Wednesday, July 14, 2010

GSK hid the Rosiglitazone (Avandia) is associated with cardiovascular risk

The New York Times has published an article which alleged that GlaxoSmithKline (GSK) has withheld the results of a study, organized by the very multinational pharmaceutical company, which showed an increased cardiovascular risk in patients treated with rosiglitazone (Avandia).

Rosiglitazone, a drug used in the treatment of diabetes, is also marketed in the European Union, in combination with Metformin (Avandamet) and Glimepiride (Avaglim).

This study, conducted prior to the approval of the product, comparing rosiglitazone with pioglitazone, concluded not only that it was not superior for treatment, but also produced an increased cardiovascular risk. Although the results were clearly unfavorable to the drug of GSK, the laboratory not only did not published them but, according to company files, deliberately concealed them, stealing relevant information for the approval of the regulatory agencies.

Currently, the agencies responsible for authorization of medicines in USA (FDA) and the European Union (EMEA), are assessing the safety of Rosiglitazone, after the publication last year of two studies concluding that it increases the likelihood of suffering serious cardiovascular problems and even death.

That is, new trials agree in indicating cardiovascular risks identified previously by the manufacturer in 1999 and hidden from the authorities, patients and professionals. Meanwhile thousands of patients, only about 80,000 in Spain, are taking a drug that some studies indicate may increase the risk of suffering a cardiovascular event like heart attack, stroke and even death.

There is a fierce debate in the FDA over the decision to take on Avandia, in which the director of new drugs, John Jenkins has defended the retention of the drug on the market, and has even informed GSK managers about the internal deliberations of the agency.

Rosemary Johann-Liang, an former member of that department of the FDA, who was sanctioned for recommending to emphasis Avandia's cardiovascular warnings in its package information leaflets, has now joined the voices calling for a change in the leadership of the FDA.

+ Info on NYT Diabetes Drug Maker Hid Test Data, Files Indicate

See also in this blog: GSK recibe una reprimenda de la FDA por ocultar datos sobre su antidiabético Rosiglitazona (Avandia)

Posted by Jesús Palacio
English version by Jesús Moreno and Erika Céspedes

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