Friday, October 13, 2006
By Eva von Schaper
Oct. 13 (Bloomberg) -- The German developer of an experimental treatment that left six men with multiple-organ failure in a U.K. medical test didn't supply information that may have alerted regulators to the possible risk, scientists said.
Key documents submitted to U.K. regulators lacked data from studies that may have shown the danger of the treatment, called TGN-1412, researchers said in an article in The Lancet today.
``Essential information was absent,'' the researchers including Adam Cohen of the Center for Human Drug Research in Leiden, the Netherlands, said in the article.
TeGenero AG, a six-year-old biotechnology company based in Wuerzburg, Germany, didn't include proof that biological structures vital to the function of the drug were identical in humans and monkeys, which were used in preliminary medical trials. Other published data also wasn't included.
In the trial, six men were given a laboratory-produced antibody designed to treat arthritis, leukemia and multiple sclerosis at a north London facility run by Waltham, Massachusetts-based Parexel International Corp. The men were hospitalized for weeks after severe reactions to injections of the medicine developed by TeGenero. TeGenero has since filed for bankruptcy.
Tests in Monkeys
In March, TeGenero AG said swollen lymph nodes in monkeys reported in earlier tests wouldn't be enough to rule out human trials. Thomas Huenig, an immunologist at the University of Wuerzburg and a supervisory board member of the company, said it was impossible to overdose rats and mice using the drug. The swollen lymph nodes in animals was evidence of the way the drug worked, rather than a side effect, the company said.
Ethicists, shown the Parexel clinical trial consent form after the March 13 medical test, said the document describing the experiment and its risks didn't sufficiently inform participants of the therapy's possible dangers or properly depict the treatment as a novel drug that can disrupt the body's immune system.
The 13-page form also exploited the subjects' need for money, threatening to withhold the 2,000 pound ($3,725) payment if the men left the test early, the ethicists said.
To contact the reporter on this story: Eva von Schaper in Munich at email@example.com .