“Everyone’s a little bit afraid of Alzheimer’s, so the average person hears about FDA approval of a treatment and doesn’t know the controversy about whether it works or not,” said Craig Garthwaite, health economist at Northwestern University Kellogg School of Management who criticized the FDA’s Aduhelm approval. “You hear that there is a new treatment and that’s great, it’s a sign of hope. Do you want to be the politician who says: ‘I want to take that from you?’ “
The drug was the first to be approved for Alzheimer’s in nearly 20 years, and it’s the first to aim to slow cognitive decline rather than just treating symptoms of the disease. But the agency’s accelerated approval has been criticized by many drug experts, has led to the resignation of three outside FDA advisors, and has hardened opposition to incumbent FDA Commissioner Janet Woodcock, who is President Joe Biden’s obvious favorite for running the agency .
The severity and complexity of Alzheimer’s, an incurable neurodegenerative disease that affects approximately 6 million Americans and takes a heavy toll on their families, makes it difficult for even many Democratic drug critics on the hill to speak up. Patient associations campaigned hard for Aduhelm’s approval for years after many other candidates had failed over the years. And Biden, who is calling for billions of dollars to expedite research into cures for Alzheimer’s and other diseases, was delighted with the drug’s approval, POLITICO reported Thursday.
For Republicans, the weak evidence that Aduhelm is effective makes it more difficult to promote the treatment as an example of breakthrough cures that they believe would stifle Democratic drug price proposals. Sen. Jerry Moran (R-Kan.), Who was one of the few senators to mention the drug during a hearing with Woodcock Thursday, praised the approval and said he hoped it could pave the way for other treatments to develop more quickly.
“I believe that with more timely approvals, more private investment will be made in research to find these life-saving and life-enhancing drugs,” said Moran.
The few Democratic lawmakers who have criticized the drug’s price are the ones who tend to be most explicit, including the chairman of the Senate Finance Committee Ron Wyden (D-Ore.), Who writes the revision of the party’s drug prices in the upper chamber. representative Peter Welch (D-Vt.), A pharmaceutical hawk, admitted the drug’s difficult politics but said Democrats risked missing an opportunity to campaign to contain drug prices.
“We all really support a cure or treatment for Alzheimer’s, so we want it,” Welch said. “But it is misguided on our part not to tackle the price gouging.”
Biogen declined to comment on the story, but CEO Michel Vounatsos said in comments this week that the price of the drug is justified by the value it will bring to patients and a society less affected by Alzheimer’s. This is a message picked up by some Republicans who have allied with the industry to oppose Democratic efforts to contain prices.
“I think there is general hope for the new drug,” said Rep. Kevin Brady of Texas, the top Republican on the House Ways and Means Committee. “I think we’re pricing it, even though Alzheimer’s is devastating in terms of both human and healthcare costs.”
Some progressive groups stressed that lawmakers are still reviewing the FDA’s decision, which has surprised many. They said the backlash could intensify in the coming weeks as more experts raise concerns about the drug’s approval and the financial stress that could weigh on the health system and patients.
“I didn’t understand why there has been a relative silence on Capitol Hill so far,” said Frederick Isasi, CEO of Families USA, a consumer protection group that owns the Drug price calculation House spokeswoman Nancy Pelosi is pushing for inclusion in infrastructure legislation.
A senior Democratic adviser, however, expressed doubts that many party lawmakers will make Aduhelm a rally for this bill, which would mandate negotiations on drug prices for the government. However, the adviser also said the muted response said nothing about the party’s appetite for drug prices.
“Hopefully there is a much more effective drug for Alzheimer’s on the horizon,” said the consultant. “If that’s the kind of cost we’re talking about, there has to be price negotiation. Or what else are you doing? Or not everyone gets the drug. “
Much of the drug’s review over the past few days has focused on FDA decision-making. The agency gave the drug broad approval, although nobody on its independent advisory panel voted for it. The FDA is not required to follow the recommendations of its advisory boards, but it usually does.
Although the agency typically requires two clinical trials showing a drug’s effectiveness before granting approval, two Aduhelm trials have produced mixed results. The FDA requires Biogen to conduct a follow-up study to prove effectiveness. It can or does not have to revoke approval if it fails, and such withdrawals are rare.
The FDA said it approved the drug because it reduced the presence in the brain of the amyloid protein that many scientists believe may cause Alzheimer’s disease. But this connection has never been proven – and the failure of Biogen’s second study has been interpreted by many researchers as a strong blow to the so-called “amyloid hypothesis” of the disease.
While Garthwaite, the health economist, has criticized the Democrats’ proposal for Medicare drug negotiations, he said the shaky foundation for Aduhelm’s approval could lay the foundation for it. He and other experts fear that the low bar for this drug could lead other manufacturers to work on similar treatments instead of investing in potential big breakthroughs for the disease – in which case the FDA’s actions would undermine research.
The Alzheimer’s Foundation of America, an influential nonprofit that celebrated Aduhelm’s approval, did not respond to a request for comment on the award. AARP, which represents Americans 50 and older, declined to comment.
Robert Egge, chief public policy officer for the Alzheimer’s Association, said the group was “excited about the cost” and described it as an “insurmountable barrier” in a briefing in Capitol Hill this week.
“The Alzheimer’s Association, like all of us, is focused on ensuring that this treatment can benefit people with early-stage Alzheimer’s disease and that these people must have access to this treatment,” he said. “We aim to do everything in our power to ensure access to the drug, any diagnostic or other tests required during the treatment process.”
Isasi of Families USA described the intricate political issues raised by the drug as “a bomb on a slow fuse”. Federal Medicare has not yet said how it will cover the drug, which will be given as monthly intravenous infusions. It could provide clinical guidelines that effectively limit who is eligible for the drug – a cost-saving move that could face resistance from patient advocates.
Health experts predict the costs will hit the Medicare program hard. The program could cost an additional $ 29 billion annually if only a quarter of the 2 million beneficiaries using Alzheimer’s treatments now available are prescribed Aduhelm, according to a recently released Study by the Kaiser Family Foundation.
“Better for Congress to act now than to look back and see that this was a turning point and they didn’t act,” said Mark Miller, executive vice president of health at Arnold Ventures, which funds the work in health care Reform efforts.