The U.S. Senate versus the FDA.
Healthcare is an investment, a down payment on human infrastructure. The idea is straightforward enough: The medical R&D and other expenditures we make today toward the goals of improving human health and preventing early death will ultimately pay off in a happier, more productive society—just as investing in bridges, highways, and high-speed connectivity will pay off in the long run, too. Or so the theory goes.
And in the past two days, we have seen two strikingly different views on the importance of such investment—each, notably, from a different arm of the U.S. government.
Yesterday’s verdict was rendered by a drug advisory panel to the Food and Drug Administration, which unanimously recommended that the agency approve an important new therapy for certain very hard-to-treat blood cancers in children and young adults. The expert panel voted 10-to-nil to encourage the FDA to approve an experimental Novartis treatment called CTL019—a complicated approach that involves extracting specific immune cells from each individual patient, retrofitting those cells with genetic instructions that make them fiercer and more accurate cancer hunters, vastly increasing their numbers until they are a veritable army in themselves, and then injecting them back into the patient’s body.
CTL019—which is part of a class of engineered hybrids known as CAR-T cells, for “chimeric antigen receptor T-cells”—is no magic pill, I should point out. It’s risky: The cross-effect from revving up the immune system can sometimes cause a deadly internal storm of its own. This “living drug” is difficult to mass-produce: Each treatment is precisely tailored to an individual patient. It’s time-consuming to make and, heck, it’s expensive. But as with other new immune therapies, CTL019 has led to some miraculous results in patients—in some cases, curing otherwise surely lethal malignancies outright.
It’s also, importantly, a story of investment. No, I don’t mean Novartis’s here, though that should be applauded too. I mean the investment in medical science that got us to this point—a down payment in the seminal work of investigators like Steve Rosenberg at the NIH; Jim Allison at MD Anderson (and before that, at a slew of other institutions); Carl June at Penn; and countless others going back to William Coley—who, in 1891, reported on his efforts to elicit an immune response against cancer by way of an ingested stew of bacterial toxins.
Novartis is seeking FDA approval now to market CTL019 (Tisagenlecleucel) as a treatment for just a select group of patients in the U.S.—those (aged 3 to 25) who have B-cell acute lymphoblastic leukemia that has either relapsed or resisted standard treatments—a cohort that may number as few as 5,000 people. But there are about 100,000 cases of the broader class of B-cell [lymphoma] tumors that express the protein that CTL019 targets, Dr. June told me in an interview at Penn last year. “We haven’t found one yet that doesn’t respond to our CD-19 CAR-T,” he said.
So what of that other view of healthcare investment I noted up top? Well, that can be seen in the now-revised Obamacare-replacement bill the Senate unveiled today. In short, it looks much like the old bill, slashing spending for Medicaid by hundreds of billions of dollars, just as the earlier version would do. (The CBO, Congress’s in-house bill auditor, will estimate the full financial, economic, and insurance-coverage effects of the bill in the coming days.)
That’s not a down payment on the health of the American people, in my view. That’s a foreclosure.
This essay appears in today’s edition of the Fortune Brainstorm Health Daily. Get it delivered straight to your inbox.