Five things for Pharma Marketers to know: Friday, August 29
Good—and bad—news for Actos
Takeda's diabetes drug, Actos, is having a good-news, bad-news kind of week. The Japanese drugmaker revealed the results of a 10-year post-market analysis of the thiazolidinedione which showed no link between the onset of bladder cancer and taking Actos. Takeda said it expects to submit final results for publication in 2014. But Reuters reported Friday that Takeda and co-defendant Eli Lilly faced a setback in their effort to overturn a $9 billion ruling that the diabetes duo are responsible for understating the drug's risk for bladder cancer. Even though the results of the post-marketing study released conclude that “there is no statistically significantly increased risk of bladder cancer among [Actos] patients, US District Judge Rebecca Doherty of the Western District of Louisiana said there is “sufficient evidence…that the information about bladder cancer contained in Actos labels did not adequately warn of the increased risk of cancer.” In 2011, a five-year study observed an increased risk among patients taking Actos for two or more years. Legal experts tell Reuters this courtroom loss is unlikely to be the final decision, because the district court's denial is still open to retrial or a reduced verdict through a separate appeal.
AstraZeneca has moved its experimental PD-1 immuno-oncology drug MEDI-4736 into a mid-stage colorectal clinical trial. Reuters reports that 48 patients will participate in the Phase-II trial, and that this indication joins lung cancer and head and neck cancers in the roster of indications the company is exploring for the drug. AstraZeneca's pipeline is coming under a strong degree of scrutiny, because successes could bolster its claims that it is on track to hit $45 billion in sales by 2023 and thereby justify its demand that Pfizer up its takeover bid. Acquisition talks died out this summer, but the no-contact rule has lapsed, allowing the potential colleagues to talk once again.
Researchers have linked Sierra Leone's Ebola virus outbreak to a funeral at which 14 women were infected. The New York Times reports that researchers confirmed the hypothesis after sequencing the virus among 78 patients who were treated at a local hospital. “It's frightening that a single event could catalyze a whole outbreak, but that's what it looks like happened,” Columbia University's Ian Lipkin told the Times. Cures remain elusive—doctors are unable to attribute the recovery of two Zmapp recipients to the treatment (another recipient has died)—but GlaxoSmithKline and the National Institutes of Health are kicking off a human trial of GSK's experimental drug next week. Efforts to contain the disease have included quarantines, and the Times reports that one in Monrovia, Liberia has touched off local anger and may, in fact, be enhancing its spread.
Twenty-seven percent of rheumatoid arthritis patients are not taking their medication as prescribed. The University of Manchester reports that a study by its Arthritis Research UK Centre for Genetics and Genomics found that this group of non-compliant patients was quick to not follow the rules: this 27% veered away from taking the medication as prescribed (or at all) within the first six months of receiving the prescription.
Fewer anticipated healthcare device and service costs have prompted the Congressional Budget Office to scale back its estimates for just how much Medicare and Medicaid will cost over the next decade, trimming forecasts by around $89 billion. The Advisory Board's Daily Briefing blog notes that the CBO modified its estimates based on changes which are nudging doctors and patients to modify their healthcare behaviors. This does not mean that all healthcare spending is falling—the Daily Briefing notes that spending on major healthcare programs will rise 9% this year, by $67 billion. This increase is fueled by an uptick in Medicaid, federal subsidies to help patients pay for health insurance and rising Medicare costs.Correction: A previous of this article misstated that Actos is DPP-4 inhibitor.