As we begin our genetics unit, you may be aware of the recent ban that the FDA put on the genetics testing offered by the company "23 and Me". Please read the news story linked below and post a few lines on what you think about the FDA's move and the accessibility of genetics testing in the future.
http://www.bbc.co.uk/news/technology-25100878
The company "23 and Me" is a very interesting business. I think the intentions of this business is to get people around the world interested in the technology that they have produced. With a relatively low price costumers are jumping at this opportunity without much thought in how well developed this testing is. Just like the FDA, I am worried about the accuracy rate of the results. Many costumers that are requesting to be taken off certain medications are possibly worsen their health conditions because of this new process that may or may not be 100% correct! If the "23 and Me" company posted its accuracy rates then people's decisions and trust in this system may change.
ReplyDeleteThough I think the technology and its intentions are very cool, I do agree with the FDA's decision. If 23 and Me isn't going to verify the accuracy of their testing process or publish statistics regarding their margin of error, they shouldn't be offering their services. I think this sort of service will be available in the future. The FDA hasn't put up a barrier to the business, but rather established public safety standards for a technology that has only recently been made available to the general public. If the company releases the accuracy of its test results and publishes the likelihood of error, I think it highly likely that we'll see them back on the market in the future.
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ReplyDeleteI always get a little nervous when I hear about genetics in the business world. It reminds me too much of science fiction stories I've read involving superhuman mutations and government-regulated reproduction. Genetics is a powerful tool when in knowledgeable hands and can be used in many beneficial ways, such as for genealogical tracing, disease treatment and prevention, and other medical and academic purposes. However, history has shown that when the public starts acting based on faulty information under the principles of eugenics, trying to improve the human race by eliminating unfavorable traits, it can lead to devastating results. The beautiful thing about DNA processes and evolution in general is the immense variety of creatures they produce. I am glad the FDA is keeping a close eye on commercial genetics testing. I'm sure 23 and Me has good intentions, so as long as they follow the rules and the public understands how to use the information they get the company can keep providing their services.
ReplyDeleteEven though I wish this weren't the case, I do agree with the FDA in their punishment of 23 and Me. All that they do as a company is vey interesting: I'm a bit freaked out by the designer baby aspect, but the rest of the company's actions are fascinating. However, the company could do some serious harm with incorrect information. If a test for a genetic disease came back incorrect, a patient could either stop taking medicine or begin taking unnecessary remedies. Likewise, they could forever live in fear with a completely unfounded issue, which is simply unfair. I think, were the company to comply with he FDA, I would certainly be supportive of their continuance. However, currently I believe that they should stop what they're doing and reassess the way the company is run.
ReplyDeleteI believe that the FDA has acted to the best of its abilities, and I also believe that the move was well-played. Perhaps it is just my interpretation, but the language in the article did not seem to imply that this is a permanent shut-down of any sorts, merely a punishment for failing to act according to regulations. I think that 23andme is interesting enough a company, but I fear (like Jacob above) that the information it provides (including its margin and percent error - which it failed to file and make known to the consumers) can be dangerously used. I say that it is interesting enough because, like anything, when taken out of perspective, it can become potentially cultish (for lack of an appropriate word), or what you will - perhaps more intensely dependent - which then leads to who knows what types of problems. That being said, I am by no means saying that companies like this should not exist. There is definitely a market for it, and when the market and companies are managed, they can be both fun and interesting. But there is always the fear that it can be taken too seriously, and in the future, taken prematurely or inappropriately to the "next level" - designer babies? Just because we can doesn't mean we should - there ought, need, to be limits.
ReplyDeleteI believe that the intentions of the 23andme company is good, they just need to find a way to perfect the test. I do agree with the FDA that they need to find a way to prove that this information is correct. With this test, it could be feared that this information could be incorrect, and therefore stopping someone from having a child. Aside from discouraging people from having children, this could also put an unnecessary fear in peoples lives because the tests may be incorrect. If the 23andme test is not going to shut down completely, it needs to at least make sure it clearly warns the consumers that it could be incorrect. I think in the best interest of the company and its consumers, the FDA should shut it down until the company can find a way to make sure that the results they are distributing are correct.
