This seems absolutely reasonable. The letter indicates that the FDA has notified 23andMe that their products are not satisfactorily cleared, they're reached out to them several times, and they've offered assistance through a group they specifically set up to help companies in this situation.
Meanwhile, 23andMe went ahead and began marketing and selling their product, despite the FDA's concerns.
Relevant quotes:
> Most of these uses have not been classified and thus require premarket approval or de novo classification, as FDA has explained to you on numerous occasions.
> However, to date, your company has failed to address the issues described during previous interactions with the Agency or provide the additional information identified in our September 13, 2012 letter for (b)(4) and in our November 20, 2012 letter
> To date, 23andMe has failed to provide adequate information to support a determination that the PGS is substantially equivalent to a legally marketed predicate for any of the uses for which you are marketing it; ...
> ...we have proposed modifications to the device’s labeling that could mitigate risks and render certain intended uses appropriate for de novo classification.
> As part of our interactions with you, including more than 14 face-to-face and teleconference meetings, hundreds of email exchanges, and dozens of written communications, we provided you with specific feedback on study protocols and clinical and analytical validation requirements, discussed potential classifications and regulatory pathways (including reasonable submission timelines), provided statistical advice, and discussed potential risk mitigation strategies...
> Thus, months after you submitted your 510(k)s and more than 5 years after you began marketing, you still had not completed some of the studies and had not even started other studies necessary to support a marketing submission for the PGS.
If you look at the FDA's website, it's littered with dozens of communications begging 23andme to submit some documentation about their product so that the FDA can evaluate the medical claims they're making.
All the FDA wants in this letter is some kind of understanding that their genetic tests are actually valid and correct, since they are making medical claims regarding their accuracy:
> 23andMe has never submitted information on the analytical or clinical validity of its tests to FDA for clearance or approval. However, your website states that the 23andMe Personal Genome Service™ is intended to tell patients in advance how they will respond to certain medications including warfarin and clopidogrel. It also states that the data generated from the 23andMe Odds Calculator, a feature ofthe 23andMe Personal Genome Service™, includes the contribution of single-nucleotide polymorphisms (SNPs) to disease risk. Consumers may make medical decisions in reliance on this information.
The FDA then establishes its ability to regulate this (remember, it's legally required to do this):
> During a meeting between 23andMe and FDA on July 29, 2009, you described the 23andMe Personal Genome Service™ as consisting of a software program that analyzes genetic test results that are generated by an external laboratory in order to generate a patient specific test report. Thus, the 23andMe Personal Genome Service™ is a diagnostic device and subject to all applicable requirements of the Act.
They then very helpfully point them to all the forms, documents, etc., necessary to satisfy the legal requirements:
> For a device requiring premarket approval, the notification required by section 510(k)of the Act, 21 U.S.C. 360(k), is deemed satisfied when a PMA is pending before the agency. 21 C.F.R. 807.81(b).
There's even a helpful mailing address and fax number:
> Please direct your questions and response to: James L. Woods, Food and Drug Administration, 10903 New Hampshire Avenue, W066-5688, Silver Spring, MD 20993
Honestly, this sounds like 23andme has been getting away with something for a while and the FDA is tired of giving them leeway.
Moreover, it appears from the letter that the concerns are about marketing; ie, presumably the FDA was simply asking for 23AM to clarify their copy to remove any implication that you could use the product as a substitute for a doctor's assessment of your e.g. cancer risk.
"For instance, if the BRCA-related risk assessment for breast or ovarian cancer reports a false positive, it could lead a patient to undergo prophylactic surgery"
Uh, you don't think the surgeon is going to demand a second BRCA test be done before performing the surgery?
Am I the only one this seems completely reasonable to? There are probably people who take action over the results they get from the service and if the results are incorrect the actions could have negative impact on their health. Therefore the service should have to prove the results are accurate before advertising it as a first step in prevention.
Summary:
5 years ago, 23andMe started marketing a test for among other things a BCRA indicator
July and Sept 2012 - 23andMe submits a form to the FDA saying "our test isn't really useful for diagnosis and thus shouldn't fall under these rules"
Nov 2012 - FDA says we don't agree with you you need to either prove your effectiveness or change your marketing
Jan 2013 - 23andMe says "it will take us a couple months to do the tests, we'll get back to you"
Nov 2013 - FDA says, "its been 11 months and you never got back to us. Stop selling and let us know within 15 days what you're going to do explicitly because you ignored us for close to a year"
Exactly. I am no fan of the FDA, but what 23andMe did here was extraordinary: they essentially ignored the agency. If Anne Wojcicki was CEO of a similarly-sized medical device company she would have gotten her walking papers today.
