Comments on: TGN1412 http://sepiamutiny.com/blog/2006/03/16/tgn1412/ All that flavorful brownness in one savory packet Sat, 30 Nov 2013 11:11:28 +0000 hourly 1 http://wordpress.org/?v=3.2.1 By: aram1990 http://sepiamutiny.com/blog/2006/03/16/tgn1412/comment-page-1/#comment-148181 aram1990 Sun, 08 Jul 2007 04:01:36 +0000 http://sepiamutiny.com?p=3150#comment-148181 <p>The drugs were tested on mice.</p> <p>The measured minimum dose that had hazardous side effects was scaled DOWN by a factor of 500 and administered to humans (previous doses to mice had no side effects)</p> <p>however, the scientists that administered the doses were stupid.</p> <p>the antibodies of TGN1412 were raised against the human antigens.</p> <p>if the scientists had done a simple flow cytometry experiment and done a 10 minute calculation, they could have avoided giving this dose to the humans in the clinical trial and figured out that they had to give a much smaller dose. However, biologists and doctors think they are too high and mighty for mathematical calculations and computational modeling.</p> The drugs were tested on mice.

The measured minimum dose that had hazardous side effects was scaled DOWN by a factor of 500 and administered to humans (previous doses to mice had no side effects)

however, the scientists that administered the doses were stupid.

the antibodies of TGN1412 were raised against the human antigens.

if the scientists had done a simple flow cytometry experiment and done a 10 minute calculation, they could have avoided giving this dose to the humans in the clinical trial and figured out that they had to give a much smaller dose. However, biologists and doctors think they are too high and mighty for mathematical calculations and computational modeling.

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By: Michael http://sepiamutiny.com/blog/2006/03/16/tgn1412/comment-page-1/#comment-77134 Michael Fri, 04 Aug 2006 18:19:00 +0000 http://sepiamutiny.com?p=3150#comment-77134 <p>Changing the culture of research</p> <p>See this week’s BMJ (August 5): http://bmj.bmjjournals.com/</p> <p>Editorial Further lessons from the TGN1412 tragedy New guidelines call for a change in the culture of research BMJ 2006;333:270-271 (5 August), doi:10.1136/bmj.38929.647662.80</p> <p>“As eight young men assembled at a London hospital on 13 March this year, they had no idea that within an hour their lives would be changed irrevocably and they would have contributed to a fundamental rethinking of the development and testing of new drugs. The first trial of TeGenero's TGN1412 (a T cell agonist) in humans took place at Parexel's clinical pharmacology research unit at Northwick Park Hospital, London. The events that followed fuelled speculation not only into the conduct of the trial and the nature of the drug, but also into aspects of research as diverse as comparative molecular biology, bioethics, and health economics.</p> <p>The Medicines and Healthcare Products Regulatory Agency initiated an investigation, but the BMJ and other journals called for a more far reaching inquiry independent of the regulatory agency that had approved the trial. On 5 April the agency released its interim report, and the government announced that an independent Expert Scientific Group, chaired by Professor Gordon Duff, would be appointed "to learn from the Parexel clinical trials incident." On 25 July this group released their interim report and recommendations. …..”</p> <p>http://bmj.bmjjournals.com/cgi/content/full/333/7562/270?ijkey=whP3FyWKdYWdMvy&keytype=ref</p> Changing the culture of research

See this weekÂ’s BMJ (August 5): http://bmj.bmjjournals.com/

Editorial Further lessons from the TGN1412 tragedy New guidelines call for a change in the culture of research BMJ 2006;333:270-271 (5 August), doi:10.1136/bmj.38929.647662.80

“As eight young men assembled at a London hospital on 13 March this year, they had no idea that within an hour their lives would be changed irrevocably and they would have contributed to a fundamental rethinking of the development and testing of new drugs. The first trial of TeGenero’s TGN1412 (a T cell agonist) in humans took place at Parexel’s clinical pharmacology research unit at Northwick Park Hospital, London. The events that followed fuelled speculation not only into the conduct of the trial and the nature of the drug, but also into aspects of research as diverse as comparative molecular biology, bioethics, and health economics.

