FDA’s Gottlieb Preparing To Lower The Bar To Approval

–Shifting the burden of proof from preapproval to postapproval. The new FDA commissioner Scott Gottlieb is quietly and persistently revamping the FDA to make it easier for drug and device companies to get their products on the market. The news, which is being welcomed by industry, also almost certainly means that more people will be…

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Benefits Of Physical Activity Seen Worldwide

–Latest findings from the influential PURE study Observational studies have consistently established a link connecting physical activity and cardiovascular health, but the vast majority of this research has occurred in high-income countries, where physical activity is often recreational. Now the latest report from an enormous worldwide observational study offers powerful evidence that the connection exists…

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What If PCI Is Just A Sham?

–A small study might upset assumptions about the benefits of stent. What if PCI for stable ischemic heart disease (SIHD) is just a big lie? That is, what if it’s no better than a sham procedure? This may seem like a crazy proposition, but there’s at least an outside chance that a small trial coming…

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Cardiac Stem Cell Therapies May Get Boost From New FDA

–The FDA may not require companies to prove that stem cell therapies are safe and effective prior to approval. Cardiac stem cell therapy could gain FDA approval far earlier than most people expect, despite the fact that these therapies have consistently failed to produce any convincing evidence of safety and efficacy. Under the old FDA…

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Julio Palmaz Really Doesn’t Want You To Read This Story

—Raising questions about a trial provokes a ‘cease-and-desist’ letter. The world  stent pioneer Julio Palmaz really doesn’t want you to read this post. After I raised questions about a recent paper involving Palmaz I received a “cease-and-desist” letter from his lawyer. Here is the background to this story: Last year I wrote a brief post…

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Cardiology Is Dead. Long Live Public Health.

Cardiology is dead. Here’s two new important pieces of evidence: The FDA’s Cardiovascular and Renal Drugs Advisory Committee hasn’t met since April 2015, and even then it was for the decidedly uninspiring drug cangrelor. And the committee has no meetings scheduled for the rest of this year. Take a look at the list of late-breaking…

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REVEAL Revealed: A Slightly Positive CETP Inhibitor Trial

—After 3 strikes a CETP inhibitor finally scores. BARCELONA — Finally there is a CETP inhibitor that actually confers more benefit than risk: anacetrapib. The benefit emerged from the Randomized EValuation of the Effects of Anacetrapib through Lipid-modification (HPS3/TIMI55-REVEAL) trial which was presented here at the European Society of Cardiology meeting and published simultaneously in…

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Renal Denervation Resurrected With Modest BP Reduction

–Preliminary results from SPYRAL HTN-Off Med BARCELONA – Renal denervation is back from the dead, but only as a faint shadow of its former self. Initial interim results of the SPYRAL HTN-Off Med study suggest that the new and improved version of renal denervation (RDN) produces a real but very modest reduction in blood pressure….

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CANTOS Validates Role Of Inflammation In Heart Disease

–Modest treatment effect of canakinumab may limit clinical role in heart disease, but strong anti-cancer signal sparks interest. Despite questions about its clinical importance, the CANTOS trial is being hailed by experts for finally validating the role of inflammation in heart disease. The cardiovascular benefits in the trial were real but modest. Even more exciting,…

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New Economic Analyses Fail To Make Case For PCSK9 Inhibitors

(Updated) –PCSK9 inhibitors have ‘the dubious distinction of being the most expensive preventive therapies by far in the history of cardiovascular medicine’ Two new economic analyses conclude that PCSK9 inhibitors are far too expensive to be cost effective. Both studies incorporate data from FOURIER, the first and still the only large cardiovascular outcomes trial with…

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Big Mismatch In Risk Perception Between Heart Failure Patients and Their Physicians

There’s a big discrepancy between the way patients with “advanced” heart failure view themselves and the way their doctors view them, a new study published in JACC: Heart Failure shows. In a cohort of 161 ambulatory patients with advanced heart failure, physicians categorized 111 patients (69%) as being at high risk for urgent transplant, LVAD,…

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Renal Denervation: Back From The Dead Or Deja Vu All Over Again?

  Renal denervation is back. Or not. The failure of renal denervation (RDN) was one of the most spectacular failures in cardiovascular medicine in recent years. Great expectations for RDN appeared to die with the Simplicity-3 HTN trial, the first rigorous test of the technology, which showed that it was ineffective in the treatment of resistant…

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Generic Atenolol in Short Supply

–The latest sign of turmoil in the generic drug marketplace. The widely prescribed beta-blocker atenolol is in short supply around the country. The FDA first reported an atenolol shortage on July 26. According to the FDA website, three companies that manufacture generic atenolol — Mylan, Sandoz, and Teva — say that the cause is a…

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Pharma Phantasy: The $30 Billion PCSK9 Inhibitor Market

–Drug company dreams up a study showing all the benefits and none of the costs or risks of PCSK9 inhibitors. Here’s a pro tip for pushing a drug (or, indeed, any aggressive treatment or screening strategy): focus exclusively on the benefits, even if they are modest at best, and completely ignore side effects and costs….

