In fact, besides people working for the genetic testing industry, not one person interviewed for the story you are reading felt this trend was a good idea. “I see four fundamental problems,” says Ellen Matloff, the Director of Genetic Counseling at Yale Medical School and the Yale Cancer Center. “Have their claims been validated? Who is interpreting these test results? What do you do about it if it turns out you have a genetic disposition for a particular disease? Are these labs regulated?” And while Matloff’s concerns are nowhere near the full list of potential hazards, they are a decent place to start.

The old model was akin to spear fishing: a hunt for variations in a single gene that had been exactingly correlated to rare diseases.

The question of “have their claims been validated?” sits at the forefront of this discussion. Genetic testing has been around for years, but not like the version that’s going on today. The old model was akin to spear fishing: a hunt for variations in a single gene that had been exactingly correlated to rare diseases. Over the years, for things like cystic fibrosis, Down syndrome, and Huntington disease, this method has proved invaluable. The new model, as practiced by companies like GeneticHealth, deCODEme, Navigenics, and 23andMe, is more like drift netting. Using gene arrays—specially designed microchips—these companies comb large swatches of the genome looking for single nucleotide polymorphisms, or SNPs, indicative of a vast assortment of conditions. According to the direct-to-consumer genetic testing companies offering these services, their final reports provide some of the best genetic information science is currently capable of—and while they may not be wrong about this fact, what we’re currently capable of detecting remains an open question.

The issue being that information—in this case genetic data—cannot be confused with interpretation of that data. “SNPs haven’t entered mainstream clinical practice yet because we’re still validating these tests,” says Matloff. “Currently, we don’t have any real notion of what they mean and even less of one about what to do with them.” A great example of this is in David Ewing Duncan’s four part series, done last May for Portfolio.com, in which he personally tested these services and three different companies returned three different answers concerning his apparent risk for heart attack. These confusing results occurred because much of modern genetics relies on looking at genotype, the genetic identity that we cannot observe as physical characteristics, and correlating to phenotype, the traits (or lack thereof) we can readily observe. But correlation is not mechanism and without mechanism many fear what’s left is mere extrapolation. The reason being that for correlation to be accurate a huge sample population is required to provide a convergence of traits. But 23andMe wants to use your DNA to build their genetic database because of a current paucity of such data, which most critics argue is still too small to really determine much of anything.

There are more issues as well. “Almost every genetically rooted abnormality is related to environmental causes,” says Tufts University professor Sheldon Krimsky, author of Biotechnics and Society: The Rise of Industrial Genetics and Vice Chair for the Council for Responsible Genetics, “which means that the entire notion of genes as the master planner is suspect.” Then there’s all the new research in epigenetics—the study of heritable changes in gene expression caused by things besides alterations in DNA sequence—which shows that there are a great many DNA-changing environmental exposures that don’t actually show up as mutations. “At the Washington State University,” continues Krimsky, “they exposed animals to certain chemicals. The genetic effects carried on for two and three generations, but didn’t show up as a mutation on SNP tests.”

All of the above are core issues for companies marketing their products primarily for medical purposes. For example, according to the “About Us” portion of the company’s website: “Navigenics was founded on the premise that by helping people understand what health conditions they are at risk for, before they develop symptoms, we can arm people with the information and support to take the next steps to improve their health outcomes.” 23andMe too provides this information, but they have also expanded on the model. “We take a holistic approach to genetics,” says co-founder Linda Avey, “and give us as much information to our customers as is scientifically appropriate, given the current state of knowledge. Hence, we provide not only information about how genetics may affect your health, but also information about inherited traits (such as eye color, height, lactose intolerance, etc.) and ancestry.” And it is this last bit which causes even more concern, as the genetic basis for disease is far better understood than the genetic basis for ancestry.

While 23andMe does admit this portion of the science is still in its infancy, even the veracity of their claims to be able to tell you if you’re from Asia, Africa or Europe—arguably the simplest genealogical information around—remains very much an open question. “That’s because,” continues Krimsky, “the relationship between ancestry and DNA relies on assumptions about the stability of alleles and that stability has yet to be accurately validated.” Moreover, the current limits on this type of testing allows researchers to trace either the maternal mitochondrial line or the paternal Y chromosome, but not both at the same time. This means you can learn about half of a family tree, but not its entirety. And, again because of the novelty of this science, even that half sits on shaky footing.

