The Aduhelm lawsuits claim that Alzheimer’s patients who took Aduhelm were susceptible to a known side-effect of the drug (amyloid-related imaging abnormality-edema (ARIA-E) or swelling of the brain) that could result in death.
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What Do We Know About Aduhelm ARIA-E Lawsuits?
A 75-year-old Canadian woman died after taking the Alzheimer’s disease treatment medication Aduhelm, according to the Food & Drug Administration (FDA)’s quarterly adverse event reporting dashboard. When the woman was hospitalized, she was diagnosed with swelling in the brain, or amyloid-related imaging abnormality-edema (ARIA-E), which is a known side effect of Aduhelm. ARIA-E is believed to be the cause of her death, according to The Hill
The FDA Adverse Event Reporting System (FAERS) also revealed other instances of ARIA-E in Alzheimer’s patients who had taken Aduhelm. One event involves a clinical trial case report of a 79-year-old female patient who had enrolled in the study and suffered from seizures, ARIA-E, and amyloid-related imaging abnormality-hemorrhage (ARIA-H). The woman was taken to the emergency room after suffering dizziness and an inability to speak. The investigator who reviewed the patient’s MRI connected the woman’s condition to her having received five doses of the Aduhelm.
Aduhelm also goes by the name aducanumab. The FDA fast-tracked approval of Aduhelm for the treatment of Alzheimer’s in June 2021 amidst criticism from critics who deemed the approval too hasty. Alzheimer’s expert and neurologist David Knopman of the Mayo Clinic remarked, "The evidence shows [aducanumab] will offer improvement to none, it will harm some of those exposed, and it will consume enormous resources."
Knopman was not alone in his concerns about the drug. Ten members of an 11-member FDA advisory panel voted against the drug’s approval. Aaron Kesselheim of Harvard Medical School called the approval "probably the worst drug approval decision in recent U.S. history." Both he and Knopman resigned after the FDA approved Aduhelm.
Main Legal Issues Involving Aduhelm
The primary legal issue is whether Biogen, manufacturer of Aduhelm, failed to adequately warn doctors and patients about the increased risk of potentially fatal brain swelling (ARIA-E) caused by Aduhelm (aducanumab).
Adding insult to injury, the drug was priced at $56,000 a year, despite calculations from the Institute for Clinical and Economic Review revealing that a proper price for the drug would be between $3,000 and $8,400 a year.
With allegedly excessive pricing and a deficit of evidence supporting the drug’s effectiveness, concerns about the implications on Medicare and the healthcare system at large grew.
On November 15, 2021, the LA Times reported that Medicare’s newly announced 2022 premium increase resulted in large part from the projected cost of Aduhelm.
The nonpartisan Kaiser Family Foundation reported that with a conservative estimate of 500,000 Medicare members being placed on Aduhelm, total spending for the drug in a single year would reach $29 billion.
Aduhelm Injuries & Side Effects
Biogen (the manufacturer of Aduhelm) reports that ARIA-E is the most common adverse event connected with taking Aduhelm, with 35 percent of patients developing the condition in the two late-stage clinical trials. Clinical studies showed various levels of ARIA-E—mild, moderate, and severe—in patients who were administered Aduhelm.
Forty-one percent of patients who took a planned dose of 10mg developed ARIA-E or ARIA-H. This compares to 10 percent who developed this condition after taking a placebo.
The Aduhelm website further reveals the radiographic severity of reported ARIA events as follows:
- 10%: Mild
- 58%: Moderate
- 13%: Severe
Clinical trials of Aduhelm showed that around 30 percent of patients who received high doses of the drug suffered from brain swelling. Patients who have not experienced this side effect still suffer in having to monitor their own health with regular MRI tests to keep tabs on similar developments in their brains.
The Timeline Important to the Aduhelm ARIA-E Lawsuits
March 2019: Biogen abruptly ends two late-stage trials for aducanumab, and the company’s market value drops by billions of dollars. The company stopped trials when analysis suggested the drug would not be effective.
Oct. 22, 2019: Biogen announces it will seek regulatory approval for aducanumab—and shares enjoy a spike of more than 26 percent.
Nov. 4, 2020: Preceding review by an outside panel of experts, a group of FDA reviewers appears to provide a major endorsement of aducanumab, suggesting its belief that the Alzheimer’s drug is sufficiently safe and effective.