I'd like to point out that -- as much as I'm sure most people love 23andMe -- it's not really a scrappy start-up. It's a nearly 8 year old company which has received something like a hundred million in funding.
So this isn't really a case of the gov't stomping on the little guy before he has a chance to grow; 23andMe has had its chance to grow into a fairly big deal, and now it's time to start playing by the rules.
The average drug costs around a billion dollars to bring to market and decades in development and approval. 23andme might not be a small fish by internet standards, but they are by medical industry standards.
> So this isn't really a case of the gov't stomping on the little guy
Last time I checked, the US federal government had an annual funding rate of $3.45 trillion compared to "a hundred million in funding" total for 23andMe.
So yeah, government stomping on the little guy definitely fits the picture. Then again, it would fit the picture no matter who the government decided to stomp on. Perhaps we should focus on less stomping and on more cooperative behavior?
This reminds me of a blog post in German [1] by a person who due to a software bug had been falsely diagnosed by 23andMe with limb-girdle muscular dystrophy. (Fortunately, he was able to identify that it was a misdiagnosis.) It appears that in this case potential misdiagnoses aren't just a theoretical problem.
As usual, the government is trying to meddle with companies. Read the letter, but make no mistake - the "kind" tone, especially when reminding how they did they best to get in touch, have meetings, help insuring compliance etc. is just a decoy. The truth is with "must immediately discontinue marketing the PGS".
The gov wants to decide what's best for the people. Should the people decide differently, using their wallets for example, this anomaly will be quashed.
This trend is especially strong in the medical field - gov approval required everywhere, then people wonder why medical things are so damn expansive.
I use 23andme and I'm happy with the information provided. I know it's not reliable - it's not a lab test anyone will use to base important decisions on, since it is not a full sequence of genes.
Yet, by being commercially available and easy to use, it is paving the way for commercial offers of full genome sequencing, which I damn well intend to use when they reach the $500 threshold.
However, gov actions like this one may very well make that impossible, making sure the only full genome sequencing offers there will be will be "FDA cleared" at a huge markup.
Suggestions to "medical" like companies - get out the gov eye. Move your business to Asia, the caribbean or wherever the gov will not get in your way like this. I want to keep using (and recommending) your products!
> The gov wants to decide what's best for the people. Should the people decide differently, using their wallets for example, this anomaly will be quashed.
Wallets are incredibly poor judges of medical efficacy. The FDA rules are in place for very good reasons, namely to prevent snake-oil salesmen and other unscrupulous merchandisers from foisting their -- potentially harmful -- products upon an unsuspecting public.
I would much rather have FDA clearance for medical products and devices than the alternative that you seem to be proposing.
> The gov wants to decide what's best for the people. Should the people decide differently, using their wallets for example, this anomaly will be quashed.
There are huge information asymmetries involved when it comes to medical drugs, and also huge barriers to experimenting with different products. "Voting with your wallet" is appropriate for determining which cell phone should be popular, not which medical drugs or medical tests.
We as a society have determined that the appropriate risk versus innovation trade-off when it comes to medicines and drugs is less risk at the potential cost of less innovation. The FDA exists to safeguard that policy.
It's funny that you mention Asia, because the trend in Asian countries is to follow the American/European model. Asians have had enough of thinking "is this rat meat?" every time they bite into a lamb kebob, and are regulating their food and drug industries. And by "asians" I mean the Chinese, because the Japanese and Koreans have adopted the Western regulatory model long ago.
> I know it's not reliable - it's not a lab test anyone will use to base important decisions on, since it is not a full sequence of genes.
If they made that more clear, then they wouldn't have had to send the letter. It's why you see "This is not intended to diagnose, treat, or cure any disease" on all the non-FDA-approved supplements/energy drinks. My money is on them paying the fine and scaling back the marketing.
