By Justin Yamashita, MSc. Benchtop, site, CRO: three levels of basic and clinical research, explained without spin.

Plain Talk is Root to Rx's plain-language teardown: the myth, the evidence, and the one question that beats it.

Last week ended in the room that watches a drug after approval, on a line about going somewhere the money is louder. This is that place. It’s also the answer to the question Marisol asked in a grocery aisle on Monday: if that cleanse really did what the video says it does, wouldn't a drug company be selling it by now?

Start with the bill, because everything else follows from it. A 2025 study in JAMA Network Open looked at the 38 new drugs the FDA approved in 2019 and put the direct cost of getting one of them through development at a median of about $150 million. Then add the two things that make the headline numbers so much larger: the cost of the money itself over a decade, and every candidate that failed on the way. With those counted, the median lands near $708 million and the average near $1.31 billion, in 2019 dollars and order-of-magnitude rather than precise. Either way, a company only signs up for that bill if it can be the only one selling the result long enough to earn it back. We’ve walked through that in the last 19 issues before this one.

Here’s the shape of it. Imagine that somebody gets paid to survey a new road. They drive it first, write down every pothole and every blind corner, and publish all of it, because afterwards they get to charge a toll on that road for a while. The toll is what pays for the survey and the known safety or risks for anyone wanting to take that new road plus continual monitoring if new risks appear.

The ginger in Marisol's basket is a footpath that people have walked for a thousand years. Nobody owns it, so nobody collects a toll on it, so nobody was ever sent out to fully map it. The path isn’t blocked, rather, it was never surveyed. Those two things look identical from where you are standing, but they’re not the same thing at all.

Under U.S. patent law's "product of nature" doctrine, something you simply find in nature and extract isn't patentable on its own; it has to be "markedly different" from its natural state to qualify. Ginger is ginger whether you or a company pulls it out of the ground. Nobody can lock up the exclusive right to sell it, which means nobody can borrow against a future monopoly to pay for the trial in the first place.

This is not an Eastern-medicine problem. A 2025 review in Frontiers in Pharmacology describes the identical collapse for cheap Western drugs once they lose patent protection. The authors call it a free-rider problem: nobody funds the trial that proves a new use, because the moment it succeeds every competitor can sell the same generic into that new market having paid for none of the research. The same paper points at where the gap sits. Public money funds a great deal of early research and very little of the confirmatory trials, which is the exact stage where evidence for approval gets made. Same wall, same reason, nothing to do with East or West.

None of this is a verdict on whether anything in a traditional system works. It is a statement about what got written down and who paid to write it. A tradition that kept its knowledge in practice and apprenticeship rather than in a protocol is not a tradition that was wrong. It is one that never produced the kind of receipt a regulator reads. And there are two receipts missing here, not one, which almost every argument online blurs together. The first is does it work. That is the trial, and everything above explains why it does not exist.

The second is different: is what is in the jar what the label says? That one has nothing to do with any tradition. The FDA states plainly that it "does not have the authority to approve dietary supplements before they are marketed." Manufacturing rules do exist, and they are real ones. What does not exist is anybody checking before the jar reaches you. The firm certifies itself and the FDA arrives afterwards, if it arrives.

You can see what that produces. When researchers measured the active compound across 28 commercial red yeast rice products, a remedy used in China for centuries, the amount varied more than 60-fold between brands. Same name on the label. Sixty-fold difference in the thing that does something.

Put those two gaps together and you have the opening somebody is selling into. No proof it works, no verified contents, so it gets wrapped in something that already has credibility, and the cheapest credibility going is a tradition thousands of years old that belongs to nobody.

That is the whole move in Monday's video. The tradition supplies the authority, the seller supplies neither receipt and keeps the money, and when the jar does nothing, or interacts with somebody's chemotherapy, the name that takes the damage is the tradition's. Which is worth being angry about. It is just a different thing than the one you were handed.

And here is the part almost nobody in this argument knows. In Japan, this category of medicine is not a supplement. It is a prescription drug. Since 1986, 148 Kampo formulas, Japan's traditional herbal medicine, have been approved for ethical use, meaning a licensed physician prescribes them and the national health insurance program pays for them.

So the jar sold to an American online, wrapped in the authority of an Eastern tradition, is frequently held to a lower standard than that tradition is held to in the country it came from.

That closes the second receipt, not the first. Japan regulates what is in the box, which is not the same as saying every formula has the trial evidence a new drug would need. But it ends one argument for good. "The West won't take it seriously" cannot survive the fact that the East regulates it as medicine and America sells it as a smoothie ingredient.

This is the part the conspiracy version skips, because it has an answer and the answer is boring. When no company can earn a trial back, the funder has to be somebody who was never trying to earn it back: governments, public research agencies, foundations, academic consortia.

Some of that money is already spent, and it's not hidden. The National Cancer Institute keeps a freezer bank of more than 230,000 extracts from plants, marine organisms and microbes, and is splitting them into a library of more than a million fractions any lab can request, free, to screen against any disease. That's the front of the pipeline, publicly funded and given away. The looking is paid for. The finishing is not.

