A federal investigation finds conflicting test results and false marketing claims.
Consumers who buy genetic tests in hopes of seeing what diseases they are likely to contract may be misled, according to a report from the U.S. Government Accountability Office. In addition, the results can vary so widely that they are "of little or no practical use," the report concludes.
Congress and the U.S. Food and Drug Administration are trying to regulate this nascent but burgeoning field even amid uncertainty over the meaning of test results that indicate someone has genetic risks for certain diseases. "The problem with these marketing practices is that it is not clear today whether the exciting scientific developments in human genetics research actually transfer into ways to improve and individualize health care," Rep. Henry Waxman (D-CA) said Thursday at a congressional hearing on the industry.
The most shocking findings from the GAO report come from a series of undercover phone calls made to 15 genetic testing companies. Fictitious consumers asked about test reliability, privacy policies, and sales of nutritional supplements or other products tailored to an individual's DNA. In the phone calls, people who sound like telemarketers are heard giving unsubstantiated and sometimes nonsensical medical advice. For example, at least four companies "claimed that a consumer's DNA could be used to create personalized supplements to cure disease," according to the GAO. Two companies condoned the "potentially illegal practice of testing DNA without prior consent." Overall, the GAO found, 10 of the 15 companies engaged in fraudulent or deceptive marketing.
Both congressional leaders and company representatives said they were dismayed after hearing the calls. However, lawmakers and the companies maintained that genetic testing has a strong potential future in medicine, and that it would be unfortunate if snake-oil salesmen stained the entire industry.
This new level of federal scrutiny follows three years of minimal regulation for direct-to-consumer genetic testing. Several testing companies sprung up around three or four years ago to take advantage of rapidly expanding knowledge of how human genetics can be linked to diseases such as diabetes and cancer. The tests, which can be ordered over the Internet and range from about $100 to $1,000, typically analyze a person's genome for common genetic variations that have been linked to a relatively minor increased risk for a particular disease.
The industry has been under fire since its inception, as physicians and scientists question whether this information about modest risks can truly be used to make health-care decisions. Complicating matters further are claims from many of these companies that they are not providing a medical service and therefore do not require regulation from the FDA, even though many of their marketing materials allude to the promise of better health.
To evaluate direct-to-consumer genetic testing, the GAO sent DNA samples from five donors to four companies--23andMe, Navigenics, Pathway Genomics, and DeCode--for testing. These four are "touted as the most reputable in the industry," said Gregory Kutz, managing director of Forensic Audits and Special Investigations at the GAO. For each of the donors, one sample used factual information, while the second had fake age and ethnicity information. GAO investigators then made undercover calls to the companies to discuss the results.
Questions arise over several companies' plans for over-the-counter genetic tests.
New research suggests that most people can cope with learning that they are at high genetic risk for disease.
The emerging market of direct-to-consumer genetic testing gets down to business.
Questionable value of genetic testing
Questionable value of genetic testing.
I have reviewed numerous original articles on this subject. Most only suggest a correlation, and some are no more accurate than a flip of the coin, yet, the costs are high, anywhere from 500 dollars to 2000 dollars. Hardly worth the information one has received.
With regard to Lynch Syndrome, whether or not if the genetic test is positive, that will not change the recommended guidelines for screening of colon cancer.
In addition, there are many other associations’ bedsides Lynch Syndrome with colon cancer.
Regardless of the genetic test, the presence of colon cancer history in the family, the recommendations are increased anyway.
Lastly, the results of the genetic test can have emotional stress to one’s life. Perhaps, doctors should offer the test, and leave it to the patient whether or not he wants to pay for it himself.
Approximately 3 out of a 100 colon cancer patients will be positive by testing, and the only means that there is an increased risk, not a guarantee that you will get cancer.
Also, keep in mind, there are many other genetic links to colon cancer. to test for all of them, would be super expensive.
Ron Hansing 7.26.10
Critical Examination of Genetic Tests
We must realize that no one disputes the
fact that genetic testing,especially, if
properly carried out,saves life.
Furthermore,no body contests that
genetic tests conjure
potentiality for human life
prolongation on earth.
However, when it touches on
humans,extraordinary precautions
become the order of the day.
The greatest troubling
question, rests more, on
procedural approach leading
to scientific data assembly
and conclusion that are
validatable. Such procedural
methodologies,results and
conclusions affording any
predictions must hold elements
of congruency and reliability.
Our intellectual community and
society are aware of unscrupulous
minds out there who might place
material importance over
professionalism,and not less,
to human life.
It is this category of
professional few,
that embrace,shamelessly,
greed and fabrication
tendency of scientific data
for genetic predictions that
gravitate urgent need for
human vigilance, incessant
activity monitor and govermental
issued set of guidelines for
genetic tests oriented practicum.
