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Medical Forum / Diseases and Disorders / Arthritis / March 2006RA drug trial.
http://news.bbc.co.uk/1/hi/england/london/4807042.stm Six men are in intensive care after taking part in a clinical drugs trial in north-west London. They suffered a bad reaction to an anti-inflammatory drug being tested at a research unit and were rushed to Northwick Park Hospital on Monday. Relatives are with the patients, who are seriously ill. Some cases are believed to be life-threatening. An investigation has begun at the unit, run by Parexel, which said it followed recommended guidelines in its trial. The men were volunteers in a trial for the drug to treat conditions such as rheumatoid arthritis and leukaemia. Eight men had taken part, but two were given a placebo during the trial 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, but all were in a serious condition. He said they were receiving "close monitoring and appropriate treatment". BBC London correspondent Tim Donovan said some cases were believed to be life-threatening. The Medicines and Healthcare products Regulatory Agency (MHRA) immediately withdrew authorisation for the trial. Alison >http://news.bbc.co.uk/1/hi/england/london/4807042.stm >Six men are in intensive care after taking part in a clinical drugs trial >in north-west London. >They suffered a bad reaction to an anti-inflammatory drug being tested at a >research unit and were rushed to Northwick Park Hospital on Monday. It would be interesting to know if it was simply the new NSAID being trialed that caused this or a reaction with medicines already taken by the people on the trial? -- preceed with 2006 to email > >http://news.bbc.co.uk/1/hi/england/london/4807042.stm > >Six men are in intensive care after taking part in a clinical drugs trial [quoted text clipped - 7 lines] > -- > preceed with 2006 to email>. I got the impression it was a new drug but the company are being cagey about giving details. Alison >> It would be interesting to know if it was simply the new NSAID being >> trialed that caused this or a reaction with medicines already taken by >> the people on the trial? >I got the impression it was a new drug but the company are being cagey >about giving details. > Alison I've just been watching Sky news about it and they are reporting that the effect has been to increase dramatically the size of several of their internal organs. I wish them a speedy and hopefully full recovery, and pray for their families in this difficult time. It's all speculation that the media are doing just now, but I'm sure the facts will come out eventually. I once thought about going for a RA drug clinical trial, but was not accepted as I was sero neg not sero pos. I fear now, they will have a shortfall in future volunteers for clinical trials. >I got the impression it was a new drug but the company are being cagey >about giving details. > Alison This updates your link http://news.bbc.co.uk/2/hi/uk_news/england/london/4808836.stm This tells a little more about the TGN1412 http://www.tegenero.com/documents/pr_tegenero_march_11_2005.pdf I think the Leukemia mention in the reports was significant and guessed that it might be some kind of biologic. No doubt we shall hear exactly what happened in due course, but it sounds as tho the effects were/are devastating. Peter >I think the Leukemia mention in the reports was significant and guessed >that it might be some kind of biologic. No doubt we shall hear exactly >what happened in due course, but it sounds as tho the effects were/are >devastating. > >Peter More news, aged between 18 and 30 years and one was a kiwi http://www.stuff.co.nz/stuff/0,2106,3605151a10,00.html >>http://news.bbc.co.uk/1/hi/england/london/4807042.stm >>Six men are in intensive care after taking part in a clinical drugs trial [quoted text clipped - 5 lines] >trialed that caused this or a reaction with medicines already taken by >the people on the trial? The men in question were healthy, not taking any medication at all. Anne >http://news.bbc.co.uk/1/hi/england/london/4807042.stm >Six men are in intensive care after taking part in a clinical drugs trial >in north-west London. >They suffered a bad reaction to an anti-inflammatory drug being tested at a >research unit and were rushed to Northwick Park Hospital on Monday. Placebo man talks to The Sun Newspaper "They "went down like dominoes", according to Raste Khan, 23, one of two trial volunteers who escaped unscathed after being given a placebo. He told the Sun newspaper: "They began tearing their shirts off complaining of fever, then some screamed out that their heads felt like they were going to explode. " http://news.bbc.co.uk/2/hi/uk_news/england/london/4811626.stm >http://news.bbc.co.uk/1/hi/england/london/4807042.stm >Six men are in intensive care after taking part in a clinical drugs trial >in north-west London. >They suffered a bad reaction to an anti-inflammatory drug being tested at a >research unit and were rushed to Northwick Park Hospital on Monday. http://news.bbc.co.uk/2/hi/health/4808090.stm "It is thought one other European country is currently carrying out trials on the drug." Does anyone know which one? The other country doesn't seem to be in the news. Latest report seems to be that 2 of the six are critical, the other 4 are serious but responding to treatment. Drug was a monocolonal antinbody. In other words a somethingmab. Peter >The other country doesn't seem to be in the news. > [quoted text clipped - 4 lines] > >Peter Thanks Peter, I noticed my previously posted link to the drug companies PDF has server problems This tells a little more about the TGN1412 http://www.tegenero.com/documents/pr_tegenero_march_11_2005.pdf I think it said something about B cell depletion, don't you remember a few years back when Prof Jo Edwards told the press about his efforts in this field and it was reported as "a cure" his was a "mab" as well. http://www.ucl.ac.uk/~regfjxe/B.htm >>The other country doesn't seem to be in the news. >> [quoted text clipped - 15 lines] >in this field and it was reported as "a cure" his was a "mab" as well. >http://www.ucl.ac.uk/~regfjxe/B.htm Great information thanks! >Great information thanks! You are welcome Mary They are improving http://news.bbc.co.uk/2/hi/uk_news/england/london/4820188.stm >http://news.bbc.co.uk/1/hi/england/london/4807042.stm >Six men are in intensive care after taking part in a clinical drugs trial >in north-west London. Animal tests 'false reassurance' http://news.bbc.co.uk/1/hi/health/4817178.stm >>http://news.bbc.co.uk/1/hi/england/london/4807042.stm >>Six men are in intensive care after taking part in a clinical drugs trial >>in north-west London. > >Animal tests 'false reassurance' >http://news.bbc.co.uk/1/hi/health/4817178.stm Some more http://news.bbc.co.uk/1/hi/health/4863734.stm >Some more >http://news.bbc.co.uk/1/hi/health/4863734.stm And just incase you've never had a shot in the arm the Sun shows you http://www.thesun.co.uk/article/0,,2-2006140654,00.html It was certainly a terrible experience for the 6 men, but from the look of the newspaper item, the Sun really knows how to lay it on. Peter > It was certainly a terrible experience for the 6 men, but from the > look of the newspaper item, the Sun really knows how to lay it on. > > Peter Newspaper is a bit strong...gutter rag or adult comic would be a better description. Unfortunately it's the best selling daily in the UK. >> It was certainly a terrible experience for the 6 men, but from the >> look of the newspaper item, the Sun really knows how to lay it on. [quoted text clipped - 3 lines] >Newspaper is a bit strong...gutter rag or adult comic would be a better >description. Unfortunately it's the best selling daily in the UK. But what to date have we had from the drug company? someone give them a call For further information please contact TeGenero AG PD Dr. Thomas Hanke Phone: +49 (0) 931-35 96 2-0 Science Park Würzburg Fax: +49 (0) 931-35 96 2-11 Friedrich-Bergius-Ring 15 Email: hanke@tegenero.com D-97076 Würzburg www.tegenero.com >But what to date have we had from the drug company? > [quoted text clipped - 5 lines] >Friedrich-Bergius-Ring 15 Email: hanke@tegenero.com >D-97076 Würzburg www.tegenero.com The TV just said, they [one of the trial blokes] is on Tonight with Trevor at 8PM Monday.
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