The Falconi’s needle against anti-vaccination: A minimally invasive tool in the nineteenth century

Abstract

The history of Giovanni Falconi’s career and his vaccination campaigns is two hundred years old. It is however very relevant today because of the widespread negative social opinion against vaccination at that time, opinions which seem to have re-emerged even in the current century. In his very important role of “Vaccine Conservator” (a sort of national supervisor for the quality of vaccinations), he clashed with the prejudice of the people and with the anti-scientific attitudes of some of his illustrious colleagues. He investigated how to simplify the procedure with a smallpox needle that became known as “Falconi’s Needle” or “Falconian Needle”. Falconi also made several experiments on smallpox vaccine preparation and was a supporter of the use of “animal” and “humanized” formulas despite the prejudice regarding the latter. Due to his profound anatomical knowledge and the strength of mind that characterized him, he was able to follow evidence-based scientific principles in his methods. Thanks to this he managed to convince people not to oppose vaccinations. He also succeeded in bringing the number of vaccinated people to exceed the number of newborns, a great achievement that led to remarkable progress in Italy and the rescue of thousands of lives throughout Europe. Unfortunately, it was not possible to find a copy of this instrument, which required the author to have the needle reconstructed.

Introduction

Giambattista Falconi (his complete official name) was born in Cagliari, on 11 July 1817 to Angelo Falconi (from Florence) and Rita Corongiu (from Samatzai) [4]. He only had one brother, Saturnino. His father, who was a coal merchant from Florence, succeeded in inserting the family into the petty bourgeoisie of the city. In 1838 he enrolled in the Faculty of Surgery, which in Cagliari remained separate from that of Medicine until 1857, and in his second year (1840) he received his phlebotomist license and began practicing in the Penitentiary Colony of St. Bartolomeo of Cagliari. In 1843 he graduated in surgery and in 1845 he won a competition to become an anatomical prosector in St. Antonio Hospital of Cagliari. He also became Surgeon of the Army with the grade of Major and in 1849 he was assigned to the Military Hospital in Vercelli. In the same year he enrolled in the Faculty of Medicine, where he graduated brilliantly in 1850. He became head of the anatomical theatre of the University of Cagliari in 1856, a role that corresponds to today's university anatomy researcher. In 1857 the king awarded him the title of knight, and then knight commander of the order of Ss. Maurizio and Lazzaro for the work carried out during the epidemics of smallpox and cholera and for his commitment to the spread of mass vaccination. In 1863 Falconi became an Ordinary Professor of human anatomy and held the chair until 1889. From 1884 to 1889 he was elected dean of the Faculty of Medicine and Surgery of the University of Cagliari. In 1869 he was named Knight, and then Officer of the Order of the Crown of Italy. He also received two bronze medals of merit for public health. At the end of his career he was named emeritus professor [5].

He was very passionate and responsible in his anatomical work and concerned about the future of the institute. On October 29, 1883, he wrote a letter to the mayor of Cagliari asking for financial aid to build two rooms in the anatomy institute. In the letter he stated: “Although I have repeatedly asked the ministry for a grant of 700 lire to repair the serious deterioration of our lab, I have not received anything. This year I have had to sacrifice 2/3 of the budget of the institute in order to repair the most urgent things” [6]. He left us a very detailed and complete 672 page manuscript of anatomy lectures written in 1885 [3]. He was an esteemed and respected man in the kingdom of Sardinia and throughout Europe. Citizens of Cagliari saw him as an authoritative and imposing figure [Picture 1, Picture 2, Picture 3], especially given his height of about six and a half feet. He was also a very sociable man who did not disdain to participate cheerfully in convivial encounters. He is remembered as a valuable man whose goal was to take care of the health of citizens, and of the training of doctors. He fought to break ties with some anti-scientific concepts that characterized the medicine of his time. He died in Cagliari on 10 July 1900 at the venerable age of 83. His tomb reads: “[..] worshipper of science and of the kingdom. He obtained esteem and honor. Dedicated and fearless soldier, brave weapon against the invasions of cholera and smallpox. The children gratefully remember[..]”.

