Clinical Trial Knowedge Gap

The government of India and major pharmaceutical companies have a strangle hold on information about medical research that presents a stumbling block for investigations on medical ethics. The most obvious problem is that there is no national directory of clinical trials in India. While pharmaceutical companies have to seek approval from the Indian Center for Medical Research (ICMR) to run a trial, the center keeps the applications under lock and key. Even if researchers did have access to the data, the information is scattered amongst a hundred thousand color-coded folders in central offices and nearly impossible to reference. For the government, such a directory would be useless, anyway. Vasantha Muthuswami, the head of the ICMR, she told me several months ago that while the in center has the duty to authorize clinical trials, it has no power punish companies who skirt the process or conduct an unethical study.

Even more troubling, is a new trend by major pharmaceutical companies to outsource clinical trials to local Contract Research Organizations, who often sign strict confidentiality agreements that keep the identity of their partner companies and details of ongoing trials secret.

So, while we know that Johnson & Johnson, Wyeth, Astra-Zeneca, Pfizer and GlaxoSmithKline have corporate offices in India, most of their research is conducted by proxy organizations. With confidentiality agreements in place the organizations then have the ability to deny any knowledge or relationship to a CRO that gets caught doing something naughty.

The knowledge gap created by these two things means that the only way to investigate clinical trials is to locate whistle blowers in the organizations themselves or find patients who are willing to talk about the experiments. Finding those people is a challenge in itself. (Bodyhack)