Healthy Skepticism Library item: 3871
Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.
Publication type: news
Lister S.
Drug trial axed after patients poisoned
Times Online 2006 Mar 15
http://www.timesonline.co.uk/article/0,,2-2086563,00.html
Notes:
Ralph Faggotter’s Comments:
100% of trial subjects suffered severe life threatening reactions to the drug.
I wonder if this is bad enough for the FDA to slap a blackbox warning on it?
Full text:
The Times March 15, 2006
Drug trial axed after patients poisoned
By Sam Lister, Health Correspondent
SIX healthy volunteers have been rushed into intensive care after suddenly falling ill while participating in the trial of a new drug.
The six men, who were paid volunteers, are understood to have taken an oral preparation of the drug, being developed to treat inflammatory conditions and leukaemia, at a private research facility in Harrow, northwest London.
All of the men, who were admitted on Monday night, were suffering from multiple-organ failure at Northwick Park Hospital and two were said to be in a very serious condition.
The Medicines and Healthcare products Regulatory Agency (MHRA) sent out an international alert to regulatory bodies and suspended the Phase 1 trial for the product. It is understood that no one else has taken the drug.
An MHRA official said that inspectors would be sent to the Clinical Pharmacology Research Unit, run by the US firm Parexel International. He added that the regulator was also in contact with the North West London Strategic Health Authority, the Department of Health and the Metropolitan Police.
The drug was identified last night as TGN 1412, being developed by TeGenero AG, a small German pharmaceutical company. It is thought to be designed primarily as a treatment for rheumatism, but also has potential as a leukaemia medication because treatment of the cancer requires inflammation suppression.
Eight healthy men aged between 18 and 40 took part in the trial. Two received a placebo and are unaffected. One patient was last named as student Ryan Flanagan, 21, from Highbury in North London, who was paid £2,000 to take part in the trial, according to The Sun.
He was admitted to intensive care three hours after taking the pills suffering from poor breathing and heavy swelling to the neck and head.
A 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. His mother got a call last night to say his head and neck were swelled up and his leg had turned purple.”
Ganesh Suntharalingam, clinical director of intensive care at Northwick Park, said that staff were working without a break on the patients’ care. “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,” he said. “They are all receiving close monitoring and appropriate treatment.”
Kent Woods, chief executive officer at the MHRA, said that as well as suspending the clinical trial authorisation (CTA) for the study with immediate effect, it was also reviewing the data submitted with the application for authorisation.
“Our immediate priority has been to ensure that no further patients are harmed,” Professor Woods said. “We will now undertake an exhaustive investigation to determine the cause and ensure all appropriate actions are taken.”
A MHRA spokeswoman added that the product had gone through the usual strict procedures before coming to the clinical trial stage, including MHRA and ethics committee approval. She said that, as with all new drugs, the product had been tested on animals and there was nothing to suggest it should not be used by humans. “There could be a number of things that might have gone wrong. I cannot speculate but we are investigating,” she said.
“The trials on animals did not give any grounds to say the clinical trial could not go ahead. The first stages of a clinical trial are to prove the safety, the quality and the efficacy of a drug. There are tight regulations which stipulate what a clinical trial should look like to make it safe.”
She added that the men were all in good health before taking part in the trial and had fallen ill soon after taking the drug. It is not known if the sudden illness is linked to the particular dosage given to the patients or the composition of the drug.
It is the latest controversy to be associated with anti-inflammatory medication, following the withdrawal of Vioxx, one of a group of Cox-2 inhibitor drugs. Vioxx was voluntarily removed from sale by its manufacturer last year following evidence suggesting that it was linked to an increased risk of heart attacks and strokes. Concerns have also been raised about other Cox-2s, including most recently Celebrex, which a study linked to heart attacks this month.
A spokeswoman for Parexel confirmed that the company was aware of what had happened in London. Herman Scholtz, the head of clinical pharmacology for Parexel, said the incident was likely to have been caused by a drug reaction. He said the company was co-operating with the hospital to support the families of the volunteers by providing updates on the clinical conditions of the patients whenever possible.
“Such an adverse drug reaction occurs extremely rarely and this is an unfortunate and unusual situation,” Professor Scholtz said. “We have a high quality medical team in our Northwick Park unit. 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 provides clinical research services to major pharmaceutical, biotechnology and medical equipment companies. The 36-bed Parexel unit, which is on the Northwick Park Hospital campus and is leased out by the NHS trust, is designed for the conduct of clinical trials. It employs more than 60 staff.
TeGenero AG, which was founded in 2000, was specifically created to develop the anti-inflammatory/cancer drug. It followed the identification by scientists of a new class of monoclonal antibody, which targets a single foreign substance, thought to be a breakthrough in treating the conditions.
The company, which has a staff of 15, is based in Wurzburg, Germany, and is supported by about £9million of venture capital backing. It is not a listed company and therefore news of the trial will have no impact on the stock market.
GOING ON TRIAL
- Before being granted a licence all drugs must go through a series of trials, normally in three distinct phases: laboratory tests, then tests on healthy volunteers and then trials on patients requiring the intended treatment
- A clinical trial is the scientific term used to describe the testing of a new medicine or medical device to evaluate whether the drug or device is effective and safe for people to use
- Healthy volunteers accepted for clinical trials are normally young (between 18 and 40), weigh between 60 and 100kg, and have a body mass index (BMI) that ensures they are not overweight
