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What Needs to Change?

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Insulin to treat people living with diabetes has been available for over 90 years, but why aren't there generic alternatives available for people who must spend impossible percentages of their income on their insulin supply? In a BBC article Joanne Silberner noted that "People used to say that AIDS drugs were too costly and too difficult to deliver in developing countries, yet millions of people with HIV in places such as Uganda and Haiti are now being saved". Why aren’t we seeing the same for insulin? What needs to change in the system to make medicine (particularly insulin) accessible to those who need it the most?

In a Q & A session with the great philanthropist Bill Gates (who co-founded the Access to Medicine Index), the question was posed to Mr Gates asking if he believes that patents are critical to innovation in medicine or if they are simply market distorting mechanisms that help create monopolies. He responded that pharmaceuticals were getting better at offering the cheapest prices of drugs for people in the poorest of countries. I’m a Bill Gates fan and I love the idea of the Access to Medicine Index, but I’m not sure that I agree with him on his statement when it comes to insulin. Despite these supposed better deals for resource poor settings, a Guardian piece noted that "it is unclear whether the price reductions are enough to meaningfully increase affordability...they [pharmaceuticals] do not always disclose the full extent of the reduction nor take account of mark-ups by sales agents within a country. ”

We know that there are alternative options to the preferred and patented analogue insulin, yet some countries do not allow for production of generics, which in turn allows pharmaceutical companies to continue to charge unaffordable prices. Animal Insulin is disappearing off the market, human insulin is relatively cheap, but analogue insulin is, on the whole, incredibly expensive in most places. According to Gill, et al in The insulin dilemma in resource-limited countries. A way forward?, governments in countries with limited healthcare resources and finances can spend up to 10% on drugs. This is in part because newer analogue insulin tends to be the first-choice option and is as much as 13 times more expensive than biosynthetic human insulin.

The International Insulin Foundation’s position statement on the issue noted that ‘’considerable cost savings may be possible by using animal (pork or beef) or biosynthetic human insulins, rather than analogue insulins. The benefits of analogue insulins are small (particularly in the absence of glucose self-monitoring) but their costs are very high.’’ If simple human or animal – and presumably cheaper – insulins will nearly always suffice, the question remains – why is expensive analogue insulin the only option available to many who may die because a cheaper option isn’t available?

In 2010 when the Patient Protection and Affordable Care Act was passed in the USA, generic insulin was allowed to be created in the US. Unsurprisingly, the company trying to take generic insulin to market, Elona, is running out of money and support. ‘’One problem for Elona has been that making generic versions of biotech drugs will be much more complicated—and much more expensive—than it is for making generic versions of chemical drugs. Nearly a year ago, the FDA (Food and Drug Administration) issued draft guidance on “biosimilar” drugs that indicated it would require additional clinical trials of a biosimilar drug. That means a company like Elona would have to spend significant money to test its drug in patients before the FDA would declare it similar to an existing insulin. Because of that high standard, which the FDA has yet to finalize and put into effect, most pharmaceutical analysts do not expect Lilly and other makers of branded insulins to see their sales decline even after patent expiration.’’

There’s a lot more to this story and you can read some interesting info on producing generic insulin in America. Basically, there are a lot of problems around regulations, time, and cost which all stand in the way of producing generic versions of insulin. There’s also a comprehensive background document by Scott Strumello here. All of the issues he mentions can be applied to generic insulin production not only for US citizens, but for people all over the world.

Strumello’s piece notes that ‘’Patients with diabetes are irritated by what they see as the big pharmaceutical company’s arrogance and greediness and the FDA’s failure to assist in bringing generic competition to market.’’ Insulin prices are still increasing and profits are huge for pharmaceuticals. Despite this global profit made by pharma giants, these price increases make insulin even more unaffordable for people with diabetes, as well as for health systems and governments.

Dylan Gray, the director of Fire in the Blood, a documentary about the Western pharmaceutical companies and governments that blocked access to low-cost AIDS drugs for the countries of Africa and the global south, wrote an excellent piece on pharma monopolies with some very relevant thoughts. He puts it this way: ‘’Relentless pressure is being applied to poor countries by western governments determined to strangle supplies of lower-cost medication relied upon by the vast majority of the world's people who will never be able to afford branded drugs, and the outlook for access to medicine in the global south grows bleaker by the day. As unthinkable as it may seem, the horror that saw millions of people die unnecessarily of HIV/Aids while being denied safe and effective generic medicines produced at a fraction of the prices brand-name companies were charging, could be a mere taste of things to come.’’

If we don’t raise our voices against these practices and push pharmaceutical companies and governments to make cheaper insulin options available, we will be saying the same about diabetes and access to insulin. In fact, we already are.