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Bez
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Post by Bez »

Drug trial volunteers 'critical'



Six men are in intensive care after taking part in a clinical drugs trial in north-west London.

They were admitted to Northwick Park Hospital on Monday from an independent research unit in its grounds, suffering from a bad reaction to the drug.

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

The UK medicines watchdog immediately withdrew authorisation for the trial of the anti-inflammatory drug.





The Medicines Watchdog the Medicines and Healthcare products Regulatory Agency (MHRA) said its inspectors would be visiting the research unit.

Its 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 is working with the local strategic health authority, the Department of Health and police on the investigation.

Two given placebo

The men were volunteers in a trial for an anti-inflammatory drug to treat conditions such as rheumatoid arthritis as well as leukaemia.

Eight men had taken part, but two were given a placebo.

Intensive care director Ganesh Suntharalingam said the patients had been admitted very quickly, but all were in a serious condition and were receiving "close monitoring and appropriate treatment".





BBC London correspondent Tim Donovan said some cases were believed to be life threatening. Relatives are at the hospital with the patients.

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."

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."

He stressed Parexel had acted within regulatory, medical and clinical research guidelines during the clinical study.

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Bez
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Post by Bez »

Scientist defends clinical trials



The six are being treated at Northwick Park hospital

A top scientist has defended Britain's system of clinical testing after six men fell seriously ill during a London trial of an anti-inflammatory drug.

Fertility expert Lord Robert Winston told the BBC he rejected claims that regulation was "weak and ramshackle".

Britain's system was among the "strongest and most carefully regulated" in the world, he said.

The six men have been in intensive care since falling ill on Monday. Two of them remain in a critical condition.

Doctors at Northwick Park Hospital in north-west London said the men had been given several blood transfusions to try to rid their bodies of toxins.

Four were said to be showing signs of improvement but doctors said it was still early days.

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

The men suffered multiple organ failure within hours of taking the drug TGN1412 during a trial at a research unit based at the hospital.

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

Lord Winston, professor of fertility studies at Imperial College London and vice-chairman of the Parliamentary Office for Science and Technology, told BBC Radio 4's The World Tonight Britain's system of clinical trials had "lots of safeguards".

Responding to a question by Labour MP Paul Flynn, he said: "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."

Animal testing

He said he was concerned about growing resistance to animal testing in Britain and the effect this might be having on drugs trials.

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."

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

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

Family support

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 for safety with no adverse effects and no drug-related deaths.

He added that the company's first concern now was making sure the patients got the best treatment possible and to support their families.

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

The 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".
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tedhutchinson
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Post by tedhutchinson »

In this case the drug trial was for another anti-inflammatory drug which would help the immune system.

Why do we need another anti-inflammatory immune boosting drug?

Because we are getting further and further away from the diet and lifestyle in which humanity evolved.

Boston USA is roughly in the same latitude in Spain yet half of all hospital patients were deficient in vitamin d3 when tested. This isn't because there is a shortage of sun in Spain or Boston USA, it's because people do not expose their skin to sunshine sufficiently. If we raised awareness, particularly in those living North of Boston or Spain and more particularly those with brown or black skins, that Vitamin D3 controls the immune system and people with low vitamin d3 get sicker more often we wouldn't need so many immune boosting drugs.

One of the ways Vitamin d3 helps is by providing an ion exchange to enable omega 3 to pass through cell walls. However first people have to eat sufficient omega 3 and that means 2-4 portions of oily fish a week. At present in the UK we struggle to manage one portion (140g) every month so you can tell the average person in UK is omega 3 deficient (hence rise in VIOLENCE, ABUSE,ADHD/AUTISM/APSERGERS/DYSLEXIA/DYSPRAXIA ETC)

Attending to the quality of the food we eat and changing the current Sunexposure policies promoted by disease mongers would do more to prevent disease and promote good health than continueing with the current policy of developing and promoting new drugs to deal with poor lifestyle choices.

right I know I'm http://www.forumgarden.com/forums/images/smilies/zbanghead.gif

:-5 but it's about time someone pointed out the obvious.

Would also like to point out that some of the volunteers were "Students" It's a sad reflection on the state of education funding in the UK that Students feel they have to volunteer as guinea pigs to facilitate their education.
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Peg
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Post by Peg »

I have to wonder about the whole picture here. Were these normally healthy individuals with inflammation problems? I know at one point with my RA, I would have gladly been a human guinea pig if there was a chance that a new drug would work. I can't imagine them giving the drug to people without inflammation. Could it be some of them did it out of desperation for help and not for the money even though one man planned to send his mother on vacation with the money?
tedhutchinson
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Post by tedhutchinson »

Peg wrote: Were these normally healthy individuals with inflammation problems?......... I can't imagine them giving the drug to people without inflammation. Could it be some of them did it out of desperation for help and not for the money even though one man planned to send his mother on vacation with the money?
Drug trials are required to test the drugs on "healthy" individuals before trying them on sick people. So it's standard practice for the first tests on humans will be on healthy fit ones which is why these people were selected.

