Quincy Bioscience, the fast-growing Madison brain supplement maker, has all but settled its problems with the federal Food and Drug Administration, says Quincy president Mark Underwood.
"To make a long story short, we're in a fine place with the FDA," says Underwood. "We've been able to satisfy all of their requests."
Inc. magazine ranks Quincy among the top third of the 5,000 fastest-growing companies in the country. Founded in 2004 by Underwood and Michael Beaman, Quincy manufactures Prevagen products for memory enhancement. These are based on a synthesized version of a jellyfish protein called apoaequorin. Quincy's website says apoaequorin supports healthier brain function and is clinically proven to "improve memory within 90 days."
On Oct. 16, 2012, the FDA issued a warning letter, stating that Quincy was selling "unapproved new drugs" -- and not dietary supplements -- based on the unverified health claims on its website and Facebook page of "miraculous" cures of memory loss, including from Alzheimer's and dementia. The FDA further alleged that Quincy failed to report more than 1,000 "adverse events" among Prevagen users, including some that required hospitalization.
Fourteen months later, the FDA still lists the Quincy case as "open." According to FDA records secured through a Freedom of Information request, Quincy has reported a series of wide-ranging steps taken to comply with FDA demands, including scrubbing the suspect claims, videos and links from its online profile, retraining its employees on FDA supplement regulations and improving its internal record keeping.
But the company refutes the FDA contention that Prevagen should be considered an unapproved drug rather than a dietary supplement. This is a key point. Dietary supplements are subject to dramatically less regulatory oversight than drugs.
FDA approval of a new drug for release on the market requires extensive clinical testing and may take 10 to 15 years at a cost of $300 million to $1 billion to ensure its safety and effectiveness, according to John Centanni, a regulatory affairs manager at the UW-Madison School of Medicine and Public Health.
In contrast, dietary supplements are not subject to premarket approval; the manufacturer must only notify the FDA of their public sale and marketing claims. "This does not guarantee that the FDA agrees that the product is reasonably safe for human consumption," Centanni says.
The FDA declined repeated requests to clarify the status of the Quincy warning. Underwood correctly points out that the "open" designation is not unusual. Of the 72 FDA warning letters issued in October 2012, only 16 are listed as closed.
"We're in their good graces," Underwood says of the FDA during an interview at Quincy's modern-looking headquarters at 301 S. Westfield Rd.
When asked about the FDA's assertion that Quincy "failed to report serious adverse events...like seizures, strokes and worsening symptoms of multiple sclerosis that had been reported to your firm as being associated with the use of Prevagen products," Underwood admits "we needed to sharpen our paperwork" on recording complaints.
But he says serious problems only numbered about a dozen and argues they weren't evidence of a problem with Prevagen. "We sell a product to an elderly population, and they do have strokes. They do have issues," he says. "But we don't have evidence in any of those cases that our product is causative."
Desperate to believe
Quincy has 65 employees and has been profitable "for many years," says Underwood. In 2010, the Milwaukee Journal Sentinel reported that Quincy had raised $1.5 million in venture capital, including $250,000 from the DaneVest Tech Fund. The story described Prevagen as an "anti-aging" supplement and noted that sales were skyrocketing.
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.
Carlsson, who runs a memory clinic at the Madison Veterans Hospital, says the various brain supplements sold over the counter probably won't hurt anyone, "but some do have side effects. As to their claims they can help you, I can't validate that, whether it's Prevagen, coconut oil, Coenzyme Q10. We just don't have the answers."
Her advice: "Instead of taking Prevagen, I'd encourage people to get a membership at a health club."
Far more scathing in his criticism is UW-Madison neuroscientist Baron Chanda. "This product doesn't make sense. It's basically quackery," he says after reviewing some of the online Prevagen research. He says there is no way the apoaequorin protein could survive the digestive tract and make its way to the brain. Prevagen purchasers, he suggests, are basically being played for "suckers."
Underwood is unfazed. He says researchers trained in the '70s and '80s aren't up to date on the newer findings. (Chanda says he was trained in the '90s and '00s.) For substantiation, Underwood points to the apoaequorin research conducted by UW-Milwaukee psychologist James Moyer Jr. Moyer himself is measured in saying he was intrigued by his study that showed the Prevagen protein surviving the gastrointestinal tract, but he adds that nothing definite could be concluded until the results were replicated two or three more times.
Not a cure
Business continues at a brisk pace at Quincy.
The company has begun marketing Prevagen to retired professional athletes through a special hotline. And the company even has a doggie subsidiary selling an apoaequorin product to help old Sparky remember where he buried his dog bone.
To mark the holidays, Quincy has announced a special sale of its "Holiday Memory Kit," which includes a free copy of "The Brain Health Guide" with an order of Prevagen Extra Strength, which costs $69.95 for a one-month supply.
"We are really excited to see our clinical research translate into practical assistance for families, especially during the holiday season," Underwood says in the press release. "Prevagen has a proven track record of safety and efficacy and has help[ed] hundreds of thousands of families that have memory concerns."
The press release ends with the cautionary note that the FDA does not evaluate supplement claims. And then it makes a critical point, as far as the FDA is concerned when it comes to the public understanding the nature of supplements: "This product is not intended to diagnose, treat, cure, or prevent any disease."