When wounds won’t heal
Patients suffer, even die, amid dearth of proven treatments
Doctors who care for the 6.5 million patients with chronic wounds know the depths of their struggles. Their open, festering wounds don’t heal for months and sometimes years, leaving bare bones and tendons that evoke disgust even among their closest relatives.
Many patients end up immobilized, unable to work and dependent on Medicare and Medicaid (in California, Medi-Cal). In their quest to heal, they turn to expensive and sometimes painful procedures, and products that often don’t work.
According to some estimates, Medicare alone spends at least $25 billion a year treating these wounds. But many widely used treatments aren’t supported by credible research. The $5 billion-a-year wound care business booms while some products might prove little more effective than the proverbial snake oil.
The vast majority of the studies are funded or conducted by companies that manufacture these products. At the same time, independent academic research is scant for a growing problem.
“It’s an amazingly crappy area in terms of the quality of research,” said Sean Tunis, who as chief medical officer for Medicare from 2002 to 05 grappled with coverage decisions on wound care. “I don’t think they have anything that involves singing to wounds, but it wouldn’t shock me.”
A 2016 review of treatment for diabetic foot ulcers (released by the American Society of Plastic Surgeons) found “few published studies were of high quality, and the majority were susceptible to bias.”
The review team included William Jeffcoate, a professor with the Department of Diabetes and Endocrinology at Nottingham University Hospitals Trust in England. Jeffcoate has overseen several reviews of the same treatment since 2006 and concluded that “the evidence to support many of the therapies that are in routine use is poor.”
A separate Health and Human Services review of 10,000 studies examining treatment of leg wounds known as venous ulcers (updated January 2014) found that only 60 of them met basic scientific standards. Of the 60, most were so shoddy that their results were unreliable.
While scientists struggle to come up with treatments that are more effective, patients with chronic wounds are dying.
The five-year mortality rate for patients with some types of diabetic wounds is more than 50 percent higher than breast and colon cancers, according to an analysis led by Dr. David Armstrong, a professor of surgery and director of the Southern Arizona Limb Salvage Alliance.
More than half of diabetic ulcers become infected, 20 percent lead to amputation, and, according to Armstrong, about 40 percent of patients with diabetic foot ulcers have a recurrence within one year after healing (per a study he coauthored, published in the New England Journal of Medicine).
“It’s true that we may be paying for treatments that don’t work,” said Tunis, now CEO of the nonprofit Center for Medical Technology Policy, which has worked with the federal government to improve research. “But it’s just as tragic that we could be missing out on treatments that do work by failing to conduct adequate clinical studies.”
Although doctors and researchers have been calling on the federal government to step in for at least a decade, the National Institutes of Health and the departments of Veterans Affairs and Defense haven’t responded with any significant research initiative.
“The bottom line is that there is no pink ribbon to raise awareness for festering, foul-smelling wounds that don’t heal,” said Caroline Fife, a wound care doctor in Texas. “No movie star wants to be the poster child for this, and the patients … are old, sick, paralyzed and, in many cases, malnourished.”
The NIH estimates that it invests more than $32 billion a year in medical research. But an independent review estimated it spends 0.1 percent studying wound treatment. That’s about the same amount of money NIH spends on Lyme disease, even though the tick-borne infection costs the medical system one-tenth of what wound care does, according to an analysis led by Dr. Robert Kirsner, chair at the University of Miami Department of Dermatology and Cutaneous Surgery.
Emma Wojtowicz, an NIH spokeswoman, said the agency supports chronic wound care, but she said she couldn’t specify how much money is spent on research because it’s not a separate funding category.
“Chronic wounds don’t fit neatly into any funding categories,” said Jonathan Zenilman, chief of the division for infectious diseases at Johns Hopkins Bayview Medical Center and a member of the team that analyzed the 10,000 studies. “The other problem is it’s completely unsexy. It’s not appreciated as a major and growing health care problem that needs immediate attention, even though it is.”
Commercial manufacturers have stepped in with products that the FDA permits to come to market without the same rigorous clinical evidence as pharmaceuticals. The companies have little incentive to perform useful comparative studies.
“There are hundreds and hundreds of these products, but no one knows which is best,” said Robert Califf, who stepped down as U.S. Food and Drug Administration commissioner in January. “You can freeze it, you can warm it, you can ultrasound it, and [Medicare] pays for all of this.”
When Medicare resisted coverage for a treatment known as electrical stimulation, Medicare beneficiaries sued, and the agency changed course.
“The ruling forced Medicare to reverse its decision based on the fact that the evidence was no crappier than other stuff we were paying for,” said Tunis, the former Medicare official.
The companies that sell the products and academic researchers themselves disagree over the methodology and the merits of existing scientific research.
Thomas Serena, one of the most prolific researchers of wound-healing products, said he tries to pick the healthiest patients for inclusion in studies, limiting him to a pool of about 10 percent of his patient population. “We design it so everyone in the trial has a good chance of healing,” said Serena, who has received funding from manufacturers.
But critics say the approach makes it more difficult to know what works on the sickest patients in need of the most help. The emphasis on healthier patients in clinical trials also creates unrealistic expectations for insurers, said Fife: “The expensive products … brought to market are then not covered by payers for use in sick patients, based on the irrefutable but Kafka-esque logic that we don’t know if they work in sick people.”