The pharmaceutical supply and distribution chain is increasing vulnerable to business and criminal abuses. On the micro level, there is a need to police abuse of prescription drugs through prescribing “pill mills.” On a macro level, counterfeit drugs jeopardize our ability to provide treatment to critical ill persons. On Jul 12, 2012, the FDA issued letters to 19 practices in the US 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 on November 20,2012, the Wall Street Journal reported:
“ A Tennessee cancer doctor has pleaded guilty to purchasing illegal foreign drugs, as part of a long-running investigation into overseas distributors that sold fake versions of the cancer drug Avastin and other unapproved medicines to U.S. clinics.”
Oncologists have been in the spotlight. Medicaid has cut reimbursement for expensive cancer drugs, eroding the financial recovery oncologists have enjoyed for buying, and then reselling these costly meds. In an attempt to hold on to more revenue, practitioners have been buying cheaper versions from overseas suppliers. And many have become caught in this web – while not intentionally trying to compromise patient care – by trying to maintain the profitability of their practices. I would ask at this juncture, if there should be any profit incentive in medical care – an overarching issue our country needs to address.
The deliberate use of inert materials instead of real chemotherapeutic agents, or the sale of counterfeit drugs of unknown purity and potency would, in my humble opinion, rise to the level of crimes against humanity. Each and every one of us is at risk every time we walk into a pharmacy, because counterfeit and contaminated materials are entering the supply chain at an ever increasing frequency.
Counterfeit drugs raise significant public health concerns, because their safety and effectiveness is unknown. A counterfeited product might contain toxics. A non-toxic counterfeit might contain a substitute or no active ingredient . Think of the immense harm to a patient who thinks they are getting a lifesaving or life-sustaining medication but, in fact, is relying on a phantom.
In 2003, over $20 million in illegally imported and counterfeit Lipitor, a popular cholesterol-lowering drug, was distributed throughout the United States. The source and manufacturing methods of the product were unknown and had the potential to endanger patients.
Cargo thefts of prescription drugs also pose a significant public health threat. In 2009 alone, an estimated 46 drug cargo thefts occurred, valued at $184 million. These incidents are concerning to companies and consumers alike. Cargo thefts cost manufacturers millions of dollars. They put consumers at risk because the stolen drugs may not be stored or handled properly or be tampered with while outside of the legitimate supply chain.
In March of 2010, thieves broke into a warehouse and stole $75 million worth of prescription drug products, including chemotherapy, antidepressants, and blood-thinners. These products have not yet been recovered. In 2009, stolen insulin was reintroduced into the supply chain and reportedly caused a number of problems related to reduced potency, and impaired glucose control.
OTC are stolen and then reenter the system. I was shopping at a local drug store and on a mark down table at the front of the store saw boxes of Remifemin, a botanical menopause remedy, containing the herb black cohosh. At the time, I was consulting to SchaperBrummer, the German manufacturer, and their American distributor. Remifemin at $4 a box. Wow, what a score! I knew that the wholesale price was at least $7 at that time.
I bought the entire available stock in the store, figuring I could give it to patients to try. But frankly, my underlying shopping disorder got the better of me. I cannot resist a bargain. I was born under the sign “clearance.” But when I got home, I started pondering how the store could manage to sell this stuff so far below its wholesale cost. So I called the office of the US distributor and talked to the product manager. Now comes the good part. Believe it or not, the entire supply of Reminfemin for the west coast, a tractor trailer truckload, had been hijacked earlier in the month. No kidding! In my hands, I was holding “hot” herbs for hot flashes.
The manager asked me to send him the box so that they could try to match the product to the lot numbers of the stolen merchandise. And, of course, they wanted the name and address of the local store. I never heard if my corner pharmacy was fencing stolen stuff. But I did have to pause and consider how the boxes I bought might have been handled. Were they out in the sun? Were they transported in unsanitary conditions? Should I give them out at my office? In the end, I never gave them away. I just could not risk even the remote chance that this seemingly innocuous stuff had been mishandled or contaminated. In fact, a rash of hepatitis cases was associated with black cohosh soon thereafter, though not seemingly related to the hijacked materials.
Typically, jobs working in drug safety systems require a background in life sciences or other technical fields. One needs know the US Federal Regulations and Guidelines, methods of validation, and be familiar with a variety of databases for tracking adverse events and drug tracing. This is a growth center within the pharmaceutical world, because this kind of oversight not only protects the public, but also helps to indemnify manufacturers from litigation and liability.