Counterfeit grey-market medication. Now what?
May 19, 2013 1:03 AM
Mail-order pills from a reputable overseas vendor (have seen them recommended in Ask) turned out to not contain any active ingredient according to a blood test. I switched meds when I found out, but am at a loss as to what to do beyond that.
What's the responsible way of dealing with this? I haven't done anything beyond set the remaining pills aside, but I don't want other people hurt like I was (6 months of problems that in hindsight make all too much sense). I alternate between doubting the strength of my evidence (but how else would a serum level test read ZERO), or thinking nothing I could do would make a difference.
What would someone a lot more assertive and together than I am do in this case? I'm in the US, so initially I was just happy the pills had made it through customs. Bummer.
What's the responsible way of dealing with this? I haven't done anything beyond set the remaining pills aside, but I don't want other people hurt like I was (6 months of problems that in hindsight make all too much sense). I alternate between doubting the strength of my evidence (but how else would a serum level test read ZERO), or thinking nothing I could do would make a difference.
What would someone a lot more assertive and together than I am do in this case? I'm in the US, so initially I was just happy the pills had made it through customs. Bummer.
Inhouse.
I guess it was kinda unreasonable to want to leave that out...
posted by tigrrrlily at 1:35 AM on May 19, 2013
I guess it was kinda unreasonable to want to leave that out...
posted by tigrrrlily at 1:35 AM on May 19, 2013
I can see two ways of dealing with this. Firstly, the only group that can change the way this company manufactures it's medications is whatever regulatory body is present within their country (e.g. the FDA in USA, The Irish Medicines Board here in Ireland where I live, whatever government thing it is in the relevant country). So I'd start by reporting the issue there. Keep the pills for now, you may be able to send them in for analysis as evidence depending on how interested they are in your report.
However, if it's a country that doesn't have regulatory oversight or rules or laws about pharmaceutical manufacture that this would be in breach of then there's probably not much you can do on that front. A company only has to manufacture to it's local standards. The FDA may be interested in preventing counterfeit drugs being imported into the US, so a quick google to look into that might be worthwhile (the Irish Medicines Board would care for example), but I don't know the legality of your importing them personally so that's also something to consider.
But otherwise you're left with my second option, which is raising awareness about the lack of manufacturing standards that this company works under (assuming this is the case). Then people ordering from them can make their own decisions about whether to do so and how to monitor their symptoms etc afterwards. How you do that and how far you go is up to you, e.g. word of mouth, mentioning it online in places like ask.me, or something more widespread or formalised (lobby group maybe?).
posted by shelleycat at 2:54 AM on May 19, 2013
However, if it's a country that doesn't have regulatory oversight or rules or laws about pharmaceutical manufacture that this would be in breach of then there's probably not much you can do on that front. A company only has to manufacture to it's local standards. The FDA may be interested in preventing counterfeit drugs being imported into the US, so a quick google to look into that might be worthwhile (the Irish Medicines Board would care for example), but I don't know the legality of your importing them personally so that's also something to consider.
But otherwise you're left with my second option, which is raising awareness about the lack of manufacturing standards that this company works under (assuming this is the case). Then people ordering from them can make their own decisions about whether to do so and how to monitor their symptoms etc afterwards. How you do that and how far you go is up to you, e.g. word of mouth, mentioning it online in places like ask.me, or something more widespread or formalised (lobby group maybe?).
posted by shelleycat at 2:54 AM on May 19, 2013
The FDA has a form for reporting counterfeit meds.
posted by fingersandtoes at 3:17 AM on May 19, 2013
posted by fingersandtoes at 3:17 AM on May 19, 2013
Confirm with the lab that tested the serum that the drug is detected by the assay. Some estrogen assays will not detect some pharmaceutical forms of estrogen, for example.
posted by txtwinkletoes at 5:30 AM on May 19, 2013
posted by txtwinkletoes at 5:30 AM on May 19, 2013
Assuming what txtwinkletoes suggests does not apply here (though it makes sense to check that out) and the drug in question is supposed to be from a manufacturer you're heard of (as opposed to Smith Pharmaceuticals and Doughnuts Inc.), I suspect the fault is in Inhouse's supply chain and that the pills you were taking probably have nothing to do with the company whose name is stamped on them.
My former corporate masters had a web page full of info on identifying counterfeit and falsified medication and who to contact if you suspected you had received such, so you might want to check the manufacturer's web page.
The EMA and FDA both take this stuff VERY SERIOUSLY. People go to prison for this shit.
posted by Kid Charlemagne at 7:42 AM on May 19, 2013
My former corporate masters had a web page full of info on identifying counterfeit and falsified medication and who to contact if you suspected you had received such, so you might want to check the manufacturer's web page.