Nov. 6, 2020: An outside panel of experts votes 10-1 against the FDA's approval of aducanumab. Members of the panel indicated that the clinical trials data did not sufficiently show that the drug was effective in slowing cognitive decline.
June 7, 2021: Aducanumab gets FDA approval, with no restrictions on which types of Alzheimer’s patients can be administered the intravenous drug. More than six million patients are eligible to receive the drug, with Biogen has now branded as Aduhelm.
June 7, 2021: Biogen and Eisai (a development partner) announce they have entered a contract with Cigna to track performance and patient outcomes with Aduhelm. The companies also speak of cognitive screenings to be offered at CVS Health in major cities.
June 8, 2021: Biogen decides to price Aduhelm at $56,000 per year, meaning beneficiaries might pay as much as $11,5000 annually in coinsurance for the drug, according to Kaiser Family Foundation estimates.
June 9-11, 2021: The following members of the FDA’s advisory panel resign after the agency approved Aduhelm despite the panel’s vote against the approval: Joel Perlmutter, MD, neurologist; David Knopman, MD, a clinical neurologist from Mayo Clinic; and Aaron Kesselheim, MD.
June 16, 2021: Butler Hospital in Providence, R.I. administers Aduhelm to a patient outside of a clinical trial, the first hospital to do so.
June 16, 2021: Washington, D.C.-based consumer advocacy group Public Citizen pens a letter to HHS Secretary Xavier Becerra requesting that he remove the FDA's acting commissioner Janet Woodcock, MD; Patrizia Cavazzoni, MD, director of the agency's Center for Drug Evaluation and Research; and Billy Dunn, MD, director of the Center for Drug Evaluation and Research's office of neuroscience, after they approved Aduhelm.
June 16, 2021: Altrarum, a research nonprofit, releases a report stating that Aduhelm could represent one percent of U.S. healthcare expenditures by the mid-2020s.
July 9, 2021: FDA head requests investigation into FDA’s Aduhelm approval.
November 9, 2021: FDA’s FAERS reveals that a Canadian Alzheimer’s patient died after being diagnosed with ARIA after taking Aduhelm.
November 24, 2021: FDA launches investigation into death of a 75-year-old Canadian patient who died while participating in the Aduhelm clinical trial.
What Is the Purpose of Aduhelm?
Aduhelm is a drug designed to treat Alzheimer’s disease, a progressive brain disease that affects over 9 million people (11.3 percent), according to the National Institute on Aging’s Aging, Demographics, and Memory Study (ADAMS)
Aduhelm represents the first new FDA-approved Alzheimer’s disease treatment in 18 years. The FDA approved the drug under the agency’s accelerated approval pathway. Biogen has nine years to finish clinical studies, according to The Hill
What Aduhelm is designed to do
Aduhelm is not a cure for Alzheimer’s disease. It was designed as a treatment.
The FDA acknowledges that the drug has not shown it can actually slow progression of Alzheimer’s in patients, but the agency voiced its appreciation for the drug’s novel approach in addressing the "underlying pathophysiology" of Alzheimer’s and gave Aduhelm makers conditional approval, with time to provide data showing the drug’s effectiveness in this capacity.
According to the Aduhelm website, the drug "binds to and induces removal of aggregated forms of certain plaques in the brain that are characteristic of patients with Alzheimer’s disease." According to the FDA, the removal of this plaque—clumps of amyloid proteins that form in Alzheimer’s patients—makes it "reasonably likely" that the drug might slow cognitive decline.
As one Seeking Alpha writer and Alzheimer’s expert wrote, the FDA first decided that amyloid plaques cause Alzheimer’s, then reasoned that a drug that removes these plaques should put the brakes on the disease in a clinically significant way. However, Alzheimer’s disease experts say only a low correlation exists between these plaques and cognitive decline.
The Aduhelm website says the drug is indicated for treatment of the disease in patients who suffer only from mild dementia or mild cognitive impairment stage of Alzheimer’s.
The Alzheimer’s Association’s 2021 report outlined various drugs available for treating Alzheimer’s dementia. Of the four treatments in use when the report was written, none had worked to stop or slow neuron damage and destruction—which is what causes Alzheimer’s symptoms and makes the condition fatal.
