Big Brother FDA Going After 23andme

[Reub]

23andme does personal genetic analysis for a reasonable price of $99 plus shipping. They will analyze your DNA via your saliva and help you to determine your potential health risks and ancestry too. It seems that the big brother FDA doesn't think that we, as consumers, can handle the truth about our own DNA and are putting pressure on the company to stop testing and analysis. I just ordered my test kit today as it may become impossible soon. Here is their link:

https://www.23andme.com/

[RuralEngineer]

Saliva is a food or drug now?  There are some creepy people at the FDA.

[Gumby]

I find the halting of sales to be extreme, but I will say that I'm glad there's a discussion happening about the true value of genetic marker testing, at this stage. I signed up for 23andme a few years ago, and I can't help but wonder if the information is mostly useless. When you sign up for 23andme, they make you agree to a long legal agreement where they basically make you understand that the information provided by 23andme may be useless and misleading — since genetics is still in its infancy. And then they basically tell you how you're going to die.

I'm well aware of the fact that there are some genetic markers are highly likely to indicate a propensity for various diseases. But, what they don't emphasize is that there are many, many other factors that determine whether those genes are expressed or not. Everything from your environment to your microbiome (the ever-changing genetics of the trillions of microbiota that live in and on you) play a significant role in what happens inside your body.

And what really happened is that the geneticists over-promised what sequencing the human genome would do for us. When they were sequencing the ~25,000 genes in the human genome, many geneticists claimed that it would give us all the information we needed about ourselves — as if 25,000 switches were responsible for every little minuscule aspect of our bodies. And they claimed we'd be able to manipulate those 25,000 switches and cure many modern diseases. Meanwhile, there was a part of our DNA called "junk" DNA which they claimed was useless and garbage information.

Now, as they look closer, they are beginning to realize the can of worms they've opened up. First of all, someone can have a genetic marker or mutation but its expression of suppression isn't well understood right now. And, it turns out the ~25,000 DNA markers that can be expressed or suppressed are just the tip of the iceberg — and the new hypothesis is that it's incomplete without figuring out what "junk DNA" really does and what your microbiome is doing.

So... now there is a race to sequence the "main" components of the human microbiome. Problem is...

The human microbiome consists of about 100 trillion microbial cells, outnumbering human cells 10 to 1. Thus it can significantly affect human physiology

Source: http://en.wikipedia.org/wiki/Microbiome

So... now we are going to spend the next decade sequencing our insanely complex microbiomes in the hopes of comparing the most basic classifications of the bacteria and microbes within them — with one another — to see if we can find correlations between chronic diseases and the main components of those microbiomes. And then we'll spend the next few decades after that trying to find how the microbiome plugs into the human genome and understanding our "junk DNA". No doubt, people will line up (probably, myself included) to spend their money obtaining this information when in reality we will likely have no idea what it really means during our lifetime.

I don't want to come off as being against these sequencing endeavors. I think they extremely important for advancing our understanding of the human body. But, I'm glad that the conversation has been opened up to the value of offering everyday people incomplete information about their bodies.

I don't think the FDA should have banned the sales of 23andme kits (all that does is halt scientific progress) but I think they could have just put a warning on the side of the box saying something like...

"WARNING: The information provided by 23andme may be incomplete and entirely useless to consumers."

...and let consumers decide for themselves.

[dragoncar]

Yes, I'd prefer to let any company give medical diagnoses unregulated.  Smart consumers will understand that this isn't a true medical service, just as we don't need the FDA regulating horoscopes for saying you are a cancer.  This is just like big brother from 1984 because the FDA now has cameras in all of our personal spaces.

[Jan Van]

The FDA letter states they have had more than a year to address issues. Seems like they can't. So why can't they change the descriptions on the website? Like homeopathic stuff that can be sold, but never states that it actually really good for anything?

[Kshartle]

Guys......don't worry about all this. We're just not smart enough to decide what is good for us or what products and services we value. Let the trained professionals at the FDA do it. That's what you're forced to pay them for, to decide what you can buy and sell.

[Reub]

Thank goodness we, at these forums, are not "every day people" and, as such, are qualified to be entitled to receive our own genetic results. 

[Gumby]

Guys......don't worry about all this. We're just not smart enough to decide what is good for us or what products and services we value. Let the trained professionals at the FDA do it. That's what you're forced to pay them for, to decide what you can buy and sell.

Heh. I get your point, but you'd be surprised how many people sign up for 23andme, get their results and then freak out that they are going to die of X, Y or Z. And then they walk into their doctor's office with this information and their doctor has no clue what it really means. Never mind that they just as well might have a protective genetic marker or microbiota colony that won't be discovered for 50 years. The service probably causes more stress than it helps anyone. But, I agree that it's not the government's job to stop us from using such services.

