Drug Trial Fiasco!

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Six taken ill after drug trials

Six men remain in intensive care after being taken ill during a clinical drugs trial in north-west London.
The healthy volunteers were testing an anti-inflammatory drug at a research unit based at Northwick Park Hospital when they suffered a reaction.

Relatives are with the patients, who suffered multiple organ failure. Two men are said to be critically ill.

An investigation has begun at the unit, run by Parexel, which said it followed recommended guidelines in its trial.

The men were being paid to take part in the early stages of a trial for the drug to treat conditions such as rheumatoid arthritis and leukaemia until they were taken ill on Monday within hours of taking it.

Eight volunteers were involved, but two were given a placebo at the unit which is on Northwick Park Hospital's grounds but is run independently.

This is an absolutely exceptional occurrence - I cannot remember anything comparable

Richard Ley, Association of the British Pharmaceutical Industry


'They say he needs a miracle'
Q&A: Drug trials
Send us your experiences

The hospital's intensive care director Ganesh Suntharalingam said the patients were admitted very quickly and were receiving "close monitoring and appropriate treatment".

A Northwick Park Hospital spokesman said two were in a critical condition, while the other four were "serious but stable".

Richard Ley, spokesman for the Association of the British Pharmaceutical Industry, said: "This is an absolutely exceptional occurrence. I cannot remember anything comparable."

The Medicines and Healthcare products Regulatory Agency (MHRA) immediately withdrew authorisation for the trial. An international warning has also gone out to prevent it being tested abroad.

Its inspectors will visit the research unit and it is in contact with the local strategic health authority, the Department of Health and police about the cases.

Animal testing

Chief executive officer Professor Kent Woods said: "Our immediate priority has been to ensure that no further patients are harmed.

"We will now undertake an exhaustive investigation to determine the cause and ensure all appropriate actions are taken."

It had approved the trial and the drug had already been tested on animals and in a laboratory.

Volunteers are paid up to £150 a day to take part in clinical trials.

Healthy volunteers are used to test the safety of the drug in "phase one" of the trial before further tests with people who have the condition to determine whether the drugs work.

'Swift response'

Parexel, which was running the trial, said it had followed guidelines and such cases were extremely rare.

Professor Herman Scholtz, from Parexel, said the clinical research organisation had followed regulatory, medical and clinical research guidelines during the study.

He said: "When the adverse drug reaction occurred, the Parexel clinical pharmacology medical team responded swiftly to stop the study procedures immediately."

He added: "Such an adverse drug reaction occurs extremely rarely and this is an unfortunate and unusual situation.

"Since our unit is located within the hospital, we have immediate access to world-class medical care and we did everything possible to get the patients treated as quickly as possible."

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Trials are vital to the production of new drugs
Six men are in intensive care after experiencing a serious reaction to drug taken during a clinical drugs trial in north-west London.
What happened to make the men ill, and how is such research governed?

What has happened?

The six healthy men, all under 40, had volunteered to take part in a trial of an anti-inflammatory drug, called TGN1412, to treat conditions such as rheumatoid arthritis and leukaemia being tested at an independent research unit based at Northwick Park Hospital.

The six have suffered multiple organ failure and two are said to be critically ill.

Another two men, who had been given a dummy pill in the trial, are not ill.

The trial was stopped as soon as the men fell ill.

An investigation into what happened at the unit, run by clinical trial company Parexel, is being carried out by the watchdog, the Medicines and Healthcare products Regulatory Agency (MHRA) and the police.

It is thought one other European country is currently carrying out trials on the drug.

What went wrong?

This is what the investigation is designed to find out.

Parexel say they followed all the rules set in place for drug research.

A spokesman for the German company TeGenero, whose drug was being tested, said the results were "completely unexpected" and "did not reflect the results we obtained from initial laboratory studies".

Dr Benedikte Hatz, chief executive officer for the company, said the drug had been developed in line with all regulatory and clinical guidelines, and had been shown to be safe in earlier non-human studies.

The company said its thoughts were with the patients and their friends and relatives, and would work with the doctors treating the men.

