In June, the U.S. Food and Drug Administration approved the Alzheimer’s disease drug aducanumab, marketed under the brand name Aduhelm. The company behind it, Biogen, had said clinical trials showed the drug slowed cognitive decline in some patients. But some doctors have refused to prescribe it, and members of Congress are investigating its approval.
George Perry is the Semmes Foundation distinguished university chair in neurobiology at the University of Texas at San Antonio. He told Texas Standard that aducanumab consists of antibodies that are infused into the bloodstream of an Alzheimer’s patient each month. It reduces amyloid deposits in the brain that experts believe cause Alzheimer’s disease.
“It removes most of the amyloid from the brain,” he said.
The study that led to aducanumab’s approval followed 3,000 patients who were treated with it, as well as a control group that received a placebo. Perry says a large number of the patients who received the drug didn’t benefit, while around 20% did experience less cognitive decline.
“None of the patients got better, but they declined a little bit more slowly, although this was after considerable statistical manipulation,” Perry said.
The Biogen clinical trial was initially suspended because a monitoring group found that the study results would not be of value. But then the FDA got involved, Perry says, suggesting a different way of analyzing that data that might show a benefit to patients. That change in analysis turned up the 20% reduction in the rate of patient decline.
“If you look at the raw data, you see really no benefit,” he said.
Perry says the FDA should not have approved the drug.
“They’re supposed to be independent, and they’re supposed to also judge drugs to be effective and safe,” Perry said. “This drug is neither; it has tremendous side effects.”
Patients in the study have experienced severe headaches and cerebral bleeding, he says.
“And that was well-controlled in the study because patients were carefully monitored,” he said. “Whether that monitoring is possible in the community setting for patients throughout the United States and world is less clear.”
Monitoring those potential side effects would require MRI and other imaging that isn’t included in the already high cost of the drug.
Perry says other Alzheimer’s drugs don’t have serious side effects but also aren’t very effective.