Follow-Up Roundup

Many of the stories I’ve previously covered on Sword of Science have resurfaced in the news within the past couple of weeks, too many to give each of them the full attention they deserve. I’ve compiled a number of links to the latest information on these topics, together with the links to the original SoS articles. Catching up seems like a fine way to spend a cold and rainy Saturday afternoon.

The proposed Mars One lander, which would be the first private mission to Mars. Courtesy of the Mars One Foundation.

The Arctic 30 – Although all of the 30 Greenpeace activists arrested by Russian authorities during a protest of Arctic drilling have been released on bail, the international group has been ordered to remain in Russia during the legal proceedings. Russia’s decision is in direct conflict with that of the International Tribunal for the Law of the Sea, who ruled in late November that the 30 should be allowed to leave the country and that their ship, the Arctic Sunrise, should also be released.

Mars One – The private Mars colonization project has announced plans for an unmanned mission to the planet in 2018 that will prepare the way for its eventual astronauts. The aerospace firms Lockheed Martin and Surrey Satellite Technology Ltd. have signed agreements with Mars One, which plans to fund the mission largely through selling corporate sponsorships of its spacecraft and advertising rights to its broadcasts.

3-D Firearms – On Monday, the Senate passed an extension to the Undetectable Firearms Act, which outlaws the sale, manufacture or possession of firearms that can escape the notice of scanning technology. Congress debated the strength of the act in light of advancements in 3-D printing; although current printed gun designs call for the inclusion of some metal, these parts can be easily removed to make the firearms completely undetectable.

NSA Surveillance – The revelations of former National Security Agency employee Edward Snowden continued last week with documents suggesting that the NSA conducted operations inside virtual gaming worlds such as those of World of Warcraft and Second Life. The agency claims that terrorists could use the communication functions of these games to plan operations in secrecy, but none of the leaked documents indicate that any actual terrorist activity was foiled.

Sea World and “Blackfish” – The animal rights group PETA staged a protest of SeaWorld’s float in the Macy’s Thanksgiving Day Parade, hoping to bring visibility to the theme park’s mistreatment of killer whales as outlined in the documentary “Blackfish.” Although the mass of protesters stayed behind the crowd barricades, 12-year-old Rose McCoy leapt into the path of the float to chant “Boycott SeaWorld” before police removed her from the route. At the park itself, a number of high-profile musicians such as the Barenaked Ladies and Willie Nelson have canceled shows in light of the film.


Follow-Up: Genetic Disease Testing and the FDA

In June, I published a post on genetic disease testing after the highly publicized double mastectomy of actress Angelina Jolie, who had the procedure after a genetic screen showed she possessed a version of the BRCA1 gene associated with breast cancer. Consumer genomics has since garnered attention from the US Food and Drug Administration, which claims that manufacturers of home genetics kits are effectively selling unlicensed medical devices. The FDA’s scrutiny of genetic testing recently escalated in a strongly worded letter sent to Anne Wojcicki, the CEO of 23andMe, the largest American manufacturer of these tests.

Anne Wojcicki, CEO of 23andMe, courtesy of 23andMe.

In this warning letter, FDA director of in vitro diagnostics and radiological health Alberto Gutierrez ordered 23andMe to “immediately discontinue marketing the PGS [Personal Genome Service, the company’s genetic testing kit] until such time as it receives FDA marketing authorization for the device.” Although the company has previously attempted to register some of the tests included in the PGS under 510(k) applications, which bypass costly clinical trials by proving that a test is substantially the same as one already on the market, the FDA claims that these efforts are insufficient for the long list of conditions assayed by the kit

The letter focuses on the risks of false positives and negatives, using the same BRCA test that Jolie took as an example. “[I]f the BRCA-related risk assessment for breast or ovarian cancer reports a false positive, it could lead a patient to undergo prophylactic surgery, chemoprevention, intensive screening, or other morbidity-inducing actions, while a false negative could result in a failure to recognize an actual risk that may exist.”

Wojcicki has apologized for her company’s failures to comply with the FDA’s past information requests, saying that “We stand behind the data that we return to customers—but we recognize that the FDA needs to be convinced of the quality of our data as well.” However, the company has issued no comment on whether it will discontinue sales of its kits while it prepares regulatory submissions to the government.

UPDATE: 23andMe has announced that while it will continue to sell its kits, it will restrict the results of the tests it releases to its customers to ancestry and raw data. None of the company’s previous health-related claims will be included.