In the past couple of weeks, the price hike of EpiPen has permeated the airwaves. From armchair philosophers on twitter to Candidates for highest office, everyone has weighed in on reasons why something that cost less than a hundred dollars less than a decade ago now costs over $600. Coporate greed and market need have come under scrutiny.

Some articles have talked about competition in the market for injectingtwi epinephrine. They have focused on how other producers cannot keep up with the demand now coming into focus, how marketing and lobbying have led to Mylan having a monopoly over the market, and how the price hike of EpiPen is a symptom of a system that restricts government agencies from negotiating prices. In 1999, congress suspended Medicare’s ability to set payments. Subsequently in the year 2000, the total national expenditure on prescription drugs jumped by 11.6% when compared to 1990, more than any other classified type of health expenditure. To put this into perspective, total national health expenditures grew by 6.6%.

Sitting in the center of all this is the clinical trial system. Armed with two different databases that we have synthesized and analyzed over the past year, ClinicalTrials.gov and Biomedtracker we went after two questions in particular: what did the original trials on epinephrine autoinjection look like and what kind of trials are being done today? The answer to the first question was baffling; here is literally a screenshot from one of the databases on the trials performed for EpiPen:

Details on Clinical Trials for EpiPen

The other database was not helpful either. But there’s a good reason for that. EpiPen was approved for the public’s use based seemingly on zero clinical trials. Yes, that is correct. We are currently seeing a price hike for a combined device and drug that did not even have to go through the clinical trials process. Dosing for EpiPen was, in fact, decided based on “published literature and established clinical practice.” This is somewhat understandable given that epinephrine’s mechanism of action and utility have been well known for nearly 100 years, and the military developed the autoinjector in the 1970s. However, Mylan certainly can’t claim they are raising the price of the EpiPen to recoup the costs of R&D. Even though EpiPen never went through any clinical trials, it still reaps the advantages of other treatments in the clinical trial system. For example, its patent does not expire till 2025, and the public generally views it as a safe and effective treatment.

And what about current trials? Even though approval for similar products should be relatively easy, there have been a number of trials that deal with new uses for epinephrine, comparative effectiveness research, as well as newer products that could improve on the EpiPen. The number of interventional trials initiated each year in clinicaltrials.gov eerily mirrors the price hike we have seen over the past decade.

There is a lot to learn from this story. First, the demand-side pricing issue we have talked about before is real, and it is showing itself in a way that should make us realize that there are structural problems with the system. Second, the price hike of EpiPen had nothing to do with the cost of research and development, and very little to do with the clinical trials process; but now the system could be more proactive in providing alternatives and competition for the EpiPen. Finally, there is a sense of irony here in how we perceive medicine and research. Despite risk averse nature of medicine, we as a society are putting all our chips on a treatment that never went through a gold-standard, scientific testing process. Yet companies producing comparable autoinjectors who want to challenge Mylan’s market dominance must subject their product to a rigorous, yet simple, linear process; in this case, Americans are leftwith the devil they know best (EpiPen), rather than a variety of choices.

As Don Berwick said on one of our calls, “there was never a trial where we tested parachutes.” Any solutions offered for the clinical trial system cannot just be about getting treatments through faster and cheaper; that already happened with EpiPen. But they must also make sure that issues of access, choice, and transparency are put at the forefront.

By:
Jen Bernstein and Sauleh Siddiqui