The purpose behind these FDA rules are to make sure things aren't marketing as "cures" when they aren't. People's health is serious business; there's no room for failure. If 1.0 doesn't work (or makes things worse), then the people that need it might not live to see 1.1.
This is more complex than the simplistic picture you paint.
I'm moderately on the side of government not interfering where possible. But medicine and medical devices is one area in which such interference is quite likely a positive influence, on the whole.
Fact is, we don't want a return to the era of patent medicines. For every user of 23andme who is well-informed enough to know that the information is not reliable, experience shows that there will be another who is not. And these people will base life- and health-affecting decisions on the results provided by unregulated products. Then maybe they'll get sick or die.
That's why there are regulatory standards for medical devices and services. These standards don't prevent the sale of 23andme's services, but require that they are either a) regulated and proven to work, or b) explicitly and clearly described as not being so.
Yes, there are rampant inefficiencies within this system. But I'd wager that it's probably better than the alternative.
Ah, the "people will vote with their wallets" argument against medical regulation.
I'm with you. I'd much prefer a bunch of people die first so the rest of us can "vote with our wallets" instead of having a government agency step in and try to fix things before anyone gets hurt. I mean, my start-up is going to sell baby food laced with arsenic because I once heard that arsenic makes babies smarter and I think I once ingested some accidentally and I didn't die. If it really does end up killing babies, well, the market will eventually correct itself. And no harm, no foul, man. Except the dead babies. But at least I wouldn't have some nebbish bureaucrat knocking at my door trying to tell this American how to live his life.
> I use 23andme and I'm happy with the information provided. I know it's not reliable - it's not a lab test anyone will use to base important decisions on, since it is not a full sequence of genes.
You have unwittingly affirmed the very argument you are attempting to refute. Their inability to make accurate functional predictions from genomic data has much less to do with the technology (sequence vs. array) than it does with the fact that, isolated instances aside, nobody knows how to do this well. I am a 23andMe user myself and, knowing a bit about statistical genomics, I was surprised how credulously the results of one or two GWAS papers are presented as an almost-diagnosis on their website. GWAS are plagued by all sorts of confounding issues and the statistical evidence in favor of their conclusions is often extremely weak. This is not something that the general public appreciates, so I can see why FDA might get involved.
Hey! You should check out Elixir Sulfanimide! It prevents infections, but it's available over the counter. So easy! And it's from a Massengill, an established pharma company, so you can trust it!
So actually you can't buy elixir sulfanimide anymore. Because it was poisonous. It resulted in more than 100 deaths in 1937. This was before the FD&C Act, requiring safety tests. The founder of Massengill refused to take responsibility for the results: "We have been supplying a legitimate professional demand and not once could have foreseen the unlooked-for results. I do not feel that there was any responsibility on our part." It should be noted that there was a sulfanimide craze on at the time, as the first commercial antibiotic, so there was much money to be made.
One woman wrote to President Roosevelt, about her dead daughter: "The first time I ever had occasion to call in a doctor for [Joan] and she was given Elixir of Sulfanilamide. All that is left to us is the caring for her little grave. Even the memory of her is mixed with sorrow for we can see her little body tossing to and fro and hear that little voice screaming with pain and it seems as though it would drive me insane. ... It is my plea that you will take steps to prevent such sales of drugs that will take little lives and leave such suffering behind and such a bleak outlook on the future as I have tonight."
Massengill paid a minimum fine and continued on until it was acquired in 1971.
I don't mind that we have set up an agency to make sure that medical products and devices are safe to use and do what they say they are going to do. It's far more efficient than having to do it individually. And there's always, evidently, people who won't, because they trust their doctor or the brand. And, being medical products and devices, sometimes those people or their loved ones die.
I agree for the most part (I tend towards libertarian ideals if you've read any of my comments), but it's a difficult balance to maintain between allowing for medical innovation and preventing an objectivist distopia a la Bioshock. The government has a legitimate responsibility to ensure that medical technology is used and marketed responsibly, while at the same time giving companies some wiggle room to innovate.
Look how smallpox vaccine was discovered. Edward Jenner inoculated a young boy with cow pox, then attempted to infect him with smallpox a dozen times. Obviously we can't go around convincing young children to take infectious doses of deadly viruses. But we also cant send FDA thugs after every Silicon Valley startup pushing the boundaries of genomics research. So where do we draw the line?
