The summer of our government’s discontent (with personal genetics tests) continues. Yesterday an investigator with the Government Accountability Office reported back to Congress on its undercover investigation of the tests on the market, saying that testing the DNA of GAO staffers returned frequently contradictory and confusing answers.
“Consumers need to know that today, genetic testing for certain diseases appears to be more of an art than a science,” said GAO investigator Gregory Kutz [CBS News].
Here at 80beats, we’ve gone over some of the potential problems with these tests. DISCOVER blogger Ed Yong covers them in great detail in a post he wrote this week after getting his genes tested by 23andMe, including the dearth of data appropriate for interpreting results if you’re of Asian rather than European descent, and deciding whether to peek into the data that says whether you have a much higher than average risk for Parkinson’s disease.
The federal government began to worry about the same things this summer after Walgreens announced plans to sell tests by Pathway Genomics in its drug stores. Then, last month, the FDA announced that it intended to regulate these tests, whereas before they existed in a cloud of regulatory uncertainty—Pathway had told Walgreens the tests didn’t require the government’s OK. Congress got in on personal genomics, too, which led to this GAO investigation.
The GAO report suggests the companies still have a long way to go in drawing accurate conclusions. The agency submitted DNA samples from five staffers to four different genetic testing companies. When considering the same disease, the companies’ results contradicted each other nearly 70 percent of the time, according to GAO. In response to the same patient’s DNA, one company claimed he was at above-average risk for prostate cancer, a second said he was below average and two others said his risks were average [AP].
The FDA is holding meetings this week, trying to decide how it will regulate the tests.
Image: flickr / nosha
crimeandpunishment writes “If Governor David Paterson has his way, New York would take DNA samples from even the lowest level of criminal….doubling the state’s DNA database. He says it would help to both solve crimes and clear people who were wrongly convicted. New York would become the first state in the country to do this. Currently DNA isn’t collected in most misdemeanors. The plan is getting lots of support among law enforcement, but the New York Civil Liberties Union says there are questions about privacy.”
suraj.sun writes with this excerpt from CNET: “Millions of Americans arrested for but not convicted of crimes will likely have their DNA forcibly extracted and added to a national database, according to a bill approved by the US House of Representatives on Tuesday. By a 357 to 32 vote, the House approved legislation that will pay state governments to require DNA samples, which could mean drawing blood with a needle, from adults ‘arrested for’ certain serious crimes. Not one Democrat voted against the database measure, which would hand out about $75 million to states that agree to make such testing mandatory. … But civil libertarians say DNA samples should be required only from people who have been convicted of crimes, and argue that if there is probable cause to believe that someone is involved in a crime, a judge can sign a warrant allowing a blood sample or cheek swab to be forcibly extracted.”
shadowbearer writes “SF writer Peter Watts, a Canadian citizen, whose story we have read about before in these pages, was sentenced three days ago in a Port Huron, MI court. There’s not a lot of detail in the story, and although he is still being treated like a terrorist (cannot enter or pass through the US, DNA samples) he was not ordered to do any time in jail, and is free and has returned home to his family. The judge in the case was, I believe, as sympathetic as the legal system would allow him to be.”
bbsguru writes “A court settlement has ended a controversial case of medical privacy abuse. From the NYTimes: ‘Seven years ago, the Havasupai Indians, who live in the deepest part of the Grand Canyon, issued a ‘banishment order’ to keep Arizona State University employees from setting foot on their reservation, an ancient punishment for what they regarded as a genetic-era betrayal. Members of the tiny tribe had given DNA samples to university researchers starting in 1990, hoping they might provide genetic clues to the tribe’s high rate of diabetes. But members learned their blood samples also had been used to study many other things, including mental illness and theories of the tribe’s geographical origins that contradict their traditional stories.’”
An anonymous reader writes “Michael Seringhaus, a Yale Law School student, writes in the NY Times, ‘To Stop Crime, Share Your Genes.’ In order to prevent discrimination when it comes to collecting DNA samples from criminals (and even people who are simply arrested), he proposes that the government collect a DNA profile from everybody, perhaps at birth (yes, you heard that right).”
Regarding the obvious issue of genetic privacy, Seringhaus makes this argument: “Your sensitive genetic information would be safe. A DNA profile distills a person’s complex genomic information down to a set of 26 numerical values, each characterizing the length of a certain repeated sequence of ‘junk’ DNA that differs from person to person. Although these genetic differences are biologically meaningless — they don’t correlate with any observable characteristics — tabulating the number of repeats creates a unique identifier, a DNA ‘fingerprint.’ The genetic privacy risk from such profiling is virtually nil, because these records include none of the health and biological data present in one’s genome as a whole.”