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Lest you think the baby formula shortage occurred overnight or is an isolated problem, think again. It can and will be solved with fewer regulations, a worldwide market, a Trumpian style public / private partnership, and a deep reserve. But baby formula is just the tip of the supply chain shortage iceberg. Insulin for example, is a far more chronic problem with deeper roots and just as life-threatening.
As with baby formula, the problem starts with big pharma territoriality, where the definition of chemicals is narrow, and the level of competition is insufficient. Dr. Scott Gottlieb, when he was FDA commissioner, took a big step in adding biosimilars and generic versions of older drugs to the insulin market but these efforts have thus far proven insufficient to keep prices down or ensure sufficient product.
According to the Centers for Disease Control and Prevention there are 37.3 million people with diabetes in the US which is 11 percent of the US population. An additional 96 million over the age of 18 have prediabetes. 7.4 million Americans with diabetes use one or more formulations of insulin and this number is growing. Unfortunately, the insulin supply is not. Just the opposite, in fact.
The FDA announced just before the pandemic started, in February, 2020, that there was going to be a drug shortage including insulin due to the initial COVID outbreak in China. Insulin prices have skyrocketed 600 percent in the past 20 years, and at least three states, California, Washington, and Maine, have been passing legislation with the intention of producing their own insulin, as has Civica RX, a consortium of health care providers, insurers and philanthropists.
ABBOTT NUTRITION INFORMED ABOUT PROBLEMS WITH BABY FORMULA PLANT MONTHS BEFORE PREVIOUSLY KNOWN: REPORTS
In March, the House of Representatives passed the Affordable Insulin Now Act, which would limit the cost of insulin to $ 35 per month for Americans with health insurance. I supported this act writing in these pages, though the bill has yet to pass the Senate. The Democracy Policy Network has suggested publicly owned pharmaceutical enterprises bypass big pharma and develop medicines in the public interest including insulin.
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The insulin supply chain involves the delivery of insulin to patients and the flow of payments back. There are multiple middlemen that clog up the chain, and the monopolies of the three major companies involved, Novo Nordisk, Sanofi, and Eli Lilly, is part of the problem, as it is with baby formula.
The solution is multi-faceted and it includes more generics, biosimilars, public production, federal reserve, management algorithms and slow replacement of insulin with newer drugs which both help control diabetes and also reduce hunger and weight, a handy “two-for” which decreases insulin requirements. The new Lilly drug, tirzepatide, is very promising in this regard. But of course, there will be shortage of these drugs too (a similar drug, Wegovy, made by Novo Nordisk, is already in short supply) and many insurances are not routinely covering them.
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Another possible and exciting approach includes the latest in stem cell biotechnology, where canine stem cells are manipulated into becoming insulin producing cells. Unfortunately, clinical application of this technology is likely still years away.
In the meantime, the likelihood of a worsening insulin shortage is high. Quality control concerns, few manufacturers, and expense are earmarks shared with the baby formula crisis.
CLICK HERE TO READ MORE FROM DR. MARC SIEGEL