FDA Drives Medical Innovation Overseas As 23andme Looks Elsewhere To Help People

from the fda-failures dept

Thu, May 15th 2014 12:59pm — Mike Masnick

Last fall, we noted that the FDA had come down hard on 23andme for offering its inexpensive and easy to use genetic testing without first getting detailed FDA approval. As we noted at the time, this seemed to be a typical FDA overreaction. People aren't using 23andme as the final word on something, but rather as a useful indicator to explore more deeply with medical professionals if they needed to be aware of something, change lifestyles, etc. Furthermore, we noted how stopping 23andme and similar offerings would only delay important innovations that the medical world really needs today.

And, now it appears that all the FDA has really succeeded in doing is driving that innovation overseas, as 23andme focuses on expanding in various countries abroad, rather than the US.

While it awaits the agency's approval, a process that could take years, 23andMe aims to offer partial or full genetic-testing services in one or more countries outside of the United States by the end of the year, with likely contenders including Canada, Australia and the United Kingdom, the source said.

A big part of the problem is that the FDA is simply not designed to actually deal with innovative healthcare products. It was built to handle one thing and one thing only: approving pharmaceuticals. And it has a very hammer-and-nail approach to everything it does. Nearly a decade ago, we wrote about Andy Kessler's book The End of Medicine. While that book is now a little outdated, one thing that was quite clear in that book is how ill-prepared (and ill-interested in ever becoming prepared) the FDA is for technological innovations in the healthcare space. The FDA understands clinical testing for drugs, and has trouble understanding anything that doesn't fit into that paradigm.

Providing more useful information to people about their own genes and makeup is a very useful tool. Yes, there can be false positives, but is it better to keep people totally ignorant, or to better inform them across the board? Sure, perhaps it makes sense to do thorough testing of drugs to make sure they're safe (though, even with that there are plenty of compelling arguments for why the FDA does that wrong too), but when it comes to a service that is about providing more information to people, allowing them to be better informed and do more research to be healthier, you'd hope that the FDA would learn how to enable more innovation, rather than shutting it down... and sending the innovation overseas.

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Filed Under: fda, genetics, information, overseas, personal genetics, regulations
Companies: 23andme

38 Comments

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Skeptical, 15 May 2014 @ 1:06pm

"People aren't using 23andme as the final word on something, but rather as a useful indicator to explore more deeply with medical professionals if they needed to be aware of something, change lifestyles, etc."

This sort of statement requires evidence. Where's the evidence that people aren't interpreting 23andme results as an accurate and reliable indication of various risk factors?
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Mason Wheeler (profile), 15 May 2014 @ 1:24pm

Re:
Exactly. And even if such evidence existed, I wouldn't take it as particularly conclusive. New products are used by early adopters, who tend to be more savvy in the field in question. Release it to the general public, and you're going to have a bunch of idiots using it in idiotic ways.

A woman I used to know told me once about a recent doctor's visit in which, after some tests, he told her she had a benign tumor that was not harmful and was unlikely to become malignant or cause any real problems for her. And she said that the doc straight-up admitted to her that the only reason he was even telling her about it is because he had known her for many years and knew she was grounded enough to take the news without overreacting in some stupid way. Unfortunately, that is the world we live in.
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Anonymous Coward, 15 May 2014 @ 1:31pm

Re:
A few things...
1. Asking to prove something is not happening adds no value to a conversation.
2. FDA has proven that they are poor stewards of Food and Drug oversight, often a paid prostitute for Food Companies, and are too political about how they do business.
3. Considering these things, you would rather that potentially positive information be squashed just in case something bad is interpreted from it?

Why do you even internet? Considering #3.
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John Fenderson (profile), 15 May 2014 @ 1:36pm

Re: Re:
"the only reason he was even telling her about it is because he had known her for many years and knew she was grounded enough to take the news"

Those sorts of stories is what makes me suspicious of doctors. Doctors should never withhold information about my health or the results of tests from me, not even if I'm not "grounded enough to take it." It's my body, my health, and my data. Give it to me.

Doctors are much better about this sort of thing than they used to be (it used to be that they routinely withheld news that patients were terminal!) but it's behavior like that that makes services like 23andme look useful.
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Anonymous Coward, 15 May 2014 @ 1:41pm

The pharmaceutical industry's position seems to be, "Products like that are supposed to be making us lots of money! It just won't do to have people acquiring them easily and at a low cost!"
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Anonymous Coward, 15 May 2014 @ 1:50pm

Re: Re:
"Asking to prove something is not happening adds no value to a conversation."

Neither does stating opinions as fact. I'm merely asking Mike to substantiate his opinions.
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Jake, 15 May 2014 @ 2:30pm

Re: Re: Re:
That's a perfectly valid choice, but not everyone feels that way.