The Medicines and Healthcare Products Regulatory Agency initiated an investigation, but the BMJ and other journals called for a more far reaching inquiry independent of the regulatory agency that had approved the trial. On 5 April the agency released its interim report, and the government announced that an independent Expert Scientific Group, chaired by Professor Gordon Duff, would be appointed “to learn from the Parexel clinical trials incident.” On 25 July this group released their interim report and recommendations. Â…..”

http://bmj.bmjjournals.com/cgi/content/full/333/7562/270?ijkey=whP3FyWKdYWdMvy&keytype=ref

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By: Filip http://sepiamutiny.com/blog/2006/03/16/tgn1412/comment-page-1/#comment-50955 Filip Mon, 20 Mar 2006 00:33:02 +0000 http://sepiamutiny.com?p=3150#comment-50955 <p>Well, they did apply 4 the testings. They wanted easy money,but it turned really wrong. I feel for them, but just sometimes, when you dance with the devil, U have to wait untill the song is over...</p> Well, they did apply 4 the testings. They wanted easy money,but it turned really wrong. I feel for them, but just sometimes, when you dance with the devil, U have to wait untill the song is over…

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By: SajiniW http://sepiamutiny.com/blog/2006/03/16/tgn1412/comment-page-1/#comment-50906 SajiniW Sun, 19 Mar 2006 17:56:33 +0000 http://sepiamutiny.com?p=3150#comment-50906 <p>My father's colleagues work on the Northwick Park site where the trial took place. Their Intensive Care director told him that four of the six men are conversant, alert and ready to go home. They do not require further treatment.</p> <p>The two that are critically ill are in a much better condition now. Both are conscious, one is conversant.</p> My father’s colleagues work on the Northwick Park site where the trial took place. Their Intensive Care director told him that four of the six men are conversant, alert and ready to go home. They do not require further treatment.

The two that are critically ill are in a much better condition now. Both are conscious, one is conversant.

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By: Maitri http://sepiamutiny.com/blog/2006/03/16/tgn1412/comment-page-1/#comment-50567 Maitri Thu, 16 Mar 2006 21:15:49 +0000 http://sepiamutiny.com?p=3150#comment-50567 <blockquote>Are you referring to Dafoe as a human trial gone wrong?</blockquote> <p>Hey, Dafoe is from Wisconsin and, therefore, in all ways perfect.</p> <p>I think this is the opportunity for Abhi to enter that phone booth. Ideas for a cape abound.</p> Are you referring to Dafoe as a human trial gone wrong?

Hey, Dafoe is from Wisconsin and, therefore, in all ways perfect.

I think this is the opportunity for Abhi to enter that phone booth. Ideas for a cape abound.

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By: asdf http://sepiamutiny.com/blog/2006/03/16/tgn1412/comment-page-1/#comment-50545 asdf Thu, 16 Mar 2006 19:55:18 +0000 http://sepiamutiny.com?p=3150#comment-50545 <p><i> as it pretty clearly demonstrates the foolishness of animal testers' assumption that humans and non-human animals will react the same way to a substance. </i></p> <p>There are exceptions to every rule. Animal testers in general are not "foolish" -- you are, if you think that most of the drugs on your shelf did not go through a period of animal testing.</p> as it pretty clearly demonstrates the foolishness of animal testers’ assumption that humans and non-human animals will react the same way to a substance.

There are exceptions to every rule. Animal testers in general are not “foolish” — you are, if you think that most of the drugs on your shelf did not go through a period of animal testing.

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By: Mousepad Marauder http://sepiamutiny.com/blog/2006/03/16/tgn1412/comment-page-1/#comment-50500 Mousepad Marauder Thu, 16 Mar 2006 16:37:57 +0000 http://sepiamutiny.com?p=3150#comment-50500 <p>Are you referring to Dafoe as a human trial gone wrong? :-)</p> Are you referring to Dafoe as a human trial gone wrong? :-)

