Bayer says rivaroxaban meets primary endpoint in ROCKET AF Reply

Rivaroxaban (Xarelto) was as effective as warfarin in patients with AF in the ROCKET AF study, according to an announcement released by Bayer on Sunday ahead of the scheduled presentation of the trial at the AHA on November 15.
Click to continue reading, including a perspective from Harlan Krumholz…


Paper on Cardiopulmonary Bypass Priming Retracted; 200 Additional Papers Under Question Reply

The journal Anesthesia & Analgesia, which calls itself “The Gold Standard in Anesthesiology,” has retracted a paper on cardiopulmonary bypass priming and has raised questions about 200 additional published papers by the author, Joachim Boldt, the head of the Department of Anesthesiology and Intensive Care Medicine, Klinikum Ludwigshafen, Bremserstr, Germany. A detailed report about the retraction was first reported by Adam Marcus and Ivan Oransky on Retraction Watch, a blog that covers scientific misconduct by tracking retractions of scientific papers.

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Meta-Analysis Examines Risk Associated with CYP2C19 Genotypes 1

There has been widespread debate and disagreement over the clinical significance of people with reduced function CYP2C19 genotypes who take clopidogrel. In an effort to shed light on the topic, Jessica Mega and colleagues analyzed data from 9685 patients enrolled in nine clinical trials. Some 26% of patients had 1 reduced-function allele, and 2% had 2 reduced-function alleles.
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Pradaxa (dabigatran) Pricing Starts to Emerge 7

It looks like Pradaxa (dabigatran) will cost about $237 a month at the drugstore counter. A Boehringer Ingelheim representative told CardioBrief that the wholesale acquisition cost (WAC) of the drug will be $6.75 per day for 2 pills. The price will apply to both the 150 mg and the 75 mg capsules.  According to knowledgeable experts, the retail cost of drugs at the pharmacy is typically 17% over the WAC. The retail price of Pradaxa is therefore likely to be $7.90 per day, or $237 per month.
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Top New York City Interventional Cardiologists Now Making $3 Million a Year 4

There’s no recession for top interventional cardiologists in New York City. Mt. Sinai’s Samin Sharma and New York-Presbyterian’s Jeffrey Moses now make at least $3 million a year, Sharma told CardioBrief.

Sharma will make his money staying in one place at Mt. Sinai. Moses, however, will have to travel between New York-Presbyterian’s uptown (Columbia University Medical Center) and east side (Weill Cornell Medical Center) medical centers. New York-Presbyterian announced on Friday that Moses will now play an expanded role at New York-Presbyterian, serving as the director of interventional cardiology at both centers. Moses was previously located at the Columbia University site.

Sharma told CardioBrief: “I wish Dr. Moses good luck on the new enhanced job. He well deserves it.” But, Sharma told  CardioBrief:
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FDA Issues Complete Response Letter for Bydureon (extended-release exenatide) Reply

The approval of Bydureon (extended-release exenatide), which had been widely anticipated, now will be delayed until 2012. The sponsoring companies (Amylin, Lilly, and Alkermes) announced on Tuesday that they had received a complete response letter from the FDA in response to the NDA for the drug.

According to the companies, the FDA has requested a thorough QT study with higher doses of exenatide than typical therapeutic levels.  In addition, the FDA wants to review the DURATION-5 study “to evaluate the efficacy, and the labeling of the safety and effectiveness, of the commercial formulation of BYDUREON.” The companies said they hope to submit their response to the letter by the end of 2011 and anticipate a response from the FDA will take an additional 6 months.
Click here to read the press release…

Dabigatran Gains FDA Approval 2

The FDA has approved dabigatran (Pradaxa) for the prevention of stroke and blood clots in patients with atrial fibrillation. Boehringer Ingelheim first announced the approval in a tweet (of all places).

The FDA says the drug will be available in 75 mg and 150 mg capsules. (In its review of the drug the FDA had been critical of data supporting the 110 mg dose, though the FDA Cardiovascular and Renal Drugs Advisory Committee advisory informally favored approval of the 110 mg dose.

Here is the FDA press release:

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FDA Won’t Soften Clopidogrel-Omeprazole Warning Reply

The FDA has no plans to withdraw or soften its warning about a possible interaction between clopidogrel (Plavix) and omeprazole (Prilosec), according to an article in the Wall Street Journal. Despite the recent publication of the COGENT study which found no evidence for an adverse clinical interaction, the FDA is standing by the advisory it issued last November and the black box warning added to the clopidogrel label in March.
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A ProPublica Investigation: Docs on Pharma Payroll Have Blemished Records, Limited Credentials Reply

Editor’s Note: The following article is reprinted with permission from ProPublica, the “independent, non-profit newsroom that produces investigative journalism in the public interest.” This is the first installment of an ongoing investigation titled “Dollars for Doctors.” For more information and resources about the investigation, including a tool to look up drug company money paid to physicians, visit the Dollars for Docs website.

