Rx for diabetes not pill, but will
After all those well-intentioned New Year’s resolutions have yielded to the force of habit, many of the nation’s 79 million obese adults will have a day of reckoning with their primary care physicians.
Lose weight and get active, the doctor will order, or risk developing diabetes. Then the MD will scribble a prescription.
For most patients, the prescribed treatment will not be a pill. It will be a 12-week program aimed at preventing Type 2 diabetes by getting obese adults to shed as little as 10 pounds and exercise for a little more than 20 minutes a day.
That regimen -- the Diabetes Prevention Program -- may soon become the blockbuster prescription medicine you’ve never heard of. In 2013, it is poised to become the envy of pharmaceutical companies, a new rival to programs such as Weight Watchers, and a target of opportunity for healthcare entrepreneurs.
Led by a trained coach, it is a testament to the power of a mentor and of setting modest goals in spurring healthful behavior. And it may be a crucial first test of the Affordable Care Act’s focus on preventive health.
In nearly 30 clinical trials, scientists have established that the program is far more effective at helping people lose weight and prevent or delay the onset of diabetes than “usual care” -- essentially, a doctor telling a patient to slim down and get active, and then sending him on his way. But the program hasn’t been packaged in a form that healthcare providers can simply and cheaply offer to patients, said Dr. Jun Ma of the Palo Alto Medical Foundation Research Institute, who studies diabetes prevention.
The Diabetes Prevention Program is not rocket science. In 12 weekly sessions, a coach teaches obese subjects at high risk of developing diabetes to set goals for losing 5% to 7% of their body weight, limit the fat and calories they consume, track their food intake, get at least 150 minutes of exercise each week, and devise strategies to avoid gaining back lost pounds.
In trials, subjects who attended the tightly scripted sessions and followed the regimen were far more likely than those who were on their own to reach their weight-loss goals in three months -- and to keep that weight off for more than a year. By doing so, they drove down their risk of developing Type 2 diabetes by 58%, according to a landmark report published in the New England Journal of Medicine in 2002.
The program, in short, is powerful medicine.
“If you could take it as a pill, it would definitely be commercialized,” said Sean Duffy, a software designer and former Google employee who launched an online version of the program about a month ago.
In June, a panel of physicians and public health experts that advises the Department of Health and Human Services gave the program a mighty push into everyday medical practice. The U.S. Preventive Services Task Force recommended that doctors refer their obese patients to “intensive, multicomponent behavioral interventions” designed to promote weight loss and physical activity. It cited only one that met its strict standards: the Diabetes Prevention Program.
Under the Affordable Care Act, that carries significant weight. Starting in June, most health insurers will be required to make proven weight-loss and behavior-modification programs available without a copayment to obese customers with a doctor’s referral.
No one knows whether expanded coverage of such programs can save money and head off a public health disaster. But without it, experts believe a tidal wave of Type 2 diabetes and heart disease -- with a 20-year price tag estimated at $550 billion in the U.S. alone -- is a virtual certainty.
For all its promise, the program has remained little more than a good idea -- and a pretty expensive one at that -- for years. The researchers who developed it at the University of Indiana pegged the cost of the trial’s intensive 12-week phase and nine months of maintenance at about $1,300 per patient. To make it cheaper and more accessible, they trained a few YMCA chapters to deliver the program.
Today, about 75 chapters in 28 states and the District of Columbia offer it. The Centers for Disease Control and Prevention, which has been charged with broadening access to “lifestyle change” programs, disbursed $6.75 million in 2012 to encourage health insurers, public health advocates and employer groups to offer versions of the program.
But with more than 78 million people potentially in line to get it, demand far outstrips supply.
Researchers like Ma have been working on ways to use technology to make the program more widely available. In a study published last month in the Archives of Internal Medicine, she and her colleagues found that putting the 12-week curriculum on an inexpensive DVD and assigning a coach to answer questions and offer support helped 37% of obese participants lose 7% of their body weight -- a rate more than twice as high as for those who got no help at all.
In a related study published in the same journal, researchers gave obese volunteers a personal digital device to monitor their weight, diet and physical activity and had them check in with a coach every other week. The volunteers lost more weight than trial subjects who were on their own.
The UnitedHealth Group’s Diabetes Prevention and Control Alliance in Minnetonka, Minn., has worked to make the Diabetes Prevention Program available on demand to Comcast cable subscribers nationwide. UnitedHealth Group physicians and public health specialists worked with a TV production crew to create a reality-show version of the program. After the pilot aired last year in Philadelphia and Knoxville, Tenn., it took just three weeks to get 700 people to volunteer for a clinical trial of the TV-based program. The results of that will be published soon, said Dr. Deneen Vojta, chief clinical officer for the UnitedHealth program.
“These people lost a ton of weight,” she said.
The growing scientific consensus around the diabetes program has not been lost on one of the nation’s most ubiquitous and respected weight-loss programs, Weight Watchers. With 20,000 meetings a week across the United States, Weight Watchers International has the infrastructure that the Diabetes Prevention Program lacks. Like the diabetes program, its groups are run by coaches who give advice and encouragement and teach members to track their intake. The company has steadily added features -- most recently a spate of food-tracking apps -- as clinical trials showed their value.
Weight Watchers has been lobbying the government to recognize its programs as an effective tool for diabetes prevention. The stakes are huge: If insurers were required to cover the costs of patients’ Weight Watchers memberships, the customer base could expand by leaps and bounds.
In Britain, the National Health Service will pay for the company’s initial 12-week course, said David Kirchhoff, chief executive of Weight Watchers International in New York City. Given the program’s widespread presence in the U.S. and evidence of its effectiveness in clinical trials, it makes sense for insurers here to pay too, he said.
Entrepreneurs are also getting in on the act. Duffy’s San Francisco-based startup, Omada Health, launched an online version of the Diabetes Prevention Program called Prevent that may be the first of many digital spinoffs.
Designed to win CDC approval, Prevent resembles a Facebook version of the Diabetes Prevention Program while preserving the privacy of customers who prefer it. Incoming members are matched to a group, and everyone works toward losing 5% to 7% of their body weight in 12 weeks under the supervision of a coach. Members’ weights are transmitted to the coach by a digital scale upon enrollment and weekly thereafter.
Early testing has shown that as groups jell, members learn from -- and lean on -- one another, Duffy said. He plans to sell the program at about $120 per month for four months, primarily to insurers and companies for use by their customers and employees. Payment will be due only after users show results, he said.