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Today: The FDA approved the first Alzheimer’s treatment in nearly 20 years — but there’s not a lot of evidence that it works. It’s also priced extremely high. Meanwhile, President BidenJoe BidenBiden DOJ adopts Trump’s liability stance in E. Jean Carroll defamation suit Boston mayor fires city’s police commissioner months after domestic abuse allegations emerge Book claims Trump believed Democrats would replace Biden with Hillary Clinton or Michelle Obama in 2020 election MORE is hitting crunch time to get the U.S. to his July Fourth goal.
We’ll start with the Alzheimer’s drug:
FDA approves first Alzheimer’s treatment since 2003 in controversial decision
The FDA on Monday granted approval for the first new Alzheimer’s treatment since 2003, drawing mixed reactions amid opposition from some experts and an independent advisory committee.
A top FDA official said the agency decided to use the “accelerated approval” process for Biogen’s drug aducanumab to provide for patients enduring “serious diseases where there is an unmet need” and an expectation that the treatment will benefit patients.
The agency called the demand for treatments “urgent” as Alzheimer’s affects more than 6 million Americans and is the sixth leading cause of death in the U.S.
“In determining that the application met the requirements for Accelerated Approval, the Agency concluded that the benefits of Aduhelm for patients with Alzheimer’s disease outweighed the risks of the therapy,” Patrizia Cavazzoni, director of the FDA’s Center for Drug Evaluation and Research, said in the statement.
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Background: Two earlier clinical trials for the drug, also known by the brand name Aduhelm, examined by the FDA produced conflicting results on whether the drug slows cognitive decline.
These trial results prompted the independent Peripheral and Central Nervous System Drugs Advisory Committee to overwhelmingly recommend in November for the FDA to reject Biogen’s drug. But the FDA strayed from the committee’s advice with its Monday approval.
What’s next: With the accelerated approval, Biogen will be required to conduct another trial to prove the clinical benefit of its drug. The FDA could take steps to remove the drug from the market if the benefit is not proven.
“We believe that the data supports accelerated approval, while holding the company accountable for conducting an additional study to confirm the benefits observed in one of the trials, which we fully intend to do,” Cavazzoni told reporters on a press call Monday.
Read more here.
Biogen’s CEO defended the $56,000 price tag
CEO Michel Vounatsos on Monday said in an interview that he believed charging $56,000 per year for his company’s newly-approved Alzheimer’s medication was “fair,” citing years of “no innovation” in the marketplace.
The drug is a massive windfall for Biogen, especially given the fact that just two years ago, the company halted both Phase 3 clinical studies because the drug did not demonstrate effectiveness.
There are about 6 million people suffering from Alzheimer’s in the U.S. Even if only the approximately 2 million people with mild disease use the drug, Biogen will rake in $112 billion. Appearing on CNBC’s “Power Lunch,” Vounatsos said the price of the drug, sold as Aduhelm, was a reflection of “two decades of no innovation,” and said it would allow Biogen to fund medications for other diseases.
He also vowed that his company would not raise the price of Aduhelm for at least the next four years.
Notably, he said Biogen has up to 9 years to complete the FDA-mandated study so he wasn’t concerned the agency would actually pull it from the market.
Coverage questions: The price tag, combined with the questions about the drug’s effectiveness, might mean private insurance plans could decline to cover the cost. But Medicare is required to cover most, if not all, FDA-approved drugs. The implications of that cost on the U.S. healthcare system, and on seniors who will need to pay the premiums, are potentially staggering.
Price criticism: The Institute of Clinical and Economic Review (ICER), a nonprofit that analyzes the clinical and economic value of medical care, slammed both the FDA’s approval and the price tag. ICER initially estimated that the drug would be cost effective if it were priced between $2,500 and $8,300 per year — if it actually showed even a small benefit for patients.
“No one should assume that approving a drug with such conflicting and uncertain evidence will necessarily help patients and families,” the group said. “FDA has failed in its responsibility to protect patients and families from unproven treatments with known harms.”
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Read more here.
Biden hits crunch time on vaccinations
President Biden has less than a month left to reach perhaps his toughest coronavirus vaccination goal yet.
Biden’s objective is to give 70 percent of the U.S. adult population at least one dose of COVID-19 vaccine by July 4, even as the pace of vaccinations slows and those without their shots are increasingly hesitant to get them or are harder to reach.
The president has thus far been rewarded by the public for his coronavirus response, which has been his administration’s principal focus since he took office. Biden had set realistic, achievable vaccine goals in the first months of his administration as a way to measure his response to the virus.
And there has been good news on the virus front with large numbers of Americans getting vaccinated: COVID-19 cases and deaths fell to their lowest levels since March 2020 over the past week.
Where we’re at: About 63 percent of the U.S. adult population has received at least one dose of coronavirus vaccine, according to CDC data. But according to a Washington Post analysis, the vaccination rate has plummeted to fewer than 1 million a day
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What’s next: The White House is now ramping up efforts to incentivize vaccinations, address concerns about the shots and make it as easy as possible for Americans to get vaccinated as it looks to reach the remainder of the population.
“I don’t think it is against the odds,” said William Galston, a senior fellow of governance studies at the Brookings Institution who also served as a policy adviser in the Clinton White House. “It’s what’s known in the business community as a ‘stretch goal.’ If the administration is very well organized and focused, there’s a pretty good chance they can get there.”
Read more here.
But a new poll indicates 78 percent of unvaccinated Americans are unlikely to change their minds
Among U.S. adults who do not plan to be vaccinated, 78 percent in a Gallup poll released Monday said they are unlikely to reconsider their plans. Roughly half — 51 percent — indicated they are “not likely at all” to change their mind and get vaccinated.
Overall, just 1 in 5 vaccine-reluctant adults said they are open to reconsidering, with 2 percent saying they are “very likely” and 19 percent saying they are “somewhat likely” to ever get inoculated.
The same poll found 60 percent of U.S. adults say they have been fully vaccinated against COVID-19, meaning two weeks have passed since their final dose, and 24 percent do not plan to be vaccinated.
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More than half of all U.S. adults polled, 53 percent, said they are worried about people opting against getting a vaccine, including 25 percent who said they are “very worried” about vaccine hesitancy in America.
Weeks away from July 4: The poll results signal the upcoming challenge for the Biden administration to close the gap in vaccinations and get more than 16 million people their first dose before the Fourth of July deadline.
Read more here.
What we’re reading
FAQs: What you need to know about the Alzheimer’s drug Aduhelm (Stat)
Vaccination rates fall off, imperiling Biden’s July Fourth goal (Washington Post)
Do air purifiers protect against Covid? Lawsuit says company makes ‘false’ claims (Kaiser Health News)
How the ‘Alpha’ coronavirus variant became so powerful (New York Times)
State by state
As immunized deadline approaches, unvaccinated Houston Methodist nurses plan walkout (Houston Chronicle)
Mississippi’s only abortion clinic facing biggest challenge (Associated Press)
Montana med school clash revives for-profit vs. nonprofit flap (Kaiser Health News)
Op-eds in The Hill
Social distancing should stick around
COVID vaccine passports pose more questions than answers
Naomi Osaka is raising awareness of mental health issues in professional sports
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