Home » Health » Aduhelm, the controversial Alzheimer’s drug that could cost half the US defense budget

Aduhelm, the controversial Alzheimer’s drug that could cost half the US defense budget

The US Food and Drug Administration (FDA) granted accelerated approval in early June for a new drug for the treatment of alzheimer, developed by the biotech company Biogen. But what makes millions of Americans hopeful has sparked a lot of controversy.

By giving the drug Aduhelm the green light, the FDA has launched a treatment against . for the first time since 2003 Alzheimer’s disease approved. A milestone, given the lack of effective treatments for the degenerative disease. Alzheimer’s is the leading cause of dementia and the sixth leading cause of death in the United States.

But since the FDA gave its approval, many critics have spoken out. Patients and their relatives, as well as scientists, are opposed to the drug. According to them, the effectiveness of the drug has not been proven in clinical trials and therefore it was approved too quickly. The studies would not have yielded the expected results and the few encouraging signs were only seen in patients with a mild form of the disease.

Failed clinical studies?

Adulhem – or ‘aducanumab’ as its scientific name goes – was investigated in two large trials led by Biogen. These were discontinued in 2019 after the publication of an independent interim study that concluded that the drug did not work. But Biogen went back to the data from the two previous trials anyway. One of those studies found that the drug slowed patients’ cognitive decline somewhat. But that would be insufficient, according to opponents, especially since it does not necessarily imply a cure for memory problems.

Critics have also warned of the potentially very serious side effects of Aduhelm – brain swelling and cerebral haemorrhage – which would make the benefit-risk balance clearly negative.

In addition, an FDA advisory committee had initially advised not to give Biogen the green light. This advice was ultimately rejected by the FDA’s decision makers, who argued that such accelerated approval was intended to “allow patients with early-stage serious disease to access potentially valuable treatments that promise a medical benefit, despite remaining uncertainties about the benefits.” ”.

Three members of the advisory committee resigned in early June in protest. And a watchdog has called for the resignation of three senior FDA officials who were behind the approval.

Insane price

In addition to these scientific concerns, there is also a financial argument for recalling Aduhelm. Biogen plans to charge as much as $56,000 per person per year for treatment. That large expense falls on the shoulders of Medicare, the American insurance program for people over 65 or people who meet certain criteria.

A recent analysis by the Kaiser Family Foundation found that if just a quarter of the 2 million Medicare beneficiaries currently receiving Alzheimer’s treatment—about 500,000 patients—were to use Aduhelm, it would cost Medicare about $29 billion a year. In comparison, Medicare spent a total of $37 billion in 2019 on all prescription drugs.

Stat, a website specialized in the biotech and pharmaceutical sector, also made a calculation last Monday. If all 5.8 million adult Alzheimer’s patients started taking Aduhelm through Medicare, it could cost Medicare $334.5 billion a year. That’s nearly half of the US defense budget.

The role of politics

Last week, the case took a political turn. Democratic Senator Elizabeth Warren and Republican Senator Bill Cassidy called for a hearing to examine “the new and troubling questions and challenges” to Medicare that Aduhelm’s approval raises.

Shortly thereafter, the House Oversight and Reform Committee announced it would investigate Aduhelm’s approval and cost. “We are deeply concerned about the high price of Aduhelm and the process that led to its approval, despite questions about the drug’s clinical benefits,” said Democrats Carolyn Maloney and Frank Pallone Jr., who lead the study. in a joint statement.

So far, neither the FDA nor Biogen has bowed. The FDA has reaffirmed its approval, and Biogen called the award “justified by the value the drug is expected to provide to patients, healthcare providers and society.”

Leave a Comment

This site uses Akismet to reduce spam. Learn how your comment data is processed.