In this story for Isthmus, I examine the Oct. 16, 2012, complaint issued by the federal Food and Drug Administration against the Madison manufacturer of a memory supplement called Prevagen. The feds say that unverified claims have been made on behalf of the various Prevagen products, and that makes them not supplements but “unapproved new drugs.”
The manufacturer, Quincy Biotechnology, has taken steps to deal with the FDA warning, but denies that its flagship product is being marketed as a drug. The FDA says that–14 months after the warning was issued–the case is still “open.” But Quincy President Mark Underwood reports that the regulators are satisfied that Quincy has resolved all problems. No word from the FDA on that.
Today, Prevagen is available at more than 20,000 retail locations, including Walgreen’s and CVS drugstores, and it’s sold online as well. Inc. magazine says Quincy’s annual revenue has grown 234% from 2009 to 2012 — from $5.3 million to $17.8 million.
Graying baby boomers are driving the demand.
“People are desperate to believe in something, because they don’t want to get Alzheimer’s,” says Dr. Cynthia Carlsson, a UW-Madison Medical School geriatrician and memory researcher.
Underwood denies that Quincy is targeting Alzheimer’s patients. “There are five million Alzheimer’s patients, but there are 80 million baby boomers. As businesspersons, we’re much more interested in helping the 80 million baby boomers long before they have any diseases of dementia,” he says.
Alzheimer’s, however, is not a disease of age, according to Dr. Mark Sager, who is the principal investigator of the Wisconsin Registry for Alzheimer’s Prevention. This well-regarded longitudinal study of adult children of parents with Alzheimer’s is trying to detect the early markers of the disease.
“People think Alzheimer’s is a disease of aging,” he says. “But it’s a disease of a lifetime that only becomes evident in older adults.”
Sager says Alzheimer’s manifests itself for both genetic and environmental reasons, much as a person’s genetic propensity for heart disease can be exacerbated by smoking and lack of exercise.
“We find that diet, exercise and lifestyle — stress, for example — are all associated with Alzheimer’s,” says Sager. “If you’re overweight and don’t exercise in midlife, you have an increased risk of developing Alzheimer’s later on. “
Sager, who runs the Wisconsin Alzheimer’s Institute, says it does not recommend taking Prevagen “primarily because there’s no evidence it does any good.” He suggests people worried about Alzheimer’s would be better off adopting the Mediterranean diet, which he says has proven benefits.
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