On Oct. 31, the U.S. Food and Drug Administration sent an approval letter to 23andMe related to its “Personal Genome Service Pharmacogenetic Report.”
“Pharmaco” refers to medications, “genetic” refers to DNA and “Personal Genome” refers to the specific individual providing the DNA sample. This type of DNA testing and reporting is specifically related to medication response and not disease risk or other genetic information.
Numerous genetic/DNA variations have been identified as having an effect on how an individual responds to medications. Why is this important? It is likely that you or people you know have taken or received a medication that was ineffective or resulted in an adverse reaction or event.
Data show that in some cases a large percentage of individuals receiving a medication do not get the desired therapeutic effect. Additionally, through Sept. 30 in the United States, there were more than 1.6 million reports of adverse reactions or events. Of these, more than 820,000 were serious, requiring medical intervention. Unfortunately, more than 150,000 deaths were attributed to an adverse reaction or event.
The 2018 numbers are outpacing 2017, when there were 1,815,716 reported adverse reactions or events with 906,336 serious events and 164,091 deaths.
It is likely that genetics plays a role, along with other factors, such as lifestyle, in how well drugs work and/or contribute to adverse events. In either case, individuals suffer, which promotes further trial and error with medication use, which further puts an economic burden on individuals and the health care system.
While the FDA ruling states that “the information provided by (the Personal Genome Service Pharmacogenetic Report) should not be used to start, stop, or change any course of treatment,” it goes on to say that “this report is for over-the-counter use by adults over the age of 18 and provides genetic information to inform discussions with a healthcare professional about metabolism of therapeutics.”
To have efficient, effective discussion between an individual and their health care professional, all parties need to be educated.
In 2015, Manchester University, in collaboration with the Indiana Pharmacists Alliance, offered the nation's first education certification program in pharmacogenetics in Fort Wayne for health care professionals.
Manchester also started the nation's first master of science in pharmacogenomics (genomics being a similar term to genetics), with the program being delivered at the Fort Wayne campus or online. These educational efforts are grounded in science and evidence-based medicine. Our efforts in education related to DNA and response to medications have been extensive and are being expanded to the public at large.
It is imperative that we move to a new personal standard of understanding our own DNA relative to how we respond to medications.
The FDA ruling will lead to information being presented by patients to their health care professionals.
To facilitate this new reality, Manchester will offer a public education forum open to all, including health care professionals, to provide education that encourages meaningful, useful discussions between patients and health care professionals. Additionally, a free textbook I co-authored is available at www.manchester.edu/pharmacogenes/book. Look for an announcement related to the public forum to take place early in 2019.
David F. Kisor is a professor and director of Pharmacogenomics Education at Manchester University.