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?”

marathon-man1

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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FDA puts TIDE on “partial clinical hold”

The FDA has put the controversial Avandia safety trial TIDE on “partial clinical hold.” The action means that new patients may not be enrolled in the trial until the FDA gives the green light. Patients already enrolled in the trial will continue to participate in the trial. In its statement the FDA said it had…

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Guest post: Prophylactic ICDs may not benefit women…

(The following guest post is reprinted with permission from the blog of Dr John Mandola, an electrophysiologist in Louisville, KY.) The heart of a woman may be much different than that of a man. The “Go Red” campaign would surely agree.  As would most masters of the obvious. But in the case of whether female hearts garner the same…

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2 Avandia panel members found to have received money from GSK and Takeda

[This is an update of an earlier story.] At the Avandia panel last week the FDA said it had carefully reviewed disclosure statements from all potential panel members and that all 33 voting members had no relevant conflicts. But two panel members, it now turns out, had received speaking fees, one from GlaxoSmithKline and one…

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Avandia panel member received speaking fees from GSK

This post has been updated and replaced with the following story: 2 Avandia panel members found to have received money from GSK and Takeda…

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Avandia aftermath: who are the winners and losers?

Responses to the Avandia panel have been all over the map, as cleverly noted on the Wall Street Journal health blog. Avandia is “dead” (Forbes), or, perhaps worse, “now a Zombie” (BNET). By contrast, others thought the panel granted Avandia a “reprieve” (Wall Street Journal and that Avandia would now probably be allowed to stay on…

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Cleveland Clinic retains top position on USN&WR list of top heart hospitalis

US News & World Report has published its annual “Best Hospitals” list. Once again, the Cleveland Clinic is the top hospital for heart and heart surgery. Johns Hopkins, third on the list of heart hospitals, retained its position as the top hospital overall. Here are the top 10 hospitals for heart and heart surgery:…

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FDA announces safety review of ARBs and cancer

The FDA announced today that it was conducting a review of angiotensin receptor blockers (ARBs) following the recent publication (CardioBrief story here) of a metaanalysis last month in the Lancet by Sipahi and colleagues that found a modest but statistically significant increase in the risk of cancer associated with the use of ARBs. The FDA states…

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Dick Cheney receives an LVAD

Former Vice President Dick Cheney received a left ventricular assist device (LVAD) last week, according to reports in USA Today, the Wall Street Journal, and MSNBC. “A few weeks ago, it became clear that I was entering a new phase of the disease when I began to experience increasing congestive heart failure. After a series of recent tests and…

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GSK issues statement in response to FDA Avandia Panel

Here’s the statement:…

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Day 2 of the FDA Avandia Panel: Live Blogging the End

Meeting Adjourned. 4:33: Konstam: I don’t get him. He’s defended rosi for 2 days and then votes E. Now he votes against TIDE but says it should be cont’d. 4:29: Would love feedback from readers about this live-blogging experiment. This is my first time doing it. Fun but exhausting. Did you find it useful? Any…

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Day 2 of the FDA Avandia Panel- Live Blogging the Morning

NOON: LUNCH BREAK 11:59: Marciniak claims RECORD suffers from “differential informative censoring”– a great way to influence mortality statistics! 11:57: Marciniak says the problem in reporting events was NOT at the sites, it was from the middlemen. Says GSK tried to influence adjudication. 11:50: GSK clarifying concerns about RECORD.  Nearly all diabetes trials are open…

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Day 1 of the FDA Avandia Panel: Live Blogging the Afternoon

6:21: Kaul winds up to deliver a knock-out punch to the Nissen meta-analysis but Nissen pulls a judo move and turns the question around. Admitting his methodology and data are weak he asks: “who’s fault is it that there’s no better data?” After 11 years on the market GSK can only blame itself if there’s…

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Day 1 of the FDA Avandia Panel- Live Blogging the Morning

The afternoon will be blogged in a separate post. Lunch break until 1 PM. 12:05: Ungar: to answer the malfeasance question we may have to audit the entire trial 12:02: Kaul: Did Marciniak unearth malfeasance in RECORD? How many missing MIs in RECORD were biomarker-only or clinical events? 11:59: Ungar says he is concerned about…

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NY Times: GSK concealed negative Avandia study

Update: The Senate Finance Committee has released its letter to FDA leaders and documents it unearthed about the missing Avandia trials. GSK issued a response. GSK began a study comparing the safety of rosiglitazone (Avandia) to pioglitazone (Actos) back in 1999 and spent the next 11 years keeping the study a secret, according to a report…

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