Editor’s Note: On April 30, 2017, the Wall Street Journal published a column, Personalized Medicine is Here, on the Food and Drug Administration’s recent approval of 10 screening tests for the company 23andMe. The authors Peter Huber and Paul Howard, who are senior fellows at the Manhattan Institute, write:
“We applaud the decision. Consumers’ right to know their own genetic health risks will become more important as sophisticated diagnostics like whole-genome scans, artificial intelligence, and targeted drug and gene therapies reach doctors’ offices in the years to come. Together, these tools can empower patients to become co-directors of their own medical destinies. In fact, the right to know the risks contained in your genetic code will likely become the most fundamental medical right of the 21st century.”
According to the most recent press materials, FDA approved screening tests for the following 10 diseases and conditions:
- Parkinson’s; 2. late onset Alzheimer’s; 3. Celiac, 4. Alpha-1 antitypsin deficiency; 5. Early inset dystonia; 6. Factor X1 deficiency; 7. Gaucher disease type 1; 8. Glucose Phosphate Dehydrogenase deficiency; Heredity hemochromatosis, and 10. Heredity thrombophilia
At Today’s Practitioner, we too applaud FDA’s decision, however integrative care providers may be at a loss in how to respond when a patient brings in a 23andMe test result. Are your patients asking about their genetics or do they want advice on genomics? If the future of medicine is as easy as a cheek swab, then practitioners need to get trained up quickly on to add these services to one’s practice. We consulted Bobbi Kline MD and Joe Veltman, PhD co-founders of Genoma International for their opinions.
Why 23and Me is Not Personalized Medicine
Regarding the recent opinion expressed by Peter Huber and Paul Howard, senior fellows at the Manhattan Institute, a think tank focused on domestic policy and urban affairs published in the WSJ on April 30, 2017 entitled Personalized Medicine Is Here. We would like to clarify a few of their statements and set the record straight about personalized medicine.
First, genetics and genomics are different fields of study. While many people including physicians, researchers and scholars use the words interchangeably, it is important to use the term correctly, since each has a different meaning and interpretation.
Genetics refers to the study of inherited gene mutations; they have a very clear-cut and direct impact on health. Examples include Tay-Sachs syndrome, hemophilia, muscular dystrophy. Treatment strategies are very limited for these genetic diseases.
Genomics refers to small changes in a person’s genes called single nucleotide polymorphisms, or SNPs. Gene SNPs can increase a person’s susceptibility to a chronic disease, such as heart disease, diabetes, Alzheimer’s, or cancer – and it is the interaction between these gene SNPs with each other and with a person’s environment and lifestyle choices that determines the ultimate health outcome.
Unlike the black and white aspects of an inherited disease, interpretation of genomic data can be challenging for clinicians, for whom this is a new concept, since most, if not all, were trained in genetics, not genomics. This requires a thorough understanding of cell biology, biochemistry, physiology, nutrition science, functional medicine, and biological systems in order to communicate the health significance and personalized action steps associated with genomic results to a patient. It can be even more difficult if there are multiple gene SNPs in a metabolic pathway, understanding how they might interact with nutritional, exercise and environmental factors.
Personalized medicine through the lens of genomics increases in its complexity exponentially. It simply it no longer valid to only look at a handful of genes and give a simple answer as to what they mean. For this reason, the value of genomic testing in the direct-to-consumer market has been very limited. Interpreting complex genomic data requires a clinician trained in genomic medicine, who has expertise in the biological sciences and in the ability to relate the information to the whole person.
Together we have 20 years of experience using genomics in a clinical practice, creating personalized roadmaps for diet and lifestyle choices for our patients. Dr. Veltmann has demonstrated improved health outcomes using genomic testing for people enrolled in a corporate wellness program, and healthcare costs decreased by 20% each year during the 4-year study.
Personalized medicine is here, and when used correctly, genomic information empowers clinicians and patients to work together to achieve optional health.