BBC: Six taken ill after drug trials

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
They say he needs a miracle'
Q&A: Drug trials
Send us your experiences 
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.

Two Parexel Drug Trial Patients in Critical Condition (Update1)

March 15 (Bloomberg) -- Two men are in critical condition at a London hospital after taking part in a clinical trial conducted by Parexel International Corp., said a spokeswoman for the hospital.
Another four men are in serious but stable condition, Caroline Lord, a spokeswoman for North West London Hospitals, said in a telephone interview. She declined to provide more details about the men's condition or identities, citing patient confidentiality laws.
Parexel, which conducts research for drugmakers, yesterday said six volunteers were in serious condition after taking part in early clinical tests for TGN 1412, a medicine being developed by closely held TeGenero AG of Germany to treat conditions including rheumatoid arthritis and leukaemia. Boehringer Ingelheim GmbH, the world's biggest closely held drugmaker, makes the drug's active ingredient.
The volunteers suffered an ``adverse drug reaction,'' Waltham, Massachusetts-based Parexel said last night. All six men, who had to be healthy to join the trials, are in the intensive care unit at Northwick Park Hospital.
The U.K.'s Medicines and Healthcare products Regulatory Agency has started an investigation and suspended trials of the drug. It said it was liaising with the Department of Health and London's Metropolitan Police.
No Other Participants
``Eight men took part in this stage of the clinical trial; six were given the product and two were given a placebo,'' the agency said on its Web site. ``The MHRA has been assured that nobody else has been given the product.'' The agency also said it notified other European regulatory bodies.
The clinical trials started only in the U.K., though TeGenero had also gained permission to test the drug in Germany, according to Sarah Coakley, a spokeswoman for the MHRA. The agency is analyzing the product, she added. ``We're quite keen to get some answers as quickly as possible,'' she said.
Reactions such as the one affecting the volunteers ``occurs extremely rarely and this is an unfortunate and unusual situation,'' Herman Scholtz, head of clinical pharmacology at Parexel, said in an e-mailed statement. ``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.''
Parexel uses ``standardized procedures for testing a drug in humans for the first time, based on a protocol approved by ethics committees and regulatory authorities,'' Scholtz said.
`Just Relax'
Parexel's London office referred calls to spokeswoman Jen Baird in Boston, who didn't immediately return a voicemail message. A receptionist at TeGenero in Wuerzburg, Germany, said no executives were available to take calls.
London's metropolitan police was called at 3:30 a.m. local time yesterday to help move life-saving equipment to Northwick Park Hospital from Harefield Hospital to help treat the volunteers, according to MHRA's Coakley.
Parexel's London clinical trial site specializes in experiments testing the effect of drugs given to humans for the first time. It has 24 beds, a staff of 26, and has done more than 160 studies, according to its Web site. The company has more than 5,000 employees in 37 countries.
A Web site recruiting participants for the London trial site poses the question, ``What's in it for you?'' It answers the question by offering trial participants a free medical checkup, payment and free food, and telling volunteers they will have ``plenty of time to read or study or just relax, with digital TV, pool table, videogames, DVD player and now FREE Internet access.''
``We have no responsibility for the clinical trials,'' said Judith von Gordon, a spokeswoman for Germany's Boehringer Ingelheim. ``We only do the contract manufacturing according to TeGenero's specifications. We regret that it has come to these adverse effects.''
MHRA Chief Executive Officer Kent Woods said the ``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.'' 

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Двое из восьми британских добровольцев, испытавших новое лекарство, до сих пор находятся в критическом состоянии.

Четверо чувствуют себя лучше после вмешательства врачей.

С воскресенья группа добровольцев, среди которых были британцы, австралийцы и южноафриканец, находилась в центре испытаний препарата, которые проводила американская компания Parexel. Они испытывали новый препарат TGN1412, который, как ожидала компания-разработчик TeGenero, должен помочь больным ревматоидным артритом и лейкемией.

Первые пострадавшие от побочного действия препарата были доставлены в лондонскую больницу Northwick Park во вторник утром.

Участникам эксперимента были обещаны две тысячи фунтов стерлингов и 30 фунтов дополнительно за каждый из 11 последующих медосмотров. .

