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Her refusal to approve a dangerous drug changed medical history

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Sixty-five years ago this fall, Dr. Frances Oldham Kelsey made history for doing something that might seem remarkably ordinary: she served as the proverbial red tape of the federal bureaucracy. She challenged a drug’s safety claims and repeatedly refused to approve its sale in the United States — a decision that saved lives and prevented widespread harm.

Amid thousands of layoffs in the federal government and an ongoing shutdown, the contributions of civil servants like Kelsey are a reminder of the power of one person.

Kelsey was a new medical officer at the Food and Drug Administration in September 1960 when she received an application to market a sedative drug for pregnant people with morning sickness. The sedative was called Kevadon, but the generic drug was known as thalidomide.

Kelsey, who had multiple degrees and had been trained as a doctor, was skeptical of thalidomide’s safety. At the time, the FDA had a 60-day window to either approve or reject a drug, or it would automatically go to market. Kelsey, who could not prove the drug was dangerous at the time but also knew there wasn’t information shared about its safety, made repeated requests for scientifically reliable evidence from the pharmaceutical company — a process that effectively reset the 60-day window under the guise that the application was incomplete. 

“Here was a drug that looked like it should be no problem, but at the same time there was just a feeling that there was something in the data or the absence of data that was a cause of concern,” Kelsey said in an interview years later, according to the Lost Women of Science podcast that featured her story. The pharmaceutical firm, the William S. Merrell Company, grew increasingly frustrated with her.

But the side effects of thalidomide began to surface in Europe and other countries. As Kelsey stonewalled at the FDA, reports were emerging about children whose severe birth deformities were linked to the drug. (This also did not fully prevent harm in the United States, where several hundred pregnant people took thalidomide through samples that had been distributed to doctors’ offices.)

Kelsey actions inspired new regulatory legislation for drugs, including more requirements that a pharmaceutical company ensure a drug is safe and effective. She was awarded the nation’s highest federal civilian service award — only the second woman at the time to get the recognition.

President John F. Kennedy awards Dr. Frances Oldham Kelsey the nation’s highest civilian honor at The White House.
In 1962, President John F. Kennedy awards Dr. Frances Oldham Kelsey the nation’s highest civilian honor for blocking approval of the drug thalidomide, which caused severe birth defects abroad. (The White House)

“Her exceptional judgment in evaluating a new drug for safety for human use has prevented a major tragedy of birth deformities in the United States,” President John F. Kennedy said in 1962 during a ceremony at the White House.

Kelsey later led efforts at the FDA to better test and regulate new drugs. Her work over a 45-year career with the agency included rewriting regulations and ensuring the scientific integrity of data. She retired in 2005 and died in 2015 at 101.

“She’s the embodiment of someone who took her responsibilities seriously and [impacted] not just Americans, but people worldwide through the regulatory structure that emerged from her,” Leslie Ball, Kelsey’s successor, told a publication under the University of Chicago Medicine.

Yet Kelsey’s actions were nearly stymied by her gender. In the 1930s, when she went by her maiden name, she wrote a letter to the head of the pharmacology department at the University of Chicago about a research assistant opening.

She was offered a research assistantship and scholarship at the university’s PhD program, which would lead to a master’s degree in pharmacology. But the initial acceptance letter addressed her as “Dear Mr. Oldham.” In an autobiographical reflection available on the FDA website, Kelsey wondered if the spelling of her first name had confused her future boss.

“I knew that men were the preferred commodity in those days. Should I write and explain that Frances with an “e” is female and with an ‘i’ is male?” she said through a series of interviews.

Her pharmacology professor at McGill University, where she had received a bachelor of science degree and a master’s, told her, “Don’t be ridiculous. Accept the job, sign your name, put Miss in brackets afterwards, and go!”

“That is what I did,” Kelsey said, “and, to this day, I do not know if my name had been Elizabeth or Mary Jane, whether I would have gotten that first big step up. My professor at Chicago to his dying day would never admit one way or the other.”

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angelchrys
2 hours ago
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Overland Park, KS
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The Jacket Potato Jacket. “Supermarket chain Aldi has teamed up with London...

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The Jacket Potato Jacket. “Supermarket chain Aldi has teamed up with London fashion brand Agro Studio to create a puffer coat that resembles a giant baked potato.”

💬 Join the discussion on kottke.org

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angelchrys
4 hours ago
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It's so dumb, I love it
Overland Park, KS
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https://pizzacakecomic.com/post/798069239019945984

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angelchrys
5 hours ago
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Overland Park, KS
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Kohler’s new toilet camera provides health insights based on your bathroom breaks

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The Kohler Dekoda health tracker clamped to the side of a toilet bowl.
Using an expanding clamping mechanism the Kohler Dekoda installs on most toilets without tools. | Image: Kohler

Knowing what’s coming out of your body can be just as useful for maintaining a healthy lifestyle as being choosy about what goes into it. As part of a new initiative focused on “turning the bathroom into a connected, data-informed health and wellness hub,” Kohler has announced a health tracker called the Dekoda you attach to your toilet. It’s designed to peer into the bowl using sensors and analyze what it sees using algorithms to provide insights into your hydration and gut health, and it will discreetly notify you when blood is detected which can be indicative of more serious medical issues.

