From Andrew Schneider / Hearst Newspapers
Every seven minutes, someone in the U.S. loses a limb to diabetes. Now, those likely to add to those horrifying statistics may be among the biggest beneficiaries of normalized relations with Cuba.
Entangled for years in the U.S. trade embargo has been a high-tech medicine Heberprot, developed in 2006 by a Cuban research center. Diabetic wound specialists say Heberprot, described as a “recombinant human epidermal growth medication,” may be the best chance to save the lives and limbs of tens of thousands of Americans. The drug restores areas where gangrenous tissue was cut away as the wound spread.
Studies in peer-reviewed medical journals say the limb-saving medication has been administered to more than 170,000 patients in 23 countries. But the U.S. policy forbade the developer of Heberprot, Cuba’s Center for Genetic Engineering
and Biotechnology, to bring the drug to the U.S. for comprehensive clinical testing needed to prove its safety and effectiveness.
“It just rips me apart to know that there may be something out there that has the potential to save limbs and we can’t get a chance to test it because of politics rather than public health,” Dr. David Armstrong
said last week, after spending hours in operating rooms working to reconstruct the feet of two patients to try to prevent leg amputation.
Armstrong is the director of the University of Arizona
‘s Southern Arizona Limb Salvage Alliance
, a clinical and research organization specializing in preventing foot destruction and amputations caused by diabetes. The group treats about 12,000 patients from around the world each year, the surgeon said.
The American Diabetes Association
estimates that more than 29 millions Americans have the disease, typified by high blood glucose or sugar levels and the body not using insulin properly.
Diabetes can result in reduced blood flow to limbs and can also cause nerve damage. That combination increases the chances for ulcers and infections, which results in 73,000 diabetes-related lower limb amputations annually in the U.S.
Armstrong and other diabetic wound specialists say the problem is even worse worldwide, where they describe a growing epidemic of amputations that claims a limb every 20 seconds.
Surgeons in the U.K and France say that biotech companies have begun initial testing of the drug, but both physicians said most are waiting for the comprehensive gold-standard clinical testing required by the Food and Drug Administration
, which the embargo had blocked.
To compound the ramifications of Washington’s refusal to admit the drug, the FDA has only approved one drug for diabetes-caused foot ulcers. It’s called Regranex, but most physicians rarely use it because in 2008 the FDA issued a “black box warning.” This highest of warnings cautioned of “increased risk of cancer death in patients who use three or more tubes of the product.”
The Cuban studies on Heberprot, written by physicians and scientists with the Center for Genetic Engineering and Biotechnology, say there have been no reports of secondary cancer or other serious adverse effects.