Thanks to FDA, even Cuba is ahead of US

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Pioneer Founding member
AS KERRY REOPENS EMBASSY, MIAMI COMPANY BRINGS CUBAN LUNG CANCER DRUG TO U.S. PATIENTS
BY JESSICA WEISSFRIDAY
AUGUST 14, 2015

http://www.miaminewtimes.com/news/as-kerry-reopens-embassy-miami-company-brings-cuban-lung-cancer-drug-to-us-patients-7821961

Cuba is now open for business. This morning, John Kerry is in Havana to officially inaugurate reopened diplomacy between the nations by rechristening the U.S. embassy there. There's still plenty of debate about the pros and cons of the move: Kerry won't meet with dissidents, which has enraged reformers, but would-be travelers and business leaders are primed for big change.

There's a less-talked-about change with an even wider-reaching impact, though: Americans may soon be lining up to benefit from one of Cuba's most prized commodities: medicine.

This week, a South Florida company announced that a heralded Cuban-developed lung cancer vaccine will now be available for patients from the United States who are willing to go to Mexico to receive it. The vaccine, called CimaVax, works by helping a patient's immune system create antibodies to fight a protein that causes cancerous cells to grow, effectively slowing a tumor’s progress. It has been used in Cuba to treat cancer patients since 2011, for just $1 a pop.

"Cuba is so far ahead of us in biotechnology and medicine in general," says Ricardo De Cubas, the founder of Regenestem, the Miami-based stem cell therapy group that's administering the vaccine in Mexico. "And they've been able to develop these treatments that prolong life."

After President Obama’s historic December announcement, New York Gov. Andrew Cuomo traveled to Havana to broker a deal to bring the CimaVax vaccine to the United States. As a result, Cuba's Center for Molecular Immunology signed an agreement in April with Roswell Park Cancer Institute in Buffalo, New York, to import CimaVax and begin clinical trials in the States.

But while the product goes through the lengthy FDA approval process, which De Cubas says could take two years, he and his colleagues at Regenestem had an idea: Why not offer it through a nearby "third country," allowing U.S. citizens to access the medicine outside of Cuba right now? Last month, a Regenestem franchise clinic in Mexico cut a deal directly with Cuba, allowing it to administer the vaccine.

"We said, 'Hey, why should they have to wait for the FDA?'" De Cubas says. "Who knows how long that is going to take."

The vaccine doesn't cure lung cancer, but it's been shown to extend life expectancy and reduce symptoms. That's especially beneficial in Cuba, where heavy cigar smoking means lung cancer has become the fourth leading cause of death. In the States, lung cancer kills more people than prostate, breast, and colorectal cancer combined. So far, 5,000 patients worldwide have been treated with CimaVax, including 1,000 in Cuba.

With this latest deal, patients can be treated through the Regenestem clinic in Mexico, or they can send a family member to Cuba to pick up the vaccine and deliver it to them in Mexico, where they can administer it themselves. Unfortunately, it costs a bit more than $1; the treatment course is one injection per week for eight weeks, at a total cost of $12,500. De Cubas says a patient must go through an authorized representative to receive the vaccine.

"For somebody who has Stage 4 small-cell lung cancer, for a shot to extend your life, that’s pretty reasonable," De Cubas says. "If it was a U.S. pharmaceutical company, the cost would be $100,000-plus.”

Regenestem, which has 16 licensed administers around the world, from Bogotá to Manila, also hopes to plan a regenerative-medicine conference in Havana for educational exchange between Cuban and U.S. doctors. De Cubas says the U.S. has a lot to learn from Cuban innovations in healthcare and science. For instance, Cuba has been working with ozone therapy for 30 years and stem cell treatments for 40 years, he says.

De Cubas says greater access to Cuban healthcare innovations is extremely positive. "This," he says, "is the medicine of the future."
 
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