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23andMe Now Facing Lawsuit

Shortly after getting in trouble with the Food and Drug Administration, the personal genetic testing company is slapped with a class action lawsuit.

By | December 4, 2013

WIKIMEDIA, SAM HOWZITLisa Casey, a San Diego resident and subscriber to 23andMe’s Personal Genome Service, complains in a lawsuit filed last week (November 27) that the company misled her about its product. Casey's beef with 23andMe is similar to that of the US Food and Drug Administration's. Earlier in November the agency told 23andMe to stop marketing its Personal Genome Service (PGS) because its determinations about health risks and disease carrier status are not clinically validated.

According to the lawsuit, Casey purchased the $99 genetic test in September 2013 and received an e-mail with her results on November 19. She bought the test after seeing advertisements from 23andMe that consumers could learn about their health risks and ancestry. “In fact,” the case states, “the PGS does none of those things and the results it provides are not supported by any scientific evidence.” The suit goes on to claim that Casey has suffered injury, in addition to losing money, as a result of 23andMe’s “false and misleading representations.”

It’s not clear what the injuries were that Casey suffered. The FDA has voiced its concerns that consumers might take drastic steps—such as prophylactic breast removal—based on erroneous results of the PGS. Although people can still buy 23andMe’s kits, the company has stopped marketing the product after the FDA’s crackdown. In a post on 23andMe’s website last week, CEO Anne Wojcicki wrote that “we stand behind the data that we return to customers — but we recognize that the FDA needs to be convinced of the quality of our data as well.” 23andMe might have to convince a judge and jury now, too.

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Avatar of: LeeH

LeeH

Posts: 31

December 4, 2013

Lawyers saw an opportunity to sue regardless of the merits of the science simply because the FDA had not yet approved the tests, ergo supported the claims.  This lawsuit is motivated by money and nothing more.

Avatar of: JohnnyMorales

JohnnyMorales

Posts: 9

Replied to a comment from LeeH made on December 4, 2013

December 4, 2013

Amazing you apparently believe that when it comes to businesses the desire to make money flows from the purest spring of inspiration, sweetened by elemental good will, and thus businesspeople and their intensions are above reproach in their desires to sell a quality product.

That's the only explanation for believing so stupidly that lawyers in their pursuit of a payday are horrid parasites, some the most corrupt creatures on Earth whose intentions are always base and low.

Heaven forbid that you ever learn that making a living making sure corrupt businesses cannot profit from their lies and deceit is a virtue, and those who choose that path definitely provide a benefit to all far greater than whatever failings their greed might cause.

I do understand though. You probably think the ideal shopping world's moto is "buyer beware" and eagerly blame buyers when they buy something that is not what they were promised.

Avatar of: wctopp

wctopp

Posts: 30

December 4, 2013

23andme is pretty much the only science that will ever enter the consciousness of the average U.S. citizen.  The amount of misinformation and disinformation out there passing as "science" is enormous.  We're a Nation of profound scientific know-nothings.  Along comes 23andme and suddenly people are thinking about genetics, that genetics has relevance to their lives and that it's something they can find interesting.  I have no beef with FDA and my guess is that 23andme's top management really dropped the ball on this and that their major shareholders should be screaming for a wholesale housecleaning of management.  That doesn't change the simple fact that 23andme is science that has managed to sneak into the everyday consciousness of at least some of our citizens.  It's science and it's actually popular.  It will be a tremendous loss if some compromise can't be found, and if they sink in a sea of opportunistic lawsuits.

Avatar of: blumberg

blumberg

Posts: 32

December 4, 2013

Pop-science garbage, all based on a literature of which less than half is reproducible.

Avatar of: BillInLA

BillInLA

Posts: 2

December 4, 2013

Help me if I fail to fully understand the FDA's position: people take the test, learn of genetic predispositions toward or not toward certain ailments. FDA's concern is that a woman is going to take the test, find a history of breast cancer in her family, and then run to her doc and insist on having have her breasts cut off, despite anything the doctor might say.

