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Archives for May 2009

FDA Recall of Class I SmartMonitor 2 Infant Apnea Monitor

H. Sandra Chevalier-Batik · May 18, 2009 ·

MedWatch - The FDA Safety Information and Adverse Event Reporting Program Respironics, Inc. SmartMonitor 2 Infant Apnea Monitor, Models 4002 and 4003 Audience: Consumers, Pediatricians Respironics and FDA notified healthcare professionals of a Class I recall of SmartMonitor … [Read more...] about FDA Recall of Class I SmartMonitor 2 Infant Apnea Monitor

Filed Under: FDA Product Recall Tagged With: Class I SmartMonitor 2 Infant Apnea Monitor, FDA Recall, MedWatch 2009 Safety Summary

Politics, Profits and Pharma

H. Sandra Chevalier-Batik · May 18, 2009 ·

The following is a  transcript from the Public Television series, FRONTLINE. The program, Politics, Profits and Pharma was aired on  November 13, 2003.  I've kept in my files for years as a source reference document. This past week, while working on a paper with my writing … [Read more...] about Politics, Profits and Pharma

Filed Under: Big Pharma Watch Tagged With: Big Pharma, FDA, Prescription Drug User Fee Act (PDUFA)

Inside a Contract Research Organization (CRO)

H. Sandra Chevalier-Batik · May 18, 2009 ·

Health Decisions Celebrates 20 Years of Adaptive Clinical Research This past week we have addressed the issue of CROs (Contract Research Organizations) and how the financial relationship with Big Pharma could possible effect aspects of drug trials. The Durham-based CRO … [Read more...] about Inside a Contract Research Organization (CRO)

Filed Under: Big Pharma Watch Tagged With: Adaptive Clinical Research, Contract Research Organization (CRO)

The Atrophy Of Objectivity

Nicholas Batik · May 17, 2009 ·

Administrator's note: We included a similar article by Dan Abshear - The Human Injury of Lost Objectivity: An Insider’s Look into the Corruption of Clinical Trials. This is a copy of the comments he posted on The Scientist. These comments include specific references to legal and … [Read more...] about The Atrophy Of Objectivity

Filed Under: Big Pharma Watch

HPV-Vaccine, How We Got Here

H. Sandra Chevalier-Batik · May 16, 2009 ·

Top HPV-Vaccine Researchers Join Those Advising Caution in HPV-Vaccines Gardasil and Cervarix  Immunization Dr. Diane Harper was a lead researcher in the development of the HPV vaccine. Her HPV-vaccine trial papers were amongst the first I found when I started  researching … [Read more...] about HPV-Vaccine, How We Got Here

Filed Under: Gardasil Tagged With: Gardasil, HPV-Associated Cervical Cancer, Merck, Vioxx

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