Drug Trial Changes Urged after U.K. Incident Six young men were nearly killed by a drug experiment in England earlier this year, and that incident forced British authorities to look at the safety of drug testing.
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Drug Trial Changes Urged after U.K. Incident

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Drug Trial Changes Urged after U.K. Incident

Drug Trial Changes Urged after U.K. Incident

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MIKE PESCA, host:

This is DAY TO DAY from NPR News. I'm Mike Pesca.

MADELEINE BRAND, host:

I'm Madeleine Brand.

Here's an update now on a story we brought you six months ago. It was about a drug trial in Britain that went horribly wrong. The participants got so sick they nearly died. The six previously healthy young men are still disabled and may never fully recover.

NPR's Rob Gifford reports.

ROB GIFFORD: On the morning of March 13th this year, six young men showed up at a hospital in North London to take part in a drugs trial. They'd each been paid the equivalent of nearly $4,000, a standard sum for volunteers.

The drug they were to be injected with was touted by its manufacturer as being of potential use in fighting cancer and arthritis. One of the six men was 31-year-old Rob O. He says he doesn't want his full last name used, citing concerns about his future employment.

Mr. ROB O (Drug Test Volunteer): Okay, this is seventh floor. This is Parexel's ward, where they do their testing.

GIFFORD: And this is where you came?

Mr. O: This is where I came on that morning, yeah.

GIFFORD: Rob returns to the hospital for a check-up every month and is surprisingly upbeat for a man whose body suffered massive internal organ failure soon after he was injected with the drug.

Mr. O: Ten minutes later, maximum, I was having massive chills and freezing cold and I was shaking as though I was hypothermic or something. And it was a really horrible experience because I tried to keep still, but I just kept moving massively. And then I had aches running up and down my back and in my hips and all of my joints.

GIFFORD: He'd been injected with a drug called TGN 1412, a potent immune system stimulant. Rob says he had no idea that it was anything so powerful or that the others who'd already been injected with it had suffered adverse reactions to the drug. Soon all the victims had swollen bodies and were screaming in pain. One of them came close to death.

Rob is most angry that it took 17 hours for the drug testing company to transfer him from their private ward to the intensive care unit of the hospital. He says medical experts have told him that if he had been administered steroids immediately he would not have become so ill.

The U.S. company conducting the test - Parexel, based in Waltham, Massachusetts - refused to comment for this report, but has previously said it followed all the correct procedures. The manufacturers of the drug, a Germany company called TeGenero, went bankrupt in July. Its insurance policy was unable to cover the long-term cost of treating the victims. Not surprisingly, Rob and the other volunteers are angry.

Mr. O: Obviously I was gaining financially, but on the whole I felt like I was doing something quite noble and it could have helped a lot of people with arthritis, and now I just feel like I was just a tool in a corporate machine. And I really don't see that this corporation values me any more so than the primates that were tested on in the first place.

GIFFORD: The men have received a one time payment of $20,000, but Rob says he's now broke and may be evicted from his apartment. Medical experts say the catastrophe could and should have been avoided.

Dr. David Glover is one of the U.K.'s leading experts on drugs used to treat the immune system. He says that because the monkeys that the drug had previously been tested on lack a particular protein that sparked the adverse reaction in humans, there was no way to measure the potency of the drug.

Dr. DAVID GLOVER (Drug Expert): As a result of that, it was not possible to accurately predict or calculate what sort of dose to use. And the consequence of not having that sort of information was that the trial went ahead with what turned out to be a very large dose and led to side effects that were predictable, given the drug's mechanism of action.

GIFFORD: Though it's no consolation to the six men involved in the trial, the U.K. regulatory body is now re-examining the way trials of drugs like this are tested on humans. Meanwhile, Rob O is trying to look on the bright side, even though he says he feels completely abandoned by everyone involved in the test. Experts say the patients are highly likely in the future to develop health problems associated with a dysfunctional immune system.

Mr. O: Recently I had a feeling in my chest. I thought that it was probably something like indigestion, and so I just waited. And then obviously a few days later if it's still there - which it has been - makes me wonder it it's something like a blood clot or if it's something to do with my lungs going wrong. Because obviously we had problems with our lungs, kidneys and liver. So nobody really knows what the future holds for us. Nor do I.

GIFFORD: He says if the insurers will not settle with a reasonable sum out of court, he and the others will have to sue to get compensation for the trial that ruined their lives. Rob Gifford, NPR News, London.

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