Cost Effectiveness Of Entresto And CardioMEMS Evaluated
The new Novartis heart failure drug Entresto (the combination of sacubitril and valsartan, formerly known as LCZ696) is cost effective but the CardioMEMS monitoring system (St. Jude Medical) is not, according to draft reports issued last week by the Institute for Clinical and Economic Review (ICER). The same organization released a widely discussed report about the cost...Click here to continue reading... (Source: CardioBrief)
Source: CardioBrief - September 14, 2015 Category: Cardiology Authors: Larry Husten Tags: Heart Failure Policy & Ethics CardioMems cost effectiveness Entresto ICER LCZ 696 Source Type: blogs
Praluent, the Next Expensive "Game Changer," Blockbuster," "New Hope," - But Not Yet Shown to Benefit Patients
ConclusionsThe NEJM study was accompanied by an editorial by Stone and Lloyd-Jones(2) which documented that drugs previously shown to lower cholesterol were never proved to do any good for patients, and concluded,it would be premature to endorse these drugs for widespread use before the ongoing randomized trials, appropriately powered for primary end-point analysis and safety assessment, are available. After an FDA advisory committee recommended approval of aliromucab and another PCSK9 inhibitor in June, 2015, John Mandrola entitled a Medscape article,Dear FDA: Resist the Urge on PCSK9 DrugsHis reasons included lack o...
Source: Health Care Renewal - August 5, 2015 Category: Health Management Tags: aliromucab evidence-based medicine health care prices manipulating clinical research PCSK9 inhibitor Praluent Regeneron Sanofi-Aventis Source Type: blogs
Entresto: Blockbuster, or Just Over Hyped? - Whatever, It Will Cost $4500 a Year
The newest drug for congestive heart failure, Entresto, a fixed combination of valsartan and sacubitril, has just hit the market at an elevated price. Like other drugs recently introduced as blockbusters, the high price does not seem clearly justified by clinical evidence about the drug's benefits and harms. Questions Raised by the One Big Published Controlled Trial Last year, we discussed the hoopla around a study of a new drug for congestive heart failure (CHF),(1) a fixed combination of valsartan and sacubitril. Also, on the now defunct CardioExchange blog, Dr Vinay Prasad discussed the same study (look her...
Source: Health Care Renewal - July 30, 2015 Category: Health Management Tags: CHF clinical trials Entresto evidence-based medicine manipulating clinical research Novartis sacubitril Source Type: blogs
Why don’t some parents believe the safety of vaccines?
As a medical student, I strongly support vaccination. It works, it’s safe, and it doesn’t cause autism. But I also understand why many parents don’t believe me and the medical community when we beg them to vaccinate their kids.
Medicine has come a long way from “do no harm.” Now we talk about risks and benefits: and none of our tests, medicines, or procedures are without risks. Increasingly, pharmaceutical companies have been caught concealing those risks from doctors and the public.
Around 2000, Merck (the manufacturer with a monopoly on the MMR vaccine that protects against measles) ...
Source: Kevin, M.D. - Medical Weblog - February 28, 2015 Category: Journals (General) Authors: Vamsi Aribindi Tags: Meds Pediatrics Source Type: blogs
Medications After a Heart Attack
From: www.secondscount.orgYour heart attack recovery will include medications. Taking these medications exactly as prescribed is one of the best tools at your disposal for avoiding death in the months following a heart attack. According to an article published in Circulation, the journal of the American Heart Association, heart attack patients who had not filled any of their prescriptions within 120 days of being discharged from the hospital had 80 percent greater odds of death than those who filled all of their prescriptions.Medications you are likely to be prescribed after a heart attack fall int...