The Kohler Dekoda system, which includes the sensor itself, a magnetic charging pad, and a wall-mounted remote, is available for preorder now for $599 with shipping expected to start on October 21st. The collected health data is made available through the mobile Kohler Health app — which is currently available for iOS and coming soon to Android — but only with a Kohler Health membership that’s $6.99 per month or $70 per year for single users, or $12.99 per month or $130 per year for a family plan that accommodates up to five users.

The Dekoda is designed to be installed on the rim of most toilet bowls using a simple expanding clamping mechanism, although Kohler warns it will not work on darker colored toilets where the lighting is reduced. On the outside of the bowl, you’ll find most of the electronics and a magnetic battery that can be removed for charging instead of having to completely uninstall the Dekoda.

The Kohler Dekoda health tracker against a gradient background.

On the inside you’ll find advanced optical sensors that use spectroscopy to “observe how light interacts with your waste.” To ensure privacy, the sensors are angled down so they only see what’s inside the toilet bowl. The data shared to the app, which includes the frequency, consistency, and shape of your waste, is end-to-end encrypted, and the Dekoda uses a fingerprint sensor on its wall-mounted remote to differentiate multiple users.

A person presses their finger onto a wall-mounted fingerprint sensor.

The data shared through the Kohler Health app based on the Dekoda’s findings over several days can make you aware of when you should be hydrating more frequently or how dietary changes could improve your digestion or nutrient absorption. And while the system can’t provide details on the origin of blood detected in your waste, it helps ensure the potentially serious symptom doesn’t go unnoticed so you can get it checked out by a doctor and dealt with sooner rather than later.

Screenshots of the Kohler Health mobile app.
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angelchrys
1 day ago
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Absolutely the fuck not
Overland Park, KS
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Against The New Feudalism Of Algorithms And Oligarchs

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Americans are not peasants. We are citizens of a republic founded on the revolutionary proposition that ordinary people can govern themselves. This isn’t poetry or aspiration—it’s the foundational premise of the American project. And right now, a faction of tech oligarchs is betting everything on proving that premise wrong.

They want to replace “We the People” with “We the Users.”

When Peter Thiel writes that democracy and freedom are incompatible, he’s not making a philosophical observation. He’s stating a preference. When Elon Musk guts federal agencies while posting American flags, he’s not reforming government. He’s replacing citizenship with administration. When Silicon Valley oligarchs speak about “optimization” and “efficiency,” they’re not talking about improving systems that serve citizens. They’re talking about managing peasants.

Because that’s what they think we are. Peasants. Masses incapable of self-governance. Users to be monetized. Workers to be replaced. Voters to be manipulated through algorithmic feeds designed to exploit our psychological vulnerabilities. Populations requiring management by those with superior intelligence and technological sophistication.

You see this in your daily life. An algorithm decides what news you see, not your own judgment about what matters. Your feed is curated by systems optimized for engagement rather than truth, designed to keep you scrolling rather than thinking. Your attention becomes their commodity. Your consciousness becomes their resource. Your capacity for independent judgment gets systematically eroded by platforms that treat you as a user to be optimized rather than a citizen capable of self-governance.

This represents the complete inversion of the American founding premise. The revolutionary generation staked everything on a radical proposition: that ordinary people could govern themselves, that citizenship was possible, that republican self-governance was superior to rule by kings, aristocrats, or anyone claiming the right to govern based on superior status, breeding, or intelligence.

“We hold these truths to be self-evident” means exactly what it says—not that kings acknowledge these truths, not that the intelligent agree with them, not that the powerful grant them, but that citizens assert them as the foundation of legitimate government. Self-evident to whom? To us. To the people who govern ourselves through collective deliberation rather than submitting to administration by our betters.

Lincoln understood what was at stake when he stood at Gettysburg and declared that the war would determine whether “government of the people, by the people, for the people, shall not perish from the earth.” Not government for the people by superior managers. Not government of the people by technological elites. But government by the people themselves—the radical proposition that citizens possess the capacity to govern rather than requiring governance by those who claim superior qualification.

The distinction between citizens and peasants isn’t semantic. It’s ontological. Peasants exist to be governed. Their role is obedience, tribute, and acceptance of decisions made by those qualified to make them. Citizens govern themselves. Their role is participation, judgment, and shared responsibility for collective outcomes.

We are not peasants. And yet every assault on American institutions over the past several years represents the systematic effort to transform us into exactly that.

The systematic elimination of civil service protections doesn’t improve government efficiency—it replaces professional judgment answerable to law with personal loyalty answerable to power. The attacks on independent agencies don’t reduce bureaucratic waste—they eliminate the institutional mechanisms through which citizens check oligarchic extraction. The celebration of “disruption” doesn’t foster innovation—it destroys the stable frameworks within which genuine self-governance becomes possible.

