–The Wizard of Oz-themed ball seeks to raise $2 million on the yellow brick road. The American Heart Association’s annual Heart & Stroke Ball will be chaired by John Thero, the CEO of Amarin Corporation, the controversial pharmaceutical company. Amarin manufactures the prescription fish oil product Vascepa for which it is aggressively seeking an expanded indication…
TV Ads Pushed Inappropriate Use of Testosterone
March 21, 2017 by Leave a Comment
–Study: prescriptions spiked in direct response to blizzard of ‘Low T’ ads Television ads for testosterone products were highly successful, leading to dramatic increases in the number of men taking testosterone drugs, according to a new study published in the Journal of the American Medical Association. J. Bradley Layton (University of North Carolina, Chapel Hill)…
Another HDL Therapy Crashes and Burns
March 19, 2017 by 3 Comments
–Failure of pre-beta HDL mimetic puts another nail in the HDL coffin Once again, an HDL-inspired therapy has failed when put to the test in a clinical trial. Although there are still ongoing trials with other HDL-related therapies, most experts now feel that it is time for the field to turn its attention elsewhere and…
Ebbinghaus Study May Help Refute Doctor Google
March 18, 2017 by 3 Comments
–No neurocognitive adverse effects linked to very low LDL levels Reaching very low LDL levels with a PCSK9 inhibitor was not associated with any increase in neurocognitive adverse events, according to the largest and most rigorous study to assess the topic to date. Small and preliminary studies have raised concerns over the possibility of the…
Novel Drug Delivers Long Term Cholesterol Reduction
March 17, 2017 by 1 Comment
A novel drug that dramatically lowers LDL cholesterol and needs to be administered only a few times a year has reached a new milestone. Positive results from a phase II study with the drug, now known as inclisiran, were reported at the American College of Cardiology meeting in Washington, DC and published simultaneously in the…
FOURIER Shows New Cholesterol Drugs Work, But Are They Worth It?
March 17, 2017 by 6 Comments
–Doctors and patients now must wrestle with a modestly effective but expensive drug. As it turns out the PCSK9 inhibitor saga ends not with a bang but a whimper. The results of the highly anticipated FOURIER trial show that the drugs work, though not as powerfully as many had hoped and expected. The question now…
Scott Gottlieb’s Sham Ideology Rejects Clinical Trials
March 14, 2017 by 3 Comments
Donald Trump has nominated Scott Gottlieb to be the next FDA Commissioner. To his credit, Gottlieb is not certifiably crazy like several of the other candidates who were reported to be under consideration for the job. But he is is a deeply conservative ideologue who is determined to reduce the government’s role in healthcare. On two occasions in…
For Scott Gottlieb, Business Trumps Health
March 14, 2017 by Leave a Comment
Donald Trump has nominated Scott Gottlieb to be the next FDA Commissioner. To his credit, Gottlieb is not certifiably crazy like several of the other candidates who were reported to be under consideration for the job. But he is is a deeply conservative ideologue who is determined to reduce the government’s role in healthcare. On two occasions in…
Has Nutrition Science Been Poisoned?
March 9, 2017 by 9 Comments
–The inevitable weaknesses of observational and diet studies “Science is the great antidote to the poison of enthusiasm and superstition,” Adam Smith wrote more than 200 years ago. Unfortunately, it often seems as if the science of nutrition has itself been poisoned. Two recently published papers illustrate this problem. Nutrition and Mortality A good example of…
Top Cardiologist Blasts Nutrition Guidelines
February 27, 2017 by 15 Comments
–Salim Yusuf says new evidence fails to support many major diet recommendations. One of the world’s top cardiologists says that many of the major nutrition guidelines have no good basis in science. “I’m not a nutrition scientist and that may be an advantage because every week in the newspaper we read something is good for…
After Yet Another Failure, Stem Cell Leaders Double Down
February 20, 2017 by 1 Comment
–Could repeated doses of stem cells turn the tide of negative trials? Despite an unrelieved history of negative trials, stem cell leaders continue to defend their field. In response to the failure of yet another cardiac stem clinical trial, Roberto Bolli, a prominent leader in the field, argued that it’s time for a “paradigm shift” in…
International Experts Call Salt Guidelines Far Too Restrictive
February 14, 2017 by 5 Comments
A broad group of international experts are recommending a far more modest and less draconian approach to sodium restriction than current U.S. and international guidelines. In a new paper, published online in the European Heart Journal, they also focused on the broad gaps of knowledge in the field and drew attention to the paucity of…
Enormous Rivaroxaban Study Stopped Early For ‘Overwhelming Efficacy’
February 8, 2017 by Leave a Comment
(Updated) –Oral anticoagulant reduced CV events in patients with coronary and peripheral disease. The very large COMPASS study has been stopped early for “overwhelming efficacy,” according to a press release issued by Bayer AG and Janssen, manufacturers of rivaroxaban (Xarelto). The phase 3 trial randomized 27,402 patients with coronary artery disease (CAD) and peripheral artery…
