Well I have finally moved away from the East coat to the West coast. Not it in the USA but across the Arabian peninsula. We said good bye to the Red Sea and now enjoy the waters and coastal winds of the Arabian Gulf. I thought I would read the Medscape 2015 and 2014 reviews and make a list of what caught my eye and give you their blurb and links of you felt like reading more:
- Oct 2015: Does money driven medicine make doctors act in a different way? I loved this quote as it showed how human doctors really are and they are subject to the same commercial pressures as the rest of the inhabitants of this beautiful planet of ours.”the trend of hospital buying up medical practices is bad for physicians, patients and society.”
- Sep 2015: More ?amazing medication for the treatment of DM (EMPA-REG trial data) SGLT-2 inhibitor (SodiumGLucoseTransport Inhibitor)
- Sep 2015 – Diagnostic error rate: 5% OPD clinic errors – I wonder what the rate is in Primary Care land
- Sep 2015 – SPRINT Trial: 3.5y trial, even tighter controls of BP, but inc risk of CKD induction esp if diastolic also low. Did they stop the trial too early to work out the increased harms at 5 yrs??
- Jun 2015 – Will the monoclonal Antibodies change the face of medicine? FDA Approved a once monthly subcutaneous PCSK9 Inhibitors: AliroCUMAB, evoloCUMAB . They can reduce LDL by 70%. Expensive for now. Trial data awaited.
- May 2015 : Small moving parts are where bacteria hide – Risk of ERCP carriage of bacteria even after sterilisation – cases in USA
- Feb 2015 US IOM Starts to believe in ME – at least they have a label for it at last – the power of a label.
- Sep 2014 Artificial sweeteners (aspartame, saccharin, sucralose) cause blood glucose abnormalities (in mice) – something to do with the gut microbiome! As humans we have to care about human and bacterial cells, perhaps a new slogan would be: “Don’t forget to feed your friendly germs the right food everyday”.
- Sep 2014 Salt in moderation is better than too low the PURE study reported. The question I am left with: How much time do researchers spend getting the right acronym for their study?
- July 2014 CVD risk of Naproxen > Ibuprofen;
- July 2014 Aspirin does not dec CVD risk with Naproxen but does so with COX2 inhibitors!
- May 2014 Too much exercise bad (>5hrs per week at 30y inc risk of AF), or daily exercise inc risk of CVD death.
- June 2014 Inhaled Insulin new approval (Afrezza), Restless Legs Syndrome (Relaxis), DNA testing in colorectal Ca screening (Cologuard)
- Mar 2014 Hep C New drugs – amazing to see new drugs cropping up in this field
October 2015: Doctors are human and can be incentivised by MONEY! I loved this quote as it showed how human doctors really are and they are subject to the same commercial pressures as the rest of the inhabitants of this beautiful planet of ours.”the trend of hospital buying up medical practices is bad for physicians, patients and society.”
Whistleblower Doctor Wins Lawsuit
Last month Broward Health agreed to pay $70 million to settle allegations that it engaged in “improper financial relationships” with doctors under laws prohibiting kickbacks in return for patient referrals. The settlement stemmed from a federal whistleblower lawsuit filed by Michael Reilly, MD, and the US Justice Department against the nonprofit healthcare system. Giving doctors incentives to generate medical revenue is widely deemed unethical because it tempts them to order unneeded treatment or send patients to lower-quality providers. Physicians with a financial interest in a medical facility tend to order more procedures than those who don’t, studies show. Dr. Reilly, a Fort Lauderdale, Florida, orthopaedic surgeon, said the trend of hospital buying up medical practices is bad for physicians, patients and society.
Hospital employment for physicians, as opposed to running independent practices, was a continuing trend this year and can present professional challenges that range from loss of autonomy to pressure to boost productivity.
Sep 2015: More ?amazing medication for the treatment of DM (EMPA-REG trial data)- : Empagliflozin shows reduction in CVD risk, a SGLT-2 inhibitor (SodiumGLucoseTransport Inhibitor) in established CVD disease (i.e. secondary prevention). NNT 39 to reduce one CVD event, mechanism unknown. European trial. But something weird : “38% less likely to die from cardiovascular disease and 32% less likely to die from any cause over the 3 years of the study.But no effect on heart attacks and strokes” ??you get the same no of heart attacks and strokes but the no of fatal ones go down?! and another BUT ” [there was a nonsignificant increase in fatal/nonfatal stroke observed with empagliflozin vs placebo (hazard ratio [HR], 1.18; P =.26)].” … Dr Kaul, is that “we simply don’t know [how it works]. But the mortality benefit we are seeing is virtually double that of a recently approved heart-failure drug….It’s hard to put our finger on it.”
Landmark Trial Results: EMPA-REG OUTCOME
Patients with type 2 diabetes and established cardiovascular disease receiving the glucose-lowering agent empagliflozin (Jardiance, Boehringer Ingelheim/Lilly), a sodium glucose cotransporter-2 (SGLT-2) inhibitor, were less likely to die than those taking placebo in the large, much-anticipated EMPA-REG OUTCOME study, hailed at a major European diabetes meeting in September as a landmark trial. In the study, 39 patients needed to be treated with empagliflozin for 3 years to prevent one cardiovascular death.
