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wheelchairindia9

Karma KM 2500 - 0 views

www.mswindore.com/...KM-2500-Small-Wheel-Wheelchair

KM 2500 Wheelchair Karma KM 2500 Wheelchair Karma KM 2500 Karma Premium Wheelchair KM-2500 Karma KM 2500 Small Wheel Wheelchair Buy KM 2500 Wheelchair KM 2500 Wheelchair Price

shared by wheelchairindia9 on 21 Oct 15 - No Cached
  • wheelchairindia9 on 21 Oct 15
     
    Karma KM 2500 Small Wheel Wheelchair: Karma KM 2500 Small Wheel Wheelchair Specifications: Width 18" Front/Rear Wheels 6" to 14" Seat Width 47cm Seat Depth 40cm Overall Width 66cm Overall Collapsed Width 36cm Armrest Height 21cm Overall Length 90cm Seat Height 47cm Backrest Height 38cm Overall Height 86cm Weight 9.2 k.g. Karma KM 2500 Small Wheel Wheelchair Seat and Back: AEGIS Microbe Shield Approved by the FDA, EPA, EU, etc., bonded anti-microbial barrier upholstery protects from odor, staining and deterioration from bacteria, fungus and other microorganisms. It is a shield for your health. Karma KM 2500 Small Wheel Wheelchair Extended Armrest: By simulating the natural position of arms, the extended armrest design is ergonomic and creates bigger seating space. An Ultra lightweight wheelchair (9.2 kg) with a compact design for either attendant assisted or self propelling users. The use of aircraft-grade aluminium alloy and double cross brace provide this model with outstanding strength and durability. Karma Healthcare KM-2500 Premium Wheelchair is amazingly light and compact transit wheelchair which is ideal for outings and travelers. It folds down to take up virtually no space in the boot of a car and weighs just over 9.2 kg making it easy for anyone to lift into a vehicle. Backrest folds-down for easy transportation. Maximum user weight: 100 K.g. Aluminium frame. Fixed armrest/fixed footrest. Foldable frame via double cross bars. Comfortable & durable upholstery. Swing-away foot plates. Puncture proof tyres. Attendant cable brake. 14" flat-free rear wheels. Detachable and washable cushion. One Year Warranty. It folds down to take up virtually no space in the boot of a car. This amazingly light and compact transit wheelchair is ideal for outings and travelling. It comes with detachable and washable cushion. The wheel chair has attendant cable brake. It is made from aircraft-grade aluminium alloy fra
Nathan Goodyear

Safety, tolerability, and pharmacokinetics of escalating high doses of ivermectin in healthy adult subjects. - PubMed - NCBI - 0 views

www.ncbi.nlm.nih.gov/...12362927

ivermectin cancer

shared by Nathan Goodyear on 16 Apr 18 - No Cached
  • Nathan Goodyear on 16 Apr 18
     
    Ivermectin safe without significant side effects, including CNS toxicity, in doses 10x 200 mcg/kg (highest FDA approved dose).
spineneuro

Top VBT Surgeons of India in 2021 Using FDA-Approved Spinal Tethering Device - 0 views

www.briefingwire.com/...proved-spinal-tethering-device

vertebral body tethering top VBT surgeons of India in 2021 Vertebral Body Tethering (VBT) Surgery in India Cost of VBT Surgery India Top Hospital for VBT Surgery India

shared by spineneuro on 29 Sep 21 - No Cached
  • spineneuro on 29 Sep 21
     
    "As patients emerge as increasingly interested in non-fusion surgical alternatives for treating scoliosis whilst a back brace has not been effective, vertebral body tethering is an opportunity that preserves movement and flexibility-especially in younger patients as they continue to grow," says top VBT surgeons of India in 2021. For Enquiry Helpline Number: +91-9325887033 Email id: enquiry@spineandneurosurgeryhospitalindia.com
indiacardiacsurg

