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Nathan Goodyear

Availability of evidence of benefits on overall survival and quality of life of cancer ... - 0 views

  • Although the goal of cancer treatment is to improve the quantity and quality of life,123 clinical trials designed to gain regulatory approval for new drugs often evaluate indirect or “surrogate” measures of drug efficacy. These endpoints show that an agent has biological activity, but they are not reliable surrogates for improved survival4567891011 or quality of life46111213
  • two recent systematic reviews suggest that the strength of association between surrogates in cancer clinical trials and life extension is generally low
  • Available data from the US show that only a small proportion of cancer treatments approved by the US Food and Drug Administration (FDA) unequivocally show benefits on survival or quality of life.30
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  • We sought to systematically evaluate the evidence base for all new drugs and new indications for the treatment of solid tumours and haematological malignancies approved by the EMA in the five year period 2009-13
  • Three investigators (AP, EP, and EG) independently extracted data on and descriptively analysed the following trial features: characteristics of the participant population, study design (randomisation, crossover from experimental to control group, and blinding of investigators and participants), experimental and control groups, enrolment, primary and secondary endpoints, magnitude of benefit on survival and quality of life, and narrative interpretation of the findings
  • Only 18 of the 68 (26%) were supported by a pivotal study powered to evaluate overall survival as the primary outcome
  • From 2009 to 2013, the EMA approved use of 48 oncology drugs
  • Seventeen drugs were approved for treatment of haematological malignancies and 51 for treatment of solid tumours
  • Overall, 72 clinical trials supported the approval of 68 novel drug uses
  • Our scoring was limited to drugs for solid tumours
  • Among 68 cancer drug indications approved by the EMA in the period 2009-13, and with a median of 5.4 years’ follow-up, only 35 (51%) were associated with a significant improvement in survival (26/35) or quality of life (9/35) over existing treatment options, placebo, or as add on treatment
  • Only two of the 26 drugs shown to extend life also showed benefits on quality of life
  • 33 (49%) had not shown any improvement on survival or quality of life
  • This systematic evaluation of oncology drug approvals by the EMA in 2009-13 shows that most of the drugs (39/68, 57%) entered the market without evidence of improved survival or quality of life
  • At a minimum 3.3 years after market entry, there was still no conclusive evidence that 33 of these 39 cancer drugs either extended or improved life
  • What are potential reasons for the paucity of drug approvals with demonstrable survival advantages over existing treatments?
  • Firstly, only 18 (26%) indications for use in our cohort were supported by trials in which extension of life was the primary outcome
  • None of the pivotal studies supporting oncology drug approvals from 2009 to 2013 included quality of life as a primary outcome measure
  • Most new oncology drugs authorised by the EMA in 2009-13 came onto the market without clear evidence that they improved the quality or quantity of patients’ lives
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    New study from European Medicines Agency questions alot of the new cancer drugs brought to the market 2009-2013.  57% of the new drugs (39/68) were brought to the market without evidence of improved survival or quality of life.
pharmacybiz

David Webb - England New Chief Pharmaceutical Officer - 0 views

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    David Webb has been appointed as the new chief pharmaceutical officer (CPO) for England. He will take over from Dr Keith Ridge who steps down next month after serving the role for sixteen year. Webb is currently chief pharmacist and clinical director for pharmacy and medicines optimisation at Guy's and Thomas's NHS Foundation Trust, London. Sharing the news of his appointment on Twitter on Friday afternoon (January 7), he said he was "really delighted and honoured" to be named the CPO for NHS England and that he was as the appointed Chief Pharmaceutical officer for "looking forward to working with pharmacy leaders, colleagues & teams across all sectors from February." He also extended his gratitude to the outgoing CPO for his "outstanding contribution" who, in turn, congratulated Webb and said it was "an honour to be handing over to him". In the same message, Dr Ridge thanked "all the great people I've worked with over the last 16 years for your support, friendship, good humour, great ideas & challenge. I wish you all well for the future."
pharmacybiz

