5 Reasons Walgreens Selling Personal DNA Tests Might Be a Bad Idea

By Andrew Moseman | May 12, 2010 4:00 pm

WalgreensWhile you’re down at the drug store picking up toothpaste and sleeping pills, why not have your DNA tested? Walgreens says that this month it will become the first drug store to offer personal genomics tests in its store. For the low, low price of $20-30 you can pick up a kit to take a sample of your own saliva, which you mail off to Pathway Genomics, a company partnering with Walgreens.

Customers can then go Pathway’s Web site and order tests. Pathway says the tests — for drug response, “pre-pregnancy planning” and “health conditions” — start at $79 and run up to $249 for all three [AP].

With the personal genomics trend continuing to accelerate, this was perhaps an inevitable development. But the fact that personal tests are going into drug stores doesn’t mean that personal tests are as readily reliable or regulated as the rest of the tests and medications that fill the aisles.

1. The FDA is not pleased.

The Pathway test has not been approved by the Federal Drug Administration. In a statement after announcing this deal, Walgreens washed their hands of responsibility in this regard, saying Pathway assured them that the product didn’t require FDA approval. The FDA, however, does not agree.

In a statement, the FDA said it has regulatory authority over all lab-developed tests. “As new technologies become available and are marketed directly to consumers, FDA will consider all regulatory options,” the agency said. “Consumers should understand that the claims made by a company with an unapproved test have limitations and that they should not be making important medical and lifestyle decisions without first consulting a health care professional” [Wall Street Journal].

The FDA isn’t the only public body worried about these tests. Here in New York, where DISCOVER is located, we won’t be able to run down to Walgreens and pick up a DNA test. The state considers these to be medical tests, and medical tests require a license. When personal genomics companies first began to spring up, New York State issued nearly 40 cease-and-desist orders in 2007 and 2008. It’s still going to take some time to sort out the legality of who can look into your genome.

2. Can you actually learn anything useful?

Remember, only six years have passed since the human genome was fully sequenced. Incorporating personal genomics into medicine is moving fast, but it’s still in the early stages.

In most cases, the current level of DNA scanning technology and science is unable to offer meaningful predictions about the risk that a person will get a disease. “It is a really wonderful form of recreation,” said Scott R. Diehl, a geneticist at the University of Medicine and Dentistry of New Jersey. But as for applying it to health care, he said, “It’s very premature” [The New York Times].

The tests by personal genomics companies like 23andMe and Pathway look at particular point mutations that scientists think to be associated with diseases like Alzheimer’s or cystic fibrosis. Making clear predictions from a person’s DNA, though, will require not only a further understanding of what genes are linked to what diseases, but also how those genes interact with environmental factors, lifestyle choices, and each other, as our reporter found out in 2008 when having her DNA examined by several of the most prominent companies.

All that knowledge won’t come fast, or cheap.

That might take a few years and require sequencing a person’s entire genome, not just sampling selected bits, as the companies do now [The New York Times].

3. Overreaction—and mixed results

As the FDA noted in its statement quoted above, customers must understand the limitations of these tests—and not act too drastically. As DISCOVER’s own Kat McGowan wrote last year, “Another worry is that people may overreact to their results. Someone who has an elevated risk of breast cancer, for example, might take a drastic step like getting a mastectomy, not realizing that the test predicts increased risk, not a particular outcome.”

Then again, if you get curious enough to try multiple tests, you might have the opposite problem. Some curious folks who’ve tried out multiple personal genomics firms have received contradictory answers.

4. The fine print

Even if you don’t act on the information that a personal genetic test brings, it could impact you emotionally to learn about your ancestry or your family (say, if your father wasn’t your genetic father). That’s why the fine print on personal-genomics products is so extensive.

And the ramifications could do beyond the emotional realm. The Genetic Information Nondiscrimination Act of 2008 offers some protection for personal genetic information, but how much is not terribly clear. Things are changing fast in the world of personal genomics, and it may be difficult or impossible to predict the significance, or even risk, of information you learn in 2010. As 23andMe’s terms and conditions notes:

Even if you share genetic information that has no or limited meaning today, that information could have greater meaning in the future as new discoveries are made. If you are asked by an insurance company whether you have learned genetic information about health conditions and you do not disclose this to them, this may be considered to be fraud.

5. Ready for the shelves?

Still, though, why shouldn’t you have the choice of whether to test your own genome? You get to test yourself in other health capacities:

Drug stores already carry a variety of diagnostic tests, like those for pregnancy, cholesterol and blood sugar. When some of these tests were introduced, there was controversy about whether consumers could test themselves.

