The Morning Dispatch: FDA Approves Controversial Alzheimer’s Drug

Happy Thursday! Apologies if this newsletter is a little damp when it hits your inbox—the humidity in D.C. this week has been unbearable.

Quick Hits: Today’s Top Stories

• The Washington Post reported Wednesday that the Biden administration is buying 500 million COVID-19 vaccine doses from Pfizer at a “not-for-profit” price, with plans to donate them to low- and middle-income countries around the world. Distribution will be run through the World Health Organization’s COVAX initiative, with 200 million doses going out this year, and 300 million in early 2022.

• Months after President Biden revoked its necessary cross-border permit, the Keystone XL Pipeline’s developer formally abandoned the project, which was first proposed 13 years ago.

• President Biden issued an executive order yesterday replacing former President Donald Trump’s attempts to ban Chinese-owned apps TikTok and WeChat with an even broader review of software applications developed in adversarial countries.

• JBS USA confirmed yesterday that it paid the roughly $11 million ransom in Bitcoin demanded by hackers that infiltrated the meat processing company’s systems last week. CEO Andre Nogueira said it was a “very difficult decision,” but the company ultimately felt it “had to be made to prevent any potential risk for [its] customers.”

• A Department of Interior inspector general report released yesterday found that the U.S. Park Police’s decision to violently clear protesters from Lafayette Park last June was unrelated to then-President Trump’s Bible photo op that same evening. “The evidence we obtained did not support a finding that the USPP cleared the park to allow the President to survey the damage and walk to St. John’s Church,” the report reads. “Instead, the evidence we reviewed showed that the USPP cleared the park to allow the contractor to safely install the antiscale fencing in response to destruction of property and injury to officers occurring on May 30 and 31.”

• Democratic Rep. Val Demings of Florida announced yesterday she is running for the U.S. Senate, planning to challenge Sen. Marco Rubio next November. Former GOP Rep. Jim Renacci of Ohio also announced yesterday he is launching a primary challenge to Republican Gov. Mike DeWine.

• The United States confirmed 23,314 new cases of COVID-19 yesterday per the Johns Hopkins University COVID-19 Dashboard, with 4.2 percent of the 559,337 tests reported coming back positive. An additional 441 deaths were attributed to the virus on Wednesday, bringing the pandemic’s American death toll to 598,764. According to the Centers for Disease Control, 16,532 Americans are currently hospitalized with COVID-19. Meanwhile, 829,809 COVID-19 vaccine doses were administered yesterday, with 172,054,276 Americans having now received at least one dose.

Controversial Alzheimer’s Drug Gets FDA Approval

Earlier this week, the Food and Drug Administration (FDA) approved the use of an experimental new drug to treat early-phase Alzheimer’s, the progressive disease that oftentimes leads to memory loss and dementia. Known as aducanumab and developed by Biogen, the drug is the first the FDA has approved to treat Alzheimer’s since 2003.

Aducanumab—which will be branded as “Aduhelm”—is designed to reduce the amount of amyloid beta plaque buildup in the brain. “The clinical trials for Aduhelm were the first to show that a reduction in these plaques … is expected to lead to a reduction in the clinical decline of this devastating form of dementia,” the FDA said. The treatment—which is the first “directed at the underlying pathophysiology of Alzheimer’s disease”—relies on monthly intravenous infusions.

Given how many people suffer from Alzheimer’s (more than 6 million in the United States alone), aducanumab’s approval process has been subject to lots of attention—and controversy. It received the green light earlier this week through the FDA’s accelerated approval pathway, which allows companies to go to market prior to completing Phase 4 clinical trials for drugs that “treat serious conditions” and “fill an unmet medical need.”

But the FDA’s decision to approve aducanumab this week flew in the face of recommendations from its Peripheral and Central Nervous System Drugs Advisory Committee, which voted overwhelmingly back in November against approval. Asked whether it was reasonable to conclude that data from one positive study was evidence of aducanumab’s effectiveness, every committee member voted no.

