Cuban Biotech Advances Prove to Be Revolutionary

When Franklin Sotolongo injected himself with the vial of experimental liquid that day in 1985, it was one of the most emotional moments of his life.

Sotolongo was leading a small team of Cuban scientists struggling to save their nation from an epidemic of group B meningitis. Hundreds of children were dying, and there was neither a cure nor a vaccine--not only on their isolated Communist island, but anywhere on the globe.

They studied the research of scientists in Europe and the United States, and, after years of testing in monkeys and mice, Sotolongo and his team had what they thought was a breakthrough. “We tried it on ourselves first. We were sure there was nothing to worry about, but we felt the first risks should be ours.”

Thirteen years later, group B meningitis has been virtually wiped out in Cuba and Sotolongo’s government institute has the patent on a group B meningococcal vaccine so effective that international pharmaceutical giant SmithKline Beecham is appealing to Washington to waive its trade embargo of Cuba to permit its own trials of the vaccine.

But the vaccine is just one of many unheralded breakthroughs in Cuba’s little-known yet highly advanced biotechnology industry--one that has, with its infusion of foreign exchange, helped the country weather the collapse of its Soviet benefactor.

Unencumbered by competing interests in a one-party state that views biotech as a key to both its medical and economic survival, Cuban scientists have developed an array of new vaccines and drugs that are at the leading edge of biotech research.

One team is hard at work in the first phase of human clinical trials of a potential AIDS vaccine that scientists hope will be ready for commercial use in two years. Another group of scientists is perfecting what would be the world’s first effective vaccine against cholera--a disease that doesn’t even exist in Cuba. Another team has used human placenta to develop a cream that reverses the effects of certain skin diseases. And still another has successfully cloned a new species of fish that grows twice as fast as the natural variety.

That “transgenetic” fish, whose growth genes have been modified by Cuban scientists, will be Cuba’s centerpiece at an international conference it is sponsoring in Havana in late November, a five-day symposium that is scheduled to draw such notable genetic scientists as the creator of Dolly, the cloned sheep.

But Cuba’s multimillion-dollar biotechnology industry is not just for show or its own medical needs. Already, the Cuban government successfully has marketed its group B meningococcal vaccine in Argentina, Brazil and Colombia, where sales have helped Cuba repay its debts to those countries.

Heber Biotech, a semiprivate company created by the Cuban government in 1991 to market its high-tech pharmaceuticals, is now selling products in 34 countries. Among them: an indigenously developed interferon, a hepatitis B vaccine and an advanced streptokinase drug that effectively destroys coronary clots.

With annual sales as high as $290 million a year, Heber, Sotolongo’s Finlay Institute and other centers in Cuba’s biotech industry now rank behind only tourism, nickel production and tobacco as the country’s largest export earner. And it is poised for even bigger growth in the years ahead.

The Finlay Institute’s high-tech Plant No. 3 is the cornerstone of that expansion effort. Packed with more than $100 million of imported equipment, the factory has the capacity to produce 100 million doses of vaccines every year, more than double what it has marketed in the past. And the institute has prepared slick brochures and marketing campaigns to advertise its potential worldwide.

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The Biotechnology Havana ’98 Transgenesis conference scheduled to open Nov. 16 is subtitled “From the Laboratory to the Market,” and it will include commercial endeavors once unthinkable in this Communist state; exhibit space already is renting for $50 per square foot.

And Haber Biotech, marketing itself under the slogan “Approaching Horizons,” now has offices or direct business relations in more than 50 countries, and it boasts that its sales increased more than sixfold from 1992 to 1996.

“This tremendous and sustained research effort is successfully reaching the market,” says Dr. Manuel Limonta, head of Havana’s Center for Genetic and Biotechnology and the affiliated Heber Biotech.

In the center’s latest brochure, which is more a corporate annual report than the work of socialist scientists, Limonta says: “While initially our production was solely for the local marketplace, now our range of products is sold to many countries, anywhere in the world, even the Far East.”

Through most of its 30-year history, Cuba’s biotechnology research industry focused almost entirely on preventing and curing diseases at home--an island nation where medicines were scarce, largely because of the United States’ punishing trade embargo.