ReplyDeleteThe FDA definitely is doing there job by meeting and discussing the guidelines with the 23andme company. Although I do think that the 23andme company could potentially be a good idea, at this point since there is no proof that all of there test results are correct, they shouldn't be allowed to continue on. If a person's test comes back and they are told they are at risk for some disease, they could take unnecessary precautions to prevent that disease and a company should not be allowed to run if they are giving out false test results. I think in the future if the 23andme company can insure their tests are accurate, then they should be able to continue what they are doing.
ReplyDeleteWhile I don't think that an individual can be deprived access to see the impact of their own genes I think it's a very bad idea to put that kind of information (especially if it is not particularly accurate) in the hands of the uninformed. A doctor has been trained to understand certain genetic occurrences and treat their patients appropriately. Upon receiving a very basic (and possibly incorrect) summary of their genes people may decide the "best" treatment plan for themselves without fully understanding the implications. It's interesting to think that something that is so essential to who we are could be so dangerous in the hands of the public. If 23 and Me can create accurate data that comes with a comprehensive explanation of the meaning of these results the company should be allowed to continue their work.
ReplyDeleteThe company 23 and me offers an intriguing service, and it sounds like a convenient way for people to learn about their genetic conditions or traits. However, I agree with the FDA that 23 and me should provide information about the accuracy of their tests. It is very dangerous for people to make their own decisions about matters like their medication based on these genetic tests alone, especially without being informed of the accuracy; if a test were incorrect it could have detrimental consequences for the patient. The availability of genetic tests from 23 and me is also an indication of the access people will have to this kind of information in the future. If it becomes common for people to understand what genetic conditions they have, it could impact the frequency with which hereditary diseases are passed on.
ReplyDeleteWow. With the rising concern of genetic diseases and disorders in our society, "23 and me" is definitely appealing to the majority of the human population who can spare a hundred bucks to supposedly get their genes read to determine if thy have a genetic disease. Caught by the FDA as a hoax, however, proves that the only service that can provide this disclosure of information are doctors.
ReplyDeleteFor most people that tried 23andme before it was banned by the FDA, I’m willing to bet that the only reason they were able to justify paying $100 to (essentially) have their spit tested was that the company to which they’d be calling on was backed by Google, a business which, unlike 23andme by itself, has earned enormous power and respect. To them, then, 23andme was just one more of the many sub-services that the corporation provides; after all, if they already had so much of their lives entrusted to Google Search, Google Drive, and Google Plus, why would they have worried that Google Genetics Testing would be any exception? While by no means am I discrediting the integrity of 23andme’s work – because I do believe that they were on the right track –, I am implying that ANY company which has ANY scientific presence could have followed in 23andme’s footsteps, but rather than striving to provide accurate information for the well-being of its customers, it could have come up with whatever results it wanted, sent them back, and virtually no one would have known the difference. So in realizing the terrible implications of letting 23andme have so much unsupported influence, the FDA made the right the decision in, at least for the time being, banning it. That being said, government-approved, do-it-yourself genetic testing will definitely be a part of our future as soon as – and I’m getting a vibe that it won’t be long – 23andme gets its numbers straight, and matures as a corporation.
ReplyDeleteI was surprised that 23andMe was even allowed to operate this long without having the authenticity of their results and test verified. I think it is great that the FDA is stepping in and requiring verification first. It will either expose fraudulent activities or make a great service even better. I think we should establish new organizations or laws that require a verification of authenticity before a company like this goes into practice to make sure people are not getting wrong information.
