Neurological Correlates

Ok, this is strictly a pharma-geek post, but this is why there is science: combining chemistry, protein structure, medicine, computer science, and third world social sciences, scientists from Cleveland and Chicago made a mini-revolution: uber-insulin that doesn’t need refrigeration. How great is that?

Maybe a little back story: One of my side projects is working with a non-profit group that is trying to figure out how to deliver biosimilars — essentially generic biotech drugs — to third world countries.

Cost isn’t an issue — the molecules are pennies per bucket to produce. Regulatory is a bigger issue — they will probably have to be made in a place where quality control is done by experts who don’t take bribes. (Now now, no remarks about the US gov’t. . .). But even that isn’t that big a deal. Corruption on the ground is a problem. But logistics is even a bigger issue: with untrained medical personnel, how do you even deliver refrigerated medicines in extreme temperatures?

For the uninitiated, protein drugs — just like a good steak — turn bad when left out at room temperature. They can break down into smaller pieces — and if you inject these fragments, you basically get a vaccine: not good to be immune to the drug you need.

If anything, in the US and Europe, shelf-stable insulin would be a commercial coup. Insulin is generic in many markets (I don’t know the patent situation off hand, but it was cloned in the ’70’s, so you’d think its off-patent by now, but who knows). It’s always tough to launch into a generic market, even with a quantum leap in improvements.

As far as develping nations, I don’t know if diabetes is the first problem I’d tackle — basic nutrition and infectious disease, clean water — obviously that’s the priority among the most deprived areas. But certainly diabetes is an issue – here’s some facts from the World Health Organization:

DIABETES FACTS

• The World Health Organization (WHO) estimates that more than 180 million people worldwide have diabetes. This number is likely to more than double by 2030.
• In 2005, an estimated 1.1 million people died from diabetes.¹
• Almost 80% of diabetes deaths occur in low and middle-income countries.
• Almost half of diabetes deaths occur in people under the age of 70 years; 55% of diabetes deaths are in women.
• WHO projects that diabetes deaths will increase by more than 50% in the next 10 years without urgent action. Most notably, diabetes deaths are projected to increase by over 80% in upper-middle income countries between 2006 and 2015.

So, Hua et al. caught my eye because it was, I thought, a terrific example of applied science — protein structure and modeling, pharmacokinetics, molecular biology, social sciences, pharmacology, medicine. (Journal of Biological Chemistry had this as paper-of-the-week, sort of a blue ribbon). Hopefully it can work where people need it.

Qing-xin Hua, Satoe H. Nakagawa, Wenhua Jia, Kun Huang, Nelson B. Phillips, Shi-quan Hu, and Michael A. Weiss,” Design of an Active Ultrastable Single-chain Insulin Analog: SYNTHESIS, STRUCTURE, AND THERAPEUTIC IMPLICATIONS,” J. Biol. Chem. 283: 14703-14716.