7 ms·

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

• oddevan 13y 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.
  • deleted 13y ago
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    • ForHackernews 13y ago
      That's true, but it's not a slam-dunk case for rushing ahead without sufficient testing. There's a reason that "first, do no harm"[1] is considered one of the fundamental principles of medical ethics. Medical interventions can have disastrous side effects.[2] [1] https://en.wikipedia.org/wiki/Primum_non_nocere https://en.wikipedia.org/wiki/Primum_non_nocere [2] https://en.wikipedia.org/wiki/Thalidomide#Birth_defects_crisis https://en.wikipedia.org/wiki/Thalidomide#Birth_defects_cris...
      • twoodfin 13y ago
        I'm curious, are there any other examples than Thalidomide? It's a true horror story, but there should be a limit to how much precaution one disaster justifies in the future. Many other drugs with ultimately fatal but initially undiscovered side effects have made it through FDA approval, too.
        • ForHackernews 13y ago
          > are there any other examples than Thalidomide? A whole lot of people have died from contaminated blood transfusions: http://articles.latimes.com/1994-08-31/news/mn-33183_1_aids-epidemic http://articles.latimes.com/1994-08-31/news/mn-33183_1_aids-... That's another case of a medical intervention ending up doing more harm than good.
        • modfodder 13y ago
          Doesn't exactly answer your question, but here's a list of formerly approved drugs that were withdrawn due to risks to the patient (22 in the last decade). http://en.wikipedia.org/wiki/List_of_withdrawn_drugs http://en.wikipedia.org/wiki/List_of_withdrawn_drugs
          • twoodfin 13y ago
            That's kind of my point. Does that mean we should ratchet up FDA's precautionary attitude dramatically further, to the point where that number is perhaps 2 instead of 22? I don't think so. There's a sensible tradeoff to be made, but tuning exactly where that tradeoff should be isn't the kind of thing you settle with dramatic examples of things gone wrong. It's difficult to measure how many lives were saved or made substantially more livable because the FDA was not more cautious than it has been. Surely that number is not zero, and perhaps it's greater than the net harm done by drugs whose effects might have been caught by more prolonged testing. I don't think we know.
• hgsigala 13y ago
  Oh, calm down Rand Paul.
  • adventured 13y ago
    Why be so snide, instead of actually writing an informative / useful reply? That would certainly take more effort, but this is Hacker News, there's supposed to be a higher standard of discourse here.
    • kaonashi 13y ago
      Reflexive yet vague anti-government sentiments deserve derision.
      • pvnick 13y ago
        Wrong. Derision begets derision and tends to create an anti-intellectual feedback loop. There is no place for that here. Flag the people throwing insults around and move on.
    • RyanMcGreal 13y ago
      The original comment is nothing more than a generic libertarian rant, complete with the "gov" strawman, force-mapped to the matter at issue. It scarcely deserves more than the response to which you take objection.
      • adventured 13y ago
        What's the point of the down vote then, if not to enable an easy response (and influence) to something disagreeable without spurring entirely unnecessary and often negative comments?
      • ars_technician 13y ago
        Dismissing an ideology you don't agree with only highlights your own ignorance. Copy and paste and argument from the internet if you can't form one on your own. Don't pretend "herp derp Rand Paul" is valid.
• revscat 13y ago
  > 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.
  • Symmetry 13y ago
    I don't think anyone is going to argue about the FDA's role in ensuring drugs are safe, but most countries don't require positive proof of effectiveness and, frankly, have better health outcomes than the US. Doctors are quite capable of reviewing the evidence to see if drugs are effective, and the FDA doesn't in practice do anything to prevent the sail of non-poisonous snake oil.
    • seiji 13y ago
      Doctors encompass the entire range of people (from morons to geniuses). As a group, they aren't some magnificent godlike all knowing figure. "Programmers are quite capable of reviewing the evidence to see if code is effective" — yet, we end up with thousands of people using MongoDB based off fad and hype and losing data by the day. (Wait, did I just advocate for a government-level code approval board? In the right hands it would probably help if it prevented more Mongos and Hadoops from entering the world.)
      • jbooth 13y ago
        Losing data when you're a professional who should have known what you're doing is one thing. Losing your life when you're a layman in the medical field is another.
      • Symmetry 13y ago
        Doctors make mistakes, but there isn't anything preventing that in any event. In theory a doctor can prescribe any drug for any ailment (though there are lots of checks and consequences), and prescribing drugs for things other than their FDA approved use is very common[1]. You have to rely on doctor judgment at some point and efficacy trials don't substitute for competent doctors. And sometimes the whole process goes awry because a drug is approved for one problem, later becomes the only treatment for some people with a second problem, then the FDA withdraws approval because there are now better treatments for the first problem, leaving those with the second problem in the lurch.[2] [1]http://en.wikipedia.org/wiki/Off-label_use http://en.wikipedia.org/wiki/Off-label_use [2]http://nielsenhayden.com/makinglight/archives/007140.html http://nielsenhayden.com/makinglight/archives/007140.html There's some important context in the comments.
