60 Minutes - Softball Questions About Counterfeit Drugs

If you listened to the 3/13/2011 CBS' 60 Minutes' interview with the FDA Commission about counterfeit drugs, you didn't hear the difficult question, the real question, as to the difficulty that the FDA has with pharmaceutical product manufacturing and counterfeiting abroad.  Had the question been asked, perhaps the FDA Commissioner would have acknowledged that the FDA is not given sufficient money through the Congressional budgeting process to supply the systems and hire the people to take frequent hard looks abroad for shoddy pharmaceutical manufacturing processes and counterfeiters.  Those who provide our Representatives and Senators with campaign funds do not want a strong FDA regulatory process, notwithstanding that FDA regulation is a matter of life preservation for many Americans. They would rather provide election financing, pay the small fines, hire the law firms to defend themselves and let the counterfeiters skim off some of their profits.  They are unconcerned with Americans' welfare; they are concerned with corporate profits and executive bonuses.

60 Minutes: why aren't you addressing the significant issues?

Are You Taking The Drugs You Think You Are?

Reasonably sophisticated patients don't order drugs from unknown vendors on the internet. Cautionary tales of counterfeit or adulterated drugs abound, and if one has a serious medical condition, that cheap internet drug may cause trouble, perhaps even death.

But what about the drugs you get from your local or mail order pharmacy? Aren't those drugs certain to be the genuine branded product or a generic bioequivalent?

If you attended law school, the police academy, are a regular viewer of one of the CSI series programs, or if you work for the United States Postal Service handling "Registered Mail" you have probably heard about the "chain of evidence" or "chain of custody." You know that for the chain to be valid, there must be specific contemporaneous written documentation of custody and transfer of custody at each and every step during which it is handled. You might make the assumption that there is a similar chain of evidence for the drugs delivered to you by your pharmacy (local or mail order) in accordance with your doctors' prescriptions. Sorry, this isn't CSI, law school, the Post Office, or a courtroom. If you want to see a puzzled, annoyed, look on your pharmacist's face, ask if he or she knows (and how he or she knows) where and by whom the drug sold to you was produced, whether there is documentation of each step and party in the distribution process, that the drugs you received were actually delivered and received by intermediate parties in the very same sealed containers as they were delivered in, and whether the pharmacist can guarantee that the drug that the pharmacy delivers to you is the genuine branded product or a bioequivalent generic. Unfortunately, our prescription drugs have been commoditized, and the handlers anonymized, so that our faith in the products we receive may be unfounded.

If enough people asked the questions I described, perhaps the distribution process would become transparent instead of opaque. Perhaps instances of expensive counterfeit drugs would be less common. Perhaps some of the drugs we take would help us, rather than hurt us. If you can't a responsible and responsive answer to the questions, contact your Congressperson.

My personal experience was that the FDA was totally unresponsive, even when there was a serious basis to believe that I had been provided with an inactive counterfeit drug. And by the way, the local branch of the chain pharmacy hadn't a clue to what was going on and had no interest in helping me find out when I returned the suspect drug to them.