The next three of Matloff’s apprehensions tend to dovetail together, but they begin with the question of “who is interpreting these results?” At 23andMe, they offer no genetic counseling, though they will let you talk to their scientists if you have any questions. Unfortunately, knowing enough to have those questions is part of the problem. Genetic testing tells us about potential risk factors for certain conditions, but calculating risk is not a simple process. “Look,” says Matloff, “in the U.S. there’s this notion that more information is really better. But even trained genetic counselors don’t really know what this stuff means, so is more really better?”

And these are not idle concerns. As Stanford University’s Nobel Prize-winning RNA researcher Andy Fire says, “if someone off the street is looking for pointers on how to live a healthier life, there’s nothing these tests will tell you besides basic physician advice like ‘eat right, don’t smoke and get plenty of exercise.’” And even with the more well-regarded tests, like the ones that examine the BRCA 1 and 2 markers for breast cancer—which only account for between 5 and 27 percent (estimates, um, vary) of all breast cancers—identifying risk factors does not always lead to easy treatment options. As University of Pennsylvania bioethicist Arthur Caplan points out, “Say you test positive for a breast cancer disposition—then what are you going to do? The only preventative step you can take is to chop off your breasts.”

So if prevention is not available the only thing left is fear and anxiety. Unfortunately, in the past few decades, there have been hundreds of studies linking stress to everything from immunological disorders to heart disease to periodonitic troubles. So while finding out you may be at risk for Parkinson’s may make you feel informed, that knowledge isn’t going to stop you from developing the disease—but the resulting stress may contribute to a host of other complications.

Also in question is the clinical accuracy (as opposed to analytical accuracy) of these tests, but it’s difficult to assess this without also addressing the last of Matloff’s concerns: whether or not these labs are regulated. The short answer is no. The longer answer is slightly more complicated. According to Gail Javitt, Law and Policy Director for the Johns Hopkins Genetics and Public Policy Center, the only existing nationwide regulations that cover this industry are the 1988 Clinical Laboratory Improvement Amendments, or CLIA—a law that passed because of a spate of false negative results in pap smears—and those regulations are, in her words, “fairly light.” While there have been ongoing attempts to strengthen the genetics portion of CLIA, these have met with much governmental resistance and nothing has been done so far. Without a national system to review quality, there is really no way to assess the accuracy of these tests, but Javitt does mention that in 2006 the Government Accountability Office ran an undercover “sting” operation of direct-to-consumer nutrigenomic tests. “They found that the results of testing appeared to be based on the health information provided rather than a difference is customer’s genetic make up,” says Javitt, “and that the claims made by the companies were misleading and so vague as to be not useful to consumers.”

But even better laboratory regulation may not solve this problem because most direct-to-consumer companies are not actually testing labs. 23andMe uses an “off-the-rack” gene array, a chip built by Illumina which examines 550,000 standard SNPs, and has been further customized to include another 50,000 that 23andMe scientists find useful. Illumina processes the data as well, shipping the results back to 23andMe, which then assembles it into an interactive package that is delivered to the consumer via the web. This makes regulation even trickier because these personalized genetics companies are technically serving as middlemen in the actual operation.

“Most people think that GINA [the 2008 Genetic Information Nondiscrimination Act] goes a lot farther than it does.”

Beyond the question of clinical accuracy lies the entire ethical quagmire of direct-to-consumer marketing for medical technologies in general and genetic testing in particular. The list of issues surrounding this muck have been well-publicized elsewhere, with just about every major journal covering the topic to some extent over the past decade, but a greatest hits summary of potential advertising sins include: misinformation about genetics, an exaggeration of consumer risk, an overstatement of the value of genetic testing, manipulation of behavior by exploiting consumer fears and worries, endorsement of a deterministic relationship between genes and disease, reinforcement of the links between ethnic groups and disease, no pre-market review for the tests themselves, and no advertising content oversight. The Federal Trade Commission is charged with protecting consumers against these kinds of unfair or deceptive trade practices, but while they’ve already staked out genetic testing as their territory, all they’ve done so far is to tell consumers to be skeptical of direct-to-consumer claims and to discuss them with a health care provider. The Food and Drug Administration has some authority here too, but only regulates genetic tests sold as “test kits”—meaning kits used by the labs for this kind of testing—but because most of these labs are designing the tests themselves, they fall outside of the FDA’s jurisdiction and thus go unexamined.

Certainly, there is more than enough uncertainty here to justify the 2003 Journal of Clinical Oncology story entitled: “Direct-to-Consumer Marketing of Genetic Test for Cancer: Buyer Beware” (among many other examples), but the tests and the resulting information make up only one half of this entire picture. The second portion comes down to issues of privacy and discrimination and how safe your data really is. On this matter, let’s just start by saying it wasn’t just the doctors who thought direct-to-consumer genetic testing was a bad idea—the lawyers thought the same thing.

