And they suggested the change might be evidenced by today, when the U.S. Food and Drug Administration (FDA) seemed ready to approve aducanumab (Biogen) as the first new drug therapy to Alzheimer's patients in nearly 20 years.
Namely the emergence of taxpayer-funded government and nonprofit organizations as the primary drivers of research.
Alzheimer's is difficult and when a company is looking at a billion dollar expense to navigate the red tape of modern FDA approval, they have increasingly abdicated it to the government agencies that can spread the risk over 300 million people. A clinicaltrials.gov analysis and annual Alzheimer's pipeline reviews found that the number of Alzheimer's clinical trials supported by pharmaceutical companies has decreased over the past five years, while trials supported by federal government sources and public-private partnerships have increased. Pharma companies are still involved but through public-private partnerships, enabling them to distribute the cost and risk. And they largely engage only in late-stage (Phase 3) clinical trials.
COVID-19 may change that, of course. Both FDA and CDC were caught flat-footed when they learned that under the first 20 years of regulatory environment this century, a vaccine wouldn't get approved until 2026 - and would be no safer than if it were approved without 18 months negotiating the color of a font on the label.
Trials by academic medical centers are up 78% over the past five years, thanks primarily to government funding and some from the Alzheimer's Drug Discovery Foundation (ADDF).
Letting taxpayers take on more of the risk has meant the total number of agents in Alzheimer's clinical trials has been relatively steady over the last five years. The total is up slightly from 2020, driven by additional agents in Phase 2 studies. That has meant the National Institute on Aging spends 600 percent more than just a few years ago.
What does that mean for aducanumab (Biogen) for Alzheimer's patients? The private sector is not out of it yet. There were four drugs approved and commonly used to treat the symptoms of Alzheimer's dementia, plus a combination therapy that includes two of these drugs. There are currently no approved drugs that change the course or delay the progression of the disease or that delay or stop clinical decline. No new drugs had been approved for Alzheimer's since 2003.
With FDA being forced to turn into a 21st century regulatory body, it may mean that more companies will move back into spaces where the regulatory cost had previously made the expenses so high that only the largest could complete trials. This may mean that new small companies can compete again.