Clouds on the horizon for the British pharmaceutical company GlaxoSmithKline and for its oral hypoglycaemic drug Avandia (rosiglitazone): indeed, it seems that the study which appeared on May 21, 2007 in the New England Journal of Medicine, which questioned the safety of the product by noting an increase in 43% of the risk of cardiovascular attacks in patients on treatment, had been sent by fax 17 days before publication to the GSK offices. This was stated by the journal Nature, which also reveals the names of the 'culprits': Steven Haffner, a researcher at the University of San Antonio in Texas (USA), one of the peer reviewers who authored the investigation and alleged 'mole', and Alexander Cobitz, an employee of the pharmaceutical company. Now even the American parliament wants to see more clearly: Charles Grassley, a member of the US Senate Finance Committee, has requested data and information from GSK to understand what measures - if any - the company has taken after receiving the confidential information.
Haffner, reached by Nature for an interview, justified his behavior as "something impulsive and incomprehensible: the reason why I sent that fax is a mystery to me". An even greater mystery, given that the same researcher assures that no one from GSK had ever asked him to send any information. Cobitz and Haffner, however, had known each other for some time, given that the scientist has been a consultant to the British group since 1999 and received, according to Senator Grassley, "approximately 75,000 dollars" over this period. Senator Grassley now instructs the president of GSK's US pharmaceutical division, Christopher Vienbacher, to quickly provide some documentation to understand how this violation may have influenced the company's behavior, noting that the Committee was already told of the disclosure last summer: by February 15 Vienbacher was requested to describe the company's reaction to receiving the report, to compile a list of all Gsk personnel who became aware of the NEJM study before publication and to make copies available of all documents, telephone recordings and messages relating to the research in question. The senator also wants to know when and how GSK began to think about the study published on June 5, 2007 also in New England and carried out by researchers sponsored by the same company, which reanalysed the results of the prospective 'RECORD' trial, launched in 2001 to monitor the cardiovascular effects of Avandia, concluding that they are insufficient to state with certainty that the drug increases cardiovascular risk.
Finally, Grassley wants copies of any other draft studies on GSK products that the company has obtained in advance of publication since 2000, excluding those compiled by company-appointed researchers. Meanwhile - highlights Nature - from the New England Journal of Medicine they let it be known that any collaborator of the journal responsible for having broken the confidentiality of the information is excluded from future assignments and jobs for the prestigious scientific journal. Last April, for example, the newspaper penalized a famous cardiologist, Martin Leon of the Cardiovascular Research Foundation in New York, for speaking about an embargoed study during a scientific meeting. From Alberto Camuso.
Source "Pharmamarketing.it"
