The Free-Living Bureaucrat: Heather Stone, the FDA, and the Human Cost of Drug Regulation

This is part 10 of my series on Who Is Government?: The Untold Story of Public Service by Michael Lewis.

Let me tell you about a little girl named Alaina Smith, a brain-eating amoeba, and one federal employee who sat between those two things. This chapter hit differently than most in the book.

A Family on the Edge

Walter and Amanda Smith of De Queen, Arkansas were, by the summer of 2021, fighting a slow-motion civil war inside their own marriage. Walter was drinking two six-packs of Budweiser a night. Amanda felt trapped. They had four kids, a farm with poor clay soil, a pile of rescue dogs, and a whole lot of unspoken resentment.

Walter tried to make things better in all the wrong ways. He’d haul in truckloads of enriched garden soil and build raised beds, just to stay ahead of Amanda’s requests and, in his own words, “keep her off his ass.” One afternoon while he was working one of those beds, their five-year-old daughter Alaina came out to play. She got caught in a swirl of garden dust. Walter told her to move away. Then he went back to work.

That dust is where this story really starts.

Something Wrong With Alaina

On September 10, 2021, Alaina’s older brother Hunter ran inside the house. “Mom, when I’m talking to Alaina she’s not talking back to me.”

Amanda found her daughter sitting alone, eyes open, staring at nothing. Lights on, nobody home.

Alaina was five, already reading at a third-grade level, and normally the most talkative kid in any room. What Amanda saw that day was a seizure. The ER doctor in Texarkana shrugged it off, said some kids just have them. A specialist in Plano diagnosed epilepsy. The prescribed medication made things worse, not better. Alaina started saying she wanted to hurt herself. She saw polka dots. The floor looked like it was tilting.

Walter pushed for an MRI. The Plano doctor resisted but eventually gave in. When he saw the results he called immediately: “I was wrong. Get her to Dallas Children’s Hospital right away.”

Inside Alaina’s brain was a mass three centimeters wide. The surgeon removed it. “It doesn’t feel like a tumor,” the doctor said. “It’s not like anything I’ve ever seen.”

The mass was sent to the CDC in Atlanta for analysis. For a week, the family waited. Then a cluster of doctors appeared outside Alaina’s hospital room door. They beckoned the parents over. They held up their phones. They pointed to a word they couldn’t even pronounce.

Balamuthia.

The Rarest of the Rare

Balamuthia mandrillaris is a free-living amoeba. “Free-living” means it can survive without a host. It lives in soil. And on very rare occasions, for reasons scientists still don’t fully understand, it finds its way into the human brain and starts eating.

Fewer than 200 cases had ever been reported worldwide. It kills 95 percent of the people it infects. There is no proven treatment. The CDC’s recommended protocol was a cocktail of five drugs that made patients violently sick while barely touching the amoeba.

The doctors told Walter and Amanda not to google it. They did anyway.

Walter, who had been an atheist his whole life, made a quiet deal with God right then: let her live and I’ll never do anything I’m not supposed to do again. He stopped drinking.

Amanda, standing in that same hospital room, looked at Walter and said: “When we get through this, I want a divorce.”

That’s the state they were in.

Here’s Where Heather Stone Comes In

Here’s the thing about the federal government: there are people buried six levels deep on org charts who are doing work that actually matters. You never hear about them. Neither do their bosses, mostly.

Heather Stone grew up in rural western Maryland, in a stretch of Appalachian country that felt more like West Virginia than suburban DC. Her mother, Judy Stone, was an infectious disease doctor who dragged her daughter on hospital rounds, brought her Peru trip notebooks home to read, and let her flip through FDA clinical trial binders. By middle school, Heather knew how to treat an iguana bite and understood the transmission rates of Q fever.

She was going to be a doctor. That was the plan.

But here’s the problem: her own body kept getting in the way. At seven, strep throat triggered PANDAS syndrome, a rare autoimmune disorder that gave her severe OCD. She went from a happy, bubbly kid to a girl who could only walk on certain floor tiles and had to measure her dental floss to the exact centimeter. Then came mysterious stomach pain that doctors dismissed for years, until Johns Hopkins found a bacteria more commonly found in stressed-out middle-aged men. Then fibromyalgia that forced her out of marching band. Then a college illness that stripped her singing voice from three octaves down to one.

She couldn’t physically handle medical school. So she did the next best thing.

Building CURE ID From the Inside

After a graduate epidemiology program, Heather landed a fellowship at the FDA. She hated the work, kept looking for a rare infectious disease angle, and one day slipped out of her office to attend a talk. An older South African doctor named Leonard Sacks stepped up to a microphone and asked the same question she’d planned to ask: what is anyone doing about drug discovery for rare diseases that the market has no interest in solving?

She introduced herself afterward. Sacks had an idea: build a global database where doctors could report what they’d tried on rare disease patients, what worked, what failed. No one was collecting this information. Heather offered to quit her current job and build it.

So what happened next was years of design work, international testing, bureaucratic resistance from inside the FDA itself, and a website and app that finally launched in late 2019 under the name CURE ID.

