telescope, drug, clinical trials

Could a Cuban Cancer Drug Improve US-Cuba Relations?

September 03, 2009 03:00 PM
by Anita Gutierrez-Folch
The U.S. is conducting clinical trials on a cancer drug developed in Cuba, but unless embargo laws are altered, the drug won't be available for sale in the U.S.

Groundbreaking Clinical Trials

For the first time in 50 years, the U.S. is performing clinical trials for a Cuban-made drug. Nimotuzumab was developed in Havana and designed for the treatment of cancer, John Dorschner reports for The Miami Herald.

The drug, called "exciting" and "interesting" by a University of Florida researcher, is meant to “target cancer cells including those in rare and deadly types like glioma, the brain cancer that killed Sen. Ted Kennedy,” Dorschner writes. According to YM BioSciences, the company that owns most of the rights to test the drug in North America, nimotuzumab is meant for patients with solid tumor cancers.

In order to obtain permission to test the drug in the U.S., YM BioSciences had to apply to the Department of the Treasury's Office of Foreign Assets Control for an exception to the embargo. In 2006, they were allowed to perform trials on children with inoperable brain cancer. After further lobbying, YM finally obtained permission to test the drug “on patients with all sorts of cancers” in August. Almost 20 clinical trials are in progress, and are expected to take three or four years, The Miami Herald reports. David Allan, CEO of YM, told Pharmaceutical Business Review that the drug “has been demonstrating efficacy in trials throughout the world.”

The current economic embargo, however, could prevent nimotuzumab from being sold in the U.S. As Dorschner explains, YM BioSciences owns 80 percent of the rights for the development of the drug in North America, Europe, Japan and other countries where the drug has not yet been approved. The remaining 20 percent remains with the Center of Molecular Immunology, “the biotech lab in Havana that developed the drug,” Dorschner writes.

If the clinical trials prove to be successful, YM would need to apply for an alteration of the embargo law. According to a statement released by the chief of staff for Miami Republican congressman Lincoln Diaz-Balart, quoted by The Miami Herald, “The medical trials for this drug will take several years. Diaz-Balart hopes that by then the Cuban people will be free.”

Background: CancerVax and other precursors

The case of the nimotuzumab drug is not a first. Other companies such as SmithKline Beecham and CancerVax have lobbied for permission to test Cuban-made products in the U.S.

Andrew Pollack explained in The New York Times that CancerVax, a California-based biotechnology company, was allowed to license three experimental Cuban drugs and perform clinical trials for them in the U.S. in 2004. As a spokesman for the State Department explained at the time, “the exception had been made because of the life-saving potential of the experimental Cuban drugs and that the license approval did not represent a relaxation of the trade policy.”

In 1999, the pharmaceutical company SmithKline Beecham, currently known as GlaxoSmithKline, obtained a license to test a Cuban vaccine to treat meningitis B. H.P. Goldfield and Richard A. Popkin, the lawyers that handled the CancerVax approval case, told the Times that Congress made “no real opposition” to the case.

According to The Miami Herald, however, both CancerVax and SmithKline Beecham decided to forego clinical trials after research, despite having obtained the necessary permission.

Historical Context: The economic embargo and its future

As a byproduct of the economic embargo reinstated by President Ronald Reagan in 1982, Cuba was forced to fend for itself in key industries such as biotechnology, Jason Shafrin writes in his blog, Healthcare Economist. Surprisingly, the country has managed to achieve great success.

“With more than 7,000 scientists dedicated to researching new drugs, Cuba has one of the most sophisticated biotech industries in the developing world,” Mary Murray explains in the MSNBC blog, World Blog. “Last year the country earned $350 million from exporting 180 different medicines.”

In February, Indiana Sen. Richard Lugar, a Republican on the Senate Foreign Relations Committee, proposed that the U.S. reconsider its longstanding embargo on Cuba. The committee issued a report entitled “Changing Cuba Policy—In the United States National Interest.” In a letter that accompanied the report, Lugar urged for a reconsideration of the embargo due to the failure of its main purpose, “bringing democracy to the Cuban people,” CNN reported.

Although the report doesn’t necessarily advocate an immediate lifting of the ban, it does suggest ending restrictions imposed on travel to Cuba, officially working with the country to control migration and drug trafficking, and allowing Cuba to purchase U.S. agricultural products on credit.

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