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After FDA Objections, 23andMe Won't Offer Health Information
sciencehabit writes "The company 23andMe will no longer provide health information to people who purchase its DNA testing kit, it announced last night.The change was 'to comply with the U.S. Food and Drug Administration's directive to discontinue new consumer access during our regulatory review process,' the statement said. While current customers will still have access to a 23andMe online database noting the health issues associated with their particular DNA, the company will not update that information, and customers who purchased its Personal Genome Service (PGS) on or after 22 November will receive only information about their ancestry and their raw genetic data without interpretation." It would be great to see a secondary market in this kind of analysis emerge.
It would be great to see a secondary market in this kind of analysis emerge.
so, after the FDA forced 23andMe to stop analyzing, you think it's a good idea for another company to come along and do the same thing? i have a nice bridge you might be interested in ...
From snpedia.com:
Q: What does the "B." in Benoit B. Mandelbrot stand for? A: Benoit B. Mandelbrot
Good.
My family all had our genomes sequenced by 23andMe. The only area we have expertise in is Alzheimers, and (1) their Alzheimers explanations were misleading, (2) they made it REALLY hard to learn the raw data about what they found in our genomes, i.e. which SNPs they tested and what they found: instead they only boiled it down into a useless "you have 20% chance of getting Alzheimers" which was scientifically incorrect, lacked confidence levels, lacked context.
I would love to get the raw data from their results, and I'd love to have someone better than them provide the tools to analyze & understand it.
I don't know... for most people it comes down to maple syrup and hockey vs tacos, burritos, salsa and donkey shows. Mexico makes a pretty good case for second place.
I submitted someone else's DNA. Small price to pay for invisibility. It's flawed because I could be tagged with my pal's traits. But in the near future, we'll be buying/selling "prime DNA" for our test submittals, on street corners, like clean pee at La Tour de France.
(OOps, I meant to submit anonymous coward, instead of this hacked 'retroworks' account).
Gently reply
You can not say the USA is the best country in north america. Or you have not been paying attention for the last 30 years here. Or you are very very rich and have almost no touch with reality anymore.
Canada is number one. By pretty much any measure including common sense.
And yes. i am in the usa. but quite realistic about where we currently are. (which we currently are fucking sad on pretty much every measure)
Blind nationalism does not help anyone. But we do have alot of it. One of the reasons why we are not the number one country in north america....
We need to fix it. Not continue to pretend we are the best. When we clearly are not anymore.
I mean, really, who the hell would spit into a tube, pay $100 bucks and start a potentially harmful treatment regimen without seeing a doctor?
Speaking from experience, 23andme did identify that one of her genes leaves her susceptible to having bad side effects of one of the medications she was taking (and she was suffering from this side effect). Taking the 23andme health report to her doctor let her move onto an alternate treatment, which is working *much* better.
I hope that a revisited health report/traits thing comes back soon. Or maybe put it behind a test wall, and make sure people to understand exactly what they are getting.
"for entertainment purposes only" seems to be the necessary language. right?
Commie.
it would seem to me that if you're not getting the whole service, the cost should be lower....
http://wh.gov/lKu2R
Maple syrup is a huge plus. But really and truly, nationalized health care>entrenched government corruption.... hell, I could even learn to yell at hockey games.
Happiness in intelligent people is the rarest thing I know.
Ernest Hemingway
Mexico is pretty awesome it's true, but it's true, there's one country worse than both.
Although 99.9% of us have the common sense to get a professional opinion if some test bought on the internet delivers bad news, the FDA denies us access to such tests on the off chance that some idiot will take rash action without consulting a physician. Were that to happen, which I seriously doubt, the worst result would be a slight improvement in the gene pool.
Just need to link the science (published) and the genotype. It's all open.
Next up is banning people from sequencing their own genomes without a MD.
The real story here is who's the loser - it's not you; your DNA is your DNA, and the sequences are there or they aren't. The insurance industry are the ones who are actually worried about these tests - all of a sudden you have data they don't, and they can't apply their actuarial models anymore. Hilarity ensures.
May we all live in interesting times.
..don't panic
Or you are very very rich and have almost no touch with reality anymore. ...We need to fix it.
I agree with your statements, above.
But the problem is, the people you mention above ( "the very rich who have almost no touch with reality" ) ARE the //
people who are in control of the US. Can you see how that is not going to lead to any change ? They are quite
comfortable, and they have absolutely no incentive to change. Change is not going to happen unless those in control
perceive a real threat to their comfortable positions, and it's doubtful any such threat will appear from within the US.