Put a number on the finishing. The National Center for Complementary and Integrative Health is the federal center whose job is research on exactly the remedies this issue is about. Its budget has sat at roughly $170 million a year since 2023, and the final 2026 spending bill left it flat again at $170.4 million. That is the entire annual budget of the agency, against a median of $708 million to carry one drug to approval. It is not a conspiracy. It is a line item.

The shock was real, and worth being precise about rather than loose. Between 28 February and 8 April 2025, 694 NIH grants worth $1.81 billion were terminated. A research letter in JAMA Internal Medicine found 383 of 11,008 active NIH-funded clinical trials lost funding, about one in thirty, affecting more than 74,000 enrolled participants. Prevention trials were hit at 8.4 percent, which is its own quiet joke: the trials most likely to produce a result nobody can picture were among the most likely to stop.

The other half, because leaving it out would be the same trick this issue is about: the administration proposed cutting NIH by about 40 percent, to $28.35 billion, and Congress rejected it. The enacted 2026 figure was $47.216 billion, up 0.9 percent, the reorganization refused and indirect-cost rates frozen. Not a collapse. A squeeze plus a shock, and 0.9 percent does not keep pace with what research costs.

So if you're reading this believing there is real science in Eastern medicine nobody has bottled yet, you may well be right. The thing that would settle it is not a whistleblower. It is an appropriation.

That’s not a thought experiment. One of the most consequential plant-derived medicines of the last fifty years came out of exactly that arrangement, and Thursday's Informed walks through who paid and what they got.

"They're hiding it" and "nobody could afford to prove it" look identical from the outside. One says somebody made a decision. The other says nobody was ever standing there to make one. So the useful question is not "who buried this?" It's "who could possibly have paid to test it?" Most of the time the honest answer is nobody, and nobody is a problem with a budget line. Knowing which of the two you are looking at is the difference between being angry and being useful.

Q5. Am I applying the same standards to all claims?

The suppression story only survives when you hold two claims to two different standards.

The prescription drug had to say what was in it, prove what it did, publish what went wrong and keep reporting after approval. People are rightly skeptical of it anyway. The jar had to do none of that, and it is usually the one getting the benefit of the doubt.

Run Q5 in both directions or it is not Q5. Ask the drug company who funded the trial. Then ask the jar for its trial, and ask what is actually in it. If one of them gets a pass because of where it came from, that is not skepticism. That is a preference wearing skepticism's coat.

I've sat with families who felt dismissed for asking this exact question. The question is a good one. The conspiracy answer just happens to be the wrong one. Reply to this email or leave a comment: what's a remedy in your family that's never been trialed, and would you want it to be?

Forward this to the person who needs it, and you are on your way to a Series 1 set.

1. "Use of Clinical Trial Characteristics to Estimate Costs of New Drug Development." JAMA Network Open. Published 6 January 2025. Direct costs: median $150M, mean $369M. After cost-of-capital and discontinuation adjustments: median $708M, mean $1.31B, 2019 dollars. https://pmc.ncbi.nlm.nih.gov/articles/PMC11704977/
2. Garcia-Diaz M, Epstein D, Espin J. "Overcoming barriers to off-patent drug repurposing: a lifecycle-based policy solutions." Frontiers in Pharmacology. 2025. doi:10.3389/fphar.2025.1670845
3. USPTO, Manual of Patent Examining Procedure 2106.04(b), "Laws of Nature, Natural Phenomena and Products of Nature," November 2024 revision. uspto.gov
4. National Cancer Institute, Center for Cancer Research, Molecular Targets Program: the NCI Natural Products Repository and the Program for Natural Product Discovery. ccr.cancer.gov/molecular-targets-program
5. Cohen PA, et al. "Variability in strength of red yeast rice supplements purchased from mainstream retailers." European Journal of Preventive Cardiology. 2017;24(13):1431.
6. U.S. Food and Drug Administration, "Questions and Answers on Dietary Supplements." fda.gov/food/information-consumers-using-dietary-supplements/questions-and-answers-dietary-supplements
7. Patel VR, Liu M, Jena AB. "Clinical trials affected by research grant terminations at the National Institutes of Health." JAMA Internal Medicine. Research letter, 17 November 2025.
8. National Center for Complementary and Integrative Health, funding and appropriations history. nccih.nih.gov/about/budget/nccih-funding-appropriations-history
9. Final FY2026 Labor-HHS appropriations: NIH $47.216 billion, NCCIH $170.4 million. Consortium of Social Science Associations analysis of the enacted bill, February 2026. cossa.org
10. Motoo Y, Arai I, Tsutani K. "Use of Kampo diagnosis in randomized controlled trials of Kampo products in Japan: a systematic review." PLOS ONE. 2014;9(8):e104422. doi:10.1371/journal.pone.0104422

New here? Root to Rx runs three pieces a week. Monday you watch a real health claim try to work on someone. Wednesday you get the tools to run it yourself. Thursday you get the full evidence so you can check my work. Written by a clinical researcher, free, at RootToRx.com.

For educational purposes only. Nothing in this newsletter is medical advice. Talk to your doctor before making any health decision.

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Disclosure: Root to Rx is published independently by Open Label Media LLC. Views expressed are personal views of Justin Yamashita and do not represent his employer or any affiliated organization. No employer resources or proprietary information are used. Every claim is sourced from publicly available materials.

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