Approach genetic counseling

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Reference no: EM133764208

Case: Consumer genomics has become a big business and has grown out of ancestry testing from private companies analyzing anyone's genome for specific markers related to ancestry. Consumer genomics, however, offers genetic markers for clinical variants, i.e. known mutations (mostly SNPs) that are linked to diseases, susceptibility to drugs or infections. In 2013, the FDA sent a cease and desist letter to the biggest private consumer genomics company 23andMe (Links to an external site.)Links to an external site. and prohibited them from giving customers 'medical advice' (Links to an external site.)Links to an external site.. (Note: on April 6, 2017, the FDA reversed its ruling (Links to an external site.)Links to an external site. allowing 23andMe to provide consumer genetics). The company sequenced 100+ markers related to diseases and gave the customer a short explanation of the associated risk (e.g. Huntington's disease, Alzheimer's, obesity and diabetes, to name a few). It could continue its ancestry testing division. Discuss the FDA's approach, which was based on the policy that only medically trained experts (e.g. your doctor) can do genetic counseling. Is 23andMe's approach genetic counseling? Do you think you should have the right to obtain any sequence in your genome and decide on your own what to make of it?

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Something that caught my eye in the prompt was the FDA being cautious with consumer genomics and originally prohibited 23andMe from giving customers medical advice with their genetic analysis, BUT has then reversed their ruling. I completely understand the logic behind their ruling- they just didn't want people to misinterpret the information being brought to them which can be misleading if not properly informed. This can lead individuals to make poorly made medical choices and cause unneeded concern and fear, so I can see why they only have a strong preference for medical professionals to provide that information- they have medical degrees for a reason. The company has remarkably sequenced 100+ markers related to diseases, though we are unaware of the people behind these health analyses and their level of expertise.

Despite this, I am glad that the FDA later reversed their ruling. The public deserves the right to know their genetic health risks, be educated on such, and make their own decisions for their health- BUT what is important is that these decisions should be well informed by trained experts. The FDA realized the potential and growth of genetic data and gave consumers the power to have access to THEIR genetics- it's theirs afterall. Even after the fact, I believe that doctors and lab professionals should work together with the 23andMe Team to provide accurate information that is credible to guide consumers in the right direction so we can raise empowerment and create an emotionally supportive environment.

Reference no: EM133764208

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