For example. About a year ago, I ended up making a trip to my local ER in the back of an ambulance after experiencing the symptoms of a heart attack. An ECG and repeated blood-work later, I was given a prescription for some tablets to lower my triglyceride levels and advised that there might be some permanent damage already done.

After giving it some thought, I ultimately decided against the ultrasound tests that would be needed to find out. If I've got a damaged heart, there's no undoing that short of a transplant or some as-yet undeveloped stem cell treatment. Knowing for certain would just limit my ability to do the only thing I really can do, which is try not to think about it.

That's what concerns me about 23andMe, I guess. It doesn't have the ability to say to you, "You might not like the answer to this. Are you absolutely certain you want to know?" the way a good doctor could.
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John Fenderson (profile), 15 May 2014 @ 2:58pm

Re: Re: Re: Re:
But if you're the sort of person who doesn't want to know, then you're the sort of person who wouldn't use the service in the first place.

"It doesn't have the ability to say to you, "You might not like the answer to this. Are you absolutely certain you want to know?" the way a good doctor could."

But if a doctor says this to you, then you've already been informed that there's something horrible in those results anyway. I wouldn't mind a doctor asking such a question. I totally object to the notion that a doctor would simply not tell me about test results because he thinks I might not be able to handle it.
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Anonymous Coward, 15 May 2014 @ 2:59pm

Re: Re: Re: Re:
" It doesn't have the ability to say to you, "You might not like the answer to this. Are you absolutely certain you want to know?" "

But it does. A user can opt out from viewing any results with health implications. (Actually I can't recall without checking whether the person actually has to opt IN, but you are given the choice. For a couple of results even at that point the results are STILL locked away until you accept a seperate T&C and follow on by specifically unlock them. It is impossible to view the health results by accident. The presentation of results goes into a great deal of detail including references to publications and research, plus provides an easy way to print and show to a health professional.

As you can probably gather I and some in my family have used 23andme. I am a completely happy customer, they provided a great service. I strongly believe I have the right to buy genetic information about ME and that my body is my property, and that no-one should be forced into using a gatekeeper to access their own genetic information.
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Anonymous Coward, 15 May 2014 @ 3:12pm

Re:
+1

This is exactly right. While I do believe there should be an FDA our current FDA has nothing to do with product safety or reliability. The FDA exists for one reason and one reason only, to ensure everything is artificially expensive by limiting competition for anything health related. It has everything to do with America's anti-free market capitalistic - monopolistic - agenda for everything.
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Krish (profile), 15 May 2014 @ 3:17pm

While it awaits the agency's approval, a process that could take years

Maybe they should have started the process years ago then. Instead they ignored the FDAs requests that they tone down their massively overblown advertising campaign and even doubled-down on it. This went on for years before the FDA got fed up with the whole process. The FDA gave them too much leeway on this and should have come down on them years ago.
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Anonymous Coward, 15 May 2014 @ 3:29pm

Re:
"People aren't using 23andme as the final word on something, but rather as a useful indicator to explore more deeply with medical professionals if they needed to be aware of something, change lifestyles, etc."

Fair enough, you're just playing semantics. Perhaps a better way he should have worded that sentence should be

"23andme isn't intended nor being advertised as a final word on 'something', but, rather, as a potential indicator to explore more deeply with medical professionals if they need to be aware of something, change lifestyles, etc..."

Then whether or not people 'use' it as intended is irrelevant. Someone could use rubbing alcohol as a beverage as well, should we ban that too since it could cause health problems if used incorrectly?

Heck, the proper use of alcohol and cigarettes and junk food may cause health problems yet those are legal.
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madasahatter (profile), 15 May 2014 @ 3:57pm

Re:
The problem is the FDA is run by idiots who fear the masses with knowledge. The results of the DNA testing are just information which some will use incorrectly and others will use correctly. The misuse will occur with or without FDA approval. At most, I might agree to a label or statement that the results should be discussed with your doctor and not be solely relied upon to make any diagnosis or treatment plans.
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Anonymous Coward, 15 May 2014 @ 4:19pm

Re: Re:
" I might agree to a label or statement that the results should be discussed with your doctor and not be solely relied upon to make any diagnosis or treatment plans."

They (23andme) already did this. So clearly that's not the problem. Maybe it's more like "idiots who fear the masses with knowledge" though I wouldn't class them as idiots, more as greedy gussies who have a vested interest in reinforcing the hold of medieval-style guilds over the rabble not to mention fostering the growth of social-worker-style "consultants and counsellors" who demand money for "helping" the captive peasant to understand what anyone with a rudimentary understanding of biology plus their favorite internet search engine could do for free or could take to their doctor/psychiatrist/podiatrist/whatever.

