Is GlaxoSmithKline Behaving Badly in Argentina?

SANTIAGO DEL ESTERO, Argentina, Sept. 23, 2008 — -- Maria Ester, 23, lives in a crumbling, one-room stucco cottage with her mother and daughter in Santiago del Estero, an Argentine province northwest of Buenos Aires.

Ester's 5-year-old daughter and assorted neighborhood children crowd the room, and a sagging mattress that smells like it belongs to a young bed wetter is the only place for a visitor to sit down.

An adult might find the room oppressive. But from a child's perspective, a benefit to living in a shanty is that no one really minds if you draw on the walls. Ester's walls are colorfully scribbled.

Sharp-featured, with glossy hair and warm, brown skin, Ester's small body is still plump with baby weight. She had another daughter, Michaela, but the 5-month-old died May 28.

Michaela had been one of more than 13,000 Argentine children to participate in a clinical study implemented a little more than a year ago by the London-based GlaxoSmithKline, the world's second-largest drug manufacturer.

Streptococcus pneumoniae is a major cause of meningitis and pneumonia in children in Latin America. More than 12 million pneumonia episodes occur each year in this region in children under five and it is estimated that at least 50,000 children die each year of pneumonia in the region according to 2006 data from UNICEF.

Ester says that if her infant hadn't participated in the study Michaela would still be alive.

Protocol Compas is the name of the study designed to test the efficacy of Synflorix, GSK's experimental pediatric pneumonia vaccine, which can also ward off the bacteria that causes meningitis and ear infections. Synflorix is still in the preapproval stage.

GSK compares Synflorix with Wyeth's hugely successful Prevnar vaccine, which has proved effective in the United States. Besides Argentina, trials are also being conducted in Panama, Chile and Colombia.

The Outsourcing of Clinical Studies

Americans are swallowing more prescription medications than ever, and the ever-increasing appetite for pharmaceuticals has fueled the drug industry's search for cheaper and faster ways to conduct clinical testing.

In 1997, the United States conducted 5 percent of its clinical studies outside of the United States and Western Europe, according to a study conducted by Tufts Center for Drug Development. By 2007, that number had climbed to 29 percent.

Because of the multinational business of major drug companies, and how Americans fit in as U.S.-based employees and stockholders of GSK, as well as consumers of drugs that will be available in the U.S. market, there are global ramifications of clinical testing being conducted around the world.

The lion's share of drug studies has gone to regions with "emerging markets": Eastern Europe and Central Europe, Latin America, and south and Southeast Asia. In order for a region to be of use to a legitimate drug company, the country has to maintain a minimal level of infrastructure, says Mary Jo Lamberti, director of market research at the Boston-based Center Watch, a consulting firm that bills itself as the "Global Destination for Clinical Trials Information."

According to Fortune magazine, it takes about $900 million to bring a new drug to market, and procuring and retaining human subjects typically accounts for about 40 percent of a drug company's budget. Conducting trials in regions considered "poor" by Western standards makes economic sense.

Yet money is not the only factor in the equation, Lamberti says, whose work includes helping pharmaceutical companies find suitable locations for clinical trials. It's easier and takes far less time to find suitable subjects in many developing countries, she says, because they have large "drug naive" populations.

In other words, a large percentage of Americans are already on various medications, so it's difficult to find subjects with unadulterated -- that is, completely unmedicated -- bodies in the United States.

Critics say there is an additional issue that has yet to be taken seriously.

Individual countries generally have their own boards of medical professionals charged with setting standards to ensure the safety of their citizens. And the United States, for example, has an arm of the Food and Drug Administration tasked with overseeing clinical studies performed abroad. The trouble, critics say, is that the standards that exist are sometimes not upheld.