Something went horribly wrong in an early experimental trial of a German start-up drug company’s new cancer-and-arthritis med. Sometime last week, the drug—TGN 1412—was given to 6 healthy volunteers in a routine Phase 1 trial, designed to test the drug’s safety. Today, all six of those volunteers are laid up in intensive care wards in Britain, fighting for their lives.
The volunteers “experienced adverse events,” the company stated in its press release. I’ll say. One young man’s head and neck ballooned to three times the normal size. The others suffered multiple organ failure. See the BBC story here.
Here’s how big the drug business is. This company has no drugs in its portfolio. A former Roche exec launched the company, TeGenero, specifically to develop TGN-1412 (and, presumably, other drugs like it.) They got drug giant Boehringer Ingelheim on board to manufacture their as-yet-undeveloped drug. They got the European drug authorities to bestow their unborn med with “orphan” drug status (because along with cancer and arthritis, the drug might also be used for rare diseases.) They raised no less than 14 million Euros…and all this with no proven-effective drug in hand. Until nearly killing some volunteers this week, all the drug had been proven to do was help some artificially sickened rats.
One can only imagine the financial and scientific pressure on the first human test of the drug. On the other side of the test bed, the usual cohort of cavalier and cash-starved students would have lined up. For these kinds of tests, it is students and homeless people who generally bear the burden of risk. Drug companies purposely set up their early testing centers near universities to entice them. Do they understand the risks involved? Who knows? At a payrate of around $100 to $200 a day, including room and board, “it’s money fordoing almost nothing,” as a trial volunteer once explained to me.
Never mind that early trials are, arguably, the mostdangerous of all experimental drug trials. Toxic reactions occur in about 40 percent of all Phase One trials. And as we can see from this botched experiment, sometimes those toxic reactions are a whole lot worse than a minor skin rash.
This time news leaked out. But generally, the public never hears anything about failed early drugs. The experimental drug poisons a few test subjects and is quietly dropped from development, with nary a drop of ink about it, just one in a line of failed drugs lying in the wake of each and every blockbuster. We await the results of the investigation, now ongoing.
