Nutrigenetic Testing
Tests Purchased from Four Web Sites Mislead Consumers
Gao ID: GAO-06-977T July 27, 2006
Scientists increasingly believe that most, if not all, diseases have a genetic component. Consequently, genetic testing is becoming an integral part of health care with great potential for future test development and use. Some genetic tests are sold directly to the consumer via the Internet or retail stores, and purport to use genetic information to deliver personalized nutrition and lifestyle guidance. These tests require consumers to self-collect a sample of genetic material, usually from a cheek swab, and then forward the sample to a laboratory for analysis. Companies that market this type of test claim to provide consumers with the information needed to tailor their diet and exercise programs to address their genetically determined health risks. GAO was asked to investigate the "legitimacy" of these claims. This testimony reflects the findings of GAO's investigation of a nonrepresentative selection of genetic tests. Specifically, GAO purchased tests from four Web sites and created "fictitious consumers" by submitting for analysis 12 DNA samples from a female and 2 samples from an unrelated male, and describing this DNA as coming from adults of various ages, weights, and lifestyle descriptions. GAO also consulted with experts in genetics and nutrition.
The results from all the tests GAO purchased mislead consumers by making predictions that are medically unproven and so ambiguous that they do not provide meaningful information to consumers. Although there are numerous disclaimers indicating that the tests are not intended to diagnose disease, all 14 results predict that the fictitious consumers are at risk for developing a range of conditions, as shown in the figure below. However, although some types of diseases, such as cystic fibrosis, can be definitively diagnosed by looking at certain genes, the experts GAO spoke with said that the medical predictions in the tests results can not be medically proven at this time. Even if the predictions could be medically proven, the way the results are presented renders them meaningless. For example, many people "may" be "at increased risk" for developing heart disease, so such an ambiguous statement could relate to any human that submitted DNA. Results from the tests that GAO purchased from Web sites 1 and 4 further mislead the consumer by recommending costly dietary supplements. The results from the tests from Web site 1 suggested "personalized" supplements costing approximately $1,200 per year. However, after examining the list of ingredients, GAO found that they were substantially the same as typical vitamins and antioxidants that can be found in any grocery store for about $35 per year. Results from the tests from Web site 4 suggested expensive products that claimed to repair damaged DNA. However, the experts GAO spoke with stated that there is no "pill" currently available that has been proven to do so. The experts also told us that, in some circumstances, taking supplements such as those recommended may be harmful. In addition, results from the tests that GAO purchased from Web sites 1, 2, and 3 do not provide recommendations based on a unique genetic profile as promised, but instead provide a number of common sense health recommendations. If the recommendations were truly based on genetic analysis, then the 9 fictitious consumers that GAO created for these sites using the female DNA should have received the same recommendations because their DNA came from the same source. Instead, they received a variety of different recommendations, depending on their fictitious lifestyles. For example, when GAO created lifestyle descriptions stating that the consumers smoked, they received recommendations to stop smoking. In contrast, if GAO said the consumers never smoked, they received recommendations to continue to avoid smoking.
GAO-06-977T, Nutrigenetic Testing: Tests Purchased from Four Web Sites Mislead Consumers
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Testimony:
Before the Special Committee on Aging, U.S. Senate:
United States Government Accountability Office:
GAO:
For Release on Delivery Expected at 10:00 a.m. EST:
Thursday, July 27, 2006:
Nutrigenetic Testing:
Tests Purchased from Four Web Sites Mislead Consumers:
Statement of Gregory Kutz, Managing Director Forensic Audits and
Special Investigations:
GAO-06-977T:
GAO Highlights:
Highlights of GAO-06-977T, testimony before the Special Committee on
Aging, U.S. Senate
Why GAO Did This Study:
Scientists increasingly believe that most, if not all, diseases have a
genetic component. Consequently, genetic testing is becoming an
integral part of health care with great potential for future test
development and use. Some genetic tests are sold directly to the
consumer via the Internet or retail stores, and purport to use genetic
information to deliver personalized nutrition and lifestyle guidance.
These tests require consumers to self-collect a sample of genetic
material, usually from a cheek swab, and then forward the sample to a
laboratory for analysis. Companies that market this type of test claim
to provide consumers with the information needed to tailor their diet
and exercise programs to address their genetically determined health
risks. GAO was asked to investigate the ’legitimacy“ of these claims.
This testimony reflects the findings of GAO‘s investigation of a
nonrepresentative selection of genetic tests. Specifically, GAO
purchased tests from four Web sites and created ’fictitious consumers“
by submitting for analysis 12 DNA samples from a female and 2 samples
from an unrelated male, and describing this DNA as coming from adults
of various ages, weights, and lifestyle descriptions. GAO also
consulted with experts in genetics and nutrition.
What GAO Found:
The results from all the tests GAO purchased mislead consumers by
making predictions that are medically unproven and so ambiguous that
they do not provide meaningful information to consumers. Although there
are numerous disclaimers indicating that the tests are not intended to
diagnose disease, all 14 results predict that the fictitious consumers
are at risk for developing a range of conditions, as shown in the
figure below. However, although some types of diseases, such as cystic
fibrosis, can be definitively diagnosed by looking at certain genes,
the experts GAO spoke with said that the medical predictions in the
tests results can not be medically proven at this time.