ReplyDeleteAlthough the concept of genetic testing is an appealing one that could potentially help mitigate genetic disorders, the fact that 23andMe cant even offer accuracy rates for their product leads me to believe its not as accurate as they advertise. The FDA was right to require the business to offer proof of effectiveness because people could be basing important decisions on the less than accurate results. For instance if there is a worry that two parents may be carriers of a rare and life threatening genetic disorder, the parents may base their decision on the results 23andMe. offers. For future businesses that wish to enter into this market, verification should be required and made public immediately to ensure faulty genetics tests are not sold as effective ones.
ReplyDeleteI think that the general idea behind 23andMe is a good one, but because the results are not necessarily reliable, it's currently not ready for the public to use. I think being able to examine your own genes and their impact on your health and life is a cool concept, but it clearly hasn't been tested thoroughly enough for a company to charge money to customers for their service. I think in a few years when technology exists that allows this data to be recorded reliably, then 23andMe would be an interesting idea that also functions well.
ReplyDeleteAlthough the service that 23andMe provides may be useful and their intentions may be good there is still a lot to question. I am very surprised that this company was even allowed to begin its work without receiving some sort of certification from the FDA. It seems to me as though the FDA is a bit at fault themselves for not regulating this company from the start. However if 23andMe is able to identify all the information the FDA requires it would become a reliable tool that would benefit our world tremendously. A test that is that inexpensive and reliable would be able to help millions of people discover and diagnose as well as get treatment for their genetic conditions. Yet a map or our genetic makeup for only 99 dollars sounds too good to be true, and perhaps it is.
ReplyDeleteI personally see 23andMe as a mere byproduct of our capitalist society. Do people take horoscopes seriously? How about personality / aptitude tests like the ones we take on Naviance? People will do what they choose with the information they receive, and so long as 23andMe is not actively marketing their service as 100% scientifically accurate/reliable, that business venture should not suffer at the hands of a gullible consumer's ignorance. The way that genetic testing becomes ingrained in our culture as acceptable and feasible is for there to be trial-runs, and 23andMe seems like it could've been one of those. I agree with Savanna, though, that a person's genetic information is sensitive and probably should - and does, now - fall under "doctor-patient confidentiality." It seems like no one handled this scenario well, but thus are the growing pains of the 21st century.
ReplyDeleteI think that the "23andMe" company has taken things too far because they aren't respecting the rules of the FDA. I do agree that the company is interesting and could be cool, but if you don't know how accurate the tests are, then it's not worth it. I think the FDA is making the right move by being more strict towards the company because the company shouldn't be giving its customers false information that could affect their decisions.
ReplyDeleteI think the intentions behind the company 23AndMe are good, but with out the backing of the FDA and proof that the tests are reliable I feel that all potential buyers should seek professional medical testing until all business regarding this issue is cleared up. 23AndMe is a good idea because it gives patients the ability to test themselves for genetic disorders in the privacy of their own home, and it probably also saves a lot of money in comparison to the expensive lab fees which must be paid at medical facilities. If 23AndMe is approved by the FDA in the future, I think it will be a very successful business and be a revolutionary step in technological advances in the area of genetics.
ReplyDeleteI think that company "23andme" is making a step in the right direction. They are trying to offer information to people that otherwise can be difficult to access for a low price. The intentions of the company seem to be well placed because them seem to be attempting to help people and inform the common citizen about their health. Nevertheless, the FDA's ban on the companies genetics test is reasonable if the can't prove that the testing they are offering people is accurate. This is a good decision by the FDA because some people are strongly relying on the testing and might use it as grounds for future medical help and procedures they choose for themselves.
ReplyDelete23andme is doing the right thing. They are a private business and have the right to sell saliva tests. If the tests are accurate the company has nothing to worry about and they should comply to the FDA's simple requests and avoid being shut down. In the long run, trying to send a message and arguing with the FDA will only turn out poorly. It would be simple to back the marketing claims made by 23andme, however they will not cooperate. That leads me to believe that the company has something to hide, and it is probably smart of the FDA to shut down the service so nobody receives false information about their genes and potentially put themselves in danger because of it. If the tests truly are as the company claims, cheap genetic testing in the future could be beneficial to many (assuming it is FDA approved.)
