In almost 90 per cent of cases, novel drugs tested on humans by pharmaceutical companies do not work as intended and must be scrapped. Often the drugs do not work, while at worst, test subjects die. New research from the University of Southern Denmark now shows that this number can be reduced. The secret is to test the drug on cells grown as 3D structures.
In 1993, five out of 15 liver patients who participated in a medical trial following the American Federal Drug Administration's (FDA's) instructions died. The patients had been treated with the substance fialuridin that should treat them for the disease hepatitis B. The substance was tested in the laboratory and on animals and had been evaluated as safe for human testing.
Surprisingly it turned out that the substance was acutely lethal to humans and led to extensive liver failure. Five patients died and two others only survived because they received a liver transplant.
When researchers develop new medicines, there are not just billions of dollars and years of research on the line. Patient safety is also at stake.
Now, new research from the University of Southern Denmark shows that the safety for people participating in medical experiments can be improved.
"With our new technique the pharmaceutical industry can better avoid harmful or even fatal effects on medical test subjects," says cell researcher Stephen Fey from the University of Southern Denmark.
When a new drug is developed, its individual active substances are first tested for adverse effects. All substances in the world are potentially deadly if the dose is high enough this was first stated by the German-Swiss scientist Paracelsus (1493 - 1541) in the Renaissance. The challenge is to find substances that have a positive, healing effect and not a toxic or deadly one.
The substances are often tested on human liver cells in the laboratory. If liver cells do not respond negatively to the
|Contact: Birgitte Svennevig|
University of Southern Denmark