Early last week, the FDA sent Google-backed genetics testing company 23andMe a letter ordering them to halt sales and marketing of their Personal Genome Service (PGS). As part of this service, a customer sends the company a saliva sample from which 900,000 base pairs (which equals only 0.03% of the entire genome) are genotyped to determine if there are any gene mutations. 23andMe then provides a thorough report outlining an individual’s maternal ancestry which can allow you to find distant relatives and a health overview which states your risk of disease in comparison to the population average.
23andMe has marketed this service (even through a TV commercial) as a part of the prevention and management of over 240 disease conditions including diabetes, heart disease and various cancers. These very broad marketing claims have attracted the FDA’s attention.
The FDA states that 23andMe has not obtained the proper regulatory approvals for the outputs of this test for all 240+ disease conditions, which are necessary in order to make these marketing claims.
Since then, countless individuals from independent blogs to large media outlets have taken to the internet to voice their opinions and argue for or against the FDA. Here is a summary of their arguments in both sides of this case.
The common argument against the FDA is that the ruling is a heavy-handed act of paternalism as all individuals should have the right to access their own genetic information.
The type of genetic information that 23andMe provides is meant to empower individuals to manage their own health and make proactive health decisions based on their own genetic makeup.
Looking through reader comments from online articles, the general sentiment is that the FDA is serving the financial interests of the health care industry by blocking this channel of direct to consumer genetic information which forces individuals to obtain this information through doctors and specialists.
Finally, some feel that this forceful ruling will negatively impact innovation within the genetics industry as start-ups may think twice before entering this market.
The FDA’s main argument is that the disease risk information provided is not accurate and has the potential for false positives and negatives. If a person is shown to have a higher probability for a certain disease, they may ask their doctor for further testing which in itself may be harmful or have associated risks.
On the other hand, if a person is shown to have a low risk for a disease, they may not be as careful or miss screenings.
Many healthcare professionals agree with this as they have seen young, healthy, asymptomatic individuals demand unnecessary tests based on 23andMe reports. They believe individuals require proper genetic counselling as part of genetic testing to put the results in perspective and context, something that is missing from the PGS test.
Finally, many feel the purported value of 23andMe is missing as there is a lack of actionable results that come from the report. For some diseases, there may be measures like diet and exercise that have a known impact on reducing risk. However for many, the science is not yet advanced enough to give someone a tangible to-do list.
This is clearly a meaty debate and from my readings, it seems that the general public strongly support 23andMe while academics and health care providers agree with the FDA ruling.
FDA regulations in this example are just the tip of the iceberg. Stay tuned for future blog posts that will explore the science behind genetic testing and as well as examining 23andMe’s response.