At the end of the seventeenth century, the battle conducted by the illuminist clubs for the defense of “inoculation” (as it was called before Jenner's discovery [7]) became very lively [8], [9] because despite the first benefits, the vaccination methods provided were somewhat bloody or dangerous maneuvers. The first method of grafting (already known from the ancient oriental populations) was to inhale some dried skin crusts from the healing phase of a human smallpox, or to put them on the incised skin of the patient being inoculated.

These methods, which used human smallpox, had a high mortality rate and complications. In 1775 E. Jenner (1749–1823) received an assignment from the English government to practice variolation (technical term to indicate human derived vaccines) in the county of Gloucester. He realized that those who contracted cow’s smallpox (which in turn derived from horse smallpox) were subsequently immune to the human smallpox virus, therefore he began to experiment a new technique. However, his method was cruel and painful as it consisted of inoculating the patient with some drops of purulent material taken directly from the cow's pustules. When the practice of deliberately introducing material from smallpox patients into the skin of susceptible subjects was introduced into Great Britain, early in the 18th century, it was called “inoculating the smallpox” or “inoculation”. With Jenner's use of material from cowpox lesions in 1798, it became necessary to distinguish the “inoculation” from his method, which was named “vaccination”. At first the term “vaccine inoculation” was used, but later, Jenner's practice came to be called simply “vaccination” and the inoculation of material from human smallpox was called “variolation”. Variolation was always carried out with material from the pustules or scabs of patients (human virus), whereas the “vaccine lymph” (pus) was usually directly collected from the belly skin of the cow (cow’s smallpox). Therefore, it was important to reduce the number of bacteria that inevitably contaminated this lymph. It was because of this that in the 1850s some vaccination centers in Germany, France and Switzerland began adding glycerin to the preparations. Then in 1869, Muller in Berlin confirmed that glycerin diminished bacterial contamination without diminishing the activity of the vaccine. Subsequently clove essence was added to enhance the purification [10], [11].

The vaccine lymph, which contained the virus, was maintained alive through arm-to-arm vaccination in children, got dried on threads or ivory tips and was sometimes shipped over long distances as “vaccine scabs”. Between the end of the 1700s and the first half of the 1900s, several methods were developed which required scarification of the skin of the arm or forearm, some of which became very famous [11]:

• Standard lancet, which requires a deep scarification;

• Grooved lancet, similar to the bloodletting-lancet (later also disposable in sterilizable metal);

• Rotary lancet, which was very painful as it required a puncture and a rotary incision;

• Scratch/incision and pipette method, in which, after scarification/incision it was necessary to introduce the vaccine liquid into the incision using a pipette;

• Jetgun method, used in the vaccination of USA militaries, was efficient but too complicated;

• Bifurcated needle, still used today to vaccinate the personnel of laboratories that conserve the smallpox virus (USA and Russia).

Besides the problems related to the inoculation methods, the problems of hygiene and infection are also worth mentioning as in 1941 (a century after the beginning of Falconi’s vaccinations) they were far from being solved: “Many sore arms which are ascribed to the prophylactic are really due to bacterial infection, and many published and private reports from British and foreign sources demonstrate the grave risk incurred if we do not trouble to sterilize our syringes and needles by heat. Far too many practitioners still rely exclusively on alcohol as a disinfectant, although its unreliability is well-known in the bacteriological laboratory. As Bigger, Blacklock, and I (1940) have emphasized, one set of syringes and needles should be reserved solely for inoculations, and another complete set for the withdrawal of pathological fluids. A fresh sterile needle should be used for each injection. An intensive inoculation campaign should not be an excuse for slipshod methods” [12]. It is good to specify that there is still the problem of the transmission of other infectious agents via the smallpox dermal vaccines produced from the 1950s to the 1980s and currently in the national stockpiles were not tested for mycoplasma or viruses: in keeping with current standards, we urge that old smallpox vaccines come to be tested for adventitious infectious agents. The advice especially applies to viruses that have the potential for zoonotic transmission to human vaccine recipients [13]. Today the U.S. Special Immunizations Program provides immunizations to laboratory personnel who are at risk of exposure to hazardous pathogens in biodefense research. In this program the smallpox vaccine is still today a live virus (ACAM2000® (smallpox (Vaccinia) vaccine, live) [14].

