Irl Hirsch, MD; Mark Harmel, MPH, CDCES

This transcript has been edited for clarity.

We are now 101 years after the discovery of insulin. The goal when insulin was discovered and then spread throughout the world was that everybody would have access. That actually wasn't the case after the discovery of insulin, and sadly, it's not the case now.

What's very important and what came out in our session from my talk — which related to the United States but is true all over the world — is that this is as much of a political issue as anything else. Unfortunately, when you look at what has happened in the United States over the years with insulin costs, it really is a political issue. Insulin costs have skyrocketed, no matter how you look at it, and that has reduced access, especially for our more vulnerable populations.

We know in the years 2009-2015, there was an increase in ketoacidosis, both in the emergency department and in hospitalizations. I am most interested in what we will see with diabetic ketoacidosis (DKA) during COVID-19. We don't have those data yet. My guess is that it increased even more owing to the issues with insulin access.

In the United States, we know from several surveys that 1 in 4 Americans on insulin ration their insulin. We also know that insulin rationing, or insulin omission, unintentionally, is the number-one cause of ketoacidosis — which obviously, is life-threatening. If we go deep into the reasons for this, the real question is, "Why?"

Traditionally, we have pointed our fingers at the pharmaceutical industry. I think, at least now in 2022, that's the wrong place to point our fingers. At the end of the day, there are really two places to point our fingers. One is the middlemen (or the middle people, to be more precise about it), and the other is the politicians.

Let's start with the politicians. One can go on a website called OpenSecrets.org and see where the politicians receive their lobbying money from. As it turns out, in the last year, of over 400 entities lobbying our politicians in Washington, three of the top 25 companies are insulin manufacturers. Does this influence the manufacturers? It might. I think it's certainly a possibility.

What I know for sure is that every physician in this country has very openly and transparently available to the public, based on the sunshine laws, have to show who we work with from the pharmaceutical industry, whether it's a gift or a research study. It's not as transparent with the politicians. I have a problem with that.

The other bigger problem is knowing who is profiting from this increase in insulin costs. Why have the politicians not done anything, at least not as of yet? The real issue is these middlemen. It's not just the pharmacy benefit managers (PBMs), but the PBMs, the wholesalers, and the pharmacies. Their profits in the past 5 years have skyrocketed, while pharmaceutical companies' profits from insulin have gone down. Now, don't get me wrong, they're still profitable, but the profits have actually gone down. We are talking massive increases for these middle people.

The good news is that there is going to be a vote, hopefully this summer, by the Senate for a $35 per month insulin cap. The details of that are not known. This insulin cap has passed Congress. What's important to note about the congressional passage of this bill is that only 12 Republicans voted for it. The other 193 voted against an Affordable Insulin Act for legislation.

I agree with the fact that this doesn't really fix the problem, but it will spread out the cost. I totally understand that. As a physician caring for hundreds of patients with diabetes and seeing patients struggle with affordable insulin, this is a potential tremendous benefit for these patients, with the understanding that all of society is going to have to pay for it because politically, there is no other way anybody can figure out.

I am hopeful that this bill does pass the Senate and then is signed by the President, but time will tell. If that does happen, I think much of the insulin rationing we have seen in this country in the past 20 years will diminish, if not go away completely — at least that's my hope.

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Any views expressed above are the author's own and do not necessarily reflect the views of WebMD or Medscape.

Cite this: Insulin Cap Legislation: Addressing the Challenges of Access - Medscape - Jun 16, 2022.

Professor, Diabetes Treatment and Teaching Chair, Division of Metabolism, Endocrinology, and Nutrition, University of Washington, Seattle, Washington Disclosure: Irl Hirsch, MD, has disclosed the following relevant financial relationships: Received research grant from: Beta Bionics Received income in an amount equal to or greater than $250 from: Abbott; Roche

Clinical research coordinator, freelance videographer, Los Angeles, California Disclosure: Mark Harmel, MPH, CDCES, has disclosed no relevant financial relationships.

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