The editors of the European Heart Journal rejected a request by a senior GSK executive to suppress an editorial written by Steve Nissen about rosiglitazone (Avandia).

The incident is recounted in a separate editorial written by the EHJ editor-in-chief, Thomas Lüscher, and two deputy editors, Ulf Landmesser, and Frank Ruschitzka, and published online on April 23. According to the editors, the EHJ received a letter (click here to download a PDF of the letter) on February 21, 2010 from the chairman of R&D at GSK, Moncef Slaoui. In response to the online publication on February 12 of an editorial by Nissen, the GSK executive “urged the journal not to publish the online editorial in print,” according to the EHJ editors. The EHJ editors recount their response: “The journal’s editorial board discussed the issue and unanimously agreed that such a demand was unacceptable.”
Click to continue reading…

Three extraordinary papers in the Lancet provide a fascinating first glimpse at issues that will be the topic of discussion and debate for the next generation at least. For the first time, investigators at Stanford and Massachusetts General Hospital used a complete human genome of an individual patient to provide a clinical assessment of the patient, a 40-year-old asymptomatic man with a family history of coronary artery disease and sudden death.

The  analysis of  2.6 million SNPs and 752 copy number variations found that the patient was at increased risk for MI, type 2 diabetes, and some cancers, the researchers reported. They also found three rare variants of genes that have been linked to sudden cardiac death. They also found an LPA variant associated with familial CAD and mutations linked to clopidogrel resistance and a positive response to lipid-lowering therapy. These were some of the more clinically relevant findings, but an important aspect of the Lancet report is the nearly overwhelming amount of information that can be obtained from the whole-genome approach.
Click to continue reading…

Walk into any Vitamin Shoppe or GNC and you can see them: people looking to fight a cold, reduce “stress”, sleep better, or build bigger muscles. They’re all looking for a quick fix with no downside. They’re all deluded.

Two new clinical trials testing the effects of vitamin B and steroids serve to demonstrate the folly of human hopes for quick fixes that seem harmless. But they also demonstrate the only antidote to such folly: the objective and critical assessment of those hopes.
Click to continue reading…

Once again a study has turned up results that appear to favor widespread application of calcium screening. And once again an editorial has pointed out that the technique is still not ready for prime time. (And we predict that once again the proponents of calcium scans will trumpet the study as absolute justification for widespread adoption of calcium screening.)

This time, in a study appearing in JAMA, Polonsky et al used data from 6,000 patients enrolled in MESA (Multi-Ethnic Study of Atherosclerosis) to assess the value of adding coronary artery calcium (CAC) scores to a traditional risk factor. By adding CAC scores to traditional risk factor assessment, nearly a quarter of subjects who experienced a CHD event during a median 5.8 years of followup were reclassified as high risk, while 13% who had no events were reclassified as low risk.
Click to continue reading…

Editor’s Note: A transforming moment in the current discussion about conflict of interest in medicine occurred on November 25, 2007, when the New York Times Magazine published a lengthy article by Dr. Daniel Carlat, a psychiatrist affiliated with Tufts University. In the article, Carlat wrote at length about his experience as a paid speaker to other physicians and his eventual decision to quit giving such talks. Although the details of Carlat’s story could hardly have been a surprise to most physicians or other observers of contemporary medical culture, the fact is that this kind of discussion had never before occurred in public. And once the cat had been let out of the bag there was no putting it back in. Dr. Carlat now writes a blog, The Carlat Psychiatry Blog, which has become one of the most intelligent and reliable sources for information and analysis about COI issues. Dr. Carlat graciously agreed to allow CardioBrief to reprint the following item, which provides a brilliant and humorous perspective on yesterday’s announcement by the Council of Medical Specialty Societies of a new Code for Interactions with Companies.

Medical Societies’ New Ethics Code: Secret Q&A Document Revealed

by Dr. Daniel Carlat

The Council of Medical Specialty Societies just announced a new Code for Interactions with Companies. They have received good press so far. According to AP, “It’s the most sweeping move ever taken by the Council of Medical Specialty Societies to curb conflict of interest…”

But The Carlat Psychiatry Blog has just obtained a disturbing highly classified Q&A document leaked by a mole within the Council. Or maybe we just made the thing up. Read the following excerpt, and you can decide.
Click to continue reading…

Update: In response to the Washington Post article discussed below, the FDA issued a statement saying the article “leaves a mistaken impression that the FDA has begun the process of regulating the amount of sodium in foods. The FDA is not currently working on regulations nor have they made a decision to regulate sodium content in foods at this time.”

