Califf, Nissen, And Others Agree And Disagree About Regulatory Standards

Califf

Everyone agrees. A panel of US and European cardiologists, regulators, and industry executives agreed broadly that regulatory standards for drugs and devices need to be rigorous enough to prevent harm to patients. And, they also agreed, the standards shouldn’t be so strict that they stifle innovation. The problem, of course, is how to find the right…

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IMPROVE-IT Substudy: Ezetimibe Benefit Restricted To Diabetics

The beneficial effects of ezetimibe are found almost exclusively in  patients with diabetes, according to an update of the influential IMPROVE-IT trial presented on Sunday at the European Society of Cardiology meeting in London. The new finding may lead to questions about the widely accepted interpretation of the main finding of the trial, which is that it provided strong support for…

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Novel Drug Could Cut LDL With Just 2 Or 4 Shots A Year

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A novel drug still in phase 1 studies could dramatically lower cholesterol with only a few injections each year. Because the drug could be given during regular visits to the doctor it might help solve the thorny problem of drug compliance and adherence. Like the recently approved monoclonal antibodies alirocumab and evolocumab, the drug targets PCSK9 to lower LDL,…

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Hot Lines, Simultaneous Publications, And The Decline Of Medical Meetings

Back in the Dark Ages when I covered big medical conferences (like the European Society of Cardiology meeting now getting underway in London) it was necessary to attend the sessions, roam the halls, and talk to doctors. There were no late-breaking or hot line sessions and there were certainly no simultaneous publications in journals. (If memory…

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Cholesterol Wars: The Reimbursement Battle Begins

(Updated) The next stage of the cholesterol wars has officially started. With the recent approval of Repatha (evolocumab, Amgen) and Praluent (alirocumab, Sanofi and Regeneron) the big immediate question everybody wanted answered was how the battle to pay for these expensive drugs (the wholesale acquisition cost is more than $14,000/year for both drugs) would shape…

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ESC 2015 Set To Start In London

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The European Society of Cardiology meeting starts this weekend in London.   Merrie Olde Englande?   Industry will be here too.  …

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FDA Approves Repatha, Amgen’s PCSK9 Inhibitor

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Late on Thursday Amgen announced that the FDA had approved its highly anticipated and much debated PCSK9 inhibitor, Repatha (evolocumab). The drug will be the second PCSK9 inhibitor on the market, following the approval last month of Sanofi’s and Regeneron’s  Praluent (alirocumab). In a press release the FDA said Repatha “is approved for use in addition to diet…

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Labor Union Targets American Heart Association For Financial Conflicts

Unite Here, a labor union with 270,000 members, is attacking a surprising target, the American Heart Association. A report released by the group— entitled “Is the American Heart Association for sale?”– cites multiple examples of financial conflicts of interest involving prominent leaders of the organization. Among the major accusations in the report: Robert Eckel, a former AHA president…

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FDA Approval Of Second PCSK9 Inhibitor Expected Soon

The FDA has until Thursday, August 27 to make its decision about Repatha (evolocumab), Amgen’s much anticipated cholesterol lowering PCSK9 inhibitor. The drug is widely expected to gain approval. Last month the FDA approved Praluent (alirocumab), Sanofi’s and Regeneron’s similar drug. Beyond approval the major questions that should be answered this week concern the drug’s label…

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All The Woo That’s Fit To Print: An Open Letter To The New York Times Public Editor

Dear Public Editor, Why does the New York Times continue to allow fashion and style reporters to write stories that contain preposterous scientific and medical statements without providing any outside perspective from, say, real scientists or doctors? A recent and egregious case is “Sound Baths Move From Metaphysical to Mainstream” by Sophia Kercher  (August 15, 2015), which repeats a string of…

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Wow! Maybe– Finally– A Positive Diabetes Drug Outcomes Trial

Until now the best thing anyone could say for sure about all the new diabetes drugs was that at least they didn’t kill people. That’s because although these drugs have been shown to be highly effective in reducing glucose levels, a series of large cardiovascular outcomes trials failed to provide any evidence of significant clinical…

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Farewell To Forbes: No, I Am Not Dr Oz, Nor Was Meant To Be

Note to readers: The following post was just published on Forbes. As it explains, the content published here will no longer run simultaneously on Forbes.  In case there’s any confusion: I am no Dr. Oz. I am not fantastically good looking, despite what my mother says. I’m not a cardiac surgeon and, of course, I don’t have a wildly popular…

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The Amarin Decision: Free Speech Or Truthiness?