Docs on Pharma Payroll Have Blemished Records, Limited Credentials

by Charles Ornstein , Tracy Weber and Dan Nguyen

ProPublica, Oct. 18, 2010, 11:52 p.m.

The Ohio medical board concluded that pain physician William D. Leak had performed “unnecessary” nerve tests on 20 patients and subjected some to “an excessive number of invasive procedures,” including injections of agents that destroy nerve tissue.

Yet the finding, posted on the board’s public website, didn’t prevent Eli Lilly and Co. from using him as a promotional speaker and adviser. The company has paid him $85,450 since 2009.

In 2001, the U.S. Food and Drug Administration ordered Pennsylvania doctor James I. McMillen to stop “false or misleading” promotions of the painkiller Celebrex, saying he minimized risks and touted it for unapproved uses.

Still, three other leading drug makers paid the rheumatologist $224,163 over 18 months to deliver talks to other physicians about their drugs.
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FDA Advisors Go Easy on Aranesp (darbepoetin alfa) 1

The FDA Cardiovascular and Renal Advisory Committee went easy today on Aranesp (darbepoetin alfa), the embattled erythropoeisis-stimulating agent (ESA).  After considering the implications of the Trial to Reduce Cardiovascular Events with Aranesp Therapy (TREAT), the committee recommended that no additional restrictions or label changes be made for the drug. However, the vote hardly represents a ringing endorsement of the drug by the committee. Instead, most members felt that the current label already reflects the findings from TREAT and sufficiently restricts the drug’s use. (Following the publication of TREAT a year ago the drug’s label was changed to reflect the increased risk of stroke observed in the trial.)

Click to continue reading, including comments from panel members Sanjay Kaul and Darren McGuire…

Guest Post: My Journey with Heart Failure 1

Editor’s note: I am very pleased to welcome Mary Knudson to the blogosphere and to introduce CardioBrief readers to Heart Sense: A Blog About Heart Failure. Knudson’s blog will undoubtedly prove to be an invaluable resource to heart failure patients, their family members, and the health care professionals who treat people with heart failure. As this first blog post makes clear, many physicians need to spend more time listening to their patients.

Mary Knudson worked for 17 years as a medical writer for The Baltimore Sun and currently teaches science and medical writing at Johns Hopkins University. Along with Edward Kasper, clinical chief of cardiology at Johns Hopkins Hospital, she is the co-author of the highly praised book, Living Well with Heart Failure. In a previous guest post on CardioBrief, Knudson wrote about her decision to remove her blog from the aegis of US News & World Report.

by Mary Knudson

I got to know something about heart failure the hard way, by having it.  I also happen to be a health journalist.  So when I got the stunning diagnosis in 2003, I began researching this condition that sounded so fatal.  Not only was my diagnosis overwhelming, but my first encounters with the health care system were dismal.  It took me three and a half months to find good care.   My story is worth sharing because it illustrates how important it can be for a patient to become knowledgeable about an illness and get involved in her own treatment plan.
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Is the Time Right for a Preprint Archive for Clinical Trials? Reply

Here’s a great idea: a preprint archive for clinical trials.

Taking inspiration from the well-established use of preprint archives in physics, math, and other scholarly areas, Martin Fenner, a cancer researcher, proposes the establishment of a preprint archive for clinical trial research papers.

Fenner points out that “the results of clinical trials are rarely first reported in a peer-reviewed journal, but rather are usually first presented at a conference – in the case of important practice-changing clinical trials often before an audience of thousands of people.” He writes that “the peer-reviewed paper is usually published months or even years after the conference presentation” and that this publication “is not the first time the medical community learns about the results of a clinical trial, or draws conclusions for their own research or clinical practice.”
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Meta-Analysis Lends More Support to Compression-Only CPR Reply

There’s new evidence supporting the movement away from traditional bystander CPR in favor of chest-compression-only CPR. In a paper appearing online in the Lancet, Michael Hüpfl, Harald F Selig, and Peter Nagele report the results of two separate meta-analyses. In the first meta-analysis, the investigators combined data from 3 randomized trials comparing compression-only CPR to standard CPR as directed by dispatcher instructions. The rate of survival to hospital discharge was 14% in the standard CPR group compared to 12% in the compression-only group (risk ratio 1.22, p=0.40).
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Trick or TREAT? FDA Staff Highly Critical of Aranesp Trial Reply

Update: 6:00 PM: The FDA has posted the roster for Monday’s meeting. Committee members include Henry Black, Jonathan Halperin, Judith Hochman, Sanjay Kaul, Mori Krantz, and Darren McGuire. The questions for the committee will not be posted before the meeting. An FDA official told CardioBrief that the FDA is not required to post questions.

