The Pharmaceutical Medicine Year that Was
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COMMENTARY
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The Pharmaceutical Medicine Year that Was A View from San Diego, California, at the End of 2009 Anthony W. Fox Consulting Editor, Pharmaceutical Medicine
It has been an eventful year in the fields of drug safety, US Food and Drug Administration (FDA) behaviour and, not least, the dismal fiscal situation. The review from last year[1] was written as the pace of the economic crisis was accelerating, and wondered whether contrarian investing in biotechnology might result. In fact, a new model for financing small companies has emerged, and it may well threaten drug innovation. Meanwhile, the FDA budget has again grown;1 however, all is not lost and progress, both therapeutic and economic, has been made. 1. Drug Safety First of all, a follow-up to the aspersions cast 2 years ago about the hysteria surrounding the rosiglitazone meta-analysis for cardiovascular risk.[6] In a nutshell, the RECORD (Rosiglitazone Evaluated for Cardiac Outcomes and Regulation of Glycaemia in Diabetes) study (n = 4447 patients, followed-up for 5–7 years) reported this summer that rosiglitazone did not increase the overall cardiovascular morbidity or mortality in comparison with metformin or sulfonylureas.[7] Second, one would have thought that, by now, there is nothing much to be learned about aspirin (acetylsalicylic acid). Leaving aside the use of willow bark extract in ancient Rome, Hoffman’s US patent for aspirin was dated in 1900 and he had probably discovered it in 1897.[8] The association between aspirin and gastrointestinal bleeding has been written about for at least 52 years, the anti-platelet effects of aspirin were known by 1963[9,10] and by 1989 it was known that this was a specific effect that is not shared with warfarin.[11] Meanwhile, the mechanism of action for aspirin (interference with prostaglandin synthesis pathways) was known by 1971 and led to a
Nobel Prize for Sir John Vane in 1982.[12] By the late 1990s, the use of aspirin had extended from widespread use as an analgesic, via prevention of post-operative complications in arteriopathic patients, to a widely accepted mantra that ‘‘everyone over 50 should be on low-dose aspirin.’’ Now comes the swing of the pendulum. Two of the better meta-analyses conducted this year have challenged the wisdom of risking gastrointestinal bleeding for a small cardiovascular benefit in healthy people, and this doubt even extends to patients with diabetes mellitus.[13,14] Meanwhile, back at the FDA, it was again all about safety this year. The placards that adorn the Agency’s building lobbies show serpentine paths with stepping stones illustrating the various drug safety initiatives that it has in place. And, if in 2009 we still don’t know how to use aspirin properly, then who can argue? But given budget and manpower (which the FDA certainly has had during the past 2 years),[1] it is an easy thing for a bureaucracy to increase effort on drug safety and enforcement, to make self-serving statements to the public about those e
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