The blind spot in the regulation of the global drugs industry is identified in Spitzer’s suit in levelling allegations of misleading research about Paxil, the anti-depressant made by GlaxoSmithKline, the global number two by sales.
The lawsuit filed on Wednesday by the New York state attorney-general takes on what some critics say is the industry’s ability to publish only what it wants in research journals to tout drugs to the doctors who prescribe them.
Mr Spitzer charged GSK with “repeated and persistent fraud”. The lawsuit alleges GSK concealed data that Paxil’s risk of increasing suicidal tendencies in depressed children outweighed any benefits. However, it said, GSK published research saying Paxil was safe and helped children, and worked to manipulate presentation of studies.
In 2002, GSK submitted final study reports seeking paediatric approval for Paxil – but regulators found safety and efficacy concerns.
Industry critics say the selective publication of research amounts to unregulated advertising of drugs to doctors – often advocating uses of the drug for which it is not approved. Study data are filed to regulators, who keep them confidential. It is left to the industry to publish results of its studies in journals talking about new comparisons, or new uses of the drug.
“There’s a hole there and it’s inherent to how the industry is set up already,” Karen Barth Menzies, a plaintiffs attorney suing GSK, and other makers of anti-depressants such as Pfizer, on behalf of patients claiming injurious effects.
“The reality is they rely entirely on the drug company, and what the drug company submits. The science is created by companies in the medical journals.”
Arthur Levin, director of Center for Medical Consumers: “The ability of drug companies to pick and choose the research they provide doctors in support of their product is an outrageous conflict of interest and puts us all in harm’s way.”
GSK continues to stress that it acted responsibly with paediatric studies and disseminating their data. “All paediatric studies have been made available to the FDA and regulatory agencies worldwide. We have publicly communicated data from all paediatric studies,” it said.
The Food and Drug Administration, US medicines regulator, says it is not responsible for publication of research by companies in journals. It stressed a difference between its monitoring of drugs’ public advertisements and research articles.