It's a game of whack-a-mole and Amazon is doing the bare minimum. The company has no incentive to do otherwise.
I know this because I once tried to sell a pulse oximetry meter there and it got autoflagged and taken down. Apparently you can't sell (some?) medical supplies on ebay even though I bought the pulse ox meter from the store.
Clindamycin is an antibiotic, whereas benzoyl peroxide is not. Necessary characteristics for OTC drugs include an acceptable safety margin, low misuse and abuse potential, and adequate labeling. In addition, consumers must be able to self-diagnose, self-select the medication [self-selection is the decision a consumer makes to use or not to use a drug product based on reading the information on the drug product label and applying knowledge of his or her personal medical history], self-treat and self-manage the condition for which the OTC drug is intended, and additionally, a health care practitioner is not needed for the safe and effective use of the product. An OTC drug is considered to be safe and effective for use by the general public without a prescriber's authorization. At this point in time, FDA believes that clindamycin does not qualify as an OTC drug.
I'm slightly disappointed at this decision.
So no, it's not a good idea for more of it to be out there.
Prescription antibiotics are already overused; if antibiotics were over-the-counter, antibiotic-resistant bacteria would be a faster-growing problem than it already is: http://www.nytimes.com/2014/05/11/opinion/sunday/the-rise-of...
From a legal point of view? None. From a moral? Not so simple. A lot of drugs are prescription only in the US for really no reason whatsoever.
Two examples are Nystatin and Mebendazole.
I even emailed the FDA about Nystatin and they said that to become OTC it would need a sponsor, which is a stupid reason to leave them prescription only.
The day doctors sold out and started accepting bribes from pharma reps is the day that I stopped trusting them, and I certainly don't care what they think as it relates to steroids, pain killers, and antibiotics.
These are drug dealers complaining that they are being circumvented. Boo hoo.
Come on, we all know that if you have insurance and see your doctor with the sniffles, you can leave with a antibiotic prescription if you want.
I'm not defending the illegal online drug markets, but the problem of resistant germs is a much bigger problem and it has nothing to do with Amazon resellers.
Note that none of this is mean to say that sellers should not be held liable for fraud if they ship something other than what they claim to be shipping. But that's a separate issue.
Until eminently self-prescribable things like Adderall and cocaine are retailed at the corner store, I'll cheer on any "illicit" package that gets through CBP.
> I don't believe it's a proper role for government to
> regulate what substances people can buy and ingest
The FDA was invented to solve a real problem. Its nothing to do with stupidity - its to do with accountability.
Testing is good. Market standards and labeling are good. Completely prohibiting sales (by default!) between informed parties is bad.
Distribution of new antibiotics should probably be discouraged to avoid breeding resistant strains, but this is a rare exception (notice the title of this article mentions three classes of drugs, yet focuses on the only one that has moral standing). It can also be solved through less heavy-handed methods like manufacturer agreements, rather than an impermissive white list on every area the FDA sees fit for growing their clout.
No doubt. But that still leaves open a number of questions:
1. Is it a proper role for government to solve that particular problem?
2. Is the FDA (as we know it) the only possible way to solve that problem?
3. Does solving that problem outweigh the unintended consequences that result from the "solution"?
It's easy to say "Oh hey, there's this problem, let's just pass a law to fix it", but the Real World is often times more complicated than that.
People often act on good faith, that is, they buy something assuming it's been tested and is safe. Yes, it's true, we could all spend all day long reading every ingredient on every label and reading all the scholarly research on it, but it's cognitive overload.
Having medications evaluated by a trusted source is something many people actually do want, the FDA does serve that role and while it means there are restrictions, I think most people are OK with that. Of course, nothing is true for all people, and there are plenty of places you can go where you can buy any drug you want.
I do agree that the FDA is largely ineffective at preventing people from doing things to their bodies.
Ironically, the FDA would probably be able to better serve the public if it switches roles from enforcement to advisement. Keeping food, medication/devices and production methods to FDA standard, I believe, should get a UL type verification for things we use every day. Having that stamp brings trust that the FDA has verified the efficacy of whatever it is you put into your system, however there's nothing preventing you from going non UL if you're aware of the risks.
edit_ To the folks downvoting your post, I disagree with them as well!
Incidentally, some "snake oil" actually works:
http://www.scientificamerican.com/article/snake-oil-salesmen...
>are endangering public health, such as by breeding antibiotic resistance.
Yeah, because every asshole with a sniffle should not be able to self medicate with antibiotics.
If others breed antibiotic resistant bacteria by regularly ordering antiobiotics for acne or whatnot, it doesn't just effect them it effects me.
