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Personal DNA gene tests are bogus

Fri Jul 23, 2010 9:42 AM EDT
science, only-on-msnbc-com, test, breaking-bioethics, disease, testing, drug-administration, genes, government-accountability-office, genetic
msnbc.com News — Arthur Caplan, Ph.D., msnbc.com - Only on msnbc.com
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— Looks like spitomics finally got its comeuppance.

That’s what I call the growing and lucrative field of personalized genetic testing, which asks you to spit into a plastic cup and then send the sample off to a lab.

Promoters promise you can find out whether you’re at risk for cancer or heart disease, likely to have problems with certain drugs or if you’d better change your diet to avoid grisly medical problems.

Well, they all got thoroughly clobbered at a Congressional hearing this week. An undercover investigation by the Government Accountability Office found that four genetic testing companies delivered contradictory predictions based on the same person's DNA.

Investigators also found that the test results often contradicted patients' actual medical histories.

It's about time Congress, FDA took action
None of this should come as a surprise. The only surprise is that it has taken Congress and the federal Food and Drug Administration so long to go after what is nothing more than highly advertised genetic scamming.

Most of what we know about the genetic basis of disease risk rests upon a narrow sample of the population. Genetic studies are small and tend to fail to capture large categories of people, like ethnic minorities, for instance.

So saying you can sell a test which can forecast the average Japanese-American's risk for Alzheimer's disease or the average Cuban-American's risk for heart disease sits on an evidence base that is, to be very kind, completely shaky.

The companies that have entered the field do not operate with any required level of accuracy in their testing.  Nor do they have any national guidelines for how to counsel clients about the “results” of testing. 

And there is no assurance that the spit you send off to a company won't wind up being analyzed by other people working for other firms or government agencies.

Worse still, no one really has the ability to test accurately for disease risks or the likelihood of adverse events from drugs because no one knows how a single person’s lifestyle, upbringing and environment interacts with their particular genes to create risks. 

Genes alone don't tell full story
Someone who works in a coal mine, smokes three packs of cigarettes a day and lived for five decades downwind from a refinery may have the same genes as someone raised on nothing but fish and vegetables amid clean air, but they’ll each have very different risks of developing allergies, cancer or Parkinson’s disease.

Despite all this uncertain science, the companies pushing the tests insist that people have a “right” to know about their genes. 

Such talk makes for stirring language and gets people thinking that they don't want any bureaucrats, ethicists or regulators coming between them and their personalized genetic knowledge. 

Never mind that the current accuracy of the tests can’t tell you anything you would really want to know.

Because of that, the government has a proper role to play in making sure that sleazy operators and aggressive entrepreneurs are not simply separating you from your saliva for a handsome fee.

The genetic revolution has arrived, but it is not ready to take its place as a home DNA test kit next to the pregnancy test in your drug store.  Unless someone has a family history of a disease, they’re not a very good candidate for general genetic testing. 

All this will change in the future, of course. But for now, resist the lure of genetic testing advertising and its promise to tell you about your ancestry, guide your love life, or predict your future.

Your future will be far more secure if you spend your time at the gym instead of spitting into a plastic vial.

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  • Public Discussion (7)
CodeSculptor

Actually, I disagree with the majority of the claims in the article. While genetic tests will indicate a potential for the risk of developing many diseases that the person might not ever get, the risk is still absolute.

The claims of the article are no different from saying "safety precautions are stupid" because most people will absolutely never be at risk of drowning during a boat-sinking, or suffering a shark-attack, jellyfish stings, avalanches, starvation, hyperthermia, dying in an earthquake, snakebite and so on.

Fundamentally, let's take the last claim -- "your future will be far more secure if you spend your time at the gym..."

Longevity is strongly and most decisively linked to genetics. How much you work out will contribute to your quality of life, to a degree, but your genes are the most important factor to how long you can live.

It's the same from cardio-vascular, cerebro and other brain criterion and even cholesterol levels. It's not the brain-puzzles that you do, it's not the all-white omelletes you choose.

The dementia or cognitive loss that you experience is more strongly related to genes than all other factors combined.

The problem is that you can't look at how the person DOES die and then say that they were, thusly, never at risk of all the other factors.

  • 1 vote
Reply#1 - Sat Jul 24, 2010 2:23 PM EDT
Cipher-0

To me, it looks like a straight fraud claim.

    Reply#2 - Sat Jul 24, 2010 2:40 PM EDT
    Linda Bruzzone

    What the author failed to write in this story is the investigation was limited to a few small companies which produced genetic testing for "low penetrance" genes...and for internet marketing or provided direct to consumer and not to those who test for most life threatening hereditary cancers.Those particular tests for life threatening conditions such as to diagnose Lynch syndrome, a hereditary cancer, are ONLY prescribed by health care professionals who have the expertise to diagnose and treat such conditions and are essential toward saving lives. In the example of Lynch syndrome, a genetic test is absolutely necessary to protect families and to save lives. This particular test, only available through prescription and a qualified laboratory allows individuals to know their high risks of obtaining inherited cancers of the colon (up to an 85% lifetime risk) uterus (up to a 65% lifetime risk), ovaries (up to a 13% lifetime risk), pancreas, gastric tract, hepto-biliary tract, gall bladder duct, skin and brain. Genetic testing is the closest thing to a cure for individuals with Lynch syndrome. Following genetic testing and diagnosis, individuals are afforded annual surveillance and testing for cancers. If discovered, the growths are removed or treatment is given before the cancer becomes life threatening. As a result, individuals live far longer than in the past and have empowerment and control over their health situation. As well, they can protect their families.Its important not to judge all genetic tests and test manufacturers by one small hearing in Congress in which four companies, selling tests on the internet, without a prescription, were targeted. Tests prescribed by your health provider are mostly likely from major institutions or proven manufacturers and your health provider or genetic counselor will provide more information about the test, the syndrome and your risk.For more information on Lynch syndrome, please feel free to visit www.lynchcancers.com

      Reply#3 - Sat Jul 24, 2010 4:20 PM EDT
      theurgist5

      Additionally different companies tests will show different risks for the same disease (even the same gene) because they are using different markers and looking at different polymorphisms.

      In Gene X, if mutation A raises the risk of cancer and mutation B lowers the risk. One person could have several different results depending on whether the companies test looks at mutation A, mutation B or both.

      Company 1 has mutation A in their panel, Company 2 has mutation B in their panel and Company C has both mutations in their panel. THe person will get three different results (greater risk, lesser risk, blended risk) but they are all correct. No companies genetic tests look at all polymorphisms due to many reasons (effect size threshold, not enough literatue support, conflicting literature support, too infrequent etc.)

      So the tests are not necessarily bogus as much as they might not be very helpful for many diseases (but could be helpful for a small handful, like say autism, crohns disease etc.) It really requires that they have tests with polymorphisms linked to large effect sizes.

        Reply#4 - Tue Jul 27, 2010 4:38 PM EDT
        theurgist5

        To Linda,

        I believe the article really was about the internet based personal genetic tests vs specific tests that are usually authorized by a doctor.

          Reply#5 - Tue Jul 27, 2010 4:39 PM EDT
          theurgist5

          One thing to remember is that while a disease might have a strong genetic component (like heredity does), it is most likely resulting from teh interactions of many genes (tens to hundreds) that might all have too small an effect size to really get much information from a genetic test. Frankly this is the big issue with these broad genetic tests. Also gene x gene interaction and gene x environment interaction plays a large role and the information on these is not there yet.

            Reply#6 - Tue Jul 27, 2010 4:42 PM EDT
            hoho132Deleted
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