Ending Medical Sweatshops
This is my site Written by Alex on March 4, 2009 – 9:58 am   

Third world countries are used as medical sweatshops to test drugs, devices, and treatments that will be used by citizens in developing nations. Those are the overall findings of a report on the globalization of trials published in the New England Journal of Medicine on February 19. (You can read the article here.) Fixing the problems with the “ethically murky” practice of outsourcing clinical trials, the Duke University researchers who wrote the report say, “will require input from stakeholders in academia, industry, and regulatory agencies around the world.”

Even though the report is welcome, it’s a telling example of how unaware the West is with the horrific acts taking place in the developing world in the name of advancing medical science. Fortunately, people in third world countries are already insisting on ethical treatment in clinical trials and sponsors are finding themselves becoming forced to treat subjects like human beings instead of guinea pigs.

For instance, Charles is a 43-year-old brick maker who lives in Gayaza, a small town on the outskirts of Kampala, Uganda. He, along with one of his daughters, is HIV-positive. His wife and one of his children have already died of AIDS. Once a month Charles walks five miles to a government-run medical clinic to get HIV medication for himself and his daughter. Three times last year drug company representatives from different United States corporations have come to Charles’s home and offered to give him free experimental HIV medication. They said their drugs were better than the ones he was taking. They said they would make repairs to his house. They offered him money. Charles was suspicious and three times he turned them down. “The drugs I am taking are working,” he says. “I have no reason to take their drugs.”

For years people in third world countries agreed to be subjects in clinical trials when researchers from the United States came with promises of money rather than detailed information about the effects of the tests they were conducting. Such “cooperation” sent a lot researchers knocking on a lot of doors in Nigeria, Russia, China, and other countries with high rates of poverty.

In 1996 86 percent of clinical trials took place in the United States. In 2006 that number was 57 percent. Drug companies from the West are already committed to spending millions of dollars in overseas projects. GlaxoSmithKline and AstraZeneca, in England, along with Roche and Novartis, both in Switzerland, have invested $100 million in clinical research in China. With billions worth of drug patents set to expire in the next six years, U.S. companies have been aggressively developing new medicines more often in the third world countries. One Indiana-based pharmaceutical company, for instance, is spending $300 million to run clinical trials in China.

The sponsors of clinical trials have become entrenched overseas not only because it’s been much less expensive to conduct trials in underdeveloped countries. It’s also because the regulations on testing drugs, devices, and treatments in foreign countries have traditionally been laughable.

The FDA accepts data from clinical trials conducted in countries outside the U.S. if those trials meet the standards set forth in the Helsinki declaration (a set of ethical guidelines adopted in 1964) or if they meet the regulations established by the host country, whichever are stricter. The Helsinki declaration not only fails to carry the weight of law, it does not mandate overwhelmingly strict regulatory oversight. And regulations governing clinical trials have been almost nonexistent in most host countries located in the developing world.

In the 1990s one man named Ilian Ivanov oversaw the regulations governing clinical trials in Bulgaria. He also moonlighted by recruiting companies to Bulgaria to conduct trials. Ivanov insisted that this apparent professional conflict of interest did not mean he was a pushover who allowed the sponsors of clinical trials to cut corners. To illustrate this point, when he caught two Bulgarian researchers conducting trials without government permission Ivanov slapped them with a ten-dollar fine.

But Ivanov represents the past while in Uganda Charles represents the future. Some countries are starting to regulate trials or to hold sponsors of clinical trials from the West to stricter standards. In Nigeria, after a United States court refused to hear civil and criminal charges that were personally brought against executives at Pfizer after a clinical trial went badly, Nigerian courts decided to move forward with the prosecution in their own courts. China has proposed tougher import and export regulations for medical materials entering and leaving their country. In several African countries people are attending universities in the United States and returning home as bioethicists eager to establish oversight systems similar to those in place at the FDA.

With or without the “input from stakeholders in academia, industry, and regulatory agencies around the world,” sponsors of unethical clinical trials in the third world have worn out their welcome to such a degree that they are already on notice. If they want to continue recruiting subjects in poor countries and developing life-saving drugs, devices, and treatments they’ll need to start offering something other than money and small favors. They’ll need to finally bring people like Charles a valid consent form and tell the truth about the risks of what they’re testing.

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