Biogen Inc. in Eisai Co. this week joined the types of ruined companies that devoted years to expensive experimental treatments that were not useful. Now, many scientists and drug developers are wondering whether it may be time to look for another way of treating a memory-threatening illness.
The brain was a black box for drug researchers, but focusing on beta amyloid protein for a long time seemed to be the biggest hope of treating a mysterious disease that affects millions of Americans and their families. For many, the hypothesis has become an article of faith, which has led to the consumption of billions of dollars in research and clinical trials with thousands of patients.
"It's no longer science," he said. George Perry, a professor of biology at the University of Texas at San Antonio, who was very critical of the theory of beta amyloid. "It became a religion."
Alzheimer's disease: everything you need to know about this disease
Biogen and Eisai will break two advanced tests designed to assess the efficacy and safety of adukanumab, which has cost more than $ 830 million over the past three years. The results showed that it is unlikely that the medicine would help patients, the companies said in the statement, and the interruption was not related to safety reasons. The companies said they would continue to participate in other treatments for Alzheimer's disease.
Beta amyloid is a protein present in the brain that accumulates in the plaque in the case of people with Alzheimer's disease. Pharmaceutical companies have worked with the idea that the reduction in beta amyloid with drugs can prevent the disease. However, it is not yet known whether the protein is the cause of Alzheimer's disease or if it is just a neurological memory of the already caused damage.
The latest failure following similar experimental medicines Merck & Co., Eli Lilly & Co. and Pfizer Inc. in extensive tests, he urged scientists to question whether insistence on protein targeting hampered the investment. in drug tests against other possible causes of Alzheimer's disease.
Every time a drug that targets an amyloid fails, the theory adjusts, Perry said. His advocates argue that the unsuccessful drug has not shown the true form of amyloid or has not been tested in patients with an early stage disease.
"We do not have excuses" to explain why beta-amyloid-focused treatment does not work, said Zaven Khachaturian, editor of the Alzheimer & Dementia Medical Journal. The field has become so concentrated in the amyloid that it is difficult to change it, he said, but pharmaceutical companies "continue to try in the hope that the path they will follow will create successful drugs".
It has never been established that the cause is amyloid, he says Murali Doraiswamy, a specialist in Alzheimer's Health at the University of Duke. He added that the field must be regrouped. "We need to re-evaluate existing evidence in the light of new information."