In Pursuit of Profit Gardasil is the first virus-like particle (VLP) based vaccine ever approved Researching Merck’s Gardasil HPV vaccine since 2005, I have read through mountains of data, reviewed medical trial results, FDA and CDC press releases, Adverse Reaction Reports, Merck’s Annual Stockholder’s report, and thousands of articles by both Big Phama’s Evangelists and [...]
As Glaxo is forced to wait for FDA’s approval for its own HPV vaccine, Cervarix, will the company use its time on the sidelines to absorb lessons learned from Merck’s missteps? There is a building backlash against Merck’s ‘BIG-FOOT’, political lobbing strategy that aggressively pushes politicians to mandate its vaccine. Merck has pushed through from one political firestorm to the next. An increasing resentful public is feeling like Atlanta to Merck’s Sherman-like march to market share.
“The tragic story of Gardasil vaccine is one that is playing out real time in the homes of trusting parents, who thought they were doing the right thing to try to make their daughters “one less,” and in the 21st century cyberspace forum of public opinion as well as on television.” Barbara Loe Fisher, President [...]
Published at www.nejm.org March 18, 2009 (10.1056/NEJMe0902377) The Medical Device Safety Act of 2009 Gregory D. Curfman, M.D., Stephen Morrissey, Ph.D., and Jeffrey M. Drazen, M.D. PDF Add to Personal Archive Add to Citation Manager Notify a Friend E-mail When Cited PubMed Citation Challenges for the FDA: the future of drug safety — workshop summary. [...]
Will Sasha and Malia Obama be TWO More Girls Put at Risk by The HPV Vaccine, Gardasil No matter where you stand within the American, political color-spectrum, Reds and Blues all agree: Michelle Obama is a fiercely protective Momma. To my mind that is a very good thing. However as the Adverse Reactions to the [...]
FDA News FOR IMMEDIATE RELEASE March 13, 2009 Media Inquiries: Siobhan DeLancey, 301-796-4668 Consumer Inquiries: 888-INFO-FDA Agency also approved second DNA test for wider range of HPV types The U.S. Food and Drug Administration yesterday approved the first DNA test that identifies the two types of human papillomavirus (HPV) that cause the majority of cervical [...]
Merck to buy Schering-Plough in $41 billion deal Reported by David Jolly Publ With the purchase, Merck is expanding its franchise in cardiovascular, respiratory and oncology drugs and shoring up its research pipeline, in particular with a Schering-Plough product called TRA, a promising drug designed to prevent blood clotting. In addition, Merck will benefit from the [...]
The information in this post was gathered from an article published by Deb Bortifz in eCliniqua, Innovative Management in Clinical Trials. eCliniqua offers PodCasts, WebCasts, White Papers and much more. Their ‘data-rich’ site is one of my primary research resources for an objective review of clinical trial process and results. March 16, 2009 | Pfizer [...]
Will Open Source “SAGE” platform lead to more transperency to MERCK’s research and clinical trials process? Consumers can only hope. Of course if MERCK corporate lawyers figure out that such an open source platform may lead to a clear chain of custody of the type of information they would rather not have readily available during [...]
Medical imaging in clinical trials has gained momentum since the FDA began allowing imaging as part of the evidence in support of a new drug application. The FDA, in an effort to increase new drug approvals, has identified imaging as an important technology for assessing new therapeutics and accelerating drug development in the future. There [...]
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