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De Omnibus Dubitandum - Lux Veritas

Monday, December 11, 2017

Diabetes Treatment And Insulin Price Fixing

By Michael D. Shaw December 11, 2017 @ Health News Digest
In a rare case in which a Nobel Prize was awarded less than two years after the honored treatment modality was demonstrated, Canadians Frederick Banting and John Macleod shared the 1923 prize for their discovery of insulin. Banting’s first patient was 14-year-old Leonard Thompson, who at the time was close to death, but did live for another 13 years.

His first long-term success was with Elizabeth Hughes Gossett, who lived to the age of 73. She was the daughter of Supreme Court Chief Justice Charles Evans Hughes. Ironically, the treatment was so effective that she chose to deny that she had been sick as a child, and expunged all references to diabetes from her father’s papers.

Sadly, as is far too common in big-time science, there was plenty of dissent between Banting and Macleod, who headed up Banting’s lab at the University of Toronto. Macleod did not immediately buy into what Banting was doing, with good reason—as earlier researchers had failed to isolate what would be named “insulin.” Moreover, Banting always thought that Macleod claimed too much credit, although various accounts of the discovery also cast blame on Banting’s attitude.

Indeed, Banting thought the prize should have been shared between himself and his assistant Charles Best. Banting gave half of his prize money to Best, and Macleod followed suit by giving half of his to biochemist James Collip, who perfected the purification of insulin, at least on a small scale. Nonetheless, Banting bore a lifelong resentment toward Macleod. Apparently, there was even dissent on the Nobel Committee as to how the prize should have been split.

In early 1923, an American patent was awarded to Banting, Collip, and Best for insulin and their production method. The trio promptly sold their rights to the University of Toronto for $1 each. Patent protection would assure that the manufacture of insulin would be restricted to reputable pharmaceutical houses, that could guarantee the purity and potency of their products. An early licensee was Eli Lilly, and their collaboration was crucial in driving production on a larger scale.
Despite these good intentions, by 1941, Eli Lilly; distributor Sharp & Dohme; and drug maker and distributor E.R. Squibb & Sons were indicted for conspiring to unlawfully “bring about arbitrary, uniform, and non-competitive prices for insulin and to prevent normal competition in the sale of the drug.” Health writer Mike Hoskins unearthed a contemporary story from the Indianapolis Star in which titan Eli Lilly, Jr. himself was quoted, stating that 13 price decreases on insulin had been made between 1923-41. And that, “Our price is now 3.5% of what it was when it was first sold in 1923, and today it costs the average diabetic just 7.5 cents per day.”

Some fines were issued, and that was that. Still, it does seem absurd that 94 years after the patent was issued, there still is no such thing as “generic insulin.” Instead, the price has climbed since the 1970s with the popularization of synthetic insulin, and constant patentable improvements (some more significant than others). And, the situation keeps getting worse.

In January, a class action lawsuit was filed against Sanofi, Novo Nordisk, and Eli Lilly, for offenses related to price-gouging.

One approach to lowering insulin prices would be to cut demand. Virta Health is now touting a peer-reviewed study in which a cohort of mostly overweight individuals, all with type 2 diabetes, and most on at least one medication, showed marked improvement in HbA1c levels. The program involved sustained carbohydrate restriction to achieve nutritional ketosis.

Of the initial 262 subjects, 112 (42.7%) experienced a decrease in their medications with another 21 (8.0%) having their medications eliminated. For those on insulin, 87% of them reduced or eliminated their dosages.

Another study just published in The Lancet put overweight type 2s on a strict diet. Of the participants who lost more than 30 pounds, 86% were free of diabetes after one year. Notably, none of these patients were on insulin. However, the work shows that type 2 diabetes can be put into remission in certain cases, and that drugs are not the only answer.

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