GSK letter to TIDE investigators provokes Avandia critics

A letter describing the July FDA advisory panel on Avandia that was sent by GlaxoSmithKline to TIDE investigators has sparked criticism from some FDA officials and panel members, according to an article by Gardiner Harris in the New York Times….

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Saving time and setting the clock back in STEMI

Efforts to speed delivery of PCI to STEMI patients have focused on shortening the door-to-balloon time. Now a group of Danish researchers propose that efforts to improve care must include assessment of treatment from the time of the patient’s first contact with the emergency medical system. Analyzing historical data from 6209 MI patients who received…

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Debating medical promotion and education

Back in June (Listening to industry: what’s the ROI of medical education?) I commented on some statements made by Bill Cooney, the President & CEO of Medpoint Communications, which is, in its own words, “a global leader in diversified communications services for leading pharmaceutical and biotechnology companies.” Cooney recently commented on my post, and this has provoked…

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CardioBriefs: Red meat, antagonistic people, and chocolate

The following items are republished with permission from CardioExchange, a new website for cardiovascular healthcare professionals from the New England Journal of Medicine. CardioBrief readers who are healthcare professionals are invited to join the site. A Treat for Chocolate Lovers from Sweden In a report that will surely provide comfort to millions, a study of 31,823…

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CRESCENDO: The Fat Lady Sings for Rimonabant

The CRESCENDO (Comprehensive Rimonabant Evaluation Study of Cardiovascular Endpoints and Outcomes) trial testing the effects of the endocannabinoid receptor blocker rimonabant for the prevention of cardiovascular events was terminated early at the request of regulatory agencies in several countries following growing concern at the time that people taking rimonabant were more likely to commit suicide….

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AJC editorial seriously proposes that statins be offered freely at fast food restaurants

At the height of the optimism over statins people used to joke that statins should be put in the water. No one is arguing for that anymore, but now a British cardiologist is proposing– apparently seriously– that statins should be made freely available just like ketchup and other condiments at fast food restaurants. Although the…

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SHAPE shifting: transforming guidelines into a business venture

Earlier this week we reported that SHAPE was preparing to update its controversial guidelines. It now appears that the guidelines are only the public facade of a larger program designed to encourage the growth of, and take a larger share of, the business of cardiovascular screening. Although conflict-of-interest concerns have previously swirled around SHAPE, new…

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Dallas valve meeting withdraws previous statements about its relationship with TheHeart.org

The website for the Dallas-Leipzig International Valve 2010 conference has substantially altered previous remarks about its relationship with TheHeart.Org. (The change was originally reported by Pia Christensen on Covering Health, a blog run by the Association of Health Care Journalists.) As first reported on CardioBrief, here is the description of the relationship as it originally appeared…

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SHAPE getting ready to update its controversial guidelines

The Society for Heart Attack Prevention and Eradication (SHAPE) has announced the formation of a new task force “to refine and update” its earlier published guidelines. The SHAPE Task Force II held its initial meeting on July 30-August 1, according to the organization. Morteza Naghavi is the Executive Chairman of the Task Force, while PK…

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FDA advisory panel will review Meridia (sibutramine) on September 15

A spokesman for Abbott Laboratories has confirmed news reports that the Endocrinologic and Metabolic Drugs Advisory Committee of the FDA will review sibutramine (Meridia) and the SCOUT Study on September 15. (The committee was already scheduled to review the new weight loss drug lorcaserin from Arena Pharmaceuticals on the following day.)…

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At the Dallas valve meeting even the faculty is for sale

[August 6 Update: the Industry Prospectus discussed below has been removed from the DLIV 2010 website. You can download an archived copy here.] Company banners, ads in program books, sponsored badge holders, headrests on buses with company logos– these are just a few of the commercial items to be found at medical meetings these days….