Solicitor Ann Alexander, representing at least one of the critically ill men, said families had received "mixed messages" over the course of the last few days.

Professor Kent Wood, of the Medicines and Healthcare products Regulatory Authority (MHRA) said the options to be considered would be whether or not there was a problem with the manufacturing quality of the drug, if there was evidence it had been contaminated, or whether the men were given too high a dose.

The other possibility experts will consider is whether this was a completely unpredictable severe side effect of the drug in humans, which had not been indicated by earlier research.

What are drugs trials and how are they organised?

Drug trials refer to the process by which medicines are developed.

Before a drug is tested in humans, it would have been through laboratory and animal testing.

Medicines are also tested for toxicity before being given to people.

There are then three stages of drug testing in humans - and any such trials have to be approved by ethics committee.


Phase one - this stage tests for safety. A small number of people, sometimes healthy, and sometimes with a medical condition, are given a tiny dose of the drug under careful supervision, not to test if the drug works, but in order to check for any side effects

This is the stage which the Parexel research was at.


Phase two - the drug is given to people who have the condition to see if it does indeed help them

Phase three - large scale studies usually involving tens or thousands of people

Participants are often randomly allocated to either get the drug or a dummy version


In most cases neither the scientists nor the patients know who has got the real drug so that the results cannot be skewed by expectations.

Once a drug has been through all these stages of testing - which can take up to 10 years - it will be considered for licensing.

But even then, pharmaceutical companies must keep carrying out research to ensure a drug is still safe and effective.

Who gives permission for them to go ahead?

All trials which take place in the UK have to be authorised by the MHRA, which decides if they are scientifically valid and properly designed.

Local ethical committees also have to decide if the research is in the best interests of patients.

Trials are run by charitable and acedemic institutions, as well specialist companies, such as Parexel, whose units are usually based at NHS hospitals so they are close to scientific and medical expertise.

These companies carry out research on behalf of clients from the pharmaceutical industry, like the TeGenero, who are developing this drug.

Who takes part in such trials?

Researchers recruit volunteers to take part in studies. Phase one trials, because they often need healthy people, may advertise in magazines, on the internet or in the local area.

Such research can require people to spend two or three weeks in the research unit, so many of those taking part are students.

However, women of reproductive age would not be involved if there was any chance they were pregnant, in case there were effects on a foetus.

The ABPI, which has set down guidelines on how trials should be carried out, says people should not be given financial incentives to take part in research.

However, they should be recompensed for the time they are giving up. The standard rate is between £150 and £200 a day.

For phase two and three trials, where patients with a certain condition are needed, adverts may also be placed in patient newsletters or in particular clinics.

It is estimated that just a few hundred healthy people take part in phase one trials in the UK each year.

Altogether, over 100,000 will be taking part in some kind of trial.

Do people know things could go wrong?

Anybody who takes part has to be told what risks are involved and what known side effects might be.

They would also be told what compensation would be in place if something unexpected went wrong.

Ben Hayes of the ABPI said people should not take part in trials if they feel they have not been given sufficient information.

But he said trials were taking place for the good of the wider population: "At some point, scientists have to translate the theory into humans."

How common are problems such as those seen in this trial?

Drug trials are sometimes stopped early. An HRT trial in the US was stopped when researchers linked the drug to an increased risk of stroke.

However, this study was a phase three trial, so was at a much later stage than the London research.

The MHRA said it had never seen a situation such as that seen at Northwick Park before.

And Richard Ley, of the Association of the British Pharmaceutical Industry (ABPI), added: "This is an absolutely exceptional occurrence.

"I cannot remember anything comparable."

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A man who has made a 'second career' out of taking part in drug tests has said he will not be put off from volunteering for more trials despite six men falling seriously ill.

Thousands of people take part in trials every year

Vincent Moissac-Vignoux, 33, from Hackney, east London, is a construction worker by trade but said he makes about £13,000-a-year from drug trials and has been taking part in them since 1997.

He insists that despite six men being taken into intensive care on Tuesday during a clinical drugs trial he would not think twice about going for another test, he said: "I'm not worried at all - it just means more opportunities for me."

