FDA Drives Medical Innovation Overseas As 23andme Looks Elsewhere To Help People
from the fda-failures dept
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 While that book is now a little outdated, one thing that was quite clear in that book is how ill-prepared (and ill-interested in ever becoming prepared) the FDA is for technological innovations in the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
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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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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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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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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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"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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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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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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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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Neither does stating opinions as fact. I'm merely asking Mike to substantiate his opinions.
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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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Not really. There are products, medical and otherwise, that get banned or altered because they're dangerous if misused.
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Yep. Surgeons jump at any opportunity to perform "unnecessary surgery."
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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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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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You've reversed the burden
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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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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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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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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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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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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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using standard techniques, and would send you a report. Not sure I would call this innovation, medical or otherwise.
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there are many of kinds of innovation
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Re: there are many of kinds of innovation
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23andme.com
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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Haven't proven anything
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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FDA Drives Borderline Scammers Overseas
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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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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Privacy Loophole
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Million Veterans Program
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Health and fitness
Trenbolone Acetate
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