The promise of personalized medicine is a pretty big one: Tailoring treatments to a patient’s genes, their environment or their lifestyle, the thinking goes, will result in treatments that are much more likely to work. The same disease can manifest differently in different people, so why treat patients with a one-size-fits-all-approach?
But a new paper from the National Bureau of Economic Research suggests that, if personalized medicine really takes off, it could actually wind up hurting the pace of biomedical innovation.
Here’s why: Say there’s a personalized lung cancer drug targeted at the specific genetic mutation involved in causing the cancer. Not every lung cancer patient will have that same mutation. Instead, there are likely to be many different biomarkers associated with the same cancer. That means that if a drug works, instead of having a blockbuster drug for a common disease on its hand, the company that developed the drug will have a drug tailored to a much smaller market of patients. And that, the paper suggests, could “reduce some of the incentives for innovation.”
That’s not the only market impact the NBER expects tailored therapies will have. The more effective the therapy, the paper suggests, the bigger the price tag might be. At the same time, it could also reduce the cost of drugs by “allowing more sophisticated pricing systems and potentially decreasing the costs of drug development through shorter and more focused trials.” It could drastically alter what kinds of drugs are actually profitable to bring to market. It might mean that drugs targeting the same disease but different biomarkers could vary significantly in cost. The narrow scope of personalize drugs could also raise the problem of monopolies.
In assessing the future impact of personalized medicine (also called precision medicine) on healthcare spending, the NBER combed through a database of more than 130,000 global clinical trials over the past two decades and looked at trials targeting specific biomarkers.
The US is betting big on personalized medicine with the Obama-era Precision Medicine Initiative, a long-term research endeavor to understand how a person’s genetics, environment, and lifestyle can influence the expression and treatment of disease. Last year’s 21st Century Cures Act furthers the goals of the initiative by encouraging the FDA to develop new regulatory approaches for the oversight of the genomic technologies that will play a major role in developing personalized therapies. The NBER paper is a good reminder, though, that when big change is on the horizon, it’s important to consider all of the possible consequences.