Should the FDA make aging a disease?
Should the FDA make aging a disease?
The House moves on antitrust and an infrastructure deal seems to have been reached. Plus much, much, more in tech policy news.
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Last week was brutal if you were following tech. The House marked up a grouping of six bills aimed at reform of antitrust. I wasn’t even following it as close as some and even I was exhausted by the end.
Cecilia Kang and David McCabe reported in the NYT:
In a marathon session of debate and voting that started Wednesday morning and continued into Thursday, the Judiciary Committee advanced the suite of bills, which are meant to weaken the dominance of Big Tech. The bills would bulk up antitrust agencies, make it harder to acquire potential rivals and prevent platforms from selling or promoting their own products to disadvantage competitors.
The session brought to the front the fault lines within the Democrats and the Republicans. Rep. Cicilline, a Dem, was in lockstep with Rep. Matt Gaetz and Rep. Ken Buck, both outspoken conservative Republicans. For their own part, California’s Republicans and Democrats came out in opposition to the bills. Rep. Correa highlighted job creation in California, while Rep. Issa said consumers were happy with tech. Rep. Lofgren cautioned that “Congress must calibrate regulatory & antitrust laws deliberately & carefully.”
In contrast, Republican leadership was tepid. Earlier in the week, Rep. Jim Jordan and Rep. Mark Meadows had an op-ed in Fox News, calling out both Big Tech and the package: “Make no mistake, Big Tech is out to get conservatives and must be reined in. But these bills do nothing to fight Big Tech’s anti-conservative bias and censorship. These Democrat bills will only make things worse. If you think Big Tech is bad now, just wait until Apple, Amazon, Facebook and Google are working in collusion with Big Government.” And House GOP Leader Rep. Kevin McCarthy wasn’t happy with the bills either.
For a roundup of the back and forth, AAF’s Jennifer Huddleston has a couple of solid threads, which can be found here and here and here. Politico also had good reporting on the partisan split. The bills move on to the Senate where they face an uncertain future. Sen Klobuchar said she intended to file companion bills. Hopefully, the process will slow down a bit because the House held no hearings on the bills and got them passed in just two weeks.
In addition to all of these moving pieces, Leah Nylen posted this:
Meanwhile, at the Federal Trade Commission (FTC), Chair Lina Khan has signaled a change in course by holding the first open meeting in perhaps decades. She has also said that the agency will repeal the Obama-era Unfair Methods of Competition policy statement. In substance, the change doesn’t mean much. As a reflection of the change in course, I think it says a lot. Neil Chilson has a thread:
And now for something completely different, from Ilya Somin: “The NCAA didn't just lose in today's Supreme Court decision in NCAA v. Alston. They got completely blown out. The Court unanimously ruled against them in a major antitrust decision that could end up paving the way for greatly expanded compensation for college athletes. Neither liberal nor conservative justices gave much credence to the NCAA's position that they are a special kind of organization that should not be subject to conventional antitrust restrictions. They showed even less love for the pretense that the NCAA cartel is justified by the needed to protect high-minded ideals of ‘amateurism.’”
I think it’s helpful to understand these changes as expansion in two directions. At the FTC and in the courts, enforcement is getting more intensive. More companies will be caught up in litigation as the current laws are enforced more vigorously. Congress, meanwhile, is looking to make antitrust law more extensive by making more behaviors illegal. In other words, what’s helpful to consider here are the extensive and intensive margins of change.
Relatedly, Caden and I discussed the Amazon case on the podcast last week.
The EU opened an expansive investigation into Google’s ad business. In some key ways, it is the European equivalent of a case being pushed by the Texas AG. What’s unique here is that the EU is investigating Google’s plans to block certain kinds of user-tracking technologies on its platforms. To their credit, Google made these changes due to pressure from EU privacy regulators and activists. Most of the other cases against Google are thin since they focus on areas where harm is hard to prove like search engine rankings. The advertising market, however, is more tangible and thus could be easier to prove harm. Since there is new leadership at the Federal Trade Commission, a version of this case could have legs in the U.S.
