Uncle Sam paid to develop a cancer drug and now one guy will get to charge whatever he wants for it
Today (Oct 19), I'm in Charleston, WV to give the 41st annual McCreight Lecture in the Humanities. Tomorrow (Oct 20), I'm at Charleston's Taylor Books from 12h-14h.
The argument for pharma patents: making new medicines is expensive, and medicines are how we save ourselves from cancer and other diseases. Therefore, we will award government-backed monopolies ā patents ā to pharma companies so they will have an incentive to invest their shareholders' capital in research.
There's plenty wrong with this argument. For one thing, pharma companies use their monopoly winnings to sell drugs, not invent drugs. For every dollar pharma spends on research, it spends three dollars on marketing:
And that "R&D" isn't what you're thinking of, either. Most R&D spending goes to "evergreening" ā coming up with minor variations on existing drugs in a bid to extend those patents for years or decades:
Evergreening got a lot of attention recently when John Green rained down righteous fire upon Johnson & Johnson for their sneaky tricks to prevent poor people from accessing affordable TB meds, prompting this excellent explainer from the Arm and A Leg Podcast:
Another thing those monopoly profits are useful for: "pay for delay," where pharma companies bribe generic manufacturers not to make cheap versions of drugs whose patents have expired. Sure, it's illegal, but that doesn't stop 'em:
But it's their money, right? If they want to spend it on bribes or evergreening or marketing, at least some of that money is going into drugs that'll keep you and the people you love from enduring unimaginable pain or dying slowly and hard. Surely that warrants a patent.
Let's say it does. But what about when a pharma company gets a patent on a life-saving drug that the public paid to develop, test and refine? Publicly funded work is presumptively in the public domain, from NASA R&D to the photos that park rangers shoot of our national parks. The public pays to produce this work, so it should belong to the public, right?
That was the deal ā until Congress passed the Bayh-Dole Act in 1980. Under Bayh-Dole, government-funded inventions are given away ā to for-profit corporations, who get to charge us whatever they want to access the things we paid to make. The basis for this is a racist hoax called "The Tragedy Of the Commons," written by the eugenicist white supremacist Garrett Hardin and published by Science in 1968:
Hardin invented an imaginary history in which "commons" ā things owned and shared by a community ā are inevitably overrun by selfish assholes, a fact that prompts nice people to also overrun these commons, so as to get some value out of them before they are gobbled up by people who read Garrett Hardin essays.
Hardin asserted this as a historical fact, but he cited no instances in which it happened. But when the Nobel-winning Elinor Ostrom actually went and looked at how commons are managed, she found that they are robust and stable over long time periods, and are a supremely efficient way of managing resources:
The reason Hardin invented an imaginary history of tragic commons was to justify enclosure: moving things that the public owned and used freely into private ownership. Or, to put it more bluntly, Hardin invented a pseudoscientific justification for giving away parks, roads and schools to rich people and letting them charge us to use them.
To arrive at this fantasy, Hardin deployed one of the most important analytical tools of modern economics: introspection. As Ely Devons put it: "If economists wished to study the horse, they wouldnāt go and look at horses. Theyād sit in their studies and say to themselves, āWhat would I do if I were a horse?ā"
Hardin's hoax swept from the fringes to the center and became received wisdom ā so much so that by 1980, Senators Birch Bayh and Bob Dole were able to pass a law that gave away publicly funded medicine to private firms, because otherwise these inventions would be "overgrazed" by greedy people, denying the public access to livesaving drugs.
On September 21, the NIH quietly published an announcement of one of these pharmaceutical transfers, buried in a list of 31 patent assignments in the Federal Register:
The transfer in question is a patent for using T-cell receptors (TCRs) to treat solid tumors from HPV, one of the only patents for treating solid tumors with TCRs. The beneficiary of this transfer is Scarlet TCR, a Delaware company with no website or SEC filings and ownership shrouded in mystery:
https://www.bizapedia.com/de/scarlet-tcr-inc.html
One person who pays attention to this sort of thing is James Love, co-founder of Knowledge Ecology International, a nonprofit that has worked for decades for access to medicines. Love sleuthed out at least one person behind Scarlet TCR: Christian Hinrichs, a researcher at Rutgers who used to work at the NIH's National Cancer Institute:
Love presumes Hinrichs is the owner of Scarlet TCR, but neither the NIH nor Scarlet TCR nor Hinrichs will confirm it. Hinrichs was one of the publicly-funded researchers who worked on the new TCR therapy, for which he received a salary.
This new drug was paid for out of the public purse. The basic R&D ā salaries for Hinrichs and his collaborators, as well as funding for their facilities ā came out of NIH grants. So did the funding for the initial Phase I trial, and the ongoing large Phase II trial.