When you self prescribe foreign prescription medication, and die/suffer some massive side effect, there's no real recourse.
Who else is going to? There's no profit in it, so you can't expect someone to do it out of Smith-ian self-interest. And you certainly can't expect the pharma companies to police themselves; they hide studies that clearly show adverse, even deadly side effects, and otherwise outright lie, even with the FDA around. Imagine the hijinks that would ensue without it.
Then again, this type of thinking can quickly extend too far. Vast numbers of drugs require prescriptions that have nothing to do with antibiotics. Heck, I can't even get contact lenses without a prescription. That kind of thinking strikes of nannyism.
Certainly they are aware of regional policy/infrastructure, so writing this off as "it's a global product," is not really productive.
http://www.forbes.com/sites/emilywillingham/2013/11/07/study...
http://www.nytimes.com/2013/12/15/opinion/sunday/skip-the-su...
http://www.nytimes.com/2013/11/05/science/herbal-supplements...
http://www.bottomlinepublications.com/content/article/health...
Oh by the way "the informed consumer" just doesn't happen. 95% of people just grab something off the shelf and expect it to be safe and effective. Even if it isn't.
You're ignoring the informational role of retail brands. Consider toasters. I'm not a toaster expert, but when I buy a toaster at Kmart I can reasonably assume it won't electrocute me or catch fire in normal operation. I might only buy a toaster once every decade or so, but Kmart buys and sells tens of thousands at a time - it's definitely worth their while to hire an expert who looks very closely at what they are selling and responds appropriately to news about risks. Electrocuting your customer or setting their kitchen on fire is bad for business, so in order to minimize their legal/insurance expenses Kmart is quite likely to adopt such strategies as:
(1) sell mostly trustworthy brand names
(2) require 3rd-party certifications such as the UL seal in cases where those are worth what they cost
(3) run their own tests in-house as appropriate
(4) stop selling and remove from store shelves any brand that turns out to do notable harm.
Kmart decides what to sell attempting to achieve a particular balance of safety and quality, so I don't need to be informed on every specific brand I might find there - I just need to learn and know that Kmart either is or isn't generally trustworthy. If they are trustworthy, I can indeed "just grab something off the shelf and expect it to be safe and effective." (The same is true for specific name-brand product lines such as Craftsman or GE. In fact, the more a brand advertises, the safer it is to try that brand. Spending money on, say, a SuperBowl ad is equivalent to posting a performance bond - it involves spending a lot of money in advance that you can only get ROI from if the company expects to be around for a long time.)
Turning to supplements, I can be nearly certain that they are safe by that exact same logic - brands that clearly aren't safe tend to disappear pretty quickly from store shelves. (Because poisoning your customer is bad for business.)
I can't necessarily be certain supplements are effective and the FDA is, oddly enough, in part to blame for that. The problem is that supplements are not legally allowed to make health claims. They don't say on the bottle what the pill is for or exactly what outcome is expected. It's tricky for something like Consumer Reports to test whether health claims made for a product are accurate when no health claims are being made. So that one's tricky. It's possible we'd do better there with less regulation. A true free-for-all environment would let companies run ads and print packaging not only claiming their product had certain benefits but also (this is huge) comparing their product to competitors and pointing out that theirs works best. If a few large supplement companies are selling Resveratrol pills and the one called "Best" cuts corners using excess filler or a degraded supply, it's hard to think of anybody with more incentive to notice and tell us that "Best" is selling a crappy product than the competing firm "Nature Made". Open competition in which people can make any claims they can reasonably defend as true could solve a lot of the problem.
Obviously not.
> Almost a decade ago, experts were talking about how these supplements often contained “just a fraction of the ingredient on their labels–if any at all,” along with pesticide and heavy metal contamination. Just this year, news emerged that dietary supplements are tops in drug recalls for containing ingredients that pose a risk of “severe adverse health consequences or death.”
Plus only 2 companies from the study had 100% authentic ingredients. Pretty sure there are still more than two supplement companies still around.
Plus all the weight loss and body building supplements that contain drugs keep coming out and it doesn't effect sales of other products.
And anyways it is playing a game of whack a mole.
Plus you have a complete and total misunderstand about how supplement research is carried out.
No offense, but "i don't trust doctors for arbitrary subjective reason X" is, to me, the exact kind of garbage I hear from non-scientific "global warming skeptics".
They find some arbitrary, subjective reason to validate their distrust of experts in a field they are a laymen in.
I don't see how you're not doing the same thing. Vilify an industry, smear doctors because of your subjective vilification, and then apparently come online and promote your false "skepticism" rooted wholly in what sounds like a laypersons understanding of their work and industry.
