4 ms·

And yet, few FDA actions or class action lawsuits against chiropractors, acupuncturists, purveyors of bullshit diets, nutrition or exercise products, penis and

And yet, few FDA actions or class action lawsuits against chiropractors, acupuncturists, purveyors of bullshit diets, nutrition or exercise products, penis and breast enlargement devices. Turn on any radio or late night TV channel and get deluged with sheer bullshit. Better yet, look at your own insurance policy paying for the medical equivalent of scientology (chiropractic medicine). There's a long list of scams and bad products out there (Ranbaxy anyone?), many that actually harm consumers and promise miracles. And yet, here we have the government cracking down on something (as well as opportunistic ambulance chasers), that doesn't really promise anymore than a statistical printout of your DNA. Most of 23andme's customers were early adopters, especially when the price was much higher, I find it hard to believe the plantiffs in this lawsuit were duped into thinking it does anything more than claimed. Meanwhile, people who give medical advice that harms actual children, by claiming vaccination gives them autism, can run wild all over public health.

jbooth 13y ago
Most/all of those others provide appropriate disclaimers and, if the FDA is calling them, they pick up the phone. From what I saw of the FDA complaints, really all they wanted is a disclaimer and a dialback of certain marketing claims. The lawsuit is almost certainly motivated by the FDA action and trying to grab a bad-faith payday, but the existence of various other BS products where the management actually bothered to talk to a lawyer doesn't mean that 23andme was exempt from talking to a lawyer themselves.
- cromwellian 13y ago
  That's all true, but the "disclaimers" on homeopathic pills and bogus diets are so weak compared to overwhelming testimonials that the "disclaimer" amounts to ass covering boilerplate that makes no practical difference in terms of people getting fooled. Maybe 23andme screwed up by not running text in 8 point font and a fast talking muted announcer saying "information may not be accurate or useful...blah blah...", but this seems to be a huge inversion of priority compared to potential harm. People have been poisoned by "supplements" containing lead or arsenic, or killed by ginseng/ginkoba/caffeine overdoses in others. Millions more are ripped off by diets with utterly outrageous claims and faked testimonials.
  - thirdtruck 13y ago
    There are, unfortunately, very specific laws that exclude such "supplements" from the scrutiny expected of most products. These laws bind the FDA's hands. The NeuroLogica Blog touches on the topic periodically (http://theness.com/neurologicablog/index.php/cam-research-be-careful-what-you-wish-for/ http://theness.com/neurologicablog/index.php/cam-research-be...).
icelancer 13y ago
>Turn on any radio or late night TV channel and get deluged with sheer bullshit. Better yet, look at your own insurance policy paying for the medical equivalent of scientology (chiropractic medicine). This is an unfair slander if you apply it to the entirety of chiropractic procedures. Sure, the people who think subluxations cause cancer and headaches deserve to be sued to high hell, but multidiscpline approaches by good PTs often involve some manual therapy of direct spinal manipulation.
- owenmarshall 13y ago
  >multidiscpline approaches by good PTs often involve some manual therapy of direct spinal manipulation. Indeed, but the differences between the practitioners are dramatic. Physical therapy uses evidence-based medicine as performed by highly trained medical practitioners. Chiropractors are woefully under qualified to perform spinal manipulation, and patient outcomes reflect this in significantly higher injury rates. Chiropractic is a field developed and persisted by charlatans.
  - icelancer 13y ago
    I don't agree. I have a PT who uses chiropractic methods but I also have seen a chiropractor who does nothing but lower back manipulation and traction methods, both of which have evidence backing their methods to fix lower back mechanical issues. He is not a charlatan. It would be unfair to group him with the subluxation magicians.
    - sjwright 13y ago
      > It would be unfair to group him with the subluxation magicians. But then why does he call himself a subluxation magician? Is an alchemist still an alchemist if they're actually doing modern chemistry? The label chiropractic means something; the meaning doesn't change just because a few practitioners have quietly become closeted physiotherapists.
- sjwright 13y ago
  > > the medical equivalent of scientology (chiropractic medicine). An apt analogy. Scientology happens to include a few training exercises that might be considered valid or beneficial. But a small grain of validity isn't enough to overcome the metric ton of woo and indoctrination surrounding it. Anything of value can be assessed by researchers in the relevant qualified field, but those small grains aren't Scientology, and you wouldn't label them that. A chiropractor who performs physiotherapy is analogous to a scientologist who performs mainstream psychology. Or a homeopathist who slips full doses of actual drugs into their dilutions. > This is an unfair slander In my view, anyone providing services under the chiropractic banner can be legitimately called idiots, quacks, charlatans, and a danger to society. They are unqualified to perform anything. They deserve all the scorn and ridicule we can muster. I don't care if they focus on techniques consistent with physiotherapy; by using the chiropractic label, they are providing legitimacy to the ones who believe and practice woo woo. If you want to practice physiotherapy, we already have a label for that. It's called physiotherapy.
joe_the_user 13y ago
Yeah, And all those serial killers prove I should be able to assault my personal enemies. Look at all the serial killers! People who offend me know that they might risk being punched in the nose, they signed-on! This is an injustice! In other words, the parent complaint is irrelevant. The topic is 23andme. Edit: yeah, I'm sure this offends people but it's pretty telling that the top-rated defense of 23andme is "Oh, all those others are worse".
- cromwellian 13y ago
  The real topic is overreaching FDA with inverted priorities and ambulance chasers. If the government is to regulate, and it has limited resources, it should regulate those that do the greatest harm.
mcphilip 13y ago
