The Spark

the Voice of
The Communist League of Revolutionary Workers–Internationalist

“The emancipation of the working class will only be achieved by the working class itself.”
— Karl Marx

FDA Approved Ineffective Alzheimer’s Drug

Jun 21, 2021

The U.S. Food and Drug Administration (FDA) gave “accelerated approval” to a new drug for the treatment of Alzheimer’s disease, called Aduhelm. The approval was harshly criticized by scientists and others familiar with the evidence from the clinical trials of the drug.

Three members of an advisory board to the FDA who opposed the approval quit in protest. The watchdog group Public Citizen called the approval reckless and for top FDA officials to resign.

Two Phase 3 trials of the drug were ended when a review found that if they were continued they were unlikely to show that the drug benefitted Alzheimer’s patients. One study found no benefit, and the other found the drug “maybe,” might have, some small benefit at a high dosage.

So why did the FDA approve the drug? They say the drug satisfied a “surrogate endpoint” because it reduced the levels of “amyloid” in patients. Amyloid plaques are believed to interfere with transmission of nerve signals in the brains of Alzheimer’s patients. However, reduction of amyloid has not been shown to stop the progression of Alzheimer’s disease in people with the disease.

The real reason for the approval is that the drug’s manufacturer, biotech giant Biogen, “collaborated closely” with the FDA. Biogen charges $56,000 per year for each patient receiving the drug. Because Alzheimer’s is primarily a disease affecting senior citizens, Medicare will likely bear most of the costs of treatment with Aduhelm. That means Medicare would pay 57 billion dollars a year to Biogen if 1 million Alzheimer’s patients receive the drug! The FDA’s approval of a broad label for the treatment for patients “in the earliest stages” of the disease means as many as 6 million people with Alzheimer’s could be eligible to receive it.

As Public Citizen pointed out, the FDA’s approval will encourage false hopes in Alzheimer’s patients and their families desperate to stop the progression of a horrible, debilitating disease. Patients without insurance to supplement Medicare would each pay $11,000 a year for the treatment as well, which will likely lead more patients and their families to pile up debts. All for a drug with no proven benefit.