I said if you have insurance, you can easily walk into most doctors' office with the sniffles (my poor choice of words for an illness with symptoms, but most likely not needing antibiotics) and walk out with a script for an antibiotic. Perhaps my sample set is very abnormal, but I see this constantly among my friends and colleagues. When they get a cold, they go to the doctor after a few days and leave with a prescription. When I've asked folks about it, it seems mostly out of habit. You feel bad, you go to the doctor. I find it odd, because if I ever get really sick and need antibiotics to keep me alive, I want them to be maximally effective.
Yes you did:
> The day doctors sold out and started accepting bribes from pharma reps is the day that I stopped trusting them
It really depends on the doctor, which is quite a bit better than arbitrarily ordering off Amazon.
Right now, you have to go to a doctor and get a prescription - if you don't have a bacterial infection, or aren't likely to get one (e.g., post-oral-surgery stuff) they won't prescribe you the antibiotics.
If it's possible to buy it on amazon, people will end up 'abusing' them to try and treat non-bacterial infections.
That's actually not what doctors say. When they can't determine if an infection is viral or bacterial, they treat it on the chance that it's bacterial (since we have a known treatment for bacterial infections and don't usually have a treatment for viral infections).
Tonsillitis is a good example: About 50% of tonsillitis cases are viral and 50% bacterial. "Relying on clinical presentation and history alone is unreliable in differentiating streptococcal from viral tonsillitis."[1] And bacterial tonsillitis can be quite serious.
So it seems reasonable to go ahead and treat with antibiotics even when there's a 50% chance that it's wasted, because the other 50% chance was that the treatment was highly beneficial.
A fact pulled directly from your ass. Doctors never prescribe antibiotics for viral infections; antibiotics are for bacterial infections and no they don't just hand them out willy nilly.
The study referenced in the Forbes article doesn't say how it picked which 44 products to study, which seems to be key to the question at hand. Was it a random sample? Was it a sample they had prior reason to suspect? Only if they'd picked products from the shelves of a specific retailer would it be a test of a retailer's selection acumen. (The fact that a product is available from somebody somewhere doesn't mean you're likely to encounter it.)
They also don't tell us which specific products were good or had problems so there's no way for a 3rd party to check their results. (Was that the intent? Given 2 companies were absolutely reliable, why not at least tell us which 2 companies they were?)
Dietary supplements often get recalled despite being ridiculously safe. If the FDA gets more than a certain number of adverse reports they have no incentive to consider how popular the product is and do a cost-benefit analysis; as far as they're concerned the "benefit" of a popular product counts as zero so any measurable risk is too high.
Weight loss supplements are particularly prone to being recalled due to risk levels that aren't at all out of line with the potential benefit.
You have to remember that not everyone follows directions or uses medications correctly. I don't blame the FDA for not making a drug OTC unless they can prove it will be used safely.
For Nystatin: Does your baby have a rash that looks like raised red dots?
For Mebendazole: Did you drink or come in contact with potentially infected water?
There are plenty of OTC drugs with far more complicated symptoms. It's really completely arbitrary - or more accurately, it's driven by companies wanting to expand their market into OTC (as soon as it goes off patent) rather than anything actually medical.
Take Nexium for example: It was prescription only (and very expensive) till the patent ended. The day the patent expired it turned OTC.
Kind of a severe side effect, no?
Nexium was available OTC right after the patent expired because the company that made it went through the OTC approval pathway. It was actually a sales strategy because plenty of people will buy brand name OTC drugs where if the got an Rx most pharmacies require the generic be provided.
As does Acetaminophen (Paracetamol), Ibuprofen, and Metronidazole and those are OTC.
Plus there are many OTC drugs with far worse potential side effects.
Correct but those are "grandfathered" drugs so they don't count.
>Metronidazole
Doesn't look like its OTC except for cats and dogs.
>far worse potential side effects.
Have you looked at http://en.wikipedia.org/wiki/Stevens%E2%80%93Johnson_syndrom... ?
As I'm sure you know there are tons of other medications that can cause that too not just "grandfathered" ones, but it's extremely rare. It's not why those drugs are not OTC. I even asked the FDA - it's about money, and nothing else (like Nexium).
> Doesn't look like its OTC except for cats and dogs.
My mistake. But there are other azole's that are OTC.
> Have you looked at
I did, it was a poor choice of wording - I meant worse as in likelihood * harm.
How does that make any sense?
And what would you use instead of nystatin - a broad spectrum antifungal?
Mebendazole is OTC in almost all countries except the US - it's even given routinely without evidence of infection.
There's also terbinafine which works better than the 3 you listead (but more expensive).