Figure: Medical Conditions Predicted for 14 Fictitious Consumers:
[See PDF for Image]
Source: GAO.
[End of Figure]
Even if the predictions could be medically proven, the way the results
are presented renders them meaningless. For example, many people ’may“
be ’at increased risk“ for developing heart disease, so such an
ambiguous statement could relate to any human that submitted DNA.
Results from the tests that GAO purchased from Web sites 1 and 4
further mislead the consumer by recommending costly dietary
supplements. The results from the tests from Web site 1 suggested
’personalized“ supplements costing approximately $1, 200 per year.
However, after examining the list of ingredients, GAO found that they
were substantially the same as typical vitamins and antioxidants that
can be found in any grocery store for about $35 per year. Results from
the tests from Web site 4 suggested expensive products that claimed to
repair damaged DNA. However, the experts GAO spoke with stated that
there is no ’pill“ currently available that has been proven to do so.
The experts also told us that, in some circumstances, taking
supplements such as those recommended may be harmful.
In addition, results from the tests that GAO purchased from Web sites
1, 2, and 3 do not provide recommendations based on a unique genetic
profile as promised, but instead provide a number of common sense
health recommendations. If the recommendations were truly based on
genetic analysis, then the 9 fictitious consumers that GAO created for
these sites using the female DNA should have received the same
recommendations because their DNA came from the same source. Instead,
they received a variety of different recommendations, depending on
their fictitious lifestyles. For example, when GAO created lifestyle
descriptions stating that the consumers smoked, they received
recommendations to stop smoking. In contrast, if GAO said the consumers
never smoked, they received recommendations to continue to avoid
smoking.
[Hyperlink, http://www.gao.gov/cgi-bin/getrpt?GAO-06-977T].
To view the full product, including the scope and methodology, click on
the link above. For more information, contact Greg Kutz at 202-512-7455
or kutzg@gao.gov.
[End of Section]
Mr. Chairman and Members of the Committee:
Thank you for the opportunity to discuss our investigation of genetic
tests that are sold directly to the consumer via the Internet, retail
stores, or pharmacies. Recent advances in science have shown that the
human genome is made up of about 20,000 to 25,000 genes, which are in
turn made up of DNA.[Footnote 1] These genes play a critical role in
normal biological function, and scientists increasingly believe that
most, if not all, diseases have a genetic component. Variants in these
genes may increase an individual's risk for various common, complex
medical disorders. Consequently, genetic testing is becoming an
integral part of health care. There are now genetic tests available for
close to 1,000 diseases or conditions, including hereditary breast
cancer and cystic fibrosis, and there is great potential for future
test development and use.
However, only about a dozen[Footnote 2] genetic tests have been
reviewed and approved by the Food and Drug Administration (FDA) to
ensure their safety and effectiveness. A major reason is that the FDA
regulates the safety and effectiveness of medical devices, meaning
products intended to diagnose, treat, mitigate, or prevent
disease.[Footnote 3] A genetic test is considered by the FDA to be a
medical device only if it is manufactured as a freestanding "kit" and
sold to a laboratory.[Footnote 4] Presently, though, most genetic tests
are not sold as kits but are manufactured in-house by clinical
laboratories.[Footnote 5] In these cases, the laboratory itself decides
whether a test has sufficient "clinical validity" (i.e., is
sufficiently effective at measuring what it purports to measure).
Although all clinical laboratories must be approved under the Clinical
Laboratory Improvement Amendments of 1988 (CLIA) and meet general
standards applicable to all laboratories, there is no genetic testing
specialty under CLIA. This means that there are no specific
requirements or unique standards for laboratories that perform genetic
tests.[Footnote 6]
This minimal oversight makes it difficult for consumers to determine
whether a genetic test provides meaningful, scientifically based
information. In fact, some companies are directly marketing to
consumers DNA tests that provide health-related information without the
advice of a physician, including so-called "nutrigenetic" tests.
Nutrigenetic tests purport to analyze a limited number of genes to
provide personalized nutritional and lifestyle recommendations. These
tests, which have not been approved by the FDA and are sometimes
performed in laboratories that have not been approved under CLIA, range
in cost from under $100 to over $1,000. The tests require consumers to
self-collect a sample of genetic material, usually from a cheek swab,
and then forward the sample to a laboratory for analysis. Demand for
this type of service appears to be on the rise; one company estimates
that it has sold over 35,000 nutrigenetic tests to consumers since it
began selling the tests in the United States in 2003.
Although the companies that market nutrigenetic tests typically stress
that the results and information they provide are not intended to
diagnose or treat any disease or disorder, they do claim that their
tests will provide consumers with the information needed to tailor
their diet and exercise programs to address their genetically
determined health risks. Because of your concerns that the companies
marketing this type of test may be misleading consumers by providing
inaccurate information, you requested that we investigate the
"legitimacy" of these claims.