In part, the reasons the lawyers feel as such has to do with speculative fears rather than actual fears. 23andMe claims that the firewall separating your phenotypic information (hair color, weight, ailments, etc.) from your genotypic (DNA) information is invulnerable. And they are not casual about this. They have an in-house security team constantly assessing data security and hire outside consultants to attempt to break in to further augment their system’s robustness, but this doesn’t assuage everyone. “Historically,” says Deven McGraw, Director of the Health and Privacy Project for the Center for Democracy and Technology, “we’re always one step behind the hackers. It seems like if someone really wants this information sooner or later they’ll figure out how to steal it. And once this data gets out there, it’s out there. There’s no way to put that genie back in the bottle.”

McGraw and others point to the recent National Institutes of Health decision, made in September of this year, to pull all their genetic data offline because David Craig, of the Translational Genomics Research Institute in Phoenix, Arizona, devised a statistical algorithm that allows identification of individual DNA profiles from samples comprised of more than a thousand people. While this seems a very separate case from the privacy concerns facing these direct-to-consumer genetic companies, the point is that no one really knows what tomorrow’s technology is going to bring. It could very easily bring a way to identify more and more phenotypic information from less and less genotypic information so perhaps their caution does seem justified.

Caution is also justified because once that information gets out there, Americans are really afforded very scant protection under the law. “Most people think that GINA [the 2008 Genetic Information Nondiscrimination Act] goes a lot farther than it does,” says Mark Rothstein, director of the Bioethics Institute at Louisville School of Medicine. “GINA only covers employment and health insurance discrimination. For employment it only covers people who are asymptomatic. If a genetic test shows you’re at risk for Parkinson’s, you can’t be discriminated against, but if you actually develop the disease then that protection ends and it becomes a question of state law. The health insurance portion is problematic because it’s just health insurance. The protections don’t include life insurance, disability insurance, long term care insurance—and since GINA doesn’t help you once you develop a disease then these other acts are the fallback and they’re outside of the circle of protection.”

This brings us back to the social networking portion of 23andMe’s business model. According to Avey, this feature allows the curious “to compare their genome to those of family and friends who are also 23andMe participants. Customers can also join the 23andMe communities, where they can connect with others, share stories, ask questions about specific traits and ancestry groups and learn more about research studies. They can also actively participate in genetic discoveries, through our research program, 23andWe, by filling out online surveys.” While DNA-based social networking has proven especially popular with 23andMe’s clients, how many of those clients believe it either a harmless pastime or a pastime protected by GINA remains a pertinent question. So while Gawker’s notion that this is a trend that will “destroy the world” is certainly hyperbolic, their concern is not. Which is to say, as Ellen Metloff, Director of Genetic Counseling at Yale Medical School and the Yale Cancer Center, put it, “If you’re really interested in fortune telling than don’t spit in a cup, go get your tarot cards read. It’s cheaper, quicker and safer. Plus, they can probably tell you just as much about what may or may not happen to you in the future as these genetic tests.”

Steven Kotler lives in New Mexico with his wife and too many dogs. His work has appeared in The New York Times Magazine, Wired, Discover, Popular Science, National Geographic, among others. You can find him online at: www.stevenkotler.com

Experts on biological weapons, along with those who worry about novel threats to public health from any source, are watching these developments closely. To address concerns that the bacterium could be a pathogen, the lab disabled a gene that enables the bacteria to attach to human cells.

Reports indicate that Venter and colleagues believe the next step—using the DNA strand to govern a functional cell—could be accomplished within the year. When that happens, synthetic biology will have decisively left the arena of science fiction and could be the beginning of industries based on cellular factories.

Exactly what should the public make of genetic tests indicating a predisposition to depression? How can we ensure that medical information about depression does not lead to employer discrimination? Experts tackled these and other issues at a Monday symposium, “DNA and Depression: Tests, Trust, and Treatment,” part of a Johns Hopkins University series of Genetic Perspective on Policy Seminars hosted by the University’s Genetics and Public Policy Center.

Dr. Francis McMahon of the NIMH discussed the research that his team carried out on the genes that predispose patients to having suicidal thoughts while taking Selective Seratonin Reuptake Inhibitors such as Prozac. This research came in the wake of FDA research indicating that SSRIs can can cause a rise in suicidal thinking and behavior in adolescents; the Agency subsequently mandated “black-box” warnings on the medications. Dr. McMahon also noted that these types of drug side effects can be minimized as personalized medicine, which is based on a patient’s personal genome information, becomes standard practice. In the near future, doctors may be able to recommend preventative treatments based not just on family history, but on indicators found in a patient’s own genome.

