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Who Is Not Being Represented in Pharmacogenomics?

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Who is not being accounted for in the field of pharmacogenomics? Pharmacogenomics is the study of how a person’s genes affect how he or she responds to medication. Often, the data being collected during genetic testing represents a racial bias. On this episode, Darshan talks about the social issues of pharmacogenomics, and why certain minority groups are left out of pharmacogenomic testing.

Although developments in pharmacogenomics have arguably led to an improvement in the efficacy and safety of medicine, there are several ethical and social issues that are being raised.  Pharmacogenomics is defined as the study of how genetic variation affects the way an individual responds to medications. This allows for doctors and pharmacists to select for medicines that are well-suited to patients depending on their genetic composition. Despite the benefits of pharmacogenomics, genetic research suffers from racial inequity and lack of informed consent. Clinicians and drug companies must consider these problems when using genetic data and taking part in pharmacogenomics.

How Does Genetic Testing Affect Data Collection?

The data collection being performed through genetic testing by companies like 23andMe has been proven to be skewed, particularly as the people who undergo the testing are predominantly Caucasian. In fact, as reported by 23andMe, Africans, African-Americans, and Latinos make up less than four percent of individuals included in genome-wide association studies. This represents a racial bias in the data being collected by 23andMe and other DNA-testing companies, which may affect the future of drug development. As drug companies use the data collected by DNA-testing companies to develop new drugs, there is the danger that these drugs will only treat the group that is most largely represented in the genetic data (in this case, the Caucasian population). This means that under-represented groups could be neglected, as the new drugs being developed rely on genetic data which excludes them. Clinicians should be wary when tailoring drug prescriptions to individual patients and keep in mind that the genetic data being collected does not represent all racial populations equally. 

Is Informed Consent Being Obtained?

Another ethical concern surrounding pharmacogenomics is informed consent. Informed consent is getting an individual’s permission before using their personal information. With genetic testing, this means that DNA companies disclose what they will do with their customers’ data, and must provide forms for their customers to sign stating how their genetic data will be used. Unfortunately, these forms are often not readily understandable for the average consumer—they are often lengthy and not straightforward. Consumers also rarely read through the terms and conditions provided on these forms, suggesting that genetic research companies often have not received the full consent from their testing population.

How Should Companies Address These Ethical Problems?

The responsibility of addressing these ethical problems falls to the companies conducting genetic research or developing drugs. To ensure that minority populations are being included in genetic data collection, companies should consider reaching out to these groups themselves to diversify their data. Perhaps the genetic data these companies are collecting is not completely validated. As a result, perhaps this data should not be collected because patients may end up making treatment decisions based on that information. 

Yet another consideration that companies should take into account is how transparent they are being with patient disclosure. Companies should investigate how their terms and conditions are when conveying to their customers how their genetic data will be used. Improving these forms would mean that a higher percentage of people would be informed about how their data was being used in genetic research.

Although pharmacogenomics offers many benefits to the field of research and medicine, companies should weigh the various ethical issues in order to make the most of this new technology. This means not only diversifying genetic data collection, but also improving patient disclosure.

If you have any other questions about how to communicate with the FDA or how your past and/or current FDA communications affect you and your business goals, reach out to me on Twitter, LinkedIn, or send me a message here.

I also host a podcast called DarshanTalks, a show that discusses newsworthy FDA issues and how they apply to bringing a product to market – and keeping it there. From patient centricity in clinical trials to the government shutdown to CRISPR and bioethics to why big data is doomed to fail in healthcare, we’ve got quite the list of topics to review! Listen to the podcast on Google Podcasts or on Apple Podcasts.

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