From what I hear from my co-workers in the quality department (I work in a medical device company) it's even harder to get approval to go through regulation in China than in the US. And you most certainly cannot just base your company from Asia and sell your stuff to the rest of the world (unless of course you go through regulation in the rest of the world).
You might be able to find countries where regulation is less strict or non-existent but I'd imagine that people's trust in medicine in said countries is less than in the regulated ones (as you most certainly would have rouge players abusing the lack of regulation).
> For instance, if the BRCA-related risk assessment for breast or ovarian cancer reports a false positive, it could lead a patient to undergo prophylactic surgery, chemoprevention, intensive screening, or other morbidity-inducing actions, while a false negative could result in a failure to recognize an actual risk that may exist.
I cannot imagine someone getting surgery or chemo solely based on a 23andme heads up warning and without consultation with a specialist physician.
As someone working in medical devices, this dramatic language is extremely frustrating.
Anyone who thinks the FDA is overreaching here has little awareness of how stupid the majority of the world's population is. The people that this protects don't know how to even read this statement from the FDA.
Perhaps the startup echo chamber has more respect for unchecked opportunism; if that's the case, someone should make a startup called 23andMeFree (monetized by ads, duh) that has you spit in a tube, send it to some PO Box, then randomly generate positive and negatives across the board. If you wanted the scam to last longer, you could even generate random values based on statistics of certain characteristics. A true libertarian must support such a business.
I understand the FDA getting pissy if I'm consuming/injecting a substance that may or may not harm me, but why this? I spit in a tube and get some results which may or may not be accurate. Go away, FDA.
People take action based on the results of the tests.
There are different ways to mitigate risk - ensure there's adequate genetic counselling and proper easy to understand information available for anyone taking the tests would be one way.
I lean towards favouring tight regulation of medical products. One person's 23andMe genetic test is another person's quackery - see some of the nonsense offered as medical advice by the quacks on other websites.
For the same reason that the FDA tends to care if an MRI or a CT scanner displays accurate results. People make life/death decisions based on diagnostics.
When the FDA sends you a letter like this, you either pay a fine and change tactics or you embark on one of the most frustrating approval processes known to the world (all for people's protection.) Good luck with that.
It is only reasonable in the context of the standard operating procedures of the FDA. As this is essentially prior restraint upon speech and/or trade, it is unreasonable, but no more unreasonable than anything else the FDA does.
Ideally, the FDA would have independently-generated evidence indicating that the product in question is unreasonably dangerous or ineffective for some intended purpose before issuing a cease and desist order. Instead, they simply assume guilt and place the burden of proof upon the vendor.
Given that the FDA has vastly more resources than 23andMe, and companies like it, this makes the FDA seem like bullies against microbusinesses, and like the captured servants of agricultural and pharmaceutical megabusinesses.
The tone of the letter was surprising to me. I wouldn't expect the FDA to go quite so far in explaining the why behind the desist letter. I suppose that's because it was written just as much for public consumption as it was for 23andMe.
Obviously 23andMe results are not a diagnosis from your physician. You should use 23andMe in conjunction with a real physician. For example, I used 23andMe back in 2010 and it told me I had a high risk for a certain genetic condition which I recalled one of my family members having, so I went to see my physician for a real diagnosis, armed with this newly found information.
23andMe helped me catch this early enough with the assistance of my physician that I was able to get treatment long before I would have developed symptoms. If I never used 23andMe I probably would not have had this diagnosed until years later.
Given https://www.23andme.com/health/all/, I don't think you're considering the negative case properly. If 23andMe's results say you don't have something on their list of 250+ things they're checking for, you might decide against certain treatments or tests based on that.
I think it's reasonable for the FDA to tell 23andMe that if they're going to interpret the results for their customers, they need to be able to guarantee the chain of processing is there, and they need to be able to justify each "detection point" their marketing claims.
Your outcome is positive. But positive is not the only possibility.
I'm most curious to see how 23andMe is going to respond to this, because the more technical-regulatory language in this letter says essentially that in FDA's opinion the device is Class III (the highest risk of all medical device/diagnostics) and would require a PMA, unless 23andMe provides the evidence that allow FDA to de novo classify the device as Class II.
A Class III ruling would destroy the personal genomics market, because it would mean extensive clincial testing and documentation about the development of the device. I hope it doesn't stand.
