While the FDA has gotten slightly better in recent years it still suffers from a lack of consumer feedback. They need to be willing to embrace a "move fast and break things" approach with highly-informed consenting patients. They're afraid of another thalidomide but they're willing to let an unlimited number of people die so long as it was disease and not treatment that killed them, which is such utter cowardice.
I don't trust the "move fast and break things" approach with for-profit healthcare.
With open source stuff like this, it works because nobody is pushing this tech for any reason other than it works. But if commercial products were able to move at this rate, we might see a lot of snake oil because companies can be pretty effective at producing misinformation.
This isn't a critique of commercialized healthcare because I think it works, but you do certainly need regulation for it to continue to work
> I don't trust the "move fast and break things" approach with for-profit healthcare.
This a million times. At the end of the day, tying money to people's lives instantly means people are willing to do anything (it's basic survival instinct, the most basic of all). Free market absolutely does not work when the customer is "willing to do anything at any price".
> I don't trust the "move fast and break things" approach with for-profit healthcare.
This is a non-sequitur. Why is it relevant what you trust or don't trust? You should can be free to conclude for yourself what methodologies you trust, while allowing others to disagree with your judgement given their personal risk tolerance, scientific disagreements, etc. It's one thing to have an opinion on a scientific matter, its quite another to enforce it on an entire nation-state.
> With open source stuff like this, it works because nobody is pushing this tech for any reason other than it works. But if commercial products were able to move at this rate, we might see a lot of snake oil because companies can be pretty effective at producing misinformation.
A company also wants to produce tech that works -- people tend to buy tech that works. If they are lying about their evidence then we already have laws against fraud/false-advertising/tort-law which should be enforced.
Why don't those laws against fraud apply to those companies that sell "power bracelets" or "healing crystals"? Or like 80% of the supplement industry?
Snake oil is sold with regularity under our current false-advertising laws. The impact of that happening in the medical industry would obviously be drastic.
With regards to forcing my opinion onto others- I'll concede that point. This is certainly an infringement of people's liberty and you're right that it's difficult to justify. I think that in this case (medical industry), the ends justify the means. But we certainly need to be concerned of overregulation.
Then by all means, disagree. That's just my opinion man.
Any amount of law or regulation will have some amount of citizens who disagree with it. For me, I think that the average citizen should be able to trust the medical community, and I think that the best way to accomplish that is to require the medical community to meet safety standards, and to support their claims of effectiveness with science. And I think that the less regulated parts of the health industry (supplements and fitness) have proven that many businesses will not back their claims with science if not required by law to do so. And that uneducated americans aren't able to see through that sort of nonsense and will purchase from those businesses anyways. This isn't a big deal with something relatively harmless like supplements, but when it comes to medical treatment you could potentially cause a lot of harm.
> Then by all means, disagree. That's just my opinion man.
But it's not just your opinion, because I'm forced to go along with it. If it was just your opinion then we'd have a more just world, where disagreements are reconciled by argument or agreement to go our separate ways, rather than by force.
> I think that the average citizen should be able to trust the medical community, and I think that the best way to accomplish that is to require the medical community to meet safety standards, and to support their claims of effectiveness with science.
Trust is a two way street. In order to justifiably trust some person or institution, I need to know their reasoning for their decisions and decide for myself whether I agree. There can be no trust (and no science) where reasoning is enforced.
> when it comes to medical treatment you could potentially cause a lot of harm
This can be dealt with via non-enforced regulatory bodies that people consent to trusting, and through the court of law if those fail (with basic institutions like innocence until proven guilty, the opposite standard of what the FDA enforces).
> But it's not just your opinion, because I'm forced to go along with it
Welcome to society? I don't like speed limits so I feel your pain.
> There can be no trust (and no science) where reasoning is enforced.
I'm not sure what your point is here. Is there no science in the current medical community?
>through the court of law if those fail
Unless the judicial system learns how to resurrect dead people, I'm not sure that suing after the damage is done is really going to help victims of malpractice.
In the event of those who aren't killed, only injured, how do you prove malpractice if there are no legal standards of care by which to judge? Even good doctors (or good medical tech companies) can have bad outcomes, so it can't be results driven.
As the article points out, there's another OSS solution, Loop (an iOS app with a hardware dongle that talks to a few kinds of pumps), that a company is putting through the FDA approval process (https://www.tidepool.org/loop). This seems like OSS working as intended, would be awesome to have the choice of a fast-moving DIY solution (for techies, early adopters, people without insurance) or a warrantied supported option (for everyone else).
The problem isn't that you don't trust it. The problem is you don't trust me to trust it.
I have no problem with you avoiding this. I have no problem with you requiring a certification program to get a little marker that says FDA approved. Then you can go shop those. I can take the risks I want to take.
All I want is for me, a person with a different risk tolerance from you, to choose for myself something higher risk than you would choose for yourself. Instead you choose your risk tolerance as the best mode and impose it upon me.