ReplyDeleteIn order to properly examine the power the company holds to control consumers lives, one must ask themselves "What would I do if my life was built on a lie or mistake?" Though it is intended more as a punchline than an emotional statement, in the movie "The Jerk", when Steve's Martin's character discovers that he is adopted, he is horrified and his entire life is built on a lie. Perhaps more relevant to the situation is the power that medical mistakes hold to change someones life: A false diagnosis can cause people to act as though their life is at an end, and when they find out it is not, on top of having all purpose and meaning shattered, they find they are unprepared for the future the had never planned on. On the other hand, people who have a false negative diagnosis can become too safe or sure of themselves, and may ignore symptoms that they would have otherwise gotten examined. 23andme is not subjected to the current regulations and accuracy standards that most medical companies are bound to and as a result, their very existence will do more net harm than good.
ReplyDeletePrior to reading this article, I thought the FDA's involvement would mirror that of our government's jurisdiction of stem cells (an issue of ethics). In this case, I would have favored 23andMe. However, after reading the article, I supported the stance of the Center for Genetics and Society. Although 23andMe isn't medically intervening, they are jeopardizing peace-of-mind for their customers despite the accuracy/strength of the results. In their support, the customers participate with complete economic choice and full awareness of potential for bad news (it's what customers do with this knowledge that is dangerous). Because customers can't un-see their results, I think banning the test was a good move. However, I admire 23andMe's effort to bring genetics to the mass market.
ReplyDeleteBeing the devil's advocate, these tests are the same as pregnancy tests: there are two possible results (yes or no for each genetic predisposition), they can be unreliable, and the perspective and subsequent action of the user dictates the experience (unwanted pregnancies (--> action) v. wanted pregnancies (--> action)).
Also, Anne Wojcicki and Sergi Brin's son is named Benji WOJIN (a hyrid cross of their last names). I just thought that was interesting.
The fact that 23andme has not yet complied with the FDA's regulatory requirements is worrying enough. If a new company like 23andme developed a product that worked, and wanted to "increase their marketing campaign," then why wouldn't the accuracy results of their product be their foremost marketing tool? Like many have said before me, this is just a result of the increasing consumerism in our society, no different than any other successful business venture or hoax that came before it. The only reason that this particular business venture is under irregular speculation is because it deals with much more personal, uncharted territory, that we are only starting to lay down legislation for. I believe the FDA's motives for involvement are credible, and that 23andme should have to comply with the regulatory standards that others do.
ReplyDeleteThe premise of "23 and me" does not appear to be the same as other prospective parenting tests. In anthropology, we looked at their website and their main focus seemed to be tracing lineage back, rather than hypothesizing it forward. Because of this, I would imagine that regulations would be wiser to have some sort of warning label on the company, so that people can make an informed decision about what they are spending their money on, rather than shut it down entirely.
ReplyDeleteI’m glad to see that the FDA was on the job and stopped 23andme. Proving that they can accurately analyze “254 health conditions and traits” is a pretty fundamental requirement to offering the service, something they apparently did not bother to do. Even if they can, most people are not trained to correctly evaluate the results. I wonder whether even primary care physicians would feel comfortable recommending treatment on the basis of genetic testing or would refer a patient to a specialist. Marketing this service directly to the public may not be the most helpful way to make genetic information available to people. It wasn’t so long ago, in the 1920s when the idea of eugenics had many people, including scientists thinking that some people were inferior to others and should be sterilized or otherwise not allowed to reproduce. I wonder how this information might be used or misused in the future by employers and insurance companies.