As for any threats from outside the US, the rich can and will rely on the working classes to provide expendable young
men and women who are ready to enlist in the armed forces because it might be their only chance for a job. I could go on,
but I am enjoying my evening and no one here is going to care what I say anyway, so fuck it.
Bzz, dumbfuck.
The FDA is not denying access to these tests or the raw results.
The FDA is denying 23andme the ability to provide misleading medical information along with the raw results. The web is full of examples of the company's systems either misrepresenting the results of a study or demonstrating a fundamental misunderstanding by whoever implemented their web site's code - e.g. put in simple terms, drawing conclusions from a particular characteristic which appears in two different areas on each chromosome, when the conclusion would only apply if they were on the same part... and then telling the customer that they had a high likelihood of having inherited a serious degenerative disease.
Not even the rah rah libertarians should be supporting the "right" to talk bullshit - whether you're doing it with your own mouth or via the output of an overly simplistic computer program.
Mind you, my ex submitted her spit and her daughter's, and the two were identified as "identical twins". When she called them on it, they admitted that they must have re-used her sample, and that they'd lost her daughter's. So, their procedures seem definitely to put them in the For Entertainment Purposes category. Medicine is, despite the opinion of self-appointed rockstar geeks, hard. It's not just the intelligence you have to apply, but the care you have to take. $99 won't get you either, but if you're selling shit, you have to advertise it as shit.
One company, for example, offers 166 tests in one of its testing packages where approximately 60% of the tests (99) are categorized as âpreliminary researchâ(TM) because the genetic-association data have not yet been replicated (www.23andme.com/health/all/). These tests are given 1, 2, or 3 stars based on the size of the study that supports the genetic association for which they test. Information for each of these tests cites references for the original ïnding of the genetic association, including the journal where it was published and the study size. It also provides the number of attempted replications and the number of contrary studies that have been published. Although transparent, examination of the scientiïc evidence provided for many of the genetic associations in this category raises the question of whether these tests should even be included in a genetic-testing package. Two of the ïve genetic tests with 1-star status (those for âavoidance of errorâ(TM) and âobsessive compulsive disorderâ(TM)) are based on single studies with fewer than 100 participants (https://www.23andme.com/you/health/). In both cases the variants map to the D2 dopamine receptor, a gene that has repeatedly been associated with human behavioral traits and attracted newspaper headlines, only to have the associations refuted in later studies [8]. Eight of the 37 (22%) available 2-star-rated genetic associations (originating from a single study with less than 750 participants) have a âcontrary studyâ(TM) indicated. Two different 3-star tests, one for Lou Gehrigâ(TM)s Disease (ALS) and another for obesity, utilize variants that have been positively associated with disease in one or two studies, respectively. However, both these variants have failed replication in four additional studies (https://www.23andme.com/you/health/). Although, the company boasts of its 'systematic vetting processâ(TM) used to determine which research ïndings to include in its genetic-testing package, a number of highly questionable tests continue to be offered to consumers.
http://www.ncbi.nlm.nih.gov/pubmed/20828856
That answer wasn't remotely relevant, nor were the replies. Good to see some paid trolls about--this issue must be important to someone.
"It would be great to see a secondary market in this kind of analysis emerge"
Health/Life insurance Co's need to increase profit margins, employers figure out whom to fire first, police departments preventative arrests, - Minority Report-Style, paradise for extortionists getting their hand on those data worth a fortune.
The FDA can't guarantee it'll get dangerous foods off the shelves within even a few years. It couldn't halt BP from ditching millions of gallons of neurotoxic, carcinogenic dispersants into the gulf after Deepwater Horizon. But it's sure as sin make sure your life isn't ruined by an unclear genetics report--as if there were any way people could imperil theirselves with the information.
Not only that, those same young men will open fire on their own countrymen for a banker's buck, minted from thin air.
Wanna read something scary? Try Stanley Milgram's "Obedience to Authority" to see how most people will obey the headhocking of those they perceive to be in power.
If people begin to see their "leader", not as an authority, but as just a big windbag with vocal cords attached. spewing hot gas intended to motivate us to protect his interests at the cost of ours, things would change damned fast.
But for now, people will accept the coin of the realm, created from nothing, as payment for turning on their fellow man and doing to them whatever the ownership class tells them to do.