Испытания нового лекарства закончились трагедией

Британские врачи пытаются спасти жизни шести добровольцев, принявших участие в медицинском эксперименте

«Входя в палату, я ожидала увидеть привычный облик близкого мне человека - небольшое лицо и вьющиеся черные волосы. Вместо этого мне показали чудовище», - говорит Майфануи Маршалл, невеста молодого человека, пострадавшего в ходе тестирования. Ее любимый превратился в уродливого «человека-слона» из одноименного фильма Дэвида Линча: «От него осталась только оболочка. Он весь раздут - и лицо, и тело. Он практически мертвец. Я не могу уловить ни движения век, ни легкого пожатия его руки».

Врачи продолжают борьбу за жизнь жертв медицинского эксперимента

Обновлено: 17.03 14:52

Врачи лондонской клиники Нортвирк Парк, продолжающие бороться за жизнь участников испытаний нового медицинского препарата, госпитализированных в тяжелом состоянии 15 марта, обратились к международным экспертам в области токсикологии и иммунологии с просьбой оказать содействие в определении причин тяжелейших симптомов, наблюдаемых у больных.

Двое из шести доставленных в больницу людей остаются в критическом состоянии – они находятся в глубокой коме и подключены в аппаратам искусственного дыхания. Самочувствие остальных больных несколько улучшилось.

As some EU countries struggle with the Directive's regulatory demands, emerging markets such as China, India, and Russia continue to bolster their clinical research and drug development programs.
 

Jan 1, 2006

By: Jean-Pierre Tassignon

Applied Clinical Trials

In the early 1980s, Europe was seen by the United States as a mosaic of peoples, cultures, and medical practices. Contrary to the American multicenter clinical trial, the Europeans did not have enough in common to allow clinical data to be shared and collated. The clinical climate in the United States was convinced that the European data would be influenced by the genetic differences among ethnic groups, national differences in the diagnosis of disease, variations in the use of medicinal products for treatment, and differences between health care systems.

At the present time, the cross-border Good Clinical Practice (GCP) movement is a reality, and it is driven by sponsors and CROs in need of patients for critically important clinical trials as well as investigators and countries willing to invest in all the drivers of GCP. The drivers include new legislation, GCP inspectorates, ethics committees, curricula in pharmaceutical medicine, conferences, etc. The movement started from regions with advanced GCP legislation and recruited countries with enough resources to meet the same clinical standards.

The price of progress

Not everyone, however, is capable of paying the price in the EU. In May 2005, one year after its implementation, the European Forum for Good Clinical Practice (EFGCP) held a conference in Brussels on the EUCTD. The conference attendees reported that: a) there was a dwindling number of academic research studies across the Union; b) a proportion of Phase I studies with new medicinal products were exported from the EU to North America; c) statistics about Phase II and III industry-sponsored studies were still inconclusive with regard to judging the impact of the EUCTD; and d) the cost of complying with the EUCTD was expected to impact the hardest on industry-sponsored studies in Phase IV. In this climate, the academic world in Europe was not prepared to comply with the directive's mandates, whereas the pharmaceutical industry was working hard to comply with Phase II and III mandates. At this time and due to the strengthening of the Euro and capacity issues, the Phase I trials could be done in North America. The diminishing return of marketing trials on prescription in Phase IV is probably insufficient to justify a sudden increase in regulatory compliance costs.

The EU rapidly tackled the issue of academic studies by issuing the GCP Directive, which allows member states to accommodate the EUCTD to the specific environment of academic research. However, at this time, it is the speed of implementation of waivers by the member states in their national legislation that remains a challenge.

Dozens of European startup biotech companies that were ready to begin first clinical trials had to postpone their projects, beef up the IMPD, and collect more funds in order to finance additional expertise for clinical trials costs.

The EFGCP conference concluded, with cautious optimism, that the industry-sponsored compartment in European clinical research would regain pre-EUCTD levels of intensity after an adjustment period, and that the academic compartment would do the same after implementation of the new accommodations, if any.

However, given the standards set by the EUCTD, GCP and per capita GDP, which appears to go hand-in-hand, the question still remains open as to whether countries with a per capita GDP below 5000 Euro/year have a chance of joining the drug development movement, with the exception of some specific diseases such as tropical diseases.