5 ms·

A registry is a plausible idea, but in general, this article seems to assume by default that regulators are always wise and benevolent, and companies are always

A registry is a plausible idea, but in general, this article seems to assume by default that regulators are always wise and benevolent, and companies are always scheming, wicked villains. This year's coronavirus pandemic has showed that we can't just assume this. Eg., the FDA made it illegal for labs to develop their own coronavirus tests, which let the disease spread: https://www.politifact.com/factchecks/2020/mar/23/dan-crenshaw/did-fda-regulations-slow-testing-coronavirus/ https://www.politifact.com/factchecks/2020/mar/23/dan-crensh... Distilleries have been trying to make hand sanitizer, but the FDA has made this much more difficult by requiring that the alcohol be denatured first: https://abcnews.go.com/Politics/distillers-lawmakers-pressure-fda-revise-hand-sanitizer-guidelines/story?id=69918064 https://abcnews.go.com/Politics/distillers-lawmakers-pressur... Companies developed at-home coronavirus tests, but the FDA shut them down: https://www.statnews.com/2020/03/21/fda-warns-new-home-coronavirus-tests-unauthorized/ https://www.statnews.com/2020/03/21/fda-warns-new-home-coron... (the FDA later approved one by LabCorp - at-home testing does in fact work - but this took almost a month, and AFAICT the original sellers still haven't been approved) The Apple Watch has the ability to test blood oxygenation, which would be incredibly useful now, but it can't because that would be an illegal medical device: https://www.city-journal.org/fda-blocks-apple-watch-blood-oxygen-feature https://www.city-journal.org/fda-blocks-apple-watch-blood-ox...

pkaye 7y ago
Why is Fitbit able to get a pulse oximeter in the market while Apple is not?
- ggreer 7y ago
  It's not clear if Fitbit's pulse oximeter update was ever shipped in the US. I can only find forum posts by disgruntled users who say they don't have it. I asked an acquaintance and he says he doesn't have the functionality despite owning a compatible device. Amusingly, both Fitbit and Apple are part of the FDA's digital health software precertification pilot program[1], which is intended to streamline the approval process. If not for the FDA, both companies could have shipped this 3+ years ago. I'm sure the data would have saved quite a few lives. 1. https://www.fda.gov/medical-devices/digital-health/digital-health-software-precertification-pre-cert-program https://www.fda.gov/medical-devices/digital-health/digital-h...
hhs 7y ago
> A registry is a plausible idea, but in general, this article seems to assume by default that regulators are always wise and benevolent This article doesn't seem to say that regulators are wise and benevolent. It looked like the author was, in fact, troubled by the lack of regulation as cited here: > The root of the problem, of course, is money. In medicine, progress is driven by innovation, and, in our society, innovation is driven by profit. “Among implant manufacturers,” Schneider writes, “market analysis drives research and consideration of device innovation.” The implantable-device industry is even more lucrative, for many companies, than the pharmaceutical industry is. At the largest companies, operating-profit margins are typically twenty-five per cent or higher. In 2014, the industry’s over-all estimated revenues totalled more than a hundred and thirty-six billion dollars. > The financial incentives within this industry are one of the reasons that its lack of regulation is troubling.
- jessriedel 7y ago
  If you assume adding regulation makes things better without further argument/evidence, you are assuming regulators are wise and benevolent. (Regulators != Legislators.)
jellicle 7y ago
> companies are always scheming, wicked villains I believe the baseline assumption is that many people are trying to make a buck, and something like coronavirus is a great opportunity to scam people. Is that wrong? I'll bet if I purchase ten coronavirus test kits "from the internet", at least 9 out of 10 will be bogus. In the absence of regulation, that would be 13 out of 10. There's a potential for truly massive scams: 7 billion people want something in tight supply, just announce you've got a test kit for $19.95, maybe mail people some pH test strips or nothing at all, and retire to your own private island. One of the reasons government exists is to protect the populace from threats to their health such as health scams.
- ggreer 7y ago
  The way that most industries solve this problem is through accreditation and branding. If Apple made a test that was endorsed by Consumer Reports, you can bet good money that it's effective. The FDA & CDC shipped their own tests that were bogus. What's worse: They threatened researchers who invented their own tests that worked.[1] Thanks to the government's incompetence, testing was delayed by a month in the US. 1. From https://www.nytimes.com/2020/03/10/us/coronavirus-testing-delays.html https://www.nytimes.com/2020/03/10/us/coronavirus-testing-de...: Later that day, the investigators and Seattle health officials gathered with representatives of the C.D.C. and the F.D.A. to discuss what happened. The message from the federal government was blunt. “What they said on that phone call very clearly was cease and desist to Helen Chu,” Dr. Lindquist remembered. “Stop testing.”
bosswipe 7y ago
It is also not prudent to assume that regulators are always scheming, wicked villains, or power hungry idiots or whatever. For example, in your distillery link the FDA explains that incidents of kids eating hand sanitizer are up since the pandemic.
- kansface 7y ago
  Regulators don't need to be > scheming, wicked villains, or power hungry idiots to explain any of their recent misbehavior - perfectly banal explanations suffice. At the end of the day, our regulators will let people die invisibly if it means avoiding bad press because that's what they are incentivized to do.
- ahmedtd 7y ago
  That's not a problem that should be solved by poisoning ("denaturing") the alcohol.
  - mattkrause 7y ago
    The article is a little bit confusing on the nature of denaturing. Alcohol can be denatured by making it literally unsafe to drink (methanol, gasoline, etc), or by making it really unpalatable (denatonium benzoate, vinegar, etc), or both. The list of agents and formulae are here: https://www.law.cornell.edu/cfr/text/27/part-21 https://www.law.cornell.edu/cfr/text/27/part-21 Balancing the safety effects of kids eating hand sanitizer vs. the safety effects of not having enough hand sanitizer is tough, but insisting on a bitterant doesn't strike me as totally indefensible.
    - ahmedtd 7y ago
      Oh, ok. I guess bittering is reasonable.

