The Food and Drug Administration finally got it right. The FDA and other government agencies involved in healthcare have had their share of failures in the last year or more, but now there’s hope for Americans suffering with Alzheimer’s disease.
In an earlier post, Risk v. Benefits in Drug Treatments, I criticized the FDA for dragging their heels on approving Biogen’s new Alzheimer’s treatment drug, aducanumab. Now the FDA has approved the drug, the first treatment shown to slow cognitive decline, giving hope to millions. I doubt my post had anything to do with this change, but credit FDA Acting Commissioner Janet Woodcock for resisting the pressure from those on the left who have campaigned against the drug.
The Wall Street Journal editorial board says aducanumab’s twisted path to approval illustrates the challenges of drug development. Hundreds of experimental Alzheimer’s treatments have failed in clinical trials over decades. While some approved drugs can temporarily mitigate behavioral and cognitive symptoms, none before aducanumab had shown an impact on disease progression.
The cause of Alzheimer’s is still elusive but its hallmark is amyloid plaques and tau tangles in the brain, which usually begins long before symptoms become apparent. Many scientists believe removing amyloid could slow disease progression. This is how aducanumab works, by clearing amyloid. A high dose of the drug in a late-stage trial removed 71% of the amyloid buildup after 18 months.
Earlier trials of aducanumab failed, but post-trial analysis suggested the termination of the trials was premature. Significant benefits were discovered when higher doses were used. The higher doses were also needed for a longer time than initially tried.
The FDA worked with Biogen to analyze the data, which the FDA described as “exceptionally persuasive.” But an outside advisory panel disagreed, though none of its members actively treated Alzheimer’s patients. The panel accused Biogen of massaging the data. Activists on the left attacked the FDA for collaborating with Biogen. They claimed the FDA would be lowering its standards and compromising its objectivity if it approved the drug.
Perhaps this opposition from the left was related to TDS – Trump Derangement Syndrome. President Trump’s Operation Warp Speed made possible the development of three Covid vaccines in less than a year by encouraging collaboration between the FDA and pharmaceutical companies. Give credit to the Biden administration’s FDA for ignoring those on the left who would try to stifle this game-changing new drug development.
The WSJ editorial board says many of the critics seem to object to the cost more than the effectiveness. New blood tests can identify the disease years before signs of cognitive decline, so the potential patient pool may soon expand. But with Alzheimer’s costs in the U.S. estimated at $277 billion a year, a drug that can mitigate this horrible disease is well worth the investment.