In relation to Anatomy, when vaccination techniques are evaluated, it is necessary to think of the purpose rather than the tools used. Detailed knowledge of skin anatomy has increased with increasing microscopic techniques; it has been clarified over the centuries that the vaccine has to be deposited within the epidermis [15]. However, given the low depth of the epidermis, it is unlikely that this happened regularly with 19th century techniques [11]. Though dermis penetration significantly increased the risk of scarring and bacterial infections, in Falconi's time there were doubts as to whether the bleeding caused by the inoculation was harmful, beneficial or irrelevant. After thirty years there was almost a unanimous agreement that hemorrhage should be avoided and this become an official recommendation in some countries [16], [17].

Even so, there were occasional episodes that promoted consideration of the beneficial effect of bleeding [18]. Some physicians thought that if the incisions are too superficial it may not work, and bleeding also led to an immune response even against bacteria. In practice there was much confusion about the depth of the vaccine's deposition until the second half of the twentieth century. Although bleeding could theoretically be considered harmful, slight bleeding indicated that the vaccine had been deposited in the living tissue. From the first half of the nineteenth century Falconi was one of the first to demonstrate that bleeding was useless and obtained brilliant results with his superficial vaccination. Anatomical inoculum regions definitely influenced the choice of method: the inner part of the forearm, the outer part of the thighs, the abdomen, and even the foot of a child was used to some extent [19], [20]. However, inserting the needle in the deltoid region on the non-dominant arm was by far the most commonly used.

Falconi stated that “he always preferred to use the needle, despite knowing many methods described in both Italian and foreign texts.” He was a pioneer of mini-invasive innovations. In comparison to the “classic needle” he reduced the tip in width and made the excavation shorter, and moved it to the tip and added sharp edges around it. This simple device allowed the needle to gently slide through the skin, and by slightly pressing with the left hand thumb the needle was taken out leaving a very small amount of lymph immediately under the surface of the skin, between the Malphigian and the corneum layer. His needle was first handcrafted in Cagliari by Ollivier & Olmetta, then in Turin by Bertinara, in Bologna by Lollini brothers and in Modena by Coppelli.

In 1857 some colleagues tried to discredit the Falconian needle declaring in some pubblications that the needle had already been used by surgeons in some Italian regions. But Falconi immediately pointed out that the descriptions they reported did not correspond to the descriptions of his invention, which was known by a great number of his colleagues. He cites the names of more than 120 expert doctors from many Italian cities and military regiments and consultants from other nations (especially from France where Falconi was well-known), who had already asked for details on how to apply his method [21], [22]. In the course of a few years the new method went around the world, articles were published in journals in Italy, Vienna [23], Lyon, Paris and Belgium [24]. In 1869 The Lancet magazine wrote a description of the procedure. In 1875 the ophthalmologist Bussinelli successfully tested another use of Falconi’s needle outside the field of vaccinations, he used it for a particular operation on the cornea [25] in Rome. In the description of this experiment the width of the needle is also reported, whereas the article written in the Lancet journal reports that the length is the same as that of an ordinary needle [26]. In 1861, Filippo Vivanet reported that Falconi's needle spread throughout Italy, Portugal, and America, and that he had made a demonstration at the imperial academy of Paris [27]. In fact, ten years after Falconi’s presentation in Paris, which took place on the 23rd of June1857 [28], Prof. Depaul wrote a report on animal vaccines for the Imperial Academy in Paris and explained how the method with an incision had not shown any advantages over the one with the needle [29].

