Nutrigenetic Testing: Tests Purchased from Four Web Sites Mislead
Consumers (27-JUL-06, GAO-06-977T).				 
                                                                 
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.		 
-------------------------Indexing Terms------------------------- 
REPORTNUM:   GAO-06-977T					        
    ACCNO:   A57580						        
  TITLE:     Nutrigenetic Testing: Tests Purchased from Four Web Sites
Mislead Consumers						 
     DATE:   07/27/2006 
  SUBJECT:   Disease detection or diagnosis			 
	     Genetics						 
	     Health care fraud					 
	     Product evaluation 				 
	     Requirements definition				 
	     Testing						 
	     Websites						 
	     Consumer protection				 
	     Nutrition						 
	     DOJ/HHS Health Care Fraud and Abuse		 
	     Control Program					 
                                                                 

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GAO-06-977T

     

     * Summary
     * Results Contain Health-related Predictions That Are Both Med
          * Claims That Test Results Will Not Diagnose Disease
          * Predictions of Medical Conditions Received
          * Predictions of Medical Conditions Cannot Be Medically Proven
          * Medical Predictions Are Also Meaningless
     * Results Encourage the Purchase of Supplements That Are Overp
          * Supplements Recommended by the Tests Purchased from Web Site
          * Supplements Recommended by the Tests Purchased from Web Site
          * Nutritional Supplements May Also Be Harmful
     * Results Do Not Provide Recommendations Based on a Unique Gen
          * Tests Promise Unique Recommendations
          * Results Instead Provide Recommendations Based on Information
     * Other Investigative Findings Raise Concerns
     * Conclusion
     * Contact
          * Order by Mail or Phone

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

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.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 dozen2 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.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.4 Presently, though, most genetic tests are
not sold as kits but are manufactured in-house by clinical laboratories.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.6

1DNA stands for deoxyribonucleic acid.

2These 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.

3See 21 U.S.C. S:S: 360c(f)(1), 360e(c)(1) and 21 C.F.R. pt. 809.

421 U.S.C. S: 321(h).

5See  61 Fed. Reg. 10, 484.

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.

6See Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C.
S: 263(a).

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

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 Selected disclaimers                                  
Web site 1           [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.     
Web site 2           Please note that this screening is not a test for     
                        inherited disorders.                                  
Web site 3           [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.     
Web site 4           [Our] products are not intended to diagnose or treat  
                        any disease or disorder; only your doctor can do so.  

Source: GAO.

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

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

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

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

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.

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

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.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.

7Cystic 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.

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

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

           o  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.
           o  1 tablet per day of a supplement designed to "enhance the
           body's ability to repair damaged DNA." A 60-day supply costs $50.
           o  1 tablet per day of a supplement to control blood sugar and
           body fat. A 60-day supply costs $50.
           o  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 allowance8 may promote cancers and
chronic diseases. A recent statement issued by the National Institutes of
Health9 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.

8See  http://dietary-supplements.info.nih.gov for detailed information on
recommended daily allowances.

9National Institutes of Health, State-of-the-science Conference Statement:
Multivitamin/Mineral Supplements and Chronic Disease Prevention, May
15-17, 2006.

    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 Product Claims                                        
Web site 1              o  "Recommendations are based on your own DNA."    
                           o  By "adjusting your diet and lifestyle to your   
                           genetic profile, you can make sure that your body  
                           functions at an optimum level."                    
Web site 2              o  "Recommendations are based on the unique        
                           combination of your genetic makeup" because it is  
                           important to "make lifestyle choices" that match   
                           your genes.                                        
Web site 3              o  "Recommendations are based on your own DNA."    
                           o  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.

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

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.

Nutrigentic 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 [email protected]. Contact points for our Offices of
Congressional Relations and Public Affairs may be found on the last page
of this testimony.

(192190)

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www.gao.gov/cgi-bin/getrpt? GAO-06-977T .

To view the full product, including the scope

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For more information, contact Greg Kutz at 202-512-7455 or [email protected].

Highlights of GAO-06-977T , testimony before the Special Committee on
Aging, U.S. Senate

July 27, 2006

NUTRIGENETIC TESTING

Tests Purchased from Four Web Sites Mislead Consumers

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.

Medical Conditions Predicted for 14 Fictitious Consumers

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.
*** End of document. ***