Source: Dr Portnay - January 23, 2015 Category: Cardiology Authors: Dr Portnay Source Type: blogs
An Emerging Consensus About Novartis’s New Potential Blockbuster
Last year it became clear that Novartis had a potential blockbuster with its new heart failure drug, LCZ696, which is an angiotensin receptor- neprilysin inhibitor (ARNi) consisting of the company’s own well-known angiotensin receptor blocker valsartan (Diovan) and a novel compound, the neprilysin inhibitor sacubitiril. The results of the PARADIGM trial, which was stopped early because of a large and highly significant reduction in cardiovascular mortality, electrified the cardiovascular community. But the trial also sparked a lot of controversy when skeptics raised questions suggesting that the results wer...
Source: CardioBrief - January 7, 2015 Category: Cardiology Authors: Larry Husten Tags: Heart Failure People, Places & Events Policy & Ethics hypertension LCZ696 Novartis PARADIGM Source Type: blogs
Cardiology MCQ: Add on therapy in heart failure
Preferred add on therapy in heart failure,
to ACE inhibitors and beta blockers:
a) Angiotensin receptor blocker
b) Mineralocorticoid antagonist
c) Renin antagonist
d) None of the above
Correct answer: b) Mineralocorticoid antagonist
Mineralocorticoid antagonist like spironolactone or eplerenone is the add on therapy in heart failure to angiotensin converting enzyme inhibitors (ACEI) and beta blockers in the management of heart failure. Spironolactone has been shown to reduce myocardial fibrosis and corrected QT interval (QTc) [Wong KY et al. Myocardial fibrosis and QTc are reduced following treatment with spironolactone or...
Source: Cardiophile MD - November 29, 2014 Category: Cardiology Authors: Prof. Dr. Johnson Francis, MD, DM, FACC, FRCP Edin, FRCP London Tags: Cardiology MCQ DM / DNB Cardiology Entrance Source Type: blogs
Japan Pharmaceutical Companies Release Their Own "Sunshine" Data
The Japanese pharmaceutical industry has been tracking and reporting transfers of value to healthcare professionals and academic centers based in Japan. In this article, we walk through the provisions of the Japanese transparency guideline before looking at the payment data and corresponding news stories surrounding the recent release of that data.
JPMA Transparency Code
The Japanese Pharmaceutical Manufacturers (JPMA) approved the “Transparency Guideline for the Relation between Corporate Activities and Medical Institutions,” in 2011. The voluntary code states that JPMA member companies and member companies’ affilia...
Source: Policy and Medicine - November 18, 2014 Category: American Health Authors: Thomas Sullivan Source Type: blogs
Cardiology MCQ 324: Add on therapy in heart failure
Preferred add on therapy to ACE inhibitors and beta blockers in heart failure:
a) Angiotensin receptor blocker
b) Mineralocorticoid antagonist
c) Renin antagonist
d) None of the above
["Click here for the answer with explanation", "Correct Answer:"]
b) Mineralocorticoid antagonist
Mineralocorticoid antagonist like spironolactone or eplerenone is the preferred add on therapy to angiotensin converting enzyme inhibitors (ACEI) and beta blockers in the management of heart failure. Angiotensin receptor blockers (ARB) and renin antagonist (e.g. aliskiren) are not preferred. ARBs with proven benefit in heart failure like ...
Source: Cardiophile MD - September 28, 2014 Category: Cardiology Authors: Prof. Dr. Johnson Francis MD, DM, FACC, FRCP Edin, FRCP London Tags: Cardiology MCQ DM / DNB Cardiology Entrance Source Type: blogs
Japanese Research Scandal Involving Novartis Blood Pressure Drug Widens
The Japanese scandal over research using the Novartis blockbuster hypertension drug Diovan (valsartan) continues to widen. The first major figure brought down in the scandal was Hiroaki Matsubara, a prominent cardiologist and researcher at Kyoto Prefectural University in Japan, who resigned from his position after numerous retractions and investigations. Then last year accusations surfaced about another prominent researcher, Issei Komuro, a professor at Chiba University. Chiba University has now completed an investigation of one of Komuro’s most important papers, the 2011 report of the Valsartan Amlodipin...