The Phase 3 program for aducanumab consisted of two clinical trials. While both trials showed reduced levels of amyloid plaques in the brain, only one trial showed a relative reduction in the rate of cognitive decline.

The risks of aducanumab included brain swelling and bleeding, as experienced by 40 percent of trial participants. Many of these participants were either asymptomatic or had headaches, dizziness, or nausea—but 6 percent of participants were forced to discontinue because of the side effects. Some patients also experienced adverse effects like falling and disorientation.

In a statement after approving the use of aducanumab, the FDA acknowledged the risks involved in taking the drug. “In determining that the application met the requirements for Accelerated Approval, the Agency concluded that the benefits of aducanumab for patients with Alzheimer’s disease outweighed the risks of the therapy.”

The FDA also decided to approve the drug for anyone who has Alzheimer’s, despite clinical trials only consisting of participants with mild dementia or early-stage Alzheimer’s.  

Dr. Joseph Ross, a professor of public health and medicine at Yale, told The Dispatch he believes it was a mistake for the FDA to approve aducanumab.

“The people in these trials had early-stage Alzheimer’s; that could be a grandparent who’s kind of forgetful. To expose them to something that can lead to their imminent death is irresponsible,” Ross said. “This is a high risk, no reward situation.”

Biogen, the biotechnology company that developed aducanumab, has set the price of the drug at $56,000 per year and plans to ship it to 900 sites around the country. Ross warns that a therapy of this cost will have enormous implications for almost everyone.

“When a drug is as expensive as this and will presumably have widespread usage, expenses for commercial insurers will rise, and they’ll have to raise their premiums. And in order for services like Medicare or Medicaid to cover the expenses, governments will have to either raise taxes or cut money from other services in order to afford the drug,” Ross said.

Dr. Laurie Ryan, the chief of the clinical and diagnostics branch of the National Institute on Aging’s neuroscience division, told The Dispatch that while there is still much work to be done in the fight against Alzheimer’s, aducanumab’s approval constitutes progress.

“This is definitely a step forward, but it’s not just this one drug at this one time—there’s many therapeutics under development,” she said.

Ryan cited research at Georgetown and Johns Hopkins as promising signs in the fight to cure Alzheimer’s. She also noted that progress cannot be made without individuals volunteering to participate in clinical research.

“It is crucial to have individuals volunteer for clinical research in Alzheimer’s and related dementias,” Ryan said.

Arizona Republicans’ 2020 Re-Re-Recount

After a year of fantastic work, Audrey’s fellowship with The Dispatch officially came to an end this week. But we have great news: After a few months at the Wall Street Journal, she’ll be returning to The Dispatch as a full-time reporter this fall!

She spent most of last week covering Republicans’ election audit in Arizona, and we published her final piece for us (for now) this morning. Here are some highlights.

Why is this audit taking place? Haven’t Maricopa County’s 2020 results been rechecked already?

Arizona’s election results were certified on January 6, of course, and there were numerous legal challenges in Maricopa County, none of which concluded that county election officials committed any wrongdoing. Six months after Joe Biden won Arizona by roughly 10,000 votes of the 3.3 million ballots that were cast statewide in the November election, rogue GOP officials continue to propagate baseless accusations of fraud despite the fact that local election officials took pains to ensure that the county tabulated votes correctly. 

Immediately following the November election, Maricopa County election officials oversaw a hand-count of a statistically significant sampling of ballots—47,000 votes—that were cast by county residents and tabulated by Dominion Voting Systems, the election company the county has used since 1998. The results from the first hand-count—which was staffed by volunteers from the Republican, Democratic, and Libertarian parties—were 100 percent identical to the initial total tabulated on Dominion’s voting machines. 

The Maricopa County Board of Supervisors then hired two additional elections companies to conduct a forensic audit of the Dominion voting software. The companies concluded that the installed software was certified by the U.S. Election Assistance Commission and the Arizona secretary of state and that there was no malware connected to the machines. Neither company found any evidence to suggest the software was connected to the internet or that any votes were switched from one candidate to another.

What are Republicans actually trying to do with the election audit?

