FDA-Encourages Medical Device Hucksterism: Surgical Sinus Treatment_NY
"There is virtually no scientific evidence that the procedure, which involves inflating a small balloon in the sinus cavity, actually works."
GAO Report Gives FDA Flunking Grade in Detecting Drug Dangers
“More than a year after the Food and Drug Administration announced it had strengthened its drug safety system, the agency still lacks a reliable system for keeping track of emerging problems, congressional investigators concluded in a report to be released today.” [Los Angeles Times, below]
FDA Psychopharm Advisory Chair Acknowledges No Evidence for SSRI Chemical Imbalance Claims_CMAJ
"Biological psychiatrists have looked very closely for a serotonin imbalance or dysfunction in patients with depression or obsessive compulsive disorder and, to date, it has been elusive," says Dr. Wayne Goodman, Chair of the US Food and Drug Administration (FDA) Psychopharmacologic Drugs Advisory Committee.
Grassley to HHS Secretary: OHRP calls Blood Experiment UNETHICAL, Unapprovable
In a blistering letter addressed to the Secretary of Health and Human Services, Senator Grassley calls upon Michael Leavitt to give “immediate attention” to the serious issues raised by a Northfield Laboratory, non-consensual artificial blood experiment.
Drug Safety Issues-IOM Panel Blasts FDA Advisory Committee Process
IOM committee members were highly critical of FDA’s advisory panels that regularly “recommend” approval without analyzing the safety data.
FDA Plan Would Aid Drug Makers in Liability Suits
FDA political appointees have embarked on a plan to divest the American consumer of the right to seek compensation for defective prescription drugs.
FDA Weakens Rules on Testing New Drugs_LA Times
FDA is speeding the testing of unknown, potentially toxic products in humans (Phase I trials) without adequate pre-human tests.
FDA rules aim to speed drug tests and trim costs
The Food and Drug Administration yesterday issued new guidelines that make it easier for scientists working in universities and small companies to test promising therapies in humans without matching the hefty spending of large drug companies.
Mechanical ventilation in ARDS: One size does not fit all – Editorial AJCCM
Fri, 20 May 2005 ARMA was a government-sponsored, $41 million experiment involving 861 critically ill patients with severe lung injury–i.e., acute respiratory distress syndrome (ARDS). It has been at the center of continuing debate prompted by revelations that researchers at 14 of the nation’s major medical research institutions comprising the…