Reverse Decision Declining Romosozumab Use For Osteoporosis - 0 views

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    More than 100 NHS clinicians have urged the National Institute for Health and Care Excellence (NICE) to change its decision - declining recommendation of romosozumab, the first new osteoporosis medication for over a decade. In a joint letter published on January 2, the clinicians warned of the consequences of barring access to the drug to those who suffer the bone-weakening disease. The joint letter, led by the Royal Osteoporosis Society (ROS), raised concern over the scarcity of the drug pipeline for osteoporosis and lack of public funding for new research. It quoted recent government research that showed the National Institute for Health Research (NIHR) invested less than £1 million in osteoporosis research in 2020-21, against the £4.6 billion per year cost to the NHS of fractures. Craig Jones, chief executive of the Royal Osteoporosis Society said: "We're calling on NICE and the applicant company to get back round the table and work with us to ensure equal access to this important new treatment.
snfilms

SN Films Performing Arts - Film Institute at Chandannagar. - 0 views

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    New Year, New Beginning. We are here at SN Films Performing Arts, Chandannagar (Hooghly) to nurture your dreams. We will shape up your old passions to new hopes. Admissions open for acting, film making, singing, spoken English and share trading courses. Contact #snfpa at 9051355050 for detail.
George Thomas

New extrusion coating line from Davis-Standard targets flexible packaging market - 0 views

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    Plastics News Portal, Plastics Jobs, Plastics Directory And Trade Website for World and India - Plasticsinfomart.com
Nathan Goodyear

Vaccines backfire: Veterinary vaccines found to combine into new infectious viruses - 0 views

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    scary result.  Vaccine used in the prevention of ILT in chickens resulted in a new viral strain.  Two different virus strains were used.  These combined and resulted in a brand new viral strain. Apply this to our multi-dose vaccine schedule i.e. MMR
Nathan Goodyear

Statin use and risk of diabetes mellitus - 0 views

  • An increase in new onset diabetes, i.e., 3% in statin arm and 2.4% in placebo arm was reported. This was accompanied by increase in median value of glycated haemoglobin and was one of the earlier studies to report the increase in new onset diabetes in patients on statins
  • Even after adjustment for potential confounders, statin therapy was associated with an increased risk of new-onset diabetes mellitus
  • Authors suggest that statin-induced diabetes mellitus is a medication class effect
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  • Another study also reported that as compared to placebo, statin group showed a higher risk of physician reported incident diabetes and it was also observed that risk was higher in women as compared to men
  • Meta-analysis of randomized controlled trials by Sattar et al[25] involving 91140 non-diabetic patients showed that statin therapy was associated with 9% increased risk of incident diabetes
  • A number of studies showed dose dependent association between statin administration and incident diabetes
  • intensive dose of statins was associated with high incidence of new - onset diabetes
  • Treatment with atorvastatin and simvastatin may be associated with an increased risk of new onset diabetes as compared to pravastatin
  • Increased incidence of diabetes was seen with atorvastatin in the Anglo-Scandinavian Cardiac Outcomes Trial
  • Increased insulin resistance secondary to statins was demonstrated in a prospective non randomised study in patients with coronary bypass surgery
  • downregulation of GLUT4
  • Prevention of coronary and stroke events with atorvastatin in hypertensive patients who have average or lower-than-average cholesterol concentrations, in the Anglo-Scandinavian Cardiac Outcomes Trial--Lipid Lowering Arm (ASCOT-LLA): a multicentre randomised controlled trial
  • Prevention of coronary and stroke events with atorvastatin in hypertensive patients who have average or lower-than-average cholesterol concentrations, in the Anglo-Scandinavian Cardiac Outcomes Trial--Lipid Lowering Arm (ASCOT-LLA): a multicentre randomised controlled trial
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    Great review article of the increased risk of worsening insulin resistance, glycated hemoglobin, and diabetes risk.  Atorvastatin appears to be the worst culprit.  Mechanism partially through a decrease in GLUT4.
pharmacybiz

