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May 11, 2010 5:25 PM   Subscribe

"Starting Friday, Walgreens' shoppers can buy an over-the-counter genetics test from Pathway Genomics at 7,500 stores across the country. Priced at $20 to $30, the kit claims to offer information on users' possibility of developing conditions like Alzheimer's disease, breast cancer, or diabetes. Access to the scientific analysis online, however, costs another $79 to $179"* [video | 02:31]. "But doctors and geneticists fear the worst for this new over-the-counter access to genetic testing. With no physician to interpret the results of the test, and no FDA regulation of how results are processed or delivered, there is the potential for consumers to misinterpret what their risk really means for their health and their lifestyle."*

"...the U.S. Food and Drug Administration [FDA] says it has no record that the test kit was approved or validated by the agency and plans to take a hard look at any claims made by the company ... Walgreens said FDA clearance is not required to sell the kit in its stores. The drugstore chain already sells other diagnostic and testing products such as pregnancy tests, paternity tests and drug tests."*
posted by ericb (47 comments total) 6 users marked this as a favorite

 


When I first saw the words "over-the-counter genetics test" my first thought was that it was a test to establish paternity. Hoo boy, would that ever get things off to the races.
posted by orange swan at 5:28 PM on May 11, 2010 [7 favorites]


note the quote above, orange swan...the paternity tests are already available...
posted by HuronBob at 5:32 PM on May 11, 2010


...doctors and geneticists fear the worst for this new over-the-counter access...

I bet they do. But I'd trust them a hell of a lot more if it wasn't for the giant conflict-of-interest albatross hanging around their collective necks.
posted by Kadin2048 at 5:36 PM on May 11, 2010 [6 favorites]


Are they subsidizing the cost by selling your data to insurance companies? I bet the insurance industry would love to know if a potential customer is predisposed to expensive medical conditions.
posted by mullingitover at 5:40 PM on May 11, 2010 [2 favorites]


I want a genetic test that will tell me which superpowers I will develop.
posted by XMLicious at 5:40 PM on May 11, 2010 [3 favorites]


I think the pros of widely available genetic testing greatly outweigh the cons of not having a doctor interpret the results. I'd bet the docs are worried they will have one less set of tests to markup and make a profit on.
posted by thorny at 5:40 PM on May 11, 2010


I can see what they're worried about, but I think the advantages of cheap genetic testing outweight the dangers of it. This is especially true about carrier status for genetic disorders - making that kind of testing cheap and easily available could really help us minimize them.

As far as giving the information to insurance companies, I doubt they're allowed to. There's all kinds of nasty regulations about sharing someone's medical records against their will.
posted by Mitrovarr at 5:46 PM on May 11, 2010


I've actually done the Pathway test (after I got my brain tumor) since I was curious what my genetic disposition was towards bad diseases. It's kind of goofy, you just get a range of no risk, moderate/distant risk, and higher risk for a bunch of ailments and disease.

It seems crazy for them to say I'm likely to get colon cancer someday simply because I spit some saliva into a vial, but alas.
posted by mathowie at 5:47 PM on May 11, 2010 [2 favorites]


Key point from ericb's link, after the main post:

The tests look only at some genetic markers; they don’t cover anywhere near all the genes involved in common diseases, most of which haven’t been found yet, nor do they generally account for environmental and lifestyle factors. Learning that you have a gene linked to a high risk of heart disease is a little like learning you have slightly elevated cholesterol: a good thing to know, but not the only thing you need to know.
posted by Jody Tresidder at 5:48 PM on May 11, 2010 [5 favorites]


I think this is great. More information is better. Am I right, internet?
posted by psergio at 5:51 PM on May 11, 2010


The one sold at Walmart just reads "Incomplete".
posted by Inspector.Gadget at 5:52 PM on May 11, 2010


I'm so on the fence about this sort of thing, especially for myself.

On one hand, not knowing my father or his family, it would potentially be quite helpful for determining whether or not I could develop those crazy diseases you see on House all the time, and finding ways to lessen the risk. But on the other hand, what if I find out something completely terrible, like I have a 99% chance of dying of non-preventable, completely-fatal HurfDurf disease?
posted by kerning at 5:57 PM on May 11, 2010


doctors and geneticists fear the worst for this new over-the-counter access to genetic testing. With no physician to interpret the results of the test, and no FDA regulation of how results are processed or delivered, there is the potential for consumers to misinterpret what their risk really means for their health and their lifestyle

how paternal. give it up (the $$$ that come from explaining test results) Yes, it is better with the professional in the mix, but all too often that means no test, no results, etc.
posted by caddis at 6:09 PM on May 11, 2010


Are they subsidizing the cost by selling your data to insurance companies? I bet the insurance industry would love to know if a potential customer is predisposed to expensive medical conditions.