He first took part in a trial after answering an advert in TNT magazine but is now on a list of volunteers which pharmaceutical companies use.

Barred for life

He explained the list shows when you last took part in a trial as applicants can only be used in trials three or four months apart.

He said Parexcel, the company involved in the incident at Northwick Park, send out texts alerting people on the register to upcoming trials.

But he adds there are a number of safeguards.

"When you go for the trial you have to fill out a medical questionnaire, have blood and urine tests, a breathalyser test, a test to see if you are a non-smoker," he said.

I have fainted a few times and once I did go blind in one eye for about an hour

Vincent Moissac-Vignoux


'He needs a miracle'

"If they find you are a smoker or you tested positive for recreational drugs then you are barred for life.

"If you then pass the medical tests, the pharmaceutical company contacts your GP, who can veto your participation if they want."

Mr Moissac-Vignoux said the company then outlines all the possible side effects and "most importantly how much you are going to be paid".

"I don't think I've ever been put off or been scared after reading what the adverse reactions might be," he said.

"But I have fainted a few times and once I did go blind in one eye for about an hour.

I have tested potions, lotions and inhalers. I have nothing to lose and I can make good money.

Vincent Moissac-Vignoux


Q&A: Drug trials

"Every trial is different. Sometimes you are kept in, other times you are treated on an outpatient basis.

"But the treatment you get is much better than in the NHS. You have individual care, with the best facilities in plush surroundings.

"I have tested potions, lotions and inhalers. I have nothing to lose and I can make good money."

Mr Moissac-Vignoux said he has met firemen, policemen and armed forces personnel on the trials but they are mostly travellers, and generally South Africans and Australians.

If you can navigate your way around the world with just a backpack, you are not a stupid person

Lynnette Ewb, editor of TNT magazine


Drugs trial men 'seriously ill'

One antipodean, Xavier Walsh, said: "We got paid £2,500 for 15 days in a hospital.

"Of those 15 days, for only three were we being administered the drugs. The rest was just free time."

Lynnette Ewb, editor of TNT magazine which targets Australians, New Zealanders and South Africans living in London, said: "I have been at TNT for six years and have come into contact with many people who have gone on these trials.

"For travellers it is a good, fast, and on the whole a safe way, of making extra money while travelling.

"And I think it is misleading to suggest people jump blindly into these things.

"If you can navigate your way around the world with just a backpack, you are not a stupid person."

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Two men are critically ill and another four are seriously ill in the intensive care unit of Northwick Park hospital after taking an anti-inflammatory drug as part of a drug trial.
Myfanwy Marshall's boyfriend is one of those whose condition is critical. Doctors have warned he could die at any time.

She says he decided to take part in the trial - which paid about £2,000 - because he needed some money to pay his bills.

"He saw the ad, he told me it was for a leukaemia drug. He'd taken part in trials before and been fine.

"I didn't want him to do it, but he said he was helping mankind, helping scientific knowledge."

I can see beyond the wires - I know he's in there

Myfanwy Marshall


Q&A: Drug trials
Send us your experiences

Myfanwy, 35, said he went into the Parexel unit at Northwick Park to begin the trial on Monday morning.

She received a call from the hospital at 3am the next day.

Doctors said her boyfriend had had a bad reaction to the drug.

She said the man she knew was "completely gorgeous, a beautiful person, really buoyant, oozing with charm and really muscly."

Now, she says, her 28-year-old boyfriend who runs a bar in London, has changed beyond all recognition.

'In the dark'

"I went in expecting to see his smiley face and curly black hair.

"But he was completely lifeless. He's like a shell of who he is.

"He can't even move his eyelids.

"This machine is pumping out his lungs. His chest is puffed out, his face is puffed out like the elephant man.

"A day ago I was talking to him and he was fine and now they are saying he could die at any moment."

She said his friends cannot bear to see him. His parents, who live abroad, are currently trying to get over to the UK.

They say he needs a miracle

Myfanwy Marshall


Making a career out of drug tests

Myfanwy added: "I can't hold his hand because of the tubes. But I have to stay there because I can see beyond the wires. I know he's in there.

