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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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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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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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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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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No, Pharmascolds Are Not Worse Than The Pervasive Conflicts Of Interest They Criticize

Let’s start with a quick poll:  Which is worse? A. The pervasive influence of industry on medicine, which has undermined the independence and altruism of physicians. B. The critics of industry influence, who have created a paranoid culture of distrust which has undermined the partnership of industry and physicians that has brought medicine to its current heights. If you chose B then you are…

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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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Precision Medicine Approaches Peak Hype

No, Personalized Medicine Isn’t Going To Save $600 Billion Over 50 Years By Preventing Heart Disease The hype over personalized medicine has now reached astonishing new heights.  In an article published in the Lancet, Victor Dzau, the new president of the Institute of Medicine, and coauthors write that personalized and precision medicine (PPM) could deliver hundreds of billions of dollars worth…

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More Evidence Linking Sugared Drinks To Diabetes

A new study uncovers some potentially important new details about the association between sugared drinks and diabetes. In a paper published in Diabetologia [pdf], researchers in the UK report on a study of more than 25,000 adults. Over the course of more than 10 years of followup 847 participants went on to develop diabetes. Instead of relying on a food…

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Cardiovascular Outcomes With Merck’s Januvia: No Better Or Worse Than Conventional Care

Late Monday afternoon Merck released the top line results of TECOS, the cardiovascular outcomes trial with its blockbuster diabetes drug Januvia (sitagliptin).  The company said that the trial “achieved its primary endpoint of non-inferiority for the composite cardiovascular (CV) endpoint.” Merck announced only one additional detail: “Among secondary endpoints,” they reported, “there was no increase in hospitalization for…

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