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Too much suffering from sponsored biased biomedical research

Posted by plosmedicine on 30 Mar 2009 at 23:52 GMT

Author: 'Roberto' 'Scatena'
Position: Associate Professor
Institution: Istituto Biochimica e biochimica Clinica/University Cattolica
Additional Authors: Giuseppe Ettore Martorana, Patrizia Bottoni, Bruno Giardina
Submitted Date: April 12, 2006
Published Date: April 24, 2006
This comment was originally posted as a “Reader Response” on the publication date indicated above. All Reader Responses are now available as comments.

Reading the article 'Pharmaceutical Marketing and the Invention of the Medical Consumer', we were driven to recall the 'Italian Drug Management-Ministry of Health scandal' in 1992. It was a gloomy matter of corruption to facilitate the approval, inflate the prices and above all to speed up the registration in the Italian Official Drug List of various drugs with more or less doubtful effectiveness. Importantly, this scandal, with its dramatic economical consequences on public health, was not only caused by some corrupt officials, but also by a large number of unreliable and sponsored biochemical, pharmacological and clinical studies published in prestigious scientific journals, which pushed these spurious drugs onto the market.

A few months after the scandal, a lot of these industries modified their marketing strategies or shut down, and the sales and profit of a lot of these molecules were dramatically reduced and were abandoned. In some cases they were recycled in third-world countries.

Was this the end of a nasty matter in Italy? Probably not, and it probably was not only an Italian problem, nor it was so simple.
Recent episodes of drug toxicity seem to indicate that nowadays there are several biomedical areas where research is carried out in accordance with biased marketing strategies. In the last few years we have too often read about episodes of adverse drug reactions regarding molecules that have been the subject of biochemical, pharmacological and pre-clinical studies, published in prestigious biomedical journals.

We feel obliged to mention a few examples:
a. the dramatic episodes of acute liver failure induced by troglitazone, ascribed to hypersensitivity to this particular drug, but later confirmed by recent episodes of acute liver insufficiency and heart failure due to the 'new thiazolidinediones';
b. the case of COX-2 inhibitors, that after a few months of marketing displayed a series of side effects, which should have been expected, considering eicosanoid pathophysiology;
c. last but not least, we must stress the inappropriate indication for erythropoietin (EPO) in the treatment of some forms of anemia associated with cancer which, on the one hand, exponentially enlarge the market for such an expensive biological drug but, on the other hand, has strongly worsened the prognosis in some neoplastic patients. This serious pitfall could be ascribed to EPO's well-known, but disregarded, biological properties as stimulation of angiogenesis and metalloproteinase synthesis plus inhibition of apoptosis. Paradoxically, the angiogenetic and antiapoptotic activities of EPO are taken into account and are going to be employed for new potential therapeutic indications such as cerebral and myocardial ischemia and chronic congestive heart failure, again underestimating EPO-induced increase in blood viscosity, volemia and, thereby, in cardiac afterload that could be difficult to manage both in acute and chronic therapeutic regimens.

To conclude, recent data emphasize the old problem regarding the publication of partially or totally biased reports in biomedical research sponsored, directly and/or indirectly, by pharmaceutical industries that do not link their marketing activities to ethical objectives. This phenomenon should not only be reported as a diversion of funds and human resources from well-conducted studies, but it should be made clear that sponsored biased biomedical research could also be the cause of dangerous consequences to the morbidity and mortality of patients, with an 'iceberg effect', i.e. with an incidence that is impossible to estimate.

No competing interests declared.