But as a data point, we sent one of the DNA results to my spouse's doctor's and used it as a consideration in adjusting a drug dosage (the DNA predicted suboptimal response to certain dosages). Voila! Complete success and one impressed and very interested doctor.
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Krish (profile), 15 May 2014 @ 4:52pm

Re: Re:
There is a difference between knowledge and information. 23andme was selling information as knowledge ("23andme can save your life") with, in the vast majority of cases, nothing to back it up.
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Whatever, 15 May 2014 @ 5:37pm

The FDA has very much done their job with 23andMe, it's a service that while on the surface appears good, the reality is that it provides information that isn't entirely backed up by science and relies mostly on educated guesses and suppositions.

In a society that already takes way too much medication for phantom illnesses and self inflicted heath problems, you have to think that 23andMe's information would just set off a wave of people doing silly things because they may or may not be prone to something.

Good job FDA. Don't let the naysayers make you bend on things like this.
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Anonymous Coward, 15 May 2014 @ 7:49pm

perhaps the FDA is inadvertently doing the public a favour, if you don't have DNA testing results insurers can't use it against you.
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Anonymous Coward, 15 May 2014 @ 7:52pm

Medical innovation? This company would get a DNA-containing sample, would process or have it processed
using standard techniques, and would send you a report. Not sure I would call this innovation, medical or otherwise.
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Anonymous Coward, 15 May 2014 @ 7:59pm

Re:
Not being a medical service provider, I do wonder just what restrictions are imposed by law on companies like this dealing in human DNA associated with specific individuals. Worst case scenario? Categorize data associated with persons, and then sell that data to third parties...much like what has annoyingly been the case with many large websites.
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G Thompson (profile), 15 May 2014 @ 7:59pm

Re: Re: Re:
The difference is the word CAN instead of WILL.

Otherwise ALL pharmaceutical, healthfood, fitness, etc etc etc companies need to change there own advertising to remove the word CAN as well.

You are trying to change the playing field on whats considered misleading due to what you don't like or know. This is what your FDA is doing as well because it doesn't conform to there knowledge (or mandate).

Also the knowledge they were/are selling si specifically stated to be for informational purposes only and that any further testing to confirm should be done by medical practitioners specialising in the field that you are concerned about.

It's an instrument that whittles down possibilities nothing more nothing less.
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G Thompson (profile), 15 May 2014 @ 8:03pm

Re:
>> the reality is that it provides information that isn't entirely backed up by science and relies mostly on educated guesses and suppositions.

Oh like psychology, psychiatry, chiropracty, homeopathy, anti-vaxxer, astrology etc.

Compared to DNA testing that is actually legally proven and scientifically tested using legal and proven methodology.
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ADS (profile), 15 May 2014 @ 8:44pm

23andme.com
I think it is a shame that 23andme is being forced abroad to innovate. I can't imagine how this helps the US, helps individuals who want to know more about themselves and medicine in general. To the point of other persons here, I agree the FDA seems to be creatively stretching the bounds on "medical" approval or use given that DNA testing is old hat. But, somehow because the general community can now have access to something that was previously cost prohibitive (National Geographic also does/did this test as part of a separate study at a higher cost I believe) it's become a no-no...

You want to make people wait 1000 years to get a medical product approved for our safety... great! But why because i want to stick a cotton swap in my mouth or saliva in a cup for a DNA test well beyond the testing phase are they so bent out of shape?
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nasch (profile), 15 May 2014 @ 9:36pm

Re: Re:
Then whether or not people 'use' it as intended is irrelevant.

Not really. There are products, medical and otherwise, that get banned or altered because they're dangerous if misused.
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Anonymous Coward, 15 May 2014 @ 9:44pm

Re:
Stay classy, troll.
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nasch (profile), 15 May 2014 @ 9:44pm

Haven't proven anything
And, now it appears that all the FDA has really succeeded in doing is driving that innovation overseas, as 23andme focuses on expanding in various countries abroad, rather than the US.

That, by itself, demonstrates nothing. If we were talking about a company that uses lead paint on its toys, and US regulations forced it to look for other countries where it could sell its wares, we would all consider that a job well done. Certainly there are many problems with the FDA, but you haven't actually demonstrated that this is one of them. To prove your point you need to present evidence that either the FDA doesn't have jurisdiction over what 23andMe is doing (seems extremely unlikely), or what they're doing is safe, effective, and consistent with their marketing.
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PaulT (profile), 16 May 2014 @ 1:40am

Re: Re: Re:
Yes, but those would be things with medical reasons for withdrawal, not mere information as in this case. By this argument, WebMD and similar sites should be banned.
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Queex, 16 May 2014 @ 2:09am

FDA Drives Borderline Scammers Overseas
"Yes, there can be false positives, but is it better to keep people totally ignorant, or to better inform them across the board?"

