It’s not clear that the results of 23andMe where much better than chance:
Not clear, to whom?
23andme market their product in a way that suggested that the numbers they provided were bunch more informative than they were in practice.
That’s a claim about about the accuracy of the information that 23andme provides, and how that compares to the accuracy of their claims of accuracy. Where’s your evidence for that claim?
The FDA is tasked with stopped people from selling snake oil …
Not by me. If they disappeared into a black hole tomorrow, I would sing “Yippie! Yippie! Yippie!”
And what’s their evidence that 23andme is selling snake oil? What’s yours?
if you get random results on your risk type based on whether you send your DNA to 23andme or it’s competitor Navigenics
I suggest you read Jaynes on probability. The results aren’t “random”, they’re based on different information. You use different information, you assign different probabilities.
How badly should 23aneMe be allowed in your opinion to misbehave?
definition: Misbehaving—offering me information that I want, that those in power don’t want me to have, and will use guns to prevent me from having.
I like it when people “misbehave”.
People who don’t know what they are doing won’t anymore be mislead by 23andme.
Yes, people “misled” by their own incompetence about what 23andme says will now be “protected” from such confusion. They, and everyone else, will also be “protected” from the relief of their ignorance of any and all of the accurate information 23andme might have put out as well.
Couldn’t they be equally “misled” by anything anyone anywhere ever says to them?
And what’s their evidence that 23andme is selling snake oil?
From the FDA perspective 23andme has the burden of proof.
From my perspective: If SNP based genetic testing produces useful risk diagnoses that the diagnosis of different SNP based genetic testing companies should agree. As far as I know those people who used multiple of those services get different results from each one.
If you get completely different answer based on the company that you ask about your risk, do you really think that’s no issue?
The results aren’t “random”, they’re based on different information.
They are both based on the DNA and there are both based on the published literature. We aren’t even sure whether all the published literature is true.
Not by me. If they disappeared into a black hole tomorrow, I would sing “Yippie! Yippie! Yippie!”
A lot of drugs fail in stage 4 trials. Would you really want to have all those drugs on the market?
From the FDA perspective 23andme has the burden of proof.
It’s nice to have the guns.
If you get completely different answer based on the company that you ask about your risk, do you really think that’s no issue?
Discrepant diagnoses are hardly a new issue in medicine.
I’d note that the article you referred to is almost 5 years old now. How much more data does 23andMe have to make accurate predictions? A good order of magnitude at least.
How much more will they have next year? Not so much more, as our benevolent protectors have stopped their data collection efforts.
Yes, it would be nice if medicine got a lot better. They’d make predictions, they’d predict the same things, and they’d be right.
It doesn’t get better by preventing data collection efforts. It doesn’t get better by preventing prediction efforts. Get the FDA out of the way, and we’d have free GoogleCare in a couple of years for most routine doctor visits.
In the article you link, Ventner mentioned
a call to use more markers that provide information on risk factors for taking medication
This is actually the prime use for 23andMe info right now, and was useful 5 years ago. You get info on your particular genotype for some enzymes, which largely determines how well you metabolize different drugs. Turns out I’m a poor metabolizer for the enzyme that metabolizes a drug I was given years ago, and had a bad reaction to. Whaddya know, this crazy science stuff actually works.
A lot of drugs fail in stage 4 trials. Would you really want to have all those drugs on the market?
Yes. And that’s even if I don’t get the FDA incinerated in the bargain.
Having the drugs on the market doesn’t require anyone to use them, it only allows them to use them. Many drugs with failed trials would likely be very useful for a lot of people. And they still have to get permission from a duly deputized agent of the state to get a prescription. Bah! What do doctors know about medicine? About your health? It’s not like they’re the all knowing, all seeing FDA apparatchiks.
How charming it is that we have to get permission to try to heal ourselves.
By the way, Stage 4 trials? You’re talking Phase 4 monitoring?
Get the FDA out of the way, and we’d have free GoogleCare in a couple of years for most routine doctor visits.
