conscious and you are about to die without it anyway, by doctors opinion.
I personally think that the FDA approval process is bogus too. I'm just trying to expand the discussion a bit.
Yeah, maybe there should be some rules about corner cases like that (what to do with you if you are unconscious and there is nobody to ask about what you'd want to be done to you). And maybe one way to get those rules written and enforced is to have people on government payroll for that. Or maybe we should just leave it to the ER folks. But, frankly, I think it would be nice to fix the obvious big wrongs first, and worry about all this stuff later.
I'm sure this is a debatable 'fact'/statistic.
If you want to cut down the number of people taking dangerous drugs, ban doctors from prescribing non FDA-approved drugs and ban companies from marketing them. However, I have only contempt for people who want to put their fellow citizens in jail for making their own medical decisions.
How about you engage the question of whether the costs and benefits of our current policy outweigh the costs and benefits of a looser policy directly, instead of just tossing a rhetorical hand grenade into the debate ("look! mangled babies!") and running away? It would look something like this:
"The number of thalidomide birth defects estimates range from 10,000 to 20,000 according to Wikipedia. Given the rate of cancer death in this country, a net one year delay applied across all effective therapies compounded across many years almost certainly outweighs your one example. Excessively liberal medicine policy may kill and maim, but so does excessively conservative policy; it's not a pure win by any means. Are you so sure that our policy is really the best policy?"
This isn't a question you can actually determine the best answer to with a series of anecdotes. You have to actually do a statistical analysis. I have not done this statistical analysis, so all I can say is something like "I'd bet money we're being too conservative", or "My libertarian leanings lead me to say we should have a more liberal acceptance policy on the grounds of personal freedom", but just screaming about deformed babies with no other analysis like this is an emotional tactic that should be replaced with something better. Too many people's lives are on the line for this debate to be shut down with "won't someone please think of the babies?"
The fine print will say "this drug has not been tested and is not approved by the FDA. It may cause death or create an uncontrolled viral outbreak..."
The drug will sell like hotcakes though because the commercials will have lots of happy-smiley people and the distributor will get a healthy 80% profit margin on the sales.
There's some comfort in knowing that a non-profit agency is looking into the safety of a drug before it goes out to the public for consumption.
In which fields? You are entering a mine field.
> Either regulation is good for the uneducated or it is not.
There could be different kinds of regulation.
Personally, if you are stupid enough to go for the non-FDA approved drugs, you are too stupid to help anyway. Unless you are going by some other approval system, for example whatever they use in Canada, UK or Australia. But if you are just going by what you read on the website, you are a fool.
Prohibiting advertising strays dangerously close to the 1st Amendment.
I can accept that regulation of speech is inherently suspect, but not that it's inherently bad. The reasons for regulating this kind of advertising are pretty clear to me.
In this case, I agree that prohibiting advertising is a first amendment violation. Instead, we should simply disallow all outdoor advertising and advertising that is broadcast on the publicly-owned radio spectrum.
What's so awesome about non-profits? They have their very own perverse incentive structures. Proposed replacement or supplement: Any company wishing to sell Drug X to the public must be insured against patient lawsuits. Insurance companies are quite capable of hiring people to assess risk and wouldn't have the same biased weighting of risk and benefit.
Why not make getting these non-approved drugs conditional on getting X% of the questions on a MCT correct, where said test is a quiz on the effects, side-effects, toxicity etc. of the desired drug? If I was implementing this I'd mandate that the source material for said test be publicly available at a centralised registry, that you need to get 100% of the answers right that the questions be randomly drawn from a test bank and that the test cost say half a day's median wage. Have authorisation lapse after three months so you need to take the test again.
Informed consent has just been assured, and people can now make their own decisions but they need to really want the drug.
I wonder the same thing. And it's not like the people in the non-profit agencies aren't paid, and can't accept bribes.
Not that anyone bribes the FDA, of course. They're non-profit, what possible gain could there be?
BTW, bribing a government official will usually result in one or both of you doing time in a federal (not a country club) prison.
If bribed with cash, maybe, unless it can fall under "campaign finance". Sports tickets, dinners, and gifts are generally accepted though.
Cheers for pointing that out.
[0]Ain't spurious exactitude great?
You're kidding right? At least with a for profit corporation I know their motives. With a government agency I have no idea if they are returning a favor, taking money, or simply like the person. With that said, the FDA still requires a large profit motive since no one would spend the millions required to get approved unless they expected some return.
I wonder how many possible working drugs for esoteric diseases are floating around that will never be released because of the expense of getting through the FDA.
Of course, they've never made mistakes, oh no, not them. Approved medications aren't dangerous in the least degree. And no "medications" are sold which aren't FDA approved. Not supplements, not energy drinks, nothing. McD's approves their fries, so does your corner diner.
I think the solution may be to have multiple standards bodies, the FDA being one of them. If bodies A, B, and Q approve a drug, and they have a good track record, people can choose. If a drug is experimental, bodies X and Y agree with research Z and not Q because someone ate a peanut, so take your pick based on your circumstances. At least then there would be other options.
The FDA should have a rule that any drug approved by any of the following agencies is automatically approved for use in the USA.
Yet Europe has drug regulation. Maybe the problem isn't regulation as such, but the way regulation works in the US.
It is my understanding that many drugs are not entirely metabolized/naturalized by the first person they enter. So the presupposition you are working with isn't entirely true.
Or would you rather prescribe them yourself too?
Edit: to be clear, I was attempting to respond to the parent's parent post. I apparently suck at internet.
If you felt it was made in anger or hate, I would think it would classify as a retort or something similar.
Something weird happened. When I originally posted, your comment was a sibling post to mine (and was already a child of the root of this thread after the page reload from submitting my comment). I was surprised when I came back to this thread to see your comment a child to my comment.
I think it would solve a lot of other problems (e.g. submarine patents) if patent holders were required (within defined bounds) to offer their patented products for sale on the open market in order to retain the patent.
The problem described in the article is simply that so few bites occur, the effort to make antivenom is not interesting to anyone with the skills or equipment to make it. This includes individual pharmacists, university scientists, and corporations; all of who can but do not provide antivenom.
Is it possible for pharmacists to synthesize anti-venom on demand? Coral snake bites may be rare, but if you were, for example, the operator of an Everglades tour group, your probability of encountering a bite might be a bit higher, and the antivenom would be good to keep around.
...which sounds like the sort of thing you might do if you were just manufacturing it.