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Amarin, which makes the prescription fish oil product Vascepa, won a big victory last Friday in its ongoing battle against the FDA. The bottom line: a federal judge ruled that the FDA can’t restrict Amarin’s first amendment right to disseminate off-label information about Vascepa providing it is neither false nor misleading. (You can read a detailed description…

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What Role Should Coca-Cola Play In Obesity Research?

The New York Times reports that Coca-Cola gives financial support to scientists and a new foundation to help promote the message that the obesity epidemic is fueled not by too many calories or too much sugar but by not enough physical activity. The Times piece is well worth a read but the issue it takes up is not new.  Last year I wrote a…

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$300 Millions Dollars Of Cardiology Sunshine

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$300 million dollars. That’s how much industry paid to cardiologists and other related healthcare professionals between August 2013 and December 2014… … Click here to read my entire story on MedPage Today….

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Novartis Heart Failure Drug Gains Speedy FDA Approval

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Entresto, Novartis’s novel heart failure (HF) drug, gained FDA approval earlier today. The approval arrived 6 weeks ahead of the drug’s action date. Formerly known as LCZ 696, the drug had already received a fast track designation and an expedited review under the FDA’s priority review program.Novartis said the wholesale acquisition cost of Entresto will be $12.50 per day, less discounts….

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Why The Internet Stinks– Part 1

Sponsored Posting

Like many other bloggers and journalists I get a lot of unsolicited and unwanted pitches. For years I just threw them in the trash. Now I’m going to share some of these gems with the rest of you. Here’s the first installment (click to enlarge):…

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Fact Check: NY Times Heart Disease Series Gets It Right– Mostly

In my opinion Gina Kolata, who writes for the New York Times, is the most extravagantly talented and gifted  health and science reporter working today. Her virtues are abundantly evident in Mending Hearts, a four-part series about several major developments and controversies involving the treatment of heart disease. You should read it right away. You’ll learn a lot….

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Embattled Laboratory Files For Bankruptcy

Health Diagnostic Laboratory, Inc., the embattled lab company, has filed for chapter 11 bankruptcy. The once high flying company, which was founded in 2009 and achieved annual revenue of more than $400 million in a few short years, has been beset by scandal and legal difficulties. Most recently, the US Department of Justice announced that it had reached a…

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Another One Bites The Dust: On The Death Of A Social Media Site For Doctors

Like a certain late lamented parrot, CardioExchange is no more. It has ceased to be. The website was started by the New England Journal of Medicine and the Massachusetts Medical Society more than 5 years ago in the wake of the explosive and ubiquitous growth of social media. But the rise of social media also provoked tremendous uncertainty and even anxiety over its role in…

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Novartis’ Summer Blockbuster LCZ696 Gains A Name, Skips An Advisory Panel

Entresto. That’s the brand name Novartis has chosen for LCZ696, its new heart failure drug that is expected to be a blockbuster. The name won’t be final until official confirmation, which comes with FDA approval. But Novartis will introduce the name for the first time this weekend in presentations at the European Society of Cardiology Heart Failure meeting in Seville, Spain. FDA approval of Entresto is expected…

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Diet Drug Study Crashes And Burns In The Wake Of Leaked Results

The ill-fated Light trial, which was supposed to examine the cardiovascular outcomes of the weight loss drug Contrave, a combination of naltrexone and bupropion marketed by Orexigen and Takeda, came to a spectacular halt today. The action was probably inevitable given the extreme controversy generated earlier this year when it became known that Orexigen had widely disseminated results from an early…

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Prominent Harvard Cardiologist Moves To Google X To Head Large Study

Here’s a clear sign of the ascending role of digital/precision/personalized medicine: a prominent cardiologist has left a top academic and clinical position in Boston to run a large, innovative study in Silicon Valley. Jessica Mega was widely perceived as a rising star at Harvard Medical School and the Brigham and Women’s Hospital. She has now joined Google X, Google’s research arm,…

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Secret Letter To Doctors Shows That The Amarin Lawsuit Is About Marketing, Not Free Speech

A confidential letter sent by top Amarin executives to doctors clearly demonstrates that the primary motive for the lawsuit the company filed yesterday against the FDA has far more to do with marketing than free speech. Amarin said it is suing the FDA to gain the right to disseminate information about Vascepa that would support use…

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Inside The Scandal: Profit And Greed At An Embattled Laboratory Company

How does a clinical laboratory company grow in a few short years from nothing to more than $400 million in revenue and over $100 million in profit? Since the same company just settled with the DOJ for as much as $100 million, it’s reasonable to suspect that growth was probably not entirely legitimate. Now new information,…

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