Fuster To Succeed DeMaria As Editor Of JACC Reply

The American College of Cardiology has announced that Valentin Fuster will be the next editor-in-chief of the Journal of the American College of Cardiology. Fuster will succeed the current editor, Anthony DeMaria, beginning in 2014.

Click here to read the full post on Forbes.

 

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Recent €23 Million Biotech IPO Relied Heavily On Questionable Research 2

A successful €23 million initial public offering  (IPO) last week was based on highly questionable research, according to a group of UK physicians who have scrutinized the available data. In addition, one of the researchers, a prominent European cardiologist, failed to disclose in a key paper that he helped to start, and held a significant interest in, the company, Cardio3 BioSciences.

On July 4 Cardio3 BioSciences, a biotechnology company focusing on cardiac stem cell therapy, said that it had raised €23 million in an IPO on the NYSE Euronext Brussels and NYSE Euronext Paris. The company’s main product is called C-Cure, which it defines as “a unique cell therapy aimed at repairing damaged tissue and improving heart function, clinical outcomes and quality of life.” C-Cure uses uses pre-programmed cardiac progenitor cells to treat heart failure. As described by the company, “the supporting science is the result of Mayo Clinic innovation leading to advanced product development, manufacturing scale-up, and clinical trial execution by Cardio3 BioSciences catalyzed by ongoing collaboration facilitated through Mayo Clinic Ventures.”

The company plans to use the IPO money for a Phase III trial, following what the company describes as “positive Phase II results, recently published in the Journal of the American College of Cardiology.”

But the phase II results are a bit more complicated, according to Darrel Francis and colleagues (who last week published a paper highly critical of a different stem cell group). Francis et al have identified numerous errors in the paper which raise serious questions about the validity of the data and whether any useful conclusions can be drawn from the paper.

One striking finding– obvious once it has been pointed out– is that the authors report at different times different number of patients enrolled in the trial. The text of the paper says 48 patients were randomized, Figure 1 lists 47, and Table 1 lists 45 (42 men and 3 women).

Click here to read the full story on Forbes.

 

 

Blood Sample Mismatch Leads ‘Anguished’ Authors To Retract Three Lipitor Papers 1

Three substudies of the influential TNT (Treating to New Targets) trial have been retracted after the sponsor of the trial, Pfizer, discovered that blood samples from the study had been matched to the wrong participants.

The main results of TNT, published in 2005 in the New England Journal of Medicine, had a major impact on clinical practice and statin prescription patterns. The trial supported the increasingly aggressive use of statins and helped to solidify the enormous commercial success of atorvastatin (Lipitor, Pfizer).

The 3 newly-retracted substudies do not appear to affect the main finding of TNT. Two papers were published in the Journal of the American College of Cardiology. The third was published in the American Heart Journal. (The AHJ retraction notice has not yet been published, but the editors have confirmed the retraction.) Here are the 3 retracted articles:

Click here to read the full story on Forbes:

 

English: A package and pill of atorvastatin 40...

A Closer Look At A Case Of Duplicate Publication In JACC 2

English: http://en.wikipedia.org/wiki/Linda_an...

The Journal of the American College of Cardiology has published a Notice of Duplication about a review article written by a respected European cardiology researcher who has played a central role in the development of fractional flow reserve (FFR). The brief statement from JACC provides few details and could lead to various interpretations, but a further investigation suggests that the story may be fairly simple.

The notice states that a 2012 review article by Nico H.J. Pijls and Jan-Willem E.M. Sels, Functional Measurement of Coronary Stenosis, “duplicates to a considerable extent both the text and figures of a prior article,” Fractional flow reserve: a review” published in 2008 in Heart, by two different authors, Bernard De Bruyne and J. Sarma. Here is the JACC editors explanation:

Dr. Piljs attributes this duplication to the close collaboration that he has had over many years with Dr. De Bruyne, and the fact that both authors drew text and figures for these reviews from the same repository of material used for a joint educational program. He acknowledges his lack of care in the preparation of the manuscript and apologizes for the duplication. While the Editors accept this apology, we lament the replication of information that prevented the pages devoted to Dr. Piljs’ article from being filled with new material.

