By Sonia Shah, Anniston Star
More than 30 years after the scandalous Tuskegee Syphilis Study showcased the dangers of unregulated medical research, triggering an avalanche of new laws and oversight on human experimentation, American companies continue to engage in poorly regulated experimentation just beyond our borders.
Starved of adequate numbers of Americans willing to enroll in clinical trials for new drugs, over the past few decades pharmaceutical companies have quietly exported their clinical trials business to developing countries, where sick, untreated patients teem and federal oversight is minimal. This year, for example, Wyeth and Merck will conduct at least half of their clinical trials for new drugs outside the United States, and Pfizer is just one among many companies that have opened clinical-trial hubs in India.
The potential for exploitation and ethics violations in these trials is palpable. The FDA accepts data from overseas trials, but does not require any prior review (as they do for trials in the U.S.) and simply accepts the word of local ethics committees and local regulators that FDA's ethical standards have been met.
Many of these countries have weak regulatory infrastructures and poor human rights records, especially toward the impoverished residents who are most likely to enroll in clinical trials. In India, for example, government officials have dismantled rules cramping clinical trials — hoping to increase the foreign drug trials business from $70 million a year to $1 billion — but have enacted not a single law to protect research subjects. The few regulations that do govern the drug industry are lightly enforced at best. “Even if an erring company is caught red-handed indulging in illegal activities,” writes Dr. Chandra Gulhati, an Indian industry analyst, “it is let off … with a light warning.”
In the United States, before ethical standards in medical research were enshrined into law, unethical experimentation openly flourished. Reports on the U.S. Public Health Service's deceptive, non-treatment study of syphilitic black sharecroppers in Tuskegee appeared regularly in the medical literature for years, even after voluntary ethical standards that it clearly violated were publicly articulated. In developing countries, evidence that trials are falling short of ethical standards similarly abounds. Take voluntary informed consent, universally considered the cornerstone of ethical experimentation on humans.
Generally, a steady stream of enrolled subjects dropping out of trials — up to 45 percent in some trials in the United States — is considered a good indication of voluntary consent. The subjects felt free to leave (and did). This phenomenon is disturbingly scarce in trials in developing countries.
In South Africa, drug companies have reported recruiting 3,000 subjects for a clinical trial in nine days, and more than 1,300 children for another trial in 12 days. Those numbers suggest a startling lack of “no” responses. To study this phenomenon, researchers have quizzed people who have already enrolled in clinical trials about whether they are aware that they are free to leave. Studies in Bangladesh and South Africa show that around 80 percent are not.
That should be alarming. Worse yet is that the companies that conduct these experiments on behalf of drug companies tout the unduly positive response among patients in poor countries as a reason to conduct more experiments on them, not fewer. One New Delhi-based company boasts in its promotional literature that it retains “99.5 percent” of enrolled subjects. “Russian subjects don't miss appointments … and only very rarely do they withdraw their consent,” enthused a typical promotional Applied Clinical Trials article, “Discover Russia for Clinical Research.” “What a phenomenon!”
According to industry researchers involved in these trials, their impoverished subjects want to be experimented upon. As a clinician who conducts industry trials on patients in South Africa told me, his subjects are “really very happy. They say, 'Gosh, I'm really happy this happened to me.'” So were the black sharecroppers enrolled in the Tuskegee Syphilis Study, according to the nurse who recruited them. “The ride to and from the hospital … chauffeured by a nurse, was a mark of distinction for many of the men,” nurse Eunice Rivers explained. They “enjoyed waving to their neighbors as they drove by.”
Is that good enough? In a world of inequities, it's always possible to find someone who is willing to tolerate what we ourselves would avoid, be it a toxic waste dump in the backyard or a risky medical experiment. In the world of business, that might be permissible. But according to the laws and ethical codes that govern clinical research, more is expected of us — not just to protect research subjects' human rights and dignity, but our own. One hopes it won't take a travesty on the scale of the Tuskegee Syphilis Study to realize it.
Sonia Shah is an investigative journalist and author of The Body Hunters: Testing New Drugs on the World's Poorest Patients. She will be speaking about her book at the new National Center for Bioethics in Research and Health Care at Tuskegee University on Nov. 30.