Genetic tests are classified as medical devices, a category requiring a strict approval process with the FDA [1]. The other "bullshit" products [2] you mentioned do not fall in this category. The debate should start at whether 23andme tests should be classified as medical devices instead of claiming malicious targeting by lawsuits and the FDA. [1]http://www.nbcnews.com/id/37638671/#.UpWQiNIwrIy http://www.nbcnews.com/id/37638671/#.UpWQiNIwrIy [2]Acupuncture seems to help my migraines. I'm comfortable with not having a rational explanation for why it works.
- cromwellian 13y ago
  I personally don't think the government has a right to tell me I can't read my DNA. A medical device that tells me the chemical content of my spit can't physically harm me.
  - krapp 13y ago
    The government isn't saying you don't have a right to read your DNA, it's claiming this particular device is fraudulent and its ads are deceptive.
    - jonallanharper 13y ago
      The FDA’s letter to 23andMe calls “particularly concerning” the information the tests would provide about the gene linked to breast cancer (BRCA) “because of the potential health consequences that could result from false positive or false negative assessments.” According to 23andMe's site: "You should not change your health behaviors solely on the basis of information from 23andMe. Make sure to discuss your Genetic Information with a physician or other health care provider before you act upon the Genetic Information resulting from 23andMe Services. For most common diseases, the genes we know about are only responsible for a small fraction of the risk. There may be unknown genes, environmental factors, or lifestyle choices that are far more important predictors. If your data indicate that you are not at elevated genetic risk for a particular disease or condition, you should not feel that you are protected. The opposite is also true; if your data indicate you are at an elevated genetic risk for a particular disease or condition, it does not mean you will definitively develop the disease or condition. In either case, if you have concerns or questions about what you learn through 23andMe, you should contact your physician or other health care provider." (Paraphrased from Harry Binswanger's article: http://onforb.es/1iQEN4U http://onforb.es/1iQEN4U)
tvladeck 13y ago
To this point: > Most of 23andme's customers were early adopters, especially when the price was much higher, I find it hard to believe the plantiffs in this lawsuit were duped into thinking it does anything more than claimed. You've actually hit on exactly why the FDA decided to initiate enforcement action on 23andMe. The FDA has always taken the position that what 23andMe was doing was not necessarily permitted, but used regulatory discretion and did not stop them. The rationale was that since 23andMe did not do mass-marketing, the people using the tests were seeking 23andMe out and were educated on what the tests were. 23andMe has made some stupid choices, like not engaging with the FDA over the course of a number of months on this issue, and this was all brought to a head when 23andMe broke the implicit agreement with the FDA and started mass-marketing. And on this point: > that doesn't really promise anymore than a statistical printout of your DNA. Their profiles now have a "key health recommendations" section if you've taken the test (I have), which, again, is a big no-no, and part of the reason that the FDA decided to initiate enforcement.
- cromwellian 13y ago
  Lots of websites make key health recommendations based on family history/ancestry, and behavioral questionnaires. Why are they exempted? Why can someone make a website that asks you about age, drinking, smoking, activity levels, height, weight, etc and then make health recommendations, but if it comes from sampling DNA instead of verbal questioning of potential heredity traits, it's magically different and bad?
  - epistasis 13y ago
    There's a significant amount that can go wrong in the laboratory when generating test results. So congress passed laws saying the FDA must regulate these laboratories. 23andMe chose not to comply with these regulations, to not collaborate with the FDA. Blaming the FDA is quite misplaced. If you want the laws to be different, congress is the part of the government with power to change the regulations. The FDA seems to be attempting to do the minimal amount required by law, and does not appear to be in the least bit overzealous with 23andMe. That 23andMe has not complied with basic QA and analytic reassurances should concern you greatly, and doubt the quality of 23andMe. What 23andMe is doing is somewhat equivalent to writing code and not having any unit tests, integration tests, or any QA team. Or perhaps they're doing all that, but don't want to report to the FDA. In any case, quite shady.
deleted 13y ago
[deleted]
jordanb 13y ago
I expect it's a matter of precedent. If you're a chiropractor or a herbal supplement manufacturer you can hire a lawyer who will tell you exactly what you're allowed to say in your advertisements because the FDA has already litigated that over decades of chiropractors and herbal supplement manufacturers.
chasing 13y ago
First: Yes, the government goes after medical charlatans all the time. (And individuals sue like this quite often.) No, they don't get them all. And few of these cases are high profile. But that doesn't mean they aren't working to protect people. Second: What does that matter? I'm no lawyer, but I'm almost certain a law isn't nullified as soon as one person gets away with breaking it. 23andMe is pretty high-profile. It doesn't matter how much a part of the tech entrepreneur inner-circle their founders may be, if they're doing something that might be harmful or misleading, it's completely appropriate for legal remedies to be explored. Especially when it sounds like they're thumbing their noses at the rather polite requests of the FDA.
joering2 13y ago
The answer is buried within your message. As someone who worked close with company that entirely relied their existance on FDA, I will tell you FDA is not there to protect consumers or fight against miracle scam products; its there to protect business of those who pay the most (large corporations -- hello vaccines) from other small players who try to enter the market with (many times) better /cheaper/smarter product that the huge guys are offering. Its a dictatorship and protectionism at its best. Huge corporations cannot afford to spend 300 million dollars on some flu vaccine knowing that some little guy can pop up any minute with some more affordable alternative. It sad, its broken and its rot to the core when it affect human lives. As of 23 I think they simply pissed FDA off one bit too much and now they are paying the price. It has nothing to do whether their product is safe, whether or not it promises miracles or simply a basic knowledge, or anything consumer-centric.