There are no externalities. I alone will suffer.
Please, for the love of god. All I ask for is 0.07 cubic metres of autonomy. Give me that one freedom. All else is Caesar's. I'll wear a black sash. Or tattoo a red A to my forehead. Just give me freedom over myself, my body.
This snake oil market already exists. Supplements. Cupping. Ear candling. Everything sold by Goop. Essential oils. The market exists and it's already killing people like the toxic baby food from a couple years ago.
The difference is that Goop-care, by and large, doesn't really do anything, and the iatrogenic problems are mostly second-order (like, you might get an infection by putting something they recommend --- excuse me for saying this --- up your butt). An artificial pancreas is a very serious, active medical intervention. It has to work, reliably; you can't just hope it will help and that all its bases are covered.
There's another class of people that fall for this stuff, and I am not sure what label (if any) could apply, but I think of people like Steve Jobs.
Arguably, his diagnoses was essentially a death sentence, because few live long from what he had. That said, I don't think he was necessarily gullible. Desperate? Maybe - who wouldn't be? But he had immense resources at hand, but squandered them on treatments known for being snake oil at best.
Maybe fearful would be proper - perhaps coupled with desperation - leading to easier to take, but less effective (where "less" could equal or be very, very close to zero) treatments, vs the conventional ones?
I could see that, and emphasize on that choice as well.
This is a good point, and very true of Goop-style products. But I have to say, it's hard for me to reserve much charity for the way US medical regulation operates.
Homeopathic medicine got a special exemption from FDA coverage, freeing them from basic standards like filing new-drug applications and testing finished preparations for strength and purity. Most of them are just water, but some retain enough strength and toxicity to do serious first-order harm, and many are marketed for treating serious conditions that absolutely need real treatment. It took 80 years to start making progress on that ludicrous exemption, while snake venom applied and antibiotics forgone inflicted untold harm.
At the far end of the spectrum, medical devices are intensely regulated but medical procedures aren't. A mobility-assist for putting socks on has to be marketed with goofy infomercials to steer clear of FDA burdens, but a new approach to treating fibroid tumors can be deployed with no long-term studies - and then turn out to rapidly progress minor cancers to metastatic ones, and then stay in regular use with no informed consent while doctors debate.
None of this means drug regulation lacks merit, or should be pared back without serious planning and study. But the current state of affairs is so absurdly arbitrary, and so covered in the scars of ancient political squabbles, that major improvements look not only possible but obvious.
Those are markets with much less regulation than the medical market. If we deregulate medical tech we risk our medical tech market reaching similar levels of degeneracy.
That, to me, is a pretty solid argument in support of the parent -- that deregulating medical devices will strongly benefit the scammers you mentioned, rather than benefiting patients desperate for something to help.
Cupping and ear candling almost certainly aren't killing people directly. Alternative-medicine vitamin use has a significant death toll, but not an active one; high-dose vitamin regimes are commonly pushed as a cancer treatment, keeping people from effective treatments during early stages.
Homeopathy mostly kills people in the same negative sense of effective treatments skipped, but every so often it does actively cause a bunch of deaths. Several different companies have sold homeopathic medicines for infants with potentially-lethal levels of belladonna in them; the sort of thing which might be prevented if homeopathic drugs didn't have a special exemption from FDA rules around testing purity and strength. More commonly, homeopathic medicines for adults like ear and eyedrops end up causing deafness and blindness.
These things aren't especially common killers, and if the comment above was implying that alternative medicine's existence means the FDA doesn't serve a purpose, that's absurd. But the narrower point is a good one: in a country where there are special legal protections for people who peddle neurotoxins to cancer patients, it's not so wild to suggest that our regulations could be greatly improved by obvious changes.
> homeopathic medicines for infants with potentially-lethal levels of belladonna
> More commonly, homeopathic medicines for adults like ear and eyedrops end up causing deafness and blindness
Homeopathic, or "natural medecines"? I'd have trouble believing that literal water was making people blind, or that literal water had lethal level of belladonna in it.
Homeopathic. I was shocked too. Hyland's homeopathic teething tablets contained belladonna, and the strength of different batches varied from placebo to lethal.
Most homeopathy is literal water, but there's a section of the market offering low-dilution preparations ranging from 1:10,000 to 1:100. Given the "like treats like" logic, some of the active ingredients are sufficiently nasty to do real harm at 1:100 or lower. And given the exemption from batch-strength testing, some preparations are substantially stronger than intended. (As far as the ear drops, that seems to mostly be a matter of contamination or infection. Which is a secondary harm, but again one that can occur because those companies are exempt from many standard testing practices.)
k, makes sense! There's so many people who think homeopathy and naturopathy is one and the same that I thought its what was happening here. Fascinating (and horrifying!) situation you describe, though!
