Like most Americans, I have seen the devastating impact of Alzheimer’s up-close and personal. Unfortunately, the Viewpoint column by Jennifer Braisted offers false hope that legislation being considered by Congress will help Alzheimer’s patients.
The legislation, misnamed 21st Century Cures Act, would greatly benefit pharmaceutical company stockholders but would harm patients. That’s because it encourages the Food and Drug Administration to approve new Alzheimer’s drugs based on preliminary research, rather than solid scientific proof of safety and effectiveness.
Our research center examined all Alzheimer’s drugs developed in recent years that would have been approved under the proposed lower standards. We found three. All were praised in national newspapers as almost miraculous treatments, based on preliminary (Phase 2) studies: Semagacestat, Bapineuzumab and Dimebon.
Fortunately, since the FDA currently requires more conclusive evidence, better-designed studies were conducted. They found that none of the drugs worked. One drug actually made Alzheimer’s symptoms worse and also had a dangerous side effect: An additional 10 percent of patients developed skin cancer.
More than 5 million Americans have Alzheimer’s. Had any of these three drugs been approved, a very conservative estimate is that 250,000 patients would take them every year. This would have harmed patients while costing taxpayers billions of dollars.
We need new Alzheimer’s drugs, but we can’t assume new drugs are cures unless they are proven effective and safe. Alzheimer’s patients should not be unwitting guinea pigs, paying for new drugs that don’t work and may harm them instead.
Diana Zuckerman, Washington
The writer is the president of the National Center for Health Research.
See original letter here.