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Connection drugs, for "Zutectra" needed "the blessing of the well-known doctor". A chilling story

The managers of the Biotest Italia company wanted the approval of a Pisan doctor on the drug so, says the investigating judge, "the competitors understood the strength of the company". Drugs tested on patients "anyway"

 November 14, 2014 – NOON COURIER NAPLES / CHRONICLE

NAPLES - The managers of the Biotest Italia company wanted the "blessing" of a well-known Pisan doctor on the therapeutic efficacy of the new drug Zutectra, injections indicated "only for adults" for the "prevention of hepatitis B virus reinfection in HBV patients -DNA negative". It emerges from the interceptions contained in the precautionary order notified yesterday to seven people in the context of thethe investigation into the procurement of healthcare and hospital companies for the supply of medicines. "This - writes the investigating judge Antonio Cairo - so that all the competing companies and the doctors prescribers of blood-based drugs can understand the commercial strength of Biotest Italia": "Guys, you don't have to bother us, because here we rule us», says an entrepreneur in an intercepted phone call.

TEST ANYWAY – The managers of the Petrone group and of the pharmaceutical company Biotest Italia srl were pressing for drugs to be tested on patients in hospitals, and in particular in the Cardarelli hospital in Naples, «regardless of their therapeutic validity». It emerges from the precautionary custody order notified yesterday to seven people as part of the investigation into the procurement contracts for the supply of medicines to health and hospital companies. "There is evidence - writes the investigating judge Antonio Cairo, who accepted the request of the prosecutor Francesco de Falco - an activity of the managers of Biotest Italia to approach hospital doctors and to make agreements to induce them to facilitate or at least not to hinder the spread of medicinal products marketed by Biotest".

THE "GIFT" – In this regard, an interception is cited between Enrico D'Aiuto, Biotest sales manager arrested yesterday, with the director of a department of the San Salvatore dell'Aquila hospital. The latter points out a colleague of his who, at a congress in Naples, will speak about immunoglobulins and asks for a sum of money for her: «I will speak about immunoglobulins and this colleague will also speak about CMV, so I don't know if it was possible to give something, a small contribution to this colleague, because she practically has to spend everything by herself». D'Aiuto diverts him to his colleague Renato Carelli, who was in turn arrested yesterday.

SEL: CALDORO CHIARISCA SORESA – «The pages of the newspapers are these days invaded by articles that tell in great detail, after the Matacchione affair, the new scandal involving one of the sectors most massacred by the regional government led by Caldoro, which in the name of an alleged reorganization of accounts has made healthcare in Campania the one in which the least investment is made in Italy, which is in the worst conditions of the whole country and in which there is the greatest number of cases of corruption ever", they affirm, in a note, Arturo Scotto, group leader in the Left Chamber Ecology Freedom, and Salvatore Vozza, regional coordinator of Sel. «La So.Re.Sa. – they add – it had to reduce the costs of the regional health system by guaranteeing finally transparency in the assignment of tenders, and instead there is talk once again of criminal conspiracy, bid rigging and forgery. In recent months we had already reported several times, including to the National Anti-Corruption Authority, the need to intervene to verify what was happening. Today, unfortunately, we find out in the worst way. We are certain that the president of the Authority, Raffaele Cantone, will be able to act in the next few hours to shed full light on the matter".

A CHILLING STORY ON THE BACKGROUND OF THE HEALTHCARE SCANDAL WITH 7 ARRESTS

Patients used as guinea pigs in the hospital. The investigating judge: now the doctors are also being investigated

The prosecutor: "Drugs prescribed to patients regardless of effectiveness". To obtain dominance in distribution, the relationship between doctor and pharmaceutical company was altered

NAPLES – The premise, never as in this case, is mandatory. What you are about to read is a partisan version, that is the one supported by the Naples prosecutor's office and for now (largely) shared by the judge for preliminary investigations in a judicial provision issued two days ago. Therefore, the reconstruction of the defense is missing, which will probably be of a diametrically opposite sign. However, if the interpretation of the prosecutor and the investigating judge were to hold up to the scrutiny of the successive degrees of judgement, the following would be a chilling story. The story of the war fought to gain dominance in the distribution of medicines, the testimony of how the "management of the relationship between the doctor and the pharmaceutical company" has been "altered", the description of a "murky scenario" in which different interests move but aimed at a single objective: "To facilitate the diffusion of medicines to be administered to hospital patients" to "increase the profits of the companies that distribute them". All this, sometimes, on the skin of the patients.