> Government agencies empowered to weild regulatory force against citizens are a threat to everyone
Yes! How dare those jack-booted thugs infringe on my freedom to sell "Dr." Smacktoward's Bona-Fide Health Elixir and Youth Restoring Tonic (99% water, 1% radium) to anyone dumb enough to buy it!
It's turning into a dang police state, I tell you!
I am so glad of this. Without regulatory force we would se much more threats to everyone from other citizens (and that's why regulations came into being).
Silicon Valley "It is better to ask for forgiveness" culture meets the worst of government "We'll need that in triplicate 5 years in advance of starting to look at the paperwork."
This should be interesting, if you have the patience to watch the fallout in slow motion.
CMS/HHS will look like idiots as mRNA sequencing dips below the $100 per test price point and doctors for the first time will have a histogram of genes turned on for use in their diagnosis.
Instead of whinging, FDA needs to partner with NIST to come up with quality control protocols so doctors know the error distribution in data that they receive.
I have to agree that this seems completely reasonable... glad to see so few commenters jumping to the expected conclusion that this is some kind of government oppression.
If you believe 23andMe is a sound source for the clinical diagnosis of medical conditions, you're probably not going to read the fine print telling you otherwise.
[+] [-] jfasi|12 years ago|reply
Meanwhile, 23andMe went ahead and began marketing and selling their product, despite the FDA's concerns.
Relevant quotes:
> Most of these uses have not been classified and thus require premarket approval or de novo classification, as FDA has explained to you on numerous occasions.
> However, to date, your company has failed to address the issues described during previous interactions with the Agency or provide the additional information identified in our September 13, 2012 letter for (b)(4) and in our November 20, 2012 letter
> To date, 23andMe has failed to provide adequate information to support a determination that the PGS is substantially equivalent to a legally marketed predicate for any of the uses for which you are marketing it; ...
> ...we have proposed modifications to the device’s labeling that could mitigate risks and render certain intended uses appropriate for de novo classification.
> As part of our interactions with you, including more than 14 face-to-face and teleconference meetings, hundreds of email exchanges, and dozens of written communications, we provided you with specific feedback on study protocols and clinical and analytical validation requirements, discussed potential classifications and regulatory pathways (including reasonable submission timelines), provided statistical advice, and discussed potential risk mitigation strategies...
> Thus, months after you submitted your 510(k)s and more than 5 years after you began marketing, you still had not completed some of the studies and had not even started other studies necessary to support a marketing submission for the PGS.
[+] [-] jxf|12 years ago|reply
See, e.g., this one from June 10, 2010:
[0] http://www.fda.gov/downloads/MedicalDevices/ResourcesforYou/...
All the FDA wants in this letter is some kind of understanding that their genetic tests are actually valid and correct, since they are making medical claims regarding their accuracy:
> 23andMe has never submitted information on the analytical or clinical validity of its tests to FDA for clearance or approval. However, your website states that the 23andMe Personal Genome Service™ is intended to tell patients in advance how they will respond to certain medications including warfarin and clopidogrel. It also states that the data generated from the 23andMe Odds Calculator, a feature ofthe 23andMe Personal Genome Service™, includes the contribution of single-nucleotide polymorphisms (SNPs) to disease risk. Consumers may make medical decisions in reliance on this information.
The FDA then establishes its ability to regulate this (remember, it's legally required to do this):
> During a meeting between 23andMe and FDA on July 29, 2009, you described the 23andMe Personal Genome Service™ as consisting of a software program that analyzes genetic test results that are generated by an external laboratory in order to generate a patient specific test report. Thus, the 23andMe Personal Genome Service™ is a diagnostic device and subject to all applicable requirements of the Act.
They then very helpfully point them to all the forms, documents, etc., necessary to satisfy the legal requirements:
> For a device requiring premarket approval, the notification required by section 510(k)of the Act, 21 U.S.C. 360(k), is deemed satisfied when a PMA is pending before the agency. 21 C.F.R. 807.81(b).
There's even a helpful mailing address and fax number:
> Please direct your questions and response to: James L. Woods, Food and Drug Administration, 10903 New Hampshire Avenue, W066-5688, Silver Spring, MD 20993
Honestly, this sounds like 23andme has been getting away with something for a while and the FDA is tired of giving them leeway.
