Our several posts about FDA actions against
23andMe caused, while often one-sided, emotional and heated conversation. So we decided to do a more extended posting hoping that it will explain legitimacy of our concerns and will remove prevailing notion that FDA actions were unusual, selective or motivated by prejudice.
The cover image of the blog is actually used by another direct to consumer genetic company
Graceful Earth Inc. that markets its own saliva test to detect Alzheimer's disease (AD). In fact, the cover of the US News and World Report January 8, 2007 issue and the article
Unraveling Your DNA's Secrets where written when the
Graceful Earth Inc. company was located in Hawaii and
"the Alzheimer's test, sold for $150 by Graceful Earth of Honolulu, examines the APOE gene." Today the company is
located in Florida and the test is priced at
$280.00, hardly "cheaper" (many were crediting
23andMe for helping to bring the price of the genetic tests down) then 6 years ago. What is more important is that in 2010
FDA issued a letter to the
Graceful Earth Inc. inquiring about company's test
It has come to our attention that you are currently marketing the Graceful Earth Alzheimer's Test, a home-use saliva collection kit, intended to report customary and personal genetic health disposition results for Alzheimer's Disease. The Genetic Health Report appears to meet the definition of a device as that term is defined in section 201 (h) of the Federal Food Drug and Cosmetic Act.
Furthermore, aside from the FDA controversy
Graceful Earth Inc. was also, as it appears,
violating the 3 “method” patents that belong to Duke University and
"covering APOE genetic testing." In fact, as the article explains the Duke University patents were exclusively licensed exclusively to
Athena Diagnostics that currently offers the AD
APOE test and actually is using blood probe rather than saliva.
Direct-to-consumer APOE testing was available March-October 2008 through Smart Genetics. Smart Genetics ceased offering APOE risk assessment for Alzheimer’s disease to consumers in October 2008.3 Direct-to-consumer APOE testing remains advertised through Graceful Earth’s website, and APOE ε4 status is indirectly assessed by at least one of the “personal genomics” firms.
Perhaps, these inquiries explain why
Graceful Earth Inc. relocated to a new location in Florida. Yet even, these problems with the AD test offered by the
Graceful Earth Inc. are not the only considerations whether their service should be used because as the
US News and World Report article Unraveling Your DNA's Secrets explained
Unfortunately, three of the tests that we analyzed [including the AD APOE test] that are marketed as gauging the risk of major diseases relied on genes that don't provide a clear view.
......
Our tester, a 41-year-old female, was told that she had APOEe3. Not having APOEe4, the test results said, offered "moderate protection" from Alzheimer's. But half of people with Alzheimer's don't have APOEe4, and many people with it will never get Alzheimer's. "It doesn't have a lot of value to the patient," says William Thies, vice president of medical and scientific affairs for the Alzheimer's Association, which recommends against using APOE for predictive testing. Kenneth Friedenberg, vice president of Graceful Earth, agrees that having APOEe4 doesn't mean that someone will get Alzheimer's. "We've gotten criticism from doctors," he says. "But I think people really want to know, especially if they'd had it in their family." Knowing a person is at increased risk, he says, could prompt him or her to eat healthier. "What is the harm if someone starts increasing their intake of antioxidants? Or fish oils? How is that going to hurt them?"
Despite quite unflattering description of its test
Graceful Earth Inc. company is still using US News and World Report cover on its website. Possibly counting that most people will not get into details.
Another genetic test and analysis that was actually provided by
23andMe and mentioned by one of the our post commentators was for detection of hemochromatosis. Here is what
Unraveling Your DNA's Secrets article stated about this test
DNA Direct's most popular test is its $199 screening for hemochromatosis, which elevates iron in the blood and can lead to liver cancer. Ever since a gene that causes the disease was detected in 1996, doctors have debated widespread screening. Sandra Thomas, president of the American Hemochromatosis Society, encourages people who contact her to use DTC tests and thinks that everyone should be screened for the disease, which killed her mother. But a National Institutes of Health study of almost 100,000 people in 2005 found the correlation between gene and disease not strong enough to be useful as a screening tool. The U.S. News staffer, who took the test through HealthCheckUSA, had no family history and came up negative. "Some people have cirrhosis and liver cancer, and some people have the same genetic profile and don't even have iron overload," says Paul Adams, a gastroenterologist at the University of Western Ontario who led the NIH study.
In fact, FDA has at least one special page
Letters to Manufacturers Concerning Genetic Tests where 14 different companies were inquired about their genetic tests marketed directly to consumers. And this is despite that FDA clearly stated as early as 2007 in the
"Pharmacogenetic Tests and Genetic Tests for Heritable Markers" Guidance for Industry and FDA Staff that these test fall into category of medical devices that has to receive an approval from FDA.
In another
US News & World Report article A High-Tech Family Tree published on January 2, 2008 many other direct to consumer genetic test companies, including
23andMe are mentioned. In fact, at that time, in 2008, according to the article
23andMe Genetic scan that calculates health risks and ancestry, and allows sharing with friends and family. was priced at
$999 while other companies were offering it at lower prices and some genealogical project were offering test at the price under
$200 or even for free. The fact that
23andMe in the next 5 or so years reduced price of its test from $999 to $99 means only that there was intense competition in the market place and not necessarily company's innovation did that.
Today the excitement and thrill with genetics and genetic testing definitely causes excesses of inappropriate application of this particular technology. For example, the same US News and World Report magazine published another article
Romance in a Box? Company Offers Genetic Love Matches about several genetic testing companies that
"are promising to match couples based on the DNA testing, touting the benefits of biological compatibility." While this claim is certainly has very little scientific basis (somehow cosmetic scents are not taking into consideration - read the article) and ridiculously far stretched at the time of the publication thousands people tried it. Interestingly enough, it seems that the magic number
$99 as price of the test seems what people feel "fair" to pay to give it a try.
... GenePartner, a Swiss company that works with matchmakers and dating sites, has tested more than 1,000 people, according to chief scientific officer Tamara Brown. Some were already coupled and took the test out of curiosity.
The GenePartner Test is $99, and will be offered at the dating site sense2love.com when it relaunches next month.
GenePartner is still operating today, but the
test cost today is actually higher- $249. It would be probably correctly to guess that they have no shortage of customers. At the same time
several partner sites that were offering GenePartner tests in the past --
Sense2Love, Eventful Dating and
SuccessMatch -- are no longer in the business.
It is not new that people have high hopes for a new technology regardless whether it is snake poison or oil or genetic testing. Unfortunately, often unscrupulous sales people try to take advantage of hopes and vulnerability of consumers who hope to benefit from the new technologies. Some might say that consumers should be saved from themselves while others see nothing wrong in taking advantage of naivete and luck of understanding of the new technologies by consumers regardless whether they are exotic financial products such as mortgages and derivatives or genetic testing. However, the society as whole suffers if the cheating occurs on a mass scale. The inaccurate and misleading genetic tests are much more dangerous than knockoff of designers bags or watches or bootlegged DVDs or CDs. Not only they create unnecessary social anxieties, false and inaccurate diagnoses that lead to significant social costs, but they actually cause disappointment with a particular technology when the ungrounded hopes do not materialize and lead to delays and setbacks of progress.