The EMA and FDA both take this stuff VERY SERIOUSLY. People go to prison for this shit.
posted by Kid Charlemagne at 7:42 AM on May 19, 2013
The pills could be counterfeit but it could also be an issue with incorrect storage (of the ingredients or the end product) leading to the active ingredients breaking down or something like that. There are a lot of ways you can end up with a dud batch, all of which should be covered by the manufacturing and supply chain regulations.
Assuming the Inhouse Pharmacy I found via google is the same one as you were using they claim that all their products come from FDA approved labs. Which is good news actually, because then the FDA cares about what the manufacturer does regardless of local rules or the legality of importing the pills into the US. Reporting the problem to the FDA should have the problem fixed or the FDA approval revoked, either of which would stop inactive drugs being sold by this specific pharmacy (and by other reputable pharmacies too).
posted by shelleycat at 8:28 AM on May 19, 2013
Assuming the Inhouse Pharmacy I found via google is the same one as you were using they claim that all their products come from FDA approved labs. Which is good news actually, because then the FDA cares about what the manufacturer does regardless of local rules or the legality of importing the pills into the US. Reporting the problem to the FDA should have the problem fixed or the FDA approval revoked, either of which would stop inactive drugs being sold by this specific pharmacy (and by other reputable pharmacies too).
posted by shelleycat at 8:28 AM on May 19, 2013
I would report it to the FDA. You can report it online, anonymously. Since the online pharmacy is clear that they source from FDA-approved labs, either the lab has a problem or the pharmacy is using the name FDA when they shouldn't. I would guess that the FDA would care.
posted by insectosaurus at 8:47 AM on May 19, 2013
posted by insectosaurus at 8:47 AM on May 19, 2013
I ordered generic Wellbutrin from Inhouse in 2007. I actually stopped taking it altogether after that because it was having zero effect and I thought Wellbutrin had just pooped out for me.
I tried it again last year (this time from a U.S. pharmacy) and this time it did seem effective. I was puzzled about that. But maybe now I know why.
posted by El Sabor Asiatico at 9:21 AM on May 19, 2013
I tried it again last year (this time from a U.S. pharmacy) and this time it did seem effective. I was puzzled about that. But maybe now I know why.
posted by El Sabor Asiatico at 9:21 AM on May 19, 2013
I'm not sure what the FDA can do about an overseas vendor. A claim like "FDA approved manufacturers" is a little nebulous. They buy boxes of medication that say Bayer or Pfizer or Teva or whatever, and those are indeed FDA approved manufacturers, but how can we know they weren't counterfeitted further up the chain?
I wouldn't use a non US vendor for anything that is super important. I do use them for things like albuterol (salbutamol) inhalers, because those obviously work or don't. For something like an anti depressant or thyroid medication, I wouldn't trust their suppliers to be terribly competent. Even generic drugs purchased in US pharmacies sometimes have potency problems. (I won't name names, because I can't remember for sure which one, but there was a specific vendor of sertraline that just didn't work as well as the others.)
posted by gjc at 9:31 AM on May 19, 2013
I wouldn't use a non US vendor for anything that is super important. I do use them for things like albuterol (salbutamol) inhalers, because those obviously work or don't. For something like an anti depressant or thyroid medication, I wouldn't trust their suppliers to be terribly competent. Even generic drugs purchased in US pharmacies sometimes have potency problems. (I won't name names, because I can't remember for sure which one, but there was a specific vendor of sertraline that just didn't work as well as the others.)
posted by gjc at 9:31 AM on May 19, 2013
Did you contact the vendor? I've gotten duds from another overseas pharmacy, and they replaced them at no charge, no shipping fee. I've gotten dud thyroid meds from US pharmacies, too. But it you're buying w/o an RX, reporting to the FDA is a whole lot trickier.
posted by Ideefixe at 9:43 AM on May 19, 2013
posted by Ideefixe at 9:43 AM on May 19, 2013
They buy boxes of medication that say Bayer or Pfizer or Teva or whatever, and those are indeed FDA approved manufacturers, but how can we know they weren't counterfeitted further up the chain?
Theoretically GMP and whatever else is necessary for FDA approval is supposed to make sure they aren't. There are rules and procedures in place for tracking ingredients and end products etc to the end user, although I'm not sure exactly how all that stuff works. Which is why the FDA will most likely care about this regardless of where the problem is coming from.
posted by shelleycat at 10:08 AM on May 19, 2013
Theoretically GMP and whatever else is necessary for FDA approval is supposed to make sure they aren't. There are rules and procedures in place for tracking ingredients and end products etc to the end user, although I'm not sure exactly how all that stuff works. Which is why the FDA will most likely care about this regardless of where the problem is coming from.
posted by shelleycat at 10:08 AM on May 19, 2013
txtwinkletoes, that occurred to me as a possibility but now that someone else mentions it it's definitely something to double-check. Thanks.
posted by tigrrrlily at 3:59 PM on May 19, 2013
posted by tigrrrlily at 3:59 PM on May 19, 2013
This thread is closed to new comments.
posted by oceanjesse at 1:23 AM on May 19, 2013