You Didn’t Invent That Drug

 Remember when Barack Obama declared that companies owe their success to the government? “You didn’t build that,” he said. Well, now the National Institutes of Health claims credit for Biogen‘s

A new treatment for Alzheimer’s disease showed success in a large trial last week.

“Potentially promising outcomes such as this one are the result of continued public investment in medical research, the tireless work of scientists around the world, and assistance for people with Alzheimer’s disease and their caregivers,” the National Institutes of Health wrote in a news release this week. Although the National Institutes of Health did not fund the successful study, it says that “decades of research paved the way” for it.

Sorry. The apparent success of Biogen is mainly due to the sustained private investment in drug research and development over many decades, which has led to dozens of failures and write-offs of billions of dollars in investments. Biogen may finally recoup some of its investment with a new Alzheimer’s drug, if the Biden administration allows it.

Amyloid buildup is associated with Alzheimer’s disease. Many scientists believe that removing amyloid from the brain can slow cognitive decline. But the long line of failed amyloid therapies has raised doubts in some quarters. Many rejected the first-in-class amyloid drug Aduhelm from Biogen despite positive results from a late-stage trial because another trial showed mixed results.

The Food and Drug Administration approved Aduhelm based on the entirety of the evidence. But Medicare refused to pay for it and other anti-amyloid treatments that might get rapid government approval outside of clinical trials because they weren’t convinced that removing amyloid could slow the disease. Biogen’s new experimental drug lekanimab provides more evidence that it can.

Even the National Institutes of Health seem to agree. Lecanemab slowed the rate of cognitive decline by 27% over 18 months, similar to Aduhelm. “Government funding has been integral to helping us understand the role of amyloid, the protein targeted by lekanimab,” says the National Institutes of Health. Well, but Biogen and other drug makers have taken the risk of investing complications of that in experimental treatments without guaranteeing they will ever pay off.

The failed experiments led Biogen to specifically scan patients’ brains for amyloid. However, the National Institutes of Health is trying to claim credit for this revelation, writing that “selection of participants in lecanemab clinical trials is based on amyloid positron emission tomography, a technology developed with publicly funded research.”

Government bureaucracies like to take credit, but the National Institutes of Health essentially claims the intellectual property for Biogen. Will the NIH also claim inventors’ rights to Biogen’s patents so it can earn royalties on its drug sales, as it did with Moderna on 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 seize 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 that the agency is just trying to get Congress to give it more money, but the government never stops absorbing all it can. Sorry, NIH, you didn’t invent that.

https://chof360.com/you-didnt-invent-that-drug/