FDA Approved Konect Resilia Aortic Valved Conduit, by Dr Ajay Kaul India for Bentall Procedures - 0 views

www.briefingwire.com/...l-india-for-bentall-procedures

Dr. Ajay Kaul India Bentall treatment Dr. Naresh Trehan Best Cardiologist Delhi #Fortis Hospital Delhi

shared by indiacardiacsurg on 11 Dec 21 - No Cached
  • indiacardiacsurg on 11 Dec 21
     
    Dr. Ajay Kaul India stated that patients who present process a Bentall process are commonly younger than 60. So the Konect device with the Resilia tissue "would possibly offer extended valve sturdiness for a more active affected person populace," he stated. Fortis Hospital Delhi, India Dr. Ajay Kaul Phone No.: +91-9370586696
Nathan Goodyear

Selective Publication of Antidepressant Trials and Its Influence on Apparent Efficacy - NEJM - 0 views

www.nejm.org/...NEJMsa065779

NEJM antidepressants depression

shared by Nathan Goodyear on 13 Jan 12 - No Cached
  • According to the published literature, it appeared that 94% of the trials conducted were positive. By contrast, the FDA analysis showed that 51% were positive
  • Nathan Goodyear on 13 Jan 12
     
    NEJM reanalyzed the results from 12 antidepressant studies involving over 12,000 patients and found that 40% of studies that found no benefit for antidepressants were omitted.  This seriously altered the statistics and is obvious manipulation of data.  This brings the current recommendations on antidepressants into serious question.
wheelchairindia9

Ultra Lightweight Wheelchairs - 0 views

disabilityproduct.in/...Ultra-Lightweight-Wheelchair

Transport Wheelchair Designed For Disabled people folding chairs with four small wheels Transport Chair stored into a small space light durable frame and great features Ultra Lightweight Wheelchairs

shared by wheelchairindia9 on 07 Aug 15 - No Cached
  • wheelchairindia9 on 07 Aug 15
     
    Selection of portable travel wheelchairs, utilizing small caster wheel and lightweight materials, can tip the scale at as little as 13 lbs! Like transport chairs, travel chairs are geared towards storability and portability, but they're even more convenient for those on-the-go. These chairs feature four smaller wheels, rather than the large rear-mounted wheels that characterize standard wheelchairs, and their design ensures that they're always foldable and convenient to carry. Whether it's a family vacation, or a good ol' fashioned road trip, these lightweight wheelchairs are best bet. Lightweight travel wheelchairs give the most independence of movement with the least amount of effort. This type of wheelchair is recommended for someone who cannot self-propel in a standard wheelchair. The weight of this type wheelchair ranges from 28-34 pounds. Lightweight wheelchair is for the highly active individual as they are more easily maneuverable and durable. This type wheelchair weighs in as low as 14 pounds. This helps with ease of use and transport. Travel wheelchair assists people to become more mobile and independent. There are many different types of wheelchairs that are used for various reasons. It is important to understand the limitations and safe operation of whatever wheelchair choose or need. The travel chair seat size (width and depth), seat-to-floor height, footrests/leg rests, front caster outriggers, adjustable backrests, controls, and many other features can be customized on, or added to, many basic models, while some users, often those with specialised needs, may have wheelchairs custom-built. A single-arm drive enables the user to turn either left or right while the two-armed drive enables user to move forward or backward on a straight line. Another type of wheelchair commonly used is a lever-drive wheelchair. This type of chair enables the user to move forward by pumping the lever back and forth. Travel Wheelchairs are usually designed fo
wheelchairindia9

Transport Chair - 0 views

disabilityproduct.in/...TRAVEL-WHEELCHAIR

Transport Wheelchairs For Active Wheelchair Users lightweight aluminium wheelchairs height adjustable frame vertical position of the rear wheel provide a smooth and true roll maximum weight capacity have swing-away leg rests

shared by wheelchairindia9 on 06 Aug 15 - No Cached
  • wheelchairindia9 on 06 Aug 15
     