Although broader in scope, Pathway’s test is not the first DNA-based analysis to be sold in drug stores. Sorenson Genomics began selling a paternity test through Rite Aid stores in late 2007. Sorenson has sold more than 100,000 tests through Rite Aid and other major pharmacy chains since then, according to Jacob Moon, a spokesman for the company [The New York Times].

But personal genomics is a different ballgame. Paternity tests and pregnancy tests bring you clear yes-or-no answers; they don’t evaluate complicated, multifactorial questions like those that personal DNA tests try to answer. And that complexity may be more than consumers bargained for.

Related Content:
DISCOVER: How Much Can You Learn from a Home DNA Test?
DISCOVER: Your Genome, Now Available for a Relative Discount
Gene Expression: Creative Destruction in Personal Genomics
Gene Expression: Personal Genomics Is Dead; Long Live Personal Genomics

Image: flickr / twodolla

CATEGORIZED UNDER: Health & Medicine
  • Cisse Spragins

    Do we really need FDA regulating a test kit? What is the point of this? Is swabbing some saliva really going to put people in danger? People are smart enough to decide for themselves if they want this information, and to discuss any concerning results with their doctors if they so warrant. And their doctor can order confirmatory tests if needed. The FDA is an incompetent anchor against progress.

  • http://www.usa-siliconvalley.com Andras J. Pellionisz

    5 Reasons why it may be a GOOD idea:

    1) The FDA is not pleased. That may be a very, very good thing. Francis Collins, M.D. Ph.D., Head of NIH, eligible for the Nobel Prize explains it in his bestseller book on Personalized Medicine. He argues that the core philosophy of FDA (“one size fits all”) is obsolete. Of course, those stuck with obsolete axioms are not pleased when progress finds them overtaken. Please yourself, not the FDA.

    2) Can you learn anything useful? Again, read Francis Collins’ book (or view YouTube “Shop for your Life!”). He already altered his lifestyle, e.g. to help prevent late-onset macular degeneration (that already occurred in his family) – and he is eating lots of fish (for Omega-3). He can’t go wrong, since he likes fish, anyway. On the other hand he can be even more proud of himself as a trail-blazer looking after his own health before becoming a victim of “Sick Care”.

    3) Overreaction – or mixed results. That is actually fantastic. Hollywood has long known that there is no such thing as “bad publicity”. Histeria or overreactors or mixed-up people saves $$$ for marketing.

    4) The fine print. Helpful to keep away lawyers that few people seem to like.

    5) Ready for the shelf? Wrong question. Are the shelves ready? Apparently in two days kits will be flying off the shelves, making better good for you than bubble gum, silly key-chains or tons of useless junk. CVS is already trying to catch up with trailblazer Walgreen’s.

  • jones

    Advances in science should only be used by governments to keep surveillance over it’s people or maybe to kill people from other countries. We certainly can’t allow regular people to use the benefits of science. They’re not responsible enough! /s

  • Shotgunner

    How is it the government’s concern? What harm is there for me to send $30 to a company who then tell’s me what they learn about my genes. I think this is terrific. What if my bride has a genetic predisposition for breast cancer? Then she can be diligent in screening and communicating with her doctor about this topic.

    My only concern is privacy. If the testing does indeed learn something the only one who should know are the testing lab, me and my physician. Other than that, sounds great to me. Great work on a terrific business that in all likelihood will increase longevity in many individuals.

  • gisela hersey

    i am all for this aid in cheaper advance testing, and the government should stay out of it. what people decide, weather it is useful for them or not, should still be an individual choice.

    It’s always good to know your predispositions and either act on them or not, it’s still
    your choice.

    personally, I am sick and tired of the so called government protections.

    they don’t accomplish that much, they are expensive, they mislead people
    and take away precious time, which some of us senior citizens don’t have.

    thanks for giving me the opportunity to voice my thoughts on the subject.

    sincerely, Gisela Hersey

  • Warren Emerson

    Despite the ‘potential problems’ there is no health risk to the individual ordering it and therefore there is no role for the intervention by the FDA. Doctors have created many procedures with equally questionable results and no one stopped them. Companies offer many products offer dubious if any benefits and no one has stopped them. The ‘problems’ with this seem relatively benign.