I’m not aware that the FDA was responsible for Google ending Google Health.
By the way, Stage 4 trials? You’re talking Phase 4 monitoring?
Sorry I was mentally starting to count with 1 and not 0.
Having the drugs on the market doesn’t require anyone to use them, it only allows them to use them.
The question would be whether the companies would still run the trials if they weren’t legally mandated. Trials are expensive and if the government wouldn’t force big pharma to pay for those trials, do you think Big Pharma would pay?
I’m not aware that the FDA was responsible for Google ending Google Health.
This seems like and debating point more than a good faith evaluation of the situation.
Really, it’s a mystery to you that Google would want to create a health service, and that the regulatory environment would have a significant effect on their ability and desire to create such a service?
Google is in the business of getting eyeballs, largely by aggregating data to be able to make better predictions than other people can.
People’s records are already stored, and they flow through the medical system. The value add from the point of view of most patients view comes from making diagnoses and recommendations. Exactly what the FDA is prohibiting 23andme from doing.
Of course there would be much greater value add if we were able to act on those recommendations, and purchase medications, tests, treatments, and devices. You know, what would happen if we were free.
Google said they closed it for lack of demand.
Do you find the link between what functionality they’re allowed to provide and the associated demand for that functionality mysterious?
The question would be whether the companies would still run the trials if they weren’t legally mandated.
“The” trials?
They almost certainly wouldn’t run trials in the form the FDA requires today. They’d still want to convince people to buy their products. They’d still want to avoid getting sued. People would still want convincing.
We want to be well, we want to find medicines that will make us well, and companies want to sell us stuff, but you can’t imagine us arranging that without threats of violence from the government beyond enforcing contracts?
Presumably, then, we couldn’t get together on this list and find a solution to some shared medical problem without the government stepping in and threatening us all with violence?
People’s records are already stored, and they flow through the medical system. The value add from the point of view of most patients view comes from making diagnoses and recommendations. Exactly what the FDA is prohibiting 23andme from doing.
The FDA seems to say that 23andMe is supposed to provide some evidence that the diagnosis and recommendations they make are better than rolling a dice.
The FDA also gave them years to do that it didn’t shut them down immediately to give them some time to actually provide evidence.
As far as the timing goes Google Health got shut down before the FDA got 23andMe to stop giving diagnoses.
They almost certainly wouldn’t run trials in the form the FDA requires today. They’d still want to convince people to buy their products. They’d still want to avoid getting sued. People would still want convincing.
There are many ways to convince people to buy products that don’t have much to do with running expensive medical trials. You can bring the doctor to a fancy all expensive paid vacation where he get’s lectured on all the great benefits.
They’d still want to avoid getting sued.
I rather have a group of experts in a government department examine whether or not a drug does what is claimed than push that task to courts and let juries make the corresponding decisions.
Do you think this case is handled better if someone sues 23andMe in court because they got cancer and 23andMe told them they had a low cancer risk? It’s somehow less violence if the whole process goes through a jury than when it’s government regulators doing their job?
I don’t think the libertarian position of passing all issues to the courts is a wise move. Having regulations where a diagnostic company can tell a jury: “We follow the rules laid out by government agency X” is valuable. Otherwise the jury has to make up rules on the spot.
The FDA seems to say that 23andMe is supposed to provide some evidence...
No, that’s not what they say. They’re not asking for “some evidence”, they’re asking 23andme to jump through their hoops. Dance for me, peasant.
23andme provides plenty of evidence in terms of peer reviewed papers as citations to their customers. Evidence isn’t lacking, freedom is.
As far as the timing goes Google Health got shut down before the FDA got 23andMe to stop giving diagnoses.
This strikes me as yet another dishonest debating point. Are you unaware that the regulatory regime controlling the right to “practice medicine”, and thereby the right to give a diagnosis, predated the latest FDA attack on 23andme and Google Health by decades?
You can bring the doctor to a fancy all expensive paid vacation where he get’s lectured on all the great benefits.
