Matches in SemOpenAlex for { <https://semopenalex.org/work/W1955473499> ?p ?o ?g. }
Showing items 1 to 73 of
73
with 100 items per page.
- W1955473499 endingPage "308" @default.
- W1955473499 startingPage "305" @default.
- W1955473499 abstract "In March 2006, a phase I clinical trial turned into tragedy when six healthy volunteers became critically ill in response to a new humanized monoclonal antibody, TGN1412. Soon after receiving the anti‐inflammatory substance intravenously at Northwick Park Hospital in London, UK, the participants complained of headaches, fever and pain, and then began vomiting. All six were transferred to the hospital's intensive care unit, where they were treated in response to a severe allergic reaction. Within one month of the incident, five of the volunteers had returned home, but the sixth remained in hospital for a further two months. Despite their recovery, there have been suggestions that the drug could have caused long‐term damage to the volunteers' immune systems.![][1] An investigation by the UK Medicines and Healthcare Products Regulatory Agency (MHRA; London, UK) concluded that the adverse effects were caused by an unprecedented biological action of the drug and not by errors made by either TeGenero AG (Wurzburg, Germany), the company that developed the antibody, or Parexel (Waltham, MA, USA), the subcontractor that organized and performed the clinical trial (MHRA, 2006). However, independent researchers have suggested that several preventive measures could have been taken (Kenter & Cohen, 2006). First, it was a mistake to administer the drug to all six volunteers at almost the same time; it would have been more vigilant to ensure that each volunteer remained healthy before proceeding onto the next. Second, from an ethical point of view, it would have made more sense to test the drug in a patient suffering from the disease that the substance was designed to treat, because it might have had some beneficial effects.> Arguably, there is no fundamental difference between using the precautionary principle to abolish clinical trials, mobile phones or genetically modified foodThat said, it is worth remembering—and accepting—that … [1]: /embed/graphic-1.gif" @default.
- W1955473499 created "2016-06-24" @default.
- W1955473499 creator A5091478302 @default.
- W1955473499 date "2007-03-09" @default.
- W1955473499 modified "2023-10-10" @default.
- W1955473499 title "The precautionary principle should not be used as a basis for decision‐making" @default.
- W1955473499 cites W2095785440 @default.
- W1955473499 cites W2137571650 @default.
- W1955473499 cites W2144246525 @default.
- W1955473499 cites W2159391191 @default.
- W1955473499 doi "https://doi.org/10.1038/sj.embor.7400947" @default.
- W1955473499 hasPubMedCentralId "https://www.ncbi.nlm.nih.gov/pmc/articles/1852769" @default.
- W1955473499 hasPubMedId "https://pubmed.ncbi.nlm.nih.gov/17401402" @default.
- W1955473499 hasPublicationYear "2007" @default.
- W1955473499 type Work @default.
- W1955473499 sameAs 1955473499 @default.
- W1955473499 citedByCount "39" @default.
- W1955473499 countsByYear W19554734992012 @default.
- W1955473499 countsByYear W19554734992013 @default.
- W1955473499 countsByYear W19554734992014 @default.
- W1955473499 countsByYear W19554734992015 @default.
- W1955473499 countsByYear W19554734992017 @default.
- W1955473499 countsByYear W19554734992018 @default.
- W1955473499 countsByYear W19554734992019 @default.
- W1955473499 countsByYear W19554734992020 @default.
- W1955473499 countsByYear W19554734992021 @default.
- W1955473499 countsByYear W19554734992022 @default.
- W1955473499 countsByYear W19554734992023 @default.
- W1955473499 crossrefType "journal-article" @default.
- W1955473499 hasAuthorship W1955473499A5091478302 @default.
- W1955473499 hasBestOaLocation W19554734992 @default.
- W1955473499 hasConcept C112930515 @default.
- W1955473499 hasConcept C12426560 @default.
- W1955473499 hasConcept C144133560 @default.
- W1955473499 hasConcept C150903083 @default.
- W1955473499 hasConcept C162324750 @default.
- W1955473499 hasConcept C21016645 @default.
- W1955473499 hasConcept C2524010 @default.
- W1955473499 hasConcept C33923547 @default.
- W1955473499 hasConcept C86803240 @default.
- W1955473499 hasConceptScore W1955473499C112930515 @default.
- W1955473499 hasConceptScore W1955473499C12426560 @default.
- W1955473499 hasConceptScore W1955473499C144133560 @default.
- W1955473499 hasConceptScore W1955473499C150903083 @default.
- W1955473499 hasConceptScore W1955473499C162324750 @default.
- W1955473499 hasConceptScore W1955473499C21016645 @default.
- W1955473499 hasConceptScore W1955473499C2524010 @default.
- W1955473499 hasConceptScore W1955473499C33923547 @default.
- W1955473499 hasConceptScore W1955473499C86803240 @default.
- W1955473499 hasIssue "4" @default.
- W1955473499 hasLocation W19554734991 @default.
- W1955473499 hasLocation W19554734992 @default.
- W1955473499 hasLocation W19554734993 @default.
- W1955473499 hasLocation W19554734994 @default.
- W1955473499 hasOpenAccess W1955473499 @default.
- W1955473499 hasPrimaryLocation W19554734991 @default.
- W1955473499 hasRelatedWork W1502720009 @default.
- W1955473499 hasRelatedWork W198421414 @default.
- W1955473499 hasRelatedWork W1988074940 @default.
- W1955473499 hasRelatedWork W2005578848 @default.
- W1955473499 hasRelatedWork W2084637020 @default.