[+] [-] tptacek|12 years ago|reply
[+] [-] dnautics|12 years ago|reply
"For instance, if the BRCA-related risk assessment for breast or ovarian cancer reports a false positive, it could lead a patient to undergo prophylactic surgery"
Uh, you don't think the surgeon is going to demand a second BRCA test be done before performing the surgery?
[+] [-] Ssanders|12 years ago|reply
Thanks for the info.
[+] [-] judk|12 years ago|reply
[+] [-] k-mcgrady|12 years ago|reply
[+] [-] pilom|12 years ago|reply
July and Sept 2012 - 23andMe submits a form to the FDA saying "our test isn't really useful for diagnosis and thus shouldn't fall under these rules"
Nov 2012 - FDA says we don't agree with you you need to either prove your effectiveness or change your marketing
Jan 2013 - 23andMe says "it will take us a couple months to do the tests, we'll get back to you"
Nov 2013 - FDA says, "its been 11 months and you never got back to us. Stop selling and let us know within 15 days what you're going to do explicitly because you ignored us for close to a year"
[+] [-] seehafer|12 years ago|reply
[+] [-] saalweachter|12 years ago|reply
So this isn't really a case of the gov't stomping on the little guy before he has a chance to grow; 23andMe has had its chance to grow into a fairly big deal, and now it's time to start playing by the rules.
[+] [-] ig1|12 years ago|reply
[+] [-] maratd|12 years ago|reply
Last time I checked, the US federal government had an annual funding rate of $3.45 trillion compared to "a hundred million in funding" total for 23andMe.
So yeah, government stomping on the little guy definitely fits the picture. Then again, it would fit the picture no matter who the government decided to stomp on. Perhaps we should focus on less stomping and on more cooperative behavior?
[+] [-] sqrt2|12 years ago|reply
[1] http://www.ctrl-verlust.net/23andme-wie-ich-fur-todkrank-erk...
[+] [-] mntmn|12 years ago|reply
[+] [-] evan_|12 years ago|reply
[+] [-] guylhem|12 years ago|reply
The gov wants to decide what's best for the people. Should the people decide differently, using their wallets for example, this anomaly will be quashed.
This trend is especially strong in the medical field - gov approval required everywhere, then people wonder why medical things are so damn expansive.
I use 23andme and I'm happy with the information provided. I know it's not reliable - it's not a lab test anyone will use to base important decisions on, since it is not a full sequence of genes.
Yet, by being commercially available and easy to use, it is paving the way for commercial offers of full genome sequencing, which I damn well intend to use when they reach the $500 threshold.
However, gov actions like this one may very well make that impossible, making sure the only full genome sequencing offers there will be will be "FDA cleared" at a huge markup.
Suggestions to "medical" like companies - get out the gov eye. Move your business to Asia, the caribbean or wherever the gov will not get in your way like this. I want to keep using (and recommending) your products!
[+] [-] revscat|12 years ago|reply
Wallets are incredibly poor judges of medical efficacy. The FDA rules are in place for very good reasons, namely to prevent snake-oil salesmen and other unscrupulous merchandisers from foisting their -- potentially harmful -- products upon an unsuspecting public.
I would much rather have FDA clearance for medical products and devices than the alternative that you seem to be proposing.
[+] [-] rayiner|12 years ago|reply
There are huge information asymmetries involved when it comes to medical drugs, and also huge barriers to experimenting with different products. "Voting with your wallet" is appropriate for determining which cell phone should be popular, not which medical drugs or medical tests.
We as a society have determined that the appropriate risk versus innovation trade-off when it comes to medicines and drugs is less risk at the potential cost of less innovation. The FDA exists to safeguard that policy.
It's funny that you mention Asia, because the trend in Asian countries is to follow the American/European model. Asians have had enough of thinking "is this rat meat?" every time they bite into a lamb kebob, and are regulating their food and drug industries. And by "asians" I mean the Chinese, because the Japanese and Koreans have adopted the Western regulatory model long ago.
[+] [-] oddevan|12 years ago|reply
If they made that more clear, then they wouldn't have had to send the letter. It's why you see "This is not intended to diagnose, treat, or cure any disease" on all the non-FDA-approved supplements/energy drinks. My money is on them paying the fine and scaling back the marketing.
