The issues discussed in the 1987 filmed interview of Merck’s chief vaccine researcher, Dr Maurice Hilleman, conducted by Dr. Edward Shorter, Professor of the History of Medicine and Professor of Psychiatry, University of Toronto raise serious doubts about the propaganda the public has been fed about the safety of Merck vaccines. Vaccines that have been promoted as “safe and effective” miraculous cures have been infecting (possibly) millions of people with cancer, leukemia, and AIDS.
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.
Its time to look at the faces of lives lost… In the early 1990s, faced with protests by AIDS activists about the glacier-like approval of potential life saving drugs, the Clinton administration changed the FDA drug approval process. They allowed pharmaceutical companies to “fast track life-saving” drugs by absorbing the extra costs involved. The unintended [...]
A BIG thank you to the Philadelphia Inquirer… One of the few major media outlets that consistently cover Big Pharma and the FDA… This weekend The Philadelphia Inquirer examined how Sen. Chuck Grassley (R-Iowa) has “found a congressional calling” in “creating uproars that often transform public opinion and policy” and “in recent years … has [...]
DeLauro Seeks Info From FDA Amid Political Influence Concerns By Jared A. Favole, Of DOW JONES NEWSWIRES WASHINGTON -(Dow Jones)- Congresswoman Rep. Rosa DeLauro, concerned about political influence in device and drug approvals, wants details about what products the Food and Drug Administration has approved in the last several months. She fears that industry influence [...]
By DAN RODEN, M.D. • October 10, 2008 Dr. Dan Roden is professor of medicine and pharmacology, director of the Oates Institute for Experimental Therapeutics, and assistant vice chancellor for personalized medicine at Vanderbilt University School of Medicine. The Food and Drug Administration recently announced a public Web site listing potential drug side effects it [...]
FDA Releases Draft Guidance on Regulation of Genetically Engineered Animals Printer-friendly PDF (420 KB) On this page: Genetic Engineering Benefits of GE Animals GE Animals Regulated Under New Animal Drug Provisions The Food and Drug Administration (FDA) is inviting the public to comment on draft guidance that discusses FDA’s approach to regulating genetically engineered (GE) [...]
FDA Consumer Update addressing recent, questions about the safety of Gardasil, a HPV-vaccine that prevents infection with types of human papillomavirus (HPV) that cause most cases of cervical cancer and genital warts, and some vulvar and vaginal cancers.
The FDA rejected Merck’s request to approve its HPV vaccine, Gardasil for women between ages 27 and 45, citing “issues that preclude approval within the expected review timeframe,” Merck offered no additional specific explanation in their prepared statement. Merck indicated that it is in ongoing discussions with FDA officials about to the application and expects to officially respond to the agency within the next 30-days. The HPV- vaccine, Gardasil, was approved June 8, 2006 for girls and women between 9 and 26 years old to prevent human papillomarivus related cervical cancer.
How to Use the Consumer Complaint System and MedWatch On this page: Consumer Complaint Reporting Reporting Problems Can Spur Action MedWatch Reporting How to Report to MedWatch Problems to Report to MedWatch Reporting Emergencies FDA Consumer Complaint Coordinators (regions and telephone numbers) If you have a complaint about a product regulated by the Food and [...]
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