FDA often ignored or just not there for many drug approvals and trials

Study examines FDA influence on design of pivotal drug studies An examination of the potential interaction between pharmaceutical companies and the U.S. Food and Drug Administration (FDA) to discuss future studies finds that one-quarter of recent new drug approvals occurred without any meeting, and when such meetings occurred, pharmaceutical companies did not comply with one-quarter…

Discrepancies between trial results reported on clinical trial registry and in journals ( nearly all had discrepancies )

– nearly all had at least 1 discrepancy in the study group – Our findings raise questions about accuracy of both ClinicalTrials.gov and publications, as each source’s reported results at times disagreed with the other. During a one year period, among clinical trials published in high-impact journals that reported results on a public clinical trial…

Several FDA-approved anti-cancer drugs induce stem cell tumors, perhaps thwarting therapy

Drosophila intestines provide ‘ready-made stem cell microenvironments’ that are ‘difficult-to-impossible’ to create in petri dishes, offering an unconventional screen that allows researchers to test drugs in vivo. Credit: University of Massachusetts Amherst                                          Using a new approach to systematically test chemotherapy drugs in an unusual animal model, a research team led by University of…

Drug company CEO hangs up on charity head who called with offer to pay $50,000 for life-saving treatment for a dying 7-year-old boy

– the company received $72 million in federal funding to develop Brincidofovir The CEO of  pharmaceutical company that could supply a life-saving anti-viral drugs to a 7-year-old cancer sufferer refuses to hand the drugs over Chimerix chief Kenneth Moch hung up on charity that offered to pay $50,000 for Josh Hardy’s treatment Hung up when…

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 missing or unimpressive follow-up data – company has never conducted a mandatory follow-up study to…

Doctors Group Sues FDA over ( Daxas, Daliresp) , Roflumilast for COPD

Highlights: -Physicians for Integrity in Medical Research says in its federal complaint against Food and Drug Administration Commissioner Margaret Hamburg – best-case scenario showed that roflumilast reduced the number of exacerbations by one episode a year for every five patients treated – the regulator ignored the “statistically significant increase in incidents of prostate and lung…

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 a study published by JAMA Internal Medicine, a JAMA Network publication. The FDA is authorized…

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  issue By  Daily Mail Reporter PUBLISHED: 08:14 EST, 16  October 2013 |  UPDATED: 10:04 EST,…