"I sit and talk into his ear and tell his body to heal itself."

Myfanwy said doctors were working round the clock to treat the affected men, and were talking to scientists in the US and Germany who had worked on the development of the drug.

But she added: "The doctors say they are in the dark. They don't know the drug or what it can do.

"It's a drug they haven't tested on humans before, so they don't know what they're dealing with. All they can do is look at how his body has reacted."

"They say he just needs to get the drug out of his system.

"They say he needs a miracle."

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The six are being treated at Northwick Park hospital
A drugs company says it has apologised to the families of two critically ill men and four others in a serious condition after a clinical drugs trial.
All are still in intensive care in Northwick Park Hospital, north-west London, after falling ill on Monday.

TeGenero, which manufactures the anti-inflammatory drug, described the reactions as "shocking developments".

Scotland Yard said officers are talking to the Medicines and Healthcare products Regulatory Agency and doctors.

On Thursday morning, a hospital spokesman said there had been no change in the men's clinical condition overnight.

One of the critically ill victims has been named as student Ryan Wilson, 21, of Highbury, north London.

Some screamed out that their heads felt like they were going to explode

Trial volunteer Raste Khan


Drug trials: Your views

Another who was taken seriously ill has been confirmed as a New Zealander.

It was the first time the drug TGN1412, designed to treat conditions such as rheumatoid arthritis and leukaemia, had been tested on humans.

Within hours of taking it on Monday, the six young volunteers had to be admitted to intensive care.

They "went down like dominoes", according to Raste Khan, 23, one of two trial volunteers who escaped unscathed after being given a placebo.

He told the Sun newspaper: "They began tearing their shirts off complaining of fever, then some screamed out that their heads felt like they were going to explode.

"It was terrifying because I kept expecting it to happen to me at any moment. But I felt fine and I didn't know why."

Guidelines followed

The Medicines and Healthcare products Regulatory Agency is looking at whether the reaction was caused by a manufacturing problem, contamination, a dosing error or whether it was some "completely unanticipated side-effect of the drug in humans".

Myfanwy Marshall, 35, whose boyfriend is critically ill, said the normally healthy 28-year-old's face was so puffed, he "looks like the Elephant Man".

"They just keep saying he's very, very sick and we are doing all we can," she added.

The hospital says it is continuing to treat the men's "inflammatory disorder" and would do all it could to support the families.

American company Parexel, which ran the trial, said it had followed recommended guidelines.

'Mixed messages'

And TeGenero said the new medicine had showed no signs of problems in earlier tests.

Chief scientific officer Thomas Hanke added the company's first concern now was making sure the patients got the best treatment possible and to support the families.

He said: "They were shocked, devastated. We deeply understand that they are. We are devastated at these shocking developments which we were not anticipating."

But the families said they had been given "mixed messages" during two meetings with the companies.

A Metropolitan Police spokeswoman said it was "more than likely" officers had visited the hospital, adding that police were keeping a close eye on the case.

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A student who was due to take part in a trial of the drug which has left six men seriously ill has spoken of his concern for those involved.

Student David has done a number of drugs trials

Student David O'Donnell, 19, was expecting to take part in a higher dose trial of the drug, TGN1412, in April but it was cancelled when the six men were taken ill.

One of his friends, who is said to be in a serious condition in hospital, was actually on the trial.

"I am very worried about him indeed but I had a message from my friends to say they have managed to get in contact with him."

He said that as he was "partly responsible" for letting his friend know about the financial benefits of the trial, he felt a certain amount of "irrational guilt".

Financial rewards

The first year economics student at university in Birmingham said that as someone who has done a number of different drugs trials, he was "very shocked" when he heard how the subjects had reacted to the drug.

It is a freak, unlucky accident

David O'Donnell

But Mr O'Donnell said his main reaction was one not of relief for himself but of fear for those left ill.

He told the BBC News website: "Understandably, it was a strange experience, but primarily I was more concerned with the well-being of those involved.

"There's a certain sense of relief. But it's a situation where the bad luck involved definitely outweighs the good luck.