Three of the drugs—rivastigmine, galantamine, and donepezil— succeed temporarily in improving cognitive symptoms in Alzheimer’s patients by boosting the number of neurotransmitters in the brain. Memantine, however, tackles symptoms by protecting brain receptors from excessive, nerve-cell damaging stimulation. None of the drugs showed consistent effectiveness across patient populations.
As of the report’s writing, aducanumab was still under FDA review for approval. Although the drug showed promise for slowing the progress of Alzheimer’s, it had been tested only in patients with early dementia or MCI.
Aduhelm ARIA-E Lawsuit News
Biogen investigating death of patient taking Alzheimer's drug
The death of the 75-year-old woman in Canada was reported and published in the Food and Drug Administration's (FDA) quarterly adverse event reporting dashboard. The patient was hospitalized after taking Aduhelm and was diagnosed with swelling in the brain before dying. Read more at The Hill
Biogen probes death of Aduhelm user after brain swelling
Biogen Inc said on Tuesday it was investigating the death of a 75-year-old patient who had taken the company's newly approved Alzheimer's drug, Aduhelm, adding that it was not yet known whether it was related to the treatment. Read more at Reuters
Retired neurologist with Alzheimer’s knows firsthand the risks of Biogen’s new drug
Much of the controversy surrounding the medication, called Aduhelm, has centered on conflicting trial data about whether it slows cognitive decline, its $56,000 annual cost, and the unusual process that led to its June approval. But for all the attention focused on the disputed benefits of the Cambridge biotechnology firm’s medicine, Gibbs says an important aspect of Aduhelm has been downplayed ― its risks. Read more at Boston Globe
Panel of neuroscience experts lays out the complications with using Biogen's new Alzheimer's drug
One of the biggest issues with aducanumab is that it substantially increases the rate of amyloid-related imaging abnormalities, also known as ARIA, compared to rates observed in natural history studies or trial placebo groups. And while ARIA only led to about 6% of patients on aducanumab stopping their involvement short in the trials, compared to 0.6% of patients on placebo, ARIA (ARIA-E and ARIA-H) occurred in about 35% of patients on the high dose of aducanumab compared to about 3% of those in the placebo group, the panelists note. Read more at Endpoints News
Third member of FDA advisory panel resigns over Alzheimer's drug approval
A third member of a Food and Drug Administration (FDA) expert advisory panel has resigned over the agency's controversial approval of an Alzheimer's drug this week. In a resignation letter sent to acting FDA Commissioner Janet Woodcock on Thursday and shared with The Hill, Aaron Kesselheim, a professor of medicine at Harvard Medical School, said the approval of Biogen's Alzehimer's drug "was probably the worst drug approval decision in recent U.S. history.” Read more at The Hill
FDA & Scientific Studies Regarding Aduhelm ARIA-E
The Effect of 6 Months’ Dosing on the Rate of Amyloid-Related Imaging Abnormalities (ARIA) in the Marguerite Road Study
This study concluded that a six-month dosing at 105 mg gantenerumab prior to escalating to 225 mg resulted in an overall ARIA rate of 10.8 percent in study subjects. Read more at Alzheimer's Association International Conference
Spontaneous ARIA-Like Events in Cerebral Amyloid Angiopathy-Related Inflammation
This study underscores the importance of identifying ARIA-like events in the population of Alzheimer’s disease patients, especially in light of the potential ARIA side effects associated with aducanumab. Read more at Journal of Neurology
Amyloid-Related Imaging Abnormalities-Haemosiderin (ARIA-H) in Patients With Alzheimer’s Disease Treated With Bapineuzumab: A Historical, Prospective Secondary Analysis
This research paper addresses the reportedly increased incidence of ARIA-H in individuals receiving drug treatments that aim to lower amyloid plaque in patients. Read more at J Neurol Neurosurg Psychiatry
MR Imaging Features of Amyloid-Related Imaging Abnormalities
This paper reveals results of MR scans of 201 patients receiving an anti-amyloid treatment. Thirty-six of the participants were identified as having ARIA-E, while 26 of the subjects had ARIA-H. The authors suggest that familiarity with these outcomes should help the medical community better manage patients receiving this type of treatment. Read more at Am J Neuroradiol