Ethicist cautions on at-home DNA tests
Catholic Spirit, June 2010, In Our World
By Nancy Frazier O’Brien
Catholic News Service
Catholics should use caution in deciding whether to have genetic testing and should do so only with a doctor’s counsel, a Catholic ethicist said.
Stephen Napier, an ethicist at the National Catholic Bioethics Center in Philadelphia, was commenting May 24 on recent controversies surrounding the use of at-home DNA tests, which are being marketed as predictive of a patient’s likelihood of contracting a variety of diseases as well as his or her predisposition to everything from alcoholism and artistic ability to obesity and optimism.
“There’s nothing inherently wrong with” wanting to know about one’s genetic makeup, Napier told Catholic News Service, “but it needs to be done within the context of medical expertise.”
National drugstore chains Walgreens and CVS Caremark recently announced they had reversed decisions to sell an over-the-counter DNA test kit produced by the San Diego-based Pathway Genomics Corp. after the Food and Drug Administration said the kits might require FDA approval as a “medical device.”
“The Genetic Health Report appears to meet the definition of a device,” said James Woods, deputy director for patient safety and product quality in the FDA’s Office of In Vitro Diagnostic Device Evaluation and Safety, in a May 10 letter to Pathway. “If you do not believe that you are required to obtain FDA clearance or approval for the Genetic Health Report, please provide us with the basis for that determination.”
The House Committee on Energy and Commerce and its Subcommittee on Oversight and Investigations also announced in mid-May that it would open an investigation into “personal genetic tests sold to consumers over the Internet.” The House panels asked Pathway and two other companies to submit information by June 4 about the tests, patient risks and compliance with the Federal Food, Drug and Cosmetic Act and FDA regulations.
In a statement on its website, Pathway Genomics called personalized genetic testing “a relatively new science that has developed rapidly over the last several years under limited FDA oversight.”
“During that same time there has been a robust conversation between scientists and experts from the genetics industry, the FDA and Congress about whether updated regulations are needed, and the appropriate role that government should have in oversight of this new science,” it added. “We look forward to working collaboratively with (Congress and the FDA) as any new regulations or guidelines are considered for developing public health policy.”
The genetic test kits offered on the Pathway website cost $249 for a “genetic ancestry” analysis or $399 for a “total health” analysis, including information on susceptibility to more than 70 health conditions, pre-pregnancy planning and likely drug responses. The kit that was to be sold at Walgreens and CVS reportedly was to cost $30, with analysis by Pathway of the saliva sample submitted ranging in cost from $79 to $249.
Napier of the National Catholic Bioethics Center said he had “two worries” about how the genetic test kits could be used.
If a patient “adopted a false view of genetic determinism” –– the theory that human behavior is determined by genes rather than by culture, environment and individual choice –– and was found to carry the gene associated with alcoholism, for example, he or she might be affected “in a deleterious way,” the ethicist said.
In addition, if a couple were to use genetic testing for pre-pregnancy planning, they might use any propensity for genetic problems “as an excuse not to realize the procreative end of marriage,” he said.