A Navy fact sheet on what it calls 'non-lethal optical distractors' reads:
Non-lethal optical distracters are visible laser devices that have reversible optical effects on human targets. These types of non-blinding laser devices use highly directional optical energy to support several non-lethal capabilities, including:
Perhaps all this was a type of "burn it down", punk activism, and it will be released on twitter for public download. The BTC could have been their funding mechanism. Not for profit, but for the lolz in an election year?
Not all of it. I blog here[1]. The post where I talked about the end is here[2]. Note the 'laws' I quote at the end of the post. My first post is here[3]. There I talk about the HPC market, accelerators, and some of our plans. We were working on board level inexpensive accelerators before these were a thing. We gave up trying to get funding for this in 2006.
I did say, you have to be at the right place, at the right time. And be lucky. We got 2 of 3. Luck eluded us.
> Or when you go visit customers, they love your product, the benchmark results are mind blowing … and then the CIO/CFO kills the deal because, you know … you are too small.
We've been in similar situations several times. We're serving a niche, but this niche is a core piece of our customers business. Without software like ours, their whole operation stops.
Anyway, we'd have demos. Department heads were on fire, wondering if we could install same day we had demo, all smiles, everything looked great. And then we lost because someone higher up decided we were "too small". We're small, but we're pretty much the best in our niche and we have had very solid financials for decades.
Those we lost went with bigger, supposedly "safer" competitors and had some very sub-par years with them before they had to pay their way out of those contracts and come back to us.
We had a customer that POCed on our systems, then bought some crap from HP + one of the SSD card vendors in 2013. They then called us up in 2014 and asked to pay us to help them achieve the performance they saw on our system, on their 5x as expensive "low risk" HP + SSD card system.
My response was simple. No.
I invited them to throw away the crap they bought and buy the right thing from us, but that was politically untenable. Turns out spending multiple millions of dollars for crappy half baked "solutions" versus a lower sum of money for something that actually worked, would likely get some people fired.
The world isn't fair, and sometimes not even sane. The people who made these decisions, despite being disastrous ones, were promoted. Enough of these built up that we couldn't survive.
Oh man, I remember reading your blog when I was in grad school (mid-2000s) doing molecular simulations on HPC systems (and not really enjoying the science aspect, but I did like working on the tools), thinking that you were a great example of being able to bootstrap a business in the HPC space. Sad to hear it didn't work out.
You can throw shade at a consultancy without necessarily referring to one of their alumni. McKinsey was a major player in the field long before Buttigieg was an ultrasound.
I personally hope this shows (some) irrelevance of FDA bureaucracy...if they weren't need in the worst of times, why are they needed in the best of times?
Let entrepreneurs, doctors, and patients decide their individual risk level. I would rather have more options than less.
Edit: as an alternative to any knee jerk critism (I said "some"), why can't states handle this and the best emerge? I'm a big proponent of localism.
I will repeatedly and loudly criticize the US government response to COVID-19 so far as inept, particularly the FDA in the early days. Brittle laws combined with their failure to move quickly hamstrung our chance at containment.
Under normal circumstances though, health and safety oriented regulatory bodies such as the FDA play an absolutely essential role in protecting us from bad actors. The only reason I have confidence when purchasing medications of any sort is because of them. They also protect our food supply from all sorts of misguided and dangerous production practices.
Even in an emergency situation, they have an essential role to play in preventing bad actors from popping up left and right peddling snake oil. There certainly needed to be more flexibility and speed in responding to the current crisis, and I'd argue that states ought to have _significantly_ more autonomy in a number of areas, but that's a far cry from calling them irrelevant.
(As an aside, I was disappointed that none of the states defied the federal government in this instance. I had hoped for a state-level authorization for established medical labs to develop in house tests, and a subsequent court case challenging federal law on the matter. As far as I understand, the FDA only derives its authority from the frequently abused interstate commerce clause.)
>
(As an aside, I was disappointed that none of the states defied the federal government in this instance. I had hoped for a state-level authorization for established medical labs to develop in house tests, and a subsequent court case challenging federal law on the matter. As far as I understand, the FDA only derives its authority from the frequently abused interstate commerce clause.)
Yeah, seriously. Every state is happy to defy DEA with marijuana. You'd have near universal support for defying FDA in this instance, and it would be a welcome breath of fresh air for the states, who have honestly been continuously disempowered by the federal government.
In general having a drug regulatory agency is a good thing, I'd certainly agree. But the FDA is known for being excessively paranoid compared to similar bodies in other countries. So we didn't have UVA sun screen until long after Europe did, basically only have Epi-Pens which are subject to price jacks when Europe has 12 competing brands, got beta-blocking drugs a decade after Europe, etc. Though in fairness we also managed to avoid thalidomide so that's a point in the FDA's favor.
> Under normal circumstances though, health and safety oriented regulatory bodies such as the FDA play an absolutely essential role in protecting us from bad actors.
