On Monday, news broke that Walgreens was about to announce a genetic test kit, available in stores starting on Friday. The kits would allow consumers to test for such things as how you respond to statins or blood-thinners; whether you carry genes for Tay-Sachs disease or cystic fibrosis; whether you have an increased risk for coronary artery disease, Alzheimer’s, MS, colon, lung or prostate cancer; and your chances of becoming obese, developing psoriasis, or going blind. There are three separate tests, individually priced, so you don’t have to confront the bad news all at once.
On Tuesday, when the announcement became official, commentators speculated on how the FDA would react. A spokesman for Pathway Genomics, the developer of the test partnering with Walgreens, said: “FDA clearance is not necessary to sell the … Kit in retail.” He also confirmed that the product had not been submitted for FDA approval.
Meanwhile, FDA officials, contacted for their comments, were saying that any test that “could lead to a consumer making a decision on whether they are going to terminate a pregnancy — we consider that a very important decision to be made on a test that has not been looked at by the FDA.”
The FDA requires products that make health claims to be reviewed. Walgreens/Pathway argued that the test provides consumers with “information about their personal genetic makeup and traits,” hoping that would be sufficient to avoid the FDA’s purview.
On Wednesday the FDA made public a letter to Pathway “suggesting” that the kit did need regulatory approval. The FDA was on top of this all along. The letter was actually written on Monday.
Late Wednesday, Walgreens announced it would postpone sales of the kit.
It’s the mass marketing that triggered a response
The FDA had already been investigating the legality of other direct-to-consumer genetic tests, such as those sold by 23andMe and Navigenics. When a test is performed by a single laboratory, as opposed to a test that’s sold for use in hospitals and doctors’ offices, the FDA does not typically require approval. Since Pathway would be analyzing consumers’ saliva in a single laboratory, they thought they would be OK. The trigger in this case seems to have been retail marketing through Walgreens.
Meanwhile, the incident has generated considerable commentary on whether the public is ready for genetic testing (see Resources below).
What the medical profession thinks of genetic testing
As I wrote last year when discussing genetic tests for supertasters, the medical profession has serious reservations about do-it-yourself genetic testing. It’s not that doctors are afraid of losing your business if do something on your own. If anything they appear concerned that you’ll come into the office with your genetic test results and they won’t know what to say.
Reasons for medical caution include:
• The accuracy of the testing is not known.
• The relationships between the genetic data and disease are highly complex and not fully understood (genes may be present, but their “expression” depends on the environment).
• It’s questionable whether risk factors such as genetic markers are actually associated with subsequent disease.
• There’s no evidence (yet) that awareness of genetic risk markers leads to modifying behavior, for example, losing weight if the test indicates a predisposition for heart disease or diabetes.
• Conversely, there’s some concern that if a test tells you you’re not at risk, this may lead to unhealthy behavior, for example, overeating and not exercising.
Given all this, it’s not clear that do-it-yourself genetic testing is worth the cost or the possibility of unnecessary anxiety. If a patient is concerned about disease, doctors argue, they are probably better off with a healthy diet, not smoking, and moderate exercise than with a gene test.
Employee fired based on her genetic test
Meanwhile, there’s this story to consider. The NY Times reports that Pamela Fink was fired by her employer, MXenergy, when she volunteered the information that she would be undergoing surgery based on the results of a genetic test.
There is a new federal law that prohibits considering genetic information in firing, hiring, or promotion. Ms. Fink has filed one of the first complaints of illegal dismissal based on the new law.
[Ms. Fink’s] lawyers say that if she loses her case, it could discourage other workers from going for genetic testing about particular illnesses and from having surgery in response to such testing — steps that are good for their health.
The genetic information Ms Fink received concerned the BRCA2 gene. The test kit to be sold by Walgreens currently does not include testing for the mutated BRCA1 and BRCA2 genes, which are linked to breast and ovarian cancer. The patent for these genes, held by Myriad Genetics, was only recently struck down in court, and appeals to the ruling have not been exhausted.
Related posts:
Compression only CPR: Be the Beat
Are you a supertaster: DNA testing
The genetics of supertasting
Resources:
Photo source: Tampa Bay Online
Rob Waters, Walgreen Stores to Sell Spit-and-Mail Gene Test Kits, Businessweek, May 11, 2010
Sandra M. Jones and Bruce Japsen, FDA to Investigate Genetic-Test Kits, Los Angeles Times, May 12, 2010
Andrew Pollack, Start-Up May Sell Genetic Tests in Stores, The New York Times, May 10, 2010
Rob Stein, Company plans to sell genetic testing kit at drugstores, Washington Post, May 11, 2010
Andrew Ross Sorkin, Walgreens Delays Selling Genetic Test Kit, The New York Times, May 13, 2010
Steven Greenhouse, Ex-Worker Says Her Firing Was Based on Genetic Test, The New York Times, April 30, 2010
Courtney Rubin, Fired over Breast Cancer?, Inc., May 11, 2010
John Schwartz and Andrew Pollack, Judge Invalidates Human Gene Patent, The New York Times, March 29, 2010
Angela Townsend, Walgreens to offer personal genetic-testing kits, Cleveland.com, May 11, 2010
Daniel J. DeNoon, Concerns Raised About Drugstore Genetic Test, WebMD, May 13, 2010
Rob Stein, Walgreens won’t sell over-the-counter genetic test after FDA raises questions, Washington Post, May 13, 2010
Scott Hensley, No Gene Test At Walgreens Just Yet, NPR, May 13, 2010
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