Sun, Jun 04, 2006 - Page 9 News List

Revealing the widespread torment of human research subjects

By Adil Shamoo

The media, legislators and other organizations often raise concerns about human-rights violations and ethical breaches in clinical research. Such cases are legion. Human subjects are allowed to be bitten by 100 mosquitoes that could carry malaria in a study in Brazil. A French doctor performs a face transplant without the benefit of the usual research that would accompany such a high-risk procedure. An 18-year-old subject in a gene therapy trial dies, with numerous lapses in the clinical trial noted after his death.

The general public is aware of clinical research trials, but there is little awareness that the number of subjects enrolled in research is much larger than the number enrolled in clinical trials alone. While some research-related deaths reach the popular media, the actual number of deaths in research is higher. Even regulators and industry experts are not aware of the true numbers of deaths and adverse events, due to the lack of proper reporting.

The large numbers of human subjects in research are an outgrowth of the legitimate need for more and better health care throughout our ever-lengthening lifespan. No single entity keeps track of the real extent of the abuse of all human subjects engaged in research in the US or worldwide. I have estimated that in the US alone, there are more than 20 million subjects, half of whom represent drug trials. Worldwide, this number could exceed 50 million, with about half that number in drug studies. These staggering numbers present an awesome responsibility for our citizens and our governments alike.

The immediate ethical issue facing us is the real harm inflicted on unsuspecting subjects through a vast array of indignities, adverse events, injuries and death. Many of those who are harmed are poor, uneducated and politically powerless. Some are also impaired in their ability to give informed consent due to mental or cognitive disabilities, or are exposed to coercion, improper monitoring and pervasive conflicts of interest. Moreover, the justice of the distribution of risks and benefits is questionable when research subjects are concentrated on a vulnerable segment of our society.

Bloomberg's Market magazine recently published an extensive article on the unethical practices of a large contract research organization conducting some clinical trials in Florida. Illegal immigrants from the Latin American community were used as trial subjects and threatened with reporting of their status to the US Department of Homeland Security if they complained about the risks of the drug that they received.

That is only one example. The system of protections for human subjects worldwide is either non-existent or broken. In the US, this system has three levels: federal regulation, institutional oversight and researchers' ethical obligations. But there are serious shortcomings and gaps throughout the system. At the federal level, the protections apply to publicly funded research and those seeking a drug license, which probably covers 60 percent to 70 percent of all human subjects, although no one knows for sure (contrast this with the protection of animals in research, which since 1966 covers all animals, regardless of the sponsor).

Further down the chain of supervision, research institutions are designated to "manage" their own conflicts of interests as well as those of their investigators. Yet many institutions and investigators have a financial stake in the clinical trials they are conducting. Most investigators have little or no training in ethics and regulatory compliance, for which there is no mandatory education.

This story has been viewed 2771 times.

Comments will be moderated. Keep comments relevant to the article. Remarks containing abusive and obscene language, personal attacks of any kind or promotion will be removed and the user banned. Final decision will be at the discretion of the Taipei Times.

TOP top