So I was reading today’s Cracked article. I came across this statement, in the context of someone trying to piece together their dubious paternity:
This seems odd to me. They can show you your DNA markers but are legally prohibited to offer interpretation? What is the basis for that?
To me, this would be like saying a doctor can hand you an x-ray but isn’t legally allowed to tell you whether your bone is broken. I’ve tried Googling this, but the only results I get are in the context of genetic discrimination. I can see why a lab would be prohibited from providing genetic test results to an employer or an insurance company, but I don’t understand the harm of explaining a test result to the patient.
I believe it means that they are not allowed to use it to provide medical predictions because only medical professionals are allowed to do that. 23andMe was started to provide consumers with predictions about their long-term health risks based on their genetic makeup but they had to stop doing that in the U.S. at least because it isn’t legal unless it is approved by the FDA for use as a medical device for specific purposes. They are still around but they had to switch to providing ancestry DNA testing like Ancestry.com. Both companies are allowed to use DNA to analyze who people are related to.
Close. It would be like saying a guy who builds X-ray machines, but is not a licensed medical professional, handing you an x-ray, but is not allowed to tell you how to treat your wrist.
The key here is that the DNA testing company is not legally allowed to give medical diagnosis and advice (for money) without being duly licensed.
The FDA has decided DNA-testing counts as a medical device and must apply for federal approval, so it’s more like you’re not allowed as a private citizen to by an x-ray machine because you won’t know how to interpret the results and it might cause you more harm than good. 23andMe - Wikipedia
Reading about 23andMe’s full genome test at the time they were forced to stop giving you the whole shebang concern was expressed (by doctors and other IIRC) that people were getting these tests back and were freaking out over genes connected with increases in risk despite the actual risks being miniscule. “Aaagh, I’m have a quadrupled risk of Edginson-Pong syndrom! What do you mean that increases it to just 1 in 100 000? I have a quadrupled risk I tell you, give me medicine!”
The problem is that these companies are not doctors practicing medicine, and weren’t held to any standards when they give you interpretations of your genetic information. If they told you that one of your genetic variants was associated with a higher risk of diabetes, that’s dancing right on the edge of giving medical advice or diagnosis. But that interpretation could have come from less-than-thorough research, e.g. that variant was weakly correlated with reduced diabetes incidence in a very small sample of patients at the Mongolian National Medical University in Ulaanbaatur*. In reality, there’s a very real possibility that the correlation was just a fluke.
With advice like that, a lot of people are going to either seek unnecessary testing or avoid getting treatment.
*not to denigrate the fine researchers in Ulaanbaatur, I just happen to be working on a project characterizing genetic variants discovered there. But I would never use that information to give medical advice to parents of children with birth defects!
What stops me from buying an X-ray machine as a private citizen? Most states seem to require a license for anything that uses ionizing radiation, but that looks easy to get, and not substantially more difficult for medical vs. industrial (X-ray inspection of welds, etc.) use. Some states don’t even require licensing of the technicians who take medical X-rays (article, “Texas is one of 39 states that license X-ray technicians”, other article, “Idaho X-ray techs don’t need license”).
In any case, yeah, basically they can’t say because that would be a medical diagnosis, and they’re not doctors individually treating the customers, and they also mostly haven’t done the paperwork and/or don’t have the evidence to get the test approved as a medical device. Maybe a good analogy is those unlicensed ultrasound facilities that take keepsake photos of the fetus? They’re allowed to do that (in some states) as long as the pictures are just keepsakes for the fridge, but they’d get shut down if they tried to offer medical advice based on the scan.
This is very odd did they do the test or send it way to have it done? Normally you will discuss the results with genetic specialists. Did you meet with such person? Did he or she send you way for DNA test?
Did your family doctor referral you to genetic specialists? I known some people that had DNA test done :eek::eek: but they where referral from a family doctor and are working with genetic specialist.
These are private for-profit firms that do DNA analysis. They aren’t part of the medical system. That’s the whole point of this thread. Did you read the thread?
Couldn’t these companies just hire a few doctors to interpret the results for you? I understand the “no practicing medicine without a license” deal, but why couldn’t they hire someone with a license?