Does it though? There's a perception that government agencies are impartial watchdogs, but this belies the reality that governments have agendas of their own. The FDA is so politically removed from the people it was created to ostensibly protect that there's now little incentive for it to relieve real suffering today. A brief example:
My brother and thousands of people suffer from type-1 diabetes. We have had the technology for years now to create an artificial pancreas, but FDA and EMA regulatory procedures have stopped any device from being sold. People are creating their own DIY systems because no commercial, professionally-developed, reasonably-priced alternative exists yet.
This isn't snake oil. There are solutions for many people's ailments available today. And the FDA is a massive giant standing in the way of people living healthier, unencumbered lives.
Treat people like adults. On the whole they're pretty good at figuring out what's best for themselves and taking care of each other.
I think you reacted too strongly, IMO. I only said some. People and their doctors are the MOST concerned with their lives...not you, not politicians, and not FDA staffers.
If I want to treat my (illegal war) PTSD, depression or anxiety with novel treatments like 2CB, LSD, or MDMA, that is my choice. It immoral to restrict my supply with the barrel of a gun.
The FDA is not what is restricting your supply of 2CB, LSD, and MDMA though. I think this present crisis is a perfect illustration of why the FDA is incredibly important. Just look at all the misunderstanding about chloroquine, hyrdoxychloroquine, chloroquine sulfate, etc. flying around.
I completely agree - I had (mis)interpreted what you previously wrote to mean throwing them out entirely. I just can't stress enough that despite all their issues, the FDA still plays an absolutely essential role in keeping our society functioning.
Don't make the mistake of conflating concern for one's life with a desperation to avoid losing it. Safety concern is our own in-built countermeasure to desperate irrationally.
The fallacy that patients cannot act rationally in the face of adversity is a common excuse for compulsory regulatory bodies. While there is value in having a centralized body like the FDA provide consumers with qualified advice on drugs and food, a certification authority can provide that information for individuals to use at their own prerogative.
You're conflating a different issue. Congress made those drugs illegal. The FDA can't unilaterally make those legal without the support off the President or Congress.
If you want that policy to change, it'll have to happen at the voting booth, not because some FDA bureaucrat decided it.
"Stodgy gatekeeper" and "nothing" are not the only regulatory regimes available.
Like you could have looser requirements to enter the market and then penalize/ban companies/people that make bad/unsafe tests. (yes, I'm proposing that people involved in marketing useless medical tests be banned from doing it a second time. Might be hard to structure it, but the goal is clear enough).
I would like this, especially for tests (I understand being more restrictive for treatment but still disagree with the winner take all corpratism that results under current regime)
I don't see all that much "winner take all" in the medical industry. There are multiple competitors for many/most products, evidenced in this situation by many companies racing to develop & compete against each other for better testing. A few weeks ago there were news stories about rapid testing w/ 1 day turn around. Now we're down to fractions of an hour.
And let’s see if my nastier, more cynical Derek-Against-Humanity prediction comes true: that the next wave will not be just people who have seized on this plan opportunistically, but who have targeted it right from the start. Who will pick out terrible diseases for which there are no therapies at all, the better to insure a supply of completely desperate patients and families, and provide them with utterly useless therapies at stiff, stiff prices. Utterly harmless therapies, though – don’t want to get sued while you’re raking in the bucks. I’m talking polysaccharide therapy for pancreatic cancer, antioxidant phytonutrients for Alzheimer’s: in other words, corn starch and grape juice. What the hell. The customers are going to die, anyway. Why should they die with their money as well?
This is still being done in the U.S. by "chiropractors" pushing their own mixtures of zinc lozenges and herbs. Google "chiropractor" and "COVID-19" if you want to be disgusted. And local news channels are reporting on this as if it's real.
Under your scenario you will be targeted by extremely sophisticated psy-ops (think cambridge analytica *1000) to convince you that the super-snake-oil 2xt is the absolute best cure for your disease. Don't let the gov't tell you any different. Just look at this incredibly misleading data.
That is indeed a risk factor. I've seen a lot of people argue that there's no downside, that shoving the FDA out of the way would be a pure positive, and you're right to consider that very naive.
But should we expect the FDA itself to be immune to such manipulations?
Your confidence is misplaced. I mean look at those nigerian scams, they nab people every day and they are the worst in terms of efficacy. Now up the monetary incentive to BILLIONS of dollars, and remove the FDA, and you will find extremely sophisticated players entering the game. I really don't know where you derive your "zero" number from, but I'm guessing you are thinking it will have no effect on YOU. I actually help run clinical trials and regularly advise on clinical trial read-outs, and I can assure you that I could be fooled by a sophisticated scam if I didn't have a governmental entity that can and will actually do inspections and their own investigations with the power of criminal penalty. I think your confidence is entirely misplaced.
> I mean look at those nigerian scams, they nab people every day and they are the worst in terms of efficacy.