This is the first time a glucose-lowering drug has shown superiority in a cardiovascular-outcomes trial — similar trials with diabetes drugs from other classes have demonstrated only neutrality (ie, cardiovascular safety). Senior author of the study Silvio Inzucchi MD, of the Yale Diabetes Center, New Haven, Connecticut, and the other investigators urged prudence, however, noting that they had only recently seen the results of EMPA-REG and that extensive work is still needed to unravel the mechanisms by which this SGLT-2 inhibitor is exerting its seemingly beneficial effects. In addition, the trial population studied in EMPA-REG — type 2 diabetes patients with existing cardiovascular disease — is not representative of all patients with the condition.
Sep 2015 – Diagnostic error rate: 5% OPD clinic errors – I wonder what the rate is in Primary Care land
Landmark Report Urges Reform to Avert Diagnostic Errors
Little progress has been made in reducing diagnostic errors, which can have fatal consequences, according to a new report. Consequently, “most people will experience at least one diagnostic error in their lifetime, sometimes with devastating consequences.” The report, Improving Diagnosis in Health Care, from the IOM, found that 5% of US adults who seek outpatient care each year receive incorrect diagnoses. Diagnostic errors contribute to approximately 10% of patient deaths. Causes include poor collaboration among clinicians, patients, and their families; a healthcare system that does not support the diagnostic process; limited feedback to clinicians about their diagnostic performances; and a culture that discourages disclosure of errors.
Sep 2015 – SPRINT Trial: 3.5y trial, even tighter controls, but inc risk of CKD induction esp if diastolic also low. Did they stop the trial too early to work out the increased harms at 5 yrs??
SPRINT: More Intensive Blood Pressure Management Saves Lives
A more intensive strategy of blood pressure management reduces the risk for death and cardiovascular events when compared with a strategy that lowers systolic blood pressure to the conventional target of 140 mm Hg, a large study found. In the Systolic Blood Pressure Intervention Trial (SPRINT), investigators reported in a September media briefing that treating high-risk hypertensive adults aged 50 years and older to a target of 120 mm Hg significantly reduced cardiovascular events by 30% and all-cause mortality by nearly 25%. The study, which was funded by the National Institutes of Health, was stopped early because of the benefit of the intensive strategy, according to investigators. However, absolute risk reductions were small and some adverse effects were higher in the intensive-treatment group. The SPRINT investigators said it is too early to speculate on how the results will change clinical practice; the data need to be reviewed and updated guidelines incorporating the results still need to be written.
Aug 2015 – An electronic device for obesity! vBloc – Implantable “pacemaker like” Vagal Blocking Therapy for Obesity – new device to treat obesity – approved by FDA
FDA Approves Novel Device for Treating Obesity
In January the FDA approved a new device for treating obesity. The vBloc vagal blocking therapy is delivered via a rechargeable device implanted into the chest wall. It intermittently blocks the vagus nerve, reducing hunger and increasing feelings of satiety. The first-of-kind device, made by EnteroMedics, is for the treatment of obese adults who have tried and failed at least one supervised weight management program within the past 5 years. The concept came from the fact that patients who undergo surgical vagotomy experience temporary weight loss. Vagotomy is a procedure once commonly used to treat problematic stomach ulcers. The vBloc therapy is reversible and can be noninvasively adjusted or turned off when necessary.
Separately, the FDA also approved two minimally invasive gastric balloons for weight loss this year, the ReShape Dual Balloon (ReShape Medical) in July and the Orbera Intragastric Balloon System (Apollo Endosurgery) in August.[47,48]
Jun 2015 – Will the monoclonal Antibodies change the face of medicine? FDA Approved a once monthly subcutaneous PCSK9 Inhibitors: AliroCUMAB, evoloCUMAB . They can reduce LDL by 70%. Expensive for now. Trial data awaited.
FDA Approves PCSK9 Inhibitors for Treating High Cholesterol
This summer, the US Food and Drug Administration (FDA) approved two drugs in a new drug class that is expected to be a game-changer in managing cholesterol. The drugs are alirocumab (Praluent, Sanofi/Regeneron) and evolocumab (Repatha, Amgen).[21,22] The two new drugs, which are proprotein convertase subtilisin kexin 9 (PCSK9) inhibitors, differ from statins in their mechanism and mode of delivery. Statins have been the most recent means of lowering LDL-cholesterol levels. The PCSK9 inhibitors have potential to change the way physicians treat and manage a wide range of patients with elevated LDL-cholesterol levels. However, the costs of the drugs have been controversial.[24,25]
May 2015 : Small moving parts are where bacteria hide – Risk of ERCP carriage of bacteria even after sterilisation – cases in USA
FDA Takes Action Against Dirty Endoscopes
The FDA ordered Custom Ultrasonics to recall all of its endoscope reprocessors. Persistent regulatory violations could increase the risk of transmitting infection, the FDA said. The recall is the agency’s latest move to reduce the spread of antibiotic-resistant bacteria via dirty endoscopes, particularly duodenoscopes. In recent years, there have been at least six outbreaks of multidrug-resistant bacteria — some lethal — tied to duodenoscopes, even when the proper reprocessing instructions were followed. The device’s many small, hidden parts make it particularly difficult to clean. The problem topped the 2016 list of healthcare technology hazards identified by the nonprofit ECRI Institute.