On the heels of today’s release of an Institute of Medicine report, “Strategies to Reduce Sodium Intake in the United States,” the FDA will announce tomorrow a major initiative that would gradually reduce the amount of salt added to processed foods. The FDA initiative was reported by Lyndsey Layton in the Washington Post.
Click to continue reading…

Cardiologists and other physicians have reported receiving an email lately from an organization called the Residual Risk Reduction Initiative. Here’s how the organization describes itself:

The Residual Risk Reduction initiative (R3i) is a worldwide, academic, multidisciplinary, non-profit, Swiss-law Foundation established by international researchers and clinicians who recognize the importance of the high risk of fatal and non-fatal macro- and micro-vascular complications occurring in patients with atherogenic dyslipidemia who are already receiving the current standards of care.

It sounds like a worthy program. Who could be against efforts to further reduce cardiovascular risk? Unfortunately, R3i, in reality, is something more (or less) than an altruistic organization: it’s a keystone in the promotional efforts of Abbott to sell more of its fenofibrate drugs (TriCor and TriLipix) and to “spin” the negative ACCORD trial into a positive message for fenofibrate. ACCORD, you will recall, was a negative trial that failed to demonstrate the benefits of fibrates in type 2 diabetics already taking statins, although there was a possible benefit in the subgroup of patients who had both high baseline triglycerides and low HDL cholesterol (interaction p=0.057).
Click to continue reading…

I’m feeling a bit like Al Pacino in Godfather III: every time I think I’m out of the Multaq story I get pulled back in.

A sharp observer forwarded an article posted online in the Journal of Cardiovascular Electrophysiology: “The Impact of New and Emerging Clinical Data on Treatment Strategies for Atrial Fibrillation.” First author: Eric Prystowsky.

The simple truth is that the entire article was developed and paid for by Sanofi. The reason is very simple: Under the pretense of a comprehensive review of new data on AF, the article recommends that dronedarone (Multaq) be considered as a first line agent for all but one indication for AF across the entire cardiovascular spectrum. (This appears to be identical to Prystowsky’s position in the lecture on the ACC/HRS website.)

Here are a few further details and observations:
Click to continue reading…

Fixing a failing porcine or bovine heart valve with the percutaneous implantation of a mechanical valve inside the previous valve appears promising, according to a new report by  John Webb and colleagues in Circulation. But an accompanying editorial warns that the new technology needs to be carefully assimilated.

“Generally the transcatheter valves work very well for treating leaky, failed surgical valves,” said Webb, in an AHA press release. “The procedure only works well if the original surgical valve is large enough for the new transcatheter valve to fit inside it. Most surgical valves are large enough, but not all. If the surgical valve is small, the new valve may open more fully than the old valve but not as well as you would like.”
Click to continue reading…

The short-term benefits of endovascular abdominal aortic aneurysm repair seen in previous trials appear to evaporate with long-term followup, according to results of two large trials published online in the New England Journal of Medicine.

In EVAR 1 (United Kingdom Endovascular Aneurysm Repair 1), between 1999 and 2004, 1,252 patients with large abdominal aortic aneurysms were randomized to either endovascular or open repair. As seen in previous trials, the early results appeared to favor endovascular repair: at 30 days the operative mortality was 1.8% in the endovascular-repair group versus 4.3% in the open-repair group.
Click to continue reading…

“We were surprised that consistently and pervasively, through every way of looking at the data, it turns out this isn’t about skin color or gender. It’s about being poor.” So said Colleen Koch, in a press release from the AHA, about her study in Circulation: Cardiovascular Quality and Outcomes. Along with her colleagues, Koch followed more than 23,000 patients who had CABG between 1995 and 2005. They found that lower socioeconomic position (SEP) was associated with reduced survival after surgery; after adjusting for SEP race and gender were no longer significant. As the investigators expected, blacks and women had lower SEP compared to whites and men.
Click to read the AHA press release…

Editor’s Note: This post originally appeared on Dr. John Halamka’s  Life as a Healthcare CIO blog. It is written by Dr. Larry Nathanson, who leads the Emergency Medicine Informatics efforts at Beth Israel Deaconess Medical Center. (Note that the photo contains only fictitious patient names.) One further note: I believe that it is a distinct probability that the iPad is going to dramatically alter the manner in which many of us find, consume and share all kinds of information and media. I’m sure that there are many of you out there who are skeptical of this view. On the chance that I’m right, the following post provides a fascinating glimpse at one possible use of the iPad in a medical setting.

I had been anxiously awaiting the arrival of my iPad –This is the form factor I have been asking (begging) of all the vendors for years. I’m very happy to say that it appears to be living up to my high expectations.
Click to continue reading…