Biogen’s controversial Alzheimer’s drug is linked to patient deaths, just as the company presented its last study data
To say that Biogen’s controversial drug aduhelm would not do the hard work of ratifying justice. To say it’s complicated is even less satisfying, since the studies that led to its approval have been started, stopped, and restarted. Added to this were reports of questionable meetings between pharmaceutical company scientists from Biogen and Food and Drug Administration (FDA) officials, leading to a joint investigation. FDA’s guidelines for drug approval, and it is conceivable that the drug is supposed to change the way Alzheimer’s disease occurs. Treatment has not exactly taken the patient and the medical community by storm.
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And at least one death potentially linked to aduhelm, according to the FDA’s database of adverse drug events, involves a known side effect of the drug, swelling and bleeding in the brain.
The drug’s approval in June was immediately questioned by many in the medical community, partly because of the problematic relationship between Biogen and FDA officials but also because of the many doctors who treated patients. Alzheimer’s felt that the complex data did not provide convincing evidence that the drug could actually improve. patients with impaired mental function. There is no doubt that aduhlem can reduce levels of amyloid plaques, a sticky protein that builds up in a patient’s brain, damages brain neurons and is thought to affect reasoning, intelligence, and reasoning. memory and other higher-level cognitive functions. What’s less clear is whether that reduction translates into clinical benefit, in the form of patient scores on tests of mental skills. Even so, the FDA has approved the drug as a first-line drug to treat the underlying causes of the disease.
What does the new Biogen data show
At the 2021 Clinical Treatment for Alzheimer’s conference in Boston, Biogen hopes to clear the air. The company presented its final report on key studies examining the effectiveness of aduhelm – the people behind the drug’s approval – in people with mild cognitive impairment or mild Alzheimer’s dementia. The main difference from previous reports is the new finding that aduhelm also reduces levels of another protein, tau, which tends to accumulate and affect neurological function later in Alzheimer’s disease. Protein levels in participants taking aduhelm decreased by 13-16% since the start of the study, compared with an 8-9% increase in those taking a placebo. Tau’s findings are further evidence that the drug may help slow the progression of Alzheimer’s disease, the company said.
The data were taken from 1,800 people who participated in the aduhelm trial until they briefly paused in 2019, and then returned to the drug in a new study when the trials were continued for about a year. half later. Due to the nature of the way patients were enrolled in this new study, the trial was not placebo-controlled and may represent a biased population that is motivated to continue using the drug. In fact, the data shows that people who perform better on cognitive tests tend to go back to taking the drug after that time period. However, the researchers hope these patients can help them understand the impact that stopping and then restarting the drug can affect amyloid formation and disease progression.
Read more: Biogen explains how its Alzheimer’s drug went from poor to promising
Overall, the data show that the dosing interval does not appear to adversely affect patients; Any decline in amyloid levels, as measured by brain imaging for amyloid, achieved during the initial study was maintained until the study initiation was restarted. That’s encouraging, and the ongoing study, which will follow the participants for two years, will continue to assess whether that level of amyloid continues to drop – and more importantly, whether this Does that have any effect on improving brain function?
Will the new findings settle the aduhelm controversy?
Biogen officials hope that, taken together, the tau findings and evidence that the flaw in the drug isn’t causing harm, will make more doctors and patients more comfortable trying an over-the-counter drug. as quickly as they expected. Doctors are mostly hesitant because they don’t yet believe that the reduction in amyloid in the brain will translate into improvements in scores on cognitive tests. Brain specialists are also concerned about aduhelm-related side effects: encephalitis is treatable if caught early through regular CT scans, but left untreated can lead to bleeding. dangerous brain and even death.
It didn’t help that when Biogen scientists realized that their drug had some potential benefits, they met with FDA officials at a conference to discuss next steps, which some critics say. deemed unsuitable. The company says it relies on the drug and process integrity for which it was approved. However, the controversy prompted acting FDA director Dr. Janet Woodcock to launch an internal investigation to ensure that no regulatory processes were disrupted.
Currently, only about 100 patients are taking the drug, according to STAT. Citing uncertain benefits to patients, doctors at the Cleveland Clinic and Mount Sinai decided not to administer the drug to the patient; if the patient wants aduhelm, they need to go elsewhere for the infusion. The Alzheimer’s Association, which backs the FDA’s approval of the drug as a key option for patients, still questioned the drug’s price, which is about $56,000 a year. “We strongly disagree with Biogen’s pricing decision and we have made that clear,” said Harry Johns, president and chief executive officer of the Alzheimer’s Association. The Centers for Medicare and Medicaid Services is currently looking into whether aduhelm is covered; Its decisions often set the standard for other insurers. If CMS decides not to cover the drug, that may discourage other drug makers from pursuing anti-amyloid treatments for Alzheimer’s disease.
For patients, that would be a step back, Johns said. “For us, this has always been about opening the door to treatments. As the first treatment approved to treat Alzheimer’s disease, [aduhelm] There’s a long way to go, but we’ll never advocate for any treatment unless it works scientifically. And we believe so. ”
Read more: Clinic will not provide. Insurance companies will not cover. So will the first Alzheimer’s drug make a difference?
At the Mayo Clinic, doctors have not treated anyone with aduhelm, but formed a review panel of about half a dozen experts, including neurologists and radiologists, to evaluate each case. before prescribing the drug, to make sure that the patient has a good chance. benefit without the serious inflammatory side effects. Dr Ron Petersen, director of the Alzheimer’s Disease Research Center at Mayo, says the new data on tau probably won’t change people’s perception of the drug — it’s essential, he notes, that more people get informed. more valuable so that scientists can get a better picture of its actual effects on people. “The drug does what it’s supposed to do biologically,” he said. “But will it have a major clinical impact? I think there’s a clinical effect, but I don’t think it’s huge.”
Petersen also points out that the Biogen studies only followed patients for a few years, while amyloid accumulation can take years, if not decades. And that for many patients, it’s unrealistic to expect any change in their condition in such a short amount of time. “The reality is that amyloid is misprocessed and deposited in the brain for years, and possibly decades, so the idea is to get rid of it in 12 to 18 months and expect clinical impact,” he said. probably quite ambitious,” he said. “We are not looking for clinical improvement here. We are just asking to stabilize their condition. ”
Aduhelm’s approval has opened the door for other companies, including Eli Lilly and Roche, to reconsider their similarly active drugs chewable amyloid. It is possible that the class of anti-amyloid drugs, which aduhelm leads, will become a new option for Alzheimer’s patients — at least after the growing pains of the first drug have resolved. And while the FDA is investigating the conditions surrounding the drug’s approval, a final report isn’t expected until 2023, and for patients eager to try the drug in the hope of preventing it. block their disease, it’s too long to wait.