Source: CardioBrief - September 11, 2014 Category: Cardiology Authors: Larry Husten Tags: People, Places & Events Policy & Ethics Diovan Komuro Matsubara Novartis valsartan Source Type: blogs
Logical Fallacies in Defense of the PARADIGM - HF Trial of Valsartan - Sacubitril, Suppsedly the "Game Changer" for Heart Failure
We frequently discuss how commercial sponsors manipulate clinical research to serve their interests. There have been many cases of commercially sponsored controlled trials ostensibly designed to assess their sponsors' products manipulated to make these products look better.Unfortunately, often such manipulation seems to escape public notice. What skepticism they may generate often gets little notice, an example of the anechoic effect. Very rarely do the people responsible for the trial deign to address skeptical criticism. However, we recently noted that cogent criticism of a very recently published ...
Source: Health Care Renewal - September 5, 2014 Category: Health Management Tags: anechoic effect conflicts of interest logical fallacies manipulating clinical research Novartis sacubitril Source Type: blogs
Sacubitril - Valsartan, a "New Threshold of Hope" or Hype for Heart Failure?
Summer must be over, because the next new blockbuster drug appears to be here. At the end of August, the media heralded the results of a study of a new product for congestive heart failure (CHF) from Novartis.Novartis' New "Game Changer" The New York Times article was fairly restrained, simply saying ithas shown a striking efficacy in prolonging the lives of people with heart failureThe Reuters article's headline saidNew Novartis drug may upend heart failure treatmentIn Forbes, Matthew Herper called it aGame ChangerThe accompanying editorial in the New England Journal of Medicine (1) suggested the drugmay well repres...
Source: Health Care Renewal - September 3, 2014 Category: Health Management Tags: CHF clinical trials evidence-based medicine manipulating clinical research Novartis sacubitril Source Type: blogs
MKSAP: 68-year-old woman with exertional leg discomfort
Test your medicine knowledge with the MKSAP challenge, in partnership with the American College of Physicians.
A 68-year-old woman is assessed for a 6-month history of progressive exertional leg discomfort, described as a “heaviness” involving both calves. The symptoms are relieved within 5 to 10 minutes of rest. She has noted the same limiting heaviness with bicycling. Medical history is significant for hypertension, type 2 diabetes mellitus, and hyperlipidemia; she does not smoke cigarettes. Medications are valsartan, hydrochlorothiazide, metformin, and rosuvastatin.
On physical examination, the patient is ...
Source: Kevin, M.D. - Medical Weblog - July 26, 2014 Category: Journals (General) Authors: mksap Tags: Conditions Heart Source Type: blogs
Tokyo prosecutor to charge Novartis Japan unit as well as ex-employee
over manipulating data
(Reuters) - Tokyo prosecutors said on Tuesday they will charge the Japanese unit of Novartis AG and a former employee in connection with allegations of data manipulation in promoting its best-selling blood pressure drug Diovan.The prosecutors office said in a statement that it had decided to arrest Nobuo Shiraishi on allegations he gave false data to researchers whose work was used for advertising. Shiraishi was initially detained in June.The prosecutor also said that Novartis Pharma KK, the Swiss drugmaker's wholly owned local subsidiary, will be charged in connection with the case under a provision that alleges responsib...
Source: PharmaGossip - July 1, 2014 Category: Pharma Commentators Authors: insider Source Type: blogs
Former Novartis Japan Employee Held for Data Manipulation
A former employee of Novartis AG (NOVN)’s Japanese unit was arrested in Tokyo on charges of manipulating data on a drug study, the latest setback for the pharmaceutical company in the country.Nobuo Shirahashi, who was a director of the unit’s scientific affairs department, violated pharmaceutical law by understating side effects in a study that evaluated hypertension drug Diovan’s efficacy in cutting stroke risk and getting researchers to publish it, the Tokyo prosecutors office said in a faxed statement today.Shirahashi couldn’t be reached and Novartis Japan declined to make contact information for him or his...
Source: PharmaGossip - June 11, 2014 Category: Pharma Commentators Authors: insider Source Type: blogs
