Six In London Hospital After GE-Drug Trial

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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

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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."

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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...

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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 CRITICS

Although 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