I am so brimming with disgust over how I have seen the "ownership" class ramrod their agenda over the "working" class that I am going to have to post AC. I know there are those who are keeping records over who sees through their petty scheme to keep the masses enslaved, by owing to the banks that which the banks themselves created from a charter issued from our own government to create notes ( money ) from absolutely nothing. People are expected to WORK for any money they EARN, while the banks are allowed to simply PRINT it, and even then, they do not even have to declare that which they printed as income.
This whole mess makes me sick.
Yet people accept it.
Please do not get me wrong... I am not against owning private stuff... what I am against is law enabling one class of people to print their wealth, while another class must work for it. I feel we ALL must work for it. Not print it. and ALL pay property tax, not just the working class who does not qualify for the loopholes of the people who have the funds to buy laws.
Oh i wouldn't bet on the armed forces going after the citizens of america if ordered to.
We have been treating our vetrans like dirt lately. And the word is starting to get around.
By the time the shit hits the fan. The armed forces will be on the other side with the rest of us.
What we do to our vets now is shameful. Tragic. Unacceptable.
But. It will put them on the side of the rest of the people being fucked over.
More likely it will be 'UN security forces'. A much worse thing. But at least we'll have plenty of soldiers on our side as well.
Future gonna be interesting.
They can't do analysis, a secondary market can't do it, nobody can. The science just isn't there yet to draw useful conclusions for an individual on the basis of DNA in isolation.
Note that: in isolation. That's what 23and Me was peddling. Hospitals and genetic counselors and doctors are doing something else. They have the whole medical history. They have, or should have, enough training to understand population genetics, statistics, and where somebody's DNA data fits in to all that. (Although a comment lower down this thread talks about a blank-brained counselor. They happen. Run, do not walk, out of their offices.)
So, no, it would not be "great to see a secondary market in this kind of analysis emerge." It would be just as bogus as 23andMe, given our current state of knowledge.
> It would be great to see a secondary market
> in this kind of analysis emerge.
There are already companies (livewello.com, for instance) that will take your 23andme raw data and analyze it for certain traits and risk factors.
If you disagree with me on social issues, then it's pretty clear that you are a narrow-minded bigot.
You can ger tacos, burritos, and salsa in Canada.
And Vermont also makes maple syrup.
-- hendrik
I don't think there's any law that requires you to have IRB approval for anything you do. If you receive government funds, then sure, a condition of the grant or contract will be "you need to have an IRB". You can also hire an IRB. That is, there's no objective standard for approval. You sign up to the Belmont principles, etc, but it's not like there's some certification process for IRBs.
There Will Never Be Another You
Oh i wouldn't bet on the armed forces going after the citizens of america if ordered to.
Tell that to the Japanese. The armed forces imprisoned American citizens without a trial or some kind of due process.
But they didn't imprison the German Americans or the Italian Americans. So maybe, just maybe, there was something about the Japanese Americans and Japanese born legal residents that the armed forces saw differently. Just maybe there was something different about the US back then. "race prejudice, war hysteria, and a failure of political leadership" comes to mind but I'm not sure how loudly it gets said when it is talking about FDR.
And that is not to mention that Japanese Americans were in the armed forces during the same time period too.
But they didn't imprison the German Americans or the Italian Americans.
Sorry, guy. That's incorrect.
Well, the Italians were treated with a bit more discretion, but many innocent Italians were interned.
"The laws regarding "enemy aliens" did not make ideological distinctionsâ"treating as legally the same pro-Fascist Italian businessmen living for a short time in the U.S. and trapped there when war broke out, anti-Fascist refugees from Italy who arrived a few years earlier intending to become U.S. citizens but who had not completed the process of naturalization, and those who had emigrated from Italy at the turn of the 20th century and raised entire families of native-born Italian Americans but who were not naturalized themselves. They were all considered enemy aliens."
http://en.wikipedia.org/wiki/Italian-American_internment
The Germans had it a bit rougher, but neither compared to the scale or extent of the Japanese internment.
http://en.wikipedia.org/wiki/German-American_internment
Strat
Progressivism (aka US 'Liberalism'): Ideas so good they need a police/surveillance-state to enforce.
There are plenty of tools and sources that help you analyze the data. Long term, the FDA decision will simply mean that people who are skilled and/or rich enough to go abroad will get the benefit of this analysis, while everybody else will be screwed. Congratulations, FDA, for doing your part in increasing health disparities.
