Pharmaceutical companies will earn nearly $2 billion this year selling drugs that patients never take.
These are expensive cancer drugs that can cost upward of $13,000 per month. A new study suggests that the way drug companies package these intravenous drugs — in single-use vials that contain way more medication than an average patient needs — ends up wasting a lot of money.
"What manufacturers are doing is they're not right-sizing the vials to the dosages patients actually need," says study author Peter Bach, who is a physician at Memorial Sloan Kettering Cancer Center.
Cancer drugs are different from most other medications because they are delivered intravenously. Unlike pills that get dispensed out of a bottle, these are liquids or powders that will lose their potency if they sit on a shelf. Once opened, safety standards mandate that they must be used within six hours. After that, any leftovers have to go in the trash.
Bach and his co-authors argue in their new paper, published Monday in the British Medical Journal, that some drug companies sell too-large dosages that inevitably lead to waste. This creates income from medication that hospitals and patients will never actually use. That's bad for the health care system but good for the drugmakers who net more revenue.
One drug only comes in 3.5 milligram doses — even when patients only need a fraction of that
One of the most striking examples of this oversizing is a drug called Velcade that treats multiple myeloma, a bone marrow cancer.
Takeda Pharmaceutical, which makes Velcade, only sells the drug in 3.5 milligram vials in the United States (the company does manufacture 1 milligram vials abroad).
The amount of medication that patients need turns out to be significantly smaller than the single dosage size. Using data on the weight distributions of cancer patients, Bach and his colleagues estimate that the average Velcade dose is 2.2 milligrams.
The green bars below represent the estimated dosage of Velcade (also know by the name of its active compound, bortezomib) that American cancer patients need. The red line represents the current dosage that Velcade's manufacturer, Takeda, sells.
Each vial of Velcade contains 1.3 milligram more medication than the average cancer patient needs. This disparity between vial size and patient dosage means hospitals will waste about 27 to 30 percent of the Velcade they purchase. They'll spend $308 million on leftover Velcade that they never use.
I reached out to Takeda, the pharmaceutical company that manufactures Velcade, and spokesperson Amy Atwood told me the vial size was developed in coordination with the Food and Drug Administration.
"Takeda worked closely with the FDA to establish the VELCADE vial size of 3.5 mg to ensure that one vial of VELCADE would provide an adequate amount of the drug for a patient of almost any size," she wrote in an email.
But there is a solution that doesn't create nearly as much waste, and allows for accurate dosing.
A better way to package drugs — and save money
Bach argues that this much leftover medication is pricey and unnecessary. As a counterexample to Velcade, he points to Treanda, a leukemia drug manufactured by Teva Pharmaceuticals.
Teva sells its drug in 25, 45, 100, and 180 milligram vials. This means that providers can essentially mix and match the different vials to more closely match the dosage their patients need.
You can see in this graph below how the different dosage combinations of Treanda (also known by the name of its active ingredient, bendamustine hydrochloride) overlay with the population of patients. The red bars show all the possible combinations of Treanda with those different-size vials.
This graph looks really different from the Velcade one; it shows that there are lots of dosage combinations. And that means less drug waste: Bach estimates about only 1 percent of all Treanda gets thrown out.
"When there are drugs where 30 percent are wasted and drugs with only 1 percent waste, its inconceivable that drug companies don't know about this," Bach says. "These are extremely sophisticated businesses. They know everything about the patients getting their drugs, and certainly have the capability to figure out what we've described in this paper."
There are, however, risks to combining dosages: Using more than one vial of medication does leave more space for math errors on the part of the provider. This is why the FDA generally encourages single vials that have enough medication to treat a patient.
If the FDA wanted to go further, it could more strictly regulate vial size — looking for dosages that are enough to treat the average patient but not so large that they lead to significant waste.
And this is something that PhRMA, the trade group for drug companies, did express some openness toward.
"Manufacturers are committed to working with FDA and Congress ... to modify their products as we learn about the safety, efficacy and manufacturing of new medicines from the real world clinical setting," PhRMA spokesperson Allyson Funk said in a statement.