Renewed U.S.-Cuba Relations: Saving American Lives and Limbs?

heberprotPor Gail Reed/Editora ejecutiva de la Revista MEDICC

Some 29.1 million Americans have diabetes, nearly 8 million unaware of their condition. Between 70,000 and 80,000 diabetics become amputees every year from one of the disease’s most nefarious complications: diabetic foot ulcers. As a result of the recent opening to Cuba, these amputees — over half of whom will otherwise die within five years of amputation — may be thrown a lifeline by Cuban innovation.

Because of our estrangement from the Caribbean nation, most may be unaware that its biotech industry is booming, since the 1980s one of the ‘big three’ in the global South (with Brazil and India). Its latest R&D breakthrough is a medication called Heberprot-P, which has already treated 165,000 diabetic-foot patients in 26 countries, reducing relative risk for amputation by 75%. The treatment is in trials in 5 countries and in Europe, where it’s known as Epiprot.** Results on safety and effectiveness have been published in the International Wound Journal,Diabetes Careand MEDICC Review, among others, documenting ten years of clinical experience.

Our California-based nonprofit MEDICC (Medical Education Cooperation with Cuba), took a bipartisan delegation to Havana to see diabetes care and Heberprot-P at work — as it happened, on the eve of the December 17 historic announcement by the U.S. and Cuban governments. The group included Rep. Diana DeGette (D-CO), chair of the Diabetes Caucus, the largest caucus in Congress with 345 members; more Caucus members; and diabetes experts and patient advocates.

Among them, Rep. Karen Bass (D-CA), who said living with her mother’s diabetes brought the disease “up close and personal for me.” She also said her Los Angeles district has more than its share of diabetics: “Since the disease disproportionately hits low-income people of color, now I see it everywhere among my constituents. And I also see too many diabetic-foot amputees.”

Diabetes certainly looms larger and more crippling in Native American, African American and Latino communities, in that order. According to the Alliance to Reduce Disparities in Diabetes at the University of Michigan, Native Americans have the highest diabetes prevalence in the world: 16% of Native Americans and Alaska Natives suffer from the disease. This compared to nearly 13% of African Americans, about 12% of Hispanics, some 8% of Asian Americans and Pacific Islanders, and just 7% of non-Hispanic whites.

To the human health dimension, add the cost to patients and to federal programs, estimated at some $250 billion annually, with diabetic-foot ulcer patients paying double what other diabetics pay for their care. And this does not count the cost of years of the disability itself, associated with lost income and deeper poverty. Quoted in The Washington Post’s special on diabetes, the American Diabetes Association (ADA) says $1 of every $5 U.S. healthcare dollars is spent treating patients with diabetes.

And the disease is indeed epidemic in the USA — growing at alarming rates in most states, and affecting nearly 30 times the people it did in 1958. The most common is type 2 diabetes, with aging, poor diet, physical inactivity, high blood pressure and obesity playing an even bigger part than inherited factors.

So can U.S. doctors prescribe Heberprot-P for their patients? Or has the FDA fast-tracked it for clinical trials as the unique medication it is? Are trials about to start? Can the medication be sold if Heberprot-P proves effective? Well, no, no, no and no.

Because it’s a Cuban product (yet patented in the USA). The Department of the Treasury’s Office of Foreign Assets Control (OFAC, charged with enforcing the U.S. embargo on Cuba) denied a license for trials and sales back in 2010. Then, in 2014, the agency licensed clinical trials only, but refused to green-light future sales, even if the FDA approves the medication as safe and effective.

Thus Healiance — a French company’s U.S. subsidiary applying for the two-pronged license — hasn’t enough incentive to risk millions in extensive trials, enlisting patients for a treatment their doctors may never be able to prescribe.

Treasury’s decision was communicated last June, rebuffing a December 2013 letter initiated by Rep. Barbara Lee (D-CA) and signed by 111 members of Congress, urging the department to license not only trials for Heberprot-P, but sales as well, if trial outcomes and FDA ruling are positive. “OFAC has granted similar authorizations in the past,” the letter reminded Treasury Secretary Jack Lew, “for example in 2004, OFAC granted [such] a license to a company for a cancer vaccine developed by a Cuban research institute.”

“Having this medication assist with prevention and decreasing the high number of amputations would be a life changer here in our city,” notes Helene Velazquez, the ADA’s Program Director of Mission Delivery in New York.

Says Rep. Bass: “I think it’s a travesty not to provide people access to a one-of-a-kind drug that could spare them such terrible suffering and disability… all because of a political disagreement with Cuba, the country where the medication was developed. Access to this treatment should be the right of American patients.”

Perhaps including patients like Halle Barry, Nick Jonas, Randy Jackson, Salma Hayek, Jay Cutler, Patti LaBelle, Anne Rice, Larry King…and yes, Mike Huckabee…all diabetics.

Will the White House and its new opening towards Cuba prevail upon Treasury to approve the full license for Heberprot-P? To approve others that may land on OFAC’s desk…for monoclonal antibodies targeting lung and childhood brain cancers, or a new dengue or cholera vaccine from Cuba? Or will we keep paying the awful price of politics?

Because Heberprot-P is proof that the U.S. embargo, still to be lifted by an act of Congress, isn’t just hurting Cubans. American lives and limbs are also, quite literally, at stake.

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