'I nearly died in a medical drug trial'

When Rob Oldfield signed up for a drugs trial at Northwick Park Hospital in 2006, he thought he had found a way to earn some easy money, and do his bit for medical science. But the trial went disastrously wrong, leaving him and five other healthy men fighting for their lives.

On the morning of 13 March 2006 Oldfield joined seven other test subjects at an independent clinic at Northwick Park Hospital run by Parexel, a company which conducts drug trials for pharmaceutical companies.

He was taking part in the first human trial of what was known as TGN1412, a drug that manipulated the immune system.

The German company that developed the drug hoped it would revolutionise treatment of leukaemia and rheumatoid arthritis.

But within minutes of having the drug administered, all of the test subjects began feeling unwell.

"I was injected at about 8am," says Oldfield. "Around midnight I was taken to intensive care."

The group of eight people had initially been split into two groups of four, who were put in separate rooms. One person in each room was given a placebo. The remaining six were given TGN1412.

"They administered to everybody in the other room," recalls Oldfield, who was subject number seven, "then they came into our room."

"We all had a catheter fitted to our arm and an electronic syringe. They came around, plugged in the syringe and pressed go.

"People started feeling cold. Everyone was starting to look a bit under the weather, freezing cold, a bit of the shivers. I thought 'it'll be OK, I'll probably be a placebo'."

Oldfield had no such luck. Subject number eight was given the placebo and went home shortly afterwards.

"They activated the needle - injected me - then I began to feel cold," recalls Oldfield. "The nurses didn't know what was going on really. They were faffing around looking for blankets to keep us warm.

"I remember being sick into a biohazard bag, and all of us being very ill. But the worrying point for me was when one guy, they drew the curtains around him, then these guys with gowns came up, like from an operating theatre.

"They went behind the curtain, then went away and came back with all this equipment - life-support stuff."

Oldfield had signed up to the trial for a fee of £2,000. He had spent two months in the US training as a screen actor, and returned to the UK with some debts he wanted to clear.

"A friend of mine had told me about medical trials before I'd gone. I thought I may as well take of advantage of it. Plus I thought I could be a kind of ambassador for medical science."

Like the other men taking part, he filled out an 11-page consent form which detailed the risks of taking part. But he had no inkling that the "potential hazards" could have resulted in him needing life-support.

"I didn't know it was dangerous. I had no idea it altered the immune system."

But TGN1412 had a catastrophic effect on the six men's bodies. Headaches and chills rapidly gave way to vomiting, severe pain and shortness of breath.

Swollen tissue, plummeting blood pressure and multiple organ failure followed. One by one, all six were transferred to intensive care.

"I remember quite vividly being pushed through those corridors that hospitals have, and when they go outside and it's like a glass enclosure.

"I remember the cool air hitting me and feeling faint because of the temperature change."

Oldfield ended up in an area where people recover after surgery. Intensive care was short of room.

"There were six of us in this triage space, and that's where they started putting machines on us - haemo-filtration, cleaning your blood."

Despite the drama, it took Oldfield some time to grasp the danger he was in.

He was given steroids, which masked his symptoms, and for a time he thought the adverse reaction to TGN1412 was within expectations - it was a trial after all, and the medical staff treating him were not being explicit about his situation.

"They were just saying we need to put this in the top of your leg, put a big tube into the neck, just to give drugs - it wasn't like 'you are seriously ill'."

At about 02:00, some 18 hours after Oldfield was injected, medical staff called his mother and told her she should come to the hospital.

In the middle of the night, she started driving from her home in Bristol to Northwick Park. "The doctors were saying this is your goodbye perhaps - this person could die," he says.

When his mother arrived, the look in her eyes told him that he was in a bad condition. "I now know that I was very puffy because of the steroids," he says. "The whites of my eyes were orange because of the toxins. I didn't look well."

How trials are regulated

People running clinical trials have legal obligations that are set out in Medicines for Human Use (Clinical Trials) Regulations 2004. conditions include:

• Anyone taking part in a trial must have a full understanding of the objectives of the research, and any risks and potential inconveniences they may experience when taking part. This information will be given to them at a meeting with a member of the research team

• A point of contact must be provided so patients can obtain more information about the trial

Before a clinical trial of a new medicine can begin, all of the following needs to be in place:

• The science the research is based on must be reviewed by experts

• The researchers must secure funding

• An organisation, such as a hospital or research institute, must agree to provide a home base for the trial

• The Medicines and Healthcare Products Regulatory Agency (MHRA) needs to review and approve trials of a medicine and issue a clinical trial authorisation (CTA)

• A recognised ethics committee must review the trial and allow it to proceed

Find out more at NHS Choices

For two weeks, Oldfield's blood was filtered 24 hours a day, he recalls. His immune system had crashed, and his liver, kidneys and lungs were failing. Fluid seeped into his lungs and he had to breathe air through a mask, while a direct line pumped vital drugs into his heart.

Thankfully, like all of the men injected with TGN1412 that day, Oldfield survived. After three weeks in hospital, including seven days in intensive care, he emerged alive.

His short-term memory was impaired - for months afterwards he would forget conversations and appointments - and his immune system made extremely weak. Doctors advised him not to use public transport, and avoid other places where he might be exposed to viruses.

But he was, relatively speaking, fortunate.

At least one of the other men in the test experienced severe swelling of the head, leading to the episode being dubbed the "elephant man" trial.

Another spent four months in hospital, and had his toes and parts of his fingers amputated.

Oldfield received substantial cash payments over the course of two years as compensation. He used some of the money to hire a personal trainer to help "get myself in shape and feel more active".

Although he doesn't want to make public the amount of money he received, he believes the compensation was inadequate. He is also critical of Parexel.

He notes that Parexel's own document about the trial said TGN1412 could cause a cytokine storm - the dangerous reaction the men experienced.

The speed at which TGN1412 had been administered was criticised at the time, with one scientist, Prof Terry Hamblin of Southampton University, describing it as "reckless". The eight men in the test were injected at two-minute intervals, leaving very little time to assess its impact on one person before moving on to the next.

An interim review by the Medicines and Healthcare products Regulatory Agency found that Parexel had acted within protocols. But its final report said the trial had not properly considered the safe dosage of the drug for humans - a consideration that at the time was not required by law. It was also noted that there was no formal system in place to provide 24-hour medical cover.

Parexel says it "cannot discuss the specifics of any one patient-related matter to ensure the privacy for our patients and confidentiality for our clients".

Patient safety is the firm's top priority, it says. "Carefully designed and conducted clinical trials are essential in evaluating investigational compounds and treatment regimens."

Oldfield has pursued a career as an actor, and feels his health is reasonable, if not perfect.

"I think my immunity is a bit damaged. I get mouth ulcers more than I ever used to. The specialists say that after two years we should be at the same level as everybody. I don't see how that could be accurate.

"I try to be healthy in general, but who knows?"

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