Whether you have a variant dopamine receptor is certainly a reasonable thing to include in a genetic testing package like 23andMe: even if current studies don't have clear results about what that means, there is a good chance that there will be meaningful associations in the future. If 23andMe only included those tests for which absolutely clearcut associations had been worked out, people would have to get retested constantly.
The company did what it should have done: it picked a large number of important markers and disclosed things correctly and properly.
Fortunately, this kind of FDA stupidity is not going to work long term: people are simply going to get their entire genomes sequenced, and there will be a huge number of free tools and web sites for searching for disease associations, ancestry, and relatives.
Being a pissed-off American, sick of how the elite have screwed us over, may not be of any specific ethnicity, I am very sure they are going to use the general classification of "terrorist".
Lookit Junior: That opinion might get you into some drunk, fat freshman girl's panties, but it ain't worth shit in the real world.
Without the US to absorb the brunt of illegal immigration, Canada would have been annexed by Mexico, and even the smelly fucking Quebecois would be speaking Spanish just to get a job. The EU? Fuck, boy - without the US Army camped in their borders, Russia could, even post-cold-war, take the whole continent in about the same time it takes to drive from Moscow to Lisbon at highway speed.
But I don't even have to bring any of that up, because like most children trying to debate for the first time ever, your very premise is full of fail. No, not your stupid opening line, but the self-loathing, self-hating bullshit that gave birth to it.
Tell you what, boyo - if it's so damned rotten here, then maybe you can move to your belled "number one" country? Oh, that's right - you can't - because Canada, like most EU nations, have immigration requirements that are tighter than a schoolgirl's asshole. Oh, and you suddenly have to watch what you say (free speech is diminished - you can go to jail for using the wrong words out there), what how much you make (get too successful and you get taxed incredibly hard), and oh yes, almost forgot - be certain that you don't have any complicated health issues. Oh, I know what you'll say, dumbass: "but they have free healthcare, derp!" Sure - which explains why Canadians are busting ass to come to the US for treatments they are otherwise denied, cannot get locally due to technological retardation, or on a waiting list 40 kilometers long for (essentially meaning that by the time they get their turn, their conditions are too far gone to get any real benefit from it).
But, that's the problem with dumbasses like you; you don't know shit about the outside world beyond what your PolSci 1001 prof spewed out, and his total experience comes from a combination of what he read on cpusa.org and a chauffeured PeaceCorp gig he did 42 years ago.
Neither you or he knows shit about the ugly side of the planet. You've never seen a man beheaded in a Saudi marketplace for the 'crime' of selling weed on the down-low. You've never watched local mobsters beat the unholy fuck out of some poor schlub on a St. Petersberg street corner while the morning crowd and a couple of cops do their collective best to not see it happen. You've damned sure never had to deal with the levels of bribery that are usual and required to do business in China, Egypt (before it went to hell), Italy, France (yes, France), or any South American nation you care to name.
But yeah - please continue to 'enlighten' us on how the US sucks oh-so-bad. Please save everything you write, too. Why? Because when (if) you finally grow the fuck up and realize just how good you had it with Mommy and Daddy's money caring for your pimple-specked sorry ass while you pursue a major in Ethnic Art, you might just learn something.
i KNEW that the FDA was gonna shut this company down after i saw another post here on slashdot about the same company. I thought to myself "The FDA would never allow a company to do shit like this" low and behold they went after them.
...salt.
The FDA is wrong for trying to ban information based on it's source when that source has no reason to deliberately lie or mislead.
It is one thing when a drug company says that its miracle drug makes hair regrow or fixes acne or prevents breast cancer without having proved these claims in some other way since the company benefits by selling the drug; it is another thing when a company offers an inexpensive test for blood sugar leveles but does not sell anything beyond the test and the results itself.
In this case, 23andme was selling a test and its results for a low price. With the results, the consumer could make a decision to take out more insurance, see a doctor, get medical tests, tell their relatives that they could be at risk for things, etc but 23andme does not benefit for most of this (they may sell more tests, but $99 is not going to make or break anyone).
For example, gallstones. My risk is 6.2%, where avg risk is 7.0%. Not bad, I have a lower chance.
If you think that "23andMe" can detect a 0.008 difference in the probability of your getting gallstones based on a genetic test, then you have been duped. The studies that 23andMe use to estimate these values are not nearly accurate enough to make these kinds of statements. That sort of statement has not been validated, and that is part of the FDA's problem with these scams.
Please remove your shoes and step into the full body microwave scanner.