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Ethical Questions Raised About NIH Blood Transfusion Trial

–Public Citizen says the MINT trial comparing blood transfusion strategies after MI should be halted. Public Citizen is calling for the immediate suspension of a large NIH-sponsored trial comparing blood transfusion strategies after heart attacks. The Myocardial Ischemia and Transfusion (MINT) trial should be halted “because of potentially serious ethical violations,” said the consumer advocacy…

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How Statins Make Some People Crazy

–Intelligent discussion about statins is threatened by zealous partisans. What is it about statins that causes so many people to go crazy? I’m not talking about any pharmacological effect of the drugs. Instead my focus here is on the zealous partisans— both against and in support of statins— who go off the deep end. Unfortunately…

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Nissen Calls Statin Denialism A Deadly Internet-Driven Cult

–“We are losing the battle for the hearts and minds of our patients.” A leading cardiologist has unleashed a blistering attack on “statin denial,” which he calls “an internet-driven cult with deadly consequences.” In an editorial in Annals of Internal Medicine, Steve Nissen (Cleveland Clinic) expresses grave concerns over statistics showing that only 61% of…

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Forthcoming Expert Guideline May Upgrade PCSK9 Inhibitors

Results of the FOURIER trial might bolster the embattled cholesterol drugs.Results of the FOURIER trial might bolster the embattled cholesterol drugs.Results of the FOURIER trial might bolster the embattled cholesterol drugs.Results of the FOURIER trial might bolster the embattled cholesterol drugs.Results of the FOURIER trial might bolster the embattled cholesterol drugs.Results of the FOURIER trial…

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Study Estimates Benefits Of Broad Primary Prevention Strategies With Statins

–But the benefits may be substantially diminished when patient preferences are considered. A new analysis provides staunch support for the use of statins for the primary prevention of cardiovascular disease. But the same analysis also emphasizes that this support varies dramatically based on the values and concerns of individual patients. Kirsten Bibbins-Domingo (UCSF) led a…

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Questions Raised About Trump’s New CDC Boss

–Fitzgerald championed Coke-backed obesity program and practiced ‘anti-aging medicine’ Serious questions are being raised about Brenda Fitzgerald, MD, the Georgia doctor who Trump is appointing to be the new head of the CDC. Fitzgerald is an ob/gyn with long involvement in Republican politics in her state. She currently serves as the Commissioner of the Georgia…

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Labscam: Rogue Laboratory Testing At Center Of Addiction Treatment Scandal

–‘Sober homes’ in Florida are just the tip of the iceberg. A massive scandal involving fraudulent addiction treatment centers and rogue laboratories has recently surfaced. Several recent news reports have focused on the scandal’s epicenter in Florida, but industry observers say that the scandal is the tip of an iceberg of corruption, abuse, and fraud…

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Merck Reveals Positive Findings For Its CETP Inhibitor

–Surprising success after 3 previous drugs in the class failed. Merck announced on Tuesday that the REVEAL trial with anacetrapib had met its primary endpoint, significantly reducing the rate of coronary death, MI, and coronary revascularization in high risk patients already taking statins. Full results of REVEAL will be presented on August 29 at the European…

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Does Whole Genome Sequencing Have A Role in Primary Care?

–Pilot study confirms feasibility, but clinical value for healthy-seeming people is not obvious Whole genome sequencing (WGS)may one day play an important role in routine medical practice. But the results of a small study suggest that WGS, though perhaps promising, is certainly not ready for prime time. The price of WGS has dropped spectacularly in…

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My Beef With The AHA’s Saturated Fat Recommendations

–We shouldn’t forget the unintended consequences of dietary recommendations.    The American Heart Association’s position on saturated fat pretends to be science-based but is not, writes Gary Taubes, in a brilliant and wildly popular guest post published here on CardioBrief late last week. The AHA’s statement, which recommends that saturated fats be replaced with polyunsaturated…

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Guest Post: Vegetable Oils, (Francis) Bacon, Bing Crosby, And The American Heart Association

–Gary Taubes responds to the AHA presidential advisory on dietary fats. Editor’s note: I was planning to write about the American Heart Association’s new statement about dietary fats so I asked Gary Taubes for a brief quote. Taubes, of course, is an investigative science and health journalist who has written three major books (Good Calories,…

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