    Lightweight wheelchairs provide convenience and comfort to the user and caregiver alike and are often built using materials like aluminum and titanium alloy, while foldable wheelchairs allow for easy storage and transport. Merge the two styles, and got a great mobility aid that isn't a pain to lug around. Utilizing small wheels and lighter materials, transport wheelchairs can tip the scale at as little as 19 lbs, ideal for those looking for a highly portable option. Transport chairs also tend to be more affordable and offer the benefit of increased mobility without breaking the bank. Transport wheelchairs or companion chairs are companion wheelchairs where the purpose is for a companion to push the user. Most transporters have swing-away leg rests, fixed armrests, and side panels. Instead of the usual large back - small front wheels typical of most wheelchairs, light travel chairs have four small wheels providing much easier maneuverability of the chair. Karma KM 2500 Small Wheel Wheelchair: Karma KM 2500 Small Wheel Wheelchair Specifications: Width 18" Front/Rear Wheels 6" to 14" Seat Width 47cm Seat Depth 40cm Overall Width 66cm Overall Collapsed Width 36cm Armrest Height 21cm Overall Length 90cm Seat Height 47cm Backrest Height 38cm Overall Height 86cm Weight 9.2 k.g. Karma KM 2500 Small Wheel Wheelchair Seat and Back: AEGIS Microbe Shield Approved by the FDA, EPA, EU, etc., bonded anti-microbial barrier upholstery protects from odor, staining and deterioration from bacteria, fungus and other microorganisms. It is a shield for your health. Karma KM 2500 Small Wheel Wheelchair Extended Armrest: By simulating the natural position of arms, the extended armrest design is ergonomic and creates bigger seating space. An Ultra lightweight wheelchair (9.2 kg) with a compact design for either attendant assisted or self propelling users. The use of aircraft-grade aluminium alloy and double cross brace provide this model
wheelchairindia9

Wheelchair Lightweight - 0 views

www.wheelchairindia.com/...Ultra-Lightweight-Wheelchair

Lightweight And Folding Transport Wheelchair Transport Wheelchair Wheelchair Lightweight Ultra Lightweight Wheelchair Lightweight Wheelchair Karma KM 2500 transport chair

shared by wheelchairindia9 on 06 May 15 - No Cached
  • wheelchairindia9 on 06 May 15
     
    Transport chairs, also known as companion wheelchairs, have four small wheels instead of two small and two large. A transport chair is designed to only be push by caregiver, other common names are 'companion chair' or 'rollabout chair'. A huge variety of different widths and weight capacities are available. A transport wheelchair is a mobility chair designed for convenience, short-distance use and easy handling by a caregiver. Lightweight and foldable, these wheelchairs are easily moved and typically fit in the trunk of most vehicles. There is even a model designed to fold into a bag to be carried over the shoulder. They are much smaller than standard manual wheelchairs and similar in size to the front wheels. Without large rear wheels, the user must rely on someone else to push the chair, which is why the transport chair is often referred to as a companion wheelchair. 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. Ultra Lightweight Wheelchair: Its compact design and feather light weight makes it suitable for people on the go. Ultra Lightweight Wheelchair Specifications: Frame Style : Foldable Frame Material : Aluminium (Light weight) Rear wheel to wheel width in open position (inches) : 20" Handle to Handle : 16" Seat Width (inches): 13" Rear Wheel Size: 7" Front Wheel Size: 5" Seat to floor height (inches): 19" Seat Depth (inches): 13" Back height (inches): 16" Total height (inches): 35" Max User Weight Capacity (kgs): 80 k.g. Net Weigh
Nathan Goodyear

Normalization of testosterone level is associated with reduced incidence of myocardial infarction and mortality in men | European Heart Journal - 0 views

eurheartj.oxfordjournals.org/...2706

low T low Testosterone Testosterone Testosterone therapy mortality MI stroke heart men male hormones

