PHILADELPHIA (CN) – Regulators failed to act on signs that the popular antipsychotic Risperdal causes teenage boys to grow breasts, a federal complaint from the law firm Sheller PC alleges. Sheller notes in the Jan. 29 action that it represents… Read More ›
FDA
FDA fails to withdraw unproven blood pressure drug that has been on the market for 18 years in spite of the manufacturer’s failure to submit evidence that it actually helps patients
Public release date: 16-Aug-2010 – HRR: UPDATE As of 15 FEB 2014 ProAmatine or generic versions are still on the market being prescribed – According to the GAO, the FDA has never once pulled a drug off the market due to… Read More ›
After Avandia: Does the FDA Have a Drug Problem?
Thursday, Aug. 12, 2010 HRR: How a drug company intentionally kills thousands for profit and no one goes to jail. – the agency decided to keep the drug on the market — a move worth billions of dollars to GSK but that… Read More ›
Doctors Group Sues FDA, Saying Drug Does More Harm Than Good
roflumilast, a drug used to treat chronic obstructive pulmonary disease By ELIZABETH WARMERDAM LOS ANGELES (CN) – A physicians group sued the U.S. FDA, seeking revocation of FDA approval of roflumilast, a drug used to treat chronic obstructive… Read More ›
Study examines expedited FDA drug approvals, safety questions remain / Avg. Drug is tested on only 104 patients prior to approval
Contact: Renee Brehio rbrehio@ismp.org 704-831-8822 The JAMA Network Journals Fewer patients were studied as part of expedited reviews of new drugs approved by the U.S. Food and Drug Administration (FDA) in 2008 and some safety questions remain unanswered, according to… Read More ›
Ew! Injectable antibiotic ( VOLUNTARY ) recall prompted by floating bits of hair, cotton and metal inside drug vials
The FDA announced a recall of cefepime, an intravenous drug used for pneumonia, urinary tract, skin, and abdominal infections The visible particles in the drug, which was distributed nationwide, can cause blood clots, strokes, and heart attacks, among other catastrophic … Read More ›
INSIGHT-Big Pharma braces for retirement of favorite regulator
Source: Reuters – Thu, 10 Oct 2013 04:59 AM Author: Reuters By Toni Clarke WASHINGTON, Oct 10 (Reuters) – The retirement of Dr. Janet Woodcock as head of the Food and Drug Administration’s pharmaceutical division is at least a… Read More ›
Drug companies paid big bucks to attend FDA painkiller meetings
Article by: Peter Whoriskey Washington Post October 6, 2013 – 11:15 PM WASHINGTON – A scientific panel that shaped the federal government’s policy for testing the safety and effectiveness of painkillers was funded by major pharmaceutical companies that paid… Read More ›
Cancer-causing arsenic retained in chicken meat – FDA
Photo: EPA After a year of dismissing the issue the FDA finally admitted that chicken meat sold in the United States does contain doses of arsenic – a highly poisonous cancer-causing chemical lethal in high does. Arsenic is reported to… Read More ›
Drugs now to be approved based on a educated guess that it will help the patient, not necessarily improved survival
U.S. drugmakers cheer ‘speed lane’ for breakthrough therapies Source: Reuters – Wed, 24 Jul 2013 11:53 PM Author: Reuters By Toni Clarke WASHINGTON, July 24 (Reuters) – A new regulatory pathway could shave years off the traditional drug approval process… Read More ›
International Counterfeit Drug Ring Hit in Massive Sting / 1,677 illegal pharmacy Web Sites claiming to be CVS, Walgreens etc..
Pill of Goods: International Counterfeit Drug Ring Hit in Massive Sting Court documents review process that led the FDA to shut down more than 1,600 illegal pharmacy Web sites By Dina Fine Maron | Wednesday, July 3, 2013 | 5 Pill… Read More ›
All Hackable from fetal monitors used in hospitals to pacemakers implanted in people
FDA, facing cybersecurity threats, tightens medical-device standards By Lena H. Sun and Brady Dennis, Published: June 12 | Updated: Thursday, June 13, 6:01 AM The Food and Drug Administration is tightening standards for a wide range of medical devices — from fetal… Read More ›
FDA – 2012 law now in effect which lifts conflict of interest restrictions on FDA advisory panels
Contact: Kathy Fackelmann kfackelmann@gwu.edu 202-994-8354 George Washington University School of Public Health and Health Services Conflict-of-interest restrictions needed to ensure strong FDA review Panel members with ties to industry might lead to approval of unsafe drugs, new analysis suggests WASHINGTON,… Read More ›
Watchdogs Blast EPA for Allowing Arsenic in Chicken & Swine Feed
By REBEKAH KEARN (CN) – Lax federal regulators allow arsenic-based additives in chicken and swine feed that can cause cancer in humans, the Center for Food Safety claims in court. Eight other watchdogs joined the Center for Food… Read More ›
FDA redactions policy violates Freedom of Information Act / Conceals Drug and Medical device dangers form the public
Open gov’t groups: FDA redactions rules skirt law Transparency groups: Long-standing FDA redactions policy violates Freedom of Information Act By Matthew Perrone, AP Health Writer | Associated Press – 22 hrs ago WASHINGTON (AP) — A federal policy that allows the… Read More ›
Dairy Industry Wants to Put Aspartame in Milk ” would particularly benefit school children “
By NICK MCCANN WASHINGTON (CN) – Dairy industry groups have asked the Food and Drug Administration to be able to put artificial sweeteners in milk, and not change the label, claiming that it is so consumers can “more easily identify… Read More ›
Almost one-third of chemotherapy used “off-label”
4:44pm EST By Andrew M. Seaman NEW YORK (Reuters Health) – About one-third of chemotherapies are used to fight cancers that drug regulators never approved them to treat, says a new study. Chemotherapies – drugs that kill rapidly dividing cells… Read More ›
FDA withheld documents of defective defibrillator device to avoid embarrassing the manufacturer – and itself, a union claims in court.