To complete our work, we investigated a nonrepresentative selection of
four Web sites selling nutrigenetic tests. We chose these Web sites
because they all claimed that their tests would analyze a limited
number of genes, between 4 and 19, to create personalized dietary and
other lifestyle-related recommendations; they also stated that their
products would not test for disease or predisposition to disease. These
tests ranged in price from $89 to $395. We purchased several similar
types of tests from each site--14 in total--so that we could compare a
variety of results. To create a testing scenario, we developed a series
of "fictitious consumers." To do this, we ultimately submitted 12 DNA
samples taken by cheek swab from a 9-month-old female, with consent
from her parents. For comparison purposes, we also submitted 2 DNA
samples taken from an unrelated 48-year-old male. We had originally
submitted DNA samples taken from a dog, a cat, and "blank" samples
containing no DNA information, but these submissions were returned to
us because they could not be processed by the laboratories.
On questionnaires that were included with each of the tests, we
described the DNA from the female and the DNA from the male as coming
from adult men and women of various ages, weights, and lifestyle
descriptions. Each questionnaire asked for the same type of information
about exercise, smoking, vitamin consumption, and intake of a variety
of foods, but did not ask for information about current medical
conditions or prescribed medications being taken. Figure 1 provides the
basis for the 14 fictitious consumers we created.
Figure 1: DNA and Lifestyle Descriptions Used to Create 14 Fictitious
Consumers:
[See PDF for image]
Source: GAO.
[End of figure]
To assess whether the 14 results and related recommendations we
eventually received provided any scientifically-based information, we
consulted with outside experts in the fields of genetics and nutrition.
These experts have background in a variety of areas related to both
fields, including genetic technology, genetic discrimination, legal and
public policy issues pertaining to genetics and human research,
pediatrics, prevention of communicable diseases and diseases associated
with poor nutrition, and defining global nutrient requirements. We also
reviewed recent studies on genetic links to specific diseases and on
the efficacy of nutritional supplements. In addition, we interviewed
representatives from the Web sites marketing the tests and the
laboratories processing the results. We conducted our investigation
from August 2005 through June 2006 in accordance with quality standards
for investigations as set forth by the President's Council on Integrity
and Efficiency.
Summary:
The results we received from all the tests we purchased mislead the
consumer by making health-related predictions that are medically
unproven and so ambiguous that they do not provide meaningful
information to consumers. Although the results contain statements
indicating that the information provided is not intended to diagnose
disease or predisposition to disease, all of the 14 results we received
do contain predictions that a consumer may interpret as diagnoses. For
example, the 14 results indicate that our fictitious consumers are at
risk for developing a range of conditions, including osteoporosis, high
blood pressure, type 2 diabetes, heart disease, a reduced ability to
clear toxins, brain aging, and cancer. The 3 results we received from
the tests we purchased from Web site 4 also stated that our fictitious
consumers were at below average risk for developing certain medical
conditions. Experts informed us that although some types of diseases,
such as cystic fibrosis, can be definitively diagnosed by looking at
specific genes, the kinds of predictions we received cannot be proven
given the level of scientific evidence available today. Even if the
predictions could be medically proven, the way the results are
presented renders them meaningless. For example, many people "may" be
"at increased risk" for developing heart disease because of a variety
of factors, so such an ambiguous statement could apply to any human
that submitted DNA.
Results from the tests that we purchased from Web sites 1 and 4 further
mislead the consumer by recommending costly supplements that they claim
are developed according to an individual's unique DNA. In reality, the
pills are not unique in any way, make unproven medical claims, and are
potentially harmful. For example, the 3 results we received from the
tests from Web site 1 encourage the purchase of "personalized" dietary
supplements, supposedly formulated based on our fictitious consumers'
DNA and lifestyle profiles, and costing approximately $1,200 per year.
However, when we examined the lists of ingredients, we found that the
pills do not appear to be customized because the 3 fictitious consumers
we created for this Web site received recommendations to purchase the
same product, despite the fact that there were 2 different DNA donors
and each had a different lifestyle profile. Moreover, experts confirmed
that these supplements are substantially the same as typical
multivitamins that can be found in any grocery store for about $35 per
year. In addition, the 3 results we received from the tests we
purchased from Web site 4 claimed that for over $1,880 per year, its
"unique" and "personalized" products could repair damaged DNA. The
experts we spoke with stated that there is no "pill" currently
available that has been proven to do so. Again, these supplements do
not appear to be personalized because the 3 fictitious consumers we
created for this site received the same recommendation. Finally, the
experts we spoke with told us that in some circumstances, taking
supplements such as those that were recommended to us can be harmful.
For example, taking levels of some vitamins and nutrients that exceed
the recommended daily allowance may promote cancers and chronic
diseases.