After the collapse of the Soviet Union, however, Cuba lost billions of dollars that had kept its socialist economy afloat. The government was forced to inventory its state industries for potential exports to raise the money it needed to continue subsidizing food and providing free education and health care. Its biotechnology industry emerged near the top of the list.

In recent years, the government has invested hundreds of millions of dollars in biotech facilities and research. That has created something of a technology gap here: scientists using advanced genetic techniques to clone fish in a land where the U.S. embargo has made antibiotics scarce on hospital shelves and smoke-belching, ‘50s-vintage Chevys and Buicks commonplace on the streets.

Dr. Mario Pablo Estrada, who heads the fish-transgenesis project, explains the phenomenon with simple mathematics: “With $7 million, we couldn’t even begin to produce our own basic medicines,” which he said are far more costly to mass produce than highly specialized “niche” products such as vaccines.

“But with a $7-million investment here at the genetic research center, we can make $30 million in sales, and we can use that to buy a lot of basic medicines.”

Estrada conceded that the European and U.S. biotechnology markets are highly competitive and that Cuba will need “very strong joint-venture partners” such as SmithKline to penetrate them.

U.S. market analysts, who confirmed that Cuba does have state-of-the-art research and production capability, agreed that Cuba’s entry into the global biotechnology market will be an uphill battle. But they stressed that, after decades of isolation, little is known about the country’s achievements and capacity outside the island.

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Still, U.S.-Cuba trade experts, backed by U.S. scientists familiar with Cuba’s work, say the key to Cuba’s success so far in biotechnology research has not been the financial incentive. They credit the talent of Cuba’s mostly young scientists--along with the ability of an omnipotent one-party state to minimize internal competition and bureaucracy--as the chief reason for the medical breakthroughs.

The U.S. scientists said that the Cubans’ safety and research standards equal or even exceed those of the U.S. Federal Drug Administration and the European Union.

“Cuba’s greatest asset in the biotechnology field is its people, highly skilled scientists who work for next to nothing in salaries and yet maintain the highest possible standards,” says John Kavulich, president of the U.S.-Cuba Trade and Economic Council, an independent, nonprofit group based in New York.

“But Cuba’s biggest challenge in the future is going to be rather simple: money--being able to compensate their people at a comparable level to the multinationals. That is the only way they’re going to keep these people and prevent brain drain.”

The meningococcal vaccine--and the proposed joint venture with SmithKline--is a prime example of how Cuba hopes to accomplish that.

Although the vaccine already has been tested fully in Cuba and South America, SmithKline is required to perform its own clinical trials before marketing the drug. It hopes to do that at the company’s laboratories in Belgium. But, because the laboratories are affiliated with a U.S. subsidiary, U.S. law required SmithKline to apply for a waiver from the embargo.

That application, the first of its kind for a Cuban vaccine, is pending in Washington. But Kavulich says his council, which monitors and reports on trade developments between the United States and Cuba, believes that the U.S. government will approve it.

“The SmithKline proposal is a tremendous development,” he says. “It showed that a Cuban product had value to a multinational and that our Commerce Department is most likely going to approve it. And if that vaccine saves one life in the United States, it’s certainly worth it.”

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Already, a number of top U.S. scientists have weighed in with letters and opinions supporting the waiver. They include a Maryland-based FDA scientist who traveled to Cuba to study its research on the vaccine in the mid-1980s.

“I found the Cuban scientists to be very well trained and were able to produce a well-characterized and well-controlled group B vaccine,” scientist Carl Frasch wrote on FDA letterhead.

He added that the U.S. Centers for Disease Control “has recently reported an ongoing group B meningococcal outbreak in Oregon state. Thus, we too need an effective group B vaccine in the United States. . . . In my opinion, the U.S. would benefit from a collaboration between a large vaccine manufacturer, now licensed in the United States, with the scientific institutes in Havana, Cuba, to produce an improved group B meningococcal vaccine suitable for use in the United States.”

In Sotolongo’s opinion, the Cuban scientists also would benefit.

“For us, every joint collaboration is good. We learn each time, and we teach what we know. And we’ve learned that we can become more powerful when we join together.”