"I have another friend who was going to do that trial as well, and he is equally relieved."

The 19-year-old said many students took part in the trials because of the large sums of money involved.

He added: "Being a student, it is very difficult to find flexible employment. Clinical trials allow us to earn large sums of money in a small amount of time."

The fee for the trial in question, he said, was the equivalent of a student loan and would make a real difference to a student's life.

'Freak accident'

They might even enable them to pay off their tuition fees.

However, the events at Northwick Park Hospital have not shaken Mr O'Donnell's faith in clinical trials and he still plans to take part in one in the near future.

"When I've been doing these trials there have been a number of safety measures in place.

"I've always found them to be professional and responsible for everything they have done.

"I sincerely believe this is an anomaly and not a regular occurrence. It is a freak, unlucky accident."

He added that without them the pharmaceutical industry and the medical profession would not be able to find new cures for devastating diseases.

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All medicines are tested on humans before being widely used
Clinicians are urging people not to be deterred from volunteering for medical research after men in a drug trial fell seriously ill.
Two men are critically ill and four others are in a serious condition after being the first people to take an anti-inflammatory drug.

But researchers say human trials of new drugs are crucial in their development.

Experts have stressed that the severe reactions to this drug are unprecedented.

Clinical trials are fundamentally important to get better drugs

Professor Robert Moots, University of Liverpool

TeGenero, the company which has developed the drug, said the reactions in the men were completely unexpected, given earlier findings from animal and laboratory work.

Its chief scientific officer Thomas Hanke said the company's first concern now was making sure the patients got the best treatment possible and to support the families.

Professor Robert Moots, a rheumatologist at the University of Liverpool, runs clinical trials.

He said they were fundamentally important to get better drugs.

"That's not just to get more effective drugs, but also their safety."

"But I'm concerned that this horrible thing that's happened will put people off.

"I've never seen anything like this before."

'Safeguards are in place'

Professor Janet Darbyshire, who is director of the clinical trials unit of the Medical Research Council, told the BBC: "Clearly this is very worrying and we hope that the end result is going to be positive.

"But I think that the most important thing we must remember is that this is a very, very rare occurrence and that thousands of people enter drug trials every day.

"Without such trials, we're not going to have any new developments for treatment or vaccines," she added.

She said everything was done to protect volunteers from unnecessary risk.

"We have many, many safeguards in place and all these safeguards are put there to minimise the risk.

"What we can't predict is the unpredictable," she said.

She said it was not yet known exactly what had happened in the Northwick Park trial, but added: "Every precaution is taken to minimise the risk but we can't remove the risk of things we truly can't predict."

'Somebody must be first'

Ben Hayes, of the Association of British Pharmaceutical Industry (ABPI), added: "All of the medicines from which we benefit today would have been through these tests.

"Such tests are essential and, at some stage, somebody has got to be the first to take a new drug."

And Dr Evan Harris, a Liberal Democrat MP, who took part in early trials of an HIV vaccine trial six years ago, said it was vital that volunteers and patients continued to take part in such trials.

"Such trials are a critical step in the generation of new treatments for human diseases.

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One of the men given a dummy drug as part of the clinical trial that left six men seriously ill has said the study was like "Russian roulette".
Raste Khan said that the test ward in north-west London became a "living hell" as the men spasmed in agony.

Two remain critically ill but four have shown signs of improvement.

A solicitor representing one man said it was not clear if successful animal tests had been previously held.

Some screamed out that their heads felt like they were going to explode

Trial volunteer Raste Khan


Human trials 'fundamental'
Drug trial student's fears
Drug trials: Your views

Ann Alexander, whose 29-year-old client is on a life support machine, said: "There is confusion about whether the drug had actually been tested successfully and safely on animals before the tests on these volunteers."

She said the "problem" needed to be "investigated urgently".

"The other six have obviously gone through a terrible time. I don't know what their families are going through."

Mr Khan from Barry, near Cardiff, was given a placebo, and spoke to the BBC courtesy of the Sun newspaper.

He said: "It was Russian roulette. There were eight of us. Two of us were really lucky."

He added: "They must be going through a terrible time at the moment. I really hope they're going to get through this.