This assumes that information they're getting meets even the most basic level of reliability. If what they're getting is little other than noise, they will be _worse_ off with it than without. It doesn't matter how carefully you couch the results in caveats, there's a level of quality below which the service will do more harm than good.

The current state of the art medical genetics involves either mutation-specific screening or high-coverage whole exome sequencing. The former is restricted to a handful of known, common variants. It requires greater scrutiny by genetic counsellors that 23andme can possibly offer at their price. The latter is _expensive_, far above 23andme's price point, requiring as it does not only the sequencing kit, but hours of time for skilled lab technicians, bioinformaticians and clinical experts. Even with best technology and people, diagnosis is very much a hit-and-miss affair because we haven't built up a large enough information base yet. That will only come with time.

And even then, there are huge question marks about about the quality of the sample provided: blood is used most often for sequencing (I don't think saliva is ever used in real research or diagnosis) and sending it through the ordinary post is not going to help matters. Plus there are ethical considerations surrounding a service where you could send anyone's saliva and claim it was your own.

A 23andme-like product would be a wonderful thing, assuming suitable oversight of the ethics angles. Unfortunately, no such product exists yet. It's going to be a good few years before we an even approach it. If they restricted themselves to a little light ancestry and a few well-understood phenotypes, I'd be cheering for them.
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grichens, 16 May 2014 @ 12:35pm

Re:
"In a public warning letter, the FDA said it feared false positive or false negative results from 23andme's genetic test could prompt patients to take 'morbidity inducing' actions, like unnecessary surgery."

Yep. Surgeons jump at any opportunity to perform "unnecessary surgery."
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nasch (profile), 16 May 2014 @ 3:13pm

Re: Re:

Yep. Surgeons jump at any opportunity to perform "unnecessary surgery."

In case you want to learn about the topic...

http://lmgtfy.com/?q=unnecessary+surgery
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sudotrin (profile), 17 May 2014 @ 5:45am

Re: Re: Re: Re:
Actually that's EXACTLY what 23 and me does. For results for conditions that have life altering implications, you can choose to view or not view the results on a case by case basis. Well at least I can because I signed up before the FDA decision.

Also, if you have your genetic testing results you can explore genetic markers outside of 23 and me and research the results. It's not just that the FDA's decision is silly, it's also ineffectual when I can explore the results myself.
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Nick, 17 May 2014 @ 6:18am

Re:
What business is it of yours what people do?

So what if they do? Its not as though they get much better answers from doctors.

You sound like a fascist control freak.
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semiautomata (profile), 17 May 2014 @ 6:26am

You've reversed the burden
The rule (particularly for an information product) shouldn't be "you have to prove your product is perfectly safe before we'll let you sell it." The burden should be on the government agency to show that the product is causing substantial harm, and that harm outweighs the benefits. If a company has to ask the government for permission to innovate, innovation will slow - and that harms consumers a lot.
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semiautomata (profile), 17 May 2014 @ 6:34am

there are many of kinds of innovation
Including business method innovation. What you're saying is like saying that Amazon just takes book orders using standard techniques and then ships them using the long syncing postal service.
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semiautomata (profile), 17 May 2014 @ 6:37am

Re: there are many of kinds of innovation
Standing, not syncing.
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richard40 (profile), 18 May 2014 @ 10:31am

I think the only mandatory FDA requirement should be to test for safety, not effectiveness. There should be 2 levels of FDA certification. The first should be for safety, and should be sufficient to go to market, as long as there are no serious side effects, or the side effects are outweighed by benefits in comparison to existing alternatives.

The second certification, for effectiveness, should be either optional, or conducted after the product is allowed on the market. I suspect that in most cases where a product has been certified as safe, but not yet as effective, most doctors would still be reluctant to use it, but they would have the option to, as long as preliminary indications are good, and other treatments are not working. This would prevent tragic cases where people are suffering from an untreatable disease, but cant get a new treatment because it is still undergoing double blind tests. You don't need a double blind test to certify it does no harm, you just need to give it to a bunch of people and watch for side effects, which can be completed much quicker. And in the case of a test like this, there is never a question of harm, only of wrong info, so it could be approved for use immediately, and certified for effectiveness much later.
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Anonymous Coward, 18 May 2014 @ 5:16pm

Privacy Loophole
I heard that side effects of bad drugs are not being reported to the FDA because of the privacy loophole.
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Anonymous Coward, 18 May 2014 @ 5:17pm

Million Veterans Program
The Veterans Administration is collecting a genetic database under its Million Veterans Program.
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james howard, 26 May 2014 @ 2:13am

Health and fitness
Lives are precious and these should be cared for.All the health departments and authorities should manage the system of proper check and balance to avoid daily unpleasant happenings.
Trenbolone Acetate
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