Opinion | You Didn’t Invent That Drug

Sorry. The Biogen drug’s apparent success is mainly the result of sustained private investment in drug research and development over many decades that has resulted in dozens of failures and billions of dollars in investment write-offs. Biogen may finally recoup some of its investment with its new Alzheimer’s drug, if the Biden Administration will let it.

Amyloid buildup is associated with Alzheimer’s disease. Many scientists believe that removing amyloid from the brain could slow cognitive decline. But the long line of failed amyloid treatments has prompted skepticism in some quarters. Many dismissed Biogen’s first-in-class amyloid drug Aduhelm despite positive results from one late-stage trial because another trial showed mixed results.

The Food and Drug Administration approved Aduhelm based on the totality of evidence. But Medicare refused to pay for it and other anti-amyloid treatments that might win accelerated government approval outside of clinical trials because it wasn’t convinced that removing amyloid can slow the disease. Biogen’s new experimental amyloid drug lecanemab provides more evidence it can.

Even the NIH seems to agree. Lecanemab slowed the rate of cognitive decline by 27% over 18 months, similar to Aduhelm. Government “funding was integral to helping us understand the role of amyloid, the protein targeted by lecanemab,” the NIH says. OK, but Biogen and other drug makers took the risk of investing multiples of that in experimental treatments with no guarantee that it would ever pay off.

Failed trials led Biogen to screen patient brains specifically for amyloid. Yet the NIH even tries to claim credit for this revelation, writing that the “selection of participants for lecanemab clinical trials hinged on amyloid PET imaging, a technology that was developed with publicly funded research.”

Government bureaucracies love to take credit, but the NIH is essentially claiming intellectual ownership of Biogen’s drug. Will the NIH also demand inventor rights to Biogen’s patents so it can earn royalties on its drug sales, as it did with Moderna for its Covid-19 vaccines because its scientists contributed to coronavirus vaccine research?

Progressives also say that the Bayh-Dole Act allows the federal government to confiscate patents for drugs developed with government funding. You can expect to hear this argument if Medicare covers lecanemab. The Administration’s political narrative is that drug makers are greedy and don’t care about patients.

It’s possible the agency is merely trying to convince Congress to give it more money, but government never stops grasping for whatever it can. Sorry, NIH, you didn’t invent that.