Furthermore, results from the tests that we purchased from Web sites 1,
2, and 3 do not provide dietary and lifestyle recommendations based on
a unique genetic profile as promised. Instead, the recommendations we
received simply provide generally accepted health advice directly
linked to information we submitted via the questionnaires included with
the tests. If the recommendations were truly based on a consumer's
unique genetic profile, then the 9 fictitious consumers that we created
for Web sites 1, 2, and 3 using the female DNA should have received the
same recommendations. Instead, these 9 consumers received a variety of
different recommendations, depending on the fictitious lifestyles we
provided for them. For example, if we said the consumers smoked, we
received recommendations to stop smoking. In contrast, if we said that
the consumers never smoked, we received recommendations to continue to
avoid smoking. These results lead us to conclude that we could have
invented any type of lifestyle description for the DNA we submitted and
the recommendations would simply echo this information. Although these
recommendations may be beneficial to consumers in that they constitute
common sense health and dietary guidance, DNA analysis is not needed to
generate this advice.
During the course of our investigation, we found other information that
raises concerns for consumers purchasing these tests. For example, we
discovered that Web sites 1, 2, and 3 were in fact selling the same
genetic test developed by the same company, and that this company was
pressured by consumer groups in the United Kingdom to stop selling the
test in that country. The company now sells the same type of test in
the United States. In addition, we found evidence suggesting a lack of
quality control by the laboratory actually conducting the DNA analysis
for Web sites 1, 2, and 3. For example, even though all of the genetic
information contained in the test results based on a single source
should be identical, we received disparate results for a sample from
the same source from the tests we purchased from Web site 1. We also
found that a laboratory used by Web site 4 is not approved under CLIA.
Results Contain Health-related Predictions That Are Both Medically
Unproven and Meaningless:
Although there are numerous disclaimers indicating that the tests we
purchased do not diagnose disease, the 14 results we received predicted
that our fictitious consumers were at risk of developing a myriad of
medical conditions. These predictions were similar for all of our
fictitious consumers, no matter which DNA or lifestyle description we
used. Results from the tests we purchased from Web site 4 also stated
that our fictitious consumers were at below average risk for developing
certain diseases. However, after consulting with outside experts, we
determined that these predictions cannot be medically proven at this
time. Even if the predictions could be medically proven, the results
use ambiguous language to describe the supposed health risks, rendering
them meaningless.
Claims That Test Results Will Not Diagnose Disease:
As shown in table 1, the results we received from the tests we
purchased from all four Web sites contain statements indicating that
the information they provide is not intended to diagnose disease or
predisposition to disease. The results also contain language stressing
that the tests do not screen for genetic disorders and advising
consumers to consult with a physician if they feel that they might be
ill.
Table 1: Claims That Test Results Are Not Intended to Diagnose Disease:
Tests purchased from: Web site 1;
Selected disclaimers: [This is] not a genetic test for disease or
predisposition to disease, nor does it determine a medical condition;
If you think you may be ill, consult your doctor.
Tests purchased from: Web site 2;
Selected disclaimers: Please note that this screening is not a test for
inherited disorders.
Tests purchased from: Web site 3;
Selected disclaimers: [This is] not a genetic test for disease or
predisposition to disease, nor does it determine a medical condition;
If you think you may be ill, consult your doctor.
Tests purchased from: Web site 4;
Selected disclaimers: [Our] products are not intended to diagnose or
treat any disease or disorder; only your doctor can do so.
Source: GAO.
[End of table]
Predictions of Medical Conditions Received:
Despite these statements, the results we received from the tests we
purchased from all four Web sites do contain medical predictions that a
consumer may interpret as diagnoses. The overriding impression from all
the results is that the 14 fictitious consumers we created are at risk
for developing a variety of medical conditions, as shown in figure 2.
Figure 2: Medical Conditions Predicted for 14 Fictitious Consumers:
[See PDF for image]
Source: GAO.
[End of figure]
Furthermore, the results from the tests we purchased from Web site 4
even suggested that our fictitious consumers with the female DNA were
at below average risk for developing certain conditions. As comparison,
the 2 results we received from Web sites 1 and 3 for the fictitious
consumers with the male DNA contained similar predictions, despite
having different DNA variants from the female sample. Specific
predictions from each test are discussed in further detail below.
With regard to the tests we purchased from Web site 1, the 3 results we
received stated that the DNA sample from the female displayed an
"increased risk of reduced calcium and Vitamin D absorption," meaning
that she "may be at increased risk of developing osteoporosis." Results
from the same tests contained similar predictions with regard to risks
for developing high blood pressure, type 2 diabetes, and heart disease.
The DNA sample from the male that we submitted for this test showed the
exact same risks, despite having different DNA variants from the
female, as shown in figure 3.
Figure 3: Predictions Received from the Tests Purchased from Web Site
1:
[See PDF for image]
Source: GAO.
[End of figure]
As shown in figure 4, the 3 results from the tests we purchased from
Web site 2 stated that the DNA sample from the female showed "gene
variations that may alter the body's ability to metabolize cholesterol"
and variations that may affect "mineral absorption and bone
metabolism." These results also suggested that "certain protective
systems" in the body "may have altered activity."
Figure 4: Predictions Received from the Tests Purchased from Web Site
2:
[See PDF for image]
Source: GAO.