Arizona State Senate Republicans ordered a so-called forensic audit contesting the victories of President Biden and Democratic Sen. Mark Kelly. The Republican-led audit began on April 23 after a judge granted subpoenas from Arizona Senate President Karen Fann for ballots and other election materials.

Republican Party activist Randy Pullen claims that the recount will be completed by the end of June. As of Wednesday, more than 1.7 million of the county’s 2.1 million ballots have reportedly been counted. 

The partisan operation has been criticized by Democrats and Republican election officials in Arizona for its lack of transparency and its failure to adhere to state election rules. Audit organizers also aren’t being shy about their long-term goals. “What will come out of this is the entire process for how you do this large of an audit will be written up,” Pullen said. “It will be a plan that someone else can take and use as the basis for doing something similar to this.”

The idea is already gaining traction among rogue Republicans in swing states. Three members of the Pennsylvania Senate toured Maricopa County’s election site Wednesday and told reporters they plan to launch a similar audit in their own state.  

In many ways, the audit can best be summarized by one word: “dominoes.” Arizona GOP leaders are hoping this Maricopa County audit will launch similar undertakings nationwide. “Arizona is the first domino that will fall and then other states will look into irregularities, abnormalities, mistakes and potentially outright fraud that happened in their states as well,” state Republican Party Chair Kelli Ward said on Newsmax on May 1.

…

Audit organizers claim they are abiding by a wait-and-see approach. “If it turns out that, you know, we find 12,000 ballots that were somehow changed, one way or another—and I’m not saying we will—which means that could result in a change in the result of the election, you know, that’s, I have no idea,” [former Arizona GOP chairman and audit liaison Randy] Pullen said in an interview Thursday. “I’m not a lawyer,” he said. “Whether they can go to court and overturn the election in the state—I don’t know.”

What is the audit process like?

A bird’s eye view of the audit from the press box makes the ongoing recount look like a game of Sorry! The ballot counters are divided into four pods, each a different color: red, blue, green, and yellow. Three ballot counters tabulate votes as two other volunteers spin a turntable that contains just two ballots at a time. Audit managers wear black, volunteer observers wear orange, ballot inspectors wear gray, and runners—who carry ballots to and from different stations—wear purple. 

Volunteers wearing pink shirts are observing on behalf of Democratic Secretary of State Katie Hobbs, who announced her candidacy for governor on Wednesday and has repeatedly called the audit a “farce.” Hobbs’ observers have been reviled by audit organizers ever since they were first allowed on the audit floor, but they ventured even further into enemy territory when they issued a report detailing “new and ongoing” incidents noticed by observers beginning on May 24. The report includes several concerns over security, equipment, and policy changes. 

Pullen, on the other hand, maintains that he and his estimated 300 audit volunteers follow strict ballot handling procedures. “Now, as you look down on the floor you can see that people go out and take a break right?” Pullen said as he pointed to a small crowd of people milling about in the hallways on the lower floor last Thursday. “And so they’ll leave their box of stuff there, right? It doesn’t mean that there’s no chain of custody on it, because there’s still managers down there.” 

But the secretary of state’s observers claim that confidential election materials have been left unattended and that volunteers no longer adhere to protocols that were established at the beginning of the recount. “If you were to go in on day one and go back and look at some of the videos from day one, there was a scanning station where the ballot was scanned, and put up on a screen, there are no longer screens, there’s no longer a scanner,” said one secretary of state observer, Ryan Macias, in an interview on Friday. 

“This is what their written procedures say will happen: They scan the ballot, it goes up on screen and then the counters will count off of the image of the ballot that’s on screen,” he said. 

Macias, who claims he has been there almost every single day over the past six weeks, said he and other observers are routinely denied access to certain areas. “We are constantly, on a daily basis, pretty much being told where we can and cannot go,” Macias said.

Journalists were also originally prohibited from observing the audit unless they signed up to be a volunteer observer and completed a six-hour shift. Now, local reporters sign up for shifts in a press pool that permits just one reporter, one photographer, and one videographer at a time. Journalists who work for national media organizations must be granted permission directly from audit organizers.

