Six In London Hospital After GE-Drug Trial
Six persons who participated in a drug trial have been taken into intensive care after experiencing strong adverse reactions to a genetically engineered drug being tested in a hospital in north-west London.
The trial has been stopped by the Medicines and Healthcare products Regulatory Agency and an international warning was sent to other health authorities.
The company running the trial said that such reactions were extremely rare.
BBC asks for comments from readers who have personal experience with clinical trials gone wrong. There is a form to provide your comments at the end of the article.
Sue Kedgley, a New Zealand - Green MP calls for restrictions on future tests of GM drugs:
"It is possible that the severe symptoms the six men are experiencing are unanticipated side effects of the genetic engineering process, and this needs to be fully explored"GE medicine derived from human/mouse hybrid gene
22 March 2006
Green MP Sue Kedgley is calling for assurances that no drug trials involving GE medicines are being carried out in New Zealand without participants being informed that the drug is genetically engineered.
Her call follows confirmation that the medicine (TGN1412) that has left six men in London seriously ill, including a New Zealander, was genetically engineered and is derived from a human/mouse hybrid gene.
Professor Peter Wills of Auckland University has confirmed this after searching the original patents that were granted for this medicine.
Ms Kedgley says trials involving genetically engineered medicines are inherently more risky than other drug trials because of the possibility that unintended side effects could occur.
"It is possible that the severe symptoms the six men are experiencing are unanticipated side effects of the genetic engineering process, and this needs to be fully explored," she says.
"In the meantime it is essential that all participants in drug trials are informed whenever genetically engineered medicines are involved, so that volunteers are aware of the increased risk. I am seeking government assurance that this is the case."
Ms Kedgley says it is also important that all medicines which are derived from a genetically engineered process are labelled as such.
"Consumers have a right to know when medicines they are taking are derived from GE, just as they are entitled to know whether food contains GE ingredients in it or not."
Sue Kedgley MP
Green Party of Aotearoa New Zealand
Room 8.06 Bowen House
Parliament Buildings, Wellington
Ph: 04-470-6717 Fax: 04-472-6003
Email: sue.kedgley@parliament.govt.nz- - -
Six taken ill after drug trials
(original on BBC)
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.
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 are in a critical condition, while the other four are "serious but stable".
'Exhaustive investigation'
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.
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, though the fee can vary depending on the amount of discomfort involved.
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."
- - -This article on BBC is asking for people with their own experience to relate, to comment on the BBC website:
Have you taken part in a drug trial? How did you find the experience? Send us your comments using the form below.
Here is again the link to the article in case you'd like to comment...
- - -
ALLIANCE FOR HUMAN RESEARCH PROTECTION (AHRP)
Promoting Openness, Full Disclosure, and Accountability
http://www.ahrp.org/cms/
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.
The Phase I trial - the first in humans - was set up by US drug research company Parexel International Corp on behalf of German pharmaceutical company TeGenero.
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 BBC is requesting comments from the public.
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.
Vera Hassner Sharav
212-595-8974
veracare@ahrp.org
CONSENT FORM FOR DRUG TRIAL DISASTER FLAWED, SAY CRITICSAlthough British authorities say that a drug trial which made six healthy young men violently ill was conducted properly, critics have savaged their informed consent form. The drug, TGN1412, was a monoclonal antibody, a promising type of treatment which has seldom been approved for humans.
Bioethicists claim that the document did not sufficiently inform participants of possible dangers and did not depict the treatment as a novel drug that could harm the body's immune system. The 13-page form also appealed to the subjects' need for money and threatened to withhold their £2,000 payment if they withdrew early.
The drug company "failed to adequately disclose the degree of uncertainty around a first-in-man trial," said Michael Goodyear, a Canadian cancer physician and research ethicist. "The risks were well known. They're not disclosed in the consent form."