As David Dayen writes in The American Prospect, the proposed patent transfer will make Hinrichs a very wealthy man (Love calls it "generational wealth"):
This wealth will come by charging us ā the public ā to access a drug that we paid to produce. The public took all the risks to develop this drug, and Hinrichs stands to become a billionaire by reaping the rewards ā rewards that will come by extracting fortunes from terrified people who don't want to die from tumors that are eating them alive.
The transfer of this patent is indefensible. The government isn't even waiting until the Phase II trials are complete to hand over our commonly owned science.
But there's still time. The NIH is about to get a new director, Monica Bertagnolli ā Hinrichs's former boss ā who will need to go before the Senate Health, Education, Labor and Pensions Committee for confirmation. Love is hoping that the confirmation hearing will present an opportunity to question Bertagnolli about the transfer ā specifically, why the drug isn't being nonexclusively licensed to lots of drug companies who will have to compete to sell the cheapest possible version.
If you'd like an essay-formatted version of this post to read or share, here's a link to it on pluralistic.net, my surveillance-free, ad-free, tracker-free blog:
My next novel is The Lost Cause, a hopeful novel of the climate emergency. Amazon won't sell the audiobook, so I made my own and I'm pre-selling it on Kickstarter!
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The USPTO answerphone machine while keeping me on hold for 15 minutes and going: āHey, did you know that you can also send us an email with your question? šā
Me, who sent an email more than a month ago that just got ignored completely:
By Miriam Kleiman, Public Affairs, in honor of Zamboni drivers Alex B (NGA's Sculpture Garden Ice Rink) and Uncle Hank (Northern MI University).
Alex rocks the Zamboni at the National Gallery of Art Sculpture Garden Ice Rink, 12/29/22, image by Miriam Kleiman.
Ever wonder about the incredibly cool āIce Rink Resurfacing Machineā (aka Zamboni)?
Weāve got the patent! See all 124 pages in our Online Catalog (NARA ID 117724382).
Thanks to the Zamboni, the ice was smooth enough for this talented monkey! See Ice Skating Chimpanzee, 1963 (The Unwritten Record).
Excerpt from the release sheet:
SPORTS MONKEY SHINES! THIS CHIMP IS A GAY BLADE:
Usually, summer is the whacky season, but this winter things arenāt on an even keel in Germany. Theyāve taught a Chimp to Skate and heās a real swinger! After some tricks āArchibaldā leads a Conga that proves heās a real gay blade with quite a line figure-8-atively.
PROBLEM: "The maintenance of a satisfactorily smooth surface on the ice is one of the major problems in connection with the operation of a skating rinkā¦ The squeegees have no effect on the hard-frozen rough ice, and the ice therefore remains rough 'until the next time that it is scraped."
BEFORE the Zamboni: "Heretofore, the usual method of cleaning off and smoothing the surface of the ice has been to send attendants out onto the ice to sweep off the cut ice with scrapers or sweeps that are pushed ahead of them; while in other instances, the ice is scraped clean by scraper blades mounted on towed sleds towed sleds or on automotive vehicles such as the small, four-wheel drive vehicles formerly used in the military services and known popularly as the jeep In either case, after the surface of the ice has 'been scraped clean, a thin film of water is spread over the ice to fill in the cracks and low spots, and surplus water is then squeegeed away, usually by a number of attendants on skates, pushing the squeegees ahead of themā¦Ā
GOAL of ZAMBONI: "[An] object of the invention is to provide a self-propelled vehicle that can be operated by one man, and which functions automatically to shave the ice, convey the shaved ice to a large receptacle attached to the vehicle, and then squeegee a thin film `of water over the surface of the ice so as to provide a like-new surface when the water has frozen."
Full citation: Frank J. Zamboni & Co., Inc. RG 241: Records of the Patent and Trademark Office, 1836-1978, Patent Case Files, 1936-1976, Patent Case File No. 2,642,679, Ice Rink Resurfacing Machine, Inventor Frank J. Zamboni. NARA ID 83876135
Much more online!Ā
Ice Skating in the National Archives, National Archives News special topics page
Records Reveal Winter Olympics History, National Archives News:Ā
Ice Skating at Rockefeller Center, 1937, The Unwritten Record:Ā
The recent USPTO decision that copyrightable art requires "human authorship" is good to prevent flooding the copyright space with machine-generated works in the monkeys-and-typewriters approach, but I'm really curious how present legal precedents could apply to non-human intelligent creatures. Will the legal definition of "human" be extended to include all sophonts, or will a new term be coined that isn't "human" or "person"?
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For this weekās Favorite Design Patent Friday, a classic retro-futuristic design from the golden age of water guns. Charles Arlissā originalĀ ātoy water pistolā was copied dozens of times over ensuing decades, and the version I had in the 70ā²s was even more Buck Rogers than the original. But the artistry and passion for design is evident in every detail of Arlissā work, all the more amazing as his target customers were unlikely to fully appreciate the beauty in those swoopy lines and carefully sculpted laser beams. These molded plastic works of art have become valuable collectibles, from an era of design where even inexpensive toys tried to capture the dreams of a high-tech future.
