Serious Harm By Research

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.

Just months ago, a clinical trial in London that saw the first use of a drug in humans resulted in six healthy subjects becoming violently ill. Two of the volunteers nearly died. The volunteers were paid several thousands of dollars to participate in the trial.

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 numbers 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 lifespans. No single entity keeps track of the real extent of the abuse of all human subjects engaged in research either in the United States or worldwide. I estimate that in the US alone, there are more than twenty million subjects, half of whom represent drug trials. Worldwide, this number could exceed fifty million, with about half that number in drug studies. These staggering numbers present an awesome responsibility for our citizens and our governments alike.