5 ms·

> The gov wants to decide what's best for the people. Should the people decide differently, using their wallets for example, this anomaly will be quashed. Wall

by revscat 13y ago

> The gov wants to decide what's best for the people. Should the people decide differently, using their wallets for example, this anomaly will be quashed. Wallets are incredibly poor judges of medical efficacy. The FDA rules are in place for very good reasons, namely to prevent snake-oil salesmen and other unscrupulous merchandisers from foisting their -- potentially harmful -- products upon an unsuspecting public. I would much rather have FDA clearance for medical products and devices than the alternative that you seem to be proposing.

Symmetry 13y ago
I don't think anyone is going to argue about the FDA's role in ensuring drugs are safe, but most countries don't require positive proof of effectiveness and, frankly, have better health outcomes than the US. Doctors are quite capable of reviewing the evidence to see if drugs are effective, and the FDA doesn't in practice do anything to prevent the sail of non-poisonous snake oil.
- seiji 13y ago
  Doctors encompass the entire range of people (from morons to geniuses). As a group, they aren't some magnificent godlike all knowing figure. "Programmers are quite capable of reviewing the evidence to see if code is effective" — yet, we end up with thousands of people using MongoDB based off fad and hype and losing data by the day. (Wait, did I just advocate for a government-level code approval board? In the right hands it would probably help if it prevented more Mongos and Hadoops from entering the world.)
  - jbooth 13y ago
    Losing data when you're a professional who should have known what you're doing is one thing. Losing your life when you're a layman in the medical field is another.
  - Symmetry 13y ago
    Doctors make mistakes, but there isn't anything preventing that in any event. In theory a doctor can prescribe any drug for any ailment (though there are lots of checks and consequences), and prescribing drugs for things other than their FDA approved use is very common[1]. You have to rely on doctor judgment at some point and efficacy trials don't substitute for competent doctors. And sometimes the whole process goes awry because a drug is approved for one problem, later becomes the only treatment for some people with a second problem, then the FDA withdraws approval because there are now better treatments for the first problem, leaving those with the second problem in the lurch.[2] [1]http://en.wikipedia.org/wiki/Off-label_use http://en.wikipedia.org/wiki/Off-label_use [2]http://nielsenhayden.com/makinglight/archives/007140.html http://nielsenhayden.com/makinglight/archives/007140.html There's some important context in the comments.
- JPKab 13y ago
  I think the US's for profit healthcare system makes the FDA very important. Here in the US, we have pharmaceutical salesman who come in and schmooze the staff to then get to the doctors. Pharmaceutical rep is a job known to be very amenable to attractive women with little skills outside of flirting.
  - nickff 13y ago
    Your definition of "for profit" is somewhat misleading, as many Canadian doctors, nurses, pharmacists, etc. are the residual claimants ('profiteers') of almost any course of testing or treatment; and I suspect that this is true of many countries with less strict drug regulations.
- venomsnake 13y ago
  Can you please give example of such a country? I can't think of any country with working healthcare where you are allowed to claim anything medical (or heaven forbid perform) before clearing it with the authorities.
  - Symmetry 13y ago
    No, every country I can think of requires new medicines to be cleared with the authorities. The difference is what that clearance entails.
- _delirium 13y ago
  A number of western countries take a strategy that tries to make questionable-but-safe drugs legal-but-rarely-used. For one, they ban direct-to-consumer advertising; the USA and New Zealand are the only two developed countries where it's legal to advertise to consumers. And for another, state health-care systems will typically not pay for drugs that lack evidence of efficacy, and most people are used to getting their healthcare through the state health system. That leaves it technically legal for consumers to buy, out-of-pocket, a drug that can't be advertised to them. In practice a handful of people do so, but not too many. It looks like they do sell this in Europe. Although I'm not sure if that's because it's approved at all, or just because Europe considers it some kind of novelty product rather than a medical device; the FDA and EU categorization of drugs/devices/etc. is a bit different.
deleted 13y ago
[deleted]
VMG 13y ago
> Wallets are incredibly poor judges of medical efficacy. So are bureaucrats who are subject to the influence of lobbyists. Snake-oil salesmen and peddlers of alternative medicine do sell their stuff under the current system, while true innovation is crushed, as is evident in this case.
- aroch 13y ago
  23&me isn't particularly innovative...They just took existing genotyping and made it available to everyone in pretty graphs
  - VMG 13y ago
    Care to share a link to a competitor?
    - aroch 13y ago
      Any hospital offering primary care has a lab at their disposal that can do this. Genotyping is nothing new...but as for competitors in 23&me's area (aka public access genotyping for cheap an that I can remember off the top of my head): deCODEme, lumigenix, Dna Genotek and MapMyGenome
    - dragonwriter 13y ago
      Navigenics, with Navigenics Health Compass, was a competitor to 23andMe with their PGS offering, but Navigenics appears to have discontinued the competing offering (Navigenics was received initial contact from the FDA at about their product at the same time 23andMe did, they also went through similar rounds with the State of California for licensing to operate their before that.) There's a number of other offerings that have been made in the same general space, as well.
Houshalter 13y ago
>Wallets are incredibly poor judges of medical efficacy. The FDA rules are in place for very good reasons, namely to prevent snake-oil salesmen and other unscrupulous merchandisers from foisting their -- potentially harmful -- products upon an unsuspecting public. There is snake oil for sale in every store, and no one has ever been hurt from their test.

