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Increased Venous Thromboembolism Risk Associated with Oral, but not Transdermal, Estrogen Use
Data suggests that norpregnane derivatives are thrombogenic, yet micronized progesterone and pregnane derivatives may be safe in terms of thrombotic risk. The oral estrogen use in postmenopausal women may elevate the risk of venous thromboembolism (VTE). However, the use of transdermal estrogen does not appear to increase the risk of VTE. This is according to the Estrogen and Thromboembolism Risk (ESTHER) study.
This was a multicenter study using 8 hospitals. It was a case-control trial in France which assessed VTE in postmenopausal women, aged 45 to 70 years, from 1999 to 2005. A total of 271 case patients (208 hospital-based and 63 outpatient-based) with a first recorded occurrence of VTE were matched with 610 control patients (426 hospital-based, 184 community-based). Excluded from the study were patients with a personal history of VTE, contraindication for hormone therapy, and/or a predisposing factor for VTE.
An editorial on the ESTHER study stated that this study provides significant data supporting the theory that the type of hormone therapy and mode of delivery do affect outcomes. A number of cited strengths of the study included the number of carefully selected cases, a large population of transdermal estrogen users, and the variety of progestogen types assessed.
http://formularyjournal.modernmedicine.com/formulary/Medication+Safety/Oral-but-not-transdermal-estrogen-use-associated-w/ArticleStandard/Article/detail/436317?contextCategoryId=44254
FDA Warns Teva on Propofol Production Problems
The FDA has warned Teva Pharmaceutical Industries about manufacturing violations at an Irvine, California plant. They said a July 2009 inspection found problems with the manufacture of the sedative propofol. As an example of the problems, the company failed to test each lot of raw materials used to make propofol for certain toxins (endotoxins). The FDA said Teva's previous responses were inadequate. Teva has stated that the company is working with the FDA to address the concerns.
http://www.reuters.com/article/idUSN2711731020100427
Healthcare Law to Cost Drugmakers More Than Previously Thought
Over the next 10 years, drugmakers face $105 billion in costs-$25 billion more than the industry first estimated-resulting from discounting medicines sold through government health programs. The source of these extra costs will come from expanded drug rebates through Medicaid, the U.S. insurance program for the poor. The new healthcare overhaul places the biopharmaceutical industry in the position of being a larger contributor to health reform than a lot of people understands. The industry also feels that the costs it will be shouldering are at risk of rising.
http://www.bloomberg.com/apps/news?pid=20601202&sid=a_TC.yB.SbaY
Genentech Eye Treatment Found to Help Prevent Vision Loss in Diabetics
Lucentis was found to improve eyesight being lost to diabetes, researchers have reported; a finding they hailed as a major advance in combating a common cause of blindness. The study was from a large government-sponsored clinical trial that tested the drug as a treatment for diabetic macular edema.
Nearly half the patients treated with Lucentis (often in combination with standard laser therapy) had an improvement in vision of at least two lines on an eye chart after one year, as compared to only about 30 percent of those receiving laser therapy alone. These findings were hailed as the first new treatment for people with diabetic macular edema in a quarter of a century. At least one million Americans now have diabetic macular edema with an increase in the number is expected with the increasing incidence of diabetes.
Lucentis is not approved as a treatment for macular edema but is approved for age-related macular degeneration. This drug is already used off-label and now, with this successful Phase 3 trial, insurers may be more likely to pay for such off-label use.
However, some doctors criticized the organizers of the trial for testing Lucentis rather than another Genentech drug, Avastin, which works in the same way as Lucentis but is far cheaper than Lucentis, costing only $20 to $100 a dose, compared with $2,000 for Lucentis. Avastin is undercutting sales of Lucentis, which totaled $1.1 billion in the U.S. last year. The trial investigators admitted that a major reason Lucentis was chosen was that Genentech agreed to provide the drug free of charge and to contribute $9 million in additional financing-but only if Lucentis was used.
http://www.nytimes.com/2010/04/28/health/research/28eye.html?hpw
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