A 24-year-old woman who died after taking part in a Johns Hopkins University asthma study was not fully informed of the risks involved. A committee has been formed to investigate the death as reported to the federal government's Office of Human Research Protection (OHRP).
Hexamethonium, one of the drugs administered in the study, is not approved by the US Food and Drug Administration (FDA) and is no longer in clinical use. The patient developed a cough after inhaling hexamethonium as part of the trial. The cough turned into respiratory disorders within a month, and she died of hypotension and organ failure.
So last week, the federal government's (OHRP) suspended almost all of the studies because of the recent death of this woman who had enrolled in a Hopkins asthma trial as a healthy volunteer. As the lead researcher had not been aware of the published reports of toxicity associated with the prolonged usage of this drug before starting the study and had not discovered it during the literature survey he had conducted. There were many drawbacks with the way the research was conducted.
However after working it out among the Hopkins representatives and OHRP officials it is now decided that the studies will resume and it will be conducted under the terms and conditions formulated by Hopkins and approved by the OHRP and the additional guidelines imposed by the government agency.
Medicines are being developed to treat new diseases or improve upon the existing treatment, thus research is usually concentrated on selective therapeutic areas. Research and development is fast becoming the major area of focus in India due to the pressures from the developed countries, across the world in implementing the uniformity in the patent laws, after 2005.
Reuters; July 2001