Feb 2015 US IOM Starts to believe in ME – at least they have a label for it at last – the power of a label.
01/09/2014 Artificial sweeteners (aspartame, saccharin, sucralose) cause blood glucose abnormalities (in mice) – something to do with the gut microbiome! As humans we have to care about human and bacterial cells, perhaps a new slogan would be: “Don’t forget to feed your friendly germs the right food everyday”. Question: How much time do researchers spend getting the right acronym for their study? Salt in moderation is better than too low the PURE study reported.
Moderate salt better than low salt
Artificial Sweeteners and Salt
Artificial sweeteners made headlines in September, when researchers reported in Nature that aspartame, sucralose, and saccharin cause blood glucose abnormalities in mice and some humans. The changes in glucose tolerance seem to be driven by the gut microbiome and can be reproduced in germ-free mice by giving them gut microbes from a person who has consumed the sweeteners. And the debate on appropriate salt intake rages on: The results of the PURE study were presented at the Word Congress of Cardiology in May and published in an article in the New England Journal of Medicine in August. The PURE article suggests that moderate (as opposed to low) sodium intake may be best for CVD prevention. A separate study on salt reached very different conclusions.
01/07/2014 CVD risk of Naproxen > Ibuprofen; Aspirin does not dec CVD risk with Naproxen but does so with COX2 inhibitors!
Naproxen and Cardiovascular Safety
Regular intake of naproxen entails more CV risk than ibuprofen, according to an analysis of NSAID use among participants in the Women’s Health Initiative. Regular intake of ibuprofen, in fact, did not seem to involve any elevation in CV risk. The analysis, published July 8 in Circulation: Cardiovascular Quality and Outcomes, also saw a complicated relationship between aspirin and most other NSAIDs. It suggested that concomitant aspirin may alleviate the increased CV risk long associated with selective inhibitors of COX-2 such as celecoxib, but not the risk from others, such as naproxen. The study’s publication followed an FDA advisory committee meeting in February in which most of the panel said the data were insufficient to say naproxen has a lower risk for CV thrombotic events than other available NSAIDs.
June 2014 Inhaled Insulin new approval (Afrezza), Restless Legs Syndrome (Relaxis), DNA testing in colorectal Ca screening (Cologuard)
Major Drug and Device Approvals
Two drug and two device approvals made headlines this year: The FDA approved the inhaled human insulin product Afrezza (MannKind, above) to improve glycemic control in adults with type 1 and type 2 diabetes, making needles no longer necessary. The FDA also approved a first-in-class insomnia drug called suvorexant (Belsomra, Merck). The agency also granted clearance of the first device to help improve quality of sleep in patients with restless legs syndrome (Relaxis, Sensory Medical Inc). The FDA approved Cologuard (Exact Sciences Corporation), a stool-based colorectal cancer (CRC) in vitro diagnostic device intended for the detection of colorectal neoplasia–associated DNA markers and for the presence of occult hemoglobin in human stool.
May 2014 Too much exercise bad (>5hrs per week at 30y inc risk of AF), or daily exercise inc risk of CVD death.
Exercise and CVD Risk: Too Much of a Good Thing?
When it comes to exercise, there apparently can be too much of a good thing. In one study published online May 14 in Heart, investigators report that men who exercised for more than 5 hours per week when they were 30 years old had a significantly higher risk of developing atrial fibrillation later in life compared with men who exercised less. In a second study, a separate group of researchers found that those who participated in daily “strenuous” physical activity had an increased risk of dying from cardiovascular causes. An editorial in the same issue notes that both studies are limited by the self-reported measurements of physical activity but still raise important clinical questions.
Mar 2014 Hep C New drugs – amazing to see new drugs cropping up in this field
Flood of New Drugs for Hepatitis C (and High Prices)
Approximately 1% of US residents are infected with chronic hepatitis C virus (HCV), according to findings of a survey published in the March 3 issue of the Annals of Internal Medicine. Several new hepatitis drugs have flooded the global market in 2014, providing promise for making HCV infection a rarity in about 20 years. Simeprevir (Olysio, Janssen Pharmaceuticals) was the third protease inhibitor for hepatitis C to hit the market in November 2013, and it was also approved in Europe in May, but it still needed to be combined with ribavirin and interferon, which could cause serious adverse effects. Sofosbuvir (Sovaldi, Gilead), the first nucleotide analogue inhibitor, was approved in December 2013 and was a component of the first interferon-free regimen. However, its price tag, $84,000 per year, has been controversial.[60-64] The price of a second Gilead drug, ledipasvir/sofosbuvir (Harvoni), which was approved in the United States in October, is even higher, at $94,000 annually, which is causing pharmacy benefits managers and other stakeholders to hope that new drugs from AbbVie and others will be less expensive.