- W1955473499 hasRelatedWork W2088528091 @default.
- W1955473499 hasRelatedWork W2140645870 @default.
- W1955473499 hasRelatedWork W2395506891 @default.
- W1955473499 hasRelatedWork W2412915157 @default.
- W1955473499 hasRelatedWork W2273204615 @default.
- W1955473499 hasVolume "8" @default.
- W1955473499 isParatext "false" @default.
- W1955473499 isRetracted "false" @default.
- W1955473499 magId "1955473499" @default.
- W1955473499 workType "article" @default.
!["In March 2006, a phase I clinical trial turned into tragedy when six healthy volunteers became critically ill in response to a new humanized monoclonal antibody, TGN1412. Soon after receiving the anti‐inflammatory substance intravenously at Northwick Park Hospital in London, UK, the participants complained of headaches, fever and pain, and then began vomiting. All six were transferred to the hospital's intensive care unit, where they were treated in response to a severe allergic reaction. Within one month of the incident, five of the volunteers had returned home, but the sixth remained in hospital for a further two months. Despite their recovery, there have been suggestions that the drug could have caused long‐term damage to the volunteers' immune systems.![][1] An investigation by the UK Medicines and Healthcare Products Regulatory Agency (MHRA; London, UK) concluded that the adverse effects were caused by an unprecedented biological action of the drug and not by errors made by either TeGenero AG (Wurzburg, Germany), the company that developed the antibody, or Parexel (Waltham, MA, USA), the subcontractor that organized and performed the clinical trial (MHRA, 2006). However, independent researchers have suggested that several preventive measures could have been taken (Kenter & Cohen, 2006). First, it was a mistake to administer the drug to all six volunteers at almost the same time; it would have been more vigilant to ensure that each volunteer remained healthy before proceeding onto the next. Second, from an ethical point of view, it would have made more sense to test the drug in a patient suffering from the disease that the substance was designed to treat, because it might have had some beneficial effects.> Arguably, there is no fundamental difference between using the precautionary principle to abolish clinical trials, mobile phones or genetically modified foodThat said, it is worth remembering—and accepting—that … [1]: /embed/graphic-1.gif"](?object=%22In%20March%202006%2C%20a%20phase%20I%20clinical%20trial%20turned%20into%20tragedy%20when%20six%20healthy%20volunteers%20became%20critically%20ill%20in%20response%20to%20a%20new%20humanized%20monoclonal%20antibody%2C%20TGN1412.%20Soon%20after%20receiving%20the%20anti%E2%80%90inflammatory%20substance%20intravenously%20at%20Northwick%20Park%20Hospital%20in%20London%2C%20UK%2C%20the%20participants%20complained%20of%20headaches%2C%20fever%20and%20pain%2C%20and%20then%20began%20vomiting.%20All%20six%20were%20transferred%20to%20the%20hospital's%20intensive%20care%20unit%2C%20where%20they%20were%20treated%20in%20response%20to%20a%20severe%20allergic%20reaction.%20Within%20one%20month%20of%20the%20incident%2C%20five%20of%20the%20volunteers%20had%20returned%20home%2C%20but%20the%20sixth%20remained%20in%20hospital%20for%20a%20further%20two%20months.%20Despite%20their%20recovery%2C%20there%20have%20been%20suggestions%20that%20the%20drug%20could%20have%20caused%20long%E2%80%90term%20damage%20to%20the%20volunteers'%20immune%20systems.!%5B%5D%5B1%5D%20An%20investigation%20by%20the%20UK%20Medicines%20and%20Healthcare%20Products%20Regulatory%20Agency%20(MHRA%3B%20London%2C%20UK)%20concluded%20that%20the%20adverse%20effects%20were%20caused%20by%20an%20unprecedented%20biological%20action%20of%20the%20drug%20and%20not%20by%20errors%20made%20by%20either%20TeGenero%20AG%20(Wurzburg%2C%20Germany)%2C%20the%20company%20that%20developed%20the%20antibody%2C%20or%20Parexel%20(Waltham%2C%20MA%2C%20USA)%2C%20the%20subcontractor%20that%20organized%20and%20performed%20the%20clinical%20trial%20(MHRA%2C%202006).%20However%2C%20independent%20researchers%20have%20suggested%20that%20several%20preventive%20measures%20could%20have%20been%20taken%20(Kenter%20%26%20Cohen%2C%202006).%20First%2C%20it%20was%20a%20mistake%20to%20administer%20the%20drug%20to%20all%20six%20volunteers%20at%20almost%20the%20same%20time%3B%20it%20would%20have%20been%20more%20vigilant%20to%20ensure%20that%20each%20volunteer%20remained%20healthy%20before%20proceeding%20onto%20the%20next.%20Second%2C%20from%20an%20ethical%20point%20of%20view%2C%20it%20would%20have%20made%20more%20sense%20to%20test%20the%20drug%20in%20a%20patient%20suffering%20from%20the%20disease%20that%20the%20substance%20was%20designed%20to%20treat%2C%20because%20it%20might%20have%20had%20some%20beneficial%20effects.%3E%20Arguably%2C%20there%20is%20no%20fundamental%20difference%20between%20using%20the%20precautionary%20principle%20to%20abolish%20clinical%20trials%2C%20mobile%20phones%20or%20genetically%20modified%20foodThat%20said%2C%20it%20is%20worth%20remembering%E2%80%94and%20accepting%E2%80%94that%20%E2%80%A6%20%5B1%5D%3A%20%2Fembed%2Fgraphic-1.gif%22){kind=link}