Drug Waste Costs a Fortune

Pharmaceuticals create great value for patients; however, they often cost the patient an arm and a leg.  Take for example, the Eli Lilly cancer drug Cyramza, which increases a patient’s life span by 1.6 months, but costs $50,000 per treatment course.  Much of the public believes that drug prices are astronomical simply to increase profits for drug manufacturers.  The Martin Shkreli price hike controversy, which saw the price of Daraprim (an antiparasitic drug used by AIDS patients) increase by over 3000%, highlights the problem of high drug costs.  Shkreli, former CEO of Turing Pharmaceuticals, who has been called  evil,” “opportunistic,” and “pretty much a terrible person,” became Public Enemy Number One as the price hike was seemingly implemented for no apparent reason other than to boost profits.  More recently it was revealed that Mylan, the maker of EpiPen, a life-saving injection device for individuals with severe allergies, was silently raising its price by over 400%.  One consumer who depends on EpiPen said, “hold[ing] my life, and the millions of children and adult lives hostage for profit, is extortion and an outrage.”

These drug pricing controversies are exacerbated by a recent study conducted by Memorial Sloan Kettering Cancer Center, which revealed as much as $3 billion worth of unused cancer drugs is thrown away each year.  Peter Bach, the director of Memorial Sloan Kettering and co-author of the study, notes that once drugs are opened they either have to be administered or discarded.  Due to differing patient body sizes it is unlikely that they will need the exact amount remaining in the vial; thus, there is always some left over drug that is discarded.  For example, Avastin, a colorectal cancer drug, is available in a 400mg vial, but the typical patient dose is only 350mg. The remaining 50mg is often wasted.

Even when discarded, the left over drug still has to be paid for.  Mr. Bach claims, “[this] mak[es] it possible for drug companies to artificially increase the amount of drug they sell per patient by increasing the amount in each single dose vial relative to the typically required dose.”  This means Medicare and private insurers waste nearly $3 billion each year to buy cancer drugs that are thrown away because drug manufacturers only distribute the drugs in vials that hold too much for most patients.  As put by the New York Times, “[d]rug companies are quietly making billions forcing little old ladies to buy enough medicine to treat football players, and regulators have completely missed it.”

The solution seems easy: allow vial sharing or manufacture the drugs in vial sizes such that leave no leftovers.  However, the safety standards for vial sharing are unclear.  Currently, the Centers for Medicare and Medicaid Services encourage vial sharing, while the Centers for Disease Control and Prevention (hereinafter “CDC”) declared the practice unsafe.  The CDC discourages vial sharing in order to “prevent inadvertent contamination of the vial through direct or indirect contact with potentially contaminated surfaces or equipment.”  Regulators should clarify the rules surrounding such practices to allow medical providers a clear understanding of whether it is acceptable to share vials. 

Additionally, multiple vial sizes should be available in order to minimize drug waste.  Mr. Bach reported, “the companies have full control over what vial sizes they produce and if they only want to market in one vial that’s too big for any patient in the country, that’s their call.”  Merck once produced Keytruda, a melanoma treatment, in 50mg vials, but switched to 100mg vials in February 2015.  A 150-pound person requires a 140mg dose of Keytruda.  This patient would waste 60mg of Keytruda when he could only waste 10mg if Merck had not discontinued production of the 50mg vials.  Oddly enough, Keytruda is still sold in Europe in 50mg vials.  Currently drug manufacturers are permitted to chose what size vial to sell their drug; however, regulators should encourage drug manufacturers to produce multiple vial sizes so there is less drug wasted per patient.

Clearly, “it is quite possible to market a drug with negligible waste.”  It is up to regulators and the drug manufacturers to ensure drug waste is reduced thereby preventing huge costs from being passed onto the patients and insurers.

Kathryn Brown is a May 2017 J.D. candidate at DePaul University College of Law. Kathryn is the Managing Editor of Lead Articles for the DePaul Law Review, a Fellow and Co-director of Programming for the Jaharis Health Law Institute, and an Editor and Staff Writer for the Institute’s online publication, E-Pulse.