  • Jamie

    The big problem I see with this is over-reactive people will start getting tons of testing done, such as colonoscopies, mastectomies, mri’s, ct’s, and more, costing insurance companies, and the government. With the government subsidizing a big portion of healthcare costs, we as tax payers cannot afford over zealous people burdening the system with unnecessary testing.

    As long as tax payers do not foot the bill on unnecessary testing, and insurance companies don’t pass on the higher costs to me and my family for unnecessary testing, then I have no problem with DNA tests being available to all. But, come on, let’s be serious, this will increase healthcare costs.

  • Jeffrey Uhlmann

    Doctors already prescribe similar tests, e.g., for breast cancer risk, so it seems reasonable for a woman with a family history to want a convenient (and cheaper) alternative to making a doctor’s appointment. It’s not like she’s going to go out and get a prophylactic double mastectomy based on the result without any consultation with a doctor, so where’s the problem?

    Also, in this article and similar ones there’s an implicit assumption associated with all the hand-wringing that the average physician is trained and gives adequate “counseling” to patients in association with test results obtained through conventional procedures. To what extent is this true? The article basically reinforces a stereotype that the average consumer interested in genetic information is an uniformed person prone to hysterical overreaction. I find that tone completely demeaning because it’s directed at the reader: me.

  • MyMed

    Can You Say: “Giant Government DNA DataBase”…

  • Im_dumbfounded

    I see that many of you, like my family and I, believe that the government has grown (and is still trying to grow) into one massive Nanny-State. They seem to believe that the average person is not competent to take care of themselves, so they feel the need to intervene – rather they see an opening and impose the intervention.

    However, almost everyone here has addressed the fact that this test would be cheaper than having it done in a doctor’s office, or stated that this may be a less expensive alternative.

    Go to http://www.walgreens.com and search for the product. BE SURE TO READ THE FINE PRINT.

    You buy the 2 swabs and the individual envelopes for $30. Then, to have the actual test done, you send the swabs along with $119.00 into the lab.

    The problem I see is that this could potentially cause a major issue within families. It is not being marketed as a test to find key disease markers. Nooo, it IS being marketed as a PATERNITY TEST. I have grown up with a sister who believes she has not been sired by our father. (Frankly, she is too much like him for it to be denied). In the eventuality that someone would like to use these results in a paternity suit in court – more of the fine print clearly states AN ADDITIONAL $200 MUST BE SENT (THIS IS IN ADDITION TO THE $30 FOR THE PURCHASE AND THE $119 FOR THE TESTING). It states that the DNA samples must be collected and handled in a ‘strict’ manner to be admitted to court. I should hope that any biological testing would be handled with the utmost of care, especially given the charges and potential damages that could happen.

    I don’t like the government telling me what I can and cannot do; but I’m not so sure society is ready for do-it-yourself DNA testing.

  • Pensacola Florida


  • Cory

    Wow, I think it all comes down to “we’re too dumb for this”. Are we really to the point where everyone, from doctors to our bloated government’s departments, has such a distrust of the common man’s intelligence? It’s insulting, giving the climb in literacy, knowledge and higher education in the population.

    Anyone who withholds non-harmful tests like this because they believe we’re too stupid and neurotic to deal with our own genetics and health is nothing short of a patronizing tyrant.

  • Im_dumbfounded

    Hi Cory,

    i don’t believe it actually comes down to “We’re too dumb for this” Though I do agree wholeheartedly with what everyone is saying about the regulations.

    I think, rather, that it comes down to power and money, just as it always does. They see a way to manipulate and maintain control “for the good of our citizens, the poor little embaciles (spelled incorrectly on purpose).
    They believe they have the power (and they do) to tell us what we can and cannot put in our bodies. Just think of it this way; in a Royal Society System, the King/Queen has total control of everything (not modern-day England where the title is kept for respect and tradition, I’m speaking of those monarchs who actually wield the power of their station): They knew they had total control within their own borders, so they craved more lands and more riches….Extremely few times in history do you see anyone giving up power willingly. Rather, you see them invade other countries in attempt to force them to act on your will alone.

    I would have to do some major research to see precisely why the FDA was created. But in the game of politics, the thing one does is “grow your domain” That means they believe they should have control over what a person puts into their body – I’m sure it must have started as a safety net – to keep people from doing wrong to one another, to keep individuals fro becoming wealthy on products where they are sold as “cure all ails” but really is a high concenration of Belladonna – a very slow acting painful deadly poison.