228 PAGES - It is a "system", writes the investigating judge Antonio Cairo in the 228 pages of the ordinance with which two days ago he sent the manager of the Sun Policlinico Pasquale Corcione, the pharmaceutical entrepreneur Massimo Petrone and five other suspects under house arrest as part of the investigation coordinated by the deputy prosecutor Alfonso D'Avino and delegated to the prosecutor Francesco De Falco. How that battle should be conducted to acquire dominance in the sector, explains the marketing manager of the company Biotest Italia srl, Henry D'Aid. It is 5.27 pm on 7 April 2010, and the manager explains on the phone «the strategy to follow to ensure the commercial penetration of the pharmaceutical company». A strategy that the judge, on page 102 of his provision, summarizes as follows: «Extend to hospital patients, at least fifteen in number, therapeutic treatments based on drugs marketed by the company. It is considered functional to the interests of the company that this commercial diffusion is implemented through the prescriptions of several doctors in service at various health facilities, with the aim of including their name in clinical trials, it would seem regardless of the therapeutic validity". In short, if this story were true, those who marketed those medicines were unaware of their effectiveness: "Their name is on the study, who cares".

THE AGREEMENTS AND THE GIFTS - It is at this point that - taking the reconstruction of the Naples Public Prosecutor's Office for good - "there is an activity by the managers of Biotest aimed at approaching hospital doctors and making agreements to induce them to facilitate the diffusion of medicinal specialties of the society". And those agreements would have been concluded in exchange for "gifts or other benefits" to the white coats. Like the trip to Greece. The baskets of sunscreen. Or those new iPads that Enrico D'Aiuto orders to buy on 10 May 2010 "as they are intended for doctors". The employee, on the phone, advised him on the top version: «I had considered the eight hundred euro one. He's the coolest of them all." Twenty-one days later (May 31) D'Aiuto's strategy becomes more explicit: "The best way is to show the doctors your index finger and thumb", that is, "give out sums of money to obtain prescription drugs in exchange" . If true, there would be "hospital doctors" who receive undue fees for favoring certain drugs. And, to do so, they also go so far as "not to modify or change - depending on the case - the therapeutic treatment according to the economic interests of society".

THE GIP: LET THE DOCTORS FEEL - Those doctors are unrelated to the ongoing investigation, it should be specified. Yet - the judge points out - «a more careful investigative reflection on the role of a series of subjects belonging to the medical area involved in the reported anomalies would have been dutiful. These are fully identified doctors, public officials who accept without any hesitation various utilities for the prescription of the drugs marketed by the company". However, the company is not just for them. It moves on parallel tracks, try to hook the public administrators, look for institutional covers. AND Giuliano Tagliabue, sole director of Biotest, on 24 June 2010, illustrated on the telephone (intercepted) the strategies that the Bioricerche cooperative society must implement: «An attempt is being made to propose Annamaria Colao as scientific director of the consortium. (…) At this point, Granata could no longer pose any obstacle». Annamaria Colao is one of the most brilliant Italian scientists, but coincidentally just under three months earlier her husband — Stefano Caldoro — was elected president of the Region. The professor, however, is an attentive person, and does not want to get personally involved in the affair. Thus — as Tagliabue himself explained on June 28, 2010 during a phone call with Massimo Petrone — "Annamaria said she'd agree if the department where she works or the University also enters." And, according to the company's board, Colao is not there to date. The search for shores, however, continues.

"WE ARE IN COMMAND HERE" - The suspects boast of having had "the sponsorship of the Cardinal's foundation" for a conference, plan to involve politicians ("You have to work the departments for them"), try to invite Raffaele Calabrò to a debate ( «If it comes it's a good thing, that's smelling…»), they seek the help of the then managing director of Soresa Francesco Tancredi «in exchange for political help». They try to bring in even luminaries of surgery, as happens, for example, on May 4, 2010, when Enrico D'Aiuto and Renato Carelli "plan ways to convince the head of the transplant center in Pisa to take part in a conference organized in Naples". The target? «To obtain his blessing on the therapeutic efficacy of the new drug Zutectra», so that the competing companies understand the commercial strength of Biotest: «We are in control here, you don't have to break our c…». Pharmaceutical entrepreneurs want Cardarelli and the Polyclinic, but they are not satisfied. They are aiming for Rome, at the Fatebenefratelli, at Tor Vergata, at the Bambin Gesù. And they are concerned with how the company's managers in Germany can evaluate their initiatives: "It is difficult to explain how things work in Campania to those who don't know them". But how things work - the investigating judge comments - "unfortunately the conversations attest to it". The hope of healthcare in Campania, now, is that those directly concerned have a more than valid explanation for those conversations

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Promote the cohesion and union of all members to allow a univocal and homogeneous vision of the professional problems inherent in the activity of pharmaceutical sales reps.

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Fedaiisf Federazione delle Associazioni Italiane degli Informatori Scientifici del Farmaco e del Parafarmaco