ReplyDeleteNot to continue to elaborate into redundancy on "designer babies" as several others have already alluded to the dangers of parents picking and choosing which genes to include in their children and which ones to omit leads to a very dark and frightening place. The fact that babies are imperfect, inevitably human, is a fact of the specieis as a whole, some children will be endowed in some areas where others are left to struggle. Certainly no perfect child exists, and from a biological perspective, the variation of genes and a lack of uniformity is one of the strongest elements of humans as a species. I am pleased to see the 23 and Me was halted by the FDA as their claims were unfounded based on where the research had actually reached.
ReplyDeleteI think the better question is "what grounds could there possibly be for the FDA to not shut down 23 and Me?" Considering they violated FDA guidelines to conduct a sketchy sounding operation to map out an individual's genes (something that could be done by a great many other approved medical institutions, albeit at a higher cost) that may in fact produce an incorrect result, and delude people about what issues they may face later in life. Good on the FDA for making them close shop.
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ReplyDeleteI think that the FDA made the right choice in shutting down 23 and Me, seeing that this company doesn't seem like they'd want to follow rules that are in place to protect the general public. While I'm open to the idea of modifying a baby's genes to prevent them from having disorders once they're born, this just seems like nonsense. ("Dip your toes into genetics"? Really?) Although the company seems well-meaning on the outside,they give off the air of wanting to delude people that any disorder they could ever have can be pinpointed, and that their offspring will be the child of their dreams. This generally just doesn't seem right to me.
ReplyDelete"23 and Me" to me seems like quite the revolutionary company! They have created something unique and inventive and is something that no one else in the world is currently pursuing. I believe that it is a great way to get the American public interested in the sciences, but the FDA does have a very valid point about reporting accuracy ratings. These ratings are essential because for all we know, this company could be a complete scam!
ReplyDeleteI think the FDA made a good move. Something as important as genetic information should be reported accurately. If 23andme provided an inaccurate result to me, whether a false positive for a genetic disease, or failing to report a disease I have, I would be upset - and rightly so. Knowledge of certain genetic conditions can drastically change a person's life, for better or for worse.
ReplyDeleteI think genetic testing will become commonplace, eventually coming down to tests you can buy at the store and fully operate at your house. I also anticipate them becoming much more accurate.
This article certainly brings to light a number of ethical concerns. Under FDA rules “23 and me” should be providing proof about how accurate its detection methods are as well as supplying error rates. Unfortunately many people utilizing this kit may depend on its results to determine if they are at risk for future diseases. Believing that the results from the kit are accurate, participants will either be convinced that they have a disease causing a tremendous amount of stress. On the contrary some may believe that they do not have certain diseases and will refuse future testing. The accuracy of the kits and the error rates are essential to prevent participants from coming to false conclusions about their health.
ReplyDeleteI believe the FDA should not necessarily put a ban on the company "23andMe", but perhaps they should warn against the potential setbacks of inaccurate results. The idea of gene-testing is revolutionary; if the FDA would allow it, other companies could potentially come forward with more accurate ways of testing for disease and other genetic issues--competition makes the world go around. With more companies producing more results, the public would demand more accuracy; it's simple supply and demand.
ReplyDeleteAlthough I like the company's service and think that it proposes a very intriguing view into one's personal genetic code, the lack of information that the company is supplying the FDA concerning the accuracy of their genetic test is very worrying. Through the comments from "23andme," it seems as though the company is dodging the FDA's requests because it simply doesn't have information at the moment that puts its product in a positive light. This move is most likely to satisfy investors or the general public that their genetic testing process is indeed accurate and provides a proper result. Since the company is not supplying enough information to the FDA or customers, I believe that the ban on its genetics testing kit is valid and will protect consumers from potential misdiagnosis in the future, especially when it comes to decisions relating to life-altering genetic diseases.
ReplyDeleteThe company 23andMe seems to have good intentions by providing people with their genetic code. The general population being able to take tests and find if they are prone to any diseases could be detrimental, especially if these results are false. The desire to know one's health future is common, but it could lead to individuals to become overly concerned. If this service will be continued in the future, it is very important that the company obeys the FDA's restrictions and makes their costumers aware of how accurate the test is.
