JAMA writers call for medical groups to sever financial ties to industry 3

A group of distinguished medical leaders have called on professional medical associations (PMAs) to radically alter their relationship with industry. The Special Communication appeared in JAMA and was co-authored by a diverse group of writers, including first author David Rothman, of the Institute on Medicine as a Profession at Columbia University, JAMA editor Catherine DeAngelis, former ACC president Steve Nissen, and the past or current presidents or CEOs of the American Academy of Pediatrics, the American Psychiatric Association, and the American College of Physicians.

One key proposal is that “PMAs should work toward a complete ban on pharmaceutical and medical device industry funding ($0), except for income from journal advertising and exhibit hall fees.”

Since PMAs can not sever all their financial ties to industry immediately, they recommend a number of interim measures, including:
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ACTIVE A: clopidogrel + aspirin better than aspirin alone in AF Reply

For AF patients who can’t take warfarin, the combination of clopidogrel and aspirin is better than aspirin alone, according to results of the ACTIVE A trial, which was presented in Orlando at the ACC this morning.
Stroke was reduced by 28% and MI by 23% in the 7,554 patients who were randomized in the trial. Stuart Connolly said that if 1000 patients were treated for 3 years, the combination therapy would prevent 28 strokes (17 disabling or fatal), and 6 myocardial infarctions, at a cost of 20 major bleeds.
At an ACC press conference, Connolly said that about 40-50% of patients with AF who are at high risk for stroke do not receive oral anticoagulant therapy. Connolly said that ACTIVE A had addressed “a major unmet need” but that before dual antiplatelet therapy can enter clinical practice, clopidogrel will have to gain an AF indication and guidelines will have to be revised.
Click here to read the ACC press release…

TIPS: promising phase II trial for polypill Reply

The polypill is back. Results of a phase II study presented at the ACC and published online in the Lancet suggest that a polypill could cut cardiovascular risk and reduce events. The polypill is a combination of three low dose antihypertensives (12.5 mg HCTZ, 50 mg atenolol, and 5 mg ramipril), a statin (20 mg simvastatin), and aspirin (100 mg).
Click here to continue reading and to read the Lancet press release…

Even more JUPITER: CRP and LDL equally influence outcome Reply

Reductions in CRP and LDL are equally effective in predicting the efficacy of rosuvastatin, according to an analysis of the JUPITER study presented at the ACC and published online in the Lancet. The best results were observed in subjects who had large reductions in both LDL and CRP.

In their conclusion, the authors note that lifestyle changes remain the bedrock of primary prevention:
Click here to to continue reading and to read the Lancet and ACC press releases…

More JUPITER: rosuvastatin also prevents VTE Reply

Rosuvastatin lowers the rate of symptomatic venous thromboembolism (VTE) in healthy people with low LDL cholesterol and high CRP levels, according to the latest results of the JUPITER study, presented in Orlando at the ACC and published simultaneously in the New England Journal of Medicine.

Among 17,802 people, VTE occurred in 60 patients treated with placebo and 34 treated with rosuvastatin, a highly significant 43% risk reduction.

Click here to read the ACC press release…

PRE-RELAX-AHF: promising phase II results for relaxin in HF Reply

Relaxin, a hormone that helps regulate the cardiovascular system during pregnancy, may be beneficial in acute heart failure patients with normal or elevated blood pressure, according to a phase II study published online in the Lancet.

In an accompanying editorial, Chris Granger and Adrian Hernandez say that relaxin deserves further investigation, but warn that the results “need to be interpreted in light of its exploratory nature, particularly in view of the history of small heart-failure trials in which benefits turned out to be the play of chance. The results are probably too good to be true, in view of the lack of a dose-dependent effect and the surprising effect of a short treatment on postdischarge outcomes…”

Click to read the Lancet and the ACC press releases…

FIX-HF-5: trial misses endpoint, but hope remains for cardiac contractility modulation in HF Reply

FIX-HF-5, a study of cardiac contractility modulation (CCM) using a new implantable device that delivers electrical impulses to class 3 and 4 heart failure patients, missed its primary endpoint, but William Abraham, the primary investigator, told an ACC news conference that the device showed enough promise that it should continue to be developed. Results were presented today in a late-breaking clinical trial session at the ACC meeing in Orlando.
Although there were no significant differences in outcome in the primary efficacy endpoint, anaerobic threshold, CCM significantly improved the clinically important secondary endpoints of peak ventilatory oxygen uptake (pVO2) and quality of life, said Abraham. The trial compared CCM to medical care in 428 narrow QRS patients.

Click to read the ACC press release…

STICH: SVR provides no added benefit to CABG Reply

Surgical ventricular reconstruction (SVR) produces no further benefit when added to CABG in patients with ischemic heart failure, according to results from the STICH (Surgical Treatment for Ischemic Heart Failure) Hypothesis 2 trial. The results were presented at the ACC and published online in the New England Journal of Medicine. SVR succeeded in reducing LV volume, but had no impact on symptoms, exercise tolerance, or major events. (The STICH Hypothesis 1 trial, which is comparing medical therapy plus CABG to medical therapy alone, is ongoing.)
Click here to continue reading and to read the ACC press release…

JAMA editors now subject of AMA investigation 3

In response to growing concerns that JAMA editors Catherine DeAngelis and Phil Fontanarosa may have responded inappropriately to a researcher who publicly pointed out an undisclosed conflict of interest of a JAMA author, the AMA, which owns the journal, has asked an oversight committee to investigate the affair. This latest episode in the ongoing saga was reported yesterday in a story in the Wall Street Journal by David Armstrong. You can read about the background to this story in our previous post, in which we noted that the JAMA editors did not appear to be doing themselves any favors by taking a strong stance against both conflict of interest and freedom of speech.

