Rocky road continues at Biogen
FOR CAMBRIDGE-BASED Biogen, it’s been the best of times and the worst of times.
The biotech powerhouse saw its Alzheimer’s drug Aduhelm approved in June by the Food and Drug Administration. The first new Alzheimer’s therapy in nearly 20 years, the drug looked poised to become a blockbuster treatment that would reap billions in sales for the company given the millions of people affected by the degenerative and fatal brain disease.
But Aduhelm’s approval has been dogged by controversy. An FDA advisory committee recommended against its approval, and there has been widespread criticism from the scientific community that the approval came despite no clear evidence that the drug confers benefits to Alzheimer’s patients. Dr. Aaron Kesselheim, Harvard Medical School researcher and member of the advisory committee who resigned following the FDA action, called it “probably the worst drug approval decision in recent US history.”
Congressional committees are seeking more information on behind-the-scenes interactions between FDA officials and Biogen leading up to the agency’s approval.
The Wall Street Journal, citing a source, says the 64-year-old scientist had been “discussing retirement for some time but wanted to wait until Aduhelm’s development was completed.” STAT characterizes his departure very differently, saying he is “leaving in the midst of a federal investigation” of the Aduhelm approval.
Sandrock has led the company’s efforts to launch several successful new drugs, but Aduhelm, priced at $56,000 per year, is proving to be more of a drain than a boon. A number of prominent hospital systems, including Mass. General Brigham, have said they won’t offer it to patients. The biggest question, though, is what the federal Medicare agency will decide about covering the drug, since it is the insurer for all Americans 65 and older – the population that Alzheimer’s is mainly affecting.
Even though that decision is still pending, Amitabh Chandra, an economist who is director of health policy research at the Harvard Kennedy School, told CommonWealth last month that he can’t see how Medicare won’t cover a drug approved by the FDA. “So it will be paid for by taxpayers,” he said.
And also, it seems, by older Americans on Medicare. On Friday, Medicare announced that the cost of premiums for “Part B” coverage of outpatient care will jump by $21.60 in 2022. That’s one of the biggest annual increases ever, and Medicare officials said about half of the increase is due to anticipated costs to the program from Aduhelm. The Associated Press says that will eat up a big share of the average $92-a-month cost-of-living increase recently announced for Social Security recipients.
The rate increase seems to confirm the fears some scientists and health care advocates have expressed — that Aduhelm could significantly increase health care costs without any clear evidence that it’s doing any good for patients.
How this will all play out for Biogen still seems unclear. STAT calls it “a company in decline,” with revenue for 2021 on track to come in 20 percent lower than projected, and layoffs being considered. Meanwhile, Biogen announced today that a European Union drug review panel has given Aduhelm a “negative trend vote,” meaning it’s unlikely to receive approval there.
Wu takes over: Michelle Wu took office as mayor of Boston at a ceremony that reflected the priorities of a 36-year-old mother of two young boys. It was symbolic, offered a clear message, and most of all was efficient.
— In her speech, which lasted a little over eight minutes, Wu promised to pay attention to the most basic city service needs while also thinking big and bold about the change she says is needed to make Boston work for all residents.
— The swearing-in took place in the chamber of the City Council, which she joined in 2013. She becomes the first elected mayor of Boston who is a woman and a person of color. Read more.
Baker on UI fund: Gov. Charlie Baker signals his priorities on the state’s unemployment insurance trust fund. He favors a high balance of around $2 billion and wants to achieve it using $500 million in ARPA funding and the rest from bond proceeds. Sen. Patricia Jehlen of Somerville says issuing bonds that need to be paid off over 20 years makes no sense when easily obtainable federal loans at low interest rates are available. She also calls for a full accounting of the fund. Read more.
Parents bullish: A new poll sponsored by the Barr Foundation finds parents bullish on the return to in-school learning, with 51 percent saying they expect their child to finish the current school year at grade level and 35 percent above grade level. Read more.
TCI on hold: Connecticut Gov. Ned Lamont said he is putting his pursuit of the Transportation Climate Initiative on hold, leaving Massachusetts in a precarious go-it-alone position as the cap-and-trade gasoline initiative is scheduled to begin practice runs in 2022 and launch formally in 2023. Read more.
Critique of House: A group of progressive activists that includes three ex-state reps issues a report slamming the House for perpetuating a structure that centralizes power in the speaker and limits the influence of rank-and-file lawmakers. Read more.
Another run: House Speaker Ron Mariano says he intends to run for speaker again and is almost giddy at the prospect of spending billions of dollars in federal aid. Read more.
Catch-22: Rural Massachusetts towns find themselves in a Catch-22 on broadband. Many have borrowed money to pay for their buildouts but now find themselves cut off from federal aid set aside for such work because the rules bar use of the money for debt service. Read more.
FROM AROUND THE WEB
The state’s temporary vote-by-mail law is set to expire next month and there is no permanent statute on the books to keep it in place. (Boston Globe)
Massachusetts lawmakers are preparing to send Gov. Baker a bill that would require schools to teach about the history of genocides and set up a fund to develop the new curriculum. (State House News Service)
A Berkshire Eagle editorial says the State House’s protracted closure is an affront to good governance.
Legislation filed on Beacon Hill would ban the use of Native American mascots at Massachusetts schools. (Boston Globe)
To help alleviate the situation at Mass. and Cass in Boston, the state is considering erecting cottages at Shattuck Hospital to address homelessness and addiction. (WBUR)
New Bedford municipal employees protest against the city’s vaccine mandate. (Standard-Times)
New Bedford Light’s Jack Spillane profiles Shane Burgo, who said he did not expect to win his race for a seat on the New Bedford city council — but did.
Brigham and Women’s Hospital is launching a clinical trial to test a new nasal vaccine for Alzheimer’s. (MassLive)
After a four-hour recount, the city clerk in Framingham declares a “failure to elect” as the two candidates for the District 3 City Council seat tie with 997 votes apiece. (MetroWest Daily News)
Thomas Edsall says the national outlook for Democrats isn’t just bad, it’s horrible. (New York Times)
Fenway Sports Group, the parent company of the Boston Red Sox, is close to securing a deal to buy the Pittsburgh Penguins. (Boston Globe) If the sale goes through, it will represent FSG principal owner (and Red Sox and Boston Globe owner) John Henry flipping the bird to the Boston Bruins, says Bill Speros (aka the Obnoxious Boston Fan). What’s next he asks, bringing A-Rod here as Henry’s “special adviser for fan enragement.” (Boston Herald)
Northampton’s eighth cannabis dispensary opens — the first owned by a minority. (Daily Hampshire Gazette)
Students and parents in Springfield are complaining that the meals served in Springfield schools, through a contract with Home Grown Springfield, are unappetizing and improperly cooked. The company blames new rules requiring them to serve individually packaged portions. (MassLive)
Energy costs are expected to soar this winter. (Salem News)
The town of Sandwich voted to ban single-use plastic water bottles in May and reversed that decision this week. (Cape Cod Times)
An audit finds the Cape Cod Municipal Police Academy has been operating with lax or no financial oversight and running up unexpected deficits. (Cape Cod Times)A Holyoke police officer who posted a video alleging corruption and racism within the department was fired just before a new mayor took office. An internal investigation faulted the office for failing to comply with an order to take his video down, unbecoming conduct, criticism of the department, and violation of social media rules. (Daily Hampshire Gazette)
Three student officers at the police academy at Northern Essex Community College test positive for COVID-19 so the whole class wins a pass grade and is sent home. (WBUR)