by revscat 13y ago

Symmetry 13y ago

I don't think anyone is going to argue about the FDA's role in ensuring drugs are safe, but most countries don't require positive proof of effectiveness and, frankly, have better health outcomes than the US. Doctors are quite capable of reviewing the evidence to see if drugs are effective, and the FDA doesn't in practice do anything to prevent the sail of non-poisonous snake oil.

seiji 13y ago
Doctors encompass the entire range of people (from morons to geniuses). As a group, they aren't some magnificent godlike all knowing figure. "Programmers are quite capable of reviewing the evidence to see if code is effective" — yet, we end up with thousands of people using MongoDB based off fad and hype and losing data by the day. (Wait, did I just advocate for a government-level code approval board? In the right hands it would probably help if it prevented more Mongos and Hadoops from entering the world.)
- jbooth 13y ago
  Losing data when you're a professional who should have known what you're doing is one thing. Losing your life when you're a layman in the medical field is another.
- Symmetry 13y ago
  Doctors make mistakes, but there isn't anything preventing that in any event. In theory a doctor can prescribe any drug for any ailment (though there are lots of checks and consequences), and prescribing drugs for things other than their FDA approved use is very common[1]. You have to rely on doctor judgment at some point and efficacy trials don't substitute for competent doctors. And sometimes the whole process goes awry because a drug is approved for one problem, later becomes the only treatment for some people with a second problem, then the FDA withdraws approval because there are now better treatments for the first problem, leaving those with the second problem in the lurch.[2] [1]http://en.wikipedia.org/wiki/Off-label_use http://en.wikipedia.org/wiki/Off-label_use [2]http://nielsenhayden.com/makinglight/archives/007140.html http://nielsenhayden.com/makinglight/archives/007140.html There's some important context in the comments.
JPKab 13y ago
I think the US's for profit healthcare system makes the FDA very important. Here in the US, we have pharmaceutical salesman who come in and schmooze the staff to then get to the doctors. Pharmaceutical rep is a job known to be very amenable to attractive women with little skills outside of flirting.
- nickff 13y ago
  Your definition of "for profit" is somewhat misleading, as many Canadian doctors, nurses, pharmacists, etc. are the residual claimants ('profiteers') of almost any course of testing or treatment; and I suspect that this is true of many countries with less strict drug regulations.
venomsnake 13y ago
Can you please give example of such a country? I can't think of any country with working healthcare where you are allowed to claim anything medical (or heaven forbid perform) before clearing it with the authorities.
- Symmetry 13y ago
  No, every country I can think of requires new medicines to be cleared with the authorities. The difference is what that clearance entails.
_delirium 13y ago
A number of western countries take a strategy that tries to make questionable-but-safe drugs legal-but-rarely-used. For one, they ban direct-to-consumer advertising; the USA and New Zealand are the only two developed countries where it's legal to advertise to consumers. And for another, state health-care systems will typically not pay for drugs that lack evidence of efficacy, and most people are used to getting their healthcare through the state health system. That leaves it technically legal for consumers to buy, out-of-pocket, a drug that can't be advertised to them. In practice a handful of people do so, but not too many. It looks like they do sell this in Europe. Although I'm not sure if that's because it's approved at all, or just because Europe considers it some kind of novelty product rather than a medical device; the FDA and EU categorization of drugs/devices/etc. is a bit different.

deleted 13y ago

[deleted]

VMG 13y ago

> Wallets are incredibly poor judges of medical efficacy. So are bureaucrats who are subject to the influence of lobbyists. Snake-oil salesmen and peddlers of alternative medicine do sell their stuff under the current system, while true innovation is crushed, as is evident in this case.

aroch 13y ago
23&me isn't particularly innovative...They just took existing genotyping and made it available to everyone in pretty graphs
- VMG 13y ago
  Care to share a link to a competitor?
  - aroch 13y ago
    Any hospital offering primary care has a lab at their disposal that can do this. Genotyping is nothing new...but as for competitors in 23&me's area (aka public access genotyping for cheap an that I can remember off the top of my head): deCODEme, lumigenix, Dna Genotek and MapMyGenome
  - dragonwriter 13y ago
    Navigenics, with Navigenics Health Compass, was a competitor to 23andMe with their PGS offering, but Navigenics appears to have discontinued the competing offering (Navigenics was received initial contact from the FDA at about their product at the same time 23andMe did, they also went through similar rounds with the State of California for licensing to operate their before that.) There's a number of other offerings that have been made in the same general space, as well.

Houshalter 13y ago

>Wallets are incredibly poor judges of medical efficacy. The FDA rules are in place for very good reasons, namely to prevent snake-oil salesmen and other unscrupulous merchandisers from foisting their -- potentially harmful -- products upon an unsuspecting public. There is snake oil for sale in every store, and no one has ever been hurt from their test.