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By: Areem http://sepiamutiny.com/blog/2006/03/16/tgn1412/comment-page-1/#comment-50487 Areem Thu, 16 Mar 2006 15:02:42 +0000 http://sepiamutiny.com?p=3150#comment-50487 <blockquote>I'm surprised, that this drug was used on humans... because i'm wondering if they had data from animal trials beforehand..as i think that mice/other animal subjects/etc would have had the same reaction.... was there animal testing done before going into this phase I trial and subjecting human beings????</blockquote> <p>Yes, the media reports that I have read says it was tested on animals. The article has been posted on several vegan forums that I visit regularly, as it pretty clearly demonstrates the foolishness of animal testers' assumption that humans and non-human animals will react the same way to a substance. All pharmaceuticals, including the much-publicised ones (like Vioxx, Phen-Fen, etc.) since recalled for producing...well, death, are the products of extensive vivisection prior to their release.</p> <blockquote>There are quacks out there who sell urine as cure for brain tumors, and people flock to them... no joke.</blockquote> <p>Urine therapy is, of course, a long established natural treatment for many ailments, including various types of cancer, is advocated by many natural healers (esp. in India), and is, IMHO, often quite effective.</p> I’m surprised, that this drug was used on humans… because i’m wondering if they had data from animal trials beforehand..as i think that mice/other animal subjects/etc would have had the same reaction…. was there animal testing done before going into this phase I trial and subjecting human beings????

Yes, the media reports that I have read says it was tested on animals. The article has been posted on several vegan forums that I visit regularly, as it pretty clearly demonstrates the foolishness of animal testers’ assumption that humans and non-human animals will react the same way to a substance. All pharmaceuticals, including the much-publicised ones (like Vioxx, Phen-Fen, etc.) since recalled for producing…well, death, are the products of extensive vivisection prior to their release.

There are quacks out there who sell urine as cure for brain tumors, and people flock to them… no joke.

Urine therapy is, of course, a long established natural treatment for many ailments, including various types of cancer, is advocated by many natural healers (esp. in India), and is, IMHO, often quite effective.

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By: chick pea http://sepiamutiny.com/blog/2006/03/16/tgn1412/comment-page-1/#comment-50485 chick pea Thu, 16 Mar 2006 14:26:32 +0000 http://sepiamutiny.com?p=3150#comment-50485 <p>some clinical trials are safe, and not really invasive, those that test psychology, and breathing patterns, sleep, etc... i've done a few myself.. and they are pretty safe...</p> <p>i'm surprised, that this drug was used on humans... because i'm wondering if they had data from animal trials beforehand..as i think that mice/other animal subjects/etc would have had the same reaction.... was there animal testing done before going into this phase I trial and subjecting human beings???? this reminds me of the unethical trials from recent past (<a href="http://www.infoplease.com/spot/bhmtuskegee1.html">The Tuskegee Syphilis Experiment)</a></p> <p>when you're fighting cancer though.. you will try anything.. it's despair...and the empty straws one will pull on for a chance of cure/prolongation of life.... i see it everyday.. and it is truly sad... there are quacks out there who sell urine as cure for brain tumors, and people flock to them... no joke... it's just people latching onto a human beings despair in order to make a quick buck or two..... just horrific.</p> some clinical trials are safe, and not really invasive, those that test psychology, and breathing patterns, sleep, etc… i’ve done a few myself.. and they are pretty safe…

i’m surprised, that this drug was used on humans… because i’m wondering if they had data from animal trials beforehand..as i think that mice/other animal subjects/etc would have had the same reaction…. was there animal testing done before going into this phase I trial and subjecting human beings???? this reminds me of the unethical trials from recent past (The Tuskegee Syphilis Experiment)

when you’re fighting cancer though.. you will try anything.. it’s despair…and the empty straws one will pull on for a chance of cure/prolongation of life…. i see it everyday.. and it is truly sad… there are quacks out there who sell urine as cure for brain tumors, and people flock to them… no joke… it’s just people latching onto a human beings despair in order to make a quick buck or two….. just horrific.

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By: midwestern eastender http://sepiamutiny.com/blog/2006/03/16/tgn1412/comment-page-1/#comment-50482 midwestern eastender Thu, 16 Mar 2006 12:40:06 +0000 http://sepiamutiny.com?p=3150#comment-50482 <p>Ah, I can't wait to see what Asians in Media Sunny will say about this, considering he's anti all animal testing and pro paying poor people to take part in drug trials. (<a href="http://www.pickledpolitics.com/archives/335" target="_new">link</a>) ;)</p> Ah, I can’t wait to see what Asians in Media Sunny will say about this, considering he’s anti all animal testing and pro paying poor people to take part in drug trials. (link) ;)

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