Anyone who has had a bacterial infection can attest to the misery of being bedridden and the frustration of taking medications that sometimes do not work. Why some drugs work and some don’t has been a mystery since the advent of modern medicine a century ago, but new advances in medical research show strong links between genetic variation and drug responses.
The Food and Drug Administration (FDA) became an early adopter of “precision medicine” more than a decade ago when the agency updated the labeling on warfarin (a blood thinning medication) to reflect new evidence that certain genetic variations could impact dosage for patients. Unfortunately, the agency has since backtracked on its forward-thinking approach when they issued a statement in November riddled with fear and doubt about the efficacy of integrated genetic testing and dosing based on genes. This was done despite a lack of evidence to support these fears. Instead of doubling-down on caution and promoting regulatory uncertainty, the FDA should give a green light for more innovation and choice.
On November 1, the FDA issued a warning about “genetic tests that claim to predict patients’ responses to specific medications.” In their statement, the FDA expressed concern that “a patient may change the dose of their medication for a particular condition or disease based on the results of an unproven genetic test, which may result in inadequate care or worsening illness.” Unsurprisingly, safety-minded bureaucrats use their own agency’s approval as an indispensable barometer on whether patients should use genetics knowledge to further their own healthcare. But, in doing so, the FDA fails to take into account its excessive deliberation process, and how medical breakthroughs can be discovered then be held back by lengthy FDA delays, and the accompanying costs to human life.
Even the FDA’s designated fast-tracks for just drug approval (not even considering genetic linkages to medications) will take on average at least 6 months, and median times have been steadily increasing over the past couple of years. Testing drugs for safety and efficacy does, of course, take a long time, since any regulatory body needs to assemble study groups large enough to make sure that they’ve taken into account all of the traits and characteristics of the population at-large.
But researchers from MIT and Boston College recently found that, even taking these necessary precautions into account, the FDA is far more conservative than it should be in assessing drugs for some of the deadliest diseases. Their results confirmed a long-held suspicion that bureaucrats are risk-averse, since being “too careful” draws far less attention than being too eager. If the FDA approves a drug that turns out to be unsafe and patients are harmed as a result, those in charge of the approval process may well be held accountable. But if the FDA stymies approval of a drug that would likely have saved thousands of lives, there’s no outrage from a foregone hypothetical.
The intersection of pharmaceuticals and genetic testing is in the latter category, as evidence mounts that genome-tailored drugs can improve the quality of living and save billions of dollars in healthcare spending. Depression, a leading cause of the nearly 45,000 suicides per year in the US, can be kept at bay by some of the leading anti-depressant medications according to the overwhelming weight of empirical evidence.
But large, overall effects hide the difference in individual responses and psychiatrists often resort to a long trial-and-error process to make sure their patients are getting the mix of medications and therapies that suits them best. Researchers at the National Institutes of Health (NIH) compared a group of depression patients receiving conventional care and care tailored to their specific genetic markers and found that the latter group was 22 percent more likely to enter remission. The cost savings were staggering, at nearly $4,000 per depression patient annually.
The evidence is clear: the wider use of genetic testing to improve the prescribing of medicine has the potential to revolutionize medicine, improve countless lives, and finally bend that cost curve. The FDA should get back to embracing these developments, rather than peddling fear and caution.