The Greatest Challenge of Personalized Medicine Is Science

Researching, regulating, and testing new treatments still pose difficulties to this science. Who should pay for screening and treatments is also up for debate.

As insurance companies, governments, doctors, and patients debate who should pay for the screening and treatments of personalized medicine, many people feel that the greatest dilemma facing the personalized medicine field is economic.

But the science behind targeted treatments also poses significant challenges.

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The scope of genome science

The Genetic Testing Registry, a branch of the National Health Institutes, records tests for nearly 19,000 genes relevant to nearly 11,000 illnesses. The total number of tests that have contributed data to the registry so far is almost 78,000. After growing fast, those numbers have been fairly constant since 2019.

Translating the test results into benefits for patients is an ongoing process. Labs often don’t agree on what a genetic variation means, or doctors may not have good treatment options. But there are striking advances, especially in cancer treatment.

Testing and regulating

The human genome was first successfully mapped in 2003. Personalized medicine is still a very young branch of medical research. Standards for conducting research safely and ethically are also still in development.

Integrating the research with current medical systems is even more complicated.

Most countries require that a new drug undergo extensive clinical trials to prove safety and efficacy. On top of that, most insurance companies will cover only treatments that have been thoroughly tested, not experimental therapies.

A typical clinical trial can take years and thousands of participants. A typical drug can take millions of dollars to develop.

When the vaccine for human papillomavirus was developed, more than 24,000 men and women in 33 countries participated in clinical trials. The test population was large, but so was the candidate pool. Most healthy women and men between the ages of 16 and 33 were eligible to participate.

Precision treatments target a much smaller candidate pool. They are often intended for only 1 to 5 percent of the population, which makes finding participants for clinical trials much harder.

Participants in clinical trials must have the same genetic markers as the intended recipients of the new drugs, and screening for those markers can be difficult and time-consuming.

As Gordon Mills, PhD, director of precision oncology at the Knight Cancer Institute, told the American Cancer Society: “We need to emphasize to patients and to the public and funders and regulatory agencies that these are just very early days,” Mills explained.

As with any new science, personalized medicine still has challenges to overcome before it can be fully integrated into everyday medical practice.

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