Vittorio Fontana è geriatra, lavora all’Ospedale Bassini di Cinisello Balsamo (Milano), e fa parte dell’associazione “No Grazie Pago Io”, costituita da operatori sanitari che non accettano nulla dalle case farmaeutiche e che mantengono una rigorosa autonomia e senso critico. Ospitiamo un intervento del dottor Fontana che mette in luce le influenze dei rappresentanti dei farmaci sulle prescrizioni dei medici.
by Vittorio Fontana
The most recent systematic review on the relationship between the pharmaceutical industry and doctors comes to conclusions that are already known. On the other hand, the task of a systematic review is mostly to take stock of the situation. The conclusions are precisely the following: the relationship between doctors and the pharmaceutical industry in general and more particularly between doctors and drug representatives (also known by us as scientific drug 'informants', perhaps to underlie the ambiguous nature of the profession) influences the prescribing behaviors of doctors and probably contributes to the 'irrational' (beyond scientific evidence) prescribing of branded drugs (the brand of the company that gave you the gift).
Let's start from here, one fact above all, one simple rule, follow the money: in 2012, the pharmaceutical industry spent $89.5 billion on interactions between doctors and their representatives. If it were of no use, he would invest them differently. Some studies had already shown that representatives influence prescribing behaviors. However, the evidence in this field at the time was, according to the authors, still fragmentary and contradictory. That's why the systematic review. Review done with the sacred trappings, i.e. using the Cochrane recommendations for systematic reviews and the GRADE methodology to assess the quality of the evidence (see attached table). In other words: now let's see what you find to complain about.
Sono stati scandagliati i principali database elettronici come PubMed, Embase, Cochrane Library e Google Scholar dal Gennaio 1992 (per ciò che viene prima del ’92 vi è una precedente revisione) all’Agosto 2016. È stata anche analizzata la cosiddetta letteratura grigia: da wikipedia, “Informazione prodotta a livello governativo, accademico o industriale (in formato elettronico e cartaceo, non controllata dall’editoria commerciale), cioè da organismi o enti produttori la cui attività principale non sia quella editoriale.”. Sono stati esclusi gli studi qualitativi, ecologici, econometrici, gli editoriali, le lettere all’editore, gli studi riguardanti altre categorie 
Interactions between doctors and representatives
The authors found that interactions with representatives are the norm in the lives of physicians around the world. The frequency of interactions and the types of gifts offered and accepted depend on the public or private organization and the hierarchical position of the doctor. Young residents, for example, receive twice as many free samples as older ones. In turn, treating physicians and specialists have more interactions and receive more samples and more promotional material than residents. Those who work in the private sector receive more gifts than those who work in the public sector. The most common gifts are: drug samples, promotional materials, dinner invitations, invitations to sponsored Continuing Medical Education events, scientific journals, and free lunches.
What doctors think about interactions with representatives
Physicians generally have a favorable attitude towards representatives and perceive them as an important source of education and funding, although some studies highlight some skepticism regarding the quality of teaching and education. Conference registrations, informational lunches, departmental journal club sponsorships, anatomical models, and drug samples are considered appropriate gifts.
Most physicians view the information provided by representatives, information from sponsored conferences, and sponsored ECM as important tools for increasing their knowledge. Most studies have found that physicians do not believe that interactions with representatives impact their own prescribing behaviors. Counter-intuitively, moreover, the more gifts you receive the more you don't think they influence prescribing habits. But everyone thinks that colleagues are much more susceptible to marketing strategies. They are, colleagues, they are susceptible to the flattery of marketing, but we are not. Those who are more aware of the influence that these interactions have, generally try to have fewer interactions with representatives.
Conferences held by representatives of the pharmaceutical industry. They induce bystanders to prescribe more of the company's drugs with no more evidence to support the superiority of those drugs.
Research fees and funds. Doctors who get paid to speak at sponsored symposiums or to do sponsored research are more often prescribing the drugs from the company that sponsors them.
Congress trips. Sponsored trips have a measurable impact on attendees. There was a three-fold increase in prescription drugs produced by the company that had paid for the entire stay. Faced with the evidence, however, participants continued to deny any impact on their prescribing habits.
Sponsored Continuing Education. Participants in sponsored CME are more likely to prescribe brand name drugs. Those who refuse the sponsored CME prescribe more generics and lower cost drugs (with the same evidence of effectiveness).
Discussion
The doctor-patient relationship is a relationship based on trust. Consequently, any activity that could alter this fiduciary relationship is not acceptable. Interactions between physicians and the pharmaceutical industry and its representatives can undermine this trust. The relationship between physicians and the pharmaceutical industry is a relationship that begins early in the physician's career. Already as trainees physicians are exposed to the marketing and promotional techniques of the pharmaceutical industry and this early exposure will influence future prescribing behaviours. In the sense of encouraging irrational prescribing behaviors, favoring the prescription of branded drugs (not superior in efficacy) over the prescription of cheaper equivalents. And ultimately helping to increase healthcare costs.
Hence the need to establish and implement stringent policies aimed at limiting relations between doctors and the pharmaceutical industry and its representatives. Just as educational programs are needed to raise awareness of this problem among doctors. There is also evidence that educational policies and programs aimed in this direction are effective. Further studies are needed both on the doctor-pharmaceutical industry relationship and on the benefits of educational programs.
Fickweiler F, Fickweiler W, Urbach E. Interactions between physicians and the pharmaceutical industry generally and sales representatives specifically and their association with physicians’ attitudes and prescribing habits: a systematic review. BMJ Open 2017;7:doi: 10.1136/bmjopen-2017-016408
Warning: it is not a translation in the strict sense, it is a summary report and at times commented on the above systematic review.
