Alzheimer’s Drug Poses Ethical Dilemma

A new study offers a faint glimmer of hope about drugs that can slow or reverse the progress of Alzheimer’s disease: In mice whose brains are blogged with the protein deposits that characterize Alzheimer’s, a drug called bexarotene substantially reversed key signs of dementia and reduced by half the telltale protein deposits of the disease.

The latest findings came just a few days after a pair of pharmaceutical giants announced they are abandoning further work on bapineuzumab, an immunotherapy for Alzheimer’s disease that proved disappointing in the late stages of human testing.

In contrast, bexarotene, known commercially as Targretin, is already on the U.S. market, approved by the Food and Drug Administration as a treatment for a form of non-Hodgkins lymphoma that affects the skin.

(Related: Planning for People with Alzheimer’s Disease: Part 1)

As a result a trio of bioethicists from the National Institutes of Health ask: What’s to stop a physician from prescribing bexarotene to an Alzheimer’s patient whose family believes it’s their loved one’s only hope?

Legally, the answer is: nothing. Because bexarotene is already legally available in the U.S., physicians are perfectly entitled to use their medical judgment and prescribe the drug “off-label” to their patients.

(Read more: Medicare Benefits Periods and Re-admittance)

Ethically, however, the team of bioethicists claims that the most recent study poses a difficult conundrum — as have similar situations where early evidence suggests an existing medication may help treat an incurable disease.

The latest study, and the accompanying perspective, were published Thursday in the New England Journal of Medicine. And the ethicists’ concerns couldn’t come too soon: There’s already plenty of evidence that patients’ families are clamoring to get bexarotene, on the basis of research published last February.

For starters, the ethicists note that the results of the new research are not proof that bexarotene will have the same dramatic effects in the human brain, or on human behavior. The drug’s side effects can be dramatic, they add: It can raise cholesterol, reduce the effectiveness of insulin in diabetics, and it’s been linked to changes in thyroid function, acute pancreatitis and low white blood-cell count.

(Read more: The Affordable Care Act and the Basic Health Program)

Those facts dictate that it is too early for a physician ethically to prescribe bexarotene for Alzheimer’s disease. But even if further trials on humans are promising — a circumstance the ethicists say would likely create “sudden overwhelming demand” for the drug — the dilemma faced by physicians, patients and their advocates may persist.

Widespread use of the drug among Alzheimer’s disease patients may make it more difficult for researchers to populate the clinical trials needed to rigorously test the drug’s effectiveness in treating the disease. Those will require that some subjects get a placebo — and if bexarotene is already in wide use, many families will shy away from enrolling a loved one in a clinical trial, fearing they might not get the drug.

Second, patients and their advocates must consider if it is fair for doctors to begin writing prescriptions for bexarotene for patients with dementia, considering the unreimbursed cost of treating an Alzheimer’s disease patient with bexarotene would make this a treatment option only for the very wealthy. And to the extent that Alzheimer’s patients would likely quickly deplete stores of bexarotene, the far smaller population of lymphoma patients who need the drug would likely be unable to find it.

Castle Wealth Group Legal in Media

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