ReplyDeleteThe intentions of the 23andMe company seemed good. They wanted people to be able to see what type of life their children may have, looking at the genes from both parents. However, I agree with the FDA's response. People shouldn't be paying a company for unreliable personal information that could affect an unborn child's life. Even if this company was sure that their methods of viewing the genetic information of the parents were completely reliable, there is no documentation of that that has been published. Because of that, this company should not be allowed to do business with the public at the time.
ReplyDeleteI like the concept of the company 23 and me, and I like the idea of how people can find out which health conditions and traits they may have inherited. However, I do believe that is was right for the FDA to shut the company down, as they did not provide information that the FDA required. If the company ends up submitting the required information, I think this might be a useful company for the public. The only concern I have is that the tests may not be accurate which may endanger its customers.
ReplyDeleteI think it's cool that people can learn their genetic code but I do agree that the FDA should regulate 23 and me and other such companies. The information they are providing their clients may not be completely accurate, and based on the information given to them, the client may change their medication which could be harmful if the information they received was inaccurate. If 23 and me meets the FDA's requirements, then they should definitely continue to sell their product because its an amazing way for people to learn about their genetics.
ReplyDeleteI think the company 23andme should have the right to continue operating. I personally would not pay them to find out information about my personal genetic codes because I think the idea of trying to figure out how your health will be affected in the future goes against nature. I also wouldn’t want to worry about something that may never happen or not be accurate. However, some people may want to do this and it is up to them to make the decision for themselves. The company isn’t doing any harm by selling these results and the consumer should know that this kind of testing isn’t completely accurate.
ReplyDeleteSpecifically on the "Build a Baby" topic, I think modern society should not be allowed to posses such a power like being able to create their perfect child. Certain things that happen in nature need to be left that way. If Build a Baby got popular, the success of a child would be based on the parent's wealth, creating a society more focused on money. I truly do not see this idea as being something worth researching more.
ReplyDeleteI’m glad the FDA stepped in after 23andme has operated for so long without backing to support its claims. It’s an interesting concept, but if what you’re being told about yourself can’t be confirmed, you’re basically throwing away your money. I do think that there is potential for personal genetics testing in the future, but it needs to be handled correctly and verified, and marketed truthfully and accurately. Now that the FDA has put a hold on 23andme’s operations, hopefully these sorts of checks will be in place from the start for emerging companies with the same goal.
ReplyDeleteIt's a good thing that the FDA is looking after the health and midset of people who would have changed their entire lives over the results they received from "23andMe." However, I don't see how the FDA has the authority to regulate the legitimacy of genetic review companies; their webpage says they are there to "protect and promote your health," but how does that apply to "23andMe?" The FDA has reaches in food, drugs (understandably), radiation (which I guess could be a drug), tobacco, etc. but nothing to do with genetics. If anything, I believe that should be the job of the United States Department of Health and Human Services.
ReplyDeleteI feel that it is important for the FDA and the Department of Health and Human Services to insure that these private companies are providing accurate information. I do feel that these companies should warn consumers not to self medicate themselves based on the results and that only a medical professional should prescribe medication. The "Build-a-baby" company is an interesting idea, but users shouldn't take it seriously.
ReplyDeleteHonestly, I think the FDA was just mad they didn't think of the idea first. This article depicted the classic conflict between public and private. On the public sector's side: an adoption and/or sperm bank process which involves all of the medical records available (along with desirable traits like athletic ability and IQ)...On the private side: an affordable procedure that would reveal results about as accurate as a doctor's office could. So to me this conflict seems to be less based on ethics and more based on seeking profit.
ReplyDeleteHow I view this: the FDA should be involved just to ensure that there aren't contradicting test results for the same person. It helps to get all your health information from one source; that way you won't waste time questioning the results and devote more time to addressing your health conditions.