Initial human tests of novel drugs must go more slowly to avoid tragedies such as one this year in London in which healthy volunteers almost died, medical safety experts said.
Medicines that alter the body in completely new ways carry the highest risks, said Alastair Wood, a drug-safety expert from Vanderbilt University, and Janet Darbyshire, director of the Medical Research Council’s clinical trials unit in London. Giving them to patients for the first time requires extreme care, they wrote in the New England Journal of Medicine.
A novel drug from TeGenero AG, a small, 6-year-old German biotechnology company, caused multiple organ failure after it was injected into six men in London in March. The drug was given to all six patients at about the same time. Instead, a single volunteer should have received the drug and been monitored for immediate and delayed reactions, they wrote.
If that had been done, “fewer volunteers would have been injured, because the serious toxic effects would have been identified in the first volunteer,” they wrote. “We have an opportunity to learn from events in the TeGenero study how to improve early drug evaluation, and we clearly need to do so as we develop more and more new compounds.”
Keeping detailed information on experimental drugs in a secure database may also help regulators identify early signs of problems and inform them about previous research, Wood and Darbyshire said in Thursday’s issue of the journal. In some cases, investigators don’t know when others already tried, and failed, to safely manipulate a new biological target.
Wood is a professor of medicine and pharmacology at Vanderbilt, in Nashville, Tenn. He led the U.S. Food and Drug Administration’s advisory panel on pain drugs.