Senator Gillibrand reintroduced the Data Protection Act of 2021, which would create an independent federal agency, the Data Protection Agency, to “regulate high-risk data practices and the collection, processing, and sharing of personal data.”
There seems to be bipartisan agreement on an infrastructure deal, which includes $65 billion on broadband. This WaPo report speaks volumes: “The plan is light on details, at least from what’s been released publicly, and lawmakers face difficult work ahead in filling in the blanks.” As I have said over and over again, this isn’t the way to build out broadband.
Senators Schatz, Thune, Warnock, and Kennedy introduced the Unsubscribe Act. The bipartisan bill would require companies to be more transparent about their subscription-based business model and make it easier for consumers to cancel their subscriptions once their free or reduced-price trial period has ended.
Over in Europes:1
On the space front, my colleague Eli Dourado alerted me to this hearing in the House Science, Space, and Technology Committee. Here is the quick and skinny:
One of the big questions before Congress is whether to fully fund the Human Landing System, the key remaining technology needed to return humans to the Moon. NASA asked for $3.3 billion in fiscal year 2021 to start development of two landers. Congress provided just $850 million for this year's budget.
As a result, NASA said it only had enough funds for one lander and chose what it deemed the lowest-cost, most technically ready option: SpaceX's Starship vehicle. Nelson said he very much would like to have competition in the lander program, but, he said, "That will depend on you all." In other words, if Congress appropriates substantially more funding for a lunar lander program for the 2022 budget, then NASA will be able to support development of two lunar landers.
A while back, Eli also sent me a post from Casey Handmer: “SLS: Is cancellation too good?” It is always worth the read to understand the context of this debate.
Extra: I am a huge fan of The Space Review’s longform work. Check out this piece on shooting down satellites.
I missed this from earlier this month: “United Airlines today announced a commercial agreement with Denver-based aerospace company Boom Supersonic to add aircraft to its global fleet as well as a cooperative sustainability initiative – a move that facilitates a leap forward in returning supersonic speeds to aviation.”
Papers and research
Scott Lincicome has a new paper “Questioning Industrial Policy: Why Government Manufacturing Plans Are Ineffective and Unnecessary.” Here is his Twitter thread and here is the paper.
Pew released a big report from AI experts: “A majority worries that the evolution of artificial intelligence by 2030 will continue to be primarily focused on optimizing profits and social control. They also cite the difficulty of achieving consensus about ethics. Many who expect progress say it is not likely within the next decade. Still, a portion celebrate coming AI breakthroughs that will improve life.”
I found Schmidhuber's blog post on Kurt Gödel's 1931 paper “On Formally Undecidable Propositions of Principia Mathematica and Related Systems” dense but insightful. This paper laid the foundations of theoretical computer science, identifying fundamental limitations of algorithmic theorem proving, computing, and artificial intelligence. This blog post puts the paper into context.
Last week, I talked a bit about minimal viable regulation. My colleague Jake, who just finished at Utah State and is headed to Cornell for his PhD economics, sent me this Freakonomics podcast on scaling up policy experiments. Here is the paper on which it is built. Interesting throughout.
I still think a lot about Vitalik’s 2020 Endnotes: “What we see in 2020 is this: Big Government is as powerful as ever, but Big Business is also as powerful as ever. ‘Big Protest Mob’ is as powerful as ever too, as is Big Tech, and soon enough perhaps Big Cryptography. It's a densely populated jungle, with an uneasy peace between many complicated actors. If you define success as the total absence of a category of powerful actor or even a category of activity that you dislike, then you will probably leave the 21st century disappointed. But if you define success more through what happens than through what doesn't happen, and you are okay with imperfect outcomes, there is enough space to make everyone happy…The lines between ‘private’ and ‘public’ are once again rapidly blurring. Governments are behaving more like market actors, and corporations are behaving more like governments.”
