Should Physicians Be Business Partners With Medical Device Salesmen?

Should a Florida cardiologist co-own a business running frozen yogurt shops with a medical device salesman? That’s the question raised by reporter John Dorschner in a story posted by the Miami Herald yesterday:   “Mark Sabbota, a Hollywood cardiologist, regularly implants $5,000 pacemakers in patients at Memorial hospitals in South Broward — generating, last year alone,…

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European Heart Journal Retracts Main Paper Of The Kyoto Heart Study

The editors of the European Heart Journal have retracted the 2009 paper reporting the main results of the Kyoto Heart Study, a randomized, open-labeled study testing the add-on effect of valsartan to conventional therapy in high-risk hypertension. The retraction notice gave no details about the problems that led to the retraction. Here is the full text…

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No Sunshine For Continuing Medical Education

After many long delays, CMS today released the final details of the Sunshine Act. Starting next September all pharmaceutical and device companies will be required to publicly report payments made to US physicians.   However, there is at least one very major exception to this requirement. Although the initial draft of the rules stated that…

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Trials Of Niacin And Atrial Fibrillation Device Will Headline American College Of Cardiology Program

Two big trials will highlight this year’s American College of Cardiology meeting in March in San Francisco. First is the PREVAIL trial testing Boston Scientific‘s long-anticipated Watchman left atrial appendage closure device for stroke prevention in patients with atrial fibrillation. Second is  the detailed presentation of the controversial failed HPS2-THRIVE trial of extended-release niacin and laropiprant. Read my…

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UK Politician Urges More Use Of Ticagrelor To Preserve AstraZeneca Jobs In UK

Use it or lose it. A UK politician is urging the National Health Service (NHS) to increase use of the antiplatelet drug ticagrelor (trade name Brilinta in the US, Brilique and Possia in the EU) in order to prevent the loss of British jobs. Like nearly all the major pharmaceutical companies, AstraZeneca has been fighting…

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Two Retractions For Embattled Chief Investigator Of Kyoto Heart Study

The editor of Circulation Journal, the official journal of the Japanese Circulation Society (and not to be confused with the American Heart Association’s better known Circulation) has announced the retraction of two substudies from the Kyoto Heart Study. The papers, according to the editor, “contain a number of serious errors in data analysis.” Read my entire…

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New York Post Disavows Portions Of Article About Jeffrey Moses

The New York Post has substantially disavowed significant portions of an October 22 news story about Jeffrey Moses. The story contained allegations that the well-known interventional cardiologist had tested positive for cocaine but was allowed to continue performing procedures at New York-Presbyterian Hospital. Now, the Post says, allegations of cocaine use were “subsequently proven to be conclusively false…

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HPS2-THRIVE: No Benefit, Signal Of Harm For Niacin Therapy

The largest-ever study of niacin has failed to show a clinical benefit for niacin and even found a strong signal of harm. Merck announced today that the HPS2-THRIVE (Heart Protection Study 2-Treatment of HDL to Reduce the Incidence of Vascular Events) study did not meet its primary endpoint. In that study, the combination of a statin and Merck’s niacin compound, Tredaptive, a combination of extended-release…

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Promising One Year Results For Renal Denervation In Resistant Hypertension Spark Hype

Denervation of the renal sympathetic nerve may become an important new tool in the fight against resistant hypertension.  Previously, the main results of the Symplicity HTN-2 trial demonstrated that in selected patients renal denervation resulted in a large and highly significant reduction in systolic blood pressure (BP) at six months. Now, longer followup from the trial, published…

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Amgen Pleads Guilty To Misbranding Anemia Drug Aranesp

Biotechnology giant Amgen today pleaded guilty in federal court to a misdemeanor charge of misbranding Aranesp (darbepoetin alfa), its highly successful anemia drug. The government accused Amgen of marketing Aranesp for indications not approved by the FDA and other illegal marketing practices. The judge deferred a decision on the plea until Wednesday. When the final settlement…

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JACC Issues Notice of Concern Over Three Poldermans Papers

The editors of the Journal of the American College of Cardiology have issued a “Notice of Concern” over three JACC articles in which Don Poldermans, the disgraced Dutch researcher, served as the first or the last author. The editors relied on the report of the investigation committee at Erasmus Medical Center published in October. In each case the…

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Following Earlier Recall, Ranbaxy Halts Manufacturing Atorvastatin

Ranbaxy, the often-troubled manufacturer of generic drugs, will temporarily stop manufacturing generic atorvastatin. On November 9, 2012 the company announced a voluntary recall of some lots of atorvastatin because of possible contamination with glass particles. An FDA statement today said that Ranbaxy will discontinue making the drug “until it has thoroughly investigated the cause of the…

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Yet Another Look At The Transcendental Meditation Paper

Editor’s note: Below are two responses to Robert Schneider’s defense of his Transcendental Meditation paper, which Schneider wrote in response to my earlier article about the publication of his paper.  In the first part I respond to some of the general issues raised by Schneider. The second part, from Sanjay Kaul, addresses the statistical issues discussed by…

