The Allocation Scandal. The National Institutes of Health has an annual budget of approximately forty-seven billion dollars.
55 million people die annually. You would think those two facts would be related.
They are not. A twenty twenty-three J.A.M.A. study analyzed two hundred forty-seven billion dollars in N.I.H.
spending (two thousand ten to two thousand nineteen) and found: Eighty-four point nine percent went to basic research, totaling
two hundred nine point nine billion dollars. Mice, molecules, mechanisms.
"Experimental work without any particular application in view."
They put the quiet part in the job description. Eleven point eight percent went to applied research, non-trial, totaling
twenty-nine point three billion dollars. Research with "practical aims" that does not practically aim at testing treatments
in humans. The clinical and translational science awards, or C.T.S.A., infrastructure program costs approximately one billion
dollars per year in buildings, overhead, and salaries. Observational studies watch patients get sicker without testing treatments
(the All of Us program spent two point one six billion dollars to observe disease happening.
Heroic.). Other applied research includes drug characterization, health services research, and epidemiology.
Three point three percent went to phased clinical trials, totaling eight point one billion dollars.
Actually testing if drugs work in humans (Phases one through three).
Phase one cost one point five billion dollars, or eighteen point five percent of the clinical trial budget.
Phase two cost three point five billion dollars, or forty-three point two percent.
Phase three cost two point six billion dollars, or thirty-two point one percent.
The N.I.H. covers only three point seven to four point three percent of Phase three costs, then wanders off like a cat that
lost interest. Pragmatic trials (thirty times cheaper) are severely underfunded despite proven efficiency.
The N.I.H. spends ninety-six point seven percent of its budget on everything except the one thing that saves lives: testing
treatments in humans. It's like spending ninety-seven percent of your grocery budget on cookbooks and three percent on food,
then wondering why you're starving. This isn't just inefficiency.
It's a body count. Why This Allocation Exists. This isn't bureaucratic accident.
It's lobbied outcome. Drug companies love the N.I.H. Taxpayers absorb the risk of basic research; industry patents whatever
works. It's like if your neighbor paid for your kitchen renovation, and then you charged them rent to eat there.
But independent trials comparing drugs head-to-head? Those are terrifying.
They might reveal that the eighty thousand dollar drug works about as well as the four dollar generic.
PhRMA, the pharmaceutical lobby, has consistently opposed comparative effectiveness research.
When Congress created the patient-centered outcomes research institute, or P.C.O.R.I., in two thousand ten, industry successfully
lobbied to prohibit it from making coverage recommendations based on cost-effectiveness.
Congress literally passed a law saying "don't fund research that might lower drug prices."
They wrote it down. In legislation. On purpose. The revolving door helps.
N.I.H. advisory committees include industry representatives.
Former N.I.H. officials join pharmaceutical boards. Academic researchers depend on industry grants.
Everyone's incentives align against cheap, fast trials testing whether expensive drugs outperform generics.
It's not a conspiracy. It's just that everyone involved happens to benefit from the same terrible outcome, purely by coincidence,
repeatedly, for decades. Basic research produces publications.
Publications produce tenure. Tenure produces more grants. Nobody in this cycle needs anyone to get better.
They need papers. The three point three percent allocation isn't a mystery.
It's a business model. The Efficiency Gap: A Tale of Two Trials.
The difference between efficient and inefficient trial design isn't theoretical.
Humanity accidentally ran a controlled experiment on itself during COVID.
Two countries. Same disease. One spent like it was trying to cure death.
The other actually did. RECOVER Initiative (N.I.H. Approach).
The budget is one point six six five billion dollars (one point one five billion dollars plus five hundred fifteen million
dollars in twenty twenty-four). The timeline is four years and counting.
Approximately thirty thousand patients are enrolled. Zero trials have been completed.
The cost per patient is fifty-five thousand five hundred dollars.
RECOVERY Trial (U.K. Approach). The budget was twenty million dollars.
The timeline was six months. Forty-eight thousand patients were enrolled.
Multiple treatments were found, including dexamethasone (saved over one million lives).
The cost per patient was five hundred dollars. The N.I.H. spent one hundred thirty-three times more per patient and achieved
infinitely less (dividing by zero trials completed produces infinity, which is fitting because that's how long patients
waited). This efficiency gap is not unique to RECOVERY. A systematic review of sixty-four pragmatic trials found a median
cost of ninety-seven dollars per patient. The British cured disease for the price of a nice dinner per patient.
America spent the price of a luxury SUV per patient and cured nothing.
The problem isn't that curing disease is hard. The N.I.H. doesn't have a capability problem.
It has a shopping addiction. The Death Toll: Opportunity Cost of Misallocation.
When you misallocate forty billion dollars a year into low-efficiency research instead of high-efficiency clinical trials,
you aren't just wasting money. You are composting people. Cost Per quality-adjusted life year, or Q.A.L.Y.
The standard N.I.H. portfolio costs fifty thousand dollars per Q.A.L.Y.
(and that's being generous). Pragmatic platform trials cost four dollars per Q.A.L.Y.
