survey of La Repubblica Today, edited by Michael Bocci (http://www.repubblica.it/cronaca/2010/07/16/news/inchiesta_farmaci-5618527/?ref=HREC1-3), reveals that a growing number of Italian citizens subjects to test experimental drug in Switzerland, France and Austria in exchange for money. This is mostly healthy individuals who choose to spend own three or four days in a clinical setting and to take drugs in Phase 1 testing. The purpose of Phase 1 is as well described in the article, to test the toxicity of the molecule contained in the product. In exchange for the willingness to participate in the research, subjects receive a refund of about € 200/250 per day and play a check-up medico completo e gratuito. I rischi connessi alla partecipazione ci sono, ma sono bassissimi, e la struttura clinica si assume l’onere di eventuali cure dovute ad effetti collaterali del farmaco sotto sperimentazione.
Bisogna ricordare che questa attività di ricerca farmacologica segue la ricerca cosiddetta di base condotta in laboratorio e la sperimentazione pre-clinica su animali non umani. I test di cui si occupa l’inchiesta sono dunque il primo, indispensabile passo del lungo iter che porta i ricercatori a verificare l’efficacia farmacologica di una nuova molecola. Senza questo tipo di sperimentazione su soggetti sani, non potremmo sperare di avere nuovi farmaci a disposizione in futuro per combattere più efficacemente la malattia and to intervene on diseases currently untreatable from a pharmacological point of view.
While these considerations are clearly present in the mind of the author of the piece (which in fact talks about it in the article), the title - "The forced medication and the business of human guinea pigs" - and the general tone of the investigation are alarming and derogatory towards the activities described. It is not easy, and is likely to be ungenerous, groped to criticize a text written by its tone. But as is normal for a journalistic text, is the tone to give color to this piece. So I will try to bring out and criticize some considerations that (unfortunately) flutter soltanto nell’articolo, più che essere sostenute da una chiara linea argomentativa.
Innanzi tutto: perché coloro che si sottopongono a sperimentazioni farmacologiche vengono chiamati “forzati del farmaco”? Chi li forza? Chi li costringe? Dall’inchiesta si evince che la motivazione economica è l’unica a sostenere la scelta di soggetti sani di partecipare alle ricerche in questione. Questa ricostruzione è senz’altro plausibile, ma per quale motivo dovrebbe rappresentare una forzatura? Perché una persona non può decidere di accettare denaro e un check-up medico in cambio di una prestazione niente affatto onerosa da un punto di vista psico-fisico e solo moderatamente rischiosa da un punto di vista doctor? I do not see why such activity should be deemed incompatible with the exercise of personal autonomy (hence the name of "forced"). In exchange for money, often little money, people agree to engage in activities far more dangerous and stressful, such as working on a construction site, or driving trucks. But no one would dream of saying that these activities limit the autonomy of the workers who take, although in my opinion, a person is generally more good reasons - both prudential and social - to participate in a clinical trial not to carry vegetables on the highway or build yet another house duplex.
The other part that I would like to say a word, is the aura of mistrust with which they are represented pharmaceutical companies ("the business of human guinea pigs", as the title). Without doubt the market of pharmaceutical research is not without moral hazard of great significance. However, the research, testing and marketing of drugs are strictly regulated, the economic incentive is in fact a regulatory framework rightly severe, the best way to ensure the availability of more effective medications. Evoking scenes of conspiracy against morality of research subjects seems therefore unjustified, given the current legal safeguards to protect these individuals, and distracts the reader's attention from the need, increasingly insistent, a reinvigoration of the public and private sources of funding for biomedical research.
seems that, in the eyes of some commentators, the presence of economic incentive for those who produce drugs and who decides to test them in person, represents an element of degrading moral value of these activities. But it is precisely these activities that you expect a great return to morality in terms of effective treatment and lives saved.
In conclusion I would say that, although altruism does not seem to be the predominant motivation or by whom you test Phase 1 (as is clear from the interviews of the investigation), nor by the pharmaceutical companies, as the activities of each other, providing a valuable moral content, that the economic presence of the incentive does not affect in any way. In reality, the economic incentive seems appropriate recognition to the efforts required to make available an active ingredient and should be encouraged rather than viewed with suspicion.
Moreover, as claimed by the English philosopher John Harris, the enormous importance of scientific research results in a positive moral duty to support it and also to attend in person (see http://jme.bmj.com/content/31/4 / 242.full).
0 comments:
Post a Comment