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Lest you think the baby formula shortage happened overnight or is an isolated problem, think again. It can and will be solved with fewer regulations, a global marketplace, a Trumpian-style public/private partnership, and a deep caveat. But infant formula is just the tip of the supply chain shortage iceberg. Insulin, for example, is a much more chronic problem with deeper roots and just as deadly.
As with infant formula, the problem starts with the territoriality of big pharma, where the definition of chemicals is narrow and the level of competition is insufficient. Dr. Scott Gottlieb, when he was commissioner of the FDA, took a big step in adding biosimilars and generic versions of older drugs to the insulin market, but these efforts have so far proven insufficient to keep prices low or ensure sufficient product.
According to the Centers for Disease Control and Prevention, there are 37.3 million people with diabetes in the United States, or 11% of the American population. A further 96 million over the age of 18 suffer from prediabetes. 7.4 million Americans with diabetes use one or more formulations of insulin and this number continues to grow. Unfortunately, the insulin supply is not. Quite the opposite, in fact.
The FDA announced just before the start of the pandemic, in February 2020, that there would be a shortage of drugs, including insulin, due to the initial outbreak of COVID in China. Insulin prices have soared 600% over the past 20 years, and at least three states, California, Washington and Maine, have passed legislation to produce their own insulin, as has Civica RX, a consortium of healthcare providers, insurers and philanthropists.
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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 have supported this law by writing in these pages, although the bill has not yet passed the Senate. The Democracy Policy Network has suggested that state pharmaceutical companies bypass big pharma and develop drugs 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 in return. There are multiple intermediaries clogging up the chain, and the monopolies of the three big companies involved, Novo Nordisk, Sanofi and Eli Lilly, are part of the problem, as is the case with infant formula.
The solution is multi-faceted and includes more generics, biosimilars, public production, federal reserve, slow insulin management and replacement algorithms with new drugs that both help control diabetes and to reduce hunger and weight, a convenient “two for” that lowers insulin requirements. Lilly’s new drug, tirzepatide, shows great promise in this regard. But of course, there will also be a shortage of these drugs (a similar drug, Wegovy, made by Novo Nordisk, is already in short supply) and many insurances don’t routinely cover them.
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Another possible and exciting approach involves the latest stem cell biotechnology, where canine stem cells are engineered to become insulin-producing cells. Unfortunately, the clinical application of this technology is probably still years away.
Meanwhile, the likelihood of worsening insulin shortage is high. Quality control issues, few manufacturers and expense are shared affectations with the infant formula crisis.
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