Tailoring arthritis therapy in the wake of the NSAID crisis.

ble, and it would reduce rather than increase public expenditures. Well-targeted federally funded medication trials can more than pay for themselves; examples to date include NIH-supported studies of estrogen replacement and of medications for hyper-tension, which provided important insights into the risks, benefits, and optimal use of these therapies. These needed insights can improve care and save the nation billions in drug expenditures. 5 For instance , if a moderate-size NIH-funded clinical trial of the cardiovascular risks of coxibs had been performed in 2000 and 2001, most of the $2.5 billion per year — about $1 billion annually from public coffers — that was spent on rofecoxib (Vioxx) might have been saved. Other clinical examples abound. The torcetrapib story suggests that we have become too dependent on manufacturers as the predominant source of our scientific knowledge about the effects of medications. As Medicare prepares for an increasingly unaffordable drug benefit, the best way to contain that public expenditure will be to commit a small fraction of those funds to support such public-interest drug trials, fairly comparing competing therapies (especially costly new ones) with clinically realistic alternatives. With pharmaceutical costs increasing faster than most other health care expenditures, the nation requires studies that will meet the needs of evidence-based prescribing and not just the needs of the pharmaceutical industry. It is not a question of whether we can afford to pay for our own drug trials; it is increasingly evident that we cannot afford not to do so. safety of a novel cholesteryl ester transfer protein inhibitor tor-cetrapib when administered with and without atorvastatin to subjects with a low level of high-density lipoprotein cholesterol. Effects of cholesteryl ester transfer protein inhibition on high-density lipo-protein subspecies, apolipoprotein A-I metabolism, and fecal sterol excretion.domized, controlled trial showed that rofecoxib, an inhibitor of cyclooxygenase-2 that had been marketed as Vioxx since May 1999, was associated with fewer gastrointestinal complications than naprox-en, a standard nonsteroidal antiinflammatory drug. Unexpectedly, the VIGOR study also showed that the patients who were given rofecoxib had four times as many myocardial infarctions as those who were given naproxen. This finding of a significant increase in the risk of myocardial infarction was an early signal of a potentially serious safety problem with rofecoxib. Nonetheless, sales remained robust. By the time of rofecoxib's withdrawal from the market in Septem-ber 2004, after a placebo-controlled study confirmed its cardiovascular risk, more than 100 million …