Ed: L’articolo sopra riportato ci porta ad alcune riflessioni. Il rappresentante dell’associazione “No Grazie Pago Io”, Vittorio Fontana, dovrebbe sapere che i rappresentanti dei farmaci in Italia si chiamano Informatori Scientifici sul Farmaco (ISF) perché così vengono definiti dalla legge, il D. Lgs. 219/06, che ne regolamenta l’attività (chissà se il rappresentante di questa associazione sa che esiste una legge del genere e soprattutto cosa dice).
Il rappresentante dell’associazione “No grazie” ammette che fa riferimento a ricerche non italiane. Occorre pertanto precisare che più o meno gli informatori o i rappresentanti dei farmaci sono presenti in tutto il mondo, ma le funzioni che svolgono non sono identiche andando da un’attività commerciale ad una attività tecnico/scientifica a seconda delle nazioni.
Tralasciando i paesi extraeuropei, ove l’attività degli ISF (per brevità li definiremo così, sperando di non urtare la sensibilità semantica del rappresentante dell’associazione) è prevalentemente commerciale, ci soffermeremo a delineare a grandi linee la situazione europea
In Germania esistono i “Consulenti Farmaceutici certificati – Geprüfte Pharmareferent – ”(informatori scientifici del farmaco – ISF) alle dipendenze di un servizio scientifico e i rappresentanti farmaceutici, c’è una legge di regulation. Also in Austria the Pharmareferent is certified and regulated by law, he cannot sell drugs and must have adequate training. Companies that violate the rules will be severely fined. In Switzerland, Pharmaberater/innen (pharmaceutical consultants), in addition to providing information on drugs, organize and conduct events, carry out market research and develop marketing strategies.
In Spagna i “Visitadores Médicos” fanno parte delle vendite. hanno un contratto a tempo indeterminato con stipendio, rimborso spese e incentivi sulle vendite, ci sono però anche anche venditori a provvigioni. In Romania, e in genere i Paesi dell’est, manca un quadro giuridico chiaro e un sistema di formazione compatibile con gli standard europei. Nel Regno Unito i “Medical Representatives” hanno uno stipendio base, integrato da una retribuzione correlata alla performance, incentivi e benefit. In Belgio la situazione è simile all’Inghilterra.
In France the Visiteur Médical or Délégué Médical does not sell even if his activity was semi-commercial in the sense that he had to promote sales. However, the French situation has radically changed after the scandal of the drug Mediator, launched on the market by Servier, which caused thousands of deaths. Responsibility for this disaster was passed on to the ISF, which led the government to renew the first ethical code of 2004, imposing a new, very restrictive one at the end of 2014 (Medical Examination Charter http://www.leem.org/article/charte-de-visite-medicale ). This has resulted in "a huge reorganization in the ISF profession".
The new Regulatory Charter has introduced a quality control of Scientific Information to doctors. The "National Observatory of promotional information" was introduced. This new body will have the purpose of "measuring the quality of information, on the basis of objective, verifiable and transparent criteria".
The doctors (sentinel) will be consulted regularly to "control" the quality and frequency of the visits of the ISFs. The doctors (sentinel) will be chosen on the basis of a panel that will change cyclically. Irregular behavior will be reported to the National Agency for Drug Safety (MSNA) which will take the necessary measures. The so-called “medical representative” has been abolished.
In Italia il D.Lgs. 219/06 regola l’attività degli ISF. Essi devono dipendere da un Servizio Scientifico indipendente dalla Direzione Marketing o Vendite. La legge nazionale, le leggi e i regolamenti regionali, varie sentenze di tribunali e Cassazione, vietano gli ISF qualsiasi attività commerciale o di vendita.
E’ da considerare che la legge vieta qualsiasi pubblicità dei farmaci da prescrizione e che l’unico deputato ad informare i medici (non promuoverlo) è l’ISF. E’ da considerare che non tutti i nuovi farmaci passano da blasonate riviste scientifiche e non tutti i medici hanno la possibilità o il tempo per ricercarli (ma se non sanno che esistono, cosa cercano?). Come farebbero le imprese farmaceutiche, che non sono Opere Pie, a far saper dell’esistenza dei loro farmaci? Forse per l’esimio rappresentante dell’associazione “no grazie” la soluzione è eliminare gli ISF e nazionalizzare tutto il settore? E chi finanzierebbe la ricerca, lo Stato? Non lo fa neanche la Cina dove l’industria farmaceutica nella produzione di generici è molto florida (non sempre purtroppo di qualità).
Articles like the one reported lead nowhere, they don't go to the root of the problem, reducing everything to the fault of the ISF.
Oseremmo suggerire all’esimio rappresentante dell’associazione “no grazie” di informarsi meglio e che la soluzione non è l’abolizione dell’ISF ma pretendere che la sua attività sia conforme alle regole di legge e di denunciare i trasgressori.
Sergio Cardinals (Filctem). Scientific informants of the drug and Doctors of public and affiliated health facilities.
Questo è il rapporto virtuoso ad etico, per un controllo del corretto utilizzo delle risorse, garantendo la migliore cura possibile a tutti i cittadini. La formazione e l’informazione scientifica degli operatori sanitari è la garanzia stessa del mantenimento di una sanità pubblica nel nostro paese. Rompere questo equilibrio significa minare la colonna vertebrale dello stesso, libit was the road to private healthcare, the prerogative of a few rich people, and whose only goal is to guarantee dividends to shareholders and investment funds.
Some regional resolutions, the layoffs implemented by pharmaceutical companies, the lack of interest of the State in Public Health, are the elements that act simultaneously towards the destruction of the system.
A State that guarantees lobbies to the detriment of the community of citizens, not only no longer represents their interests but MUST BE FIGHTED WITH ALL FORCES, FORWARD WITH ALL. (Facebook)
Related news: They are stealing our health care