Título de la serie: House M. D. (2004-2012).

Title: 150 miligrams.

Original title: La fille de Brest.

Country: Francia.

Year: 2016.

Director: Emmanuelle Bercot.

Music: Martin Wheeler.

Photography: Guillaume Shiffman.

Film editor: Julien Leloup.

Screenwriter: Emmanuelle Bercot.

Cast: Sidse B. Knudsen (Irène Frachon), Benoît Magimel (Antoine Le Bihan), Patrick Ligardes (Bruno Frachon), Raphaël Ferret (biostatisti- cal), Christophe Meynet (research collaborator), Nicolas Moreau (professor Launay), Luc Gentil (Chairman of the Afssaps commission (Pharmaco), Alain Cauchi (Chairman of the Afssaps commission (AMM), Claire Conty (Chairman of the Afssaps commission, Risk management), Ahmed Khalifa (cardiac surgeon), Philippe Ménasché (expert cardiologist, Afssaps commission), Bruno Rodet (Director CNAM), Nicolas Buchoux (AMM commission laboratory expert), Eric Toledano (expert laboratory of the Pharmacology commission), Emilie Martin-Ozanne (legalistic doctor), Mireille Lescouet (legalistic medical assistant), Patricia Baley (research nurse), Aurélia Le Hir (research nurse), Lydia Le Vourc’h (research nurse), Sylvie Le Gouil (smoking patient), Charlotte David (young asthmatic), Aurélie Mestrius (resuscitation nurse), Hafida Benyagoub (CHU secretary), Philippe Sprang ( Le Figaro journalist).

Color: Color.

Rumtime: 128 minutes.

Genre: Drama.

Language: French.

Productions companies: Haut et Court, France 2 Cinéma, Canal+,…

Synopsis: The film is based on Dr. Irène Franchon’s book Mediator® 150mg. Combien de morts?, that describe the research that faces disdain and threats from those who prioritize their economic interests and belittle the health problems of French consumers. In 2010, the French Social Security estimated that at least 500 people would have died; but according to forensic reports, Mediator® could have caused 2,100 deaths during the 30 years that was in the market.

Awards: César Award (Francia, 2017): Nomination for Best Actress (Sidse Babett Knudsen), Best Adapted Screenplay (Séverine Bosschem and Emmanuelle Bercot). Lumière Award (Francia, 2017): Nomination for Best Actress (Sidse Babett Knudsen).

Links:

https://www.imdb.com/title/tt5247544 https://www.filmaffinity.com/es/film

Trailer

Since the birth of cinema, feature films have been used as a teaching tool in medicine^1-3. Films are a rich resource that allows viewers to engage deeply with biomedical subjects, favoring the assimilation of complex concepts and sparking interest in the object of study³. They also portray different perspectives of the medical experiences^3,5,6 and offer models of behaviour and professionalism.

The term Cinemeducation refers to the use of films or video clips in medical education^7,8. A literature review shows many experiences using this activity for teaching different knowledge areas such as psychiatry and mental health^9-11, acquisition of communication tools⁵, understanding of disease¹² or the resolution of bioethical conflicts¹³ but there is scarce literature regarding its use in basic medical sciences such as pharmacology^14-16.

Pharmacology may be a difficult subject for medical students because it is very wide and varied, with a large number of drugs that they should know and remember. Moreover, some aspects of drug use might be difficult to understand for naïve students. The use of cinema in teaching pharmacology is relatively recent¹⁷. In most of the cases, feature films have been used to deepen in social aspects of the use of drugs or their use in the clinical research process as well as the ethical aspects linked to them.

Pharmacovigilance is one of the most important activities of clinical pharmacology. It is devoted to the detection, assessment, understanding and prevention of adverse effects associated with the use of drugs¹⁸. Some students may find most of the processes of pharma-covigilance hard to understand, especially those related to how the decisions about a safety concern are taken, as well as the different leading roles in the decision to recommend changes in the Summary of Product Characteristics or to advise the withdrawal of the drug.

Since Cinemeducation may enhance students’ learning and understanding of pharmacovigilance processes and the adverse drug reactions, we present our methodological proposal¹⁹ regarding film choices, their use in the teaching activity Cinemeducation and its evaluation for a Pharmacology course in medical schools.

The first step was the choice of the feature film to be used in the teaching activity. A systematic search of films of interest regarding adverse drug reactions and pharmacovigilance was performed using the IMDb platform (Internet Movie Database), the most complete and currently accessible online movie database. To begin with, a keyword search was carried out, duplicates were eliminated and exclusion criteria were applied. Horror or science fiction films, titles in production or discontinued and films not dubbed or subtitled in Spanish were excluded, as they might hinder the teaching activity. Their synopsis and plots were reviewed to select the final list of films. Systematic search and selection of the film for the didactic activity is shown in Table 1 and the final list of 15 selected films appears in Table 2.

Table 1.

Search by keywords		RD	EC+RS	SM
Side effects	4	4	0
Medication side-effects	6	5	2
Side effect	20	20	4
Pharmaceutical	20	20	2
Pharmaceutical companies	3	3	0
Pharmaceutical industry	21	17	2
Pharmaceutical company	36	30	3
Pharmaceuticals	25	17	2
Adverse-reaction	3	3	0
Drug testig	15	14	1
Drug test	15	13	0
Experimental drug	36	28	0
Drug trial	6	2	0
Total	195	176	16	15

*

RD: Removing duplicates.

