"You should not change your health behaviors solely on the basis of information from 23andMe. Make sure to discuss your Genetic Information with a physician or other health care provider before you act upon the Genetic Information resulting from 23andMe Services. For most common diseases, the genes we know about are only responsible for a small fraction of the risk. There may be unknown genes, environmental factors, or lifestyle choices that are far more important predictors. If your data indicate that you are not at elevated genetic risk for a particular disease or condition, you should not feel that you are protected. The opposite is also true; if your data indicate you are at an elevated genetic risk for a particular disease or condition, it does not mean you will definitively develop the disease or condition. In either case, if you have concerns or questions about what you learn through 23andMe, you should contact your physician or other health care provider."
This is what I don't get. It's not like this is hidden. The site is completely upfront about what they are and what they do, what studies and results have more confidence and which less.
Maybe I'm just a little cynical here, but it seems the FDA would have better things to do with their time. That in mind, I wonder what spurred this...
This is much better than the other FDA story today where the FDA declared walnuts a medicine because a manufacture made the factual statement "Omega-3 Fatty Acids found in walnuts have been shown to have health benefits."
This actually makes sense. They're using marketing terminology to be say "walnuts will do this, prevent this, and help you out with this".
If you want to market your product like a drug, you should go through the regular inspection to make sure all your claims are satisfied, just like any other drug.
No, it doesn't make sense. The consequence is that no food marketing can make (even truthful and not-misleading) claims about the healthiness of the product. Carrots are healthier than Twinkies? Not unless they're a medicine.
its just a matter of knowing the game. big farma kills millions, nothing happens. small company still not pleasing the right people, huge fine/closed/etc
yes, i am implying the gov is corrupt. it is.
and this the reason everyone pays hundreds of dollars for catheters and such, and any company that tries to improve the design and price of those items are all in legislation or royalties limbo.
Not millions, and I don't want to buy into the "Big Pharma" conspiracy... but NPR's This American Life on the FDA & deaths from Tylenol was fascinating. It took the FDA 32 years to enforce warning labels for Tylenol (and other acetaminophen products) from when they were first recommended to do so:
Thalidomide, though didn't necessarily kill people, did destroy many lives. Baby formula, fire retardants, and many other products brought to market by lobbying industries have harmed consumers by varying degrees and all backed by the FDA.
"Fifty years ago, the vigilance of FDA medical officer Dr. Frances Kelsey prevented a public health tragedy of enormous proportion by ensuring that the sedative thalidomide was never approved in the United States."
> While generally safe for use at recommended doses (1,000 mg per single dose and up to 4,000 mg per day for adults), even small overdoses can be fatal. The ratio between fatal doses and therapeutic doses (the therapeutic index) is much smaller than for other over-the-counter painkillers. According to the US Food and Drug Administration as little as 25 percent above the maximum daily dose can cause liver damage when taken over several days
> In the United States, over 150 people die each year from overdoses, with up to 78,000 emergency room visits
Because drug companies aren't responsible for the actions of their customers. If you overdose on something like acetaphetamine, that's your fault, not Tylenol's. The information is out there regarding proper dosing and you've chosen to exceed that. That's really not a problem with the drug, you can overdose on practically anything, it's just chemistry. Society laughs at people (rightfully, I might add) who get busted drunk driving and try to blame Heineken for their actions. Also, taking 25% over than the recommend dosage several times may damage your liver but it certainly won't kill you. The LD50 for the drug in mice is 338 mg/kg.
yes but as I quoted, paracetamol is something you can overdose really easily, it's also a medicine everyone around me is using as a trivial thing. I might be surrounded by idiots but I think I'm the only one in my entourage who read the instructions (I've told my friends numerous amount of time "What? You're not suppose to take more than 4g per day!").
I might be surrounded by idiots but I think I'm the only one in my entourage who read the instructions (I've told my friends numerous amount of time "What? You're not suppose to take more than 4g per day!").
