London Drug Trial Goes Horribly Wrong

March 16, 2006 — -- A man who took part in the drug trial that landed six other men in a London hospital recounted the harrowing moments when the participants sitting by his side fell violently ill.

In an interview to the U.K.'s The Sun newspaper, Raste Khan, who was one of two volunteers to be given a placebo instead of the trial drug, said the other participants reacted within minutes of receiving the injection.

"The test ward turned into a living hell minutes after we were injected. The men went down like dominoes," Khan said.

Khan says he witnessed the men writhing in pain, vomiting uncontrollably, fainting, and hyperventilating.

All six of the men remain in the intensive care unit of Northwick Park Hospital in London. Two of the men are in critical condition, while four men in serious condition have shown slight improvement. The patients have suffered multiple organ failure, leaving them in a precarious medical state.

The eight volunteers were the first human subjects to be administered the drug, in a clinical trial run by the American drug research company Parexel. The drug was being developed to treat arthritis and leukemia, among other diseases.

A statement issued by Parexel said, "An initial review at the site to date has shown that best practices were followed and all of the appropriate police and procedures were adhered to. Furthermore, we commend the staff for their swift reactions with the volunteers when the adverse reaction occurred. This type of reaction is extremely rare, and is a very unusual event."

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The Medical and Healthcare Products Regulatory Agency, the British industry watchdog group, is investigating what went wrong. Among possible reasons for the violent reactions are that they were given the wrong dosage, took contaminated drugs, or experienced an unexplained reaction that wasn't seen in the earlier animal testing.

Although complications sometimes arise in clinical trials, it is rare that they happen this seriously so early in the testing process, when only a small group of healthy people are given a low dose of the drug. The drug was administered to animals in earlier testing, and the chief of the German drug company TeGenero said there "[had] been no issue on the safety of the drug on animals."

The lack of explanation is only compounding the distress of the six men's families, who have been holding vigil at the hospital.

In an interview with the BBC, the girlfriend of one of the critically ill volunteers said through tears, "This is a drug they have never tested on humans before so they don't know what they are dealing with. It's completely messed up their vital organs."

"I walked in, and I nearly fainted. He's a young, gorgeous, hunky guy. … And I walked out, and he was all puffed out like the 'Elephant Man.' He looks like a 45-year-old man who's had a cardiac arrest," Myfanwy Marshall said.

Like tens of thousands of others, the men had volunteered for the clinical test to make extra money. According to British press reports, they were being paid up to $3,500 for the study.