Union Says FDA Is Hiding Document By ELIZABETH WARMERDAM LOS ANGELES (CN) – The FDA wrongfully redacted “almost every portion” of a crucial report on problems with an implanted heart defibrillator, to avoid embarrassing the manufacturer – and itself, a… Read More ›
The Irradiation Loophole
Posted By ANH-USA On January 8, 2013 @ 9:00 pm Is this the FDA’s idea of food safety? Action Alert! [1] The Food Safety Modernization Act (FSMA) became law in 2010. We, along with other consumer groups, were able to block some of… Read More ›
Firms May Be Liable for Acne Treatment Woes: Acne Drug Solodyn related to Liver Failure, Lupus, and Hepatitis
By ROSE BOUBOUSHIAN (CN) – A college student whose liver failed allegedly as a result of using the acne treatment Solodyn may sue Medicis and Ranbaxy Pharmaceuticals for negligence, a federal judge ruled. Brittani Tigert,… Read More ›
Ready to eat: the first GM fish for the dinner table
US decision after 17-year battle over fast-growing salmon could pave way for same step in Britain Steve Connor Monday, 24 December 2012 A GM salmon which grows twice as fast as ordinary fish could become the first genetically-modified animal in… Read More ›
New task force report on bisphosphonate use and atypical femur fractures in osteoporosis patients: 94 percent (291) of patients had taken the drugs, most for more than five years
2010 study posted for filing Contact: Sara Knoll sknoll@burnesscommunications.com 301-652-1558 Burness Communications Expert panel calls for additional product labeling, international patient registry Washington, DC, SEPTEMBER 14, 2010– A widely prescribed class of drugs is highly effective in reducing common bone… Read More ›
J&J, FDA leaders take heat for ‘phantom’ recall : Removed Evidence in Secret, of defective infants Tylenol
2010 Event Reposted for Filing By MATTHEW PERRONE, AP Health Writer Matthew Perrone, Ap Health Writer Thu Sep 30, 5:58 pm ET WASHINGTON – Johnson & Johnson executives and the Food and Drug Administration both shouldered the blame Thursday for… Read More ›
Botox maker to pay $600M to resolve investigation
2010 report posted for filing Botox maker to pay $600M to resolve investigation By MATTHEW PERRONE, AP Health Writer Matthew Perrone, Ap Health Writer Thu Sep 2, 4:01 am ET WASHINGTON – Allergan Inc., the maker… Read More ›
Breakthrough Nanoparticle Halts Multiple Sclerosis in Mice, Offers Hope for Other Immune-Related Diseases
A biodegradable nanoparticle turns out to be the perfect vehicle to stealthily deliver an antigen that tricks the immune system into stopping its attack on myelin and halt a model of relapsing remitting multiple sclerosis (MS) in mice, researchers report…. Read More ›
Think that’s ACTUAL fruit in your cereal? How food companies replace the real deal with ‘imposter’ sugar balls and soybean oil
Consumer watchdogs warn lebals are fooling us with high-sugar ‘fruit imposters’ inside packaging promising ‘real fruit, full of vitamins’ The FDA permits labels to say ‘real fruit’ as long as the word ‘flavoured’ also appears on the packaging By Daily… Read More ›
GAO: FDA fails to follow up on unproven drugs ” FDA has never pulled a drug off the market due to a lack of required follow-up about its actual benefits”
2009 report posted for filing By MATTHEW PERRONE, AP Business Writer Matthew Perrone, Ap Business Writer WASHINGTON – The Food and Drug Administration has allowed drugs for cancer and other diseases to stay on the market even when… Read More ›
HHS Report Slams FDA’s Conflict of Interest Oversight: 42% were missing the required financial disclosures
2009 report posted for filing By Emily P. Walker, Washington Correspondent, MedPage Today WASHINGTON, Jan. 12 — The FDA fails to ensure that scientists conducting clinical trials on investigational products disclose financial conflicts of interest, found a review… Read More ›
Splenda may damage gut bacteria, boost weight gain: study
2008 study posted for filing By Stephen Daniells 25-Sep-2008 – Consumption of the sweetener Splenda at doses within the US FDA’s Acceptable Daily Intake may suppress beneficial bacteria in the gut, and cause weight gain, says a new… Read More ›
Antipsychotic Drugmakers Target Marketing Dollars at D.C. Medicaid Psychiatrists, Study Indicates: Prescribing Antipsychotics to non psychotic Children
ScienceDaily (Sep. 26, 2012) — The D.C. Department of Health (DOH) has released a study by George Washington University School of Public Health & Health Services (SPHHS) indicating the high levels of marketing by antipsychotic drug manufacturers to Medicaid psychiatrists… Read More ›
Half of trials supporting FDA applications go unpublished