[Jan Van]

...But, I agree that it's not the government's job to stop us from using such services...

To me this sounds more like a "false advertising" case. If 23andme marketed this kit as plain fun for all to use but totally unreliable for serious medical applications, they might still be able to sell it.

[Gumby]

...But, I agree that it's not the government's job to stop us from using such services...

To me this sounds more like a "false advertising" case. If 23andme marketed this kit as plain fun for all to use but totally unreliable for serious medical applications, they might still be able to sell it.

True. I haven't read the FDA letter, but one look at the 23andme website and it's clear that 23andme is very much set on advertising their services as a diagnostic tool against diseases. And it's true that, sometimes, a DNA test can give you some clues about mysterious ailments or diseases you may have, or alert you to something you may be at risk for. So, they are really trying to push that angle.

Interestingly, New York State and Maryland banned the mailing and transportation of 23andme saliva tests through the USPS awhile back. I don't know offhand what their motivation was, but my guess is that it had more to do with the aspects of the self-diagnostics than the concern of saliva leaking out of test tubes.

[Reub]

Do you think that lobbying from the health industry might have been a factor?

[Gumby]

Do you think that lobbying from the health industry might have been a factor?

Could very well be, though it doesn't mean they don't have a point. One point of view (right or wrong):

The majority of geneticists and medical professionals I’ve spoke with have sided with the Food and Drug Administration, arguing that many patients require genetic counseling after receiving DNA test results that point to a high risk of cancer and other life-threatening conditions.

One San Francisco-based neurologist, who asked to remain anonymous, told me that some of her healthiest patients — all 23andMe customers — have begun demanding unnecessary and expensive MRI tests for Alzheimer’s disease. “23andMe’s test is creating chaos with people in their 20s and 30s,”? she said. “They generate havoc and walk away.”?

...On its website, 23andMe claims that it is “saving lives”? by delivering clinical insights, such as your risk of developing breast cancer or Parkinson’s Disease. The company says in its marketing materials that it will provide “health reports on 254 diseases and conditions.”?

23andMe also sends you information about your ancestral history and frequently describes this process in ads and blog posts as “empowering”? and “fun.”?

That’s all well and good, but the FDA is contending that 23andMe’s method of amassing DNA — its Saliva Collection Kit and Personal Genome Service (PGS) – is a class III medical device under the Federal Food, Drug, and Cosmetic Act. The device has not obtained proper regulatory clearance and is therefore misbranded under the law...

...Regulators are concerned that a false positive from a 23andMe test could result in unnecessary surgery and that false negatives could lead to patients being less aggressive about screening for various health conditions.

The agency may have decided to take public action now, given that 23andme has begun testing various mutations of genes that indicate a woman might have a high risk of getting breast or ovarian cancer. A false positive on that test could cause a woman to undergo a needless mastectomy. And a growing number of women are requesting this test after hearing the news about Angelina Jolie’s surgery.

Source: VentureBeat: Why the FDA is targeting Google-backed 23andMe: Unnecessary MRIs, mastectomies

Basically it's causing people to freak out and have pre-emptive mastectomies and demanding MRIs when no one is really sure if it's needed.

[Reub]

Gumby, unless people are doing their own mastectomies then I don't see the problem. It would still require consultation and approval of a physician, wouldn't it?

Also, did you feel that you personally gained anything by performing the DNA testing?

Happy Thanksgiving!

[Gumby]

Gumby, unless people are doing their own mastectomies then I don't see the problem. It would still require consultation and approval of a physician, wouldn't it?

Also, did you feel that you personally gained anything by performing the DNA testing?

Happy Thanksgiving!

I think what they mean is that patients and the unproven data in their hands are pressuring doctors to perform unnecessary procedures. It puts doctors in an uncomfortable position.

I don't feel that I gained any reliable health knowledge from my DNA test. Basically the good news makes you feel good and the bad news just stresses you out. I know someone who got news that they and their mother both have the bad Parkinson's gene. Supposedly they have a ~55% chance of coming down with Parkinson's with that gene — despite the fact that the mother is 98 years old and nobody in their family has ever had Parkinson's. The mother, of course, isn't so worried about it at 98. Not fun for the other family member to hear that. And what can you do?

The genealogical info is pretty cool, but it rarely turns up any amazing finds for me. Oh well.

Happy Thanksgiving!

[Benko]

IF you google it you'll find several articles pro and several against people getting this done.  Anyone who worries or freaks out easily should not have it done.  I suspect most people would be better off not having this done.