pkaye 7y ago

Why is Fitbit able to get a pulse oximeter in the market while Apple is not?

ggreer 7y ago
It's not clear if Fitbit's pulse oximeter update was ever shipped in the US. I can only find forum posts by disgruntled users who say they don't have it. I asked an acquaintance and he says he doesn't have the functionality despite owning a compatible device. Amusingly, both Fitbit and Apple are part of the FDA's digital health software precertification pilot program[1], which is intended to streamline the approval process. If not for the FDA, both companies could have shipped this 3+ years ago. I'm sure the data would have saved quite a few lives. 1. https://www.fda.gov/medical-devices/digital-health/digital-health-software-precertification-pre-cert-program https://www.fda.gov/medical-devices/digital-health/digital-h...

hhs 7y ago

> A registry is a plausible idea, but in general, this article seems to assume by default that regulators are always wise and benevolent This article doesn't seem to say that regulators are wise and benevolent. It looked like the author was, in fact, troubled by the lack of regulation as cited here: > The root of the problem, of course, is money. In medicine, progress is driven by innovation, and, in our society, innovation is driven by profit. “Among implant manufacturers,” Schneider writes, “market analysis drives research and consideration of device innovation.” The implantable-device industry is even more lucrative, for many companies, than the pharmaceutical industry is. At the largest companies, operating-profit margins are typically twenty-five per cent or higher. In 2014, the industry’s over-all estimated revenues totalled more than a hundred and thirty-six billion dollars. > The financial incentives within this industry are one of the reasons that its lack of regulation is troubling.

jessriedel 7y ago
If you assume adding regulation makes things better without further argument/evidence, you are assuming regulators are wise and benevolent. (Regulators != Legislators.)

jellicle 7y ago

> companies are always scheming, wicked villains I believe the baseline assumption is that many people are trying to make a buck, and something like coronavirus is a great opportunity to scam people. Is that wrong? I'll bet if I purchase ten coronavirus test kits "from the internet", at least 9 out of 10 will be bogus. In the absence of regulation, that would be 13 out of 10. There's a potential for truly massive scams: 7 billion people want something in tight supply, just announce you've got a test kit for $19.95, maybe mail people some pH test strips or nothing at all, and retire to your own private island. One of the reasons government exists is to protect the populace from threats to their health such as health scams.

ggreer 7y ago
The way that most industries solve this problem is through accreditation and branding. If Apple made a test that was endorsed by Consumer Reports, you can bet good money that it's effective. The FDA & CDC shipped their own tests that were bogus. What's worse: They threatened researchers who invented their own tests that worked.[1] Thanks to the government's incompetence, testing was delayed by a month in the US. 1. From https://www.nytimes.com/2020/03/10/us/coronavirus-testing-delays.html https://www.nytimes.com/2020/03/10/us/coronavirus-testing-de...: Later that day, the investigators and Seattle health officials gathered with representatives of the C.D.C. and the F.D.A. to discuss what happened. The message from the federal government was blunt. “What they said on that phone call very clearly was cease and desist to Helen Chu,” Dr. Lindquist remembered. “Stop testing.”

bosswipe 7y ago

It is also not prudent to assume that regulators are always scheming, wicked villains, or power hungry idiots or whatever. For example, in your distillery link the FDA explains that incidents of kids eating hand sanitizer are up since the pandemic.

kansface 7y ago
Regulators don't need to be > scheming, wicked villains, or power hungry idiots to explain any of their recent misbehavior - perfectly banal explanations suffice. At the end of the day, our regulators will let people die invisibly if it means avoiding bad press because that's what they are incentivized to do.
ahmedtd 7y ago
That's not a problem that should be solved by poisoning ("denaturing") the alcohol.
- mattkrause 7y ago
  The article is a little bit confusing on the nature of denaturing. Alcohol can be denatured by making it literally unsafe to drink (methanol, gasoline, etc), or by making it really unpalatable (denatonium benzoate, vinegar, etc), or both. The list of agents and formulae are here: https://www.law.cornell.edu/cfr/text/27/part-21 https://www.law.cornell.edu/cfr/text/27/part-21 Balancing the safety effects of kids eating hand sanitizer vs. the safety effects of not having enough hand sanitizer is tough, but insisting on a bitterant doesn't strike me as totally indefensible.
  - ahmedtd 7y ago
    Oh, ok. I guess bittering is reasonable.