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Medicines Company wins key ruling in effort to extend patent on bivalirudin

The Medicines Company announced today that it had received a major boost in its efforts to extend the patent life of its biggest product, Angiomax (bivalirudin). The company has been engaged in a protracted struggle with the patent office, which had refused to extend the company’s patent on Angiomax because the application had been filed late…

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Calcium and the Law of Unintended Consequences

Dr. Steven Novella finds another story to add to the law of unintended consequences-– calcium supplements and heart disease. …

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Donald Shiley, valve inventor, dead at 90

Donald Shiley, a co-inventor of the Bjork-Shiley heart valve that helped usher in the era of valve replacement surgery, died on Saturday at the age of 90. Shiley initially worked at Edwards Laboratories but then established his own company, Shiley Laboratories, to manufacture artificial heart valves. Developed in cooperation with Viking Björk, a Swedish heart…

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A missing piece of the Multaq puzzle finally appears: DIONYSOS published to little fanfare

The Greek god Dionysos demanded a great deal of attention. When King Pentheus refused to acknowledge the divinity of Dionysos, the god exacted a terrible and bloody revenge, as recounted in the Bacchae, one of the great tragedies of all time. But the new Dionysos is far less demanding. You might even say he’s shy….

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Live-blogging the FDA Brilinta Panel-afternoon session

4:52: Panel is adjourned! The bottom line: the committee voted 7-1 in favor of approving ticagrelor for the indication of STEMI and NSTEMI patients who will be treated either medically or invasively. 4:47: Getting close to the end. Would love to hear any comments or suggestions about this live-blogging experiment. Feel free to add comments…

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Live-blogging the FDA Brilinta Panel-morning session

Click here for the live-blog of the afternoon session. Lunch. Back at 1 PM. 12:05: Temple summarizes the dilemma: this drug doesnt do what it’s supposed to do in the country in which it’s being asked to get approved. Kaul adds that if aspirin is the answer why isn’t this difference also reflected in the…

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Mixed reviews for Brilinta prior to Wednesday’s FDA panel

The reviews are mixed. Five different FDA reviewers had 5 widely diverging views of ticagrelor. Wall Street analyst predictions range from cautious optimism to concern. Barclays Capital analyst Brian Bourdot wrote that “the documents read more favorably in support of approval than we had expected,” while Leerink Swann analyst Seamus Fernandez viewed the documents as…

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Terry Ferguson moves to AstraZeneca

Cardiologist James Ferguson– universally known as Terry– has moved to AstraZeneca. Early in 2008 Ferguson left the Texas Heart Institute and St Luke’s Episcopal Hospital in Houston for the Medicines Company. Ferguson currently lives in New York City….

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FDA finally posts briefing documents for Brilinta (ticagrelor) advisory panel

Updates: 5:30 PM: The FDA doesn’t make it easy for outsiders to wade through all the documents. A good case in point is the ticagrelor package. The main briefing document contains a summary memorandum by the Medical Team Leader, Thomas Marciniak, dated June 29. You could read the whole thing before realizing that a separate…

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DC storm causes delay in release of Brilinta (ticagrelor) briefing materials

Due to a delay related to violent thunderstorms in the Washington, DC area on Sunday, the FDA has been so far unable to post the highly anticipated briefing documents for Wednesday’s advisory panel meeting on ticagrelor (Brilinta, AstraZeneca). The committee is scheduled to discuss the proposed indication of ticagrelor in patients with ACS. The FDA…

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“Is it safe?”

Is it safe? Like the Nazi dentist played by Laurence Olivier in Marathon Man, we all want an answer to the question: is it safe? And like the poor victim played by Dustin Hoffman, you can torture us as much as you want but we can’t answer the question if we don’t have the data….

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FDA refers Avandia panelist conflict of interest case to HHS Inspector General

In the wake of reports earlier this week that some members of the Avandia advisory committee may have had conflicts of interest, the FDA said on Friday that it had referred the case of one panel member, David Capuzzi, to the Health and Human Services Office of Inspector General. The FDA sent CardioBrief the following…

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FDA approves first generic low molecular weight heparin

The FDA has approved the first generic low molecular weight heparin (LMWH) for multiple indications including prevention of deep vein thrombosis (DVT). Approval for the generic enoxaparin version of Lovenox was granted to Sandoz, the generic arm of Novartis, on Friday. Generic forms of enoxaparin and other low molecular weight heparins have been been the subject of…

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JUPITER: HDL doesn’t predict residual risk in statin-treated patients with low LDL levels

HDL has long been recognized as having a strong inverse correlation with cardiovascular events, but a new analysis of the JUPITER trial suggests that it may not predict residual risk in statin-treated patients who have reached very low LDL levels. The new report by Paul Ridker and colleagues appears in the Lancet. Among JUPITER patients…

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