On the other hand, this does include a category of genes which can reveal how your body interacts with drugs which would be helpful to know (in case you ever need one of those drugs).  There is also a category of susceptibility to diseases which could be helpful as in come cases this can be modified by diet/lifestyle and supplements (at least if you're willing to be more cutting edge than the average doc).

"It puts doctors in an uncomfortable position. "
It is not your job to make you doctor comfortable.  It is your job to take care of your health.  If you doctor is willing to help that is great.  If not, then you need to find another one.  This means if you do your research and know your shit on a topic your doctor should be willing to discuss it with you or at least read the research and then discuss it with you (you could always provide him copies of articles that you found helpful on a topic).  OTOH if you are wacked out because you are worried about someone you find by having the test down...well I could recommend meditation, but that is not something the doc can help much with.

[Gumby]

I agree that the patient should not care about making a doctor "comfortable" — that's not what I meant. What I meant was that some doctors probably don't like their patients walking in with DNA data and demanding procedures and tests that insurance companies are going to question (and probably reject) and might take up resources and time that should be devoted to people with immediate problems. That's probably why the FDA might be getting pressure to deal with this.

But yeah, of course you do what's best for yourself.

[KevinW]

"It puts doctors in an uncomfortable position. "
It is not your job to make you doctor comfortable.  It is your job to take care of your health.  If you doctor is willing to help that is great.  If not, then you need to find another one.  This means if you do your research and know your shit on a topic your doctor should be willing to discuss it with you or at least read the research and then discuss it with you (you could always provide him copies of articles that you found helpful on a topic).  OTOH if you are wacked out because you are worried about someone you find by having the test down...well I could recommend meditation, but that is not something the doc can help much with.

+1

If there's one thing I own, it's my own body, and if I want to pay a service to gather information about my own body, I ought to be able to do that.

Yes, this information may cause some distress, and yes, it may be imprecise, but isn't that true of all information? If the FDA can ban any information source that might be imprecise and cause distress, I guess it could ban all of mainstream media...

If the FDA can ban any information source that might lead people to make rash health decisions, I guess it could ban horoscopes, palm readers, and Jenny McCarthy...

[Pointedstick]

If the FDA can ban any information source that might lead people to make rash health decisions, I guess it could ban horoscopes, palm readers, and Jenny McCarthy...

…And heck, online forums. Gumby, did you remember to include a "this is not real medical advice!" disclaimer with every single one of your posts on health?

[Gumby]

Yes, this information may cause some distress, and yes, it may be imprecise, but isn't that true of all information?

But, not all information advertises itself as a medical diagnostic tool — as 23andme does.

If the FDA can ban any information source that might lead people to make rash health decisions, I guess it could ban horoscopes, palm readers, and Jenny McCarthy...

Fortune-telling is illegal in most parts of the US — unless it is advertised as being for the purpose of entertainment or amusement.

http://en.wikipedia.org/wiki/Fortune-telling#Legality

Jenny McCarthy is, of course, (right or wrong) just expressing free speech — which is hopefully still allowed.

I think the difference is that 23andme is advertising that their product is a kind of medical diagnostic tool (even though they make you accept a user agreement that says otherwise).

I don't think anyone really wants to ban 23andme. From what I can gather, the FDA just wants them to comply with the laws for products that they are claiming to offer (i.e. medical diagnostics). If they were to claim that their service was for entertainment purposes, I don't think anyone would be able to stop them.

…And heck, online forums. Gumby, did you remember to include a "this is not real medical advice!" disclaimer with every single one of your posts on health?

Believe me, it's crossed my mind

EDIT: PS... You've inspired me to update my signature. Though, my dog still wants to go for a walk every morning.

[Benko]

Surprise

http://www.nytimes.com/2013/12/06/busin ... ml?hp&_r=0

[Reub]

I saw that too! FWIW, there are still ways around this new policy. I believe that 23andme will still provide raw genetic results, which can be interpreted well at other sites, such as promethease.com (at least for now).

[Benko]

I saw that too! FWIW, there are still ways around this new policy. I believe that 23andme will still provide raw genetic results, which can be interpreted well at other sites, such as promethease.com (at least for now).

"For $5 you can run Promethease from the web. It takes about 15 minutes to run"

What in the world is promethease?

[Reub]

Greek mythology. I think he had to push a boulder up a hill.

[dualstow]

Greek mythology. I think he had to push a boulder up a hill.

lol. That was Sisyphus. Prometheus gave fire to the mortals and was punished by being chained to a mountaintop where a bird ate his liver. Being a Titan, he regenerated his liver daily, so the punishment also repeated daily.

[Reub]

I think I'd rather push a rock up a hill!