I don’t think anything’s stopping them except cost. If the doctors spent a reasonable amount of time with each patient, then 23andMe would have to increase the price to levels inconsistent with its business model. If they didn’t, then they’d be risking their licenses, and there are more profitable ways (e.g., sham pain management clinics) for doctors to do that.
It’s silly - I’ve been with 23andme since the beginning. I’m grandfathered in so I can see the interpretation, but other people can not.
However - anyone can take their raw data - and use free (or very cheap software) and get the same (or similar) conclusions.
So basically - they are only stopping people that don’t know how to get the interpretations of their data.
I understand the desire to keep people who don’t understand statistics from misinterpreting the data, but IMHO - it’s my DNA - and I’d much rather have a company like 23andme making the interpretations.
We are using old laws and procedures in a society where technology is rapidly evolving. I can get tests that show blood sugar, blood ketones, uranalysis - all over the counter.
In three times I have used urinalysis tests to show a doctor something either for myself or a partner. Two of the doctors were totally suprised when they saw this and asked where I got it. They seemed totally unaware you can buy this stuff on Amazon.
Doctors have to have a relationship with their patients.
There are hundreds of thousands of SNPs that 23andme analyses. The solution is not to get doctors involved in shotgun analysis of personal genomic data.
Yes there is always a risk people will make mistakes in interpreting their data. But these were never designed to be medical tests. They are simply showing what studies says about those parts of your DNA.
People are then free to share that data with their doctors if they want to.
23andme analyses the SNPs for stuff like ancestry, characteristics, and other things.
To allow people to see that they have “wet earwax”, but then deny them the ability to see their predicted response to various medications - is well intentioned (in some cases), but short sighted.
Another reason why the FDA wants to regulate these tests is to ensure accuracy. If you just want a nifty printout saying that your ancestry is some mix of Native American, European, [del]Poodle[/del] etc., the error rate doesn’t matter much. But if we’re talking about rare genetic diseases, a seemingly decent accuracy rate can actually result in huge numbers of false positives. Especially when the test is simultaneously examining hundreds (or in the future, millions!) of variants associated with disease.
The latest StarTalk podcast is titled The Promise and Peril of the Genomic Revolution and in it Tyson interviews co-founder and CEO Anne Wojcicki of 23andme. They talk a little about the lawsuit that limits the information the company can report. If you’re interested in genome mapping you might find the podcast informative. Assuming you can tolerate Tyson’s, of course.
A relationship, but not a pre-existing relationship. In almost all states, I don’t think anything stops a doctor from meeting with each customer by teleconference, to discuss the test results and other aspects of the patient’s health, and provide personalized medical advice, as long as the doctor expends enough effort on each patient to establish some reasonable semblance of a doctor-patient relationship. It would just be too expensive.
A test that suggests a woman is likely to develop breast cancer, leading her to choose a prophylactic mastectomy, or that suggests a fetus carries a genetic disease, leading the parents to choose abortion, is also “simply showing what studies say about those parts of your DNA”. So I don’t think that’s an easy way to draw the line. In any case, the question is about the law as it now exists, not as it maybe should.
I work in this field. This is what I do: I do genetic tests and I write reports explaining what the results mean. It is FAR more complicated than most people realize. There is no all-ecompassing Excel spreadsheet that can take a genotype and pop out a reliable interpretation of what it means. Each and every change needs to be studied carefully before we can cautiously interpret what effect the change has. And more than that, these changes don’t happen in a vacuum, but rather combine in complex biological systems. It’s all well and good to say that mutation X increases your cancer risk by 10%, and mutation Y by 17%, but what if you have X and Y together? How about two copies of X and one of Y? Or one copy of X, but gene Y is completely deleted? And so on and so forth. We have to be absolutely certain that the interpretations we report are backed up by solid scientific evidence, or, when no evidence exists, we have to make sure we explain exactly what we don’t know.
Take a look at the best-studied of these cancer-related genes: BRCA1 and 2. There are online databases that store thousands and thousands of mutations that have been found in these genes and classify them from “benign” to “definitely pathogenic”. But even in this case, there are many hundreds of mutations classified as “unknown significance.”
In short, it’s wildly irresponsible to make half-assed guesses about what mutations mean, and that’s what most of these interpretations would be.