DON'T FIGHT THE SYSTEM, CHANGE THE RULES—THE BIG PHARMA SYSTEM WILL CHANGE ITSELF
It's all about patent law folks!
Why wouldn’t we fight the pharma system, it’s corrupt!
Nothing new in corrupt systems, is there?! You don’t need me to lecture you on that, as a time-served critical thinker.
You probably also know that it’s ‘moving mountains’ stuff to stop a system doing what it enjoys most, especially if other people are benefitting greatly from it.
That’s where we are with the pharma industry now, with millions of committed individuals fighting this evil money-making machine—but what would happen if we gave up the fight?
Nothing in the short-term, other than give us time to work out a strategy to stop the monster from consuming all in its path.
I’ll explain how this is the best course of action.
It’s been a boiling frog episode
We have to accept that the demise of the system has been a boiling frog episode.
For those not familiar with the analogy, here is the Wikipedia account (with apologies to non-Wikipedia fans), extract below:
The boiling frog is an apologue describing a frog being slowly boiled alive. The premise is that if a frog is put suddenly into boiling water, it will jump out, but if the frog is put in tepid water which is then brought to a boil slowly, it will not perceive the danger and will be cooked to death.
The story is often used as a metaphor for the inability or unwillingness of people to react to or be aware of sinister threats that arise gradually rather than suddenly.
This particular frog has been in the water for c. 40 years, quietly getting hotter and hotter. It has been enjoying that fuzzy warm feeling, as the kept rolling in.
Today, it’s on the verge of 100° C, about to boil to death. We can’t stop that happening; nor would we want to.
The pharma frog didn’t notice that the more it flouted the rules and good practices of developing and manufacturing new products, the closer to the wind it was flying (excuse mixed metaphor :O)!).
People systems are driven by purpose, good and bad
Any good book on Systems Thinking, such as Dynamic Systems for Everyone: Understanding How Our World Works, by Asish Ghosh, will tell you that unintended consequences can occur in complex, interdependent systems where people, as individuals, are involved.
In terms of the pharmaceutical industry, and the various players within that system, we have a perfect example. In 1950, George W. Merck, the founder of MSD, famously said:
We try never to forget that medicine is for the people. It is not for the profits. The profits follow, and if we have remembered that, they have never failed to appear. The better we have remembered it, the larger they have been!
George Merck had taken over his father’s business, making a tremendous success of it. He proved it was possible to build a thriving business by focusing efforts on those using its products.
Today, all those years later, the industry’s focus is on patents and profits—SARS-CoV-2 injections have proved that beyond all doubt.
What would George think if he was told about the subsequent Vioxx scandal?
The moral of this story is that companies may start out with every good intention, only for future leaders to lose sight of its initial purpose, delivering very bad outcomes for its customers, on the back of very large profits for its investors.
The system changed the rules—we must change them back
What we are experiencing today is the result of the system following the needs of its investors, rather than its customers (patients and healthcare professionals). To do that, it had to change the rules on how patents were awarded, using an archaic chemical patent rule known as compound claims. Read more here, or move on below:
Pharma companies began patenting molecular compounds in the early 1980. Prior to that, the manufacturing process to produce the drug, at scale, had to be in place, before award of the patent. Read how penicillin proves that, or move on:
For some strange reason, patent offices around the world thought that was OK. They began awarding patents when there was little evidence the compound had a chance of getting to market—and patients paid the price.
Over time, failure rates grew exponentially, as did R&D productivity, only in the opposite direction. Today, only one in 250 development candidates make it over ‘the valley of death’ and get to market. That was dubbed ‘the patent cliff’ by investors.
We must change the rules back to where they were if there is going to be radical change for the better!
You can help do this…
There is a way you can help get the ball rolling on this. If you have not seen it already, this is a petition I raised 4 years ago and has 733 signatures: Get the Price of Prescription Drugs Down: Change Patent Laws. It will go to Senator Bernie Sanders, Senator Rand Paul, and Senator Ron Johnson, if it gets enough signatures.
733 may not be enough! :O)
Also, people tell me that Change.org is heavily influenced by Mr Gates et al, so don’t bother. That may be right, but at least this gets the word out on the root cause issue of what we are seeing today. Feel free to sign and/or share.
Best,
Hedley
Hedley, did you see this BioNTech announcement from 17 June? Maybe the FDA is getting tough again.
“BioNTech SE has been informed by its partner MediLink Therapeutics (Suzhou) Co., Ltd (“MediLink”) that the U.S. Food and Drug Administration (“FDA”) has placed a partial clinical hold on the multicenter, open-label, first-in-human Phase 1 clinical (NCT05653752) trial sponsored by MediLink that evaluates the early-stage antibody-drug conjugate (“ADC”) product candidate BNT326/YL202 as a later-line treatment in heavily pre-treated patients with advanced or metastatic epidermal growth factor receptor (“EGFR”)-mutated non-small cell lung cancer (“NSCLC”) or HR+/HER2-negative breast cancer. The partial hold affects the enrollment of new patients in the trial in the U.S.
The FDA has shared with MediLink concerns that BNT326/YL202 may, at higher doses, expose human subjects to unreasonable and significant risk of illness or injuries. In order to address the FDA requests, certain steps need to be taken, including reviewing clinical and safety data, sharing available pharmacological data with the Agency and providing additional information in the investigators brochure regarding the safety findings including grade 5 adverse events observed in studies YL202-INT-101-01 and YL202-CN-201-01. MediLink has taken actions to pause enrollment of new patients in the U.S. and address the FDA requirements.”