https://www.thenation.com/article/rise-unregulated-drug-trials-south-america/
The Rise of Unregulated Drug Trials in South America
US regulators are turning a blind eye to the risks of offshore clinical trials.
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.
The Food and Drug Administration is clearly unable to keep up with the astounding surge of outsourcing in recent years. According to the FDA, the number of trials in developing countries has grown 8 percent a year since 1997. A 2010 report by the inspector general of the Department of Health and Human Services (HHS) notes that 40 to 65 percent of clinical trials on FDA-regulated products in 2008 took place overseas. Of nearly 6,500 foreign trial sites that year, the FDA inspected only forty-five—less than 1 percent.
What’s worse, the dramatic rise of offshore clinical trials has coincided with a loosening of standards guiding their practice. At a time when federal regulators should be scrambling to improve oversight, they are instead making it easier for the pharmaceutical industry to speed drugs to market.
The Rise of Unregulated Drug Trials in South America
US regulators are turning a blind eye to the risks of offshore clinical trials.
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.
The Food and Drug Administration is clearly unable to keep up with the astounding surge of outsourcing in recent years. According to the FDA, the number of trials in developing countries has grown 8 percent a year since 1997. A 2010 report by the inspector general of the Department of Health and Human Services (HHS) notes that 40 to 65 percent of clinical trials on FDA-regulated products in 2008 took place overseas. Of nearly 6,500 foreign trial sites that year, the FDA inspected only forty-five—less than 1 percent.
What’s worse, the dramatic rise of offshore clinical trials has coincided with a loosening of standards guiding their practice. At a time when federal regulators should be scrambling to improve oversight, they are instead making it easier for the pharmaceutical industry to speed drugs to market.