That does raise an interesting problem. With no involvement by the medical community, could these DNA test results technically skirt the definition of a "medical record"? If so, might then the test results not fall under the privacy protections awarded under HIPAA? That would allow complete sharing of the detailed results with insurers, employers, or anyone else. I could easily see a repository/database being made available (for a fee, of course) to insurers whereby they can search for the test results of their policy holders and anyone applying for coverage.

I'd advise looking long and hard at the fine print before sending the test in for processing to see whether Pathway reserves rights and/or ownership to the test results, and whether there is any language concerning 3rd-parties or "partners".
posted by Thorzdad at 6:20 PM on May 11, 2010


With no physician to interpret the results of the test

Dear physicians, remember all that volunteer work you had to do to get into med school? I've got some more for you.
posted by Panjandrum at 6:22 PM on May 11, 2010


I might be genetically predisposed to snark.
posted by ovvl at 6:24 PM on May 11, 2010 [2 favorites]


I can't wait for the AskMes.

Especially because in a couple weeks I'll have the 23andMe results I could afford thanks to MeTa and DNA Day.
posted by sallybrown at 6:27 PM on May 11, 2010


If the test results came back with a Walgreens coupon for half hour film developing or a dollar off Depends, you might have two things to worry about.
posted by hal9k at 6:36 PM on May 11, 2010


I've actually done the Pathway test (after I got my brain tumor) since I was curious what my genetic disposition was towards bad diseases.

I thought about doing one after I was diagnosed with hereditary kidney cancer but, I just can't bring myself to do it. I already have 2 diseases that come from my genes (cancer and diabetes) plus other non genetic stuff, I sure don't need to know if I'm going to come down with anything else. My anxiety issues are bad enough as i is.
posted by SuzySmith at 6:48 PM on May 11, 2010


"The results of your genetic test would suggest you should probably exercise, maintain a healthy weight, eat the right foods, limit alcohol, not smoke, and enjoy every day as if your life could come to an end at any moment."
posted by docpops at 6:48 PM on May 11, 2010 [21 favorites]


"And in past life it appears you were either Cleopatra or Alexander the Great."
posted by docpops at 6:49 PM on May 11, 2010 [2 favorites]


Dear physicians, remember all that volunteer work you had to do to get into med school? I've got some more for you.
posted by Panjandrum at 6:22 PM on May 11 [+] [!]


I painted houses in the summer and didn't want to be an engineer, actually.
posted by docpops at 6:51 PM on May 11, 2010 [2 favorites]


Are they subsidizing the cost by selling your data to insurance companies?
There is a specific law against this. However, 23andme is subsidizing its costs by sharing statistical information with drug companies. I don't really see a problem with this as long as they're forthcoming about it.

Yes, it is better with the professional in the mix, but all too often that means no test, no results, etc.

The problem is that many common medical tests lead to people getting expensive and intrusive treatment, when it isn't at all clear that the treatment improves their health outcome. See the recent controversies about younger women getting mammograms.

The paternity tests are already available...

And in a poor, predominantly African-American part of my town, there's a huge billboard advertising them right above a CVS at one of the busiest intersections.
posted by miyabo at 6:53 PM on May 11, 2010 [2 favorites]


Are they subsidizing the cost by selling your data to insurance companies? I bet the insurance industry would love to know if a potential customer is predisposed to expensive medical conditions.

Why? discrimination (including for health insurance) based on genetic information has been illegal for years.

Besides, why would you even need to give them your real name? The tests is cheap because genetic testing is actually not that expensive anymore. You can sequence an entire individual genome pretty cheaply now, I don't know the exact cost but people think it will be possible to do for a few thousand dollars.