"All we can do is hope they're going to be fine."

He said that luckily he felt OK after being given his injection but that the others on the trial began falling "like dominos".

'Significant change'

"The gentleman on my left said, 'I've got really bad headache pains.' He said he was hot and then he started hyper-ventilating.

"Then they tried to calm him down and then he passed out and came back to consciousness, he vomited and then they got a big bin liner from somewhere for him to vomit in," he said.

Then he described how another volunteer became unwell and said he could not control himself and needed the toilet.

"Everything was unplugged from him, he stood up, took several steps and he fainted. He was quite a big guy, it took quite a few nurses to help him up."


I didn't want him to do it, but he said he was helping mankind, helping scientific knowledge

Myfanwy Marshall


'They say he needs a miracle'

Earlier, Mr Khan had told the Sun newspaper: "Some screamed out that their heads felt like they were going to explode."

Clinical Director of Intensive care Ganesh Suntharalingham at Northwick Park Hospital said: "Of the six patients admitted to critical care, the four who are seriously unwell are continuing to show signs of improvement but it is still early days.

"The other two men remain critical and it could be a while until they show significant change."

One of the critically ill men has been named as student Ryan Wilson, 21, of Highbury, north London.

Another who was taken seriously ill has been confirmed as a New Zealander. The New Zealand High Commission said he was "conscious and has spoken to hospital staff".

'No signs of problems'

It was the first time the drug TGN1412, designed to treat conditions such as rheumatoid arthritis and leukaemia, had been tested on humans.

American company Parexel, which ran the trial, said it had followed recommended guidelines.

TeGenero, which manufactures the anti-inflammatory drug, said it apologised to the sick men's families and said the medicine had showed no signs of problems in earlier tests.

Chief scientific officer Thomas Hanke added the company's first concern now was making sure the patients got the best treatment possible and to support the families

Scotland Yard said officers are talking to the Medicines and Healthcare products Regulatory Agency and doctors.

The MHRA is looking at whether the reaction was caused by a manufacturing problem, contamination, a dosing error or whether it was some "completely unanticipated side-effect of the drug in humans".

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The six are being treated at Northwick Park hospital
Investigations into how a drugs trial left six men seriously ill - two of them critical - are continuing.
Police and regulators are probing whether problems were caused by errors or were an unpredictable side-effect.

Staff from Parexel, the firm that carried out the trial at Northwick Park Hospital in north-west London, insist the right procedures were followed.

Four men left seriously ill by Monday's trial have regained consciousness. The other two remain critically ill.

An initial review at the site has shown that best practices were followed

Herman Scholtz
Parexel

But medics say they are beginning to respond to treatment.

Four of the men suffered multiple organ failure within hours of taking the drug TGN1412 on Monday.

The Medicines and Healthcare products Regulatory Agency is investigating whether the reaction suffered by the men was caused by a manufacturing problem, contamination or a dosing error.

They have seized documents and sealed off offices at the hospital research unit.

Scotland Yard said officers were talking to the MHRA and doctors.

Herman Scholtz, head of Parexel, praised staff's swift response when volunteers suffered a reaction during tests of an anti-inflammatory drug.

In a statement posted on the website of US-based Parexel Dr Scholtz said: "An initial review at the site has shown that best practices were followed.

I think it's really unfortunate that there might be given an impression that our very ethical drug industry is actually not working according to proper practice

Lord Winston


Lord Winston
Drug trials: Your views

"We remain in close and constant contact with the Northwick Park Hospital concerning the medical status of the six volunteers."

On Friday, local Labour MP Barry Gardiner met the North West London Hospital Trust chief executive Mary Wells, and said there was no better place for the patients to be treated.



Mr Gardiner said: "MHRA has sealed the offices of Parexel, bagged and taken away all the relevant information, is conducting interviews with Parexel and with their staff."

He added it was unclear how long the inquiry by the UK medicines watchdog would take.



TeGenero, which manufactures the drug, apologised to the sick men's families and said the medicine had shown no signs of problems in earlier tests.

