Morning Briefing
Summaries of health policy coverage from major news organizations
Perspectives: Is Pricey Alzheimer's Drug Worth It?
Stat: Bad Medicine: Aducanumab Is A Lackluster Drug With A High Cost
Controversy has swirled around aducanumab, an experimental drug developed by Biogen, long before the FDA approved it on Monday to treat early-stage Alzheimer’s disease. The agency now finds itself under scrutiny in a situation with no good outcome. There were defensible arguments for approval, one of which is that until now there has been no disease-altering therapy to offer to individuals with Alzheimer’s or their families. (Karl Herrup and Jonathan Goulazian, 6/8)
Los Angeles Times: This Isn't How FDA Should OK Alzheimer's Drugs
The Food and Drug Administration didn’t just make a mistake by approving a new Alzheimer’s disease drug this week. It turned what is supposed to be an objective and science-based process on its head, giving the go-ahead to a drug for which there is far more evidence that it doesn’t work than evidence that it does. Patient advocates were, of course, avid to see drugmaker Biogen’s aducanumab come to market as a potential treatment for mild stages of the dementing disease, which so far has resisted efforts to combat it. Any hope, no matter how dim, is at least something in the eyes of families who watch their loved ones deteriorate mentally and physically for years before death takes them. (6/8)
Bloomberg: Approving Biogen's Alzheimer's Drug Aducanumab (Aduhelm) Is Big Mistake
"Follow the science" has been a consistent refrain during the pandemic, and it's usually a core mandate of the Food and Drug Administration in evaluating medicines. But when it came to one of the agency's most consequential decisions — the approval Monday of Biogen Inc.'s controversial Alzheimer's drug aducanumab — science took a back seat. Alzheimer's is a devastating illness with no treatments that do anything but ease symptoms. Biogen's drug is the first said to slow decline. If there was good evidence that it did so, it'd be a breakthrough, but the data is inconclusive at best. And while the FDA is and should be flexible when patients have no options, this decision does more than bend standards — it shatters them. (Max Nisen, 6/7)
Stat: FDA's Aducanumab Approval Sets Stage For Bigger Breakthroughs
The Food and Drug Administration yanked the fight against Alzheimer’s out of the mire with its approval of the first disease-modifying therapy. Although it’s a modest first step, it paves the way for more momentous breakthroughs. The drug — aducanumab by Biogen and Eisai — is a monoclonal antibody that clears a toxic protein called beta-amyloid from the brain. The drug can’t reverse Alzheimer’s-related damage once amyloid has seized a beachhead and symptoms of the disease emerge. Its promise lies in battling amyloid before it does irreversible harm. (Dana Goldman and Darius Lakdawalla, 6/7)
Also —
Fox News: Pelosi, House Democrats' Drug Pricing Bill Jeopardizes Our National Security
The lightning pace of the development and mass production of COVID-19 vaccines through Operation Warp Speed has been welcome news for hundreds of millions of Americans desperate to return to their pre-pandemic lives. More than 296 million vaccinations have already been administered with an additional 70 million more ready to go. President Donald Trump deserves credit for laying the groundwork and delivering this historic feat to the American people. His ambitious "Operation Warp Speed" enabled the pharmaceutical industry to develop and mass-produce three separate vaccines in a timeframe that the liberal media initially scoffed at with their coastal condescension. (Rep. Elise Stefanik, R-N.Y., 6/4)
The Star Tribune: Minnesota Must Pass A Prescription Drug Affordability Board
While many issues stall in a divided Legislature, Minnesota lawmakers have had a track record of passing bills on a bipartisan basis to address the high cost of prescription drugs. From the Alec Smith Insulin Affordability Act to the Drug Price Transparency Act and pharmaceutical benefits manager reforms, we have proved that progress across party lines is possible. While negotiations continue between state leaders, I urge my colleagues on both sides of the aisle to approve a Prescription Drug Affordability Board this year. (Democratic State Rep. Kelly Morrison, 6/7)
Statesman Journal: Don’t Let Big Pharma Buy Your Fear
When Justin, whose mother is fighting breast cancer and chronic illness, pays his bills each month, he also helps his mother prioritize her medications. This isn’t a choice either of them make willingly, but even with Justin’s financial help, the expense of sleep aids and pain management pills are often too much for the two of them to afford after filling the prescriptions that are keeping his mother alive. Determining which prescriptions they can afford is a heartbreaking, exhausting process that no Oregonian — or anyone — should have to face. Justin and his mother aren’t alone. Prescription drug prices are exceedingly high and keep climbing. According to Oregon’s 2020 Prescription Drug Price Transparency report, at least 160 drugs increased in price by 10% or more in 2019, leading to billions in revenue and hundreds of millions in profit. (Maribeth Guarino, 6/4)
