Drug Trials Gone wrong

I had a friend that subjected herself to three weeks of clinical trials; they paid her around $6,000. After the trial and a about a year later, she was Chronically ill. I can’t believe people actually subject their selves to this type of abuse. FYI, phase one trials can be conducted at anytime even though pre trial procedures are not made public. Most pretrial procedures are private. If this pharmaceutical company skipped animal testing- or what ever, they’re in a world of sh!@#$t.

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Q&A: Drug trials
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."

Have you taken part in a drug trial? How did you find the experience? Would you consider taking part in one? Have you conducted a drug trial? Send us your comments and experiences.

Story from BBC NEWS:
http://news.bbc.co.uk/go/pr/fr/-/1/hi/health/4808090.stm

Published: 2006/03/15 10:18:31 GMT

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