The company's chief scientific officer, Thomas Hanke, said he and his colleagues were "devastated" by what had happened.

He said TGN1412 had been tested extensively in laboratories and on rabbits and monkeys with no adverse effects and no drug-related deaths.

It was the first time the drug, designed to treat conditions such as rheumatoid arthritis, leukaemia and multiple sclerosis, had been tested on humans.

'Noticeable progress'

Dr Ganesh Suntharalingam, head of intensive care at Northwick Park, said the two men worst affected by the trial were showing signs of recovery but they remained under sedation.

He added: "Some of them have made noticeable progress in response to our treatment and we have been able to reduce the amount of organ support that is required.

"However, it is early days and they will clearly still continue to need specialist observation for some considerable time.

"There are also some very early signs of response to treatment in the most critically ill patients but I must stress that their condition remains very serious and complex and it wouldn't be sensible to comment on prognosis."

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Four men left seriously ill after taking part in a drug trial have regained consciousness, say doctors.
Another two are in a critical condition and under sedation but have shown early signs of responding to treatment, said Dr Ganesh Suntharalingam.

The men suffered multiple organ failure within hours of taking the TGN1412 drug at a research unit based at Northwick Park Hospital in north-west London.

Medical research firm Paraxel said its staff followed correct procedures.

Herman Scholtz, head of Parexel, praised staff's swift response when volunteers suffered a reaction during tests of an anti-inflammatory drug.

In a statement, posted on the website of US-based Parexel, Dr Scholtz said: "An initial review at the site has shown that best practices were followed.

I think it's really unfortunate that there might be given an impression that our very ethical drug industry is actually not working according to proper practice

Lord Winston


Lord Winston
Drug trials: Your views

"We remain in close and constant contact with the Northwick Park Hospital concerning the medical status of the six volunteers."

Dr Suntharalingam, head of intensive care, said: "Some of them have made noticeable progress in response to our treatment and we have been able to reduce the amount of organ support that is required.

"However, it is early days and they will clearly still continue to need specialist observation for some considerable time.

"There are also some very early signs of response to treatment in the most critically ill patients but I must stress that their condition remains very serious and complex and it wouldn't be sensible to comment on prognosis."

On Friday, Labour MP for Brent North, Barry Gardiner, visited the North West London Hospital Trust chief executive Mary Wells, and said there was no better place for the patients to be treated.


He added it was unclear how long the inquiry by the UK medicines watchdog would take.

The Medicines and Healthcare products Regulatory Agency (MHRA) is investigating whether the reaction suffered by the men was caused by a manufacturing problem, contamination, a dosing error or whether it was some "completely unanticipated side-effect of the drug in humans".

Mr Gardiner said: "MHRA has sealed the offices of Parexel, bagged and taken away all the relevant information, is conducting interviews with Parexel and with their staff."

Speaking to the BBC on Thursday, Lord Winston, a fertility expert, rejected claims regulation of clinical testing of new drugs was "weak and ramshackle".

The professor of fertility studies at Imperial College London and vice-chairman of the Parliamentary Office for Science and Technology, said Britain's system of clinical trials had "lots of safeguards".

He was responding to concerns raised earlier by Paul Flynn MP.

"I think it's really unfortunate that there might be given an impression that our very ethical drug industry is actually not working according to proper practice because I think on the whole it undoubtedly is," he said.

He said he was concerned about growing resistance to animal testing.

He said: "I wonder really whether in fact there's increasing reluctance to do the preliminary trials on animals because of the difficulties generally in doing animal research.

"That I think is a disaster for humans."

'Tested on monkeys'

TeGenero, which manufactures the drug, apologised to the sick men's families and said the medicine had shown no signs of problems in earlier tests.

The company's chief scientific officer, Thomas Hanke, said he and his colleagues were "devastated" by what had happened.

He said TGN1412 had been tested extensively in laboratories and on rabbits and monkeys, with no adverse effects and no drug-related deaths.

It was the first time the drug, designed to treat conditions such as rheumatoid arthritis, leukaemia and multiple sclerosis, had been tested on humans.

Scotland Yard said officers were talking to the MHRA and doctors.