[End of figure]
Of the 5 tests we purchased from Web site 3, 3 focused on
detoxification, 1 focused on heart health, and 1 focused on bone
health. The 5 results thus showed a range of predictions, including
that the DNA from the female contained gene variations that "may lead
to a reduced ability to clear toxins" and that her "natural antioxidant
defenses are less efficient at the removal of free radical damage." The
results also showed increased risk of high blood pressure and
osteoporosis. The DNA we submitted from the male showed similar risks
with regard to toxins and removal of free radicals, despite having
different DNA variants from the female sample. See figure 5.
Figure 5: Predictions Received from the Tests Purchased from Web Site
3:
[See PDF for image]
Source: GAO.
Note: Of the five tests we purchased from Web site 3, three focused on
detoxification, one focused on heart health, and one focused on bone
health.
[End of figure]
As shown in figure 6, the 3 results from the tests we purchased from
Web site 4 showed that the DNA sample from the female revealed "faulty
methylation patterns" which may lead to "an above average risk for
developing cardiac aging, brain aging, and cancer" and "sub-optimal
glycation," which can lead to diabetes and increased body fat. These
same results also stated that the DNA displayed a "significant risk of
developing the age related conditions associated with elevated levels
of DNA damage." Results from the tests we purchased from Web site 4
also contain predictions that the DNA sample from the female shows
relatively low risk for developing some diseases. For example, all the
results from these tests note that the DNA displayed a "below average
risk" of developing "the age related" conditions associated with
"oxidation" and "inflammation." According to the results, oxidation can
lead to diabetes, heart disorders, and Alzheimer's disease and
inflammation can lead to diabetes, heart failure, and fragile bones.
Figure 6: Predictions Received from the Tests Purchased from Web Site
4:
[See PDF for image]
Source: GAO.
[End of figure]
Predictions of Medical Conditions Cannot Be Medically Proven:
Despite the implication that these predictions are based on the DNA
submitted, none of the results we received contained scientific support
to assist the consumer in evaluating their credibility, and there is no
evidence to suggest that the tests have been evaluated by independent
experts. Furthermore, the genetic experts we spoke with informed us
that even though it is possible to make a definitive diagnosis of
disease by looking at certain genes, none of the predictions contained
in any of the results we received can be medically proven at this time.
According to the experts, cystic fibrosis and Huntington's disease are
examples of illnesses that can be diagnosed based on an analysis of
only one gene.[Footnote 7] In contrast, the diseases and conditions
identified in the test results we received involve complex bodily
processes. According to the experts we spoke with, although genes are
known to be associated with these processes, scientists have very
limited understanding about the functional significance of any
particular gene, how it interacts with other genes, and the role of
environmental factors in causing disease.
With regard to the specific predictions of heart disease, diabetes,
osteoporosis, cancer, altered ability to metabolize cholesterol, and
reduced ability to clear toxins, the experts informed us that research
proving a genetic connection to the development of these conditions is
at a very early stage and there are many issues yet to be resolved.
In addition, the experts we spoke with also stated that the types of
tests we purchased cannot be used to confirm that an individual has a
reduced risk of developing these types of diseases. Therefore, the
claims that a person may be at "below average risk" of developing
certain "age related conditions" based on the analysis of a few genetic
variants is misleading. There could be other genetic variants not
tested for that confer risk or other environmental factors not
assessed.
Medical Predictions Are Also Meaningless:
Even if the predictions could be medically proven, the way the results
are presented--using ambiguous language--renders them meaningless. For
example, it is unclear what is meant by a "damaged" gene. According to
the experts we spoke with, although a specific gene can be "damaged" in
that it contains a variation that causes a loss of function or impaired
function, the results do not clearly explain what this means. The
experts also told us that informing someone that they may be at
increased risk for heart disease or that they have "high levels of DNA
damage," "faulty methylation patterns," or "altered activity" in
certain genes are all statements that are so ambiguous as to be
meaningless. In fact, these types of predictions could apply to any
human that submitted DNA. For example, according to the experts, many
people "may" be "at increased risk" for developing heart disease
because of known and unknown genetic risk factors; environmental and
behavioral risk factors such as obesity, smoking, and high cholesterol;
and the interaction between these genetic, environmental, and
behavioral factors.
Results Encourage the Purchase of Supplements That Are Overpriced, Make
Unproven Medical Claims, and May Even Be Harmful:
Results from the tests that we purchased from Web sites 1 and 4 further
mislead the consumer by recommending expensive supplements. The 3
results we received from the tests we purchased from Web site 1
recommend a supplement that is supposedly based on an individual's
unique DNA; in reality, the supplements are not unique and are simply a
grossly overpriced version of a typical multivitamin. The 3 results we
received from the tests we purchased from Web site 4 similarly
recommend expensive supplements that are supposedly unique to the
consumer; these results also contain medical claims about the
supplements that cannot be proven at this time. Finally, the experts we
consulted informed us that, in some instances, taking certain
supplements may be harmful.
