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Comment by cromwellian | Hacker News Reader

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.

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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.

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?

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.

23andme complies with all the rules governing genetics laboratories. It's the offering the results to consumers and the interpretation that the FDA says makes it the equivalent of a medical device rather than a medical laboratory, and which puts it under a separate, much tougher regulatory regime.

EDIT: Of course Congress tells the FDA how it is to regulate genetics labs, and how it is to regulate medical devices. But I think the decision to regulate 23andme as a medical device is very much something the people in charge at the FDA had some leeway in.

"23andme complies with all the rules governing genetics laboratories."

You're misunderstanding the difference between "runs a competent lab" and "provides a genetic test that's useful for diagnostics". You can run a perfectly clean, professional lab, and still offer a useless (or dangerously misleading) test.

The FDA, in this case, is more interested in the latter question than the former, and it's the most important question of all. The FDA is doing exactly what it should be doing here -- questioning the validity of the test itself, not the logistics of the lab doing the test.

Genetic tests are useful for many things, some people have used them for ancestry, especially African Americans who have traced history that had been obscured by slavery.

I think "test" is even the wrong terminology. A better one would be "picture" or "snapshot". A photo can be used for many purposes, one of which is to make medical diagnoses. Personally, what I want from 23andme is not a diagnosis, I just want a dump of my DNA hyperlinked with relavent scientific artifacts on suspected function or links to diseases.

The FDA can't prove that this information isn't useful, and the fact that the utility of information is unknown is not cause to ban its acquisition.

IMHO, Personal Genomics is a personal right, in the same way that consensual sex, or recreational drugs are. As I mentioned elsewhere, the FDA should prioritize going after stuff that is actually proven dangerous or fraudulent/malevolent, not preeemptively trying to cut the kneecaps off of a potentially revolutionary new cottage industry.

If they want to impose some silly advertising disclosure, fine, but I don't think the FDA should be in the business of banning this. Hopefully eventually someone makes a version which can be built by hackers, so people can shotgun analyze DNA at home and it becomes impossible to control.

"Genetic tests are useful for many things"

Nobody is arguing that they aren't. The point is, you know nothing about the accuracy or precision of the test in question. Just because it's "genetic" doesn't mean it's a valid test.

"The FDA can't prove that this information isn't useful, and the fact that the utility of information is unknown is not cause to ban its acquisition."

That's just Not Even Wrong. The FDA's mandate isn't to prove that a drug or test isn't useful before regulating (an impossible bar) -- otherwise, we'd be back in the bad old days of patent medicines. The FDA is there to ensure that the risks of drugs and medical tests are balanced by their benefits.

In order to ensure that the risks are balanced, they need to evaluate the expected value of false negatives vs false positives. If they don't have this information, they are regulating blind.

If 23andme's gene sequencers are inaccurate, then I expect market competition between competitors over who has the most accurate sequencing. The FDA can play a role if they want to independently test sequencers and publish data like the highway safety council and crash test ratings, but I see no reason to "regulate" genetic sequencing anymore than someone should regulate mass spectrometers.

"If they don't have this information, they are regulating blind."

Yes, exactly. That's why they've been asking the company for that information for months, and why they shut down sales of the product until the company complies. Glad we agree that this is the right move by the FDA.

"If 23andme's gene sequencers are inaccurate, then I expect market competition between competitors over who has the most accurate sequencing."

They aren't sequencing anything -- they're using microarrays. How can you possibly have such a strong opinion on something that you know nothing about?

Well, excuse me for being lazy and using less specific terminology than you desire. Yes, I know how 23andme's SNP probing works. I just prefer to imagine a personal genomics market in general that evolves to the state where we can all have our full genome sequenced. And we're not going to get there without having early adopters and baby steps instead.

I don't need government protection from this, certainly not over a one time fee of $99 that has ample disclaimers, and at worst, will cause me to waste time asking my doctor over a condition I don't have, and at best, find out the cause of a disorder that doctors haven't been able to diagnose.

Yes, and in some very rare cases, some people will be told they don't have the BRCA gene when they really do, as if there's an epidemic of women have been avoiding mammograms because of DNA tests, instead of lacking healthcare, or being given confusing directives over the years over when, and how often they need to have exams.

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.

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

[2]Acupuncture seems to help my migraines. I'm comfortable with not having a rational explanation for why it works.

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.

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.

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)

That's messed up, that there are stricter standards for

a) (correctly) reporting the current state of research regarding a patient's genetic markers, than for

b) someone to sell an unproven, expensive technique as a remedy as long as they include some disclaimers.

[2]Acupuncture seems to help my migraines. I'm comfortable with not having a rational explanation for why it works.

The placebo effect is a perfectly rational explanation for why acupuncture seems to help with your migraines.

It's always impossible to tell on the internet, but I would suggest that you would be unlikely to make this statement if you've actually had migraines.

One would be more likely to make the statement the GP made (placebo effect helping with migraines) if one trusts data over anecdotes:

http://www.ncbi.nlm.nih.gov/pubmed/20187863 pdf of above review: http://www.researchgate.net/publication/41620466_Migraine_tr...)

Fair enough.

My wife suffers from migraines, so I don't mean to trivialize. Nor do I mean to demean by suggesting that it is the placebo effect. If it brings you relief, I am in no position to judge.

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.

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.

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...).

>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.

>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.

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.

> 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.

> > 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.

Why? There are plenty of chiropractors who perform manual therapy and spinal manipulation to fix mechanical low back issues - and there is a LOT of evidence behind these methods. They don't delve into the bullshit subluxation theories.

That isn't "physiotherapy." That is quite clearly chiropractic medicine. And in that regard, it works. Just section them off into subluxation believers and people who work on lower backs. That's how I split them, considering I refer my clients to chiros all the time (and use them myself for my herniated lumbar discs).

> That isn't "physiotherapy." That is quite clearly chiropractic medicine.

And that's where we vehemently disagree. Look up the definition of chiropractics. Read Wikipedia. If you want to be associated with that garbage, use the name. If you don't, don't.

> I refer my clients to chiros all the time

Why not refer your clients to physiotherapists who can perform the same techniques, and have actual qualifications to do so? At the very least you know they're not at risk of being handled by a "subluxation believer". You'll also have the peace of mind that the practitioner is licensed and regulated by non-quacks, and held to a higher standard of ethics.

Because, unfortunately based on your definition, the best manual spinal manipulator I know is a "chiropractor."

No, based on my definition, the best manual spinal manipulator you know is a semi-qualified physiotherapist who trades under the chiropractic brand.

Based on your own definition, they are "good PTs." So you agree, it's physiotherapy. Don't understand why you're arguing the point.

No, as I've said many times in this thread, SOME of them are PTs. And you responded to this comment below:

"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."

I would not call him a PT, because he is not a PT.

I have no idea why you are attempting to knock down a strawman consistently. He is a chiropractor and he's not opting out of the brand simply because you think he's a charlatan. And I am not going to call him by another name because you are on an overzealous semantic war.

It is not a straw man to describe the general field of chiropractics as anti-science quackery. Just because some narrow physio-therapeutic component of chiropractics happens not to be quackery, doesn't make the general field respectable.

You could claim that homeopathic therapies can promote good hydration. Hydration is important. But that doesn't make homeopathy respectable.

Semantics matter. Why should I show any respect to people using the chiropractic label when the preponderance of practitioners are subluxation magicians and modern witch doctors?

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.

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.

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".

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.

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