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.