With regards the money the level of recompense is supposed to be only marginally above basic expenses. It's supposed to set at a level which wouldn't encourage those desparate for money to sell their bodies/health for profit however what seems a fairly trivial amount for people on average wages or above does seem like a reasonable amount for folk who are in debt or are living above their means.
jayv
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Post by jayv »

www paulflynnmp co uk



No Whitewash on drugs trial probe.

“The regulators must not be allowed to investigate themselves”

19/3/06



Paul Flynn MP (Newport West) who last week criticised the UK drug regulatory body the MHRA as ‘weak’ called on the Government to oversee the investigation into the TGN1412 drugs trials. We now know that the MHRA failed to consult on a similar “monoclonal antibody” which had caused severe toxic reactions in patients.

The Sunday Times reports today that “Angus Dalgleish, a world expert on immunology, said yesterday that he was amazed the trial had been allowed to proceed. “The previous studies which caused similar severe side effects were in patients already suffering from cancer, but should have known they would get a meltdown because this drug was hitting exactly the same immune response pathways,” said Dalgleish, a professor of cancer at St George’s hospital medical school, south London. “

Paul Flynn said the Medicines and Healthcare Products Regulatory Agency (MHRA) has a poor record in failing to detect the severe adverse side effect of both Vioxx and Seroxat. The side effects of 144,000 heart attacks and strokes as result of taking Vioxx were detected in the United States. Our ramshackle MHRA system detected only a handful of adverse effects. The MHRA investigation into the suicidality caused by the antidepressant Seroxat was delayed because the majority of the investigating committee had interests in the pharmaceutical industry.

It appears to be an act of lamentable lack of care to give a drug, never before ingested by human beings, to six people simultaneously. We need a comprehensive, rigourous, genuinely independent inquiry. We cannot allow the regulators to investigate the regulators - especially when the MHRA is over represented by the pharmaceutical company interests. There must be no whitewash.

Paul Flynn is vice-Chairman of the Council of Europe Health Committee.

Dalgleish said an engineered antibody, developed by a team led by Steven Rosenberg at America’s National Cancer Institute, and using the same pathway as had produced severe side effects in about half of a group of patients dying of cancer.
jayv
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Post by jayv »

www guardian co uk Oct 04, 2005 (extract from full article)



Since 1989, when the then prime minister, Margaret Thatcher, took drug regulation out of the hands of the Department of Health, the MHRA has been 100% funded by the pharmaceutical companies.

The MHRA's chief executive, Kent Woods, appointed in January, has no drug company background, but critics say the agency continues in the unquestioning belief that the regulator and the industry are working together in the mutual interests of public health.

John Abraham, professor of sociology at Sussex University, who is well respected for his books on drug regulation, says that in 1989 there was a reconstruction of the regulators' mission alongside the new fees relationship. The MHRA came to believe the interests of public health are coherent with the promotion of the industry.

"The criticism of the old Department of Health medicines department in the 70s was that it didn't have any teeth. Not only does it now not have any teeth, but it is not motivated to bite," he said.

The MHRA told the Commons health select committee inquiry into the influence of the industry that it does not consider the fee relationship to be a problem.

"I would suggest to a lay person there is a big problem with the concept of independence from industry of a body that is fully funded by industry," said Professor Abraham. The UK's regulatory agency competes with those of other countries to approve drugs for the whole of Europe.
tedhutchinson
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Post by tedhutchinson »

The idea of "self-regulation" in a Capitalist society is ridiculous. One only has to look at the GMC to see how keen they are to come down hard on white male incompetant doctors. When so much money is involved in the development of new medicines it's absurd to leave the regulation of new drugs to those funded by the industry.

I'm not posting much at the moment as I'm now on dial-up due to the failure of E7 to maintain my broadband connection. Telecoms in the UK are regulated by OFCOM & OTELO and these are unable to assist for 12 weeks as they are funded by the industry and the rules are set to advantage the industry rather than the users. So access to my telephone line is determined by my current provider and although I want to change provider there is no means, apart from waiting 12 weeks and then complaining to OFCOM/OTELLO. of requiring my current provider to allow a move.

We need to have the regulatory body composed of primarily users and consumers of the process, ie those on the receiving end rather than controlled by those who are actually profitting from the process.
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Accountable
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Post by Accountable »

You do. It's called demand.
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Bez
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Post by Bez »

This is the latest on the 6 unfortunate 'guinea pigs'





Drug trial victims make good progress

(Filed: 26/03/2006)



One of two men left critically ill after a disastrous drug trial is making good progress, according to the hospital treating him.