“Everyone has predicted that the complete genome will be part of your medical record in five years or so,” McMahon said. However, as private companies offer to decode and interpret the genomes of consumers, doctors will no longer be the sole gatekeepers of genetic information. “We don’t have a monopoly on the information anymore,” McMahon affirmed.

While genome sequencing is not currently a part of regular mental health diagnoses, Kim Bechthold, CEO of Neuromark, which develops diagnostic tools to help doctors determine if SSRIs pose a risk for their patients based on their genomes, explained that surveys show that “patients and consumers trust genetic tests,” which means that “we have a very exciting and very challenging task” in trying to accurately convey genetic information to doctors and patients. She explained that the public trusts genetic diagnosis more than they trust diagnoses based on lifestyle, environmental factors, and socioeconomic status.

Bechthold also stressed the need to protect patient privacy with regard to genetic information and added that Congress must pass the Genetic Information Nondiscrimination Act in order to prevent employer discrimination against employees at risk for ailments—mental health or otherwise. “Without GINA…preventative medicine is simply not going to get off the ground,” she said.

The J. Craig Venter Institute pegs the current cost of personal genome sequencing at around $300,000 per genome, but the X Prize Foundation is offering a $10 million Genomics award for the first group to sequence 100 genomes in 10 days at a cost of $10,000 per sequence. The prize was originally set at $500,000, but in 2005 Venter pushed for the 20-fold increase.

With Venter barreling forward and the X Prize offering a significant incentive for competing groups, we are very close to the advent of widespread personalized genome sequencing, and the ethical framework must catch up to the science.

In the hands of insurance companies and employers, this information raises serious ethical concerns, but various protections are in motion. The question is whether legal protections will come fast enough.

The Genetic Information Nondiscrimination Act of 2007 (H.R.493) passed the House 420-3 on April 25, but it is currently held up in the Senate with no date set for debate. According to CQ (subscription), the President has indicated that he would sign the bill, but Sen. Tom Coburn (R-OK) placed a hold on it so that he and Sen. Edward Kennedy (D-MA) could work out Coburn’s concerns. Rep. Louise Slaughter (D-NY), who sponsored the House bill, speculated that the hold had to do with objections analogous to those raised when the bill went through the House Energy and Commerce Committee, which concerned language providing anti-discrimination protection for fetuses and embryos that would not influence debate over abortion laws.

Forty-one states have taken some form of legislative action, and the NIH-DOE Committee has suggestions for future protections.

Secretary of Health and Human Services Michael Leavitt and Harvard geneticist George Church have both expressed support for legislation prohibiting discrimination based on genetic makeup. Francis Collins, the director of the National Human Genome Research Institute, also called for the development of federal legislation to protect genetic privacy.

In 2000, President Clinton issued an executive order prohibiting discrimination in federal employment based upon genetic makeup.

This new bacteria could lead to the creation of lifeforms that might play roles in novel medical treatments, such as biofuels generation or the digestion of atmospheric CO2. Or they could lead to lifeforms that could also be used to create deadly biological weapons.

But the AFP quotes Venter’s spokesperson Heather Kowalski as saying, “The Guardian is ahead of themselves on this.” She has also promised that Venter’s Institute will not announce the creation of artificial life until they publish a scientific paper on it. “We have not achieved what some have speculated we have in synthetic life,” she explained. “When we do so there will be a scientific publication and we are likely months away from that.”

Still, in October 2006 Venter did file for a patent on the essential Mycoplasmum laboratorium genome and synthetic “free-living organism.” Whatever the case, science bloggers and academics are already busy examining how Venter’s apparent quest could play out.

Ron Bailey at Reason’s Hit & Run blog has a summation of how artificial life will change the discipline of biology. Nature blogger Philip Ball has a blog post from June about the intellectual property implications of patenting the basic building blocks of synthetic biology, even if they are isolated by researchers. And Arti Rai has an article on possible solutions to this problem in PLoS Biology.

For an international perspective, India’s merinews has a skeptical article from a citizen, which claims that Venter’s proposed creation would not be an artificial life form since it is made from a naturally existing organism with 80 percent of its genes knocked out.

For more on Venter himself, The Guardian has an excerpt from his 400-page autobiography, set to be released on October 18.