Posts Tagged ‘FDA’

Pfizer’s Reputation

Icon Written by Alex on April 27, 2010 – 10:39 am

A Ugandan health official said no trials were conducted at IDI. I was left wondering what was accurate: some trials, no trials, or lots of trials. What I was sure of was that Pfizer appeared to be a slippery operation when it came to trials . Recent articles have showed this to be true:

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Wall Street Journal Review

Icon Written by Alex on July 10, 2009 – 9:19 am

Dr. Scott Gottleib, a former deputy commissioner at the FDA, reviewed Chasing Medical Miracles favorably in today’s Wall Street Journal…

“Mr. O’Meara is adept at portraying clinical trials and in discussing ethical concerns — about CROs possibly skewing results to favor the interests of the drug companies that hire them, and about the financial incentive for clinical-trial applicants to lie about their medical history. “

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Zicam, the FDA, and Clinical Trials

Icon Written by Alex on June 18, 2009 – 10:12 am

The homeopathic nasal gel and swabs for cold relief symptoms, Zicam, has been slapped with an FDA warning that its use can cause people to lose their sense of smell. Shipment of the products have been halted by the manufacturer after 130 reports of people losing their sense of smell, perhaps some permanently. There has been no recall. Questions being asked in light of the FDA warning is: Why didn’t clinical trials reveal that Zicam has this side effect before the product was marketed? Did Zicam’s manufacturer, Matrixx Initiatives, Inc., know its product caused anosmia, the medical term for loss of the sense of smell? Here are a few clarifications on the issue of clinical trials and Zicam:

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Strange new legislation and corruption in clinical trials – June 16, 2009

Icon Written by Alex on June 16, 2009 – 9:51 am

A new piece of legislation in the U.S. House aims to increase clinical trials participation by allowing patients with rare diseases to become subjects in trials and not lose their government health insurance. The move is applauded by the Cystic Fibrosis Foundation as a new way to get medications from the research stage into the “hands of people who need them.” This is worth watching long term to see what the implications of this kind of fast-tracking is for drug development and for subjects and patients…. also, the FDA is putting tighter warnings on some asthma drugs because test facilities where some went through trials were not at all to up to par… All this plus industry news is in today’s update which you can read below…

New Legislation Seeks to Boost Participation in Clinical Trials … PR Newswire (press release) – New York, NY, USA – The “Improve Access to Clinical Trials Act” is co-sponsored by Representatives Edward J. Markey (D-MA) and Cliff Stearns (R-FL) and 30 members of the House … See all stories on this topic

FDA Move on Asthma Drug Warnings Comes After Complaints About … BNET – San Francisco, Ca, USA – The brazen “study buddy” and “crossover” arrangements, as staff referred to them, included churning or serially enrolling patients into clinical trials … See all stories on this topic

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Obama told of “corruption” involving clinical trials

Icon Written by Alex on January 9, 2009 – 11:12 am

A small group of scientists from the Food and Drug Administration in a letter to President-elect Obama complained of “corruption” at the agency in how medical devices were approved.   The letter puts the spotlight on how clinical trials are only as effective as the way in which the results are interpreted. In one case, […]

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