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From Barack To Rupert, A Thanksgiving Message

Sorry for this off-topic post, but I couldn’t resist sharing this email message forwarded from a friend in Washington, DC: Thanksgiving Day, The White House Dear Rupert, I thought on this day in particular it would be appropriate for me to send a brief note expressing my gratitude for all that you did for us over…

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Investigator Defends Controversial Transcendental Meditation Paper

Editor’s Note: Here is a response by Dr. Robert Schneider to my story last week about his controversial paper on Transcendental Meditation that appeared in Circulation: Cardiovascular Quality & Outcomes. I will respond to Dr. Schneider’s post later this week. Response from Dr. Robert Schneider We appreciate the interest in our article published in Circulation: Cardiovascular Outcomes…

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FDA Approves Zilver PTX Drug-Eluting Stent For Peripheral Arterial Disease

The FDA today approved Cook Medical’s Zilver PTX stent. It is the first drug-eluting stent (DES) approved for the treatment of peripheral arterial disease (PAD) in the superficial femoral and proximal (i.e., above the knee) popliteal artery. The new stent will provide a new treatment option for treating patients with PAD. Current treatments include exercise,…

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Mysterious Disappearing Paper Finally Reappears In Another Journal

Updated– Last year, in what may have been an unprecedented action, a paper on the effects of Transcendental Mediation (TM) in African Americans was withdrawn by the editors only 12 minutes before the paper’s scheduled publication in Archives of Internal Medicine. No definitive explanation was ever provided, though the editors and authors said that the action…

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Nine Italian Cardiologists Arrested In Broad Investigation Of Research Fraud And Misconduct

Nine Italian cardiologists have been arrested as part of a broad investigation into serious medical misconduct at Modena Hospital, according to multiple reports in the Italian media. The investigation encompasses at least 67 other individuals and a dozen medical equipment companies, including 6 foreign companies. The charges include conspiracy, fraud, embezzlement, bribery, forgery and performing…

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FDA Investigation Finds No Excess Bleeding Risk For Dabigatran

In its latest assessment of a highly controversial issue, the FDA has found no indication that bleeding rates for dabigatran (Pradaxa, Boehringer-Ingelheim) are any higher than the bleeding rates for warfarin. The FDA investigation was in response to the large number of post-marketing reports of bleeding in people taking dabigatran. Click here to for the…

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L.A. Confidential: Preview Of AHA Scientific Sessions 2012

The American Heart Association scientific sessions, which start next weekend in Los Angeles, will be bigger than ever, with 853 separate sessions– 111 more than last year– and 27 late-breaking clinical trials– 6 more than last year. Elliott Antman, chair of the scientific sessions program committee, provided a preview of some of the highlights of this…

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FDA Panel Recommends Approval Of Mipomersen For Familial Hypercholesterolemia

The FDA’s Endocrinologic and Metabolic Drugs Advisory Committee gave a weak endorsement to mipomersen, an antisense oligonucleotide inhibitor manufactured by Genzyme, for use in homozygous familial hypercholesterolemia (FH). With its relatively close 9-6 vote, and with its comments, the committee expressed concerns about both the efficacy and safety of the drug, but ultimately the severity of…

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FDA Reviewers Recommend Approval For Lomitapide For Homozygous Familial Hypercholesterolemia

The FDA Endocrinologic and Metabolic Drugs Advisory Committee voted 13-2 to recommend approval of Aegerion Pharmaceuticals’ cholesterol-lowering drug lomitapide for use in patients with homozygous familial hypercholesterolemia (FH). The lopsided vote does not completely reflect the views of many of the panel members, who expressed considerable concern  that the drug might be used in lower…

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FDA Review Raises Safety Concerns About Mipomersen

An FDA review raises a number of potentially significant safety concerns about the cholesterol-lowering drug mipomersen. The review appears ahead of a Thursday meeting of the Endocrinologic and Metabolic Drugs Advisory Committee to evaluate Genzyme’s new drug application (NDA) for use of the drug as an adjunct to maximally tolerated lipid-lowering medications and diet to reduce…

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FDA Warns About Fungal Meningitis In Transplant Patient Who Received NECC Cardioplegia Solution

Update (October 16): On Tuesday the FDA revised its initial report and said that only one transplant patient who had received the NECC cardioplegia solution had developed fungal meningitis.  The FDA said on Monday that it had identified two transplant patients with Aspergillus fumigatus infection who received cardioplegia solution during surgery. The solution was manufactured by the…

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Don Poldermans And The Dutch Research Scandal

The publication last week of the final report from the Erasmus Medical Center on the Don Poldermans research scandal in the Netherlands ends the first and most explosive chapter of an ugly episode of scientific misconduct. But there are still many important questions regarding scientific integrity and the culture of medical research raised by the case. And…

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