I don't see why the FDA should be involved. If they have a problem with it, just do the test overseas. It's just information it's not an actual object or medicine. It uses a saliva sample.
posted by delmoi at 6:56 PM on May 11, 2010


For me this would be a bad idea as I have a tendency to fixate on the smallest symptom and then be unable to stop worrying about it. I imagine every test is going to come back with some chance of developing future illnesses. It's like looking up a symptom on an internet site. The one diagnosis you can be sure you won't get is that you don't have anything to worry about.
posted by digsrus at 7:05 PM on May 11, 2010


You can read their privacy policy here:
Third Party Service Providers may have access to and use Account Information and Survey-Based Information to deliver these services to you on our behalf. They will have no access to Genetic Information, other than Type of Genetic Test.
The above involves 3rd party contractors working for pathway, not anyone they sell information too. Here the section on how they "share" information:
# Pathway Genomics will NOT share your Genetic Information or any other personal information with your employer or health insurance issuer, unless you expressly authorize us to do so.
...

We may provide your Genetic Information and Survey-Based Information, unlinked from your name and Account Information, to research collaborators to conduct Pathway Genomics-authorized scientific research and development. You cannot opt-out from this research. We also may pass on to you a research collaborator's request that you volunteer additional information or participate in a study. No name or Account Information is shared with a research collaborator without your express consent.
There is also some stuff in there about an opt-in program for "Ancestry Information Sharing"

So basically it sounds like there is some upsell, which results in, if you choose, sending your data elsewhere. They also pass your data on to scientists, but not linked to your name or any information (of course, it's always possible they could link that DNA back to you somehow)

Frankly, I think the privacy information should be more clear, and not mixed in with the standard "website" privacy policy stuff. But they are not selling your genetic data to anyone, at least not directly linked to your name. I would be worried about the data they are sending to scientists, though. Who knows where it might end up. If I were designing the service, I would just delete the data after the user got their report.

And again, health insurance companies and employers can't use genetic information to price policies or deny plans, thanks to Genetic Information Nondiscrimination Act of 2008
posted by delmoi at 7:08 PM on May 11, 2010 [1 favorite]


Frankly it is the bait and switch on price-for-test vs cost-of-results that is most morally problematic. Being able to access diagnostic and informational resources without having to go through sanctioned (ahem, "rent seeking") gatekeepers should really be unproblematically a good thing.
posted by yesster at 7:14 PM on May 11, 2010 [2 favorites]


Pay your $30 and get ready to freak out.
posted by tybeet at 7:17 PM on May 11, 2010


I don't see why the FDA should be involved.

The FDA regulates medical devices (defined in 21 USC 321(h)). If the company makes any claims that the test is "intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease" then the test may fall under the FDA's regulatory purview. This is why there's probably a block of test on the package or website somewhere stating that the test is, in fact, not intended for any such purpose.
posted by jedicus at 7:22 PM on May 11, 2010 [1 favorite]


Future headline:
9 die in school bus crash.
Driver's risk for heart attack revealed by genetic test, but not shared with employer.
Repub senators call for mandatory disclosure of genetic risks as part of employment screening.
"This man knew he was taking those sweet children's lives in his hands, but our out-of-date laws prevented us protecting them."
posted by bystander at 7:28 PM on May 11, 2010 [3 favorites]


Okay, so how does this compare to 23andMe? Why is it so much less expensive (than the non-super-sale price a bunch of us got in on)?

Also, why haven't I sent my sample back to 23andme? I paid for it the analysis already...
posted by flaterik at 8:19 PM on May 11, 2010 [1 favorite]


As a genealogy freak who has tested with Pathway Genomics and 23andMe and FamilyTreeDNA.com, I can say that the best health information, by far, came through 23andMe, and the best genealogy information through FamilyTreeDNA.com. Pathway Genomics is the least exciting and least informative of the bunch by far, so it kind of sucks that they're the ones that are going to go widespread because of these kits at Walgreens.

If you have to pick only one direct-to-consumer genetic company to test with, I would recommend testing with 23andMe, unless you're a hardcore genealogy nerd. Thanks to 23andMe, I got peace of mind that I do not carry the BRCA1 breast cancer mutation, and that's nice to know -- and I also found out a few other not-so-good pieces of news that I will talk to my doctor about, to stash away in my medical file somewhere, potentially of use to him when I get old(er). I for one find it empowering, not scary, to get a heads up about these kinds of things.
posted by Asparagirl at 8:48 PM on May 11, 2010 [2 favorites]


jedicus: "30I don't see why the FDA should be involved.