Seriously? If they can't even be bothered to read the instructions on medicine (or anything they put in their body) then they have problems and need more help. Or need to learn to read.
Considering the fact that we know 99.9% of people blindly click through agreements, this is the way it should be. Companies should not be able to use the lack of careful reading of TOS/T&C to their benefit.
Should a company should be able to bury a clause in their ToS such as "by accepting this contract, you agree to forfeit to The Company your first born and every cent you ever make henceforth"? Of course not.
People should be able to knowingly enter into whatever contract they want. The problem is that (as I cited elsewhere) information/effort/payoff asymmetries makes such a scenario ripe for exploitation. Therefore it follows that regulations should constrain what can reasonably appear in a contract. One should not have to parse 100 pages of legalese just to make sure they're not tacitly agreeing to indentured servitude for the rest of their lives. If this were not the case, it would be painfully easy for unscrupulous business to bury unsavory claims under mountains of incomprehensible legalese. What regulation does is balance the scales in favor of consumers.
This does in fact follow from the fact that 99.9% of the public does not read and/or cannot comprehend every instance from the set of possible legal contracts.
People should be able to knowingly enter into whatever contract they want.
Glad you agree.
Should a company should be able to...
Contract theory is far more rich a subject than you realize. In your example, a rational theory of contract wouldn't be enforced based on mere promise, but would allow contracts to be broken so long as it puts both parties more or less back to where they were before. E.g., if you promise to paint my home for $100, but then you don't paint my home, I can't then enslave you and force you to paint the home, rather, I get my $100 back.
And who is there to enforce the various tenets of contract theory? The fact is, if certain clauses of a contract are enforceable through state action then the state can and should have a say in what clauses it will enforce. Simple as that.
It's clearly not as simple as that, since there is such a thing as tyranny and perversion of justice. Now, you may be the kind of person who would approve of what his government does, whatever it does, and you may even be in the majority, but that doesn't make you right. I also imagine that, like most people with such views, you have cognitive dissonance. I.e., there are some governments that you think should change their behavior, on moral grounds.
>It's clearly not as simple as that, since there is such a thing as tyranny and perversion of justice.
It would be helpful if you tied in statements like that to the main discussion thread so that I could respond in a meaningful way. As is stands you're not really making an argument so I can't respond to anything without guessing at the logical connection.
> ... Make sure to discuss your Genetic Information ... before you act upon the Genetic Information
The problems are not about what someone might do with their "Genetic Information", but with the accuracy of the "Genetic Information" in the first place. The false positives/false negatives mentioned in the FDA's warning letter[1] are not referring to misdiagnoses based on the 23AndMe's results, but to misidentification of genes in those results (as the letter describes it, "false genotype results")
In a nutshell: 23AndMe claim that the genetic variants in their results are (to some degree of accuracy) genetic variants that you actually have; the FDA says that 23AndMe have not provided enough evidence for these claims.
The TOS is perfectly valid. It is a solid document advising people to take any results up with a medial professional. The service tells people that the product is not a medical diagnosis, however the service does provide medical information. This clearly puts said service in the realm of the FDA. Therefor compliance should be sought.
Really this goes for any company building medical services. Consulting someone on HIPAA compliance, as well as, FDA standards and practices is a must.
Is this fair in this case? Who knows. It is irrelevant. Resistance is futile.
"You should not change your health behaviors solely on the basis of information from 23andMe. Make sure to discuss your Genetic Information with a physician or other health care provider before you act upon the Genetic Information resulting from 23andMe Services. For most common diseases, the genes we know about are only responsible for a small fraction of the risk. There may be unknown genes, environmental factors, or lifestyle choices that are far more important predictors. If your data indicate that you are not at elevated genetic risk for a particular disease or condition, you should not feel that you are protected. The opposite is also true; if your data indicate you are at an elevated genetic risk for a particular disease or condition, it does not mean you will definitively develop the disease or condition. In either case, if you have concerns or questions about what you learn through 23andMe, you should contact your physician or other health care provider."
https://www.23andme.com/about/tos/