jbooth 13y ago

Most/all of those others provide appropriate disclaimers and, if the FDA is calling them, they pick up the phone. From what I saw of the FDA complaints, really all they wanted is a disclaimer and a dialback of certain marketing claims. The lawsuit is almost certainly motivated by the FDA action and trying to grab a bad-faith payday, but the existence of various other BS products where the management actually bothered to talk to a lawyer doesn't mean that 23andme was exempt from talking to a lawyer themselves.

cromwellian 13y ago
That's all true, but the "disclaimers" on homeopathic pills and bogus diets are so weak compared to overwhelming testimonials that the "disclaimer" amounts to ass covering boilerplate that makes no practical difference in terms of people getting fooled. Maybe 23andme screwed up by not running text in 8 point font and a fast talking muted announcer saying "information may not be accurate or useful...blah blah...", but this seems to be a huge inversion of priority compared to potential harm. People have been poisoned by "supplements" containing lead or arsenic, or killed by ginseng/ginkoba/caffeine overdoses in others. Millions more are ripped off by diets with utterly outrageous claims and faked testimonials.
- thirdtruck 13y ago
  There are, unfortunately, very specific laws that exclude such "supplements" from the scrutiny expected of most products. These laws bind the FDA's hands. The NeuroLogica Blog touches on the topic periodically (http://theness.com/neurologicablog/index.php/cam-research-be-careful-what-you-wish-for/ http://theness.com/neurologicablog/index.php/cam-research-be...).