In deed, Congress, Food and Drug
Administration,and specialized
network of national security must
be very hard on professionals of
genetic laboratories and associated
medical practitioners that dare engage
in activities that convey
any contortion,or at best,
misleading scientific knowledge
with capability of endangering
human health or life..
Only then,can ethical value,
respect and integrity that
punctuate this same career
practice be sustained,not just in
the short term, but for many years
down the road.
Martin Atayo
Washington, DC 20013
(Technologist)
Turn on the kitchen light and from the corner of your eye you see the roaches running for the corners.
Genetic Testing-- even if the Test is truly rigorous and reliable. . .when conducted by physician offices as MARKETED only have one purpose: To drive increased Patient Traffic through the Physician's Exam Room.
A Genetic test conducted on 30 year old patients that basically give a report stating that: "Oh My... did you know that there are at least 10 different ways you can probably drop dead tomorrow unless you see all my Specialist Colleagues!"
This won't be practiced as Medicine.
It will be practiced as Increased Patient Revenue Thru-put.
I'm not saying that the technology doesn't work. I'm just saying that the state of the current HealthCare Industry will only abuse this technology by stroking a patient's fear of death and disease.
we get a huge number of physician ordered genetic tests.
They are almost never the panel type mentioned in the article so you have incomplete information.
Ok, there are probably some bad apple doctors out to run unneeded tests but you don't need to be a doctor to order these, and most doctors already know they are not needed to diagnose diseases and most people are on HMOs so they don't make money paying for un-needed tests.
Most are real tests for specific genetic conditions by patients with real problems.
A few are general screening tools but due to the insurance companies insistence on an actual reason for a test, not just a patients wish, this is limited. There, I've said it, there are actual good reasons insurance companies limit unnecessary testing. You might get something like this for 'wellness' testing but is unlikely unless you have symptoms or something shows up in routine exams from other tests - blood panel abnormalities, urinalysis abnormal results, endoscopy, or skin growths, etc.
Manufacturing in the United States is in trouble. That's bad news not just for the country's economy but for the future of innovation.
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LindaBruzzone
1 Comment
Genetic Testing Saves Lives
What the author failed to write in this story is the investigation was limited to a few (7) small companies which produced genetic testing for "low penetrance" genes...and for internet marketing or provided direct to consumer --- 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
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z0rr0
98 Comments
Re: Genetic Testing Saves Lives
"individuals live far longer than in the past" is an honest, fact based statement.
That genetic testing, or anything for that matter, "saves lives" is pure snake oil.
Reply
erbium
338 Comments
Re: Genetic Testing Saves Lives
Yes, and I didn't get genetic testing to 'save lives'. Since the goal of the actual tests is to find out how your complicated body is constructed on a genetic level it is not snake oil.
That info might be analogous to getting the technical manual for your complicated car. You find out your model has a higher likelyhood of some problems or you start putting something to modify the car that is non-standard in it. Such as modifying your car to use nitrous power boost which some clever person on a popular mechanics website found out later ruined the piston walls due to the high heat.
There was no hype and no fraud involved in me getting genetic testing.
I didn't use an intermediary. They mailed me the kit.
No one made any claims. The cost was under $500.
Costs will be declining quickly so will become even more valuable.
In fact no one from the company contacted me at all.
A relative wanted me to get tested and paid for it.
It is quite valid, interesting and shows realistic chances of getting certain disease for my genotype.
I'm not doing anything different as I feel my diet and other factors are optimized to reduce my risks of such diseases that affect large chunks of the population - diabetes, prostate cancer, etc.
The one especially good thing this would do is make people less complacent of bad habits given their possible susceptibility.
If they go into hysteria maybe then they need counseling on what the tests mean. The website is very clear about this and saying that they don't mean you will die.
And a nice side benefit, a few people who may be close relatives from up to 150 years back have also been tested and you can choose to respond or not to them.
Certainly they should regulate unscrupulous dorks who try to con people into custom supplements, etc. But this is not the main thrust of genetic testing. For the FDA to clamp down on 'just plain testing' would be stupid and short-sighted. They should shut down small operators who use the tests to prey on the ignorant or unwary.
The cousins of these, actual molecular biology medical genetic tests that we and other companies do, such as Genzyme are incredibly helpful to find mutations that indicate conditions for diagnosis; Cystic Fibrosis screening is one genetic test. Tay-Sachs or sickle cell genetic abnormalties are others. Also to find progression of cancer such as FISH test for bladder cancer save lives. Just one FISH test cost almost as much as the whole 23andme panel, and only told about one part of the body.
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