    There are so many things that our government is doing that they really do not have the power to do these days, it started decades ago, if not from day 1. For example:

    Row vs Wade – This should be a decision left to the state and the Federal Government should never have gotten involved.

    Passing a Mandatory Health Insurance Plan – The constitution does not provide that kind of power to the legislative branches of government.

    The Constitution itself has a limited number of directives and states that anything not included is the responsibility and duty of each sovereign state rather than the Federal Government.

    The creation of Income Tax and the IRS – unconstitutional because they do not have the power to execute such an organization which brings us to the states sending ‘federal income tax money into the federal government” Truly the government needs money to run on. If they did away with all the ‘nanny-ing’ programs such as Food Stamps, Wic, Unemployment, Worker’s Compensation, etc. They would not *Need* as much to run the government. The States are charged for looking out for their own persons. The federal government has a completely different purpose, but as catnip is to cats, Money is to Politicians.

    I’m sorry, I seem to have jumped on a soap box to an audience who already knows these things…I do apologize. What we should be doing is getting the word out about these injustices and have each state take their money back. If we didn’t pay so much into the Fed, they could not have as much to return to us — but each state would have control over what to do with the revenue it legitimately earns and we would not need Big Brother telling us how we can spend our own money.

    Americans – need to quit relying on not working and being pampered by the state. People need to accept and take responsibility for their own selves rather than figuring out how to work the system, over-costing the system so that it is plainly quite broke and only becoming more so. There are times when a bit of help from the government (state) should be made available, but these days, so many people decide that they do not have to work because Uncle Sam will jus sit back and take care of them. Well, its happening with MY MONEY and I want it back.

    Perhaps we begin a letter writing campaign to all of our representatives, senators, vice president, and president to make clear what their job is and how they can relinquish their power base and handle those jobs for which they were elected. Until this is done – We will always have Big Brother.

  • rjs

    The main issue missed here is the point of sale information or lack therof. Consumers tend to ask specific questions about what the test will do at the point of sale. I know hundreds of retail (clinic) outlets for this test and the person sellling the test often says “yes” when the consumer asks if it will give specific information. They are obviously giving misleading information but don’t know any better. The consumer is not reading a sample report in advance of purchase and the sales person usually has no idea what they are selling.

  • Eric H

    The FDA is, A: Complete block to progress. B: Wants to “regulate” these cotton swab test’s for higher cost to us. C: Has approved drugs to be safe, whose side effects include “heart attack, stroke, even death”. D: Should be evaluated itself! And regulated itself, and foremost should replaced with an association that actually gives a damn about us the people, not doctors wallets. I am sick of all this non-sense, this shoud be a red flag for us people that we should be taking a long good look at this FDA…its getting old fast. No association should tell me what I can/cannot do with my personal information/genes/ect.

  • http://blogs.discovermagazine.com/80beats/2010/05/12/5-reasons-walgreens-selling-personal-dna-tests-might-be-a-bad-idea/ Hayley Petunia S-J.

    Good point. But there some reasons consumers should be allowed to test themselves.
    1. People HAVE their RIGHTS.
    2. People KNOW about risks and stops them MORE than we give them credit for.
    3. VERY FEW people REGRET knowing their risk.
    4. According to RECORDS overreaction and panicky actions are EXTREMELY RARE.
    5. NO medical experts need to be INVOLVED.
    I agree that consumers should not be allowed to test themselves. I am just listing the reasons. And that does not mean I do not think there is a problem with consumers testing themselves.

  • http://www.cheatmaven.com/forum/member.php?u=201 Jalisa Hooe

    I am not very excellent with English but I get hold this rattling leisurely to translate.

  • http://blogs.discovermagazine.com/80beats/2010/05/12/5-reasons-walgreens-selling-personal-dna-tests-might-be-a-bad-idea/ Hayley Petunia S-J.

    Dear Pensacola Florida,
    You know, not all of us are over 18. And also, even though we are in America, a free country, we must still have laws and rules that protect us, yes? The FDA is most definitely NOT out of control. It’s just doing its usual job of making sure kits and procedures and the like are safe for us citizens to use. And it might be true that the FDA is more intelligent than the rest of us. You can see that I am against using this procedure or kit or thing…or WHATEVER! You should think before you write stuff like that. Your comment could get “report-abused”.
    Hayley Petunia S-J.
    P.S. Could you please not write in all capital letters next time you leave a comment. It’s kind of hard to read for me, and I think for others, too. Did you accidentally put on the Caps Lock thingy?

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