No Increase In Diabetes Found With Ezetimibe In IMPROVE-IT

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A new analysis of the IMPROVE-IT trial found no significant increase in the rate of new onset diabetes in patients taking ezetimibe. Michael Blazing of Duke University presented the results of the IMPROVE-IT substudy on Tuesday afternoon at the European Society of Cardiology meeting in London. The analysis was prompted by previous findings from very…

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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

ALN-PCS

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

Repatha

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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Ignorance, Cardiology, And The Milky Way Galaxy

This is NOT a photo of the Milky Way Galaxy (Wikimedia Commons)

Question: How is the Milky Way Galaxy like cardiology (and the rest of medicine and science)? Answer: Sometimes we think we know a lot more about them than we really do. I remember staring at the page of my third grade science textbook. We were learning about astronomy and the Milky Way galaxy. There was…

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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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Cookie Monster, Free Lunch, And The New England Journal Of Medicine

Cookie Monster

In its efforts to defuse the conflict of interest issue the New England Journal of Medicine keeps setting off new explosions. The recent series of articles by Lisa Rosenbaum in the New England Journal of Medicine about conflict of interest issues provoked a storm of debate, including a powerful response from three former NEJM editors (and my own more eccentric response). Now NEJM itself has published…

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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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Doctor Scorecards: The Wrong Answer To The Right Question

ProPublica’s recent publication of a Surgeon Scorecard has drawn intense criticism from many doctors. Without going into details here, I think it’s fair to say that many of the critics’ points are valid. Even its strongest defenders agree that the Scorecard is far from perfect. I’m not sure I have much to add to the discussion…

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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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Can You Test A Drug And Also Say Negative Things About It?

In my last post I raised the possibility that Steve Nissen, a highly influential cardiologist who has been an outspoken critic of industry influence in medicine, might have his own conflict of interest (COI) problem. In response, another cardiologist, James Stein, said that my post was unfair in its treatment of Nissen and failed to…

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Steven Nissen, Conflicts Of Interest, And The New Cholesterol Drugs

(Updated) Does Steve Nissen, an outspoken critic of inappropriate industry influence in medicine, have his own conflict of interest problem? This week Nissen, the chief of cardiology at the Cleveland Clinic, was widely quoted in news reports about the FDA advisory panels evaluating two new highly promising cholesterol drugs from Amgen and Sanofi/Regeneron. Nissen was broadly supportive of the drugs….

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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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