Did Sandoz know? From the framework of the investigations, an awareness of the pharmaceutical company would emerge, which knew what had happened between 2008 and 2009, taking action in 2012. The company's documents would show that 12 people, including scientific representatives and executives, were fired on the spot. THE Nas have brought to light letters, dated 2012, in which the pharmaceutical giant contested the "illegal conduct". The letters, however, were allegedly written after the searches had "alerted" the top management of the ongoing investigation.
By Lorena Cacace Friday 7 November 2014 Nano Press
The growth hormone scandal every now and then it peeps out from the pages of social networks and sites. The first time the investigation came to the attention of the press was in October 2012: it was a alleged system of corruption to which informants of theSandoz, owned by Novartis, would appeal for push the prescription of the hormitrope. The investigations by the Nas of Bologna, headed by Commander Sabato Simonetti, coordinated by the Prosecutors of Bologna and Busto Arsizio (VA), led to the entry in the register of suspects of 80 people, including 67 doctors including pediatricians of public and private structures throughout Italy. The proceeding is still ongoing and marks some progress in recent days.
On 29 October 2014 the investigating judge of Busto Arsizio has archived the positions of two doctors in Ferrara, upon request in the same Public Prosecutor's Office that instead obtained the indictment for 41 people, with a preliminary hearing scheduled for next February.
Two years ago the hormone scandal filled the pages of newspapers and then faded with the passage of time. Even the most recent journalistic investigations date back to last year: in Italy it was Le Iene that dealt with it, while outside the national borders it was RSI, the Italian-speaking Swiss Radio and Television. To understand what we are talking about, let's retrace the various stages of the story.
The outbreak of the scandal
TO October 2012 the news of the hormone scandal is reported on the pages of the major national newspapers. The Nas of Bologna, during an investigation into sports doping, discover an alleged system of corruption set up by Sandoz to push the sale of two drugs: it is theOmnitrope, growth hormone with the active ingredient of Somatropin, and the Binocrit, a drug that increases the production of red blood cells, both also used as anabolics and considered performance-enhancing substances.
Public and private doctors than 40 hospitals in 18 Regions would have received money and gifts to prescribe medicines for children, with dosages which could in some cases reach the double the normal. "Horse doses", as would have emerged from the interceptions, given to children on growth hormone treatment or to new patients.
From the cards emerged one sort of "tariff", with respectable figures, from 5 thousand euros up to 30 thousand euros per doctor. Money but not only. Benefits include designer clothing, luxury travel, iPads and more for a total of 500 thousand euros.
In 2008-2009, for example, two pediatricians at the Gemelli Polyclinic in Rome were given "€10,000 and €8,000 per year respectively as consideration for the inclusion of some patients in therapy with Omnitrope, formally paid as compensation for consultancy and lessons given to Sandoz's Scientific Representatives which were never actually provided”, as stated in the investigation.
The money would be given in various forms, such as payment for fake clinical trials or refresher classes that were never given. They sprout trips to luxury hotels in the Principality of Monaco with his wife following, conferences in New York and we arrive at branded jeans and sweatshirts. The very name of the survey, Do ut des, clarifies the method: more prescriptions would have paid more money and gifts.
Did Sandoz know?
One of the points of the investigation concerns the involvement of Sandozowned by the drug multinational Novartis. In October 2012, documents from the company with which they were 12 people including scientific informants and executives were fired outright.
In the memorandum, dated February 7, 2012, the amount paid to each doctor and the consequent disciplinary measures: Sandoz ahe would have known what was happening and would have thus acted internally going so far as to fire his collaborators. The document cites some passages of the investigation cross-referenced with company administrative and accounting data.
The searches carried out by the Nas brought to light letters, dated 2012, in which the pharmaceutical giant contested "the unlawful conduct”: the letters would have been written after the searches had “alerted” the top management of the company to the ongoing investigation. Sandoz then issued official notes in which it stressed that "have cooperated fully with the authorities during the investigation and have taken severe disciplinary action against the employees involved”. From the framework of the investigations, an awareness of the pharmaceutical company would emerge that it knew what had happened between 2008 and 2009, taking action in 2012.
What doesn't add up, in the words of the former fired scientific informants, is that Sandoz knew everything from the beginning.
“There were considerable pressures. We were the last to arrive in a market that in Italy belongs to the 97% to other companies and the sale was pushed”, a Sandoz informant told RSI's Mario Casella and Marco Tagliabue last year. “It is not the informant who has the means to economically manage a multinational company. Consultations for doctors, contributions to departments, everything is evaluated in detail by an internal committee, the SP3, which is attended by top management and the company lawyer who then endorses everything”, he recalled, underlining how the connection between the Italian and European offices has always been constant.
At the end of 2009, in the midst of the scandal, the service recalls, Novartis certifies a net income of $8.5 billion with an annual growth of 4%: the division of biosimilar medicines of Sandoz, in which Omnitrope takes the lion's share, is grown of the 64%. Daniel Vasella, then head of the group, underlined how precisely those drugs were the reason for the strengthening of Sandoz in the sector.
The consequences
The echo of the scandal was enormous. The relationship between scientific representatives, pharmaceutical companies and doctors had been greatly compromised and the integrity of the category put at risk. Without medicines there is no cure, but the doctor, subject to the Hippocratic oath, must make his choice "in complete freedom", having as his sole purpose the patient well-being. The story then touches i weaker subjects, sick children, suffering from growth disorders such as Turner Syndrome. The action ofGH hormone, this acronym used in the scientific world, helps the little ones in their development: every evening, from an early age, they have to get the injection, first with the help of their parents and then on their own.
Growth hormone was produced in the mid-1980s and commercialized in the early 2000s, but studies on the long-term effects are still ongoing today. “We must not hide that there are health risks”, Primus Mullis, chief endocrinologist at the Inselspital in Bern, one of the leading international authorities on growth hormone, explained on Swiss TV. “We need to check the brain pressure and adjust the right dose accordingly, there can be hip problems and it's our job to know. Pediatric endocrinologists also need to know how the drug will affect these children as adults”.
In Italy the Growth hormone administration is strictly regulated from the AIFA Note 39 which establishes the clinical-auxological and laboratory parameters that every doctor must comply with (updated October 2014).
THE controls are very strict, as recalled at the time of the scandal theAfadoc, the association that brings together the families of sick children. “Many Regions have activated the Regional Commission for the use of Growth Hormone in patients with particular clinical conditions, which require its use under the supervision of the Commissions themselves“.
Furthermore, the Afadoc still recalls, the Istituto Superiore di Sanità created the Rnoc, the National Registry of Growth Hormone Consumers (http://www.iss.it/rnoc/) and set up aNational Commission to check adherence to the requirements for the treatment of doctors practicing in Regions that have not activated the Commission”. Doctors have to give benchmarks to parents who can also check them online, making sure the dose is right.
Since the scandal broke, the families of the sick children have met periodically, thus monitoring the situation: the fact that two doctors have already been acquitted of all kinds of accusations without even going to trial is a good sign, but the matter remains very serious . Families need to know in which hands they entrust their most precious asset, their children: there is no money or travel that can be worth the health of children.
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