Key Points:

• Trust in the CDC and FDA has decreased dramatically during the COVID-19 pandemic among health care professionals, according to a new WebMD/Medscape poll.
• Out of nearly 450 U.S. doctors surveyed in the same time period, 77% said their trust in the CDC has decreased and 48% said their trust in the FDA has decreased.
• Health care professionals have been critical of these agencies’ decisions during the pandemic, with some concerned that their work has been politicized and now with advisory panel members resigning as a result of the terrible decision to approve Biogen’s drug you can bet that HCPs are going o want to see a lot more clinical data.

Trust is essential to build relationships, but in the eyes of many HCPs, the trust has been broken during and now after the pandemic with the approval of Biogen’s drug. According to Medscape, “doctors and nurses reported relatively lower trust in the CDC than WebMD readers. Among doctors, 31% said they trust the CDC in general, compared to 25% of nurses and 45% of WebMD readers. The FDA didn’t fare much better: 37% of doctors, 27% of nurses, and 41% of WebMD readers said they trust the FDA in general”.

If that wasn’t enough Endpoints gathered comments from HCPs on the Biogens new drugs and the they were brutal:

— To­tal­ly dis­cred­its the FDA and po­ten­tial­ly dan­ger­ous to pa­tients with­out any re­al in­di­ca­tion of ben­e­fit.

— Un­proven ef­fi­ca­cy, un­proven sur­ro­gate that can’t be rea­son­ably ex­pect­ed to pre­dict ben­e­fit giv­en large # of oth­er failed at­tempts.

— “Bor­der­line fraud,” one read­er not­ed. “I have an eth­i­cal oblig­a­tion to my pa­tients. I will nev­er pre­scribe.”

Endpoint News

Briefly, here’s what led to its approval. Biogen’s drug clears amyloid from the brain, a buildup of plaques that are hypothesized to be part of how Alzheimer’s progresses and disrupts cognition. Yet many other agents that clear amyloid have ultimately been found ineffective in clinical trials, and for a while, it looked like aducanumab would have a similar fate. Then Biogen reported that the drug had worked in the high-dose arm of one of its late-stage trials. “Worked,” here, was stretching it: The average degree of improvement on a 0-18 point cognitive scale was just 0.39 points relative to placebo, far smaller than the 1 or 2 point threshold typically used to define a clinically important difference.

The result of all this is going to be widely felt in HCP marketing. First, let me say that Biogen reps will catch hell in the field, as are their MSLs. But the aftershock will be felt by all pharma companies who just got approval for their drugs. HCPs are going to want to see a lot of data that salespeople and MSLs don’t have. More importantly, they will not like having to tell an Alzheimer’s patients or caregivers that this medication is at best a huge, costly, gamble.

As one HCP told Endpoints News “Over­all, a very sad de­ci­sion from the FDA, sad for se­ri­ous and re­spon­si­ble drug de­vel­op­ment, not the one which is guid­ed sole­ly by the pop­u­la­tion’s un­met need. Very sad with ma­jor im­pli­ca­tions for the FDA, phar­ma, drug de­vel­op­ment and so­ci­ety. It will cost us years to re­cov­er from this one bad de­ci­sion! I do not en­vy the pa­tients … sad al­so for them who will take the risk of hav­ing un­want­ed side ef­fects, for very few ben­e­fi­cial ef­fects (if at all). Pray­ing is less risky and maybe more ef­fi­ca­cious”.