How horrible, allowing doctors to hear information. We’re much better off having the Ministry of Truth vetting all communications on medical information.
I rather have a group of experts in a government department...
That is indeed the bottom line for most all these questions.
Ronald Reagan
This is the issue of this election. Whether we believe in our capacity for self government or whether we abandon the American revolution and confess that a little intellectual elite, in a far distant capital can plan our lives for us better than we can plan them ourselves.
I’d note for people lacking the historical context, that self government meant what it said—governing your self.
I’m aware that the view expressed here is a minority one, certainly in the world, and even in the US. You, and people who think like you on this question have the numbers, and have the guns.
It’s somehow less violence if the whole process goes through a jury than when it’s government regulators doing their job?
Enormously less.
Most market transactions are perfectly satisfactory to the market participants involved. Free people exchange because they perceive mutual benefit in the exchange.
I’d prefer threats of violence to be the exception, and not the rule. I’d prefer to be free to choose. I understand your preference goes the other way.
This strikes me as yet another dishonest debating point. Are you unaware that the regulatory regime controlling the right to “practice medicine”, and thereby the right to give a diagnosis, predated the latest FDA attack on 23andme and Google Health by decades?
Look, don’t make me out as a defender of the status quo. I did sit down with someone making government regulations in this space because of my QS-media credentials and told him that we QS folks don’t really need his help.
Plenty of people do manage to create products that don’t get shut down by the FDA.
23andme provides plenty of evidence in terms of peer reviewed papers as citations to their customers.
Other testing companies seem to provide nearly the same papers as evidence for their diagnosis and then a different diagnosis. That suggest that the process has issues.
Unfortunately the full exchange between 23andme and the FDA isn’t public so we don’t know what they FDA specifically asked from 23andme. To me it’s not clear that they asked something that’s completely unreasonable in the sense that asking the same thing of Google Health would prevent it from working.
How horrible, allowing doctors to hear information. We’re much better off having the Ministry of Truth vetting all communications on medical information.
Do you believe that pharma representatives bribing doctors should be completely legal?
Crazy people like me would prefer threats of violence to be the exception, and not the rule. I understand your preference goes the other way.
If I make a product than I want to know whether not I have to expect violence. I want clear rules so that I don’t have to explain myself to some jury who’s driven by emotions.
Do you think that doctors being forced to practice defensive medicine to avoid lawsuits is no issue or somehow an absence of violence?
Mob rule is a form of violence and it’s not efficient.
Other testing companies seem to provide nearly the same papers as evidence for their diagnosis and then a different diagnosis. That suggest that the process has issues.
Given how common it is for people to get different diagnoses after going to different doctors, by that logic it seems the FDA should shut down nearly every doctor.
There were 100 of emails going back and forth and dozens of face to face meetings over five years. Then the FDA said concluded that this isn’t working and sent that letter.
Reading the letter it’s interesting that the letter doesn’t even forbid 23andMe from diagnosing people. It forbids them from marketing that they are diagnosing people.
The letter for example says:
The Office of In Vitro Diagnostics and Radiological Health (OIR) has a long history of working with companies to help them come into compliance with the FD&C Act. Since July of 2009, we have been diligently working to help you comply with regulatory requirements regarding safety and effectiveness and obtain marketing authorization for your PGS device.
[...]
You have not worked with us toward de novo classification, did not provide the additional information we requested necessary to complete review of your 510(k)s, and FDA has not received any communication from 23andMe since May. Instead, we have become aware that you have initiated new marketing campaigns, including television commercials that, together with an increasing list of indications, show that you plan to expand the PGS’s uses and consumer base without obtaining marketing authorization from FDA.
If I want to judge whether or not the FDA is reasonable in this instance than I don’t have enough data.
Not clear, to whom?
That’s a claim about about the accuracy of the information that 23andme provides, and how that compares to the accuracy of their claims of accuracy. Where’s your evidence for that claim?