I'm from Australia. We got our own problems; but America is a poverty stricken fucking shithole. (nice tourist destination though)! Affordable these days too thanks to the level of regulation you guys have on your banking sector!
Oh, and before you say: "But you rely on us to stop China Annexing you!!!" (because you are a patriotic Americentric moron) - I don't see it happening. Maybe because you exist? but it doesn't mean your country isn't a shithole.
So I guess I should say thanks, for keeping your country a shithole to fund my protection. But I won't because you're an idiot.
Let me go rah rah for you. If 23andme is so shitty at providing accurate medical information to aid the lay person in evaluating their results then the MARKET will put them out of business as consumers will a) stop using them and b) competitors who provide better service will emerge.
There is no need for government intervention here. Please go control your own person and family and leave the rest of us the fuck alone.
I really figured that all these dna testing outfits were either fronts for DHS or at least in cahoots. Shocking the FDA did not get the memo. Has Rudi Guilliani been on Fox yet to lament the loss of info for the DNA databse?
Just because the US is in third place is no reason to gloat.
You are welcome on my lawn.
Sen. Orrin Hatch (R-UT) would like to speak with you about how your health can enjoy the benefits of herbal supplements!
"We have to go forth and crush every world view that doesn't believe in tolerance and free speech." - David Brin
I had taken a 23andme test out of curiosity about ancestry and a type of cancer that ran in the family that is known to have a very strong genetic link. Before taking it though I read reviews/commentary from all over the web and I noticed one glaringly obvious reality. People don’t get statistics very well, and even those that do have a blind spot when it comes to odds that affect them. (lottery methods anyone?)
All over you see negative comments saying that the test is garbage because it said I had reduced chance of getting this and I already have it, or the opposite. There’s some cognitive dissonance there that might just be a part of human nature, nowhere on 23andme or other sites that I have looked at do they every say you will get this or you won’t get that. Heck even on the cosmetic results such as what hair or eye color it’s a likely will/likely won’t statement.
Sadly I can see one area which might be one of 23andme’s problems was something that I saw as a strength. In the initial presentation of results it dumbs it down to just numbers and a confidence—simplifies in some cases a half dozen tests into one percentage. If you dug down into where the numbers came from they provide links to the studies, sample sizes, dates, and all the scientific info one could ever want. But if you stopped at just those initial numbers and acted on them due to what you feel you know of statistics? Yeah it could cause some trouble/confusion—though still imho much less than those who go and start taking all matter of homeopathic snake oil for that twinge in their back they are sure is cancer.
My test for the most part came back with what I expected: some cool info on where some of my family likely came from and with the regards to the cancer gene I didn’t come up snake eyes. That doesn’t mean I won’t have to go in for regular testing and be vigilant, and it doesn’t really change the way I do manage my health, it just makes me a little bit more knowledgeable about what’s in me and much more curious about what future research holds. If it came back that I have that “bad” gene what would have happened? Likely the same, though I probably would have shared my results with my GP to see what she thought, I’m not a doctor after all.
They can't do analysis, a secondary market can't do it, nobody can. The science just isn't there yet to draw useful conclusions for an individual on the basis of DNA in isolation.
You are one stupid mother fucker. I have a 23andme account. I already knew going in that I was likely at higher risk of type 2 diabetes. Guess what, 23andme showed that I have about a 50% higher risk than the average person. They also told me I'm immune to the stomach flu...which was cool to learn, and not really a surprise because I have never once had any kind of "stomach bug." They also showed that I am likely to be sensitive to warfarin, which is information that could one day save my life. Oh yeah, and I found that I carry one recessive gene for hemachromatosis, which is definitely something I'd like to know before having kids. I benefited from this service. That's because unlike you, I have a fucking brain in my head. Nobody with a God damned clue goes on that site and then takes everything they read as gospel. They do have information which shows which predictions are more or less likely to be accurate, and all of that is posted. So far I have found the vast majority of the information they've posted to be more or less accurate. If you think 23andme is "bogus", then you are one dumb mother fucker. And I don't need Big Brother holding my hand, you stupid shit. Do us all a favor: pack your shit, and get the fuck out of this country. We have no room for worthless slaves such as yourself.
That is one approach. You might change your mind when some unregulated company sells you bad heart medication though. Or contaminated ibuprofen.
What the fuck is even the point of this idiotic comment? What if a REGULATED company sells you bad heart medication? What if the entire industry conspires to sell you harmful shit, pushed by your doctor, sold at profit by your pharmacy, and approved by the FDA? Jesus Fucking Christ....pull your head out of your ASSHOLE.