The FDA regulates medical devices (defined in 21 USC 321(h)). If the company makes any claims that the test is "intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease" then the test may fall under the FDA's regulatory purview. This is why there's probably a block of test on the package or website somewhere stating that the test is, in fact, not intended for any such purpose.
"

For entertainment purposes only?
posted by Bonzai at 8:53 PM on May 11, 2010


"You want to know how I did it? This is how I did it, Anton. I never saved anything for the swim back. "
posted by Justinian at 10:01 PM on May 11, 2010 [4 favorites]


"The results of your genetic test would suggest you should ... limit alcohol, ...

OK.

and enjoy every day as if your life could come to an end at any moment."

Woah, wait. Back up.

---

Did anyone else do that National Geographic genetic study thing they had a few years ago? You paid $100 and they sent you a kit where you swabbed your mouth, sent it in, and they told you where your very distant ancestors came from. I didn't find anything surprising, but it came with a map (of course) and a DVD. I was going to do it again for the other side of my family, but I didn't get around to it.

This is relevant, because it involved genetics.
posted by dirigibleman at 10:37 PM on May 11, 2010


I did the 23andMe and it was somewhat interesting but not mindblowing (partly because I'm a woman and without a Y chromosome they can't give you any genealogical info about your dad's side.) I suspect that once the initial "ZOMG genes!1!" reaction dies down this won't be such a big deal.
posted by cali at 10:43 PM on May 11, 2010


Really? Clearblue had to introduce a pregnancy test with the words "pregnant" or "not pregnant" because buyers were unable to interpret what the lines meant on the older style sticks.

And now they think that same audience is ready for over the counter genetics testing? Think what happened to hypochondriacs when WebMD came out, cube it, and multiply by infinity.

23andme is interesting because the price and experimental nature of it limited its audience to a prospective market of those who would be able to handle and appropriately treat the data from it.
posted by cgomez at 10:49 PM on May 11, 2010 [1 favorite]


Just wait til we have OTC lists of SNPs and copy numbers.
posted by kersplunk at 11:11 PM on May 11, 2010


The FDA regulates medical devices

How is this a "device"?
posted by delmoi at 11:18 PM on May 11, 2010


FADE IN:

DAY

We are MOVING TOWARD a Walgreens. Futuristic cars hover lining up for fly-through prescriptions. The CAMERA MOVES TOWARDS the Walgreens' entrance. Automatic futuristic door swoosh open. DECKARD walks out of the Walgreen's with a shopping bag in hand and a pensive look.

CUT TO

INT. DECKARD'S CAR - DAY

Deckard gets in the car, Rachael is beside him.

RACHAEL
Did you get it?

DECKARD
I got it.

CUT TO

INT. DECKARD'S BATHROOM - NIGHT

SPLASH. Deckard is pissing. An OPEN VOIGHT-KAMPFF TEST KIT BOX is sitting on the sink. Deckard is dipping a test strip in the stream of urine. THE CAMERA MOVES to reveal Rachael lying in bed outside. Deckard shakes the test strip.

RACHAEL
So?

DECKARD
Yeah, I'm a fucking replicant.

posted by benzenedream at 12:07 AM on May 12, 2010 [14 favorites]


Did anyone else do that National Geographic genetic study thing they had a few years ago?

Yeah, it's the Genographic Project (previously), and it looks like you can still do it. The map was pretty cool; I haven't looked at the DVD.
posted by kirkaracha at 6:16 AM on May 12, 2010


Go to Walgreens, buy Pathway test, go home, take it...

*bing*

YOUR BODY IS INFECTED WITH SPYWARE. CLICK "OK" TO CLEAN.
posted by BobFrapples at 8:57 AM on May 12, 2010 [1 favorite]


I want a genetic test that will tell me which superpowers I will develop.
posted by XMLicious


This can't be determined by a DNA test. The superpowers you develop are entirely dependent on the type and strength of radiation to which you are exposed as well as, in some cases, the type of biological entity that bites you.

There are some who theorize that a brooding mental state is also required proximate to the radiological event but again that cannot be predicted by DNA test.
posted by Babblesort at 9:19 AM on May 12, 2010 [3 favorites]




At least the genetic test kits actually work, unlike all the homeopathic shit Walgreens sells.
posted by benzenedream at 10:49 PM on May 12, 2010


Babblesort, that's the process for mutates (e.g. Spider-Man, Hulk), not mutants (e.g. Cyclops, Wolverine). Clearly a DNA test would be searching for homo superior markers; if the results come back positive, XMLicious would of course be rebranded "X-Malicious."
posted by nicepersonality at 8:39 AM on May 13, 2010 [1 favorite]


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