icelancer 13y ago

>Turn on any radio or late night TV channel and get deluged with sheer bullshit. Better yet, look at your own insurance policy paying for the medical equivalent of scientology (chiropractic medicine). This is an unfair slander if you apply it to the entirety of chiropractic procedures. Sure, the people who think subluxations cause cancer and headaches deserve to be sued to high hell, but multidiscpline approaches by good PTs often involve some manual therapy of direct spinal manipulation.

owenmarshall 13y ago
>multidiscpline approaches by good PTs often involve some manual therapy of direct spinal manipulation. Indeed, but the differences between the practitioners are dramatic. Physical therapy uses evidence-based medicine as performed by highly trained medical practitioners. Chiropractors are woefully under qualified to perform spinal manipulation, and patient outcomes reflect this in significantly higher injury rates. Chiropractic is a field developed and persisted by charlatans.
- icelancer 13y ago
  I don't agree. I have a PT who uses chiropractic methods but I also have seen a chiropractor who does nothing but lower back manipulation and traction methods, both of which have evidence backing their methods to fix lower back mechanical issues. He is not a charlatan. It would be unfair to group him with the subluxation magicians.
  - sjwright 13y ago
    > It would be unfair to group him with the subluxation magicians. But then why does he call himself a subluxation magician? Is an alchemist still an alchemist if they're actually doing modern chemistry? The label chiropractic means something; the meaning doesn't change just because a few practitioners have quietly become closeted physiotherapists.
sjwright 13y ago
> > the medical equivalent of scientology (chiropractic medicine). An apt analogy. Scientology happens to include a few training exercises that might be considered valid or beneficial. But a small grain of validity isn't enough to overcome the metric ton of woo and indoctrination surrounding it. Anything of value can be assessed by researchers in the relevant qualified field, but those small grains aren't Scientology, and you wouldn't label them that. A chiropractor who performs physiotherapy is analogous to a scientologist who performs mainstream psychology. Or a homeopathist who slips full doses of actual drugs into their dilutions. > This is an unfair slander In my view, anyone providing services under the chiropractic banner can be legitimately called idiots, quacks, charlatans, and a danger to society. They are unqualified to perform anything. They deserve all the scorn and ridicule we can muster. I don't care if they focus on techniques consistent with physiotherapy; by using the chiropractic label, they are providing legitimacy to the ones who believe and practice woo woo. If you want to practice physiotherapy, we already have a label for that. It's called physiotherapy.

joe_the_user 13y ago

Yeah, And all those serial killers prove I should be able to assault my personal enemies. Look at all the serial killers! People who offend me know that they might risk being punched in the nose, they signed-on! This is an injustice! In other words, the parent complaint is irrelevant. The topic is 23andme. Edit: yeah, I'm sure this offends people but it's pretty telling that the top-rated defense of 23andme is "Oh, all those others are worse".

cromwellian 13y ago
The real topic is overreaching FDA with inverted priorities and ambulance chasers. If the government is to regulate, and it has limited resources, it should regulate those that do the greatest harm.

mcphilip 13y ago

Genetic tests are classified as medical devices, a category requiring a strict approval process with the FDA [1]. The other "bullshit" products [2] you mentioned do not fall in this category. The debate should start at whether 23andme tests should be classified as medical devices instead of claiming malicious targeting by lawsuits and the FDA. [1]http://www.nbcnews.com/id/37638671/#.UpWQiNIwrIy http://www.nbcnews.com/id/37638671/#.UpWQiNIwrIy [2]Acupuncture seems to help my migraines. I'm comfortable with not having a rational explanation for why it works.

cromwellian 13y ago
I personally don't think the government has a right to tell me I can't read my DNA. A medical device that tells me the chemical content of my spit can't physically harm me.
- krapp 13y ago
  The government isn't saying you don't have a right to read your DNA, it's claiming this particular device is fraudulent and its ads are deceptive.
  - jonallanharper 13y ago
    The FDA’s letter to 23andMe calls “particularly concerning” the information the tests would provide about the gene linked to breast cancer (BRCA) “because of the potential health consequences that could result from false positive or false negative assessments.” According to 23andMe's site: "You should not change your health behaviors solely on the basis of information from 23andMe. Make sure to discuss your Genetic Information with a physician or other health care provider before you act upon the Genetic Information resulting from 23andMe Services. For most common diseases, the genes we know about are only responsible for a small fraction of the risk. There may be unknown genes, environmental factors, or lifestyle choices that are far more important predictors. If your data indicate that you are not at elevated genetic risk for a particular disease or condition, you should not feel that you are protected. The opposite is also true; if your data indicate you are at an elevated genetic risk for a particular disease or condition, it does not mean you will definitively develop the disease or condition. In either case, if you have concerns or questions about what you learn through 23andMe, you should contact your physician or other health care provider." (Paraphrased from Harry Binswanger's article: http://onforb.es/1iQEN4U http://onforb.es/1iQEN4U)

