... That our quality problems with generic medications are much bigger than we imagine.
Update 4/5/2010: see comments for more on this. A recent WSJ Health blog mentioned increased safety recalls for generics. I had not heard of the examples they cited.
Any particular reason why?
ReplyDelete(My main worry is that counterfeit meds from developing nations might get into the supply chain. Bad enough if it's something with low immediate impact -- a fake pack of ACE-inhibitors would up my blood pressure 10-20% for a month -- but if it's in something like chemotherapy agents or anti-retrovirals the consequences could be as large-scale-lethal as several airliner crashes. And as cytotoxics and shiny new antivirals tend to sell at a premium, what's the more likely target for counterfeiters?)
Nothing solid Charlie. If it were solid I'd definitely link to it. It's really a hunch coming from ...
ReplyDelete1. I don't think the Heparin problems [1] got anywhere near enough attention.
2. Some family members are on chronic generics. It's impressive how variable the "fit and finish" is. It's like buying a car with ill-fitting moldings. That doesn't make the car drive badly, but it's often a sign of quality problems elsewhere. Kind of like my asymmetric face is a sign that I really don't have uberman class genes.
3. Generics are forever running into production problems. Some drugs are unavailable. Others are missing doses. It's variable. We NEVER used to see this. It feels like things are on the edge.
4. We know how ubiquitous fraud has been in the past 10-15 years. There's a lot you can hide in multinational drug manufacturing.
5. There's no reputation to worry about with generics, no US office that might fear civil litigation.
6. We know the FDA is WAY understaffed.
Nothing real. Just circumstantial.
A hunch.
[1] http://notes.kateva.org/2008/03/toxic-heparin-was-fraud-not-accident.html