Poll Says Most Doctors Disapprove Of Alzheimer’s Drug Approval

Stat: Poll: Most Primary Care Docs Disagree With FDA Approval Of Aduhelm
A majority of U.S. physicians disagree with the decision by the Food and Drug Administration to approve the Alzheimer’s drug from Biogen and believe the medicine should not be routinely used for patients, according to a new survey from STAT and Medscape. In addition, nearly two-thirds of the 200 primary care physicians and neurologists polled said they find the trial data unclear when it comes to the benefits and risks of the drug, which is called Aduhelm. Consequently, only a small minority of these doctors think the medicine should be given to patients with early-onset Alzheimer’s, the patient population that was studied by the drug maker. (Silverman, 6/30)

Stat: Inside ‘Project Onyx’: How Biogen Used An FDA Back Channel To Win Approval Of Its Polarizing Alzheimer’s Drug
It was perhaps the most contentious drug approval in decades, shocking drug company executives, insurance companies, and politicians alike: The Food and Drug Administration, over the objections of its scientific advisers, backed the first new Alzheimer’s medication since 2003, one that could finally give millions of dementia patients a reason for optimism — and reap billions of dollars for its manufacturer, Biogen. After the FDA’s approval of the medicine called Aduhelm three weeks ago, the company’s CEO, Michel Vounatsos, proclaimed on Biogen’s website, “I have hoped for years that we would reach a moment like this.” But Biogen executives were hardly passive players hoping for FDA approval. In spring 2019, when Aduhelm’s prospects appeared dead, the Cambridge, Mass.-based behemoth mounted a secret campaign, code-named “Project Onyx,” to resurrect the drug and convince the FDA to give it the green light. (Feuerstein, Herper and Garde, 6/29)

In other pharmaceutical and biotech news —

Stat: Will Gilead's Early Data For Its CAR-T Therapy Give It An Edge Over Bristol Myers? 
Gilead Sciences released top-line trial data for its Yescarta medication that may allow the company to leapfrog over a rival in the marketing battle over CAR-T therapies. The preliminary results of a randomized Phase 3 trial showed the treatment — which involves extracting white blood cells and genetically modifying them to attack cancer — prevented the return of large B-cell lymphoma better than the standard of care, which includes chemotherapy and a stem cell transplant. The study examined patients whose initial treatment had failed and given Yescarta as a so-called second-line treatment. (Silverman, 6/28)

Stat: Primary Care Docs Need To Prepare For CGMs For Type 2 Diabetes
In the last year, Jai Smith has cycled through 13 primary care doctors. Ever since being diagnosed with type 2 diabetes in 1995, she’s tried her best to manage a disease that has devastated her family: Her grandmother and four uncles died from its complications. But she’s struggled to find a doctor in her hometown of Little Rock, Ark., that will give her what she wants to manage the condition: a continuous glucose monitor. (Palmer, 6/30)

KHN: States Step Up Push To Regulate Pharmacy Drug Brokers
Under pressure to rein in skyrocketing prescription drug costs, states are targeting companies that serve as conduits for drug manufacturers, health insurers and pharmacies. More than 100 separate bills regulating those companies, known as pharmacy benefit managers, have been introduced in 42 states this year, according to the National Academy for State Health Policy, which crafts model legislation on the topic. The flood of bills comes after a U.S. Supreme Court ruling late last year backed Arkansas’ right to enforce rules on the companies. At least 12 of the states have adopted new oversight laws. But it’s not yet clear how much money consumers will save immediately, if at all. (Houghton, 6/30)