Controversy Rages Over Consumer Access to Genome Profiles

Genetics and DNAWe’ve entered the era of personalized medicine in the US. Genome sequencing, also called genetic profiling, has become less expensive and easier to conduct. As a result, more consumers want to know what secrets their DNA holds. By allowing a lab to analyze a sample of your DNA, you can receive a detailed report that reveals your personal genetic makeup and how it may influence your health. Your physician could then use the report to identify your possible vulnerabilities and suggest personalized treatments or lifestyle changes to mitigate risk to your health. It’s that simple. Or is it?

Should Consumers Have Access to Their Genetic Information?

Genetics kits from 23andMe

Genetics kits from 23andMe

The ready access to genetic testing has spurred ethical discussions about whether consumers should have access to the findings of a genetic profile analysis conducted using their DNA. One direct-to-consumer (DTC) company, 23andMe, offers $99 DNA profiles for customers. Up until November 2013, the company sent their customers a detailed health-related genetic report. But the FDA ordered them to stop offering those reports. Now they offer “ancestry-related genetic reports and interpreted raw genetic data”. Has the FDA overstepped its bounds? Some say yes and others, no.

One side of this ethical conundrum claims the benefits of access to genetic profiles outweigh any concerns. They argue that having this information empowers the consumer, giving them:

• Quick access to genetic information. People can obtain their personal genetic profiles without having a physician order the testing. Test results from other labs may take weeks or even months to arrive.
• Information on carrier status. Reports from DTC companies can provide customers with information about disease predisposition or carrier status.
• Ability to make better life decisions. Armed with information about their personal risk factors, consumers can make better lifestyle decisions.
• Access to interesting data about family ancestry. Some DTCs offer services that determine the presence and percentage of ethnic, geographic, and other ancestral DNA.
• Affordable genetic profiles. DTC testing is much less expensive than genetic testing performed by other labs. DTCs offer services for a few hundred dollars; whereas, the testing at a typical medical lab can reach into the thousands.

Others vehemently believe that consumers should not have full access to their own genetic profile reports. They cite a number of concerns, including:

• People could misunderstand the role genetics plays in disease. The level at which genetics controls a given trait varies, but very few traits (i.e. diseases) are controlled exclusively by genes. Environmental factors and lifestyle choices can also influence gene traits.
• People may not properly assess a disease risk. When using the services of a DTC company like 23andMe, customers rely on emails and information of the website to interpret their disease risk against the risk of the average population. The reports produced by these DTC companies do not include disease risk timeframes. The risk for some diseases stays low until middle age and then rises incrementally from then on.
• Lack of psychological and emotional status monitoring. Some DTC companies provide testing for life-altering and sometimes even terminal conditions. Customers who receive bad news about these conditions may go through a wide range of emotions, such as anger and depression.
• Lack of oversight. DTC companies have only recently begun to emerge, so the government hasn’t determined how to regulate them. While many of the companies, such as 23andMe, provide quality services with reliable results, others make false claims and use faulty methodologies. Due to this lack of oversight, it’s up to the consumer to identify the good ones.
• Abuse or misuse of information. The information could get in the wrong hands, such as potential employers and insurance companies, allowing them to make decisions based on a person’s genetic predispositions.

Genetic testing is here to stay. Whether consumers will continue to have unrestricted access to their own genetic information remains to be seen. The ethical and legal questions raised by the advent of personal genetic testing deserve further exploration. What do you want to build today?