About a year ago, an agreement between Roswell Park Cancer Institute and Cuba’s Center of Molecular Immunology started the groundwork for what could be a medical boon for U.S. citizens: access to CimaVax, a lung cancer vaccine that has been used to treat 5,000 cases worldwide.
The vaccine works in an innovative way: Instead of targeting cancer cells, which is difficult because cancers can vary by host, CimaVax starves out the cancer by targeting the cells cancer needs for replication. So far, it’s looking good: It has both low toxicity and low production cost — two things that raise the odds of getting a potentially tide-turning drug to market.
But CimaVax isn’t the only medication U.S. citizens could benefit from. Cuba is also producing medicines to treat multiple myeloma, block tumor growth and combat a cadre of cancers from head to foot.
The problem is they’re all stuck behind 55 years of red tape.
So, to get these drugs into the U.S., the Medical Education Cooperation With Cuba released a White Paper in February asking for President Barack Obama to issue general authorizations for collaboration between U.S. and Cuban medical companies, institutes and government agencies. The goal is to get around some major hurdles preventing the U.S. from accessing Cuban biopharmaceuticals and the researchers who make them.
We tend to associate Cuba with classic cars and the Buena Vista Social Club, not a groundbreaking biopharmaceutical industry — but medicine has been a considerable part of the country’s recent economic growth.
As early as the 1980s, Cuban companies have been developing medications to treat illnesses on the island and in countries willing to do business with Cuban pharmaceutical companies. Now, according to Pierre LaRamée, Executive Director of MEDICC, the island has 40 research and production institutions, 58 production facilities and 12,000 people working in them. It’s a self-financing industry — and the second-largest in the Cuban economy.
“This didn’t just start happening yesterday,” LaRamée told Mic. “The government decided to prioritize [pharmaceuticals] in part because of the embargo, which has so choked off access to medications from around the world that Cuba had to adapt and develop its own industry. Now Cuba’s considered on par with China and India in terms of biopharmaceutical production.”
An island producing a Beatles anthology-sized collection of therapeutic cancer vaccines, monoclonal antibodies, anti-tumor peptides and radioactive antibodies could be hugely important to the U.S. The National Cancer Institute, part of the U.S. Department of Health and Human Services, estimates there may have been 1,658,370 new cases of cancer and 589,430 cancer deaths last year.
That’s over half a million deaths potentially preventable by new medicines — all of which improved U.S.-Cuba relations could bring stateside. Among some of the best are Heberprot-P, Racotumomab and Nimotuzumab.
The Medicines We Need
Cuban doctors have been using Heberprot-P, a cure for diabetic foot ulcers, since 2007, according to MEDICC Review. Diabetic foot ulcers contributed to 73,000 lower-limb amputations in 2010. More often than not, diabetic ulceration indicated a five-year mortality rate.
The drug works by getting deep into the tissue around a wound on the lower legs, where blood pools, and makes the tissue better at repairing itself. According to LaRamée, Heberprot-P reduces the risk of foot amputations by more than 70%. It could be the single most important medicine for the U.S. to access: According to the Centers for Disease Control and Prevention, 29.1 million people — or 9.3% of the country — have diabetes.
Racotumomab is a therapeutic cancer vaccine used to treat solid tumors like those found in melanoma, breast cancer and lung cancer cases — the latter of which claimed 158,040 U.S. deaths in 2015, according to NCI estimates. Racotumomab could also be used to treat multiple myeloma, which turns your plasma cells into multiplying cancer cells — tearing up your bones, immune system and kidneys, among other things.
Like CimaVax, Nimotuzumab targets epidermal growth factor receptor, a protein in your body that helps cancer cells grow, to starve cancer of cells it needs to multiply. According to LaRamée, Nimotuzumab is being trialed for treating head and neck cancers and gliomas, a blanket term for different types of brain tumors. Since epidermal growth factor is an active part of the equation for the development of colon and pancreatic cancer — actually, a lot of solid-tumor cancers — Nimotuzumab could have implications for stifling tumor growth in a wide range of cancers.
Drugs Crossing the Border
If everything goes right, CimaVax undergoing trials in the U.S. could start a chain reaction of U.S. institutes testing Cuban medications. There’s already a relationship between Dr. Thomas Rothstein, investigator and head of the Center for Oncology and Cell Biology at the Feinstein Institute for Medical Research in New York, and researchers at Cuba’s Center of Molecular Immunology surrounding research involving Racotumomab.
Here’s the problem: Cuba has the drug and New York has the equipment needed for analysis, but blood samples from immunized Cuban patients can’t get to the Feinstein Institute in time to still be considered fresh, Rothstein told Mic. So not only could lifting the embargo on Cuba mean express medical deliveries between the two countries, it could give U.S. and Cuban medical institutes more chances to collaborate.
The Challenge of Getting Medicines to Market
To get any domestic or imported drug approved by the Federal Drug Administration, it must go through four steps: research in the lab, research on animals, research on humans and a thorough FDA review. After approval, the drug is still monitored on the market to make sure nothing fishy is happening. The process can take a lot of time — and it can cost an alleged $1.3 billion to go to market.
For CimaVax, or any potential medicine produced in Cuba, there’s an additional government-approval step before an FDA official even sees it.
“CimaVax was brought to the U.S. under a special license from the Treasury Department for limited research,” LaRamée told Mic. According to a spokesperson from Roswell Park, the institute’s OFAC license for CimaVax covers both preclinical and clinical work on the vaccine. But in most cases, every step of the research process requires its own OFAC license, LaRamée said.
If the embargo were lifted, LaRamée said, Cuban products would be treated the same as those from any other country, with a much higher likelihood that they would actually get tested, approved and sold to U.S. doctors and patients. Research collaborations, like the one between Roswell Park and the Center of Molecular Immunology, could become more common — and in turn, they could get life-saving medicines from Cuba into the hands of citizens in the U.S. and around the world.
“I think most Americans would be astonished to learn Cuba has one of the most advanced biotechnology industries in the world,” LaRamée told Mic. “It’s producing cutting-edge treatments and successfully marketing them. But because of the embargo, they’re not available in the U.S. It’s not just Cubans being hurt, but Americans.”