uA recent British study has highlighted the real media power of pharmaceutical companies. The examination of 546 clinical trials (trials) on the use of drugs has allowed us to discover that the result is different if the study is financed by the pharmaceutical company producing the drug or if it is financed by the Government. The drug gets the promotion in the 85% of the studies in the first case, while the percentage of beneficial effects of the drug drops to a far from reassuring 50% in the second case. Another alarming fact is that, in the vast majority of cases, i trials che trovano pubblicazione sulle riviste sono quelli che dimostrano un’efficace azione terapeutica del farmaco, mentre quelli che ne dimostrano l’inefficacia, o peggio ancora la pericolosità, vengono, per così dire, dimenticati e mai pubblicati (1). Secondo Sally Hopewell del Cochrane Centre di Oxford, artefice di questa interessante analisi, i dati ottenuti “(…) hanno implicazioni notevoli per i sistemi sanitari. Finché non saranno pubblicati sia i both positive and negative results degli studi clinici, sarà impossibile una valutazione chiara e certa della sicurezza e dell’efficacia di un farmaco”. La furbizia delle aziende farmaceutiche si svela con l’utilizzo del seguente trucco: visto che non è possibile nascondere proprio tutti i risultati negativi degli studi di un farmaco, alcuni di questi vengono resi pubblici solamente 3-4 anni dopo la pubblicazione degli studi che dello stesso farmaco hanno dimostrato gli effetti positivi (2). Secondo la stessa ricerca, in 1 caso su 5 i colpevoli della mancata pubblicazione degli studi sono i ricercatori stessi e non le case editrici delle riviste scientifiche. La scusa utilizzata dai ricercatori sembra essere sempre la stessa: i dati non sono interessanti o il tempo da dedicare alla pubblicazione poco.
L’esposizione degli effetti collaterali seri (SAEs) emergenti dai trials on drugs has considerable importance, since it would allow a more objective clinical use by the doctor in assessing the risks and benefits of the drug in question. There is a US Government Registry of Clinical Trials (ClinicalTrials.gov) (3) reporting all adverse effects resulting from drug studies. One should therefore expect to find the same studies published in scientific journals and above all that the same side effects reported by the register are reported in the publication ClinicalTrials.gov for the same drug in the same trials. Instead, among the 300 examples of trials with serious side effects reported by the registry, 78 (the 26%) are not published in scientific journals and 20 (the 7%) are published with data that do not correspond to those reported by the registry. For the 202 remaining studies, 26 of them (the 13%) are published but do not mention the severe side effects that the registryClinicalTrials.gov has ascertained, 4 studies (the 2%) declare the absence of serious effects that are present and 33 studies (the 16%) do not exactly report the total number of serious side effects. Among the remaining 139 trials, for 44 of these (32%) the number of serious side effects per group published in journals does not match the data in the registry.
Pwas 31 trials, the number of serious side effects is higher in the registry ClinicalTrials.gov than on the published article with a data difference of more than 30 %s, for at least one group, in 21 studies. Only 33 trials (11%) have been published respecting number and description of serious side effects (4). The conclusion of the article, by the researchers, was that, in order to be able to understand the extent of the serious side effects of a drug, consulting the publication of the trials is not sufficient; in short, it is considered necessary to consult the register ClinicalTrials.gov.
Ergo, neither published studies nor scientific representatives are able to give the doctor prescribing the drug the minimum interpretative tools he needs. So the question is this: every time we read about a miracle drug, with incredible results that immediately opened the doors of the (rich) market, should we believe it or not? In my opinion not. In no way can a drug induce striking results in terms of healing. Pharmacological healing goes against the very essence of the drug, of the company that produces it and of its economic policy. What interests would a pharmaceutical company have in producing and marketing a drug that completely resolves a disease? You would see your sales go to zero as soon as everyone was cured of that disease. Can a pharmaceutical company afford to spread negative news about a product that has cost billions of dollars to test? Why do pharmaceutical companies only publish the 32% of the research they fund within two years of completing it? Why aren't all other results published? If the studies were all positive, therefore useful, having required many dollars for experimentation, would they all be published? Is it reasonable to think that when 2 out of 3 studies are rejected it is because they are negative and therefore dangerous for the commercial success of the drug? When we read a study reporting data on a drug, it is important that we know the sponsor of the study. The advice, therefore, is to consult the register already mentioned several times at this internet address (http://www.clinicaltrials.gov), so you can find information about the research you're interested in and help you determine the quality of clinical trials more objectively.
This at least for studies prior to 2014. From 18 September of that year, thanks to the intervention of the HRA (Health Research Authority) (5), fondata nel dicembre 2011 per tutelare e promuovere gli interessi dei pazienti e del pubblico nella ricerca sanitaria, le parti interessate si sono incontrate per discutere le proposte ed i passi necessari per la regolamentazione della registrazione degli studi clinici nel Regno Unito. L’approvazione del nuovo regolamento sulle sperimentazioni cliniche dell’Unione europea (UE CTR), avvenuta nel mese di aprile del 2014, comporterà modifiche alle modalità di ricerca clinica negli anni a venire. Il CTR UE entrerà in vigore nel 2016, probabilmente qualcosa succederà e per le aziende farmaceutiche non sarà più così semplice mascherarsi dietro studi pilotati e medici svogliati ed ‘informati’ ad arte. Il Regno Unito farà da apripista in Europa, ma questo dovrebbe essere solo l’inizio. Aspettiamo di valutare quando effettivamente la trasparenza entrerà a far parte della ricerca scientifica, anche se più che chiederci ‘quando’, forse, siamo ancora alla fase del ‘se’. Fino a prova contraria, a pilotare la baracca è ancora Big Pharma.
1. lee k-Bacchetti P-Sim I., Publication of clinical trials supporting successful new drug applications: a literature analysis in PLoS Med., 23;5(9):e191 2008.