The purpose behind these FDA rules are to make sure things aren't marketing as "cures" when they aren't. People's health is serious business; there's no room for failure. If 1.0 doesn't work (or makes things worse), then the people that need it might not live to see 1.1.
[+] [-] matthewmacleod|12 years ago|reply
I'm moderately on the side of government not interfering where possible. But medicine and medical devices is one area in which such interference is quite likely a positive influence, on the whole.
Fact is, we don't want a return to the era of patent medicines. For every user of 23andme who is well-informed enough to know that the information is not reliable, experience shows that there will be another who is not. And these people will base life- and health-affecting decisions on the results provided by unregulated products. Then maybe they'll get sick or die.
That's why there are regulatory standards for medical devices and services. These standards don't prevent the sale of 23andme's services, but require that they are either a) regulated and proven to work, or b) explicitly and clearly described as not being so.
Yes, there are rampant inefficiencies within this system. But I'd wager that it's probably better than the alternative.
[+] [-] chasing|12 years ago|reply
I'm with you. I'd much prefer a bunch of people die first so the rest of us can "vote with our wallets" instead of having a government agency step in and try to fix things before anyone gets hurt. I mean, my start-up is going to sell baby food laced with arsenic because I once heard that arsenic makes babies smarter and I think I once ingested some accidentally and I didn't die. If it really does end up killing babies, well, the market will eventually correct itself. And no harm, no foul, man. Except the dead babies. But at least I wouldn't have some nebbish bureaucrat knocking at my door trying to tell this American how to live his life.
[+] [-] hyperbovine|12 years ago|reply
You have unwittingly affirmed the very argument you are attempting to refute. Their inability to make accurate functional predictions from genomic data has much less to do with the technology (sequence vs. array) than it does with the fact that, isolated instances aside, nobody knows how to do this well. I am a 23andMe user myself and, knowing a bit about statistical genomics, I was surprised how credulously the results of one or two GWAS papers are presented as an almost-diagnosis on their website. GWAS are plagued by all sorts of confounding issues and the statistical evidence in favor of their conclusions is often extremely weak. This is not something that the general public appreciates, so I can see why FDA might get involved.
[+] [-] ganeumann|12 years ago|reply
So actually you can't buy elixir sulfanimide anymore. Because it was poisonous. It resulted in more than 100 deaths in 1937. This was before the FD&C Act, requiring safety tests. The founder of Massengill refused to take responsibility for the results: "We have been supplying a legitimate professional demand and not once could have foreseen the unlooked-for results. I do not feel that there was any responsibility on our part." It should be noted that there was a sulfanimide craze on at the time, as the first commercial antibiotic, so there was much money to be made.
One woman wrote to President Roosevelt, about her dead daughter: "The first time I ever had occasion to call in a doctor for [Joan] and she was given Elixir of Sulfanilamide. All that is left to us is the caring for her little grave. Even the memory of her is mixed with sorrow for we can see her little body tossing to and fro and hear that little voice screaming with pain and it seems as though it would drive me insane. ... It is my plea that you will take steps to prevent such sales of drugs that will take little lives and leave such suffering behind and such a bleak outlook on the future as I have tonight."
Source: http://en.wikipedia.org/wiki/Elixir_sulfanilamide
Massengill paid a minimum fine and continued on until it was acquired in 1971.
I don't mind that we have set up an agency to make sure that medical products and devices are safe to use and do what they say they are going to do. It's far more efficient than having to do it individually. And there's always, evidently, people who won't, because they trust their doctor or the brand. And, being medical products and devices, sometimes those people or their loved ones die.
[+] [-] pvnick|12 years ago|reply
Look how smallpox vaccine was discovered. Edward Jenner inoculated a young boy with cow pox, then attempted to infect him with smallpox a dozen times. Obviously we can't go around convincing young children to take infectious doses of deadly viruses. But we also cant send FDA thugs after every Silicon Valley startup pushing the boundaries of genomics research. So where do we draw the line?
[+] [-] gardarh|12 years ago|reply
You might be able to find countries where regulation is less strict or non-existent but I'd imagine that people's trust in medicine in said countries is less than in the regulated ones (as you most certainly would have rouge players abusing the lack of regulation).
edit: Added last sentence in 1st paragraph
[+] [-] dagw|12 years ago|reply
Yet their adverting makes it sound like it is. Specifically talking about how it can be used find un-diagnosed disease and health problems.