Not by me. If they disappeared into a black hole tomorrow, I would sing “Yippie! Yippie! Yippie!”
And what’s their evidence that 23andme is selling snake oil? What’s yours?
I suggest you read Jaynes on probability. The results aren’t “random”, they’re based on different information. You use different information, you assign different probabilities.
definition: Misbehaving—offering me information that I want, that those in power don’t want me to have, and will use guns to prevent me from having.
I like it when people “misbehave”.
Yes, people “misled” by their own incompetence about what 23andme says will now be “protected” from such confusion. They, and everyone else, will also be “protected” from the relief of their ignorance of any and all of the accurate information 23andme might have put out as well.
Couldn’t they be equally “misled” by anything anyone anywhere ever says to them?
From the FDA perspective 23andme has the burden of proof.
From my perspective: If SNP based genetic testing produces useful risk diagnoses that the diagnosis of different SNP based genetic testing companies should agree. As far as I know those people who used multiple of those services get different results from each one.
If you get completely different answer based on the company that you ask about your risk, do you really think that’s no issue?
They are both based on the DNA and there are both based on the published literature. We aren’t even sure whether all the published literature is true.
A lot of drugs fail in stage 4 trials. Would you really want to have all those drugs on the market?
It’s nice to have the guns.
Discrepant diagnoses are hardly a new issue in medicine.
I’d note that the article you referred to is almost 5 years old now. How much more data does 23andMe have to make accurate predictions? A good order of magnitude at least.
How much more will they have next year? Not so much more, as our benevolent protectors have stopped their data collection efforts.
Yes, it would be nice if medicine got a lot better. They’d make predictions, they’d predict the same things, and they’d be right.
It doesn’t get better by preventing data collection efforts. It doesn’t get better by preventing prediction efforts. Get the FDA out of the way, and we’d have free GoogleCare in a couple of years for most routine doctor visits.
In the article you link, Ventner mentioned
This is actually the prime use for 23andMe info right now, and was useful 5 years ago. You get info on your particular genotype for some enzymes, which largely determines how well you metabolize different drugs. Turns out I’m a poor metabolizer for the enzyme that metabolizes a drug I was given years ago, and had a bad reaction to. Whaddya know, this crazy science stuff actually works.
Yes. And that’s even if I don’t get the FDA incinerated in the bargain.
Having the drugs on the market doesn’t require anyone to use them, it only allows them to use them. Many drugs with failed trials would likely be very useful for a lot of people. And they still have to get permission from a duly deputized agent of the state to get a prescription. Bah! What do doctors know about medicine? About your health? It’s not like they’re the all knowing, all seeing FDA apparatchiks.
How charming it is that we have to get permission to try to heal ourselves.
By the way, Stage 4 trials? You’re talking Phase 4 monitoring?
I’m not aware that the FDA was responsible for Google ending Google Health.
Sorry I was mentally starting to count with 1 and not 0.
The question would be whether the companies would still run the trials if they weren’t legally mandated. Trials are expensive and if the government wouldn’t force big pharma to pay for those trials, do you think Big Pharma would pay?
This seems like and debating point more than a good faith evaluation of the situation.
Really, it’s a mystery to you that Google would want to create a health service, and that the regulatory environment would have a significant effect on their ability and desire to create such a service?
Google is in the business of getting eyeballs, largely by aggregating data to be able to make better predictions than other people can.
People’s records are already stored, and they flow through the medical system. The value add from the point of view of most patients view comes from making diagnoses and recommendations. Exactly what the FDA is prohibiting 23andme from doing.
Of course there would be much greater value add if we were able to act on those recommendations, and purchase medications, tests, treatments, and devices. You know, what would happen if we were free.
Google said they closed it for lack of demand.
Do you find the link between what functionality they’re allowed to provide and the associated demand for that functionality mysterious?
“The” trials?
They almost certainly wouldn’t run trials in the form the FDA requires today. They’d still want to convince people to buy their products. They’d still want to avoid getting sued. People would still want convincing.