That seems like a bad example to support your point. Nigerian scammers don't strike at random like lightning. If you aren't really stupid or really greedy, there is zero chance that you'll get scammed by those guys. They target people with poor cognitive abilities and people who are greedy enough to think they can scam the scammers.
They run dragnets looking for the rare individuals who vulnerable to their scheme. They are powerless if tasked to target a specific person unless that specific person by chance happens to be the sort of person their scheme works on.
Yes? Access to information does not mean access to good information. and even access to good information does not mean that people will not chose to believe debunked claims. We already have that now, but at least we can regulate what kind of claims are made and what kind of evidence is needed to make them.
I'm usually all for individual responsibility, but health is one of the rare things where you can't just rely on people being rational. It is very difficult to expect rational decision making based on evidence when it comes to a dying cancer patient desperate to find a cure. And it's very easy to see people profit from that.
Yes, because that access is not uniformly distributed. There is a lot of disinformation, and your typical person doesn't have easy access to a lot of research sitting behind paywalls. Disinformation has much less friction, and requires much less effort to ingest, than quality research.
>why can't states handle this and the best emerge?
Is it fair to die in State X because it had more inept leaders than State Y? This isn't about long term economic or social policy, this is about an exponentially growing pandemic that doesn't respect borders.
It's as fair as dying in Germany because France had inept leaders (for example, not saying either of those countries have inept or incompetent leadership). American states are way more autonomous than the regions of most countries. The populace elects the leaders they get.
It's as fair as dying in Germany because France had inept leaders
Yes, which is to say it isn't fair. You're example argues for higher level oversight and uniformity of regulation, say at the EU level, not even more balkanization of them.
I don't think that fracturing the regulations & approval processes into 50 different jurisdictions would be all that helpful. It would in fact greatly inhibit companies that do business in multiple states. Which set of rules do they follow? Lawsuits would abound whenever there's an issue and the rules of any jurisdiction they might operate within could be contrived to apply to the situation.
And consider the current circumstances: Yes, things are relaxed in an emergency. How would that be any different? State-level, or any level of oversight, would also be relaxed in an emergency. All that shows is that sensitivity to risk changes (decreases) when there is a crisis. It doesn't invalidate the greater level of care taken when there is the time to take it.
Also, no matter what level you impose oversight & regulation, patients will not be in a position to determine their desired level of risk. If it happens at the state level, there can still be plenty of people who would like a different risk threshold: They won't get it though.
Finally, it ignores the fact that what might be in the best interest of a more local jurisdiction (say, it costs less money) it might be very much against the best interests of others. A jurisdiction that decides it's comfortable with higher risk does not exist in a vacuum: It's comfort with higher risk would also bleed over into neighboring areas.
Far better to have a uniform set of guidelines and make exceptions on a case by case basis in emergencies, rather than make everything an exception, which would make coordination & consistency during a crisis a complete nightmare.
The oath ,,First do no harm'' is there for a reason: sadly for most new therapies, the alternative of using the old therapy is better in 99% of the cases. The FDA is there to make sure that companies find the remaining 1%.
The big difference here is that the speed of finding the right drug can make or break trillions of dollars and thousands of lives, so it's critical for the FDA to focus on the COVID-19 illness.
Okay, so the lobbying will move to doctors. And while FDA lobbying is public, good luck guessing who gave a kick back to your doc. A single regulatory body is easier to monitor than a hundred of thousands of them. Doctors getting kickbacks is already a thing so I can't imagine how it wouldn't get worst if they had the power to prescribe anything they want, not just FDA approved meds
It's worth mentioning that MDs and pharmacists in the US both have approximately 4 years of schooling (among other things) in addition to their bachelors.
The same is true of so many of the things that are suddenly deemed unnecessary in this time of crisis. Let's be judicious about which gatekeepers and rent seekers we choose to bring back online.
Also libertarian minded....have you considered that in a natural state, businesses this large would be very hard to maintain? The fundamental business structure we have today is based around a government-sanctioned "personhood".
If you could strip this away, there would be no corporate veil, and you could sue the person who failed to act (or whom acted wrongly) and did you wrong. Think of bankers at Wells Fargo creating false accounts in customer names...hire investigator or do your own, sue, discover, repeat...there would be MUCH MORE downside to bad behavior, even if the upside is there.
I think personally that organizations like GORE would exist, and who knows what else might emerge...more co-ops?
Of course this does require 3rd-party alternate court systems (maybe like cert issuers, but held to the same liability standard above?)...our current system cannot handle this, so it may be largely academic thoughts.
Until recently doctors and auditors weren't allowed to be limited-liability companies. There was still a ready supply of people willing to run those businesses as partnerships, with personal liability. There were good and bad firms, just not megascale conglomerates. The "liberalisation" of those rules didn't help the little guy, just the opposite: auditing became concentrated in a handful of giant companies, and quality predictably declined.
