Una campagna pubblicitaria all'inizio di aprile del 2012 25 settembre 2013 26 settembre 2013 milano.corriere.it, 30 novembre 2013 «According to the European Commission, little safety information exists for 99 percent of the tens of thousands of chemicals placed on the market before 1981.[4] There were 100,106 chemicals in use in the EU in 1981, when the last survey was performed. Of these only 3,000 have been tested and over 800 are known to be carcinogenic, mutagenic or toxic to reproduction. These are listed in the Annex 1 of the Dangerous Substances Directive (now Annex VI of the CLP Regulation)». http://en.wikipedia.org/wiki/Registration,_Evaluation,_Authorisation_and_R estriction_of_Chemicals Editorial, NATURE|Vol 438|10 November 2005 «Scientists at the European Centre for the Validation of Alternative Methods (ECVAM) in northern Italy — which was set up by the European Commission to develop alternatives to animal testing — argue that animal tests are badly flawed. They say the new drive for alternative methods will improve the science of toxicity testing. And public safety demands that the new tests are shown to be better predictors of toxicity than the existing methods.» «Perhaps the most difficult point in the action plan concerns its call for the release of more information on the performance of animal tests: how robust, reproducible and relevant are they? The data so far give grounds for concern. Yet industry has been resistant to this. If the gold standard of animal tests against which new tests are to be compared turns out to be made of tin, the political fallout would be considerable. Public trust in the ability of regulatory authorities and industry to address safety issues would be damaged. But in the interests of a thorough, economically viable and scientifically valid product-safety testing regime, information about the methods used in the past needs to be shared, and fairly investigated.» 143,000 chemicals preregistered by December 1, 2008 those to be tested reduced to 30,000 those to be be tested further reduced to 5,500 (less than 4%) T. Hartung, Nature, vol. 460 (2009), pp. 208-12 ...for a cost estimated as 8.8 billion eu 1.6 million eu for each chemical, each test requiring 3,200 animals Convenzione terminologica Con il termine “vivisezione” si intende storicamente, e tuttora, la sperimentazione invasiva su animali vivi (anche senza “sezione”). 1882 Lawson Tait [1845-1899] The Uselessness of Vivisection upon Animals as a method of scientific research 1975 – Princeton University Press 1990 – Routledge 2004 – Routledge (3 voll., 1144 pp.) La vivisezione è da due secoli contestata al tempo stesso come 1) una pratica crudele e 2) una metodica inaffidabile. 1975 “Maternal deprivation experiments”, NIH, Poolesville, Maryland (negli ultimi trent'anni) «Animal testing horror: Scientists cut open kittens' skulls and stuck electrodes in their BRAINS» Jun 02, 2014 13:17 University College London Max Planck Institute for Biological Cybernetics (7 anni di investigazione sotto copertura) - 2014 Covance Laboratory, Münster, Germany (2003) and Vienna, Virginia (2005) I National Institutes of Health statunitensi danno alla vivisezione ogni anno quasi la metà della loro dotazione: $ 15 miliardi L'anno scorso (2013) hanno tagliato di 4 milioni di dollari il finanziamento di uno dei più importanti studi epidemiologici, il Framinghan Heart Study, in corso da 65 anni: $ 9 milioni → $ 5 milioni Hanno invece mantenuto il finanziamento (per circa 12,7 milioni) sul comportamento sessuale di roditori dopo lesioni, mutilazioni e avvelenamenti Esempio The most important aspect of the Amsterdam Treaty (1997-1999), in terms of animal welfare, was the inclusion of a Protocol on animal welfare. «Desiring to ensure improved protection and respect for the welfare of animals as sentient beings, [...]» Consolidated versions of the Treaty on European Union and the Treaty on the Functioning of the European Union [...] Official Journal C 326 , 26/10/2012 P. 0001 - 0390 «Article 13 In formulating and implementing the Union's agriculture, fisheries, transport, internal market, research and technological development and space policies, the Union and the Member States shall, since animals are sentient beings, pay full regard to the welfare requirements of animals, while respecting the legislative or administrative provisions and customs of the Member States relating in particular to religious rites, cultural traditions and regional heritage.» «on the protection of animals used for scientific purposes» La precedente direttiva DIRETTIVA DEL CONSIGLIO del 24 novembre 1986 concernente il ravvicinamento delle disposizioni legislative, regolamentari e amministrative degli Stati membri relative alla protezione degli animali utilizzati a fini sperimentali o ad altri fini scientifici (86/609/CEE) Chi si deve occupare della questione? «There remains, therefore, the fourth avenue, which simply amounts to the inquiry, Has this method of scientific research – vivisection – contributed so much to the relief of suffering or to the advance of human knowledge as to justify its continuance in spite of the manifest objections to it? My own answer I shall try to give in the following pages, merely premising that an answer to justify vivisection must be clear and decisive, must be free from doubt of any kind, and above all, it must not assume the protection of a "privileged mystery".» A chi spetta pronunciarsi sulla questione «This is a question, I maintain, which can be discussed by an educated layman just as well, perhaps better, than by a physician or a surgeon or a professional physiologist. It is a question chiefly of historical criticism, and we must have a conclusive answer concerning each advance which is quoted as an instance, how much of it has been due to vivisectional experiments and how much to other sources, and this amount must be clearly and accurately ascertained.» Una questione che non si decide a maggioranza «I am quite well aware that I am one of a small minority of my profession in my view that vivisection is useless as a method of research, but the answer I am disposed to offer on this point is, that not one in a hundred of my professional brethren have ever seriously examined the question. Ninety-nine take for granted the statements of the hundredth, and he, in turn, has not gone into the matter upon that side from which alone a safe can be given – that of historical criticism.» 1a edizione, 1903 Edward Berdoe, 1908 Ludwig Fliegel, 1930 George Searle, FRS, A Survey of the Case Against Vivisection [1936] Richard P. Feynman (1918-1988) Richard P. Feynman (1918-1988) Feynman si dimise da una delle più prestigiose istituzioni statunitensi, la National Academy of Sciences, poco dopo la sua elezione nel 1954, per indignazione verso esperimenti sugli animali (annegamento di ratti) che gli sembravano al tempo stesso «a most cruel, stupid, and unnecessary thing». Hans Ruesch, 1976/1978 Hans Ruesch, 1986 Pietro Croce, 1981 2000- Zed Press (Londra e New York) «Although Croce doesn't mince his words, this is a balanced and thoroughly researched book. It also has a long history. It was first published in Italian in 1981 and was translated into English in 1991. This is an updated edition of what is generally regarded as "the Bible of antivivisection." If you want to read a book that challenges everything you think you know about science and research, then this is the one for you. It certainly changed my view.» Il primo numero del British Medical Journal 3 ottobre 1840 BMJ, 2004 September 25; 329(7468): 0. “Is it better to be smart or stupid?” Kamran Abbasi, acting editor «BMJ's usual policy is to diligently divert animal research to other journals» [“la regola abituale del British Medical Journal è dirottare diligentemente la ricerca che coinvolge animali su altre riviste”] (dall’editoriale Abbasi 2004). L'eccezione cui l'editoriale seguente articolo: allude è il Francis Collins è il genetista statunitense che ha guidato il team di ricercatori che ha decifrato il genoma umano e attualmente è il direttore dei NIH. Francis S. Collins: “Reengineering Translational Science: The Time Is Right” Sci. Transl. Med. 6 July 2011: Vol. 3, Issue 90, p. 90cm17 http://stm.sciencemag.org/content/3/90/90cm17.full <<Efficacy testing. The use of animal models for therapeutic development and target validation is time consuming, costly, and may not accurately predict efficacy in humans (28, 29). As a result, many clinical compounds are carried forward only to fail in phase II or III trials; many others are probably abandoned because of the shortcomings of the model. [→] [→] Building on a potentially extensive network of collaborations with academic centers and advocacy groups, NCATS [= National Center for Advancing Translational Sciences] will aim to develop more reliable efficacy models that are based on access to biobanks of human tissues, use of human embryonic stem cell and induced pluripotent stem cell models of disease, and improved validation of assays. With earlier and more rigorous target validation in human tissues, it may be justifiable to skip the animal model assessment of efficacy altogether.>> 4 giugno 2013 <<“We have moved away from studying human disease in humans,” he lamented. “We all drank the Kool-Aid on that one, me included.” [→] [→] With the ability to knock in or knock out any gene in a mouse—which “can’t sue us,” Zerhouni quipped—researchers have over-relied on animal data. “The problem is that it hasn’t worked, and it’s time we stopped dancing around the problem…We need to refocus and adapt new methodologies for use in humans to understand disease biology in humans.”