New Questions Raised About SPRINT
February 8, 2017 by Leave a Comment
More questions are being raised about SPRINT, the enormous NIH-funded blood pressure lowering trial. Two recent developments will likely add more obstacles to the already difficult task of applying the results of the trial in the real world. Even before the full results of the trial were first made public the NIH and the SPRINT…
27,000 Patient PCSK9 Inhibitor Trial Meets Main Endpoints
February 2, 2017 by 3 Comments
(Updated) –Cardiovascular outcomes finally available for PCSK9 inhibitors. Amgen announced on Thursday afternoon that the FOURIER trial had met both its primary composite endpoint (cardiovascular death, non-fatal MI, non-fatal stroke, hospitalization for unstable angina or coronary revascularization) and the even more rigorous key secondary composite endpoint (cardiovascular death, non-fatal MI or non-fatal stroke). The company…
In Which I Go Under The Knife And Learn About Medicine In The Real World
January 27, 2017 by 7 Comments
I’m not a doctor but I thought I knew something about anticoagulation. Over the course of a career covering cardiology I’ve written countless stories about heparin, warfarin, the low molecular weight heparins, and the new oral anticoagulants. So when I had bilateral total knee replacement a few weeks ago I thought I knew what to…
Long Unsuccessful Heart Failure Drug Once Again At Center Of Controversy
January 23, 2017 by 9 Comments
–The long, strange 30-year journey of BiDil. It’s been buried in the avalanche of related news but there’s an interesting and somewhat bizarre cardiology angle to the debate over Trump’s nomination of Tom Price to be the next HHS Secretary. ProPublica reported on Friday that last summer Price went to bat for the makers of…
2016: Great Year Or Greatest Year Ever?
December 21, 2016 by 1 Comment
Editor’s note: Once again Larry was too depressed to write the 2016 yearly review. (Actually, he’s hiding under his bed.) Veteran healthcare journalist and eternal optimist Candide Corn has again kindly agreed to take over the task this year. Candide’s motto is “all is for the best in the best of all possible worlds.” What a great year!…
More Shots Fired in ‘Sugar War’
December 19, 2016 by 1 Comment
–Industry-sponsored study questions current guidelines on dietary sugar. Dietary guidelines relating to sugar— all of which recommend significant reductions in sugar intake— are based on weak evidence and are not trustworthy, according to a systematic review published in Annals of Internal Medicine. But an accompanying editorial points out that the systematic review is itself not…
Novartis Withdraws Support For Controversial Entresto Contest
December 19, 2016 by 3 Comments
(Updated) Novartis will no longer sponsor a contest designed to support the publication of peer review articles about Entresto, the company’s important new heart failure drug. The contest is taking place on Cureus, an open access journal, publishing platform, and vehicle for industry-sponsored content. The contest offered $10,000 in rewards for articles supporting a recent…
Novartis Contest Rewards Positive Peer Review Articles About Entresto
December 15, 2016 by 3 Comments
(See the bottom of the story for updates. Since the original publication of the story the cardiologists on the “peer review panel” have resigned and Novartis has withdrawn its support for the contest.) Despite the fact that it had one of the biggest clinical trial successes in recent years, the Novartis heart failure drug Entresto has…
Seeking Profit and Investors, Rogue Lab Moves Into Small Hospitals
December 9, 2016 by 6 Comments
A controversial new laboratory company specializing in “advanced cardiovascular risk testing” is developing an innovative, highly profitable– and legally dubious– new business model. Details of the scheme are spelled out in a “Management Presentation” slide presentation sent to me by a confidential source. The slide presentation, according to my source, is being shown by executives at True Health…
The GiveAway Act
December 6, 2016 by Leave a Comment
The 21st Century Cures Act should be called the 21st Century GiveAway Act. The Act may not even deliver on its main attraction– the funding of new research– but will instantly definitely give a regulatory boost to a host of special interests, including drug and device makers. As Michael Hiltzik writes in the LA Times,…
Telling People What They Want To Hear: Alt-Med And Donald Trump
December 4, 2016 by 12 Comments
Donald Trump won* the election because he told people what they wanted to hear. Alternative medicine is growing in popularity because it tells people what they want to hear. Of course, there’s a big difference between telling people what they want to hear and actually delivering on those promises. He can say it as often as he…
Prenatal Genetic Test Billing Practices Questioned
November 29, 2016 by Leave a Comment
–Sequenom billed insurance companies $2,760 but let patients pay only $200? Patients who order an expensive prenatal genetic test from Sequenom are being told that they will not be held responsible for the vast majority of the bill if it is denied by insurance. This policy may appear to benefit patients but may be considered a…
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