23AndMe issues statement on FDA smackdown

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When intentionally or negligently false information is published in a book or magazine, the author and publisher are often liable for damages and possible criminal penalties.

Have you been to a bookshop? Have you not seen the tomes on homoeopathy, get rich quick techniques, diets, positive thinking, ufos etc? When was the last time any of this was contested in court or challenged by a regulator? The only instance I can think of was when Simon Singh was hauled over the coals for suggesting homoeopathy didn’t work.
Somehow though, we manage to get along without a benevolent organisation taking these off the shelves for our own good.

I am not a 23andm3 customer or fan, BUT

Until or unless 23andme is offering testing for communicable diseases, the FDA has no place in it.

If I see a result that worries me, I still have to see a doctor about it - and that doctor is already regulated up the wazoo.
In the example given - BRCA. Even then, if I have the breast cancer marker and want them gone, I won’t do it in the kitchen - and a surgeon must also be agreeable to my desire to be flatter and theoretically safer, or it’s not happening. That’s not enough for them?

Are we willing to give billions to CDC to generate things like this ‘Obesity Epidemic’ and consequently run around fear-mongering diabetes…and yet, only the FDA can decide if I can see my inherited risk factors for diabetes? Really?

It is MY DNA. Part of MY body. Should I not be allowed to read my very own DNA while the FDA arm-wrestles a company for an unlegislated extension of their regulatory power? Constitution says…NOPE. I don’t owe them that, and they don’t get to play God with my personal wellbeing.

And for those who may think otherwise - yes. The FDA does indeed stall out approvals of medications and procedures, a well as placing crazy limits that do harm. Like, limiting certain medications to chronic pain patients because…potential addiction is worse than intractable, suicide-inducing pain, yes? But, only if the pain isn’t caused by cancer. I you have ever had cancer, you get a pass. Because, pink ribbons and stuff. True story.

They regularly approve devices and surgeries which have been successful in EU for years. Meanwhile - too bad for you, if pain and disability are your companions in the meantime. You get the older stuff, or none at all. Because, safety first! Because rules, rule. Right? Long as it doesn’t include you or anyone you care about, right? Because, that could never happen…

Nobody is stopping you from reading your DNA, and nobody is “playing god” with your well being. The FDA is simply using it’s constitutionally recognized power under the commerce clause to ensure that if a company sells a product for the purposes of telling you what your inherited risk factors for diabetes are, they actually test for those risk factors and accurately reports the result to you.

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Must be lovely to feel so incredibly trusting of governmental authority. What good does it do me to possess such a ‘right’, if I’m effectively denied the technology necessary to operating that right?

You aren’t denied access to the technology. You’re denied access to this particular company until they complete a bit of paperwork they should have done long ago. You’re free to go elsewhere. Heck, you’re free to start your own company, or your own lab, or hire an existing lab directly, or…

If you’re complaining that those aren’t cheap… sorry, but cheap isn’t a right. It happens when the market lets it happen. And meeting FDA requirements is part of the cost of playing in this market.

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I’m not sure ‘not cheap’ even begins t cover it.

As I said - I have no prob with FDA operating within its own legislated and specified authority. No - not true. I do have SOME issues with it, as stated. But like I said, without tests for communicable disease, there simply IS not risk for them to regulate, beyond the possibility that I may waste cash on a low-quality product. But I can do that all day with thousands of other products. I can even do it with genetic testing - providing I’m only looking at ancestry rather than specific SNP’s. They aren’t regulated, because they don’t do SNPs related to possible medical issues.

One group I know of that is a particular fan is composed of people within a larger group of people having rare inherited and sometimes fatal disorders, for which no testing is even offered yet - mainly, because the research is expensive. Of those which can be tested, most are expensive, and not accurate enough in most cases to justify the expense involved. Lack of specific testing is also related to children being taken away and their parents falsely accused of abused (because their bones break and joints dislocate spontateously.)

And yet, the linked article proposing that competitive commercialization would bring down costs as an ultimate benefit to both researchers and patients, it was called ‘arrogant’? TF? You feel prepared to play God with other people’s lives like that? Where’s the ‘arrogant’ in that position? Oh yeah - right out front. Because they obviously know best what is right for others.

Clearly, 23andme acknowledges they are behind on filing paperwork - but hell. The FDA is years behind on even considering paperwork! What I want to see is any actual justification for a federal agency interfering in a private business which may not even be lawfully subject to its authority at all. Some of 23andme’s patents will go that direction, certainly. And the hysterical squawk on that lately that they would be offering a private ‘eugenics’ program, because people may choose not to have children if they know there is risk of heritable disorder. (Though, you could make the same accusation about amniocentesis being supplied to pregnant women.) But its current product? You’d have to show me something far stronger than the paperwork and worry excuses to convince me there’s no overreach or further agenda on this one.

Or maybe, you don’t actually understand that the entire business model of the FDA is to reduce all humans to statistics, which it then uses to determine who lived and who dies. Say, a particular medication is risky - but saves a life for every 3 it damages. K - good to know. We deserve to be properly informed.

But it doesn’t stop there. Because the strongest likelihood is that the medication will be banned outright. Too bad, bud! Survey says - you die, so sorry. Because, unlike our private sector pals, we are not subject to liability for making that decision. That’s NOT a theory, not a political position, nor a debate tactic. That’s the reality of what the FDA actually does on a daily basis. And yet…genetic testing is…‘dangerous’?? If that’s ok with you, then scare me way more than the FDA ever has.

Shitheads don’t become the loudest members through magic, they get there through the rest of the group letting them become big instead of debating and challenging them, and being louder about non-shithead opinions.

Besides, I did originally stipulate that there were a few issues where agreeing with libertarians makes sense. They’re very good at sounding JUST sane enough to reel normal people in, and then slowly get them into shit like Praxeology, the economic equivalent of creationism. (“The Scientific Method doesn’t apply to Economics because it invovles People and People are Unpredictable…please ignore the fact People are involved in literally everything, including things the scientific method clearly works on”)

Y’know, statements like that drive the moderates – which I am, though I’m disagreeing with you on this particular case – right into the opposite corner.

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Sorry about that. You wanted me to lie? Market that, somehow or other? They already are happy to tell you about all the lives they ‘saved’. They just leave out the costs of doing that the way they do it.

Like I said - that’s not even a position. That’s just the reality. I know it’s gross and horrifying to think about it like that - but that’s what they really truly do. I only wishtagod it was some kind of exaggeration.

Funny, that’s the way I kinda look at working with libertarians (right-libertarians, anyway), what with so many of their “Intellectual Leaders” endorsing shit like allowing literal prepubescent children to consent to sex even if it’s “procured by rewards, or promises of reward”, being apologists for autocrats of all stripes as long as they’re not leftist, and claiming parents have a right to let their children starve to death.

Oh, sure, not ALL libertarians may believe in these things, but given that the ones they look to as leaders and founders, the who are actually running for office, the ones libertarians are allowing to be their Public Faces, often do…

i may be a democratic socialist, but at least I try to call out people that get lumped into my group that I disagree with. (Soviets and modern Soviet-apologists seem to live in a fairytale world where leaders are incorruptible and governments give up power willingly, instead of (in the best case scenario) after a lot of badgering and complaining from its citizens.)

We’ll have to agree that we disagree about how we interpret what we’re seeing.

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Well, I don’t know how much of your own interpretation comes from direct personal observation that makes you too uncomfortable, and how much is purely from various media exposure, so I guess I’ll just have to leave you to it.

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