Supplements Recommended by the Tests Purchased from Web Site 1:
The results from the tests we purchased from Web site 1 recommended a
90-day supply of a "personalized, custom" nutritional formula for $295,
or approximately $1,200 per year. According to the product information,
this formula is based on "what your genetic profile reveals as areas in
your body that may need special support." Despite this claim, when we
examined the listed ingredients, we found that we were recommended the
same product for all 3 of the fictitious consumers we created for this
test--2 of these consumers actually had the DNA from the female, 1 had
the DNA from the male, and all 3 had different lifestyle descriptions,
as previously shown in figure 1. However, when we compared the contents
of the supplements recommended for the 2 fictitious consumers with DNA
from the female with the supplement recommended for the fictitious
consumer with DNA from the male, we found that the ingredients were the
same.
Moreover, the experts we spoke with confirmed that the supplements
themselves are not unique; they contain vitamins that can be found in
any pharmacy or grocery store. To find a comparable product, we went to
a local drug store and found a generic multivitamin with the same
ingredients, though with different amounts, as those in the recommended
supplement. In contrast to the exorbitant price requested for the
supplement, we paid just under $10 for a 100-day supply of this
multivitamin--or about $35 per year, as shown below.
Figure 7: Comparison of Recommended Supplement from Web Site 1 with
Generic Multivitamin:
[See PDF for image]
Source: GAO.
[End of figure]
Although these products are not identical, the experts we spoke with
said that both the supplement and the generic vitamin would probably
provide the same nutritional benefits for most people. However, they
also cautioned that the elevated amounts of certain vitamins in the
supplement may be harmful, as discussed later in this testimony.
Supplements Recommended by the Tests Purchased from Web Site 4:
The results from the tests we purchased from Web site 4 recommended a
"personalized" supplement "regimen" costing over $1,880 per year.
According to the results, these supplements are personalized based on
the DNA submitted and lifestyle descriptions provided on the
questionnaires, and they are supposed to help "compensate" for "genetic
deficiencies." Specifically, the product information accompanying the
test results claims that the regimen will repair damaged DNA through
the consumption of 7 pills per day, including:
* 4 tablets per day of a supplement containing over "70 vitamins,
minerals, and enzymes combined with "CAEs", a proprietary extract from
the Tropical Rainforest botanical Uncaria tomentosa, known as Cat's
Claw, which has been clinically shown to promote DNA repair in the
body." A 60-day supply costs $160.
* 1 tablet per day of a supplement designed to "enhance the body's
ability to repair damaged DNA." A 60-day supply costs $50.
* 1 tablet per day of a supplement to control blood sugar and body fat.
A 60-day supply costs $50.
* 1 tablet per day of a supplement designed to manage the process
"whereby certain genes are activated and deactivated." A 60-day supply
costs $50.
As with the other products we were recommended, these supplements are
not unique to the consumer. Although the 3 fictitious consumers we
created for this site in reality all had the female DNA, they all had
varying lifestyle descriptions, as previously shown in figure 1.
However, we received the same product recommendation for all 3
consumers. For example, our fictitious 72-year-old female nonsmoker
with a diet high in protein was recommended the same supplement regimen
as our fictitious 45-year-old male smoker with a diet high in fats,
which seems illogical given that the supplements are supposedly
developed based in part on the submitted lifestyle information.
Furthermore, although the regimen touts "Cat's Claw" as being the
ingredient primarily responsible for DNA repair, the experts we spoke
with told us that these claims are not medically proven at this time.
According to the experts, Cat's Claw is a plant whose pharmacological
properties are being studied for a wide variety of biological effects,
but the experts were aware of no reports in peer-reviewed scientific
literature that have demonstrated the ability of Cat's Claw to repair
DNA. Furthermore, although there is some research indicating that
taking antioxidants may help with DNA repair, no pill has yet been
proven to repair damaged DNA. In fact, manufacturers of supplements are
prohibited from claiming that their products can treat, cure, or
prevent disease; products that make these claims are considered drugs
and must be approved by the FDA before they can be sold. The FDA has
already sent Warning Letters to several dietary supplement
manufacturers who explicitly claimed that Cat's Claw could help treat
cancer and arthritis. However, we do not know whether the FDA would
consider a claim of "DNA repair" to render Cat's Claw an unapproved
drug.
Nutritional Supplements May Also Be Harmful:
Regarding safety, the nutritionists we spoke with said that it is
possible that improper use of dietary supplements can be harmful. For
example, the nutritionists said that taking levels of some vitamins and
nutrients that far exceed the recommended daily allowance[Footnote 8]
may promote cancers and chronic diseases. A recent statement issued by
the National Institutes of Health[Footnote 9] also notes that taking
more than the recommended daily intake of certain vitamins and minerals
may cause adverse health effects. For example, smokers who consume
excessive amounts of beta-carotene may be at increased risk for
developing lung cancer, while consumption of excessive amounts of
vitamin D and calcium may increase the risk of kidney stones.
Furthermore, we were told that all nutrients or "food components" can
be toxic if provided in sufficient quantities, but the susceptibility
to toxicity varies among the population. For example, there is evidence
that some people may be at risk because of excessive intakes of vitamin
E, folic acid, calcium, or selenium.
