The FDA and Drug Safety: A Proposal for Sweeping Changes
A Special Article By Curt D. Furberg, MD, PhD; Arthur A. Levin, MPH; Peter A. Gross, MD; Robyn S. Shapiro, JD; Brian L. Strom, MD, MPH
Hearing: Americans Denied Human Right to Say NO to Experimental Research Under FDA Rule
Tomorrow Hearing FDA’s Emergency Research Rule–CNN News at 8:00 P.M will inform the public about how the FDA Rule impacts on American citizens who can be put at increased risk to test an experimental treatment without their knowledge or consent.
FDA Suspends ADHD Drug Safety Study-Approves Risperdal for Autistic Children Without Public Hearing
Two actions by the FDA last week demonstrate where the agency’s priority lies—and that priority is NOT to protect public safety, NOT to protect children’s safety. FDA’s priority—as demonstrated by its actions—is approval of new drugs or approval for expanded even dubious uses of patented drugs.
Industry Influence: FDA “Critical Path”/ Biased Research: BMJ / NIH: still smoke & mirrors
The battle lines were drawn between those who recognize the corrosive effect that the pharmaceutical industry is having on the safety and integrity of medicine and medical research, and the powerful stakeholders–the pharmaceutical-academic industrial complex.
URGE THE SENATE TO PROTECT CHILDREN FROM FORCED DRUGGING!
Urge your Senators to VOTE YES for the Child Medication Safety Act (S. 4041, HR 1790) !!!
Debate: PhRMA and its relations with Gov, Academia, Doctors and Consumers_Oct 4-5
Two especially timely conferences focus on MEDICINE AND THE LAW:
Alternative Medicine Cover story: Kids & Psychiatric Drugs: Big Pharma Comes to the Classroom
Alternative Medicine is a national magazine with 165,000 subscribers. It is also sold nationwide on newsstands. Its cover story, Nov/Dec, is Kids & Psychiatric Drugs: BIG PHARMA comes to the classroom!
FDA Says Bayer Failed to Reveal Lethal Drug Risks–but Fails to Change Licensure or Label_NYT
FDA issued an advisory stating that the concealed study results demonstrate "that use of Trasylol may increase the chance for death, serious kidney damage, congestive heart failure and strokes."
Pediatric Cardiologist Explains: The crucial health stat you’ve never heard of_Slate
Dr. Sanghavi provides us with a statistical reality-check by which to gauge for ourselves whether or not we should–or need not–take a octor’s advice about starting a medical treatment for a speculated risk–rather than evidence of illness.
UK Chanel 4 Investigates: The Drug Trial That Went Wrong_Critique NEJM Editorial
“The Drug Trial That Went Wrong” is an investigative report by Chanel 4 (UK) about the circumstances surrounding the near fatal drug trial testing the safety of TGN1412, a monoclonal antibody drug, conducted in March 2006 at London’s Northwick Park Hospital. [1] http://news.bbc.co.uk/go/pr/fr/-/1/hi/health/5377226.stm It airs momorrow.
IOM Report Faults FDA Drug-Safety Process
A report by the Institute of Medicine is sharply critical of FDA’s drug safety monitoring system: "The report’s conclusions are striking and often damning – particularly when discussing the agency’s Center for Drug Evaluation and Research, known as C.D.E.R."
NIH A House of Ill Repute–Scientists for Sale While on Gov Payroll
"This is really an ethical Potemkin village, where a hollow system appears to provide the illusion of integrity, but transgressors never leave."