Want to make millions of dollars quickly while risking only a few months in prison if (and that’s a big IF) you’re caught? It’s not difficult at all. Just set yourself up as a distributor of counterfeit drugs in the United States.
This week’s announcement by the FDA that a counterfeit version of Avastin, a chemotherapy drug that is used for several kinds of cancers and tumors (lung cancer, kidney cancer, colon and rectum cancers – but no longer for breast cancer since approval was removed last year) has been found across the country, infused into the national drug supply, raises plenty of questions about how that could possibly happen.
It was followed by an interesting article in USA Today which partially answers the question. Counterfeiting is a multi-billion dollar business that is on the rise because it’s so lucrative, and because the penalties are so… well… inconsequential. I mean – would you be willing to spend no more than six months in jail if you could make millions of dollars for use when you got out? (Even if you would answer no! I don’t want to go to jail!… I’ll ask you this…. what if your child had treatable cancer and you had no insurance? Just sayin’ …)
Avastin isn’t the only drug that may be counterfeited. Any high cost drug that can be watered down, or manufactured to “look” right even if it is manufactured without its expensive ingredients, is a target for counterfeiters. Lipitor and Viagra are probably the most apt to be counterfeit, but others like drugs used to treat HIV and AIDs, or diabetic drugs, or weight loss drugs, are likely targets for counterfeiters, too.
So what happens if you are somehow treated using a counterfeit instead of the real drug? Maybe nothing. Or maybe you die. Or anything in between. The problem is, for the most part, we patients have very few ways we can detect whether a drug is real or fake.
Katherine Eban, in her book, Dangerous Doses, tells the stories of people who died from receiving infusions of counterfeit Procrit. The conventional wisdom on this most recent discovery of fake Avastin is that there was nothing in the counterfeit version that was dangerous, and it’s difficult to tell within a regimen of 18-20 doses a cancer patient might receive over six months whether one “missed” infusion of the active ingredients has a long-term effect.
The bigger picture problem is that our drug supply is not being well enough protected by the FDA, which is tasked with protecting us. The FDA has no backbone when it comes to protecting us from bogus, counterfeit drug distributors who appear to be selling “real” drugs, but target greedy doctors, pharmacies and hospitals that are so willing to buy “discounted” drugs for their patients, knowing that there will be more profit in their reimbursements. Experts estimate that about 1% of our drug supply is counterfeit. That means that 1 out of every 100 administered drugs may be counterfeit, too.
One answer to this is an electronic pedigree system, meaning, from the time the drug is manufactured, until it is given to the patient, it is followed and logged using a bar code type system. If such a system was in place, then even us patients would have a way to double check that the drugs being given to us are the real drugs they are supposed to be.
So why doesn’t the FDA insist on the development of such a system? Well, actually, they have. But again, they have no teeth, and so far, no backbone. Every time they raise the issue, the drug companies and drug distributors begin to wail about the added cost to the system. (Surprise! Follow the money!) And so, nothing gets done.
Like other issues in healthcare, it looks like little will happen to improve this system until something horrible befalls someone famous; someone who can actually override the special interests in Washington and insist on development of this electronic pedigree system.
Until then, here is information to help us patients do what we can to protect ourselves from counterfeit drugs.
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