De Buyne and Pijls are longtime colleagues who have played a central role in the development of fractional flow reserve, serving as principal investigators of the seminal FAME and FAME II clinical trials. I asked them for a response to this situation. Here is their statement:

The cryptical phrasing “repository of……..” is not ours, but made by JACC.

The “repository” they mean is a keynote lecture from the bi-annual Aalst-Eindhoven-Course on Coronary Physiology, which we organize once or twice a year in Brussels since 2001. The Course is endorsed by the European Society of Cardiology and has been organized by us already 17 times.

The opening lecture of that course (keynote lecture) is always entitled: “Practice and advanced applications of Coronary Pressure Measurement” and alternatively given by Dr de Bruyne and Dr Pijls.

That lecture has been built up by us and developed carefully over the years and has been streamlined for optimum educational content and benefit, including phrasing and slides.Not a single word is not ours.

The slides are always distributed among the participants and used by many of them for their own lectures or presentations or any educational purposes. In fact , they are public domain. Consequently, we have seen (parts of) our text and slides been used by others a myriad of times and are proud to have contributed to the dissemination of valuable medical knowledge.

When Dr De Bruyne wrote his review for HEART in 2008 , he used that keynote lecture as the basis of his paper.

When Dr Pijls wrote his State-of-the-Art paper ( i.e also a review) on the invitation of JACC in 2012, he also used text and slides of that keynote lecture (extended in the meantime) without realizing that Dr De Bruyne had done the same some years earlier. As a result, the first part of Dr Pijls paper is very close to Dr De Bruyne’s review, wheras the second part of Dr Pijls paper reflects the new data and insights obtained in those last 4 years.

So, there is nothing mysterious about that “repository” and we explained this to JACC in a similar way as we do now to you.

And by the way, when Dr Pijls submitted his paper to JACC, he mentioned explicitely in the submission letter that – as the nature of this paper was a State-of-the-Art paper – it was a concise reflection of the knowledge in the field and not original data.

Answering your last question: Neither Dr De Bruyne nor Dr Pijls ever received any financial or other compensation from whoever or in whatsoever way for writing any of these papers.

Writing these papers was on the strict invitation of the editors of Heart and JACC respectively and except the authors and staff of the Journals, nobody was even aware of it before they were published.

And as stated above: any single word or figure in any of these papers is completely our own work to which we equally contributed.

Comment: When I first read the notice it seemed to me like the case was an indication of a larger wrongdoing. I’m glad my initial suspicions were proven wrong. This is a great example of why editor’s notes should be much more detailed. The truth needs to come out no matter which way it falls.

Observation Units For Heart Failure Could Reduce Unnecessary Hospitalizations 1

Two new papers published in the Journal of the American College of Cardiology propose that most heart failure (HF) patients who present to the emergency department (ED) don’t need to be hospitalized and can be safely managed in an observation unit. Currently, the vast majority of HF patients  who show up in the ED are hospitalized….

Click here to read my complete story on Forbes.

Journal of the American College of Cardiology

 

 

Meta-Analysis Confirms Benefits Of Statins In Women Reply

Although clinical trials have consistently found a beneficial effects for statins, some critics have questioned the strength of the evidence in women, who are often under-represented in clinical trials.  A large new meta-analysis published in the Journal of the American College of Cardiology provides the best evidence yet that the relative reductions in events observed in men also occur in women, but doesn’t provide evidence about the absolute risk benefit in women.

William Kostis and colleagues analyzed data from 18 randomized trials of primary and secondary prevention, including 141,235 men and 40,275 women.  The reduction in risk was similar for both groups:
Click to continue reading…