2008 study posted for filing Contact: Andrew Hyde press@plos.org 44-122-346-3330 Public Library of Science Over half of all supporting trials for FDA-approved drugs remained unpublished 5 years after approval, says new research published in this week’s PLoS Medicine. The most… Read More ›
Sifting Social Media for Early Signs of Adverse Drug Reactions
ScienceDaily (Sep. 21, 2012) — The National Science Foundation has awarded a $130,000 grant to a team co-led by University of Virginia professor Ahmed Abbasi to fund research that will analyze social media, including tweets and online discussion forums, to… Read More ›
Rising levels of ARSENIC in rice ‘could be toxic and pose cancer risk’ – and there are NO federal standards over how much is allowed in food
Inorganic arsenic – found in some pesticides and insecticides – can be toxic Arsenic is higher in rice than most other foods because it is grown in water on the ground FDA officials are studying 1,200 samples to test for… Read More ›
Toxic drugs, toxic system: Sociologist predicts drug disasters “Drug disasters are literally built into the current system of drug testing and approvals in the United States,”
Repost 2008 Contact: Jackie Cooper jcooper@asanet.org 202-247-9871 American Sociological Association Study says harm from prescription drugs growing, cites fatal flaws in drug testing, approval and marketing BOSTON — Americans are likely to be exposed to unacceptable side effects of FDA-approved… Read More ›
29th Health Research Report 29 APR 2008 – Reconstruction
Editors Top Five: 1. High blood pressure may protect against migraine 2. Study shows pine bark naturally reduces osteoarthritis 3. Life expectancy worsening or stagnating for large segment of the US population 4. Study reveals inaccuracies in studies of cancer treatment 5. Study… Read More ›
Stanford researcher criticizes FDA plans to reduce oversight of off-label drug use: Pharmaceutial Free For All (No Rules)
Repost From April 2008 Contact: Rosanne Spector manishma@stanford.edu 650-725-5374 Stanford University Medical Center STANFORD, Calif. – Proposed guidelines from the U.S. Food and Drug Administration would allow companies to market more drugs for unapproved uses and are a step in… Read More ›
FDA ties pneumonia deaths to infant vaccine
Repost from 2008 WASHINGTON – GlaxoSmithKline Plc’s rotavirus vaccine is associated with increased pneumonia-related deaths and other adverse reactions, U.S. regulatory staff said in documents posted on Friday. The review comes ahead of a Food and Drug Administration advisory… Read More ›
Varenicline (Chantix™) Responsible for 90% of all reported suicides related to smoking- cessation drugs since 1998
Requested Repost 2Nov2011 WINSTON-SALEM, N.C. — The poor safety profile of the smoking-cessation drug varenicline (Chantix™) makes it unsuitable for first-line use, according to a study published in the Nov. 2 edition of the journal PLoS One, an online publication… Read More ›
Teething Baby? Avoid Benzocaine, FDA Says
SUNDAY, July 29 (HealthDay News) — Parents should not use benzocaine products to relieve teething pain in babies except under the advice and supervision of a health care professional, the U.S. Food and Drug Administration says. Benzocaine is a local… Read More ›
Experts challenge FDA over approval for new dose of Alzheimer’s drug – Aricept ( donepezil ) Ineffective and harmful
Observations: How the FDA forgot the evidence: The case of donepezil ( Aricept) 23 mg Approval for a new dose of a best-selling Alzheimer’s drug “breached the FDA’s own regulatory standard” and has led to “incomplete and distorted messages” about the… Read More ›
Dausey calls BPA ban ‘hollow victory’
Jul 23, 2012 | Posted in News Releases The FDA says baby bottles and sippy cups can no longer contain Bisphenol-A (BPA), an endocrine disruptor that mimics estrogen. But what about the hundreds of other plastic items, from water bottles… Read More ›
FDA Says No to Dying Patients Seeking Access to Experimental Drugs or Treatments
An important new bill addresses this situation. Action Alert! On July 25, famed civil rights attorney Jonathan Emord will be hosting a briefing on Capitol Hill about the FDA’s refusal to allow terminally ill patients access to experimental treatments. In… Read More ›
FDA surveillance operation draws criticism from lawmakers – Corruption
WASHINGTON (Reuters) – The Food and Drug Administration’s secret monitoring of its staff raised hackles in Congress on Sunday after lawmakers learned their own offices were apparently targeted by the surveillance operation. Six current and former FDA scientists and… Read More ›
Engineering Evil 