If I were stranded on a desert island and given one set of books, I would take Will and Ariel Durant’s The Story of Civilization. In 11 volumes, the father daughter team interpret 2000 years of human behavior in a way that provides living context, “why we do what we do,” in a way readers can hold in their minds decades after reading.
The first volume brilliantly distills in one phrase, what must have been like for mankind to transition from hunter gatherers to farmers and merchants– “fear did not enter the heart of man, until he began to plan for the future.”
This phrase, explains why I love the Durants’ work, and why some people are more comfortable spending every penny they earn, accumulating no wealth at all; while those who do are often more miserable. If we don’t accumulate wealth, we don’t have to worry about keeping it.
Deus ex machina— Jesus “in a syringe.” A little over two years ago, Ozempic®, Mounjaro® and Zepbound® burst onto the scene, as a redeemer of sins, salvation could be had for a price (just a little “pinprick,” and there would be no more “ahhhhhh . . .”)
(Yes. I know, I have had too much coffee on a Saturday morning, when I use Latin and Pink Floyd’s The Wall in the same sentence.)
What’s the problem? When a drug manufacturer like Eli Lilly either invents a new drug (or buys the license from someone who did), it can gain “exclusivity” for its stockholders (the people who saved money, rather than spent it all and want to protect it).
If “Eli Lilly” sounds like a Civil War character, interestingly, he was. The company was founded by a real life pharmacist and colonel in the Union Army who was captured and imprisoned by Confederates during the Civil War.
One way to gain exclusivity for stock holders, is to patent the drug, which Eli Lilly did to gain exclusivity for Mounjaro® and Zepbound®. Patents can last for up to several decades, but there are shenanigans that can extend the patent. (See, “The Mounjaro Patent Thicket,” at Greyb.com)
The other way to protect shareholder’s is to gain FDA “exclusivity” which can be granted, even to generic drugs, but usually for a shorter period of time. (See, “Exclusivity and Generic Drugs: What does it Mean? FDA.gov/GenericDrugs.)
While a US Patent is only enforceable by the patent holder, the FDA enforces compounding restrictions under Section 503A of the FD&C Act. (See, “Compounded Drug Products That Are Essentially Copies of a Commercially Available Drug Product Under Section 503A of the Food Drug and Cosmetic Act, Guidance for Industry at FDA.gov.”) Often the FDA will pay states Attorneys General to do the enforcing through Consumer Protection Divisions.
FDA Shortage list. There was only one problem, while Eli Lilly patented salvation in a syringe, it couldn’t make enough of the stuff to keep it in stock. In such a case, the FDA publishes a “drug shortage” list. (Just Google it.) Eli Lilly’s Tirzeptide had been on the list for obvious reasons, but on August 2, Lilly announced that it had plenty in stock, and to protect shareholders, you can imagine what happened next.
Kirkland Ellis to weight loss centers: “Cease and Desist.” And so it came to pass that my client, a Nurse Practitioner operating a weight loss clinic in an “itty-bitty” East Texas town (pop. of 1,239) eceived a “cease and desist” letter from Kirkland Ellis (an international law firm with more offices than we can count on our fingers and toes).
The letter was a simple “Cease and Desist” on the basis of the FDA Drug Shortage list, and not made on the basis of a Patent violation, could be, because it sounds scarier to invoke the FDA as protector of big businesses like Lilly. (Don’t know.)
It is a story for another day (meaning I need to make a “Part II”), how the FDA and US Patent Office work with State Attorneys General Consumer Protection Divisions to protect massive profits for Eli Lilly, over consumers. So many stories to tell. (More to come!)