Who is Health and Human Services (HHS)Nominee Michael Leavitt? - Quick Pulse

Summary: The nomination of EPA Administrator Michael O. Leavitt was a surprise to many. However, Leavitt is considered a rising star in the Bush administration; he is likeable, fits in well and is a good administrator. This article looks at Leavitt's background in healthcare.

North American Association for the Study of Obesity (NAASO)

Summary: Obesity specialists are excited about Sanofi-Aventis’s Acomplia, and it is likely to boost pharmacotherapy, even among doctors currently doing little or no drug treatment, but there are still unanswered questions about this agent, and it is unlikely to get a label to treat metabolic syndrome, at least initially. Patients also may be excited about Acomplia at first, but that may be followed with disappointment in the degree of weight loss. Numerous other anti-obesity drugs are in development but none are on the near horizon. Bariatric surgery has been increasing exponentially, and the growth is likely to continue, but perhaps not as fast due to payer resistance. Sources predicted use of Inamed’s Lap-Band will double over the next year.

Chemotherapy Foundation Symposium

Summary: Bone loss/fractures and timing with tamoxifen are concerns with all aromatase inhibitors. BiogenIdec’s Rituxan looks promising in CLL. The outlook appears positive for American Pharmaceutical Partners’ Abraxane, though survival data are still needed. Celgene’s Thalomid – and perhaps Revlimid – appears to have activity in recurrent ovarian cancer. Cell Therapeutics appears close to an SPA agreement with the FDA for Xyotax, which would be a positive sign. Genentech’s Herceptin may be safe to use with lower dose anthracyclines, perhaps sequentially instead of concurrently. New data on Johnson & Johnson/PharmaMar’s Yondelis suggested that it may be more effective when dosed less frequently. Lilly’s Alimta is gaining popularity in combination therapy for lung cancer, and it may move to more front-line use. Millennium’s Velcade looks promising in mantle cell lymphoma. New data indicate the fatigue with Pfizer’s SU-11248 is not cumulative and doesn’t adversely affect quality of life. Roche’s Xeloda may get a boost from the Medicare drug plan in January 2006 – but mostly from oncologists who are unable to organize an efficient, profitable infusion center. SuperGen’s Dacogen was filed with the FDA and is likely to challenge Pharmion’s Vidaza.

The FDA's Advisory Committee for Reprodutive Health Drugs Rejects Proctor & Gamble's Intrinsa Patch - Quick Pulse

Summary: An FDA advisory committee unanimously recommended against approval of Procter Gamble’s TTS (Testosterone Transdermal System) patch, Intrinsa, until more safety studies are done. The FDA is expected to make a decision on the patch soon. P&G is seeking approval of the patch for treatment of HSDD (hypoactive sexual desire disorder) in surgically menopausal women on concomitant estrogen. This report reviews the advisory panel discussion and vote.

NIH and FDA Officials Discuss the Safety of COX-2 Inhibitors - Quick Pulse

Summary: The NIH Director, the Acting FDA Commissioner, and other regulatory officials hosted a conference call with reporters to discuss the National Cancer Institute’s decision on December 16, 2004, to halt a trial of Pfizer’s Cox-2 inhibitor Celebrex (celecoxib) due to an excess of cardiac adverse events. The Adenoma Prevention with Celecoxib (APC) trial compared two doses of Celebrex (200 mg BID and 400 mg BID) to placebo. It had been ongoing for an average of 33 of the planned 60 months.

North American Spine Society

Summary: Artificial discs clearly stole the show. There was tremendous interest in discs, especially since the first artificial disc, Johnson & Johnson’s Charité, was approved at the beginning of the meeting. Doctors predicted that an average of 19% of their fusion patients over the next year will get a Charité artificial disc instead, and they expect this to be driven by strong patient demand. Spine surgeons continue to favor kyphoplasty over vertebroplasty, but growth in kyphoplasty procedures is expected to slow due to cost, reimbursement, rumors CMS will change reimbursement with a new CPT code, and improving results with vertebroplasty. Kyphoplasty is good medicine, but it’s bad from a business sense, doctors said. The high cost of the first BMP, Medtronic’s InFuse, is limiting use, and excitement over BMPs in general appears to have waned a bit.