By Cheryl LaBash on June 22, 2024
Cuba’s Heberoot P. photo: Yaima Ravelo
A recent announcement by Discovery Therapeutics Caribe in Cleveland eases a major fear coming with a diabetes diagnosis: the fear of amputation. The advocacy group Diabetes.org reveals the fear is justified. “Every 3 minutes and 30 seconds in the United States, a limb is amputated due to diabetes. Amputations are on the rise in the United States — 154,000 people with diabetes undergo amputation each year.”
In a welcome breakthrough on April 10, the Federal Food and Drug Administration greenlighted the phase 3 study of Heberprot-P, a Cuban medicine developed by the Center for Genetic Engineering and Biotechnology (CIGB) that has been shown to reduce diabetic amputation by more than 70 percent. Although Heberprot-P is currently available to patients in 26 countries and received original Cuban regulatory approval in June 2006, this is the first time it will be studied with U.S. patients suffering from diabetic foot ulcers.
Why did it take so long? The failure of the U.S. to normalize relations with the Republic of Cuba has forced even urgent health initiatives like this one to thread its way through an insidious web of laws, regulations, and executive orders that only apply to Cuba. Together with the 2021 State Department’s cruel designation of Cuba as a ‘State Sponsor of Terrorism, ’ these measures are literally intended to create unbearable hardships for the Cuban people using global dollar power.
In the words of Lester Mallory’s infamous April 6, 1960, State Dept. memo, “Every possible means should be undertaken promptly to weaken the economic life of Cuba. … a line of action which, while as adroit and inconspicuous as possible, makes the greatest inroads in denying money and supplies to Cuba, to decrease monetary and real wages, to bring about hunger, desperation, and overthrow of government.”
Cuba’s socialist focus on cooperative development of human potential has unleashed internationally recognized pharmaceutical advances like Heberprot-P as well as Cimavax, a late-stage lung cancer vaccine, and much more. Without normalized U.S.-Cuba relations, our communities and families here in the U.S. have been blocked, while the rest of the world is not.
Some steps in that direction produced a 2016 Memorandum of Understanding between the U.S. Department of Health and Human Services and Cuba’s Ministry of Public Health that may have helped open this opportunity. However, administrations have backed away since then.
On May 17, Discovery Therapeutics Caribe President Dr. Lee Weingart explained to Prensa Latina how these hurdles were overcome: “We could operate under the protection of an exception to the embargo [blockade] that allows joint medical research projects involving us and Cuban organizations, so we have taken advantage of this provision to move forward with this project.”
The diabetes care industry is growing, too, explains Medtech.citeline.com’s “Alarming Rise Of Diabetes In Several State” article “with some estimates it will reach $30bn by 2030 from $18bn in 2022 — it’s crucial that manufacturers continue to create innovative devices and products to treat and manage the disease.” Cuba’s Heberprot-P fits that need.
Weingart announced this unique therapy is expected to be available in the U.S. in 2028. Quoted in Prensa Latina on May 17, he said that “38.4 million U.S. citizens have diabetes, 1.6 million of which will develop a diabetic foot ulcer each year, …160,000 will result in amputation, and 80,000 of those will die in the next five years, so if you follow the cycle, 80,000 people die every year from the complications of a diabetic foot ulcer, making it the eighth leading cause of death in the United States and more deadly than certain kinds of cancer.”
Diabetes risk highest among African Americans
President of the Professional Education & Research Institute (PERI), an international clinical research organization, Dr. Charles Zelen, noted the disproportionate impact on African American communities where “Medicare beneficiaries are nearly twice as likely to undergo lower limb amputation within a year of DFU diagnosis compared to their non-Hispanic white counterparts.” The National Medical Association, the collective voice of African American physicians, notes on its website: “African American patients are more likely than white patients to have diabetes. The risk of diabetes is 77% higher among African Americans than among non-Hispanic white Americans.”
“Alarmingly, nearly half of patients who undergo DFU-related lower extremity amputation do not survive beyond five years. Among U.S. veterans, the prognosis is even more grim, where survival past two years is uncommon for patients presenting with gangrene.” (April 30, DTC Press Release)
The projected U.S. marketing date in 2028 will be twenty-two years after Heberprot-P was approved to save limbs and lives in 2006. At the rate of 160,000 amputations per year cited by Weingart, denying the potential healing rate of 70 percent has meant an estimated 2.5 million unnecessary amputations in the U.S. over these decades.
Finding this sweet spot to penetrate the U.S. economic, financial, and commercial blockade for the benefit of Cuba and diabetics in the U.S. is something to celebrate, but it is not a solution. Normalization of U.S.-Cuba relations begins today with removing Cuba from the State Sponsors of Terrorism List, requiring only that the President send a notice to Congress. For more information, see the ACERE.org toolkit and one-page SSOT explainer.
Conference on ulcers in Cuba
Cuba is hosting the VII International Congress on Comprehensive Management of Complex Ulcers and Wounds in Varadero, Cuba, from September 1 to 5, 2024. Spread the word to medical professionals and researchers.
Cheryl LaBash is a co-chair of the National Network on Cuba (NNOC)
Source: Struggle-La Lucha