Manufacturer: Genentech, OSI Pharmaceuticals Description: Erlotinib, a tyrosine kinase inhibitor, belongs to a group of cancer drugs known as epidermal growth factor receptor (EGFR)-inhibitors. EGFR-inhibitors can destroy some types of cancer cells while causing little harm to normal cells. EGFRs are proteins in the body that help to activate intracellular tyrosine kinase (an enzyme). This [...]

Manufacturer: American Pharmaceutical Partners, Inc./American Bioscience, Inc. Description: Abraxane™ combines the active drug pacli-taxel (Taxol®, Bristol-Myers Squibb) with a natural protein (albumin) into a nanoparticle that is one-hundredth the size of a red blood cell. As a result, no solvent is needed. This product is the first approved solvent-free, nanoparticle albumin-bound chemotherapeutic agent. It has [...]

Doxorubicin HCl Liposome Injection (Doxil®) Manufacturer: Tibotec Therapeutics, Division of Ortho Biotech Products, LP, Johnson & Johnson Updated Approval: The U.S. Food and Drug Administration (FDA) has granted full approval to doxorubicin HCl lipo-some injection for the treatment of patients with ovarian cancer whose disease has progressed or recurred after platinum-based chemotherapy.

Congressional pressure to improve  the U.S. Food and Drug Administration’s (FDA’s) surveillance of drugs, especially after they go on the market, has been building. So far, however, there has been a lot of smoke and not much fire.

Those trying to understand the complexities of contemporary biomedical research can quickly find themselves suffering not simply from information overload but also from the much more difficult problem of “frame-of-reference deficiency disorders” (FORDDs). How does all this information fit together? If we know how the different pieces of the great puzzle of biology connect, even [...]

This past May (last month), our Department of Health Policy at Jefferson Medical College, Thomas Jefferson University, helped to celebrate the 10th anniversary of ISPOR (the International Society for Pharmacoeconomics & Outcomes Research) at its annual meeting in Washington, DC. I’d like to tell you a few facts about ISPOR and its relevance to our [...]

Merck removed rofecoxib (Vioxx®) from the market early last fall because of reports of an increased number of heart attacks among users. This drug had been widely used for painful arthritis. For this “forthright” action, Merck initially received some adulation. On November 19, 2004, however, The Wall Street Journal published e-mails from Merck’s corporate files [...]