House investigation faults FDA, Biogen for Alzheimer’s drug approval

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The biotech company Biogen and its regulator, the Food and Drug Administration, worked in concert, ignoring internal concerns at the company and bypassing the agency’s own written advice, to allow Aduhelm’s Alzheimer’s treatment to receive accelerated approval and hit the market at a cost to patients. $56,000 a year, according to a report released Thursday by two House committees.

The “strange” collaboration, which resurrected Aduhelm three months after Biogen canceled clinical trials, unfolded in at least 115 meetings, calls and email exchanges between the company and the FDA in a year, said the report by the Committees on Oversight and Reform. and Energy and Commerce.

The joint effort culminated with agency staff helping Biogen draft a document that was used to brief the FDA’s advisory committee before it met to discuss Aduhelm on Nov. 6, 2020. Although the FDA often follows a committee’s recommendations advisory, he did not do this time. After no member of the advisory committee recommended Aduhelm, the FDA changed course, allowing Biogen to move its drug into an accelerated approval process.

According to the FDA’s suggestion, the drug was labeled for use by more than 6 million Alzheimer’s patients in the country, even though it was tested only on people with early Alzheimer’s and moderate symptoms, the report said.

“This is the worst decision the FDA has ever made” in the past half century, said Sidney Wolfe, founder of the Public Citizen Health Research Group. “It was an unprecedented alliance between the company and the FDA.”

“We fully cooperate with the Committee’s assessment and continue to review their findings and recommendations,” the FDA said in a statement responding to the report. “It’s the agency’s job to communicate frequently with companies to ensure we have the right information to inform our regulatory decisions. We will continue to do so, because it is in the best interest of patients. That said, the agency has already begun implementing changes consistent with the Committee’s recommendations.”

The agency has already conducted an internal investigation into its handling of Aduhelm, concluding more than a year ago that although the collaboration “exceeds the norm in some respects,” there was “no evidence” that shows the contract between companies in and regulator “was anything but. appropriate.”

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The internal report said the decision to work “proactively” with Biogen “is consistent with FDA policy” in light of both the “significant unmet medical need” for Alzheimer’s treatment, and an FDA official’s opinion that one of the studies Aduhelm could represent “a home run” as far as safety and effectiveness.

The report by two House committees also faulted the company, saying Biogen knew the initial price of $56,000 a year — reduced to $28,000 in January 2022 — would place a heavy burden on patients. But the company based in Cambridge, Mass. estimated that the treatment could earn Biogen as much as $ 18 billion per year and was happy in a slideshow presentation to his board: “Our ambition is to make history” and “establish. [the drug] as one of the biggest pharmaceutical launches of all time.”

In fact, Aduhelm proved to be a financial failure, generating $ 3 million in revenue for the entire year of 2021.

In a statement responding to the report, Biogen said it cooperated with the committees and was “confident in the integrity of the actions we took.” Biogen’s statement also cited the FDA’s internal investigation, which concluded that there was no evidence of wrongdoing in the contract between the agency and the company.

Biogen stuck with the initial price of $56,000 per year despite projections that the drug could cost Medicare up to $12 billion in a single year. Other Alzheimer’s treatments sell for much less. A year’s supply of Aricept costs less than $8,000; Exelon, a drug in the same family, costs about $8,800 a year; and Namenda costs less than $3,000 per year.

The report provides recommendations that the FDA should follow to “help restore the confidence of the American people,” as well as steps that Biogen and other drug companies should take to “fulfill their responsibilities to patients and their families.” Since the recommendations leave the FDA and companies to change their policies, it is unclear whether they will actually prevent future episodes like this from happening.

The committees recommended that the FDA document all of its communications with drug sponsors, establish a system for partnering with companies to produce reports used to brief its own advisory committees, and update its formal guidelines for developing and reviewing the new Alzheimer’s drug.

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Drug partners, the committee recommended, should be open and clear in spelling out from the FDA any concerns about the safety and effectiveness of treatment, as well as consider opinions from outside experts when setting prices for new drugs.

Aduhelm, a lab-made protein that is administered directly into a patient’s vein, is said to work by reducing a sticky substance in the brain called beta amyloid, which clumps between neurons and disrupts their function. Some scientists have theorized that the accumulation of beta amyloid in the brain causes Alzheimer’s disease.

In September 2015, Biogen began enrolling patients in two Phase 3 clinical trials, which test the safety and effectiveness of a drug and compare it to standard treatments. Three and a half years later, in March 2019, the company announced that it had ended both trials after receiving an independent report concluding that the treatment was unlikely to slow down memory loss, confusion and other symptoms of brain impairment. caused by Alzheimer’s disease.

But the drug’s death was short-lived.

The report shows that two months after the trials stopped, representatives from Biogen and the FDA met at a neurology conference in Philadelphia and discussed the results of the studies. The FDA official suggested that the agency and company plan a special meeting to discuss the data from the trials.

FDA documents reviewed in the new report show that Biogen has begun informal talks with the agency to review whether data from the unfinished trial revealed some benefit to patients. A meeting between the FDA and Biogen in mid-June 2019 led to both agreeing to form a “working group” together.

The collaboration would lead to the FDA and Biogen advancing on the drug, even if employees of the agency and the company expressed reservations about some of the decisions made.

For example, the FDA granted accelerated approval to Aduhelm despite not having the support of a single member of its own advisory committee, and without putting the idea up for discussion by any internal or external body.

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In addition, the FDA’s approval contradicted its own guidelines on the treatment of early Alzheimer’s disease, which said that there is “no sufficiently reliable evidence” that a drug’s effect on beta amyloid alone would be sufficient to benefit patients. Scientists have expressed conflicting opinions about whether beta amyloid is a cause of Alzheimer’s or simply a consequence of the disease.

The report also found that a team of Biogen employees examined the financial impact the initial cost of Aduhelm would have on patients and concluded that “more than 65 percent of the country’s population will face challenges and [their] ability to pay.” The team estimated that two-thirds of Medicare patients at risk of developing Alzheimer’s would have to pay some of these costs themselves, even though more than half have incomes of less than $50,000 a year and more than one-third have assets worth less than $5,000.

Although the report found that the company “appears to have developed financial assistance programs for eligible patients,” the investigators wrote that “these programs would leave significant gaps in coverage.”

Despite the expected hardship the price would impose on patients, Biogen expects to spend “between $500 million and $600 million to build its sales force” in the drug market, the report said.

Five months after the drug hit the market, the Centers for Medicare and Medicaid Services announced that monthly premiums for Medicare Part B would increase by 14.5 percent in 2022, half of that in anticipation of higher costs due to new Alzheimer’s treatments. .

The rate increase translated into a $21.60 increase in monthly premiums for Medicare Part B beneficiaries, “reportedly the largest dollar increase in the program’s history,” the report said.

For its part, Biogen went ahead with a broad label that Aduhelm was for “people with Alzheimer’s disease,” despite reservations from employees about the lack of evidence of clinical benefit for patients in more advanced stages of the disease than those involved in the clinic. trial Some inside the company even expressed concern that pushing forward with the label plan “could damage the company’s credibility,” the report said.

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