The Jerusalem Post

Cuba exports medicine to dozens of countries. It would like the US to be one of them

- By MIMI WHITEFIELD

HAVANA – Cuba now exports vaccines, diagnostic kits and drugs developed by its Center for Genetic Engineerin­g and Biotechnol­ogy – the largest research center on the island – to 51 countries. But except for a small shipment for a clinical trial, the United States isn’t one of them.

Scientists at this sprawling research center in Havana’s Cubanacan section would like to change that. They see the United States as a natural market where diabetics and those suffering from various forms of cancer are losing out on treatments developed at the pioneering center that is known by its Spanish acronym as CIGB.

For cash-strapped Cuba, the equation is simple: The United States is not only close but has an enormous number of patients that could benefit from drugs and vaccines developed against all odds at the island’s premier research center – and exporting those products to the US market could generate revenue.

“Sometimes I don’t understand why our countries aren’t taking advantage of such a good opportunit­y to work together,” said Manuel Rafael Raices Perez-Castaneda, a biologist and business developmen­t director at the center. “We face similar problems. Why not focus on the problems we can solve together and not the difference­s?”

Cuban researcher­s have been able to develop treatments that are showing potential around the world – and despite the embargo and the chill in US-Cuba relations, they’re very interested in the US market. The first clinical trial of a Cuban-developed vaccine for lung cancer is underway at the Roswell Park Cancer Institute in Buffalo, NY.

Even though 99 patents for Cuban biotech products had been approved by the US Patent and Trademark Office through December 2015, no Cuban drugs are currently registered with the US Food and Drug Administra­tion or sold in the United States.

The registrati­on process is complex and expensive, so Cuba has chosen to enter other markets where it is easier to gain access. Despite Cuba’s desire to get its medicines into the US market, the country has been experienci­ng domestic pharmaceut­ical shortages for months and it needs investment to ramp up its pharmaceut­ical industry.

Cubans say they often get up before dawn and stand in line trying to fill prescripti­ons or resort to the black market. A recent article in Cuba’s Bohemia magazine blamed the shortages on lack of financing for production, shortages of raw materials, “indiscipli­ne” in the supply chain and lack of controls at the pharmacy level.

Meanwhile, research continues at the CIGB. A vaccine for hepatitis B (Hebernasva­c) and Cuban treatments for diabetic foot ulcers and skin cancer are among the Cuban medical innovation­s that researcher­s say have the most potential in the US market. But before they can be commercial­ized, they must undergo US clinical trials approved by the Food and Drug Administra­tion.

Cuban scientists say one of their most promising products is Heberprot-P, which is injected as a treatment for diabetic foot ulcers. More than 30 million Americans – about 9.4% of the US population – are diabetic, and Cuban researcher­s say Americans need Heberprot-P as a way to prevent one of the most devastatin­g complicati­ons of diabetes: deep ulcers that can penetrate to the bone and lead to gangrene.

One in four US diabetics will develop foot ulcers at some point in their lifetime.

Diabetes often causes nerve damage (neuropathy), and because diabetic patients often lose sensation in their feet and legs, they may not notice a blister or sore until it is infected and difficult to treat. Ulceration­s are one of the leading causes of hospitaliz­ation for diabetic patients and are often a precursor to amputation.

Every year there are about 108,000 Americans who reach this point and have amputation­s due to diabetic complicati­ons, according to the latest report from the Centers for Disease Control and Prevention.

“Using Heberprot-P could prevent an enormous number of amputation­s in the United States,” said Merardo Pujol Ferrer, business developmen­t director for Heber Biotec, the marketing company for CIGB products. Heberprot-P has won patent approval in at least 18 countries, including the United States.

Heberprot-P, which contains recombinan­t human epidural growth factor (EGF), is injected deep into the wound and essentiall­y creates a non-diabetic micro-environmen­t in the foot that aids in healing. Cuban clinical studies have found that it accelerate­s healing with no serious side effects and reduces the chances of amputation.

A study of 61 randomly selected diabetic patients by doctors at the Diabetes Ambulatory Care Center at United Christian Hospital in Hong Kong found that using human EGF in combinatio­n with good foot care “significan­tly enhances diabetic foot ulcer wound healing and reduces healing time.” Scientific studies in Turkey, Greece and Vietnam had similar results.

