By Cheryl LaBash. Latin American Summary, June 25, 2024.
A recent announcement from Discovery Therapeutics Caribe, LLC in Cleveland alleviates a major fear that comes with a diabetes diagnosis, the fear of amputation. The advocacy group Diabetes.org reveals that 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 suffer amputations each year.”
On April 10, the Federal Food and Drug Administration gave the green light to the Phase 3 study of Heberprot-P, a Cuban drug developed by the Center for Genetic Engineering and Biotechnology (CIGB) that has been shown to reduce diabetic amputation by more than 70%. Although Heberprot-P® is currently available to patients in twenty-six countries and received the original Cuban regulatory approval in June 2006, this is the first time it will be studied in American patients suffering from diabetic foot ulcers.
Why has it taken so long? The fact that the United States has not normalized its relations with the Republic of Cuba forces even urgent health initiatives like this to make their way through an insidious web of laws, regulations and executive orders that only apply to Cuba. Coupled with the State Department’s callous designation of Cuba as a “State Sponsor of Terrorism” in 2021, these measures are literally intended to create unbearable hardship for the Cuban people using the power of the global dollar. In the words of Lester Mallory’s infamous April 6, 1960 State Department memorandum, “all possible means must be promptly undertaken to weaken the economic life of Cuba. …a line of action that, while being as skillful and discreet as possible, makes the greatest inroads to deny money and supplies to Cuba, to decrease monetary and real wages, to provoke hunger, desperation, and the overthrow of the government.”
Cuba’s socialist approach to the cooperative development of human potential has unleashed internationally recognized pharmaceutical advances such as Heberprot-P, the late-stage lung cancer vaccine Cimavax, and much more. Without the normalization of relations between the US and Cuba, our communities and families here in the US. Some steps in that direction produced a 2016 Memorandum of Understanding between the US Department of Health and Human Services and the Cuba’s Ministry of Public Health may have helped open this opportunity, but administrations have since backed down.
On May 17, the president of Discovery Therapeutics Caribe, Dr. Lee Weingart, explained to Prensa Latina how these obstacles were overcome. “We could operate under the protection of an exception to the embargo (blockade) that allows joint medical research projects in which we and Cuban organizations participate, so we have taken advantage of this provision to move forward with this project.”
The diabetes care industry is also growing, explains the Medtech.citeline.com article “Alarming Rise Of Diabetes In Several States” “with some estimates it will reach $30 billion in 2030 from $18 billion in 2022 – it is crucial “For manufacturers to continue creating innovative devices and products to treat and control the disease.” Cuba’s Heberprot-P responds to that need.
Weingart announced that this unique therapy is expected to be available in the US in 2028. Quoted in Prensa Latina on May 17, he said that “38.4 million US citizens have diabetes, 1.6 million of whom will develop a diabetic foot ulcer each year, …160,000 will result in amputation, and 80,000 of them will die in the next five years, so if the cycle is followed, 80,000 people die each year from the complications of a diabetic foot ulcer, which “It becomes the eighth cause of death in the United States and more deadly than certain types of cancer.”
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 suffer a limb amputation.” within one 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.”
“It is alarming that almost half of patients who undergo DFU-related lower extremity amputation do not survive more than five years. Among US veterans, the prognosis is even bleaker, where survival beyond two years is uncommon for patients who develop gangrene.” (April 30, DTC press release)
The planned US market 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, negating the potential cure rate of 70% has led to some 2.5 million unnecessary amputations in the US during these decades.
Finding this sweet spot to penetrate the US economic, financial and commercial blockade for the benefit of Cuba and diabetics in the US is something to celebrate, but it is not a solution. The normalization of relations between the United States and Cuba begins today with the removal of Cuba from the List of State Sponsors of Terrorism, which only requires the president to send notification to Congress. For more information, see the ACERE.org toolkit and the one-page explanatory brochure on SSOT.
Cuba will host the VII International Congress on Comprehensive Management of Ulcers and Complex Wounds, from September 1 to 5, 2024 Varadero, Cuba. Spread the word to medical professionals and researchers
Cheryl LaBash She is co-president of the National Network on Cuba in the United States.
Cover photo: Yaimi Ravelo.
Source: Cuba in Summary