Every one dollar spent on efficient pragmatic trials buys twelve thousand five hundred times more health than a dollar spent
on the current N.I.H. portfolio. The ADAPTABLE trial proved pragmatic trials cost thirty times less than traditional randomized
controlled trials, or R.C.T.s (fourteen million dollars versus four hundred twenty million dollars).
Same science. Fewer catered meetings. The "Death Equivalent" of Budget Misallocation.
The annual opportunity cost is approximately one hundred million Q.A.L.Y.s and approximately seven million death-equivalents
per year. Even the most conservative estimate is approximately ten million Q.A.L.Y.s and approximately seven hundred thousand
preventable deaths annually. You are operating at approximately two percent of your potential capacity to save lives.
If your car ran at two percent efficiency, you'd walk. If your heart ran at two percent efficiency, you'd die.
Your medical research system runs at two percent efficiency, and you gave it a raise.
The Translation Crisis: All Theory, No Medicine. The problem is not a shortage of ideas.
It is a shortage of anyone bothering to test them. There are more than twenty thousand F.D.A.
approved drugs known to be safe in humans. There are approximately four thousand seven hundred to six thousand eight hundred
clinically-tested candidates for repurposable compounds (including three thousand four hundred twenty-two marketed drugs)
gathering dust. There are hundreds of plausible dementia interventions.
There are zero clinical trials available for your grandma in St.
Louis. You have a warehouse of safe molecules that have never been systematically tested for new uses.
The warehouse is full. The testing facility is closed for a team-building retreat.
The N.I.H. is, by its own metrics, a publishing house that occasionally dabbles in medicine: Two point five million papers
are published annually. Approximately fifty new treatments are approved annually.
The conversion rate from paper to patient is zero point zero zero two percent.
For every fifty thousand papers, one drug reaches a human. The rest become citations in other papers, which become citations
in other papers, in an infinite loop of academics reading each other's homework.
Plenty of Knowledge. No Translation. Approximately five percent of patients have participated in trials.
Approximately fifty percent of patients are willing to participate if invited.
Only nine to eleven percent of patients are actually invited.
Half of all patients would join a clinical trial if asked. Almost nobody asks.
It's like having a room full of volunteers and a clipboard, and choosing to study the clipboard.
Understanding disease and curing disease are completely different activities.
One requires microscopes. The other requires giving people medicine and seeing if they stop dying.
The N.I.H. chose microscopes. The Public Goods vs. Club Goods Scam.
The N.I.H. claims to produce "public goods" like open science and training.
What it actually produces is a free R and D department for pharmaceutical companies, funded by the same people who then
pay full price for the drugs. Taxpayers funded research behind ninety-nine percent of new drugs (three hundred fifty-six
drugs, twenty-ten to twenty-nineteen). Industry patents the winners.
The public pays again through high drug prices. When research leads to a dead end, the public eats the loss.
You pay for the lottery ticket. They cash the winnings. The only things the N.I.H.
SHOULD fund are things private companies CANNOT profitably fund: Open pragmatic trial platforms are thirty times cheaper
than traditional trials, yet receive minimal N.I.H. funding.
There are over four thousand seven hundred clinically-tested compounds for re-purposing generic drugs where no patent equals
no profit equals no interest. Comparative effectiveness data from head-to-head trials reveal which drugs actually work best
(pharma's nightmare). These are the ONLY things the N.I.H. should be funding.
Instead, the N.I.H. explicitly avoids them to "not crowd out industry."
Translation: "We won't run the trials that would lower drug prices, because the people who set drug prices asked us nicely.".
The Patient Disconnect: Zero Correlation with Health Outcomes.
The correlation between N.I.H. funding priorities and actual disease burden is zero point zero seven.
That is not a typo. On a scale of zero (random) to one (perfect), the N.I.H.
scores "basically a coin flip." A dartboard would allocate research funding more rationally.
What patients want. Medicine that works. Access to experimental therapies.
Trials they can join. A cure before they die. What N.I.H. funds.
Molecular mechanisms. Papers in prestigious journals. Research empires.
Institutional overhead. Patients don't control the money. Committees do.
And committees optimize for the continued existence of committees.
This is true of all committees, everywhere, since the invention of committees.
Nobody has ever convened a committee that recommended fewer committees.
The Track Record. Since 1970, the N.I.H. has spent over one point one trillion dollars (inflation-adjusted).
Diseases eradicated: Zero. This isn't because eradicating disease is impossible: The W.H.O.
eradicated smallpox for three hundred million dollars. Jonas Salk developed the polio vaccine in a university lab and gave
it away for free (which is why nobody at the N.I.H. talks about him at parties).
Veterinarians have eradicated multiple animal diseases while the N.I.H.
was forming subcommittees about forming subcommittees. Cows have better healthcare outcomes than you do.
What Would Actually Work. The U.K. RECOVERY trial already proved it.
Five hundred dollars per patient instead of forty-one thousand dollars.
One hundred days instead of years. Over one million lives saved.
The blueprint exists. It is not theoretical. It happened. In England.
During a pandemic. While Americans were arguing about horse dewormer.
The recipe: Pay for results: Treatment equals payment. No treatment equals no payment.
Radical, I know. Publish everything: Including failures (especially failures).
Eliminate gatekeepers: Let patients vote with participation.
Automate administration: Smart contracts instead of committees (committees cannot be trusted; see above).