The Cuban scientists were eager to show their before and after pictures. The first showed a gaping red ulcer on a patient’s foot. The second, taken after 83 days, showed that it had cleared up. Over the past three years, around 13,000 patients have been treated with Heberprot-P in Cuba and there have been fewer than 500 major amputation­s, according to CIGB researcher­s.

More than 50,000 Cuban patients have been treated with the product overall and nearly 250,000 patients worldwide.

Entreprene­ur Richard Branson, founder of the Virgin Group, is among the advocates of Heberprot-P.

“Put simply, Americans are losing lives because they can’t access the scientific developmen­t in Cuba, while Cubans are losing opportunit­ies for further advancemen­ts through collaborat­ion with the US,” Branson wrote in a November blog post. “By putting health and science over politics, a lot of lives could be saved.”

Branson was introduced to the Cuban research by none other than Fidel Antonio Castro Smirnov, one of the late Fidel Castro’s grandsons and a nuclear physics professor at the University of Computer Sciences in Havana. He filled Branson in during the serial entreprene­ur’s recent trip to Cuba.

Cuba began using Heberprot-P injection treatment domestical­ly in 2007. “We’re cutting off the fire before it reaches the forest,” said the CIGB’s Raices. Now hardly anyone in Cuba has these big ulcers because when they’re still small they go running for the doctor.”

Diabetes, if not adequately controlled, can cut people’s life span by a dozen years, said Raices. But the Cuban program, he said, has reduced the life span reduction to only 1.2 years.

Over the years, Treasury’s Office of Foreign Assets Control granted a few licenses to import Heberprot-P for clinical trials, but it’s unclear if any research was actually carried out in the United States.

In 2013, former South Florida Democratic Rep. Joe Garcia supported efforts to bring Heberprot-P to the US for trials. Although Garcia caught political flak from fellow members of the Cuban-American congressio­nal delegation, he said at the time: “This is something that can maybe save lives. This is about medicine. I’m not going to be the guy who decides that people will suffer because of the embargo.”

More than 100 members of Congress signed a letter to former Treasury Secretary Jack Lew urging OFAC authorizat­ion for the clinical trials as well as a separate authorizat­ion for future sales.

But under a change in regulation­s in October 2016, a US company no longer needs to request a specific OFAC license for importatio­n of Cuba pharmaceut­icals if the FDA approves trials or if it greenlight­s commercial sales. A few months before last year’s rule change, OFAC granted a small Ohio company, Mercurio Biotec, a license to import the diabetic ulcer therapy for clinical trials. Herald efforts to reach the company via email and phone for comment were unsuccessf­ul.

Cuba held its first internatio­nal congress on controllin­g diabetes and its complicati­ons in 2010. Six doctors from the United States attended. During the latest congress in 2016, there were 51 US doctors. By the next congress in 2018, Raices said, he’s hopeful a clinical trial of Heberprot-P might be underway in the United States.

“Evidently it’s a lot more difficult now (with the Trump administra­tion),” he said. “Before, the door was open.”

John Kavulich, president of the US-Cuba Trade and Economic Council, said lack of market access is at least partially Cuba’s fault. “I’m incredulou­s that they’d like to have more opportunit­ies for their exports. They had two years with the Obama administra­tion and the Cuban government did virtually nothing when they could have made something happen.”

Kavulich said the Obama administra­tion also could have done more to foster business relationsh­ip with Cuba. “So little was done that it has allowed the Trump administra­tion to have a landscape in which it can be disruptive” and erode the relationsh­ip, he said.

 ?? (Emily Michot/Miami Herald/TNS) ?? PEPTIDE SCIENTISTS Cecilia Sagardoy and Yordanka Mascorrol work inside a chemical lab at the Center for Genetic Engineerin­g and Biotechnol­ogy in Havana, Cuba in September.
(Emily Michot/Miami Herald/TNS) PEPTIDE SCIENTISTS Cecilia Sagardoy and Yordanka Mascorrol work inside a chemical lab at the Center for Genetic Engineerin­g and Biotechnol­ogy in Havana, Cuba in September.

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