The Washington PostDemocracy Dies in Darkness

Opinion The debate over the FDA-approved Alzheimer’s drug showcases our system’s skewed priorities

The U.S. Food and Drug Administration issued accelerated approval for the experimental drug Aduhelm, for use in patients with early onset Alzheimer's disease. (David A White/Biogen/Handout/EPA-EFE/REX/Shutterstock)

The Food and Drug Administration’s first approval of a drug to treat Alzheimer’s since 2003 should be a cause for celebration. Alzheimer’s is a scourge of aging societies that already affects more than 6 million Americans. The disease strips patients of their memory and ability to manage even basic tasks of independent living, while burdening caretakers emotionally, financially and physically. Progress against this horror ought to be cheered.

But more than any potential gains against Alzheimer’s, this FDA approval — and the controversy it has sparked — underscores shortcomings in the U.S. health-care system, which too often prioritizes corporate financial interests over the needs of patients and taxpayers.

Let’s start with the conflict. Three members of an FDA advisory committee have resigned in the wake of the drug’s approval, to which outside advisers had previously objected. Supporters say the medication, called aducanumab, can slow cognitive deterioration in the early stages of Alzheimer’s. Critics say there is little evidence the drug is effective. (The treatment does not cure or reverse the disease.) Clinical studies are nebulous; the FDA, which green-lighted the medication under its program for accelerated approval, is requiring follow-up study.

The drug’s maker, the biotech giant Biogen, announced that it would charge $56,000 a year per patient for the treatment. An industry watchdog panel had forecast an $8,300 annual cost; not surprisingly, the news was a boon for Biogen shareholders, with the stock gaining 38 percent the day of the announcement.

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Because of the need for diagnostic tests and ongoing monitoring — potential side effects include brain swelling — costs are likely to run even higher.

Now, guess who will ultimately foot many of these immense bills. Most Americans living with Alzheimer’s are 65 or older. This means that Medicare is on tap to pick up the largest share of the drug’s expense, which could be as much as $50 billion annually, according to Bloomberg. Rachel Sachs, a Washington University associate law professor who studies regulatory efforts, warned that this could single-handedly triple annual expenditures on Medicare Part B, which pays for drugs administered intravenously in doctor’s offices as aducanumab would be. Such cost increases could threaten the program’s solvency. Private-insurance costs, too, could be affected if a wide array of people — such as seniors who suspect mild memory issues — seek the medication, not just the early-stage Alzheimer’s patients to whom it is targeted.

So what’s standing in the way of Biogen’s pricing plan becoming a taxpayer heist? Not much. The federal government has long been banned from negotiating Medicare drug prices. Whereas other countries don’t simply pick up whatever tab Big Pharma sends over, Americans pay multitudes more for prescription drugs — 256 percent more, according to a recent Rand Corporation study.

These excessive bills have simmered as a political issue. Despite the occasional high-profile, high-outrage congressional hearing, politicians haven’t mustered the will to effectively push back against pharmaceutical lobbying and address skyrocketing prescription-drug costs. Democrats, led by Sen. Ron Wyden (Ore.) — who called the cost of the new treatment “unconscionable” — are reportedly mounting a legislative effort, though other attempts have ended in failure. President Donald Trump promised much but delivered little. Legislation that House Speaker Nancy Pelosi (D-Calif.) pushed in this Congress and the last session appears moribund, done in by opposition from both Republicans and centrist Democrats. A series of bills by Sen. Bernie Sanders (I-Vt.) and Rep. Ro Khanna (D-Calif.) to allow Medicare to negotiate the cost of prescription drugs, as well as peg U.S. drug prices to the cost in other countries, are effectively aspirational.

Alzheimer’s is a terrible disease. If this treatment ultimately works as proponents hope, this outlay of funds would be understandable and valuable. Supporters of the new treatment hope that a big investment will spur other research that could yield benefits and, one day, a cure. But such outcomes are far from certain. Indeed, positive findings for early-stage patients emerged only after initial trials were halted due to poor results, and a division of the FDA worked with Biogen to reanalyze the data. (Do-gooder outfit Public Citizen complained about this relationship, which it termed “regulatory capture.”)

As important as it is to question the taxpayer bonanza that might be heading toward Biogen, there are other Alzheimer’s costs to consider. Patients and their families — including many unpaid caretakers — struggle here and now. Wait lists for home-based care are often long. Professional caregivers receive low wages, and turnover is high. President Biden’s infrastructure package contains $400 billion for home care of seniors and disabled Americans, but the proposal is stalling as Republicans reject the concept of human infrastructure.

Yet even this situation festers, our elected leaders are willing to pick up the multibillion-dollar tab for a drug that’s quite possibly ineffective for many who will take it. In the U.S. health-care system, patients’ interests chronically come behind the interests of big business.

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