EHJ editors rebuffed GSK efforts to suppress Nissen editorial on rosiglitazone 4

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.”
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The survey says: uphill battle for Effient, Plavix remains strong, anticipation grows for Brillinta 1

Sales of prasugrel (Effient) are slowly growing, but the road to blockbuster status appears blocked by continued strong current usage of clopidogrel (Plavix) and, in the future, widespread anticipation and excitement over ticagrelor (Brillinta). In its last financial statement Lilly reported worldwide sales of Effient of $8.8 million in the first quarter, $4.5 million in the US. (Plavix sales in 2010 are estimated at $6.5 billion.)

Leerink Swann, a financial research firm, released the results of a survey of 106 US cardiologists that provides insight into the antiplatelet market. The survey found that physicians remain comfortable using clopidogrel and rate it as the “safest drug with good efficacy,” though “drug interactions and non-responders [are] becoming clinically relevant.”
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TMI or the future of medicine? Complete human genome used in patient assessment Reply

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.
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Roche announces more positive results for taspoglutide Reply

Once again Roche has announced positive phase III results for taspoglutide, a once-weekly GLP-1 analog under development. The drug is being tested in a series of phase 3 studies that compose the T-emerge clinical trial program.

In today’s announcement, Roche said the T-emerge 3 study showed that taspoglutide was superior to placebo for the primary endpoint of change in HbA1c when used in addition to metformin and pioglitazone in 326 patients randomized to taspoglutide 10 mg once weekly, taspoglutide 20 mg once weekly, and placebo. As in previous studies, Roche said the drug “was generally well tolerated and the most frequently reported adverse events among taspoglutide treated patients were nausea and vomiting.”
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Vitamin B and steroids: monuments to human folly 4

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.
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US Judge rejects $296 million plea agreement for Guidant Reply

A US federal judge rejected a proposed $296 million plea agreement which would have allowed Guidant to settle the investigation into the company’s handling of defective ICDs. As reported here last week, cardiologists Barry Maron and Robert Hauser, who originally brought the case to public attention, wrote a letter to the judge urging him to reject the proposed settlement.

In the 37-page opinion, Judge Donovan W. Frank said that the Justice Department had not held Guidant (now owned by Boston Scientific) “sufficiently accountable” for its actions, according to a New York Times story by Barry Meier. The Times also said that the judge had “disagreed with the Justice Department’s decision not to seek corporate probation for Guidant and its current parent company, Boston Scientific.”
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Calcium screening: another positive study, another critical editorial Reply

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.
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PPIs and Clopidogrel: new study finds evidence that pantoprazole may also be a problem Reply

Over the past few years physicians have grown increasingly concerned about possible negative consequences when clopidogrel is given to people taking PPIs. Last November the FDA added a warning to the clopidogrel label and issued a public health advisory on the interaction between clopidogrel and omeprazole. Now a new study lends fresh support to concerns, and provides the first substantial evidence that another PPI, pantoprazole, may also be a problem.

Researchers at Prescription Solutions and the University of Washington reviewed data from patients enrolled in a multistate private and Medicare insurance plan who were taking clopidogrel and a PPI and compared them with matched patients (using propensity scoring) with patients taking clopidogrel alone. In their report in Archives of Internal Medicine, Karen Stockl and colleagues found that when compared to patients on clopidogrel alone, patients also taking a PPI had a 93% higher risk of rehospitalization for MI (adjusted HR = 1.93, CI 1.05–3.54, p=0.03) and a 64% higher risk of rehospitalization for MI or stent implantation (adjusted HR = 1.64, CI 1.16–2.32, p=0.05).
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Guest Post: Medical Societies’ New Ethics Code: Secret Q&A Document Revealed Reply

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.
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Guest Post: the long afterlife of Joshua Oukrop 1

Editor’s Note: In response to a plea agreement in which Boston Scientific would pay $296 million to resolve the well-known case involving defective Guidant ICDs that the company failed to disclose, the New York Times and the Minneapolis Star Tribune report that the two cardiologists who first brought the issue to public attention have sent a letter to the judge in the case asking him to reject the proposed settlement. In the following guest post, Westby G. Fisher, an Illinois electrophysiologist and author of the popular Dr Wes blog (where this post was originally published), raises the interesting question: what role should physicians play in deciding damges? More importantly, Fisher discusses the important changes brought about by the case.

When Doctors Decide Damages

by Westby G. Fisher

In an interesting twist to the ongoing saga of device recalls, the Minneapolis StarTribune reported that the two doctors, Robert Hauser, MD and Barry Maron, MD who first brought the Prism II ICD device malfunction to public attention by releasing their story to the New York Times in 2005, wrote a letter to the judge reviewing the plea bargain agreement and told him:

We are physicians who cared for Joshua Okrup (eds note: should be “Oukrop”), a 21 year-old college student, who died when his Guidant Prizm 2 implantable cardioverter-defibrillator (ICD) short-circuited and failed to deliver a life-saving shock. His unnecessary death was caused by a product defect that Guidant Inc. had known about for years and failed to inform patients, physicians, and the U.S. Food and Drug Administration. Accordingly, we are extremely dismayed by the U.S. Attorney General’s decision to enter into a plea agreement with Guidant LLC, rather than prosecute the company and the individuals responsible for this egregious act. On behalf of the patients who died or suffered pain and mental anguish as the direct result of Guidant’s illegal and unethical behavior, we urge you not to accept the plea agreement.

An out-of-court $296 million plea agreement is not enough it seems.
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IOM report heralds new FDA initiative to gradually cut salt in processed foods Reply

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.
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Small steps lead to big reduction in risk for overweight Mayo Clinic cardiologist Reply

Moderate changes in lifestyle can lead to big reductions in risk, as reported in a feature story in the Wall Street Journal by Ron Winslow. The story opens with an anecdote from Mayo Clinic cardiologist Stephen Kopecky, who describes the case of a 240 pound, 49-year-old  man with a scary lipid profile. “He may not have been a heart attack waiting to happen, but that was the direction he was headed,” writes Winslow.