>> Altro parere autorevole (2013) Hartung T. 2013: “Look Back in Anger – What Clinical Studies Tell Us About Preclinical Work”, Altex, 30, pp. 275-91. «If animals were fortune tellers of drug efficacy, they would not make a lot of money...» «Se gli animali facessero gli indovini dell'efficacia dei farmaci, non farebbero un sacco di soldi...» 2004 La conclusione dell'articolo citato: «Ideally, new animal studies should not be conducted until the best use has been made of existing animal studies and until their validity and generalisability to clinical medicine has been assessed». «Idealmente nuovi studi su animali non dovrebbero essere intrapresi finché non si sia fatto il miglior uso degli studi su animali già esistenti, e finché la loro validità e generalizzabilità alla medicina clinica non sia stata valutata» «Much clinical research follows on from animal research. If the foundations of the biomedical research enterprise are unsound, then whatever is built on these foundations will be similarly precarious». Statistiche 7th Report on the Statistics on the Number of Animals used for Experimental and other Scientific Purposes in the Member States of the European Union (2013) «In the EU, the total number of animals used for experimental and other scientific purposes from the data collected in 2011 in accordance with the provision of the Directive for this report is just under 11,5 million (with data from France from 2010).» Proscimmie, Scimmie e Scimmie antropomorfe 0,05% di 11.500.000 = 5750 G. Searle, Il problema della vivisezione, 1936 «Come abbiamo già detto, gli esperimenti sugli animali daranno sempre risultati sufficienti nel senso materiale, cioè per compilare una relazione, ed è questa una delle ragioni che dà maggior popolarità al laboratorio e, nel contempo, una loro posizione di superiorità assoluta sullo studio clinico. Ma la soluzione di un determinato problema è molto diversa e nulla dimostra, in modo più perfetto, la futilità degli esperimenti sugli animali quanto la storia delle ricerche per lo studio del cancro.» «In comparison to 2008, increases in the use of animals have also been observed for dogs, totalling above 1 000; for other carnivores about 500; for other mammals a little above 300 and for other birds above 2 500. On the other hand the number of rats used for studies on diseases has decreased by more than 250 000 animals.» «UK According to the latest Home Office figures, more than 4 million animals were used in experiments in the UK in 2012, representing a 9% increase since 2011. This is equivalent to beginning over 11,000 experiments every day and represents the highest number of animal experiments (since the introduction of the Animals (Scientific Procedures) Act in 1986) in Great Britain. This is the third annual increase in the number of animal experiments since the Government’s commitment to reduce them.» http://www.buav.org/humane-science/statistics/ In Italia Premi Nobel 2014 Nobel Prize in Physiology or Medicine (two of the three winners): «"for their discoveries of cells that constitute a positioning system in the brain"» 9 OCTOBER 2014 | VOL 514 | NATURE | 155 «But the pair wouldn’t leave his office [i.e. electrophysiologist Per Andersen's office at the University of Oslo] until he gave in and offered them an apparently simple project: how much of the hippocampus could you cut away before a rat could no longer remember new environments?» 9 O C T O B E R 2 0 1 4 | VO L 5 1 4 | N AT U R E | 1 5 3 «Both place and grid cells have practical relevance. The early stages of Alzheimer’s disease affect the entorhinal cortex, and one of the first symptoms is losing one’s way. The disease goes on to devastate the hippocampus, stripping sufferers of their memories. “ “It is a good example of how very basic research can help us gain the deeper understanding we need in such devastating diseases to move towards therapies,” says Richard Morris, a memory researcher at the University of Edinburgh, UK.» Key publications: O'Keefe, J., and Dostrovsky, J. (1971). The hippocampus as a spatial map. Preliminary evidence from unit activity in the freely‐moving rat. Brain Research 34, 171-175. O´Keefe, J. (1976). Place units in the hippocampus of the freely moving rat. Experimental Neurology 51, 78-109. Fyhn, M., Molden, S., Witter, M.P., Moser, E.I., Moser, M.B. (2004) Spatial representation in the entorhinal cortex. Science 305, 1258-1264. Hafting, T., Fyhn, M., Molden, S., Moser, M.B., and Moser, E.I. (2005). Microstructure of spatial map in the entorhinal cortex. Nature 436, 801-806. Sargolini, F., Fyhn, M., Hafting, T., McNaughton, B.L., Witter, M.P., Moser, M.B., and Moser, E.I. (2006). Conjunctive representation of position, direction, and velocity in the entorhinal cortex. Science 312, 758-762. «"greatest benefit on