An Food and Drug Administration panel's tentative approval of a test for Alzheimer's disease cracks open the window on a range of difficult ethical issues.
The panel conditionally recommended approval of a chemical that reveals plaque in the brains of Alzheimer's patients during PET scans. Before final approval, the panel is requiring the applicant, Avid Radiopharmaceuticals, to establish guidelines to help radiologists interpret the results, which are believed to be accurate in about 19 out of 20 individuals.
Currently, there is no accurate test for the fatal disease. There are clear symptoms, notably dementia, but it is often difficult to determine if those are caused by Alzheimer's or another affliction, such as physical trauma or vascular disease.
Alzheimer's is a rising concern as 77 million baby boomers start entering their senior years. About 5.3 million Americans already have the disease, and the Alzheimer's Association predicts that number will triple to 16 million by 2050, with costs rising to $1 trillion a year (excluding inflation). One in eight baby boomers will die from Alzheimer's unless a cure is found.
Accurate diagnosis can lead to earlier intervention. While there is no treatment that can effectively slow or stop the onset of Alzheimer's, earlier diagnosis is helpful because there are different therapies and practical steps that patients and their families can take to prepare themselves for the latter stages of the disease.
To help diagnose the disease, there are a variety of radiological and genetic tests under development, some which could help spot Alzheimer's years or decades before the more obvious symptoms show up. But the technological advance also poses challenging ethical questions about the long-term care of Alzheimer's patients.
"It raises some very complicated issues," said Howard Gleckman, author of Caring for Our Parents. "I think the insurance companies are just beginning to wrestle with them. They're not unaware of the potential for genetic and diagnostic testing for these diseases.
"About half of long-term insurance claims are filed by people with some kind of dementia," said Gleckman. a resident fellow at The Urban Institute who studies long-term care policy issues. "So it is overwhelmingly the single most important health issue that long-term care insurance companies have to confront."
On the individual level, Gleckman noted there is "another set of ethical questions: Do you want to know? What steps do you take in terms of your own life, or planning for your kids?"
Those issues may be a relatively minor concern in Avid's case. The test approved by the advisory panel would help to confirm fairly advanced cases of Alzheimer's where dementia is already present.
Avid developed a dye called Florbetapir that, when injected into the patient, can highlight the plaque during a PET scan. Presumably, a patient undergoing such advanced tests would already have symptoms that make it difficult for them to get long-term care insurance.
But while Avid tested the method on younger people with no sign of plaque, it didn't develop a "bright line" that would say who has Alzheimer's and who doesn't. Some people have small amounts of plaque but don't develop Alzheimer's. The FDA panel asked the company to develop a standard to guide doctors using the tests.
The Alzheimer's Association indicated in a statement it had mixed feelings on the panel's decision. While the test can help identify plaque related to Alzheimer's, the group said "the fact that all of the potential uses of this product are not crystal clear tempers our enthusiasm."
The association concluded: "Despite the concerns and complications, we believe it is valuable to the Alzheimer’s field – to the pursuit of better Alzheimer diagnostics, treatments and preventions – to have this product more widely available."