Personalized Medicine is Years Away: MIT Tech Review
Despite a push by the White House to advance personalized medicine, this “new era of medicine” is many years away if it is ever to be truly realized, according to an article in the 7/19 MIT Technology Review. Research editor Mike Orcutt says the reasons for such pessimism are that the science is still young, the market for genetic testing is unproven and expensive, and data sharing has a long way to go to advance precision medicine.
On the science side, Orcutt says that while genetic abnormalities or variants in the human genome have been discovered, “much is still unknown about what they mean medically.” Clues could be found by analyzing large collections of patient data that include genomic sequencing information as well as clinical data about which drugs the patients took and how they responded, he notes. And valuable information will come from innovative clinical trials like the National Cancer Institute’s MATCH trial, in which thousands of patients are having their tumors sequenced to find genetic abnormalities for which there are targeted drugs. More data from similar trials could help researchers determine which genes may influence whether a drug works or not, says Richard Simon, associate director of the NCI’s division of cancer treatment and diagnosis.
Orcutt also writes that advanced diagnostics still have a long way to go. While some companies are selling sophisticated tests based on advanced sequencing that can detect hundreds of abnormalities at once, the lack of FDA regulation has allowed the “commercialization of diagnostic tests based on advanced sequencing that has outpaced the underlying science of collecting and analyzing the data,” he says. Different tests can produce different results from the same DNA sample, says CDER deputy director of personalized medicine and molecular genetics Elizabeth Mansfield.
Additionally, the lack of data and data sharing is a large obstacle in advancing precision medicine. Because so few people have gotten their genome sequenced, it makes it difficult to find enough people to participate in clinical trials for new precision drugs, and this limits the pace of scientific progress, Orcutt says. Combining data into large, shared databases would be helpful, but competition leads academic researchers and businesses to keep such data private, and patients worry that sharing their data could compromise their privacy, he contends. These things must change if precision medicine is to advance, says former FDA chief information officer Taha Kass-Hout, who left the agency last month to start a consulting practice.