Boots welcomes job applications from LloydsPharmacy staff - 0 views

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    Boots has welcomed job applications from LloydsPharmacy staff impacted by the news of closure of all its branches located in Sainsbury's before the end of 2023. The company is recruiting for more than 1,500 pharmacy roles nationwide. Vacancies span pharmacy roles at all levels - from Pharmacy Advisors (Dispensers) and Trainee Pharmacists to experienced Pharmacists looking to develop their careers. Sebastian James, Managing Director of Boots UK & ROI, said: "Pharmacies deliver vital healthcare in the heart of communities. News of the closure of LloydsPharmacy branches within Sainsbury's stores will no doubt have an impact on many talented pharmacists as well as their patients. "We have many roles available at Boots and welcome applications from LloydsPharmacy employees affected by the closures. Patients who are worried about their future pharmacy provision can check our store locator online to find out where their nearest Boots store is - our pharmacy team members are ready to help." There are over 2,200 Boots stores across the UK and 85% of the population live within 10 minutes of a Boots store.
Nathan Goodyear

Update on Serologic Testing in Celiac Disease - 0 views

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    New clarification of celiac disease and the new gluten sensitivity. It has been many years that gluten sensitivity was frowned upon, but now clarification and validation comes.
Nathan Goodyear

Crossing the Quality Chasm: A New Health System for the 21st Century - Institute of Med... - 0 views

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    This report suggests that the average clinician is practicing at a level 17 years behind the current science.  Better stated, it takes an AVERAGE of 17 years for new science to reach a clinical practice.  Scary!  Though, I am opposed to their proposed resolutions to the problem, the statistic is eye-opening.
Management Health Solutions Inc

Webinar: Focusing on the Big Picture of Your Supply Chain Yields Compelling Financial R... - 0 views

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    Continuous changes in the healthcare reimbursement criteria require executives across the industry to focus on enterprise-wide changes that have a positive effect on supply chain savings. It's a complex problem and it's easy to get distracted on one issue when having the ability to see a clear BIG picture of your entire supply chain is what can lead to the most dramatic results and return on investments. Register for MHS' webinar on November 01 (2:00pm EST) to learn about how their customers experience an average 4:1 ROI with continual savings into the millions and a positive financial impact to their bottom line through inventory reduction, avoidance of obsolete and expired inventory, improved charge capture for each patient, and physician preference card optimization. Click on http://bit.ly/UvD3nq Presenters *Michael Ferris: Co-Founder, MHS with over 30 years of supply chain management experience *Steve Basiliere: Former Director of Supply Chain Services at Saints Medical Center, Lowell, MA *Art Kozyrovicius: Finance and Procurement Systems Support at New York-Presbyterian Hospital, New York, NY WHY ATTEND? Join a unique discussion with healthcare supply chain thought leaders and understand how to drive significant and sustainable supply chain operational improvements. Get a jump on making an immediate and positive impact on your bottom line as you head into 2013. Register by clicking on http://bit.ly/UvD3nq Note: Event will be online, through WebEx Please Register at http://bit.ly/UvD3nq
arunaraayala

Chris Brown 'banned from Life Time fitness center' - 0 views

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    Chris Brown has apparently been prohibited from Life Time fitness center after a claimed push with the New York City branch
Alan Rann

Plastic Surgery Loans- Get Implausible Look with Simple Financial Assistance! - 0 views

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    Plastic Surgery Loans are provided an opportunity to obtain sufficient cash support for your health conscious problems. This cash advance is very helpful to all as they give you a new life and a new meaning to live for so without any second thought apply with us.
Nathan Goodyear

Graviola: A Novel Promising Natural-Derived Drug That Inhibits Tumorigenicity and Metas... - 0 views

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    New insight to new therapy for Pancreatic cancer.  This article/study does a great job of reviewing the biochemistry by which Graviola works against pancreatic cancer.  Graviola was shown to downregulate HIF-1alpha, NF-kappaB, GLUT1, GLUT4, HKII, and LDHA.  Complex 1 of the electron transport was also inhibited.
Nathan Goodyear