Photo 1.

La fille de Brest by Emmanuelle Bercot²⁰ was chosen due to the relevance that the drug adverse reactions play in the plot. It tells the true story of Irène Frachon, a French physician (Photo 1), who was faced with the first cases of cardiotoxicity associated with the consumption of Mediator, an anorectic, which were diagnosed in the Hôpital de Brest where she worked. After an investigation carried out in the hospital (Photo 2), Dr. Frachon requested the withdrawal of the drug, of which the active substance was benfluorex, and that was sold massively in France for more than thirty years. It caused the death of more than 500 people. The film showed the legal process she undertook in 2009 against the French pharmaceutical company Servier that marketed the drug (Photo 3).

Table 2.

Title	Release year	Country	Genre
Bigger than life	1956	United States	Drama
Awakenings	1990	United States	Biography, Drama
A beautiful mind	2001	United States	Biography, Drama
I am alive today: history of an AIDS drug	2002	France, Belgium	Documentary
Side-effects	2005	United States	Comedy, Drama, Romance
The drugging of our children	2005	United States	Documentary
The constant gardener	2005	United Kingdom	Drama, Mystery, Romance
Dying for drugs	2005	United Kingdom	Documentary
Bigger, Stronger, Faster*	2008	United States	Documentary
Dallas Buyers Club	2013	United States	Biography, Drama
Side effects	2013	United States	Crime, Drama, Mystery
The big lie: american addict 2	2016	United States	Documentary
La fille de Brest	2016	France	Biography, Drama
Cause of death: unknown	2017	Norway	Documentary
120 battements par minute	2017	France	Drama

Nowadays, Servier is going on trial over this drug Mediator with the Agence nationale de sécurité du médicament (ANSM) and 21 defendants. They are facing more than 2,600 plaintiffs who believe the drug maker has deliberately misled patients for decades, helped by lenient authorities²¹.

The film also shows other important factors such as the relevance of a signal alert, the studies needed to confirm/reject the causality of an adverse drug reactions, the role played by the pharmaceutical industry and the public health agencies, the portrait of the investigation and the confrontation events among the doctor, the hospital team in charge of the epidemiological study and the staff of French agency of pharmacovigilance²². This combination of clinical, pharmacological and psychosocial aspects was considered of high didactic interest.

The film was reduced to a fifty-minute edition, suppressing secondary scenes to adjust it to the duration of the session and to focus students’ attention on the subject of interest.

The first educative step after choosing the feature film was to define the general and specific objectives of the activity. Working with cinematic material is not meant to be a form of entertainment: the focus must remain on education. In order to follow these principles, we defined a list of educational objectives for the activity (Table 3).

The list of objectives allowed us to elaborate a list of items that should have been addressed in the material presented to students before they viewed the film and in the discussion afterwards. We prepared a short introduction to the film, including comments about technical characteristics, a summary of the plot, and the historical context of the story of the production.

The discussion took place immediately after the viewing, when the events in the film and the emotions they stirred were still fresh in students’ minds. The moderator asked questions to prod students to discuss the issues dealt with in the film.

Photo 2.

Photo 3.

Table 3.

+ To learn the mechanisms of pharmacovigilance through the case of Mediator. + To discuss the social implications of pharmacovigilance. + To emphasize the importance of the signal alert and the studies needed to confirm / reject the causality of an adverse drug reaction. + To analyze the epidemiological study needed to prove the adverse drug reactions. + To establish drug’s contraindications, interactions and precautions to take into account. + To reflect about the difficulties to take a decision to withdraw a drug.

It is crucial to assess the effectiveness of the film-based activity in relation to our teaching goals. Students need to know from the start how the activity will be assessed and its weight in their final grade for the course. This emphasizes the fact that the film-based activity is an academic activity like any other. On the other hand, it is necessary to define the objective of this evaluation. We prepared a multiple choice questionnaire on the topics that students have observed in the film to compare the baseline knowledge before the activity and the knowledge gain after the intervention.

In our experience of using cinema in teaching medicine, human biology and pharmacology, we have observed that, although there are theoretical bases to justify the importance of working with films, publications about rigorous experiences are scarce^3,23. This is true for many innovations in teaching. As innovation in education is a complex process, it often stays in the classrooms and university meetings, and the experiments carried out do not always transfer to scientific publications. Educational innovation is a constant challenge, because it requires educators to be both creative and rigorous. The use of films is well valued in theory, but systematic studies providing empirical evidence of its pedagogical effectiveness are scarce.

Using films as a teaching strategy implies that they can constitute the main material of the class and are not just an entertaining component to complement other materials. In this direction, we consider that the use of a similar methodological approach may help to compare the results obtained by different research groups and to learn the comparative value of each feature film. In the present article we have suggested a simple sequence of actions that may help to carry out such common method, regarding the choice of the film, the Cinemeducation approach and the final evaluation. In this way we believe that the pre-post assessment using an objective tool, like multiple-choice questionnaires, may help to determine the knowledge gain that the activity provides.

La fille de Brest is a good example of how contextualizing pharmacological issues may give the students the possibility of understanding how to detect adverse drug reactions, the difficulties of establishing a causal relationship and the importance of pharmacovigilance to protect society against such undesirable effects of otherwise useful therapies. Empirical studies will show if this beliefs may translate in useful pedagogical tools.