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Archive for May, 2010
Evidence: Is There Ever Enough
30, May 2010The P&T committee members shuffled into the 7:30 a.m. meeting, eagerly sniffing the air for familiar signs of coffee and bagels. The agenda began, as they all begin, with approval of the previous meeting’s minutes, which virtually nobody had read; an announcement that we would have to move at a clip, since there was much [...]
Infliximab Therapy for Crohn’s Disease
29, May 2010Crohn’s disease is a chronic disorder that causes inflammation of the gastrointestinal (GI) tract, usually the small intestine and/or colon. Symptoms can include persistent diarrhea, abdominal pain, fever, and rectal bleeding. Loss of appetite and subsequent weight loss may also occur. The disease is not always limited to the GI tract; it sometimes also affects [...]
- In: Disease
- Tags: Crohn's Disease
The “Dark Side” of Anti-Tumor Necrosis Factor Therapy: INFLIXIMAB AND ETANERCEPT: MAJOR PROBLEMS WITH THERAPY
28, May 2010Infection
Controlled trials have shown no overall increase in the risk of serious sepsis in enrolled patients taking infliximab and etan-ercept. Such trials provide a comprehensive data set, but patients enrolled in trials are not always typical of those who receive these drugs in the real world. Indeed, postmarketing surveillance has identified an increased risk of [...]
- In: Main
- Tags: Anti-Tumor Necrosis, Etanercept
The introduction of biological agents in recent years for the treatment and possible reversal of the progression of some serious chronic diseases was heralded as a breakthrough in therapy, in which the benefits seemed to outweigh the risks. Although carefully controlled clinical trials demonstrated several adverse effects, the benefits of these agents led to the [...]
- In: Main
- Tags: Anti-Tumor Necrosis, Etanercept
The rest of the second day, conference topics shifted from government perspectives to the effect of the MMA on various private stakeholders. Representatives from pharmaceutical manufacturers, health insurance plans, PBMs, large purchasers of health care, health care providers, and pharmacists talked about how the bill would change their respective practices and the challenges that all [...]
- In: Drugs
- Tags: Drug Congress, Drug Manufacturers, FDA Perspective
The second day of the conference continued with more government perspectives on the effect of the MMA. FDA Commissioner Mark McClellan, newly nominated by President George W. Bush to head the CMS, stated that many senior citizens are considering gambling on the safety and effectiveness of their medications (i.e., buying re-imported medications) because they have [...]
- In: Drugs
- Tags: Drug Congress, Drug Manufacturers, FDA Perspective
Thomas Scully, former CMS administrator, gave several examples “from the battlefield” of the prescription drug legislation and its potential impact on American senior citizens and health care in general. He touted the MMA as “the deal of the century and millennium” and as a “spectacular deal for rich and poor seniors.”
- In: Drugs
- Tags: Drug Congress, Drug Manufacturers, FDA Perspective