What does this say about the Arizona GOP?

The Arizona Republican Party had rabble-rousers within its ranks long before former President Trump announced his candidacy for president in 2015. “This is nothing new,” said Kirk Adams, former Republican Speaker of the Arizona House of Representatives. “The party apparatus has been at war with other elements of the party off and on for almost the last 20 years,” Adams said.

…

The Trump-loyal fringe of the state GOP has metastasized into a mouthpiece for the former president, and now regularly doles out punishments to any Republican lawmaker who refuses to pledge allegiance to him. On January 23, the state GOP voted to censure Republican Gov. Doug Ducey, former Republican Sen. Jeff Flake, and even Cindy McCain, the late Arizona senator’s widow.

Still, establishment Republicans are convinced that the state GOP leadership does not reflect the views of the typical Republican voter in Arizona. “They have not taken over the Republican party in Arizona in terms of the primary electorate, but they clearly have a grip right now on the official apparatus of the state GOP,” Adams said.

Worth Your Time

• In her debut for The Atlantic, Elizabeth Bruenig tries to reframe the debate around capital punishment. “It goes without saying that the state should not kill innocent people, and that it is a good thing to save the innocent from a fate no one thinks they deserve. I believe it is a good thing, too, to save the guilty from a fate some would argue they have earned,” she writes. “Killing never reduces moral risk; there’s no cosmic ledger it can, by subtraction, set right, and no slate it can wash clean with the right amount of blood. In this way the lives of the innocent are no different from the lives of the guilty.”

• ProPublica made a lot of news earlier this week when it published the tax returns of some of the richest people in the United States, showing how little these billionaires actually send to Uncle Sam on an annual basis. But in an essay for Reason, Andrew Moylan and Andrew Wilford argue the story is overhyped, and missing a lot of context. “Our tax system rightly does not tax growth in one’s wealth until it is realized as income,” they write. “The reason that wealth isn’t taxable is fairly straightforward: You aren’t directly benefiting from it until it’s turned into income (at which point it is taxable). Wealthy Americans may not pay taxes on the growth that their net worth sees, but should they wish to sell assets that have appreciated in value, they would be liable for capital gains taxes on that growth.”

Presented Without Comment

Also Presented Without Comment

Toeing the Company Line

• Jonah’s Wednesday G-File (🔒) yesterday focused on conspiracies, and how they often beget additional conspiracies. This is particularly true of our current debates about democracy, he argues. “Fear of the other side cheating creates, almost in dialectical fashion, overreactions to prevent it. These overreactions, in turn, are all the proof the other side needs to confirm their fear that it’s the other side declaring war on democracy. And on it goes.”

• On this week’s Dispatch Podcast, the gang breaks down the state of President Biden’s legislative agenda, and whether it’s stalling out. Plus, the repercussions of the U.S. withdrawal from Afghanistan are already here.

• In this week’s Capitolism (🔒), Scott Lincicome delves into his newfound dad-ish hobby—gardening—and how capitalism makes it possible. “The free market gives me the money and free time to pursue agriculture as a hobby and supplement my cheap and healthy groceries with home-grown herbs and produce. And dozens upon dozens of total strangers—some of whom live thousands of miles away—are just itching to help me do it,” he writes. “By freeing us from the brutal poverty of autarky and antiquity, the market lets us pursue things we actually enjoy—for work or play. And nobody planned a thing.”

Let Us Know

Have you ever been in a position to try new and/or experimental medical treatments? What is your general approach to that sort of thing?

Reporting by Declan Garvey (@declanpgarvey), Andrew Egger (@EggerDC), Haley Byrd Wilt (@byrdinator), Charlotte Lawson (@charlotteUVA), Ryan Brown (@RyanP_Brown), Harvest Prude (@HarvestPrude), Tripp Grebe (@tripper_grebe), Emma Rogers (@emw_96), Price St. Clair (@PriceStClair1), Jonathan Chew (@JonathanChew19), and Steve Hayes (@stephenfhayes).