Six Healthy Volunteers in Phase I Drug Trial-Critically Ill_UK

Eight healthy volunteers–some are students were tempted by money.
Were they informed about the potential hazards of becoming human test subjects?
The two lucky ones received placebo.
The six who ingested the experimental drug fell ill immediately and are in critical condition.

 Parexe described the incident as "unfortunate and unusual," and said "it had followed guidelines and  such cases were extremely rare."
  How rare?  "We use standardized procedures for testing a drug in humans for the first time, based on a well-defined protocol, designed by the sponsor company and approved by ethics committees and regulatory authorities."  

There are no independent monitors who inspect clinical trial sites to ensure safety standards are followed.
Becoming a human subject under current lax standards is a gamble with one's life–much like Russian roulette.  

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

By contrast, the FDA has yet to stop an artificial blood product from being tested on trauma patients without their informed consent–
even as officials of the Office of Human Research Protections have urged the Acting Commissioner to halt the trial.

There are no laws protecting the public from being misled about the dangers of becoming a guinea pig.
The BBC is requesting comments from the public.
 
Contact: Vera Hassner Sharav
veracare@ahrp.org
 
 

http://news.bbc.co.uk/1/hi/england/london/4807042.stm
BBC:  Six taken ill after drug trials
2006/03/15
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.

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."

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.

http://www.heraldsun.news.com.au/printpage/0,5481,18478173,00.html
 Six violently ill after drug trial
15mar06

SIX men are in intensive care in a British hospital after suffering violent reactions to a new drug they took as part of a clinical trial.
One man's head had swollen up to three times its normal size, a newspaper reported today.The volunteers fell ill after taking the drug, being developed for a German company to treat chronic inflammatory conditions and leukaemia.Student Ryan Flanagan, 21, of Highbury, north London, was taken to intensive care three hours after taking the drug, The Sun newspaper reported.

His family were told he could not breathe and his head and neck had swollen to three times normal size.Family friend Sarah Brown, 27, told the paper: "Ryan was a healthy young man and he saw the trial advertised on the internet." He is at college and was doing it to make a bit of extra money."He told us he would be paid STG2,000 ($4,750) and did not think there would be any problems."  His mother got a call to say his head and neck were swelling up and his legs were purple."The Medicines and Healthcare Products Regulatory Agency (MHRA) said eight men took part in the trial, two of whom were given a placebo. The six who took the drug all became ill."An event like this is quite unprecedented," the MHRA's chief executive officer Kent Woods said.

"There are several possibilities as to what might have gone wrong," he told BBC radio today.
"We've had inspectors on site since yesterday trying to clarify what exactly the event was that caused this disaster."

Has there been some manufacturing problem?
Has there been some issue of contamination?
Has there been a dosing error or is this indeed some completely unanticipated side effect of the drug in humans, which is specific to humans?

"The trial was set up by US drug research company Parexel International Corp on behalf of German pharmaceutical company TeGenero.
Parexel described the incident as "unfortunate and unusual", adding that it assumed the volunteers had suffered an adverse reaction to the drug, known as TGN 1412.

"Such an adverse drug reaction occurs extremely rarely," Professor Herman Scholtz, head of Parexel International Clinical Pharmacology, said in a statement.
This was the first human test of the drug, designed to treat illnesses like cancer and rheumatoid arthritis.
As soon as the men fell ill, the MHRA suspended the trial and notified other European regulatory bodies about it.

The unnamed patients are being treated at Northwick Park Hospital in northwest London."They are in a serious condition," said Ganesh Suntharalingam, the hospital's Clinical Director of Intensive Care. "Their families are very concerned, and we are keeping them closely informed about their relatives' progress."

     © Herald and Weekly Times

 http://edition.cnn.com/2006/HEALTH/03/15/uk.clinical
CNN: Six in hospital after drugs trial
LONDON, England — Two men were in critical condition Wednesday in a London hospital and four others were in serious condition after taking part in a clinical trial.  The men were admitted to the intensive care unit from an independent medical research unit at Northwick Park hospital after reacting badly to the new drug, which is intended to treat chronic inflammatory conditions and leukemia.

News reports said the patients suffered extreme swelling while participating in a drug trial run by clinical research company Parexel International, based in Boston, Massachusetts.  Parexel said it had operated within regulatory guidelines and that such adverse reactions to drugs were extremely rare.
The Sun newspaper said one of the men had been taken to intensive care after his head and neck increased to three times normal size. It quoted a friend as saying the 21-year-old was a student and had taken part in the trial to make money after seeing an advertisement on the Internet.

The UK medicines watchdog — the Medicines and Healthcare products Regulatory Agency (MHRA) — immediately started an investigation.
Professor Kent Woods, Chief Executive Officer at MHRA, told the UK Press Association: "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."
The eight men had all volunteered to take part in the trial. Two were given a placebo and were unharmed.

Ganesh Suntharalingam, Clinical Director of Intensive Care, told PA: "Although they were not part of an NHS trial, we were able to admit the patients very quickly to critical care and our full team has been treating them.

"They are in a serious condition and they are all receiving close monitoring and appropriate treatment. Naturally their families are very concerned and we are keeping them closely informed about their relatives' progress."

Professor Herman Scholtz, from Parexel, said: "When the adverse drug reaction occurred, the Parexel clinical pharmacology medical team responded swiftly to stop the study procedures immediately.
"Such an adverse drug reaction occurs extremely rarely and this is an unfortunate and unusual situation.
Scholtz said Parexel had acted within regulatory, medical and clinical research guidelines during the study.
"We use standardized procedures for testing a drug in humans for the first time, based on a well-defined protocol, designed by the sponsor company and approved by ethics committees and regulatory authorities," he said.

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