UPDATE: A highly respected cardiologist told CardioBrief that he has no doubt that the criticisms being leveled at DeAngelis are absolutely true, since he himself has been the object of similar verbal abuse. For understandable reasons, he requested that his remarks be kept off the record.

Here is the AMA statement from Joseph Heyman, the AMA Board Chair (thanks to David Armstrong for passing along):
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SYNTAX: PCI begins to gain over CABG in new analysis Reply

Although CABG beat PCI on points in the first round of the SYNTAX matchup (the one year clinical results were previously published in the New England Journal of Medicine), the judges have now awarded the second round  to PCI. Results of the SYNTAX one year quality of life and economic analyses were presented in Orlando at the annual meeting of the American College of Cardiology. But many experts believe longer follow up is necessary before the heavyweight revascularization championship can be truly decided.
Click to read commentary, the ACC press release, and a Boston Scientific press release…

PROTECT AF: new device may offer alternative to warfarin for AF patients 1

A new implantable device may help patients with nonvalvular AF avoid warfarin therapy, according to results of the Embolic Protection in Patients with Atrial Fibrillation (PROTECT AF) trial. The trial was presented today in Orlando at the ACC Scientific Sessions.

The new device, called the Watchman, blocks the left atrial appendage with a fabric-covered expandable nitinol cage.  707 AF patients were randomized to receive the new device or long-term treatment with warfarin. The combined rate of stroke and cardiovascular death was 3.4 per 100 patient-years in the device group versus 5.0 in the warfarin group.
Click for more, and to read the ACC press release…

ACC in Orlando: March Madness starts Saturday Reply

CardioBrief will be blogging from Orlando starting Saturday. If you want to know what to expect you can take a look at:

Heartwire has also published a PDF document of late-breaking clinical trials that is much easier on the eye than CardioBrief‘s own list.

Boston Scientific issues product advisories on new ICDs Reply

Boston Scientific has issued a product advisory alert on certain models of its TELIGEN ICDs and COGNIS CRT-Ds. Here is the alert posted on the Heart Rhythm Society website:

Boston Scientific Advisory & Recommendations
Boston Scientific has issued a Product Advisory March 23, 2009 reporting that if the respiratory sensor of particular model numbers of TELIGEN ICDs and COGNIS CRT-Ds is programmed On, certain RV lead complications such as chronic lead fracture and acute lead connection issues may cause additional oversensing, thereby increasing the probability of inappropriate therapy. The company recommends programming the respiratory sensor to Off.

You can also read the letter sent to physicians or the Physician Advisory Notice.

Dr. Wes, the electrophysiologist with a blog, also commented.

Mehmet Oz wants to tell you your real age Reply

A website that is popular largely due to its connection with Mehmet Oz, the Columbia University cardiac surgeon who has been dubbed “America’s Doctor” by Oprah Winfrey, is used by pharmaceutical companies and other healthcare companies to market products based on personal health data of users gathered by the site, according to a front page New York Times article article by Stephanie Clifford, Online Age Quiz Is a Window for Drug Makers.

The gimmick behind the website, RealAge, is that users of the site can find out their “real” or physiologic age by answering a lengthy questionnaire. Writes Clifford:
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NEJM letter warns about ICD shocks caused by current leaks Reply

In a letter in the New England Journal of Medicine, two Danish physicians write about an ICD patient who experienced an inappropriate shock in the shower due to a current leak. They warn that “inappropriate ICD shocks due to a current leak are not common, but we suspect that they may be underdiagnosed. Shocks due to abnormal ICD sensing should be investigated carefully for potential environmental causes.”

Case reports link stress cardiomyopathy to catecholamines and beta agonists Reply

Stress cardiomyopathy (SCM) may be provoked by intravenous administration of catecholamines and beta-receptor agonists, according to a new study published online in the Journal of the American College of Cardiology. The findings of the observational series of 9 patients “provides compelling evidence that exaggerated sympathetic stimulation is sufficient to precipitate the syndrome of SCM in susceptible individuals,” write the authors.

LAMP2 mutation causes severe cardiomyopathy in young patients Reply

Young patients with Danon disease, a cardiomyopathy associated with a mutation in the LAMP2 gene, have a rapid and often fatal progression of disease, according to a new study from Barry Maron and colleagues in JAMA. In a press release, Maron called this “one of the most lethal cardiomyopathies in young and usually male patients” and said that the study helps establish “the importance of molecular diagnosis and underscores the utility of genetic testing.”
Click here to read the JAMA press release…

NICE-SUGAR: Intensive glucose control in ICU found harmful Reply

NICE-SUGAR, published online first in the New England Journal of Medicine, randomized 6,000+ ICU patients to intensive or conventional glucose control. Mortality was 27.5% in the intensive-control group verus 24.9% in the conventional-control group, a difference that achieved statistical significance.

An accompanying editorial, by Silvio Inzucchi and Mark Siegel, notes that physicians “are now left in something of a quandry” but warns against an “overreaction” to the findings:
Click to continue reading, including additional comments from Darren McGuire…