JAMA Network | JAMA Internal Medicine | Resveratrol Levels and All-Cause Mortality in O... - 0 views

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    New study finds no cardiovascular benefits from resveratrol.  It has long been claimed that reserveratrol is the polyphenol from red wine and chocolate that is the source of cardiovascular benefits such as found in the "french paradox".  However, this new study finds that resveratrol provides no benefit.  Studies still point to dark chocolate and red wine as means to reduce inflammation and reduce CVD risk, this study just points away from resveratrol as the source of the benefit.
Nathan Goodyear

Does Testosterone Lower Risk of Heart Attacks and Stroke? | Medical Research News and I... - 0 views

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    This is a short interview of the author on a recent retrospective review that revealed no increase in cardiovascular events in men.  The author rightly points out his data, which is quite different than the previous JAMA and PLOSone publications which showed an increase in cardiovascular events.   However, the lead author points out the main problem with comparisons:  his study group was younger and healthier.  So, the comparison is apples to oranges.  Studies still point to increased risk of Testosterone therapy in men with pre-existing CVD.  This new study does not refute this point at all.   Another serious flaw here, is that only Testosterone was followed.  This logic is seriously flawed as I have previously documented.  The author points out the flaw in the levels in the JAMA study post treatment.  But he fails to account for the the lack of adequate pathway assessment i.e.aromatazation.  Also, no inflammatory cytokine evaluation was performed in that study.  Both of these should have been highlighted.    In contrast, a positive was the length of follow.
Nathan Goodyear

Pharmacological ascorbate induces cytotoxic... [Anticancer Drugs. 2012] - PubMed - NCBI - 0 views

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    IV vitamin C induces cell death of prostate cancer cell lines via H2O2, which is not new, but what is new is the ascorbate-insensitive cell line.
wheelchairindia9

Ultra Lightweight Travel Wheelchair With Seat Belt - 0 views

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    Travel Wheelchair is ideal for those looking for an easily portable wheelchair without sacrificing sturdiness or weight capacity. In order to accommodate various heights, models feature adjustable backs and the threaded seat screw inserts reduce stripping from upholstery damage to give the chair a longer life. The wheels feature sealed bearings to keep dirt out, making the wheels virtually maintenance free. The Travel Chair is a lightweight sturdy aluminum framed portable chair. It is easily transportable and comes with a compact carry bag, making it ideal for stowing away in cars, buses, trains, and more. This wheelchair can be used both indoors and outdoors on forgiving terrain, with a convenient step for the attendant to lift the chair over obstacles. This travel chair gives the freedom to go, with the added convenience of folding up to a manageable size. This lightweight Steel Travel Chair with Fixed Full Arms or Detachable Desk Arms has a foldable back, making it convenient and easy to store and transport. The silver vein frame is scratch resistant and it comes standard with a comfortable, durable, and easy to clean, black nylon upholstery seat and back. The caster wheels in front and rear with provide a smooth ride over most surfaces. The padded armrests, rear wheel locks, swing away footrest and seat belt all combine to make this travel chair convenient, durable, easy to transport and safe. Karma Travel Wheelchair KM TV 20.2 Karma Travel Wheelchair KM TV 20.2 - 606 T-6 aircraft-grade aluminum-alloy frame provides incredible strength. Easy-to-fold in three seconds. Karma Travel Wheelchair KM TV 20.2 Features Type: Travel Wheelchair T-6 aircraft-grade aluminum Secure brake improve safety Padded flip back armrest PU front caster & rear wheel Karma Travel Wheelchair KM TV 20.2 Measurements Weight: 8.9kg Seat width: 39.5cm Tyre: PU front casters and rear wheels Capacity: 100kg Folded size: (L/W/H): 610mm x 350mm x710mm. Lightweight wh
Nathan Goodyear

AHA: HDL - the waters grow muddier : Clinical Endocrinology News - 0 views

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    The good and bad cholesterol thing was nothing but marketing; new study calls into question HDL as a useful cardiovascular biomarker.
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