In a political climate where climate change and alternative energy top the list of scientific national priorities, scientists tend to find themselves on the same side of the aisle as regulators—fighting business interests to advocate stricter protections for the environment. As such, the case of personal genomics stands in marked contrast. Despite the insistence of authorities in genetic science, medicine, and biochemistry, congressional regulators lately have been moving toward bans or heavy restrictions on the commercial sale of genetic tests for disease-related alleles. Categorizing personal genomics tests as “medical devices,” a July 2010 report of an undercover investigation by the General Accountability Office regulators reported that, direct-to-consumer genetic tests are “misleading and of little or no practical use.” In advance of two July hearings by the Food and Drug Administration on the subject, FDA officials warned that the tests are “high risk.”
Regarding the FDA and GAO’s concerns about the diagnostic power of these tests, it would indeed be troubling if millions of consumers were buying genomics tests with the intention of providing primary diagnoses for common ailments. This is simply not the case: The only tests claimed to be diagnostic are those for alleles that directly cause conditions, like Huntington’s disease and red hair. And for the most part, the group of people using personal genomics tests today self-selects for education and scientific skepticism.
Moreover, new regulation would stand to restrict customers’ access to personal genetic information, close off options for preventive health screening, and stifle incentives for innovation and research in genetic science and its applications. It represents a current of paranoia about advances in genetics that is, by and large, wholly irrational.
Regulatory action is unjustifiable for one, because it represents a fundamental restriction of freedom of information, enshrined as a right in the U.S. by extensive legislative protection. Despite the fact that the American government has grown to accept that it should not restrict public access to general-domain knowledge, it seems unsure of whether genetic information falls under the same scope.
At the very least, personal genetic information is no less a channel of information than any data relating to healthcare expenditures or population figures. Although scientists have yet to piece together what every gene means, it is a matter of simple biological principle that DNA contains the lion’s share of information at the foundation of life.
Accordingly, the restriction of direct-to-consumer genomics testing denies consumers easy access to the best research available on the subject of health and personal genetics. As it stands, the testing firm 23andMe conducts genomics scans that can provide information about one’s risk for over 170 diseases and health conditions. Despite FDA allegations that 23andMe and about a dozen peer companies have misrepresented the capabilities of their tests, about 100,000 consumers—myself included—have signed up for personal genomics testing, informed to some extent that the results generated rarely serve as an adequate diagnosis.
Moreover, government regulation of genomics testing denies consumers the available range of options for personal health assessment. At the date of this writing, 23andMe offers a $99 comprehensive scan of known disease markers and alleles. This is certainly more affordable for many than the treatment of conditions left unpredicted and undetected.
Perhaps most important, however, new regulation of the personal genomics industry will serve to stifle innovation and research in the emerging field of applied genetics.
With the entire human genome sequenced, researchers are making remarkable strides in the areas of genetic modification, disease screening, and population genetics. Demand for research has largely been impelled forward by private-sector interest in the implications of DNA advances. 23andMe came into being when market-keen researchers realized that amateur population genetics enthusiasts, were tired of only being able to comprehensively test their Y-chromosome and mitochondrial DNA.
Motivated by demand for targeted genetic modification, J. Craig Venter’s Celera Genomics Group has sequenced the entire human genome, leaving the federally funded Human Genome Project nearly “in the dust.” His new business venture, the Synthetics Group, has attracted $110 million in investment to create synthetic life forms. It strikes me as amiss that the government would seek to interfere with this process.
Ultimately, Congress would be sorely misguided to approve sweeping regulation of the genomics industry. To the chagrin of consumers and researchers alike, consequences for information and the pursuit of science would be far-ranging and constraining. All in the name, of course, of “protection”—even if it’s not in the league of scientific issues threatening the world’s safety.
Joshua B. Lipson ’14, a Crimson editorial writer, lives in Matthews Hall.