While both men are showing signs of improvement, one remains seriously ill in the high-dependency unit at Northwick Park Hospital, north-west London.


A hospital spokesman said: "The two men have made improvements but they remain in critical care.

"One is in a serious condition. The other is still critical but we are pleased with his progress since last week. We remain cautious however because his condition is still complex."

The men were among six volunteers who suffered a rapid inflammatory response to drugs they were given by medical research company Parexel.

Four other men who suffered severe effects after taking the drug TGN1412 are said to be making a "good recovery" at the hospital.

Te Genero, the company behind the drug, confirmed it had caused temporary swelling in the glands of two monkeys during animal experiments.

But it said the monkeys' symptoms were completely different from those suffered by the men, who suffered vomiting and fevers when given the drug two weeks ago.
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jayv
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Post by jayv »

Hmm. Self regulation by the MHRA? As in Paul Flynn MP's article - it (and the MHRA's part in their approval of the trials) needs investigating by a group OTHER than the MHRA:



Another of today's BBC items:

"The same drug made monkeys' glands swell

One of the two men left critically ill by a drugs trial almost two weeks ago is reported to be making good progress.

Doctors at Northwick Park Hospital, in north-west London, said they were pleased with his progress although he remains in a critical condition.

The other, one of six volunteers who fell ill after taking the TGN1412 drug at a research unit, is seriously ill.

Medical research firm Parexel, which carried out the tests, said its staff followed correct procedures.

'Complex condition'

A hospital spokesman said: "The two men have made improvements but they remain in critical care.

"One is in a serious condition. The other is still critical but we are pleased with his progress since last week. We remain cautious however because his condition is still complex."

The hospital said the four other men involved in the trial are out of intensive care and are said to be making a good recovery.

"They... are working on regaining their strength and mobility, and are making good progress with both," a hospital statement read.

The case is being investigated by the Medicines and Healthcare products Regulatory Agency (MHRA), which seized documents and sealed off offices.



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

TeGenero, which developed the drug, said TGN1412 had caused the glands of two monkeys to swell in earlier tests, but said the symptoms differed from those seen in the men's cases. "
jayv
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Post by jayv »

Slightly different topic, but relevant as an example as to whether the MHRA are trustworthy enough to regulate themselves:



www 24-7pressrelease.com forward slash view_press_release dot php?rID=11901

"MHRA forbids Sweden to reveal Strattera suicide data

The British Medicines and Healthcare products Regulatory Agency (MHRA) has forbidden Swedish authorities to reveal Strattera suicide data. A release in Sweden of data about suicides and suicide attempts from Eli Lilly's Strattera is said to hurt the relations between the two countries.

SWEDEN - March 10, 2006 - Data about the harmful effects from the ADHD drug Strattera were revealed in a document from 9 December 2005, written by the British MHRA and sent to the Swedish MPA (Medical Products Agency). The information was gotten as a result of FOIA-requests, and released by court order.

The document told about 130 reports of suicidality in one month from treatment with Strattera. It told about 766 spontaneous reports of cardiac disorders and 172 of liver injury, and about 20 completed suicides. The 130 cases of suicidal and self-injurious behaviour were reported September 23 - October 25, 2005.

The main part of the information was classified and not released. So was, for example, the full assessment of all data about suicidality withheld from the public. That review - on which MHRA based their conclusions - was made by the manufacturer, Eli Lilly, and was named Annex 4 to the report. It would of course be of tremendous value for independent researchers to read how Lilly has treated the statistical data, but this has not been possible.

And now MHRA has forbidden Sweden to release Lilly's review. In a decision made by the Swedish MPA, as a result of a new FOIA-request, it is written that contact has been taken with the British authority MHRA and that the release of Lilly's suicide review would hurt the relations between the two countries! Thus the review cannot be released...'



(FOIA - Freedom of Information Act)
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Bez
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Post by Bez »

Two drug trial victims released



But one still critical



By Chris Williams

Published Tuesday 28th March 2006 15:50 GMT

Doctors caring for the six human guinea pig victims of the disastrous TeGenero drug trial have discharged two of the men. Three others remain as in-patients at Northwick Park Hospital, London, while one man is still in a critical condition after being administered an experimental immune treatment more than two weeks ago.

The hospital is staying tight-lipped on the prognosis for the critical patient, but says he has shown some signs of improvement. The released volunteers will continue to receive treatment and be monitored as out-patients.

The men were given TGN1412, an antibody designed to suppress the destructive power of immune cells in diseases like rheumatoid arthritis and leukaemia. The problems didn't show up in animal trials.

Speculations about what caused the reaction have centred on contamination of the doses by bacterial toxins, and a paradoxical super-activation of the volunteer's immune system.®
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abbey
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Post by abbey »

Check out pics in the news of the world.......

http://www.newsoftheworld.co.uk/story_pages/news/news2.shtml

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