Prescription Drug Crimes: True Lies

I want to do a small series on crime and punishment. I have mentioned before that I have a degree in Russian literature. I venture to say that most life science students have not thought about jobs working at the interface between the life sciences and the law.

But there are a wide array of fascinating jobs and an increasing need for adept individuals with biotech skills to help keep the nation’s drug supply safe.

The pharmaceutical supply and distribution chain is increasing vulnerable to business and criminal abuses. On the micro level, there is a need to police abuses in prescription drugs through pill mills. On a macro level, the international trade and transport of counterfeit drugs jeopardize our ability to treat critical ill people. On Jul 12, 2012, the FDA issued letters to 19 practices in the USA about the possibility that they had distributed counterfeit Avastin, a cancer drug, compromising the efficacy of chemotherapy. According to the FDA:“Avastin is an injectable medicine used to treat cancer and is administered to patients in clinics, hospitals, and doctors’ offices. The counterfeit version of Avastin does not contain the medicine’s active ingredient, bevacizumab, which may have resulted in patients not receiving needed therapy.”And just a few days ago, on Nov 20th, 2012, in Tennessee, a doctor entered into a plea agreement regarding felony charges of introducing misbranded drugs into interstate commerce with the intent to defraud the state’s Medicaid program.Physicians have been looking to purchase “cheap” sources of oncology meds, since Medicaid has cut reimbursement. Lower drug costs are a way for oncology practitioners to maintain their revenues. (Perhaps we need to have a conversation about the profit motive and fee for service models of financing for health care.)

Given the potential loss of months or years of life for cancer patients who are given some inert material instead of real chemotherapy, sale of counterfeit drugs almost rise to the level of crimes against humanity. We are all at risk every time we walk into a pharmacy, because counterfeit and contaminated materials are entering the manufacturing and distribution chain at ever increasing frequency.

So over the next few weeks, I will discuss methods of interdiction for counterfeit drugs, programs to insure the purity and consistency of raw pharmaceutical materials, and the devastating effects of prescription drug abuse. In each installment I will provide listings of regulatory and investigative agencies involved in guarding the public health by insuring the drugs we buy are effective and safe.