Goodyear and two other medical ethicists assessed the study's risk-disclosure form for Bloomberg News. Parexel, a US company which conducts clinical trials for pharmaceutical companies, has declined requests to release the document. TeGenero, the small German biotech which designed the drug, says it did not have a copy. The bioethicists had several gripes, according to Bloomberg:
the financial penalties for not cooperating were daunting. "If you leave the study and exercise your right not to give a reason or are required to leave the study for non-compliance, no payment need be made to you," the document said. "That's very coercive language," says Greg Koski, 56, a physician and former head of the U.S. Office for Human Subject Protection.
the volunteers were not told that 75% of them would receive the drug. US bioethicist Arthur Caplan says he considers it a major" ethical violation to withhold the actual chance of receiving the drug. "The subjects needs to be able to say these aren't odds I want," he told Bloomberg.
the description of possible side effects was misleading. The consent form says that TGN1412 was designed to treat arthritis, other inflammatory illnesses and leukemia and that it had "no significant side effects" in animals. "I think it was misleading not to tell participants that that this drug was genetically engineered from hamster cells and that it was designed to alter their immune system," Goodyear commented.
"Reasonable people would think twice before allowing an experimental drug to change their immune system."
the form mentioned the possibility of a "cytokine burst" which it described as "a hives-like allergic reaction". In fact, this is what damaged the men's immune system. "Since monoclonal antibodies are known to cause Cytokine Release Syndrome, which can be fatal, and Parexel was even planning for this, the subjects should have been warned," Goodyear says. "They might have decided the risk wasn't worth £2,000." ~ Bloomberg, Apr 10
See also:London Drug Trial Catastrophe - Collapse of Science and Ethics
An unconventional member of a new class of drugs, all known to have caused serious side effects including deaths, has been approved for clinical trial based solely on unpublished animal tests. Dr. Mae-Wan Ho and Prof. Joe CumminsDrug Trial Catastrophe & Safety of Secretly Tested Pharm Crops
A monoclonal antibody drug tested in a clinical trial made all six healthy volunteers violently ill, yet transgenic crop plants with similar drugs are being tested in secret locations and the unsuspecting public are being exposed without their knowledge or consent. Prof. Joe Cummins and Dr. Mae-Wan HoWarnings on FDA Approved Monoclonal Antibody Drugs
This is a compilation of safety information on monoclonal antibody drugs already approved by the US FDA (Food and Drug Administration), most of them posted on the FDA website.Toxicogenomics
It is possible to test chemicals (and pharmaceutical medicines) on cells and observe the over- or underexpression of genes. This has shown to be more reliable than animal testing.
Antidote Europe is a scientific committee willing to contribute to the blooming of an efficient and safe biomedical research. In spite of research's dynamism at the international level, the number of individuals suffering from severe diseases is increasing. It is about time to expose the defaults of the most usual techniques, largely based on animal experimentation, and to inform the public, the media and the authorities about the existence of safe methods, at the top of today's biomedical research, for example, toxicogenomics, of which we propose an original approach.Six Healthy Volunteers in Phase I Drug Trial-Critically Ill_UK
Two drug trial men critically ill
Two men remain critically ill and four others are in a serious condition after suffering a violent reaction while taking part in a clinical drugs trial.Victims tearing at shirts
A VOLUNTEER who escaped the drug test disaster told last night how he saw six healthy young men turn into wailing wrecks within minutes. Human guinea pig Raste Khan — who did not know he had been given a harmless placebo in the test — said it was like a horror film unfolding before his eyes.Drug was genetically engineered!
Relatives' fury over calamitous drug trial
Thursday March 16, 2006 - The Guardian
Investigators began an urgent inquiry yesterday into the clinical trial that has left six healthy volunteers in intensive care, as scientists voiced fears the disaster could prove a major setback to developing cures for life-threatening diseases... The trial drug is not a chemical but a biological product, a genetically engineered "humanised" protein.Earlier trials had shown that drug group was highly toxic
EXPERTS knew that drugs similar to the one that nearly killed six men at a London hospital last week could have had dangerous side effects. Trials last year in America of a similar "monoclonal antibody" caused severe toxic reactions in patients. But the UK study went ahead after the regulatory authority failed to consult outside specialists who would have warned against proceeding. 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 [the researchers] 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.Antibody 'Puts Immune System in Overdrive'
The experimental drug that has caused the violent reaction in six healthy volunteers is an entirely new type of antibody treatment which puts the body's immune response into overdrive rather than subduing it. That may help to explain why the reaction was so severe. The antibody also stays in circulation for a long time, making it very hard for doctors to treat the young men affected.Guinea Pig Gang: Meet U.S. Students Who Rent Their Bodies for Cash
Disasterous Drug Trial - FDA New Rules Ensure More Disasters to Follow
AHRP - Tuesday, 28 March 2006
Unless Congress acts to overrule the FDA, research disasters such as occurred in London, when six healthy men were exposed to an experimental substance that brought them close to death, are likely to occur with increased frequency.