[+] [-] wnevets|12 years ago|reply
[+] [-] hgsigala|12 years ago|reply
[+] [-] labaraka|12 years ago|reply
I cannot imagine someone getting surgery or chemo solely based on a 23andme heads up warning and without consultation with a specialist physician.
As someone working in medical devices, this dramatic language is extremely frustrating.
[+] [-] rmrfrmrf|12 years ago|reply
Perhaps the startup echo chamber has more respect for unchecked opportunism; if that's the case, someone should make a startup called 23andMeFree (monetized by ads, duh) that has you spit in a tube, send it to some PO Box, then randomly generate positive and negatives across the board. If you wanted the scam to last longer, you could even generate random values based on statistics of certain characteristics. A true libertarian must support such a business.
[+] [-] geetee|12 years ago|reply
[+] [-] DanBC|12 years ago|reply
There are different ways to mitigate risk - ensure there's adequate genetic counselling and proper easy to understand information available for anyone taking the tests would be one way.
I lean towards favouring tight regulation of medical products. One person's 23andMe genetic test is another person's quackery - see some of the nonsense offered as medical advice by the quacks on other websites.
[+] [-] seehafer|12 years ago|reply
[+] [-] geetee|12 years ago|reply
"The laboratory may not be able to process your sample, and the laboratory process may result in errors."
"You should not change your health behaviors solely on the basis of information from 23andMe."
"23andMe Services are for research, informational, and educational use only. We do not provide medical advice."
"Genetic research is not comprehensive."
All from: https://www.23andme.com/about/tos/
[+] [-] wheaties|12 years ago|reply
[+] [-] logfromblammo|12 years ago|reply
Ideally, the FDA would have independently-generated evidence indicating that the product in question is unreasonably dangerous or ineffective for some intended purpose before issuing a cease and desist order. Instead, they simply assume guilt and place the burden of proof upon the vendor.
Given that the FDA has vastly more resources than 23andMe, and companies like it, this makes the FDA seem like bullies against microbusinesses, and like the captured servants of agricultural and pharmaceutical megabusinesses.
[+] [-] sethbannon|12 years ago|reply
[+] [-] Sephr|12 years ago|reply
23andMe helped me catch this early enough with the assistance of my physician that I was able to get treatment long before I would have developed symptoms. If I never used 23andMe I probably would not have had this diagnosed until years later.
[+] [-] rossjudson|12 years ago|reply
I think it's reasonable for the FDA to tell 23andMe that if they're going to interpret the results for their customers, they need to be able to guarantee the chain of processing is there, and they need to be able to justify each "detection point" their marketing claims.
Your outcome is positive. But positive is not the only possibility.
[+] [-] seehafer|12 years ago|reply
A Class III ruling would destroy the personal genomics market, because it would mean extensive clincial testing and documentation about the development of the device. I hope it doesn't stand.
[+] [-] esMazer|12 years ago|reply
It took them 40 years to get the labeling for tylenol right.. http://www.thisamericanlife.org/radio-archives/episode/505/u...
They are moving rather quickly on this one... my only question is, why/how??
[+] [-] javert|12 years ago|reply
Government agencies empowered to weild regulatory force against citizens are a threat to everyone, and this is case in point.
[+] [-] smacktoward|12 years ago|reply
Yes! How dare those jack-booted thugs infringe on my freedom to sell "Dr." Smacktoward's Bona-Fide Health Elixir and Youth Restoring Tonic (99% water, 1% radium) to anyone dumb enough to buy it!
It's turning into a dang police state, I tell you!
[+] [-] rimantas|12 years ago|reply
[+] [-] gnaritas|12 years ago|reply
[+] [-] btilly|12 years ago|reply
This should be interesting, if you have the patience to watch the fallout in slow motion.
[+] [-] crb002|12 years ago|reply
Instead of whinging, FDA needs to partner with NIST to come up with quality control protocols so doctors know the error distribution in data that they receive.
[+] [-] jheriko|12 years ago|reply
[+] [-] ChikkaChiChi|12 years ago|reply
[+] [-] carbocation|12 years ago|reply
No joking around.