shared by Nathan Goodyear on 18 Jan 16 - No Cached
  • In this study of men with low TT levels and without prior MI or stroke, normalization of TT levels using TRT is associated with lower all-cause mortality, fewer MIs, and ischaemic strokes.
  • retrospective study
  • significant benefit is observed only if the dose is adequate to normalize the TT levels
  • ...9 more annotations...
  • the mechanisms for these effects remain speculative
  • It can be postulated that the beneficial effect of normal T levels on adipose tissue, insulin sensitivity, and lipid profiles or by its anti-inflammatory and anticoagulant properties, as reported by other investigators, might have contributed to our findings
  • off-label use of TRT remains a concern
  • Recent FDA analyses suggest that currently only half of the men on TRT had been diagnosed with hypogonadism
  • 25% of users did not have their T concentrations tested prior to initiating therapy
  • 21% of those prescribed TRT did not have their levels tested at any time during treatment
  • two very recent meta-analyses suggested a lack of convincing evidence posed by TRT.
  • men without a history of previous MI or stroke who have low TT levels, TRT might be associated with decreased risks of MI, ischaemic stroke, and all-cause mortality in long-term follow-up
  • TRT should aim for doses resulting in normalization of TT level as this was shown to be associated with reduction in adverse CV events
  • Nathan Goodyear on 18 Jan 16
     
    Testosterone therapy in men with low T to restore physiologic Testosterone levels found to reduce mortality, MI, and stroke risk.
marclipman18

https://buyambienonline.org/ Buy Ambien Online From Brightway Pharmacy - 0 views

We are trained and Licensed Medical Personnel Specialized in the Supply of Ambien and other Sleeping Medications.We are Involved in the Supply of 100% Genuine and Authentic Medications FDA Approved...

BUY AMBIEN ONLINE BELSOMRA DILAUDID DOXEPIN ESZOPICLONE OXYCONTIN PERCOCET SONATA XANAX PAINPILLS SLEEPINGPILLS hormones hormone Cancer Testosterone Men inflammation disease Obesity Male low

started by marclipman18 on 10 Dec 18 no follow-up yet
Nathan Goodyear

Niclosamide Suppresses Cancer Cell Growth By Inducing Wnt Co-Receptor LRP6 Degradation and Inhibiting the Wnt/β-Catenin Pathway - 0 views

www.ncbi.nlm.nih.gov/...PMC3241710

Niclosamide cancer Wnt

shared by Nathan Goodyear on 21 Mar 18 - No Cached
  • Wnt/β-catenin signaling plays an important role in embryonic development and can lead to tumor formation when aberrantly activated.
  • Compelling evidence has indicated that there is an abnormal up-regulation of this pathway in tumorigenesis of many types of cancer
  • disruption of Wnt/β-catenin signaling represents a great opportunity to develop novel drugs for cancer chemoprevention and therapy
  • ...2 more annotations...
  • Niclosamide (trade name Niclocide) is a teniacide in the antihelmintic family that is especially effective against cestodes, which infects humans. Niclosamide has been FDA approved for such indications and has been used in humans for nearly 50 years
  • We demonstrated for the first time that niclosamide can inhibit Wnt/β-catenin signaling by inducing LRP6 degradation, and that this activity is closely associated with its antiproliferative and apoptosis inducing activity.
  • Nathan Goodyear on 21 Mar 18
     
    Niclosamide, an old anti-parasitic drug, found to inhibit the Wnt/B-catenin pathways so critical to cancer growth.  This triggers apoptosis of the cancer cell.
Nathan Goodyear

Oncotarget | Vitamin C and Doxycycline: A synthetic lethal combination therapy targeting metabolic flexibility in cancer stem cells (CSCs) - 0 views

