The New York Times' recent Op-Ed ("A Cancer Treatment in Your Medicine Cabinet?," May 19) highlights that—while it is possible that aspirin could benefit breast cancer patients—there have been no randomized trials testing this hypothesis because "no one stands to make money off aspirin." This same challenge faces patients with Alzheimer's disease.
Using drugs approved by the FDA for one condition to treat another is called "repurposing." This process saves money and time. Since the drugs have already been created and proven safe, the researchers can proceed directly to human clinical trials to test their effectiveness. Drugs already on the market today could benefit Alzheimer's patients, but the barriers to investment in the necessary clinical trials are considerable.
We can specifically address barriers to repurposing trials by:
- Increasing funding from government and foundations;
- Building innovative public-private partnerships for repurposing;
- Instituting changes in patent law related to repurposed drugs with new indications;
- Addressing roadblocks in the Food and Drug Administration (FDA) review and approval process; and
- Creating innovative royalty structures to provide financial incentives to justify the cost of testing old drugs for a new disease.
Effective treatments for diseases such as Alzheimer's may be locked in drugs already on the market. The opportunities clearly exist, but cannot be capitalized on until we address these challenges and ensure that the necessary clinical trials are expedited.
Howard Fillit, MD is the Founding Executive Director and Chief Science Officer at the ADDF.
Diana Shineman, PhD is the former Senior Director, Scientific Affairs at the ADDF.