SUMMARY: The FDA is coming under intense pressure to approve Biogen’s Alzheimer’s drug, but Aaron S. Kesselheim, a professor of medicine at Harvard Medical School via the Washington Post, says “the worst thing for people with Alzheimer’s would be to put out a product that doesn’t work.” For Biogen, the stakes are high as approval is likely to earn tens of millions, of to billions, in profits but is hope a reason to approve a drug over science?

At one point, Biogen was down as an innovative biotech company in Weston, Massachusetts. With a lot of money pouring in from MS drugs, their CEO decided that they needed to act like big pharma and moved the company to downtown Cambridge under the guise that it was necessary to get closer to biomedical R&D. Since that time, Biogen’s MS drugs have faced intense competition as MS patients continue to vent on social media that the Biogen drug has nasty side effects.

After the CEO departed the sinking ship, new management pinned all their hopes on the Biogen drug for Alzheimer’s. The first clinic; trials were everything but encouraging but so much depend ended on this drug’s approval that Biogen returned and recited the data. Too many doctors, the data was still questionable. Still, Alzheimer’s is a nasty disease, and people are desperate for treatment even if it only provided a slim chance of partial recovery.

After aducanumab showed promise in 2016, Biogen launched two late-stage trials — then stopped them halfway through, in March 2019, when an analysis concluded the studies would not reach their goal of slowing cognitive and functional impairment in participants. Seven months later, in a stunning reversal, the company unveiled an analysis that included updated data and told a different story. In one study, people given the drug had declined 22 percent more slowly than those who had received a placebo. The other trial failed to reach its goal, though the company was encouraged by data from a subset of study participants who got more of the drug. Biogen concluded the key to effectiveness was giving patients a high-enough dose, but critics howled, with one calling the analysis “a post hoc dumpster dive operation.”

“When you have one study that is positive and one that is negative, it seems to lead to an inability to draw a conclusion and therefore to a need for a third trial,” said David S. Knopman, a Mayo Clinic neurologist who treats Alzheimer’s patients and is a member of the FDA advisory committee. He had recused from the November meeting because he has been a site investigator for aducanumab.

Washington Post

If the drug is approved you can bet that it’s going to carry a huge price tag. Biogen needs a new drug revenue badly.  It could carry a price tag as high as $50,000-a-year per patient, according to drug analysts, adding billions of dollars to the nation’s health tab.

After the fiasco of approving so many drugs for COVID that really weren’t worth their price tags the FDA is under pressure to get this right. Will they follow the science or will they put a price tag on hope?