DOGE isn’t a government efficiency project. It’s the systematic replacement of citizenship with administration, democratic accountability with optimization metrics, collective self-governance with management by superior intelligence. When Elon Musk eliminates entire agencies staffed by career professionals and replaces them with political loyalists, he’s not improving government. He’s implementing his explicit belief that most people are incapable of meaningful judgment and require direction from those smart enough to know better.

This is why the flag-posting rings so hollow. Genuine patriotism implies reciprocal obligation—that loving your country means contributing to its maintenance as a collective project, that national pride entails responsibility for national institutions, that citizenship is something you participate in rather than perform. What the tech oligarchs demonstrate is nationalism without reciprocity: they want the aesthetic of belonging to a great nation while refusing every actual obligation that citizenship requires.

They love America as a brand, as an identity marker, as a territory they control. But they hate America as an actual collective project requiring their submission to democratic judgment, their participation in shared governance, their acceptance that other citizens possess equal standing to challenge their preferences and constrain their power.

Even Steve Bannon—nationalist populist, former Trump strategist, authoritarian movement builder—recognizes what the Silicon Valley faction represents. In a rare point of agreement across factional lines, Bannon has observed that the tech oligarchs aren’t patriots but post-national extractors using patriotic language to disguise systematic looting. When even authoritarian allies can see that you’re not engaged in national renewal but oligarchic capture, the performance has become too obvious to maintain.

Americans are not peasants. We are citizens of a republic founded on the revolutionary proposition that self-governance is possible, that ordinary people possess the capacity for judgment, that democratic deliberation beats optimization by superior intelligence. Every accommodation to oligarchic extraction, every acceptance of their framing, every failure to defend citizenship against those who would reduce us to subjects in their optimization experiments—all of it betrays the fundamental premise that makes America America.

We deserve better than this because citizenship is the foundation of what we are. Not subjects. Not users. Not populations to be managed. Citizens.

And citizens don’t wait for permission to defend what we are. We govern, or we lose everything that makes us who we are. The choice is here. The choice is now. History will not forgive us if we forget what we are—and surrender without a fight to those who would reduce us to peasants in a land our ancestors bled to make free.

We are not peasants. We are citizens. And citizenship is not a gift granted by superior intelligence. It is a responsibility we claim, a burden we carry, a right we defend—or lose forever to those who never believed we deserved it in the first place.

Mike Brock is a former tech exec who was on the leadership team at Block. Originally published at his Notes From the Circus.

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angelchrys
5 days ago
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Overland Park, KS
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Flock’s Gunshot Detection Microphones Will Start Listening For Human Voices

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Flock Safety, the police technology company most notable for their extensive network of automated license plate readers spread throughout the United States, is rolling out a new and troubling product that may create headaches for the cities that adopt it: detection of “human distress” via audio. As part of their suite of technologies, Flock has been pushing Raven, their version of acoustic gunshot detection. These devices capture sounds in public places and use machine learning to try to identify gunshots and then alert police—but EFF has long warned that they are also high powered microphones parked above densely-populated city streets. Cities now have one more reason to follow the lead of many other municipalities and cancel their Flock contracts, before this new feature causes civil liberties harms to residents and headaches for cities. 

In marketing materials, Flock has been touting new features to their Raven product—including the ability of the device to alert police based on sounds, including “distress.” The online ad for the product, which allows cities to apply for early access to the technology, shows the image of police getting an alert for “screaming.” 

It’s unclear how this technology works. For acoustic gunshot detection, generally the microphones are looking for sounds that would signify gunshots (though in practice they often mistake car backfires or fireworks for gunshots). Flock needs to come forward now with an explanation of exactly how their new technology functions. It is unclear how these devices will interact with state “eavesdropping” laws that limit listening to or recording the private conversations that often take place in public. 

Flock is no stranger to causing legal challenges for the cities and states that adopt their products. In Illinois, Flock was accused of violating state law by allowing Immigration and Customs Enforcement (ICE), a federal agency, access to license plate reader data taken within the state. That’s not all. In 2023, a North Carolina judge halted the installation of Flock cameras statewide for operating in the state without a license. When the city of Evanston, Illinois recently canceled its contract with Flock, it ordered the company to take down their license plate readers–only for Flock to mysteriously reinstall them a few days later. This city has now sent Flock a cease and desist order and in the meantime, has put black tape over the cameras. For some, the technology isn’t worth its mounting downsides. As one Illinois village trustee wrote while explaining his vote to cancel the city’s contract with Flock, “According to our own Civilian Police Oversight Commission, over 99% of Flock alerts do not result in any police action.”

Gunshot detection technology is dangerous enough as it is—police showing up to alerts they think are gunfire only to find children playing with fireworks is a recipe for innocent people to get hurt. This isn’t hypothetical: in Chicago a child really was shot at by police who thought they were responding to a shooting thanks to a ShotSpotter alert. Introducing a new feature that allows these pre-installed Raven microphones all over cities to begin listening for human voices in distress is likely to open up a whole new can of unforeseen legal, civil liberties, and even bodily safety consequences.

Originally published to EFF’s Deeplinks blog.

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angelchrys
6 days ago
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Amazing, it got even creepier
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