Latin Americans ‘Guinea Pigs’ for Foreign Clinical Trials

Emilio Godoy

HAVANA TIMES, Jan. 31 (IPS) — Leonor, a Mexican citizen, took part in a 2006 clinical trial of a drug to treat kidney disease, designed by a transnational pharmaceutical company.

“A friend of mine who is a nurse told me about the trial and I decided to take part,” Leonor, a 30-year-old saleswoman who has kidney problems, told IPS. “I was given regular doses of the medicine for several weeks, and they said it worked.”

Her story is just one among many as clinical trials are increasingly taking place in countries like Mexico and Brazil, for reasons that range from cheaper costs to less rigorous oversight.

“Labs need patients in a given short time,” U.S. expert Lorna Speid, author of the book “Clinical Trials: What Patients and Healthy Volunteers Need to Know,” told IPS. “Depending on the company, the costs could be lower, maybe Mexico is more expensive.”

Speid’s book, published in 2010 by Oxford University Press, is a guide to medical research and the rights of those who participate in clinical trials.

A total of 1,310 studies have been performed in Mexico, 2,090 in Brazil and 1,099 in Argentina, according to the U.S. National Institutes of Health (NIH) database.

The number of trials outside of the United States has grown in recent years. In 1990, only 271 tests of medicines aimed at the U.S. market were held in other countries, according to the U.S. Department of Health and Human Services.

But by 2008, the number of trials abroad had leapt to 6,485. NIH records show nearly 60,000 experiments in 173 countries after 2000.

The Food and Drug Administration (FDA) in the United States only reviews the results of the studies, without examining the way they are conducted. The Mexican Federal Commission for Protection against Health Risks (COFEPRIS), which approved 155 new medicines in 2010, performs a similar role.

Transparency is a key issue in medical research of this sort, and in its pursuit, the Iberoamerican Cochrane Network, a regional association of researchers, proposed setting up a Latin American Ongoing Clinical Trial Register (LATINREC), although ultimately this initiative did not prosper.

“The Cochrane Collaboration recognizes the importance of prospectively registering trials to ensure that the evidence assessed is valid and comprehensive, and to minimize the risk of publication and reporting bias,” says an article titled “The Latin American Ongoing Clinical Trial Register (LATINREC)”, by 14 researchers belonging to the Iberoamerican Cochrane Network, published in the Revista Panamericana de Salud Pública/Pan American Journal of Public Health in 2006.

The Cochrane Collaboration is dedicated to making up-to-date, accurate information about the effects of health care readily available worldwide, so that health care users have access to everything that is known about the effects and can make informed decisions.

In 2005 the World Health Organization (WHO) recommended registration of all clinical trials and full disclosure of key information at the time of registration in the interests of absolute transparency in medical research and fulfilling ethical responsibilities to patients and study participants. However, this has not yet been fully applied in Latin America.

Therefore it is not surprising to come across cases like that of Celebrex, an anti-inflammatory drug to relieve the pain of arthritis and premenstrual syndrome, made by the U.S.-based pharmaceutical giant Pfizer.

Pfizer carried out at least 290 clinical trials of Celebrex, 183 of them on U.S. soil and the rest elsewhere, according to the NIH register. At least eight research trials were performed in Mexico, six in Costa Rica and 10 in Brazil.

After Pfizer spent more than one billion dollars promoting the drug, reports began to emerge in 2004 that taking Celebrex increased patients’ risk of suffering a heart attack or stroke. The Journal of the Royal Society of Medicine reported further harmful effects in 2006. Yet Celebrex is still on the market.

In September 2010, the FDA announced that preliminary results from a clinical trial in Mexico indicated that Rotarix, a vaccine against rotavirus for children, carried a risk of causing intestinal obstruction. However, because of the lack of conclusive data, the vaccine is still available.

Rotarix, made by British-based global pharmaceutical company GlaxoSmithKline, was approved for use in the United States in 2008.

“I came out in bruises, and the doctors are trying to find out why,” said Leonor — not her real name, because she signed an agreement to keep details of the clinical trial confidential.

Speid, who spent two years writing her book based on her experience and research, said “Patients are blind about the process, they don’t know how to protect themselves, and nobody cares about their rights.”

Normally pharmaceutical companies subcontract the conduct of clinical trials to local laboratories. In the United States, doctors who take part in the research studies have to register with the FDA.

Doctor registration for this purpose fell by 5.2 percent in the United States between 2004 and 2007, but increased by 10 percent in Latin America, 12 percent in Asia and 16 percent in Eastern Europe, where regulations are more lax.

“Registration of clinical trials is expected to help enhance the general public’s trust in medical science and the pharmaceutical industry,” says the article by the Iberoamerican Cochrane Network, which has branches in Venezuela and Brazil.