The idea was straightforward. For a disease so rare you can’t run a randomized controlled trial, the only data you have is what individual doctors tried and what happened. Case reports. Anecdotes. Most medical journals won’t publish them. CURE ID would collect them anyway.

The internal criticism came fast. The FDA shouldn’t be endorsing anything that wasn’t evidence-based medicine. Why was the US government spending money on tropical diseases that mostly affected people in other countries? And the one that turned out to be most accurate: doctors are too busy. They won’t submit their cases.

Heather argued for the project at every step. She convinced enough people. The tool launched. And then almost nobody used it.

Within the first five years, CURE ID received exactly 200 case reports. Five years, 200 reports. So desperate for content that she called her own mother and asked her to submit her old cases from a Peru research trip. Her mom’s journal went in first. The very first case entered into CURE ID was balamuthia.

The Connection Nobody Made in Time

Here’s the part of this story that I keep thinking about.

In 2015, a 74-year-old Chinese woman showed up at a San Francisco hospital and died sixteen days later. Her brain, in a doctor’s words, looked like a grenade had gone off inside it. Cause of death: unidentified encephalitis, which is what 20,000 Americans a year die of without anyone knowing exactly why.

A biochemist named Joe DeRisi used a DNA sequencing machine to analyze her brain tissue after her death. He identified the pathogen: balamuthia. Then he did something nobody had done before. He grew the amoeba in a lab and bombarded it with all 2,177 drugs approved in either the US or Europe.

All but one failed to stop it. One drug, a UTI antibiotic called nitroxoline that wasn’t even approved for use in the United States, stopped balamuthia cold.

DeRisi published his findings in an academic paper in 2018. And then he went on with his life, assuming that doctors who needed this information would find it.

They didn’t.

Three years later, in Dallas, a team of doctors at one of the top pediatric hospitals in the country was treating a little girl with balamuthia. They didn’t know about nitroxoline. They were using the same toxic five-drug cocktail that was slowly failing her.

So what happened next is that Amanda Smith’s mother stayed up late one night in August 2022 and started googling. She found a preprint of a new paper from UCSF describing how nitroxoline had helped a middle-aged man survive balamuthia. She handed it to Amanda. Amanda called the Dallas doctors. Their response: “Where did you find this? Our people haven’t even found this.”

Amanda noticed that the paper thanked someone named Heather Stone at the FDA for arranging emergency authorization for the drug. So she opened a LinkedIn account, listed her occupation as “Mother Trying To Save Her Daughter,” and left Heather Stone a voicemail.

Twenty-Four Hours

Heather checked her voicemail that morning in September 2022. She doesn’t normally bother, but that day she did. She listened to Amanda Smith’s voice explaining the situation in that specific kind of calm that people use when they’re barely holding it together, and then breaking down mid-sentence, apologizing for crying, and asking if someone could please call back.

Heather knew days mattered with balamuthia. She also knew the only nitroxoline in the United States at that moment were the leftover pills from the California man who had survived. She called DeRisi and the UCSF doctor who had treated him. She arranged for the pills to be shipped to Dallas. She got the FDA to send a letter saying the hospital could use the unapproved drug without legal risk.

Twenty-four hours after that voicemail, the Smiths had nitroxoline.

Walter and Amanda took Alaina off all the old drugs themselves and ground the nitroxoline into orange juice. She kept it down. Within days her color came back. Her nausea cleared. Her energy returned. Two months later she was symptom-free. Two years later her MRI came back clean.

And here’s the thing that got me: the experience that nearly destroyed Walter and Amanda’s marriage ended up saving it. Walter stopped drinking. He started asking what it meant to be a good man. Amanda stopped wanting the divorce. One afternoon Walter called her during a break at work and asked, out of nowhere, “Am I a good man?” She told him he was the greatest man she’d ever met. He hid his tears from the guys around him.

But the Tool Still Failed

Lewis doesn’t let the story end warm.

Alaina Smith survived. But the system Lewis describes, the one Heather spent years building to make sure knowledge like DeRisi’s discovery reached doctors who needed it, played no role in saving her. Amanda’s mother found the paper on Google at midnight. Amanda tracked down Heather through a LinkedIn profile and a voicemail.

And while all that was happening, a four-year-old girl in Northern California, about an hour’s drive from DeRisi’s own lab, contracted balamuthia. Her doctors found out about nitroxoline too late. She died.

Lewis puts it plainly: if all our systems worked the way they should, there would have been no need for a miracle. The researcher found the cure. The bureaucrat built the database. The little girl walked into the hospital. None of those three things connected when they needed to. Because doctors were too busy, too skeptical of government-built tools, or just not looking.

That is the actual story. Heather Stone did her job well. The tool she built to make her job scalable barely worked. A child died an hour from the person who discovered the cure. That is what happens when you defund government and then decide not to trust the parts that remain.

Book: Who Is Government?: The Untold Story of Public Service by Michael Lewis | ISBN: 9798217047802

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