There are a lot of posts here already saying, "it's 23&me.com, of course you should get a second opinion before: {getting a double mastectomy, getting your balls cut off, ...}". But, that is always the case in the face of a life changing diagnosis. If your local doctor diagnosis you with anything you consider life changing, for me it was an allergy to a common food, you should always get a second opinion. And if it is something major like major surgery, then consider getting a 3rd opinion too.
I trust my doctor, I've been with him long enough to know he doesn't just try to get me random expensive procedures, but I've learned to listen more carefully. The more it seems something is "probably", and less definitely, the more I consider what else it could be, what else I could do, do some reading myself, and consider getting a second opinion.
Because other places are worse. We are not going to accept our own failures or even attempt to fix them.
Yeah. That's just fucking great.
Exactly, IMO the FDA is shutting down a useful service in order to protect a few idiots out there would would act on the results as gospel. On the contrary I think it could help far more than it hurts by knowing you MAY have an increases risk for a given condition, it should make you start keeping an eye on that possibility(slightly more frequent scans/tests etc).
The FDA and the CDC.
Unless I want a good, bitter, laugh.
Exactly, IMO the FDA is shutting down a useful service in order to protect a few idiots out there would would act on the results as gospel.
Bullshit. The FDA isn't "shutting 23andMe down." Nobody woke up yesterday morning and was told 23andMe had to shut down. 23andMe had YEARS to get in compliance with FDA regulations, but instead it chose to say "we don't agree that we fall under the jurisdiction of the FDA" and do nothing. And then, golly gosh, it turns out that we do actually live in a society of laws after all. If I was an investor in 23andMe, I would be steaming pissed.
Breakfast served all day!
If you believe that, I have some snake oil to sell you. In fact, that's why the FDA was created - people were making tons of money selling hokey products that claim to improve your life, from poisons to strange electro-stimulator devices. Chances are, they didn't work, and if you were lucky, you weren't worse off for it (if not, death, chronic disease (more sales!) was your fate). But enough people did get sick and die that people wanted "something to be done".
The problem is the market cannot decide - because the chances and everything is so vague and time delayed that how do you really know? It's like predicting the weather.
So you have a "greater than normal chance" of some disease. What do you do? Do you change your lifestyle? What if you got it anyways? (The big problem is genetics just tells you how prone you are to something. The environment contributes significantly to whether or not you actually get it).
Or take cancer. Perhaps the genetic test says you're less likely to get melanoma. Does it mean you can avoid sunscreen and tan yourself until you're completely charred safe in knowing you probably won't get melanoma?
And hell, fake medical information is bad. See anti-vaccination groups bringing back diseases that were well under control or even eradicated (e.g., smallpox) only a couple of decades earlier.
the MARKET will put them out of business as consumers will a) stop using them and b) competitors who provide better service will emerge.
Just like the MARKET will put all of those herbal supplements, homeopathic water solutions and penis enlargers out of business?
Have you heard of this thing they call the internet? Or global commerce? Nothing stays undiscovered for very long and if it is a big enough deal people will hear about it and competitors take advantage.
And those people are harmed how? There is a huge body of infomation readily available on all of those things. If somebody wants to believe that stuff is helping them WTF is it your business or the goverments? Are they harming you?
...seems to be the ongoing policy of US Government in general, and of the FDA in particular.
Just as they've held up the approval of 15-minute DIY HIV test kits (Orasure et al), now they're blocking access to this information. Same principle: "Because we're worried that a few morons can't understand the data, we're going to screw EVERYONE indiscriminately".
Same result: 100,000's of potentially preventable HIV infections occurred in the years the quicktests were delayed, now 100,000's of people will be denied the knowledge of potentially life-threatening illnesses and the possibility of preventative maintenance.
Way to go, FDA. Let more people get sick & die so Big Pharma profits. Motive couldn't be more transparent of it was made from Trivex.
On a larger scale, I wonder if the age of "tyranny of the moron over the intellectual" will ever come to an end.
OK, so they screw up once in a while. It's your responsibility to take ANY medical advice with a grain of salt, and to seek a 2nd opinion. Which is why there's that entire concept of a "2nd opinion", that's been around for centuries.
But noooo, we can't have that, let's shut down the information for EVERYONE because SOME people might misinterpret, or because there's a TINY error chance in the testing process.
Typical American attitude - "this might annoy/damage some morons, so let's shut it down for everyone".