When we asked the nutritionists about the safety of specific
ingredients in the supplements recommended for our fictitious
consumers, they generally believed that the supplements were comparable
to typical multivitamins, as previously stated. However, they also
expressed a variety of concerns. For example, one of the nutritionists
we consulted characterized the levels of vitamin B-6 in both products
as "disturbing." Another felt that the levels of Vitamin A in both were
"high," and that the supplements from Web site 1 contained excessive
amounts of iron, because iron stays in the blood and could become
toxic. Other experts told us that the supplements could be harmful if
taken in combination with certain medications. For example, Cat's Claw
may have an adverse interaction with a medication prescribed for people
who are at increased risk for forming blood clots, and individuals
taking this medication are advised to avoid all supplements unless a
physician approves.
Results Do Not Provide Recommendations Based on a Unique Genetic
Profile:
Results from the tests that we purchased from Web sites 1, 2, and 3
promise recommendations based on the consumer's unique genetic profile.
However, the 11 results we received from these three sites suggest that
the DNA submitted was not a factor in determining the recommendations.
Rather, the results simply provide a number of common sense health
recommendations based on information we submitted on the lifestyle
questionnaires.
Tests Promise Unique Recommendations:
Although Web sites 1, 2, and 3 acknowledge that information submitted
on the questionnaires is taken into consideration when determining diet
and lifestyle recommendations, the overall implication to the consumer
is that the information derived from the DNA analysis is the most
important factor, as shown in table 2.
Table 2: Statements Promising Recommendations Based on Consumers'
Unique Genetic Information:
Tests purchased from: Web site 1;
Product Claims:
* "Recommendations are based on your own DNA.";
* By "adjusting your diet and lifestyle to your genetic profile, you
can make sure that your body functions at an optimum level.".
Tests purchased from: Web site 2;
Product Claims:
* "Recommendations are based on the unique combination of your genetic
makeup" because it is important to "make lifestyle choices" that match
your genes.
Tests purchased from: Web site 3;
Product Claims:
* "Recommendations are based on your own DNA.";
* Recommendations will "focus on gene variations, the potential of
which may be offset by eating certain foods, increasing the intake of
specific micronutrients, or making lifestyle changes.".
Source: GAO.
[End of table]
Results Instead Provide Recommendations Based on Information Submitted
on Questionnaires:
Despite these claims, the recommendations we received are simply common
sense regimens directly linked to the information we submitted on the
questionnaires included with each test. For example, 9 of the 11
consumers we created for Web sites 1, 2, and 3 had the female DNA. If
the recommendations were truly based on the consumer's unique genetic
profile, then these 9 consumers should have received the same
recommendations because their DNA came from the same source. Instead,
they received a variety of different recommendations, depending on the
fictitious lifestyles we provided for them. For example, when we said
that a fictitious consumer with the female DNA smoked and ate a lot of
fatty foods, we received recommendations to stop smoking and eat fewer
fatty foods. In contrast, when we said that another fictitious consumer
with the female DNA never smoked and did not eat a lot of fatty foods,
we received recommendations to continue to avoid both smoking and
eating foods high in fat. Similarly, when we said that fictitious
consumers with the female DNA did not eat a lot of fruits and
vegetables, we received recommendations to eat more of these foods.
However, if we said that the consumer had a diet rich in fruits and
vegetables, we were told to continue this high level of consumption.
We received similar recommendations with regard to the 2 remaining
consumers we created using the male DNA. For example, for one of the
fictitious consumers with this DNA, we provided a lifestyle description
stating that the consumer ate only moderate levels of leafy green
vegetables, cantaloupe, and eggs--foods that are rich in antioxidants.
In this case, the consumer was told to eat more foods rich in
antioxidants. In contrast, we said that the other consumer with the
male DNA ate a lot of antioxidant-rich foods. This time, we received
recommendations to continue high consumption of these foods. Figure 8
provides further examples of the relationship between the lifestyle
information we submitted on the questionnaires and the recommendations
we received.
Figure 8: Lifestyle Descriptions Directly Linked to Diet and Health
Recommendations:
[See PDF for image]
Source: GAO.
[End of figure]
These results lead us to conclude that we could have invented any type
of lifestyle description for the DNA we submitted and the
recommendations would simply echo this information. Although these
recommendations may be beneficial to consumers in that they constitute
common sense health and dietary guidance, DNA analysis is not needed to
generate this advice.
Other Investigative Findings Raise Concerns:
During the course of our investigation, we found other information that
raises concerns for consumers purchasing these tests. For example, we
discovered that Web sites 1, 2, and 3 were in fact selling the same
genetic test developed by the same company and that this company was
pressured by consumer groups in the United Kingdom to stop selling the
test in that country. The company now sells the same type of test in
the United States. In addition, we found evidence suggesting a lack of
quality control by the laboratory actually conducting the DNA analysis
for Web sites 1, 2, and 3. For example, even though all of the genetic
information contained in the test results based on a single source
should be identical, we received disparate results from the tests we
purchased from Web site 1. We also found that the laboratory used by
Web site 4 is not approved under CLIA.