• gardarh 13y ago
  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). edit: Added last sentence in 1st paragraph
• pvnick 13y ago
  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?
  • deleted 13y ago
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  • smacktoward 13y ago
    Possibly somewhere that takes into account the significant advances in laboratory science since the 18th century?
  • vasilipupkin 13y ago
    There are lots of proposals to simplify FDA's approval process, for example, automatically approve it if it's already approved in a number of Western countries whose approval standards are high on average. But in this specific case, seems FDA isn't being totally unreasonable. For example, from the letter "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" seems like a good idea to require companies to do this
  • ahallock 13y ago
    This sounds like a false dichotomy: "The government has a legitimate responsibility to ensure that medical technology is used and marketed responsibly" So either the government ensures the above or it does not get accomplished? There are no third parties that could take this on? I find that hard to believe.
• wnevets 13y ago
  I have some snakeoil I would like to sale you, $9.99 cures all ills
• matthewmacleod 13y ago
  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.
  • dnautics 13y ago
    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. The funny thing here, is that barring lab errors, which I think are highly unlikely unless they are being incredibly shoddy, which would take effort, the information that 23andMe provides is very reliable. Now it is debatable as to whether the individual's interpretation is (for example in the Alcohol Dehydrogenase gene, many, many, many caucasian users don't bother to read that the test is only informative for asians, but it's definitely there, in bold letters, etc.) Could you explain a scenario where basing life and health decisions on 23andMe's product could lead to sickness and death? Maybe it's "because I'm sophisticated", but this biochemist can't really see that happening.
    • dragonwriter 13y ago
      > The funny thing here, is that barring lab errors, which I think are highly unlikely unless they are being incredibly shoddy, which would take effort, the information that 23andMe provides is very reliable. Certainly, there is science to support certain claims of the class made in the reports 23andMe provides being made with some degree of reliability based on the kind of inputs 23andMe takes in. Whether what 23andMe actually does from end-to-end makes the actual reports they provide reliable in real world condition is...well, exactly the question they have seem to have decided not to expend the effort to answer even after initiating the process of getting clearance from the FDA to market their diagnostic product.
• dagw 13y ago
  it's not a lab test anyone will use to base important decisions on Yet their adverting makes it sound like it is. Specifically talking about how it can be used find un-diagnosed disease and health problems.
• rayiner 13y ago
  > 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.
  • Dylan16807 13y ago
    This isn't a drug. I know you're responding to a more general point, but I don't think any of your post applies to this situation. This is about marketing materials, and more importantly the factual information therein.
  • drcube 13y ago
    > There are huge information asymmetries involved when it comes to medical drugs... This is what the FDA should be doing. Correcting information asymmetries. With labeling requirements, unbiased PSAs, drug pamphlets and literature. Not telling people what they can and can't put in their bodies, or what businesses can and can't sell on the open market. In fact, I'd say most government regulatory functions should be set up this way. Clearly inform and educate your citizens, don't opaquely dictate the behavior of your subjects.
    • deleted 13y ago
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    • PeterisP 13y ago
      Well, but this is exactly what they are doing here - the letter claims that they required corrections in the marketing claims (which would be correcting information asymmetries / labeling requirements), this wasn't done properly for a long time, so they are now enforcing it. For any reasonable requirement, if people/companies don't comply then it has to escalate to [threats of] harsher actions in order to force the reasonable thing to actually happen.
• hyperbovine 13y ago
  > 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.
• chasing 13y ago
  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.
  • ahallock 13y ago
    What an absurd argument. If you sell baby food laced with arsenic, and babies die, you've committed murder. In a true free market, you wouldn't have a liability shield and would face severe consequences for putting out dangerous products. Just because it's a free market doesn't mean you get to do whatever you want with impunity. And also, the FDA is not some magic fairy dust that will shield you from bad products. Mountain Dew still has BVO in it, for example.
    • chasing 13y ago
      You understand that the goal is to prevent the horrible thing from happening, right? Not to let the horrible thing happen and then try to fix something that's unfixable?
    • dragonwriter 13y ago
      > In a true free market, you wouldn't have a liability shield and would face severe consequences for putting out dangerous products. Liability for defective (whether through malice, negligence, or in some cases on a strict liability basis) products is government intervention in the marketplace, and is specifically designed to address one of the ways that reality does not align with the presuppositions under which an unregulated "free market" is ideal, to wit, that people generally do not, in fact, act with perfect knowledge of the outcomes of economic decisions when they engage in them. It is no different than many other government interventions in the marketplace in its basis. > And also, the FDA is not some magic fairy dust that will shield you from bad products. Mountain Dew still has BVO in it, for example. That does not mean that its approval procedures (and procedures for reviewing products already on the market) do not have utility in providing clearer information on products within its regulatory domain and helping consumers avoid bad products.
• ganeumann 13y ago
  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." Source: http://en.wikipedia.org/wiki/Elixir_sulfanilamide 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.