mankind"» ?? Ricerca di base? * Basic Research? Ricerca di base? Contoupolos-Ioannidis D.G., Ntzani E., Ioannidis J. P. 2003: “Translation of highly promising basic science research into clinical applications”, Am. J. Med., 114, pp. 477-84. Sono stati analizzati circa 25.000 articoli di ricerca di base pubblicati durante un quinquennio (1979-1983) in un gruppo di 6 riviste biomediche (Nature, Cell, Science, Journal of Biological Chemistry, Journal of Clinical Investigation, Journal Experimental Medicine), e si è andato a verificare nei 20 anni successivi quanti di essi avessero portato a progressi in campo clinico Crowley WF jr: “Translation of basic research into useful treatments: how often does it occur?”, Am. J. Med., 114(2003), pp. 503-5 «The article by Contopoulos-Ioannidis et al. (Contopoulos-Ioannidis, Ntzani, and Ioannidis 2003) in this issue of the journal addresses a much-discussed but rarely quantified issue: the frequency with which basic research findings translate into clinical utility. […] Of the 25,000 articles searched, about 500 (2%) contained some potential claim to future applicability in humans, about 100 (0.4%) resulted in a clinical trial, and, according to the authors, only 1 (0.004%) led to the development of a clinically useful class of drugs (angiotensinconverting enzyme inhibitors) in the 30 [sic: 20] years following their publication of the basic science finding. […] [→] [→] Still, regardless of the study's limitations, and even if the authors were to underestimate the frequency of successful translation into clinical use by 10-fold, their findings strongly suggest that, as most observers suspected, the transfer rate of basic research into clinical use is very low». Un altro studio autorevole (2012) Ioannidis J. P. A. 2012: “Extrapolating from Animals to Humans”, Science Translational Medicine, vol. 4, n. 151. «...it is nearly impossible to rely on most animal data to predict whether or not an intervention will have a favorable clinical benefit–risk ratio in human subjects» «è quasi impossibile fare affidamento sulla maggior parte dei dati ottenuti su animali per predire se un certo intervento avrà o no un rapporto favorevole benefici-rischi a livello clinico in soggetti umani». In un'intervista Ioannidis riassume: «Animal research is extremely important, and in theory it can offer valuable preclinical insights. However, currently published preclinical evidence from animals seems to have very limited concordance with what we see in humans. Almost everything seems to work in animals, and then almost nothing works in humans. The credibility and utility of animal research may be strengthened, if we can bolster the way animal experiments are designed, conducted, and published in the literature.» Domanda Che cosa è stato definito da The Lancet (nel 1978) come «potenzialmente il più importante progresso medico del secolo [potentially the most important medical advance of the century]»? http://www.unicef.org/sowc96/joral.htm ORS= oral rehydration salts (ORT= oral rehydration therapy) http://rehydrate.org/solutions/homemade.htm#recipe Si stima che abbia salvato almeno 50 milioni di persone dal 1978 Benché nella letteratura vengano citati esperimenti su colture celulari tratte dagli intestini di topi, questi non hanno avuto, per diretta testimonianza dei protagonisti (Chatterjee, Phillips, Cash e Nalin: 1960-70), alcuna importanza nell'effettiva scoperta e applicazione del metodo. [R. Cash, “A History of the development of oral rehydration therapy (ORT)”, 1987] In ogni caso il metodo era stato scoperto e ampiamente esposto in un libro (1853) da un medico, William Stevens: cioè più di un secolo prima (e in maniera totalmente indipendente da qualsiasi esperimento su animali)! [W. J. Daly, H. L. DuPont, CID, vol. 47 (2008), pp. 1315-9.] N.B. Né Phillips, né Cash, né Nalin ecc. hanno mai ricevuto il premio Nobel. Tuttavia ancor oggi ogni giorno muoiono circa 8000 bambini per mancanza di questo presidio medico essenziale e a bassissima tecnologia «Around 8,000 children still die each day from diarrhoeal dehydration, a toll the world can and must reduce with ORT.» [http://www.unicef.org/sowc96/joral.htm] la Repubblica, 25 aprile 2013 «“L’11% degli italiani [cioè 6,7 milioni!] rinuncia alle cure perché non ha le possibilità economiche, e nel caso delle visite odontoiatriche la percentuale sale al 23% – denuncia il segretario nazionale Codacons, Francesco Tanasi – In Sicilia la situazione è addirittura peggiore. Chi non può permettersi un medico privato, si rivolge alla sanità pubblica, settore dove però le liste d’attesa sono spesso lunghissime, al punto da spingere un numero crescente di utenti a rinunciare alle cure”.» “Palermo, ha un ascesso Gaetana Priola muore a 18 anni”, 11 febbraio 2014 Ansa, 30 settembre 2014 il Fatto Quotidiano, October 10, 2014