What are some of the challenges facing precision medicine and the Precision Medicine Initiative?

Precision medicine is a growing field. Many of the technologies that are needed to meet the goals of the Precision Medicine Initiative have only recently been developed. For example, researchers needed to standardize the collection of clinic and hospital data from more than 1 million volunteers around the country. They also needed databases to store large amounts of patient data efficiently.

The Precision Medicine Initiative also raises ethical, social, and legal issues. It is critical to protect participants’ privacy and the confidentiality of their personal and health information. Participants need to understand the risks and benefits of participating in research, which means researchers must have  a rigorous process of informed consent.

Cost is also an issue with precision medicine. The Precision Medicine Initiative itself will cost many millions of dollars in federal funding, and the ongoing initiative will require Congress to approve funding over multiple years. Technologies such as sequencing large amounts of DNA are expensive to carry out (although the cost of sequencing is decreasing). Additionally, drugs that are developed to treat conditions based on molecular or genetic variations are likely to be expensive. Reimbursement from third-party payers (such as private insurance companies) for these targeted drugs is also likely to become an issue.

If precision medicine approaches are to become part of routine healthcare, doctors and other healthcare providers will need to know more about molecular genetics and biochemistry. They will increasingly need to interpret the results of genetic tests, understand how that information is relevant to treatment or prevention approaches, and convey this knowledge to patients.