A relative gave me a 23andme for Christmas. Lazybones that I am, I've registered but not sent in the saliva test. I'd bet my life that 23andme would say that on the basis of genetic history, I have an extremely high risk of coronary artery disease.

Well, I don't have coronary artery disease. I'm as absolutely sure of that as anyone can be. Why? When I had quadruple coronary bypass surgery a couple weeks ago, the surgeon checked the other arteries.

I knew this was coming because of the horrid family history of coronary artery disease I know about (father, brother both died at 40.

So exactly what is the problem with getting information on genetic predisposition to a disease from yet another source? I don't get it. If I'd been 23 and 23andme had given me that result, I'd have tucked away the info and watched for signs. What a shame my father didn't have access to that same kind of info.

Avatar of: DrPJ

DrPJ

Posts: 1

December 4, 2013

It is difficult to fully understand this woman's complaint (or the FDA’s).  Direct-to-consumer testing has been available for a long time in many states, such as to check one's blood cholesterol levels without needing a physician’s test order.  23andme has its genome sequencing performed by a CLIA-regulated laboratory, (where “CLIA” is the set of federal requirements that all U.S. labs performing diagnostic tests must meet, and are the labs that doctors must use.)

Much of the genetic data is indeed too early to apply to definitve diagnoses, but that does not make it invalid or incorrect.  Obviously, complex diseases with multiple traits like cancer are tough to pin down exactly regarding one’s true risk.  However, 23andme’s reported gene mutations for Mendelian traits such a CF gene mutation (where two bad copies = cystic fibrosis) are the same as if it was ordered by a doctor.  I would argue also that knowledge of drug metabolizing enzyme mutations is very useful and actionable information as well.

I have used 23and me, and let's just say they can tell you without any additional information your eye color, hair type, race, etc. from this genetic data so it is not bunk.  The lack of scientific literacy of the U.S. population really goes to the heart of these lawsuits.

Avatar of: Pongo

Pongo

Posts: 1

Replied to a comment from BillInLA made on December 4, 2013

December 5, 2013

The FDAs primary problem is that the quality of the information (both techically and with interpretation) is suspect with these companies. A GAO investigation published in 2010 compared the results of four (unnamed) companies who provided direct to consumer genetic information. They used 15 fictitious consumer profiles and often got different results from all four companies, calling into question the validity of any results coming from these outfits. 


These companies are diagnosing disease and providing medical guidance (limited to disease fact sheets usually). These are activities clearly under the purview of the FDA. The fact that the FDA attempted to work with 23andMe for five years and provided them with crystal clear guidance on what they needed to do to get approval and that 23andMe not only ignored them, but went on a major marketing spree after being told they needed approval puts the issue into perspective. 23andMe thumbed their noses at the FDA--very deliberately and very foolishly. They tried to hide in the gray area where sequencing technologies are outpacing regulatory efforts (same thing is happening with stem cell 'therapies') and they got busted--as they should have. 

This is not the FDA trying to keep personal genetic information from consumers. This is the FDA trying to make sure that the information provided is accurate, especially if people may be making life-altering decisions based on it. Here is the link to the GAO report about DTC genetic testing issues titled 'Direct-to-Consumer Genetic Tests: Misleading Test Results are Further Complicated by Deceptive Marketing and Other Questionable Practices.'  Title pretty much says it all: 

http://www.gao.gov/products/GAO-10-847T

 

December 5, 2013

Some of the specific questions that need to be considered are: Should direct-to-consumer genetic tests be regulated as the practice of medicine? As a medical device? As personal health information? What intellectual property rights issues are raised by this case?

We recently published two articles addressing the opposing sides of this issue: http://lifesciencesnow.com/category/genetics/

We'll also be hosting a complimentary web-debate on the issue next Thursday: http://reaction.dbr.com/rs/vm.ashx?ct=24F76F1DD1E10AEDC1D180ABDB2B901DDFBE7BB3D38714DD4CF371647BF8D90DDD78031

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