Giovanni Falconi was a luminary surgeon and physician, he did not like ignorance and his writings show that he strongly believed in scientific progress. On many occasions he debated with his colleagues and insisted that “We are living in an age where, because of words and writings, many parents hesitate to vaccine their children. We physicians should be united for the good of humanity, because in-fighting, for the mere desire to increase our visibility, we confuse the people and distance them from the immense benefits of prevention” [30]. In fact, he immediately silenced certain pseudo-scientific theories that talked of ”mysterious forces“ hidden in his needle, such as Professor Gavino Beka’s theory, physiologist of Sassari’s university, who believed that there were ”magnetic forces in the needle“. He decided to eliminate the forms of prejudice for the vaccines. In order to do this, three kinds of strategies were necessary [31].

First of all he wanted to demonstrate to the people that a large part of the nobility and authorities were favourable to the vaccination, despite the fact that there was a portion of the clergy and of the wealthy population which was contrary. In order to start making a change he often vaccinated parts of villages starting by inoculating the mayor and his children, and the children of illustrious families.

Secondly he developed public awareness campaigns to illustrate to people that, contrary to popular belief, smallpox had no connection with divine volition and superstitions [32], [33]. He also tried to demonstrate that there were not any hidden ulterior motives. As a last resort he also recommended that priests should say “those who will die due to smallpox will have no religious funeral”, this stratagem saved thousands of lives at a time when there was no obligation to vaccinate.

Thirdly, he demonstrated the simpleness and efficiency of the use of his needle. He used both humanized and animal lymph (depending on the availability of recently vaccinated people from whom to obtain good material, or the presence of adequately prepared calves). He experimented different preparation methods in order to create a lymph that lasted longer and had better immunizing effects [30], [34]. Falconi also pointed out the great success that he had with his mass public vaccination campaigns (with more than 100.000 vaccinations per session) in several regions of Italy and in the presence of illustrious European colleagues he vaccinated more than 370 people in an hour and a half.

The fact that “it leans lightly on the skin without causing pain or blood and without even waking up children” convinced parents to have their children participate in mass vaccination programs. In this way Falconi managed to eliminate distrust and convinced his colleagues in Italy and abroad to use his method and his type of lymph [35]. In a publication from 1872 he stated that he had requested that the Italian government make vaccinations obligatory several times (in the Kingdom of Sardinia they had already been mandatory since 1826 [35], for the rest of Italy they became obligatory in 1888) and that medical students be properly trained in vaccinations during the last years of their studies. On 6 December 1870 Falconi managed to organize a three-week internship for medical students in Cagliari. This was one of the first of such internships in Italy, and was hosted by the Gynaecology Professor, Giovanni Masnata, with the purpose of vaccinating a newborn from his clinic. The medical students then continued practicing by vaccinating other children provided by the obstetrics department, each other, and volunteers. Throughout the following three weeks the students were able to observe the procedure, see its simplicity, and study the pattern of pustules and their characteristics [36].

In the period before Falconi, the Sardinian and Italian population was openly averse to vaccination. It was even thought that using “animal” vaccines could result in a transformation of the vaccinated people into animals [36], while for the humanized method it was believed that there would be risks of secondary infection and of “identity blend”. Falconi’ needle has been used successfully both for the vaccine derived from bovine pustules (called “animal vaccine”) and for the human one (called “humanized” because it was the cow's virus taken from vaccinated people). This triggered a strong controversy with some colleagues from Milan, who formed “the Milan animal vaccination committee”. The latter was so named because of its opposition to the use of the humanized vaccine [30], [36].

With the method and authority of Prof. Falconi, people began to oppose vaccines less and less and vaccination doctors became much more courageous in resolving problems concerning the distrust of the population. Antonio Piras, the vaccination doctor of a small village named Tratalias, reported that in 1863 he suffered such strong resistance from his citizens, who threatened to harm him physically, that he almost decided to resign, when Falconi suddenly arrived and convinced all the citizens to receive vaccination [37].