tvladeck 13y ago

To this point: > Most of 23andme's customers were early adopters, especially when the price was much higher, I find it hard to believe the plantiffs in this lawsuit were duped into thinking it does anything more than claimed. You've actually hit on exactly why the FDA decided to initiate enforcement action on 23andMe. The FDA has always taken the position that what 23andMe was doing was not necessarily permitted, but used regulatory discretion and did not stop them. The rationale was that since 23andMe did not do mass-marketing, the people using the tests were seeking 23andMe out and were educated on what the tests were. 23andMe has made some stupid choices, like not engaging with the FDA over the course of a number of months on this issue, and this was all brought to a head when 23andMe broke the implicit agreement with the FDA and started mass-marketing. And on this point: > that doesn't really promise anymore than a statistical printout of your DNA. Their profiles now have a "key health recommendations" section if you've taken the test (I have), which, again, is a big no-no, and part of the reason that the FDA decided to initiate enforcement.

cromwellian 13y ago
Lots of websites make key health recommendations based on family history/ancestry, and behavioral questionnaires. Why are they exempted? Why can someone make a website that asks you about age, drinking, smoking, activity levels, height, weight, etc and then make health recommendations, but if it comes from sampling DNA instead of verbal questioning of potential heredity traits, it's magically different and bad?
- epistasis 13y ago
  There's a significant amount that can go wrong in the laboratory when generating test results. So congress passed laws saying the FDA must regulate these laboratories. 23andMe chose not to comply with these regulations, to not collaborate with the FDA. Blaming the FDA is quite misplaced. If you want the laws to be different, congress is the part of the government with power to change the regulations. The FDA seems to be attempting to do the minimal amount required by law, and does not appear to be in the least bit overzealous with 23andMe. That 23andMe has not complied with basic QA and analytic reassurances should concern you greatly, and doubt the quality of 23andMe. What 23andMe is doing is somewhat equivalent to writing code and not having any unit tests, integration tests, or any QA team. Or perhaps they're doing all that, but don't want to report to the FDA. In any case, quite shady.

deleted 13y ago

[deleted]

jordanb 13y ago

I expect it's a matter of precedent. If you're a chiropractor or a herbal supplement manufacturer you can hire a lawyer who will tell you exactly what you're allowed to say in your advertisements because the FDA has already litigated that over decades of chiropractors and herbal supplement manufacturers.

chasing 13y ago

First: Yes, the government goes after medical charlatans all the time. (And individuals sue like this quite often.) No, they don't get them all. And few of these cases are high profile. But that doesn't mean they aren't working to protect people. Second: What does that matter? I'm no lawyer, but I'm almost certain a law isn't nullified as soon as one person gets away with breaking it. 23andMe is pretty high-profile. It doesn't matter how much a part of the tech entrepreneur inner-circle their founders may be, if they're doing something that might be harmful or misleading, it's completely appropriate for legal remedies to be explored. Especially when it sounds like they're thumbing their noses at the rather polite requests of the FDA.

joering2 13y ago

The answer is buried within your message. As someone who worked close with company that entirely relied their existance on FDA, I will tell you FDA is not there to protect consumers or fight against miracle scam products; its there to protect business of those who pay the most (large corporations -- hello vaccines) from other small players who try to enter the market with (many times) better /cheaper/smarter product that the huge guys are offering. Its a dictatorship and protectionism at its best. Huge corporations cannot afford to spend 300 million dollars on some flu vaccine knowing that some little guy can pop up any minute with some more affordable alternative. It sad, its broken and its rot to the core when it affect human lives. As of 23 I think they simply pissed FDA off one bit too much and now they are paying the price. It has nothing to do whether their product is safe, whether or not it promises miracles or simply a basic knowledge, or anything consumer-centric.