Unregulated Clinical Trials, Exploitation, and Profit: How the FDA Allows Big Pharma to Exploit the Poor in South America
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When her son’s diarrhea wouldn’t stop, Diana Canessa, cash-strapped and panicky, scraped together some change, grabbed her last diaper and headed for the emergency room at Lima’s public hospital for children. It was there, she says, that a nurse offered free oral rehydration therapy for her son, Fabrizio, and free meals and diapers for her.
Canessa was given a form to fill out. “I didn’t understand some of the words,” she said. “But they told me, Apurate, mamita. Apurate .” Hurry, hurry. After the two-day treatment, Fabrizio’s diarrhea subsided. Canessa got diapers and rash cream and a taxi home. But when the diarrhea returned a few days later, the people at the hospital were less helpful. “They gave me a ball and some more cream and sent me home,” she said. “They said the problem was his diet.” Then one day she saw a man on the news talking about how babies at the children’s hospital had been given an experimental oral rehydration therapy containing a genetically modified rice solution made in the United States. Soon she was telling her story to reporters. She fears Fabrizio’s allergies and chronic health problems are related to the treatment he received. “Nobody said anything about it being an experiment,” she told me. “I would never have agreed if I had known. I worry all the time.”
It could have been worse. In 2008, in the Argentine province of Santiago del Estero, seven babies died while taking part in trials for an experimental vaccine made by GlaxoSmithKline to prevent pneumonia and related diseases. Their mothers claimed they also didn’t know.
Or consider what happened in the case of Ketek, an antibiotic drug used for respiratory tract infections. In 2000 Sanofi-Aventis conducted a series of clinical trials in the United States and abroad. One Alabama doctor was paid $400 a head to recruit patients and caught the eye of FDA reviewers for signing up subjects in droves. She ultimately went to jail for falsifying data in 91 percent of her cases; another doctor presiding over trials was arrested on cocaine and gun charges. Despite warnings from its reviewers, the FDA allowed Sanofi-Aventis to submit foreign trial data in place of that compromised domestic research—Ketek got the green light for sale in 2004. It wasn’t until 2007, after a dozen deaths from liver failure had been reported, that the FDA recommended restricting its use—a day before Congress was to investigate.
Foreign clinical trials for US-bound drugs have been commonplace for decades, and ethical breaches are a frequent side effect. Last year, a professor at Wellesley College unearthed evidence of a particularly egregious case from the 1940s in which scientists working for the Public Health Service deliberately infected Guatemalan prisoners, mental patients and soldiers with syphilis and other sexually transmitted diseases in order to study the effects of penicillin. President Obama apologized to Guatemala’s government and called for an investigation into the incident as well as current standards of practice. When the Presidential Commission for the Study of Bioethical Issues submitted its report in September, commission chair Amy Gutmann said, “We must look to and learn from the past so that we can assure the public that scientific and medical research today is conducted in an ethical manner.”
But is it? A generation ago, most human testing took place in American academic institutions. Now it’s a global game dominated by corporations, called contract research organizations (CROs), that help Big Pharma bring new molecules from the lab to your medicine cabinet. More and more drug companies are turning to CROs for assistance with trial design and recruitment, regulatory compliance, marketing and branding—last year the CRO market was worth $20 billion, an estimated 100 percent jump from a decade ago. And CROs, in turn, are increasingly running trials in the developing world because doing so is cheaper and faster: regulations aren’t as onerous, patient recruitment is easier and informed consent is less clearly defined.