www.impactjournals.com/...index.php

cancer doxycycline IV vitamin C vitamin C

shared by Nathan Goodyear on 14 Jun 17 - No Cached
  • These eight distinct cancer types included: DCIS, breast (ER(+) and ER(-)), ovarian, prostate, lung, and pancreatic carcinomas, as well as melanoma and glioblastoma. Doxycycline was also effective in halting the propagation of primary cultures of CSCs from breast cancer patients, with advanced metastatic disease (isolated from ascites fluid and/or pleural effusions)
  • Doxycycline behaves as a strong radio-sensitizer, successfully overcoming radio-resistance in breast CSCs
  • cancer cells can indeed escape the effects of Doxycycline, by reverting to a purely glycolytic phenotype. Fortunately, the metabolic inflexibility conferred by this escape mechanism allows Doxycycline-resistant (DoxyR) CSCs to be more effectively targeted with many other metabolic inhibitors, including Vitamin C, which functionally blocks aerobic glycolysis
  • ...36 more annotations...
  • Vitamin C inhibits GAPDH (a glycolytic enzyme) and depletes the cellular pool of glutathione, resulting in high ROS production and oxidative stress
  • DoxyR CSCs are between 4- to 10-fold more susceptible to the effects of Vitamin C
  • Doxycycline and Vitamin C may represent a new synthetic lethal drug combination for eradicating CSCs, by ultimately targeting both mitochondrial and glycolytic metabolism
  • inhibiting their propagation in the range of 100 to 250 µM
  • metabolic flexibility in cancer cells allows them to escape therapeutic eradication, leading to chemo- and radio-resistance
  • used doxycycline to pharmacologically induce metabolic inflexibility in CSCs, by chronically inhibiting mitochondrial biogenesis
  • This treatment resulted in a purely glycolytic population of surviving cancer cells
  • DoxyR cells are mainly glycolytic
  • MCF7 cells survive and develop Doxycycline-resistance, by adopting a purely glycolytic phenotype
  • Cancer stem cells (CSCs) are thought to be the “root cause” of tumor recurrence, distant metastasis and therapy-resistance
  • the conserved evolutionary similarities between aerobic bacteria and mitochondria, certain classes of antibiotics inhibit mitochondrial protein translation, as an off-target side-effect
  • Vitamin C was more potent than 2-DG; it inhibited DoxyR CSC propagation by > 90% at 250 µM and 100% at 500 µM
  • IC-50
  • DoxyR CSCs are between 4- to 10-fold more sensitive to Vitamin C than control MCF7 CSCs
  • Berberine, which is a naturally occurring antibiotic that also behaves as an OXPHOS inhibitor
  • treatment with Berberine effectively inhibited the propagation of the DoxyR CSCs by > 50% at 1 µM and > 80% at 10 µM.
  • Doxycycline, a clinically approved antibiotic, induces metabolic stress in cancer cells. This allows the remaining cancer cells to be synchronized towards a purely glycolytic phenotype, driving a form of metabolic inflexibility
  • Doxycycline-driven aerobic glycolysis
  • new synthetic lethal strategy for eradicating CSCs, by employing i) Doxycycline (to target mitochondria) and ii) Vitamin C (to target glycolysis)
  • Doxycycline inhibits mitochondrial biogenesis and OXPHOS,
  • hibits glycolytic metabolism by targeting and inhibiting the enzyme GAPDH
  • CSCs act as the main promoter of tumor recurrence and patient relapse
  • a metabolic shift from oxidative to glycolytic metabolism represents an escape mechanism for breast cancer cells chronically-treated with a mitochondrial stressor like Doxycycline, as mitochondrial dys-function leads to a stronger dependence on glucose
  • Vitamin C has been demonstrated to selectively kill cancer cells in vitro and to inhibit tumor growth in experimental mouse models
  • many of these actions have been attributed to the ability of Vitamin C to act as a glycolysis inhibitor, by targeting GAPDH and depleting the NAD pool
  • here we show that DoxyR CSCs are more vulnerable to the inhibitory effects of Vitamin C, at 4- to 10-fold lower concentrations, between 100 to 250 μM
  • concurrent use of Vitamin C, with standard chemotherapy, reduces tumor recurrence and patient mortality
  • after oral administration, Vitamin C plasma levels reach concentrations of ~70-220 μM
  • intravenous administration results in 30- to 70- fold higher plasma concentrations of Vitamin C
  • pro-oxidant activity results from Vitamin C’s action on metal ions, which generates free radicals and hydrogen peroxide, and is associated with cell toxicity
  • it has been shown that high-dose Vitamin C is more cytotoxic to cancer cells than to normal cells
  • This selectivity appears to be due to the higher catalase content observed in normal cells (~10-100 fold greater), as compared to tumor cells. Hence, Vitamin C may be regarded as a safe agent that selectively targets cancer cells
  • the concurrent use of Doxycycline and Vitamin C, in the context of this infectious disease, appeared to be highly synergistic in patients
  • Goc et al., 2016, showed that Doxycycline is synergistic in vitro with certain phytochemicals and micronutrients, including Vitamin C, in the in vitro killing of the vegetative spirochete form of Borrelia spp., the causative agent underlying Lyme disease
  • Doxycycline, an FDA-approved antibiotic, behaves as an inhibitor of mitochondrial protein translation
  • CSCs successfully escape from the anti-mitochondrial effects of Doxycycline, by assuming a purely glycolytic phenotype. Therefore, DoxyR CSCs are then more susceptible to other metabolic perturbations, because of their metabolic inflexibility
  • Nathan Goodyear on 14 Jun 17
     
