Marc Archambault is well aware of the controversy surrounding Biogen’s new drug for Alzheimer’s disease, including that three members of a scientific advisory committee to the Food and Drug Administration quit in protest last week after the agency approved it over the panel’s objections.
Still, he was thrilled to roll up the left sleeve of his blue button-down shirt Wednesday at Butler Hospital in Providence to receive one of the first intravenous infusions of the drug, Aduhelm, since its June 7 approval. He wasn’t concerned that many in the scientific community say evidence that it works is thin.
“I’m comfortable with it a hundred percent, and whatever happens, happens,” said Archambault, 70, a real estate broker in South Kingstown, R.I. “I think it’s going to be great, and I wanted to be part of it.”
He also appeared to question the empathy of the three physician scientists who quit the advisory committee that overwhelmingly recommended in November that the FDA reject the drug in light of contradictory results in two large clinical trials.
One of the studies said people on the drug declined 22 percent more slowly than those who received a placebo. The other trial failed to reach its goal.
“I wondered if those people who quit had anybody in their families with Alzheimer’s, and I wonder if that were the case, would they have acted differently?” Archambault said, as he sat in a blue recliner during the hour-long infusion.
In response to those comments, one of the physicians who resigned, Dr. Aaron Kesselheim, a professor of medicine at Harvard Medical School and Brigham and Women’s Hospital, said he treats patients with Alzheimer’s and empathizes with them and their families.
“The desire that patients have for treatments that would help them is one hundred percent justified,” he said in a phone interview. “Unfortunately, there’s no good evidence that this drug is an effective treatment.”
Butler Hospital, which treats psychiatric disorders and substance abuse, has been one of the sites for clinical trials of the medicine since 2013. Dr. Stephen Salloway, who oversees neurology and the Memory and Aging Program at Butler, is an unabashed champion of the drug.
A paid consultant for Cambridge-based Biogen who says he received $11,000 from the company in the past year, Salloway recently told the Globe that he treated 17 patients with Aduhelm ― called aducanumab during the trials ― and that 10 didn’t decline while on it.
Following the resignations of the three committee members ― Kesselheim wrote to FDA Acting Commissioner Janet Woodcock that Aduhelm’s authorization was “probably the worst drug approval decision in recent U.S. history” ― Salloway and other hospital officials hosted a news conference to highlight the medicine’s promise.
“Today, we’re making history,” Salloway told about 70 hospital employees, guests, and journalists in a conference room. “We’re opening a new era in the treatment of Alzheimer’s disease.”
He acknowledged that Aduhelm, which was designed to delay cognitive decline early in the disease, wasn’t a perfect drug but said he hoped it led to better medicines. “This is just the beginning,” he said.
The hospital also invited journalists to witness what officials described as the “world’s first infusion” of the drug outside a clinical setting, although a Biogen spokeswoman, Allison Parks, said she couldn’t confirm that was the case.
Biogen said June 9 that it would start shipping Aduhelm to treatment sites “within about two weeks” and that “over 900 sites will be ready to treat a patient shortly.” A spokesman for the more than a dozen hospitals that make up the Mass General Brigham system said Wednesday that none of them have begun administering the drug to patients.
Archambault, a 1973 graduate of the University of Rhode Island and father of two adult children, said he began suffering mild cognitive impairment from Alzheimer’s almost a decade ago. His longtime friend and co-worker at Randall Realtors, Karen Poole, who accompanied him to the infusion, noticed that he started getting his business appointments mixed up.
He soon had to rely more on programs such as Google Calendar and lean on a co-worker, Paul Robinson, to help with e-mails and texts. Nonetheless, he said, he continues to work ― “my real estate brain is still here” ― and drive.
He participated in two other Alzheimer’s-related clinical trials at Butler in recent years and twice applied to join clinical trials of aducanumab. But he was rejected both times because his memory wasn’t impaired enough to qualify, Salloway said.
After Aduhelm became the first new approved Alzheimer’s drug since 2003, Salloway helped arrange for Archambault to receive an infusion as a patient, although questions about insurance coverage remain unanswered. He has Medicare, which should cover 80 percent of the $56,000 annual list price of the treatment. That still leaves at least $11,200. He has a supplemental health insurance plan, but it’s unclear how much that will cover.
Mary Marran, president and chief operating officer of Butler, said at the news conference that the hospital has financial advisers working with patients who want Aduhelm. (Salloway said 100 people are on a waiting list.)
She couldn’t promise that Butler would cover a shortfall if Archambault’s insurance doesn’t pick up the full cost, but said the hospital would do everything possible to help him.
“We are working through this,” she said.
Archambault, whose father died of Alzheimer’s disease, said he planned to celebrate his first infusion with friends on Wednesday night on the deck of his house. They have promised to bring him dinner, he said, adding, “I know there will be some cold beer.”
Jonathan Saltzman can be reached at firstname.lastname@example.org.