Nutrigenetic Testing in the United Kingdom: The company that
manufactures the tests used by Web sites 1, 2, and 3 used to sell the
same type of test in the United Kingdom--consumers provided DNA samples
and filled out a lifestyle questionnaire, and the company provided
advice on what consumers should do to improve their health with diet
and lifestyle changes. The Human Genetics Commission, the U.K.'s
strategic advisory body on developments in human genetics, and
GeneWatch UK, a consumer protection group, alleged that the company's
tests were misleading because no scientific evidence validated their
clinical claims. Other scientists and consumer protection groups also
cited numerous problems with the tests, including that the claims were
exaggerated, the service should not be offered without adequate
counseling, and that they provided advice which differed little from
standard guidance on diet and exercise.
Eventually, the tests were subjected to assessment by a team of three
experts--a clinical geneticist, a scientist leading a program of
research in nutritional genomics, and the chief dietitian of a leading
teaching hospital. They published the findings in a detailed report
that concluded that there was no value in the genetic tests being
offered. Subsequently, GeneWatch U.K. raised these concerns with major
retail chains and pharmacies carrying the tests and urged them to stop
selling the tests. By July 2002, the company was no longer attempting
to sell their test directly to the consumer in the United Kingdom,
either over the Internet or through retailers. In 2003, the company
moved its operations from the United Kingdom to the United States.
Despite the findings of the British experts, the company now sells the
same type of test to American consumers.
Contradictory DNA Analysis: The results we received from the tests we
purchased from Web site 1 appear to be contradictory and reflect
inaccurate lab results. Specifically, the results we received from
these tests contained a listing of the genes being analyzed and any
"variations" found in those genes. When we compared the two results we
received based on the DNA from the female, we found that the gene
variations listed were not exactly the same: one result said that the
DNA showed a variation in the "eNOS" gene, but the other result said
that there was no variation in this gene. According to the experts we
spoke with, because the DNA sample was taken from the same individual,
any gene variations should be identical. The experts also stated that a
competent laboratory should reliably be able to detect the presence or
absence of a particular gene variant. Consequently, concerns exist
about whether this laboratory has basic quality control procedures in
place to identify and prevent mistakes.
Lack of CLIA Approval: As noted in the introduction to our testimony,
laboratories performing genetic tests for medical purposes must be
approved under the Clinical Laboratory Improvement Amendments of 1988
(CLIA). In general, CLIA regulations address personnel qualifications,
quality control and assurance, recordkeeping requirements, and also
require laboratories to conduct proficiency testing. All laboratory
tests performed to provide information about an individual's health
must be conducted by law in approved laboratories. During the course of
our work, when we interviewed a representative from a laboratory
conducting tests for Web site 4, we were told that this lab is not
approved under CLIA.
Conclusion:
The current regulatory environment provides only limited oversight to
those developing and marketing new types of genetic tests.
Consequently, companies that sell nutrigenetic tests like the ones we
purchased may mislead consumers by promising results they cannot
deliver. Further, the unproven medical predictions these companies can
include in their test results may needlessly alarm consumers into
thinking that they have an illness or that they need to buy a costly
supplement in order to prevent an illness. Perhaps even more troubling,
the test results may falsely assure consumers that they are healthy
when this may not be the case.
With further advances in science, nutrigenetic tests like those we
purchased may in the future be valid, allowing consumers to use DNA-
based analysis to make diet and lifestyle changes that will actually
prevent the development of disease. However, as demand for these new
tests continues to rise, it will become increasingly important for
consumers to have reliable information in order to determine which
tests are accurate and useful.
Mr. Chairman and Members of the Committee, this concludes my statement.
I would be pleased to answer any questions that you or other members of
the committee may have at this time.
Contact:
For further information about this testimony, please contact Gregory D.
Kutz at (202) 512-7455 or kutzg@gao.gov. Contact points for our Offices
of Congressional Relations and Public Affairs may be found on the last
page of this testimony.
FOOTNOTES
[1] DNA stands for deoxyribonucleic acid.
[2] These include tests for cystic fibrosis; factor II and factor V
Leiden, which affect blood clotting; cytochrome P450 genotyping, which
affects the rate at which drugs are metabolized and thus can help in
determining dosage; and Her-2 neu, which is used to determine whether a
woman will benefit from a breast cancer drug called Herceptin.
[3] See 21 U.S.C. §§ 360c(f)(1), 360e(c)(1) and 21 C.F.R. pt. 809.
[4] 21 U.S.C. § 321(h).
[5] See 61 Fed. Reg. 10, 484.
[6] See Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42
U.S.C. § 263(a).
[7] Cystic fibrosis is an incurable disease that causes mucus to build
up in the body. People who have cystic fibrosis can have serious
breathing problems and lung disease. Huntington's disease is a rare
condition that causes parts of the brain to break down, or degenerate,
causing rapid, jerky movements and dementia.
[8] See [Hyperlink, http://dietary-supplements.info.nih.gov] for
detailed information on recommended daily allowances.
[9] National Institutes of Health, State-of-the-science Conference
Statement: Multivitamin/Mineral Supplements and Chronic Disease
Prevention, May 15-17, 2006.
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