    Not especially new, but IV vitamin C + daily doxycycline found to kill cancer stem cells.
Nathan Goodyear

Role of IL-2 in cancer immunotherapy: OncoImmunology: Vol 5, No 6 - 1 views

www.tandfonline.com/...2162402X.2016.1163462

IL-2 cancer immune system

shared by Nathan Goodyear on 17 Apr 18 - No Cached
  • IL-2 is one of the key cytokines with pleiotropic effects on the immune system
  • IL-2 as “T-cell growth factor”
  • approved for the treatment of metastatic renal cell carcinoma (1992) and later for metastatic melanoma (1998) by FDA
  • ...13 more annotations...
  • It is produced predominately by antigen-simulated CD4+ T cells, while it can also be produced by CD8+ cells, natural killer (NK) cells, and activated dendritic cells (DC)
  • IL-2 is an important factor for the maintenance of CD4+ regulatory T cells
  • plays a critical role in the differentiation of CD4+ T cells into a variety of subsets
  • It can promote CD8+ T-cell and NK cell cytotoxicity activity, and modulate T-cell differentiation programs in response to antigen, promoting naive CD4+ T-cell differentiation into T helper-1 (Th1) and T helper-2 (Th2) cells while inhibiting T helper-17 (Th17) differentiation
  • Of note, Tregs, which act to dampen the immune response, constitutively express high levels of α chain
  • IL-2Rα is unique to IL-2 and is expressed by a number of immune cells including T regulatory cells (Treg), activated CD4+ and CD8+T cells, B cells, mature DCs, endothelial cells
  • some investigators evaluated the efficacy of regimens containing low-dose IL-2
  • IL-2 can promote the activation and cell growth of T and NK cells
  • Unfortunately, not all of patients would benefit from targeted therapy and nearly all patients who initially respond to targeted inhibitors inevitably develop acquired resistance to the treatment
  • IL-2 also stimulates T-regulatory cells that constitutively express CTLA-4 and can suppress immune reactions. Hence, IL-2 might enhance antitumor reactivity in the presence of CTLA-4 blockade
  • both HD and low-dose IL-2 therapy preferentially induce the expansion of CD4+CD25+Foxp3+ Treg and the Treg level remains elevated after each cycle of HD IL-2 therapy
  • Due to rapid elimination and metabolism via the kidney, IL-2 has a short serum half-life of several minutes
  • HD IL-2-induced severe toxicities including vascular leak syndrome (VLS), pulmonary edema, hypotension, and heart toxicities
  • Nathan Goodyear on 17 Apr 18
     
    Great historical and functional role of IL-2 in the fight against cancer.
Nathan Goodyear

The FDA-approved Drug Ivermectin inhibits the replication of SARS-CoV-2 in vitro - ScienceDirect - 0 views

www.sciencedirect.com/...S0166354220302011

covid19 ivermectin coronavirus

shared by Nathan Goodyear on 04 Apr 20 - No Cached
  • Nathan Goodyear on 04 Apr 20
     
    Ivermectin inhibited COVID19 in vitro
Nathan Goodyear

Availability of evidence of benefits on overall survival and quality of life of cancer drugs approved by European Medicines Agency: retrospective cohort study of drug approvals 2009-13 | The BMJ - 0 views

www.bmj.com/bmj.j4530

cancer cancer treatment survival quality of life

shared by Nathan Goodyear on 20 Dec 17 - No Cached
  • 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
  • ...16 more annotations...
  • 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
  • Nathan Goodyear on 20 Dec 17
     
    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.
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