Halloween arrives early on Monday for Aranesp (darbepoetin alfa), the embattled erythropoeisis-stimulating agent (ESA), as the FDA Cardiovascular and Renal Advisory Committee meeting considers the results of the Trial to Reduce Cardiovascular Events with Aranesp Therapy (TREAT). The briefing documents, some of which have now been posted on the FDA website, suggest the FDA will likely revise the label for Aranesp, and perhaps other ESAs as well, and perhaps require a strict Risk Evaluation and Mitigation Strategies (REMS).
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Guest Post: Big Pharma Knows Your Private Health Matters 1

(Editor’s note: The following post is written by Dr. John Mandrola, an electrophysiologist in Louisville, KY. Mandrola is also the author of his own blog, Dr John M, where this post originally appeared.)

by Dr. John Mandrola

He was here for routine follow-up.

He has atrial fibrillation. He is, and has been well controlled on generic, well-tolerated anti-arrhythmic medicine for years.  “I feel great, Doc”

He is happy, as am I.

But he was confused.  Why hadn’t he been switched to the “new” AF medicine.
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Guest Post: “Why I Won’t Blog About Heart Failure for US News & World Report” Reply

Editor’s note: The following guest post is by Mary Knudson, who worked for 17 years as a medical writer for The Baltimore Sun and currently teaches science and medical writing at Johns Hopkins University. Along with Edward Kasper, clinical chief of cardiology at Johns Hopkins Hospital, she is the co-author of the highly praised book, Living Well with Heart Failure. This post was originally published on Speakeasy Science, a PLos blog written by Deborah Blum, a Pulitzer-prize winning science writer and a professor of journalism at the University of Wisconsin. Her most recent book is The Poisoner’s Handbook: Murder and the Birth of Forensic Medicine in Jazz Age New York. Knudson and Blum are c0-editors of A Field Guide for Science Writers.

by Mary Knudson

When U.S. News and World Report invited me to write a weekly blog on heart failure and other heart issues at its website, I looked forward to building a following of people with heart failure and their families and other members of the public and perhaps some health professionals interested in this growing health problem. My first blog post and an accompanying sidebar on what the blog would be about were ready to go public at at 9 a.m. on September 23.
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The Plot Thickens in the Case of the Exploding ICD 1

The plot thickens:

The case report of an “exploding” ICD, originally published and then withdrawn in the journal Europace, continues to provoke comment and controversy.

On Friday evening, Westby Fisher, the electrophysiologist and blogger who first drew attention to the Europace report, met with officials from Biotronik and later summarized the meeting on his blog.

The Biotronik officials shed some additional light– and perhaps raised some additional questions– on the episode. With the permission of the company Fisher reprints a PDF  of the internal Biotronik memo that appears to provide the fullest chronology of the episode so far.

The memo establishes a number of  significant facts:
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Abbott withdraws obesity drug Meridia (sibutramine) from US market 1

Abbott Laboratories has voluntarily withdrawn its obesity drug sibutramine (Meridia) from the US market after the FDA concluded that the drug’s very modest benefits did not outweigh the risk of MI and stroke associated with the drug. The drug was pulled from the European market earlier this year.

Here’s a link to the FDA Communication: Drug Safety Communication: FDA Recommends against the Continued Use of Meridia (sibutramine)

Click to read the FDA and Abbott press releases…

The Case of the Exploding ICD, the Disappearing Journal Article, and a Defensive Blogger Reply

The story so far:

The official ESC journal Europace publishes an online case report by Dr. Martin Hudec about the extremely rare and spectacular failure of a recently implanted Biotronik 340 VR-T ICD in a 46-year-old man. The battery of the device apparently overheated, causing the device to malfunction and leading to severe internal burning.

On Wednesday, October 6, US electrophysiologist Westby Fisher summarizes the Europace article on his blog and reprints several extremely gruesome pictures taken from the case report.

At 9:22 PM CST Fisher updates his blog with the information that the case report is no longer available on the Europace website. The Europace website contains no explanation for the withdrawal/retraction.
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