The FDA has approved the first generic versions of Fosamax (alendronate sodium tablets), used to treat osteoporosis. Osteoporos is a condition that causes thinning and weakening of bones and is often one of the many significant side effects from Hormone Therapy. Teva Pharmaceuticals USA has received approval to manufacture alendronate sodium tablets in three once-daily [...]
Today’s New York Times carried a story written by Reed Abelson entitled “Financial Ties Are Cited as Issue in Spine Study.” The story explained that some of the nation’s most prominent spine surgeons hailed as a medical breakthrough a study of nearly 240 patients with lower back pain. The doctors said that Prodisc, an artificial [...]
Yesterday, the FDA formally informed healthcare professionals and patients of the possibility of severe and sometimes incapacitating bone, joint, and/or muscle (musculoskeletal) pain in patients taking bisphosphonates. This severe musculoskeletal pain discussed in this alert is in contrast to the acute phase response characterized by fever, chills, bone pain, myalgias, and arthralgias that sometimes accompanies [...]
One of the most common problems brought about by treatment of prostate cancer is erectile dysfunction (ED). The degree of dysfunction varies from complete inability to experience any sort of erection to just a slight softening of the erection. The degree of the dysfunction will ultimately vary among different men. Immediately after surgery almost all [...]
Many of my prior posts about Provenge have discussed the issue of what appeared to be a conflict of interest of some of the members on the FDA advisory committee that reviewed the drug. When the committee voted to recommend that Provenge be approved, among those members who voted against the approval were Drs. Scher [...]
Today I heard back from a representative of the FDA about my concern and complaints surrounding the treatment of the public at FDA advisory committee meetings (my post of 11-20-07). It was explained to me that at the time of the advisory committee meeting for Satraplatin when the public was relegated to the rear of [...]
On November 19, 2007, the FDA posted a consumer update entitled "New Steps to Improve Advisory Committee Processes." The stated goal of these actions is to strengthen its advisory committee process in ways which are consistent with recommendations of the Institute of Medicine. "One of FDA's strengths is that we routinely enlist the nation's leading [...]
I have had the privilege of working with Leslie Mulkey, an independent video producer on a short "You Tube" video about Provenge. Our hope is that our question, "Should terminally ill patients have access to promising new therapies?" will become a part of the next national presidential debate. You can view our video by clicking [...]
Often, the FDA limits access to clinical trials to patients who have failed all other approved therapies. This means that we only evaluate potential new drugs on individuals who are already very sick and have been weakened by their disease as well as their prior treatments. Cancer cells "learn" how to survive treatments by mutating. [...]
The Life Extension Foundation has a series of "Alerts", one of which is about the problems at the FDA that I have been writing about recently. If you go to their alert web page at www.lef.org/lac you can have the following letter electronically sent to your individual congressperson (Senators and House Representative). It will take [...]
