Show notes
The pharmaceutical industry has a dirty secret: it takes $2 billion and a decade to approve the average drug, and these numbers are getting exponentially worse. While computing power doubles every few years, drug development costs double every decade—a phenomenon called Eroom’s Law (Moore’s Law backwards).Lindus Health was founded to fix this crisis. Named after James Lind, the Royal Navy surgeon who ran the first randomized controlled trial in 1747 (discovering that citrus prevents scurvy and accidentally creating the Sicilian Mafia in the process), the London-based company is slashing clinical trial costs and timelines through better software, smarter processes, and a willingness to actually keep up with FDA guidance—which, remarkably, the industry ignores.In this first part of our conversation, we explore why pharmaceutical shelves are lined with miracle drugs gathering dust, how the NHS simultaneously possesses world-class health data while being catastrophically bad at purchasing new treatments, and what Britain could gain by becoming the world’s biotech testing ground.Tom, Calum, and Meri discuss:* Why drug development costs are doubling every decade: Eroom’s Law means $2 billion and 10-12 years per drug on average. “A tech bro would say ‘it one shot me’ right? How have we got this incredibly important industry getting exponentially less efficient when all the inputs—genome sequencing, compute—are getting exponentially more efficient?” The vast majority of costs are in phase 1-3 clinical trials,* The COVID vaccine trials were archaic: Meri volunteered and “it was like stepping back 30 years.” He had to download Microsoft Edge because the signup website didn’t have an SSL certificate. “That sounds trivial and silly, but that probably puts off at least half of potential volunteers, which makes it twice as long to enroll and potentially twice as expensive.”,* Pharma shelves are lined with miracle drugs gathering dust: “You would be shocked. There are just umpteen compounds sitting on shelves gathering dust.” Often shelved for ridiculous reasons: “This was a pet project of this guy who got fired and no one else wants to touch it.” Or outdated MPV thresholds. Because trials are so expensive, it’s not worth their time,* The regulations are surprisingly permissive: “This will sound controversial but I think the regulations have an appropriate level of risk modulation. You can literally go on the FDA’s website and see briefing documents where they are admonishing pharma for not being innovative enough. What other industry is the regulator trying to force private companies to be more innovative?” Most barriers are self-imposed,* James Lind and the Sicilian Mafia: In 1747, Lind ran the first RCT to cure scurvy—up to 50% of sailors on long voyages just died. Six treatment arms, oranges and lemons won. “One of the key innovations that powered the British Empire.” The demand for citrus was so great the Royal Navy went to Sicily, and “the Sicilian Mafia formed as a collective bargaining organization to help producers get a fair price.”,* The low-hanging fruit argument is cope: “Most people would say ‘oh well maybe we’ve discovered all the early targets and all that’s left is really hard to drug.’ That just seemed like terrible cope. 30-40 years ago we discovered medicines by zapping them into mice randomly. Now we’ve sequenced the human genome.”,* Britain has incredible advantages it’s squandering: The NHS has “probably the best health data set in the world. Completely longitudinal cradle to grave, all one system, records coded the same way.” UK Biobank is world-class. “There’s a lot of early phase research that originates in the UK. But when you’re running later trials, you want a good early adopter market. That unfortunately is not the UK.”,* The NHS purchasing problem: NICE has decided its role is to get the lowest price possible “even at the expense of waiting five years to acquire a drug that could be life-saving. We’ll spend five years negotiating a thousand pounds off a course of treatment and you think, is that worth it? People are literally dying who could have not died.”,* The dream scenario for Britain: “The NHS will fund the entire clinical trial and in return the drug will be free on the NHS. Maybe the NHS earns money off royalties of sales in other markets. That would be incredibly powerful, incredibly accretive to the British economy, but it would require political will.” If everyone’s going to worship the NHS like a deity, at least make it productive,* GPs are secretly based: They’re “basically private companies and thus much more flexible and fast and easy to work with” than NHS hospitals. Lind runs many trials through GP surgeries and patients’ homes to avoid hospital bureaucracy,* The ME/CFS trial: Running a trial for chronic fatigue syndrome with a German pharma company entirely remotely because “the sickest patients are literally bed-bound.” Using a drug already approved elsewhere. “I don’t care how the disease mechanistically works. I just care that we can run a proper experiment. If it works, I kind of don’t care how it has an effect as long as it works.” Testing beats theory,* Why the industry won’t innovate: “Incredible inertia driven ultimately by pharma having huge regulatory barriers to entry and thus very little competition and thus little pressure to innovate.” COVID vaccines succeeded because there was “for once, intense competition.” The problem isn’t that regulations are too strict—it’s that nobody bothers to follow guidance that would make things faster,* What Lindus Health actually does: Makes clinical trials faster and cheaper through better tech and processes. Uses AI to generate higher quality trial documents, quality control protocols, find patients more efficiently. $80 million raised, majority of trials now in US because “healthcare market is dominated by the US.” Over half of clients’ trials are American,Plus: The hellish anti-snoring device, why thalidomide broke our risk tolerance, how decentralized trials work, the bitter lesson of machine learning applied to pharma, and why Meri thinks Britain could create the next Novo Nordisk if we just got our act together.Part two coming soon. This is a public episode. If you'd like to discuss this with other subscribers or get access to bonus episodes, visit www.anglofuturism.co/subscribe