Britain to update its drug trial rules

Aug 03, 2006

Britain is planning a major revision of pharmaceutical drug trial regulatory rules after an incident that nearly killed six men.

The trial of a new immune system drug in a London hospital earlier this year left the young men in intensive care for weeks. Physicians say they will suffer from severely damaged immune systems the rest of their lives -- but the drug companies involved in the trial have refused to cover any of their medical expenses or provide compensation, The New York Times reported.

A subsequent investigation revealed loopholes in Britain's drug testing system that, investigators said, in some instances seemed devised more to bring drugs to market rather than protect human safety, the newspaper reported.

Since the incident, the British Health Department, the U.S. Food and Drug Administration and the Association of the British Pharmaceutical Industry have issued revised recommendations for testing new medicines, particularly those aimed at essential biological pathways.

"The lesson learned is that now when we see a molecule like this -- one with a novel mechanism -- we need a very different approach," Dr. John Jenkins of the FDA told the Times. "Now that we've seen this episode, we will be very cautious going forward."

Copyright 2006 by United Press International

Explore further: Two US states order tough Ebola quarantine rules

add to favorites email to friend print save as pdf

Related Stories

Wireless sensor transmits tumor pressure

Sep 20, 2014

The interstitial pressure inside a tumor is often remarkably high compared to normal tissues and is thought to impede the delivery of chemotherapeutic agents as well as decrease the effectiveness of radiation ...

Introducing the multi-tasking nanoparticle

Aug 26, 2014

Kit Lam and colleagues from UC Davis and other institutions have created dynamic nanoparticles (NPs) that could provide an arsenal of applications to diagnose and treat cancer. Built on an easy-to-make polymer, these particles ...

Treating pain by blocking the 'chili-pepper receptor'

Aug 20, 2014

Biting into a chili pepper causes a burning spiciness that is irresistible to some, but intolerable to others. Scientists exploring the chili pepper's effect are using their findings to develop a new drug ...

Recommended for you

Two US states order tough Ebola quarantine rules

2 hours ago

New York and New Jersey on Friday ordered a mandatory quarantine for medics who treated victims of Ebola in West Africa, after the deadly virus spread to America's largest city.

NY and NJ say they will require Ebola quarantines

20 hours ago

The governors of New Jersey and New York on Friday ordered a mandatory, 21-day quarantine for all doctors and other arriving travelers who have had contact with Ebola victims in West Africa.

User comments : 0