The FDA's Demise

"What the internet was to software, or crypto was to finance, the virus will be to biomedicine."

“Until you make the unconscious conscious, it will direct your life and you will call it fate.”

Carl Jung

The Great Recession threw much of what people thought they knew about the financial system into the trash. If our money acts as transient numbers in a database, why couldn’t those in charge, the Federal Reserve, manipulate and torture the numbers to their liking? Like we will soon witness, backstopping billions of dollars of corporate debt won’t have a kind impact on the dollar’s value. Once an oddity, negative interest rates – something economists said would never happen – have become commonplace globally.

Fatalistically, the world has lurched into chaos and for the curious of us, the denomination of money has stayed a contentious topic. At civilization’s onset, we exchanged livestock and cowries for goods. Several millennia later, we’ve become subject to the whims of fiat currency and powerless to those who have the ability to control it; that is until alternative assets like Bitcoin provided a glimpse of a different future, however imperfectly. It might not act as a perfect substitute to fiat currency, but for the first time, people realized they weren’t powerless to a sovereign power: they could fight back.

Rather than a bang, the unraveling of the nation state will end with a whimper. It began slowly as we built substitutes to fiat currency, but authority will be torn apart limb from limb in other ways as people observe how our ossified institutions have failed us. The coronavirus was a test of our state capacity and by any measure, America and other western countries failed the stress test. Therefore, in the wake of these ashes, the next unbundling of the state will be in decentralizing our healthcare systems; specifically, how innovation in drug discovery is regulated by the FDA.

Stages of drug discovery

from the FDA

For the casual onlooker, the coronavirus is a convincing story of bureaucratic failure; the FDA’s stronghold on drug discovery is idiotic at best, and dangerous at worst. The current biotech community is more akin to an oligarchy where a few massive firms (Roche, Gilead, Pfizer) play fast and loose praying that the FDA will pass their drugs. If these few firms don’t choose to make a drug, it will never be pursued by anyone. However, in times of crisis, we can see that the process is rigid and slow. The risk of future diseases will only increase, so how do we make sure we’re better prepared for future scenarios?

The hacker community, like the Homebrew Computer Club, never sought to tackle the system head-on; like a form of guerilla warfare, they moved around it and nipped at its heels. And eventually their labor bore fruit: the top 5 corporations in the world are technology corporations, of which 2 are consumer internet companies. I believe we’re seeing the same with the DIY biohacker community and the eventual rise of open-source laboratories coming together to find cures for rare diseases.

Bureaucratic banality

Everyone, from legislators to average citizens, is worried about the scarcity of tests for Americans. This isn’t because the tests don’t exist, but because the tests have been blocked from Emergency Use Authorization (EUA) by all levels of the HHS/CDC/FDA hierarchy. In my last post, Going Viral, I touched on how the BBC has called the coronavirus issue an ‘infodemic’ given the infinite supply of fake news flying around the internet. Ironically, instead of combatting this with the truth, the CDC provided no guidlines regarding testing until last week. Their logic was surely that if nobody gets tested, then there aren’t any cases of coronavirus, and the issue would evaporate into thin air. With every country on lockdown, that’s the opposite of how it played out.

But the truth always comes out – we’re drastically short of ventilators, hospital beds, and medical practitioners in every state. Young people in America, asymptomatic carriers of coronavirus, are traveling around the country believing that the virus is only a flu while passing their underlying illness onto their older relatives. That’s not their fault, even those informed of the perils of the virus didn’t take it seriously. The CDC was asleep at the wheel; the vast majority of coronavirus testing is done by public labs, not national ones.

Despite this, the FDA wanted to institute more red tape around lab tests, not fewer, because it was ‘dangerous’ for labs to proceed without prior permission from the federal government. Those temporary regulations never go away, they become permanent once the power is taken like the Patriot Act.

The virus is incredibly volatile; in mere hours, someone can go from no symptoms to dying in a hospital. To counteract this, we need local authorities like state legislators delegating the right-to-try for drug developers. Without experiments, some of which might fail, there is no possibility a cure will ever succeed. The snail-like pace of the DMV will not solve this problem; indeed, one of the best antivirals for coronavirus is considered to be the drug remdesivir, which was passed through right-to-try by a local regulator and then clinically tested in China immediately after. It’s the same story with H-chloroquine and azithromycin – the FDA wouldn’t have approved any of these for treatment despite growing evidence they are possible cures.

What the internet was to software, or crypto was to finance, the virus will be to biomedicine. It is going to decentralize it, accelerate it, make it highly personal, cause an enormous surge of new talent into the area, and (most importantly) change the risk calculus.

Balaji Srinivasan

The reckoning will arrive after the surprise of the virus recedes. As a species, we’ll look at the virus as an inflection point that changed the biomedical community, and the world writ large, as a whole: speed is of the essence. Actually, America used to have this speed – we responded at a breakneck pace with regards to the 1957 Asian Flu Pandemic.

How do we reclaim our once-envied medical adroitness? As mentioned, I believe we should:

  • Have right-to-try in all 50 states for drugs and allow them to provide EUAs for labs.

  • Create an emergency system that addresses how national and state agencies will share power when living in extraordinary times. These are not the times to be playing status games as many state governors are.

  • Generate avenues where non-credentialed citizens can aid biomedical firms. Should genetic engineering be designated as the property of large, faceless corporations? I don’t think that will remain the case this decade.

  • Fund open-source laboratories. Just One Giant Lab (JOGL) is a great initiative that seeks to open source and conduct research collaboratively. Having more of these accessible labs would have immeasurably sped up the process of finding a cure as the barriers to entry are lowered. Two brains are better than one, but 1000 would indefatigable.

The broader message is that people are tired of ineffectual, centralized authority in the western world. The virus has exposed the financial fraud occurring in repurchase (repo) markets, the corporate debt bubble, and the inadequacy of the FDA to list a few of our structural issues. To top it all off, the Federal Reserve will perhaps institute the greatest slippery slope of all: UBI. “Nothing is so permanent as a temporary government program” as Milton Friedman poignantly stated.

We’re certainly living in extraordinary times, but America has dealt with uncertainty before. Despite our issues, we have the greatest ensemble of technical minds ever assembled, leveraged with the power of the internet. The virus has made it clear that the world cannot retreat once more to Plato’s cave with sights unseen; this information will stay with all of us until our demise. If we don’t prepare for the unknown, we’ll merely let it control us and call the next calamity, fate.


Until next time,

Anirudh