The lowdown: The Lancet has spoken out against what it says is premature excitement in the press and among patients over studies published in the New England Journal of Medicine showing that Herceptin could be effective in early breast cancer treatment (Piccart-Gebhart, M. et al. NEJM 353, 1659–1672; 2005; Romond, E. H. et al. NEJM 353, 1673–1684; 2005). An accompanying editorial to the studies described the results as “simply stunning”, “revolutionary” and “maybe even a cure” for breast cancer (Hortobagyi, G. N. NEJM 353, 1734–1736; 2005). The comment was unsurprisingly picked up by the media, and fuelled demand from angry patients eager for health authorities — most notably in the United Kingdom — to speed up access to the drug. But the editorial in The Lancet says that these findings are interim results and reliable judgments based on the data are difficult (Lancet published online 9 November 2005 10.1016/50140-6736(05)67670-2). In particular, the dosing in the two studies are different, which makes comparisons and conclusions difficult. Given these mitigating factors, The Lancet concludes that “[i]t is profoundly misleading to suggest, even rhetorically, that the published data may be indicative of a cure for breast cancer.” Many of the press reports did not make it fully clear that Herceptin is effective only against breast tumours that overexpress the protein HER2, which is present in less than one-fifth of cases. Although the new results are undoubtedly good news for the management of patients that fall into this category, the fear is that the vast majority of breast cancer patients, who do not have HER2-expressing tumours, will have their hopes for a new wonder cure raised unfairly.
The lowdown: Once a wilderness for pharmaceutical companies, the fear of an avian flu pandemic means that vaccines companies are now becoming hot property. After 8 weeks of negotiations, Chiron finally agreed that Novartis could acquire the 58% of shares that it doesn't already own in the company. Novartis had for years treated its 42% share in Chiron as a financial investment. But the value of this investment dropped when contamination problems at Chiron's plants in Liverpool, UK, and Marburg, Germany, prevented the company from selling its lead product, the flu vaccine, to the US government and Europe. Sensing the opportunity to enter the global vaccines market, Novartis originally offered US$40 a share for the world's fifth biggest vaccine producer, but this was upped to US$45 before a deal was struck. Novartis will have to dip into its pockets to turn Chiron around after the recent setbacks, but Chiron has already clinched a US$64-million deal to produce a stockpile of H5N1 vaccine for the US government. One point to note, at least in terms of recent criticism over dwindling R&D innovation in Europe, is that all the main flu vaccine producers are now European.
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