Sam Zell’s fumble in turning around the Chicago Tribune made me question the benefit of private equity buying newspapers. So, I didn’t expect this new research: “[Private equity] buyouts lower newspaper closure rates by about 40%. Does not appear consistent with the ‘vulture’ view of PE. But wait, there's more!” The entire thread is fascinating:
Reach matters: “Our analysis shows that deplatforming is effective in minimizing the reach of disinformation and extreme speech, as alternative platforms that will allow this kind of content cannot mitigate the negative effect of being deplatformed on YouTube.”
What does it mean if the FDA made aging a disease?
Last week, while skimming the Longevity subreddit, I came across a Change.org petition calling on the FDA to make aging a disease. The petitioner repeated an argument I’ve seen elsewhere. If the FDA doesn’t accept aging as a disease there won’t be funding and grants to tackle it.
Searching Google yields a Fight Aging! blog post that advances a similar line of argument:
The incentive is there for scientists and research institutions to have aging declared a disease because that opens doors to funding sources, and permits treatments aimed at controlling aging to run through the regulatory process at all. The FDA does not consider aging to be a medical condition at this time, and this position must change in order to allow any sort of meaningful development pipeline to form: everything that happens in cutting edge aging research today happens despite the fact that no-one is permitted to go out there and directly commercialize a treatment. As you might imagine that has a considerable damping effect on funding.
A version of this idea can be traced back to 2011, at least, as Bulterijs, Hull, Bjork, and Roy explained, “Finally, we should note that recognizing aging as a disease would shift anti-aging therapies from the Federal Drug Administration’s (FDA) regulations for cosmetic medicine to the more rigorous regulations for disease treatment and prevention (Gems, 2011).”
This one trick is going to unlock the entire field of longevity?
The question is an esoteric one. What would it mean for the FDA to treat aging as a disease? Most aren’t even thinking about aging as a disease, let alone considering the optimal incentive structure.
It’s helpful to first understand trials. Clinical trials test a hypothesis about the predicted effects of a treatment. Depending on the treatment or drug, the outcome measure or endpoint might be any number of effects like improved survival, improvement in symptoms or functional capacity, or a decrease in the chances of developing a condition or a disease.
Some clinical trials, however, aim for a surrogate endpoint that is intended to be used as a substitute for a clinically meaningful endpoint. Surrogate endpoints have to be validated, and ideally, they would be connected to the pathway of the therapeutic. For example, HIV drugs are aimed at CD4 counts or viral loads, both of which are surrogates for HIV complications.
Pressuring the FDA to make aging a disease is a sideshow to the much tougher job of proving either an outcome or a well-validated surrogate. The FDA doesn’t add and subtract diseases from a strict list.
Truth be told, I knowingly buried the lede here. Anti-aging trials are already underway. The TAME trial or Targeting Aging with Metformin began in 2015 and should be completed this year. Its primary outcome is the reduction of a range of age-related diseases. The PEARL trial is also targeted at longevity through a reduction in visceral fat.
To top it all off, there is a National Institute on Aging (NIA), funded by the National Institutes of Health. There are grants going out. Admittedly though, NIA has been targeting Alzheimer’s disease and other diseases of cognitive decline.
The specifics of the intervention matter, as José Luis Ricón wrote earlier this year,
Some will target processes that are very core to an organism. All of our cells need to make proteins and enhancing proteostasis will then have effects throughout an organism. But other interventions will be more targeted (Like cyclodextrins to reduce plaque in arteries). Anti-aging companies like Unity may have anti-aging interventions that are designed to target a single symptom of aging. For aging in general it is likely that a targeted, perhaps individually tailored, combination of interventions, ranging from small molecules to gene therapies, will be required.
Maybe I am missing something glaring here, but there is already a pathway to clinical trials that would be accepted by the FDA. As Will Manidis explained, “FDA is open to aging as a disease, you just need to define how you are measuring it.” So, the bottleneck isn’t the FDA as such. Instead, we need effective treatments that improve lives. But that goes without saying.
This ain’t a misspelling.