We want to be well, we want to find medicines that will make us well, and companies want to sell us stuff, but you can’t imagine us arranging that without threats of violence from the government beyond enforcing contracts?
Presumably, then, we couldn’t get together on this list and find a solution to some shared medical problem without the government stepping in and threatening us all with violence?
The FDA seems to say that 23andMe is supposed to provide some evidence that the diagnosis and recommendations they make are better than rolling a dice. The FDA also gave them years to do that it didn’t shut them down immediately to give them some time to actually provide evidence.
As far as the timing goes Google Health got shut down before the FDA got 23andMe to stop giving diagnoses.
There are many ways to convince people to buy products that don’t have much to do with running expensive medical trials. You can bring the doctor to a fancy all expensive paid vacation where he get’s lectured on all the great benefits.
I rather have a group of experts in a government department examine whether or not a drug does what is claimed than push that task to courts and let juries make the corresponding decisions.
Do you think this case is handled better if someone sues 23andMe in court because they got cancer and 23andMe told them they had a low cancer risk? It’s somehow less violence if the whole process goes through a jury than when it’s government regulators doing their job?
I don’t think the libertarian position of passing all issues to the courts is a wise move. Having regulations where a diagnostic company can tell a jury: “We follow the rules laid out by government agency X” is valuable. Otherwise the jury has to make up rules on the spot.
No, that’s not what they say. They’re not asking for “some evidence”, they’re asking 23andme to jump through their hoops. Dance for me, peasant.
23andme provides plenty of evidence in terms of peer reviewed papers as citations to their customers. Evidence isn’t lacking, freedom is.
This strikes me as yet another dishonest debating point. Are you unaware that the regulatory regime controlling the right to “practice medicine”, and thereby the right to give a diagnosis, predated the latest FDA attack on 23andme and Google Health by decades?
How horrible, allowing doctors to hear information. We’re much better off having the Ministry of Truth vetting all communications on medical information.
That is indeed the bottom line for most all these questions.
Ronald Reagan
I’d note for people lacking the historical context, that self government meant what it said—governing your self.
I’m aware that the view expressed here is a minority one, certainly in the world, and even in the US. You, and people who think like you on this question have the numbers, and have the guns.
Enormously less.
Most market transactions are perfectly satisfactory to the market participants involved. Free people exchange because they perceive mutual benefit in the exchange.
I’d prefer threats of violence to be the exception, and not the rule. I’d prefer to be free to choose. I understand your preference goes the other way.
Look, don’t make me out as a defender of the status quo. I did sit down with someone making government regulations in this space because of my QS-media credentials and told him that we QS folks don’t really need his help.
Plenty of people do manage to create products that don’t get shut down by the FDA.
Other testing companies seem to provide nearly the same papers as evidence for their diagnosis and then a different diagnosis. That suggest that the process has issues.
Unfortunately the full exchange between 23andme and the FDA isn’t public so we don’t know what they FDA specifically asked from 23andme. To me it’s not clear that they asked something that’s completely unreasonable in the sense that asking the same thing of Google Health would prevent it from working.
Do you believe that pharma representatives bribing doctors should be completely legal?
If I make a product than I want to know whether not I have to expect violence. I want clear rules so that I don’t have to explain myself to some jury who’s driven by emotions.
Do you think that doctors being forced to practice defensive medicine to avoid lawsuits is no issue or somehow an absence of violence? Mob rule is a form of violence and it’s not efficient.
Given how common it is for people to get different diagnoses after going to different doctors, by that logic it seems the FDA should shut down nearly every doctor.
You know that you could have checked Google, right? X-/
The letter.
There were 100 of emails going back and forth and dozens of face to face meetings over five years. Then the FDA said concluded that this isn’t working and sent that letter.
Reading the letter it’s interesting that the letter doesn’t even forbid 23andMe from diagnosing people. It forbids them from marketing that they are diagnosing people.
The letter for example says:
If I want to judge whether or not the FDA is reasonable in this instance than I don’t have enough data.