The man then started to exercise regularly and to eat a healthy diet, resulting in an 18 pound weight loss and a dramatic improvement in his lipids. Winslow quotes Kopecky, who points out that the case shows “that we can all help ourselves tremendously taking small steps and doing something that’s achievable.”

But it’s not until the very end of the story that Winslow pulls the rabbit out of the hat:
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Residual Risk Reduction Initiative: promotion or education? Reply

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).
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Boston Scientific resumes sales of Cognis and Teligen ICDs Reply

Boston Scientific announced today that it had received approval from the FDA to resume sales of most of its ICDs and CRT-Ds following a 30 day suspension. Sales of Cognis CRT-Ds and Teligen ICDs will resume immediately. The company said it had “found a few additional instances where the Company did not submit the appropriate documentation for validated manufacturing changes” in its older devices, and these will remain off the market until the company receives FDA approval to resume their sales. (You can read previous coverage on CardioBrief of this story here, here, and here.)
Click here to read the Boston Scientific press release…

Even more questions about Multaq and Prystowsky, alas 1

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:
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Final results of ARBITER 6-HALTS confirm CIMT benefit with niacin and no benefit with ezetimibe Reply

Last November the initial presentation at the AHA and simultaneous publication in the New England Journal of Medicine of the ARBITER 6-HALTS trial resulted in a storm of confusion and controversy. Now the final results of the trial have been published in the Journal of the American College of Cardiology. The data appear to provide strong confirmation that niacin was effective in inducing atherosclerosis regression as measured by CIMT while ezetimibe had no such effect.
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Promising early results for “valve-in-valve” approach to failing bioprosthetic valves 1

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.”
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Guest Post: Running on empty Reply

Editor’s Note: The following post was written by Westby G. Fisher, an electrophysiologist  practicing at NorthShore University HealthSystem in Evanston, IL and  a Clinical Associate Professor of Medicine at the University of Chicago’s Pritzker School of Medicine. He is  the author of Dr Wes, a widely known and highly admired blog about cardiology, the internet, and anything else that catches his imagination.

“In sixty-nine I was twenty-one and I called the road my own
I don’t know when that road turned onto the road I’m on.

Running on, running on empty
Running on, running blind
Running on, running into the sun
But I’m running behind.”

-Jackson Browne

“We’re stretch so thin, right now. No new hires in sight. Look at this list of patients: twenty-two of ’em, all over 70, eight “new’s” among them, every one with tons of medical issues. Didn’t get out of here until 10:30 last night. Then back at it at 8 (am) this morning. I’m telling you, I hate it. Hate it. There just doesn’t ever seem to be an end in sight. We’re just a bunch of “f**in’ employees, and no one gives a damn.”

I sat stunned. I knew him from before. His job had taken it’s toll. This wasn’t the guy I knew earlier. I really didn’t know how to respond, but did suggest that maybe hospitalist medicine wasn’t for him.
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NEJM: trials find few long term benefits for endovascular AAA repair Reply

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.
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More pieces of the Multaq puzzle 6

I don’t want to keep harping on Multaq (see the bottom of this post for links to recent stories), but then I keep running across promotions for so-called educational programs that practically beg to be scrutinized. Earlier today I received an email from CME Center. At the top of the message was this featured CME program:

Reducing Hospitalizations in Atrial Fibrillation: Optimizing Arrhythmia Control
The purpose of this activity is to educate clinicians on strategies for switching AADs and the impact of AF recurrences on hospitalization.

Not mentioned in the email was the sponsor of the program, but it probably won’t come as a big surprise to learn that it was Sanofi Aventis. I took a quick look at the transcript of the program, which appeared to be essentially a detailed list of excuses and reasons to switch AF patients from amiodarone or other drugs to dronedarone. The heavy lifting was performed mostly by one of the participants, Peter Kowey. Here’s part of his conclusion:
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Survival after CABG “isn’t about skin color or gender, it’s about being poor” 2

“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…

Experts disagree on when to use dronedarone (Multaq) 3

The billion dollar question is this: when to use Multaq (dronedarone)? A new viewpoint and commentary in JACC from Sanjay Kaul’s group (Singh et al) offers a highly conservative answer to the question. An accompanying editorial by Christian Torp-Pedersen, Ole Dyg Pedersen, and Lars Køber provides a much more liberal view of the drug.

It all comes down to different ways of interpreting the safety and efficacy data. Surprisingly, both groups agree that dronedarone is less effective than amiodarone as an antiarrhythmic drug, and both agree that dronedarone is safer than amiodarone in the indicated population of low and intermediate risk patients. And both agree that dronedarone should not be used in high risk patients (unstable NYHA class 3 and class 4 HF patients).
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Guest Post: The iPad goes live at BIDMC Reply

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.
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Waiting for IMPROVE-IT… Reply

Last week the IMPROVE-IT investigators, led by Rob Califf, provided an update on the trial’s progress in the American Heart Journal. Remember: this is the trial that everyone hopes will finally resolve the question of ezetimibe’s clinical value. (Earlier this year, as we reported, Merck announced several of the details contained in this paper.)

According to Califf et al, IMPROVE-IT will now most likely enroll the last of its 18,000 subjects in June of this year.  They project the trial will then reach completion in June 2013, when all patients have been followed for at least 2.5 years and when 5,250 primary end points will have been reached. In addition, the investigators have added an additional interim analysis when 75% of events have occurred (in addition to the previously planned analysis at 50%).
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