The Times - April 06, 2006
Scientists are cleared of blame for drug trial that went wrong
TOUGH rules are to be introduced for drug tests on people after an interim report on the disastrous trial at Northwick Park Hospital found no evidence of human error, contamination or failure to follow protocols. The findings yesterday suggested that the drug TGN1412 caused an unprecedented and unexpected reaction that did not occur in tests on animals.Here is the comment on this report of the government investigation by Vera Hassner Sharav of the Alliance for Human Research Protection. She raises an important point as to the text of the "informed consent" statement, which the government agency investigating chose not to disclose.
MHRA Releases Selective Documents--Where is Informed Consent Document?Drug trial firm knew of risk
Sunday April 9, 2006 - The Observer
The drugs company behind the clinical trial that left six volunteers fighting for their lives was well aware that the previously untested drug might seriously damage the immune system. The consent form the men were asked to sign, which has been obtained by The Observer, warned that a possible effect of the drug was 'cytokine release' - a massive immune reaction to a chemical as it triggers a uncontrollable response from antibodies. Cytokine release or cytokine storm, as it is also known, can be life-threatening, although the form does not spell that out.Biotech Drug Disaster Underlies Danger of GE Pharma Crops
Man Suffers Reactions After Drug Trial
Apr 15, 2006
A 20-year-old man who suffered severe reactions during testing of a drug intended to treat autoimmune diseases and leukemia said he will lose parts of his fingers and toes.Drug trial victims offered £5,000
Six volunteers who were taken seriously ill during a drugs trial have been offered an interim payment of £5,000, if they agree not to sue. Lawyers for four of the men said the drug manufacturer, TeGenero, had agreed to pay compensation but had attached a "no-fault" clause in the agreement. The four men have turned down the company's offer, but TeGenero said the claims are still being processed.Drug maker files for insolvency
The German firm that produced a drug at the heart of a disastrous clinical trial that left six men seriously ill has declared itself insolvent. TeGenero, a German pharmaceutical company, said it could not continue in business. Because of the fallout from the UK trial, it was impossible to attract investment, TeGenero said.Drug trial victims face high cancer risk for trial volunteers
The unfortunate volunteers who took part in the clinical trial of the drug known as TGN 1412 last March have now learned that they face an increased risk of contracting cancers and auto-immune diseases. As such, whilst they may be entitled to between £2 million and £5 million each in compensation it would appear possible that some of them could potentially be dead before they get to receive it. Meanwhile the "business with disease" continues unabated...BBC Investigates: The Drug Trial That Went Wrong_Critique NEJM Editorial
In this experiment, all six previously healthy young male volunteers (aged 19 to 34) nearly died after being infused with an experimental genetically engineered antibody drug affecting the very building blocks of life. Each of six volunteers who received the drug suffered "substantial renal impairment… acute lung injury… neurologic sequelae" and had to be on life-support; one had fingers and toes amputated. Only the two volunteers who were given a placebo were unharmed. This catastrophic experiment is a prima facie example of irresponsible medical research.Key data 'missing' in drug trial
Key information was absent from a research file prior to a London drug trial that left six men seriously ill, investigators have concluded.
posted by Sepp Hasslberger on Wednesday March 15 2006
updated on Tuesday December 21 2010URL of this article:
http://www.newmediaexplorer.org/sepp/2006/03/15/six_in_london_hospital_after_gedrug_trial.htm
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