Alzheimer’s Death Panels

 

What are “death panels?” The phrase came into popular use with the passage of the Affordable Care Act (ObamaCare) in 2010. One of the provisions of this healthcare legislation was the formation of a medical advisory board, called the Independent Payment Advisory Board (IPAB). IPAB was to be composed of 15 individuals appointed by the President who will be given significant power to cut Medicare spending in the future if there are cost over-runs. In other words, this advisory board would have the power to ration care if they thought it was too costly.

It was former Governor of Alaska and Vice-Presidential candidate Sarah Palin who first referred to this IPAB as a “death panel.” She meant that the decisions of this board could amount to a death sentence if life-saving or prolonging treatments were denied to seniors because they were deemed to be too expensive. This concept of rationing care “for the good of the whole” is a common feature of socialized medicine systems.

While the IPAB was never actually formed, as the ObamaCare legislation planned, the concept of rationing care based on the perceived value to society, rather than the individual, has not died. It is rearing its ugly head once again in the debate over the treatment of Alzheimer’s disease.

In an earlier post called Alzheimer’s Hope Arrives I reported on the Food and Drug Administration (FDA) approval of a new treatment of Alzheimer’s disease called aducanumab or Aduhelm. It is the first drug that has shown significant effectiveness in the removal of the amyloid plague buildup in the brain associated with the disease.

The approval of Aduhelm has been controversial. A randomized controlled clinical trial showed a high-dose of the treatment removed 71% of the amyloid plague buildup after 18 months and significantly slowed disease progression, as rated by care-givers and doctors. Another trial also showed amyloid clearance but failed to demonstrate a significant impact on disease progression.

The Wall Street Journal editorial board says the manufacturer, Biogen, then made a mistake by halting both trials early. But it later worked with the FDA on a post-hoc review to understand the discordant results. One major discrepancy: Patients in the second trial received less treatment. The longer patients in both trials received a high-dose of the drug, the less they deteriorated.

Critics of Aduhelm, largely on the public-health left, claim that the successful trial was likely a false positive since other experimental monoclonal antibody treatments have failed to show an effect on amyloid or disease progression. Some neurologists also believe clearing amyloid is ineffective because Alzheimer’s has other causes.

Despite these criticisms, Aduhelm is the first drug to show a meaningful effect on disease progression in early-stage patients. It has the potential to extend the time that patients can live independently and spend with their loved ones, while researchers work on other therapies that target different disease pathways. The costs associated with Alzheimer’s disease in the U.S. are estimated at $277 billion a year. You would think this alone would be a large incentive to pursue any treatments that might mitigate these costs, let alone relieve some of the suffering of these patients and their families.

Yet the critics have not let up even though the FDA approved the drug. They urged the FDA to require another large clinical trial before granting approval. When they lost this argument, they switched to obstructing payment of treatment by Medicare. They lobbied CMS – the Centers for Medicare and Medicaid Services – to restrict Medicare coverage. Although CMS has almost always covered FDA-approved drugs, they flinched with Aduhelm. Now CMS says Medicare will only pay for Aduhelm, and any future Alzheimer’s amyloid-targeting monoclonal treatments approved by the FDA, if patients enroll in a randomized controlled trial. In other words, CMS is overruling the FDA and doctors who may wish to prescribe these drugs to their patients.

There are other drugs in the development phase that also target amyloid. Three trials of other monoclonal treatments by Eli Lilly, Roche, and Biogen-Eisai have also shown positive results in early trials, some stronger than Aduhelm. But even though these drugs may obtain accelerated approval from the FDA, under CMS’s proposal, Medicare will only pay for them if patients enroll in duplicative trials in which they could be assigned a placebo, instead of the real drug.

Furthermore, it seems the CMS is also pushing for “wokeness” by saying, “the diversity of patients included in each trial must be representative of the national population diagnosed with AD.” WSJ says this is a bow to liberal criticism that the Aduhelm trials included too few blacks, who are twice as likely to develop dementia than whites. Yet these restrictions on trials will only further delay the approval of drugs that would disproportionately benefit blacks.

The real reason for the criticisms of these drugs is cost. Liberals warn Medicare spending will explode if seniors get access to Aduhelm, which costs $28,200 annually. WSJ says, “This is the real reason the Biden Administration wants to pre-emptively restrict Medicare coverage of all amyloid-targeting monoclonals. Progressives want to expand Medicare benefits to win senior votes, then ration treatments to contain government spending. Alzheimer’s drugs won’t be the last rationing target.”

Sounds like death panels by a different name.

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