Lancet Editors Raise More Questions About Prominent Harvard Stem Cell Researcher Reply

There’s more trouble for Piero Anversa, the prominent and controversial stem cell researcher.

Today the Lancet issued an expression of concern about an influential, much-cited stem cell paper. As first reported by Retraction Watch, an investigation at Harvard Medical School and Brigham and Women’s Hospital has raised concerns about the integrity of data coming from Piero Anversa’s laboratory at the Brigham contained in the 2011 SCIPIO study published in the Lancet.

Here is the full Expression of Concern issued by the Lancet:

Click here to read the full post on Forbes.

 

Studies Suggest You Can Help Your Heart By Walking More And Eating More Fiber 1

It probably won’t come as a surprise, but walking more and eating more fiber are probably good for your heart. That’s the conclusion of two new studies, but because the studies relied on observational data it should be emphasized that they are incapable of demonstrating cause and effect. And it’s by no means clear that most people are willing to undertake the effort needed to achieve effective lifestyle changes like these.

Walking

In the first study, published in the Lancet, researchers analyzed data from 9,300 people with impaired glucose tolerance (and therefore at high risk for developing diabetes) and with existing cardiovascular disease or at high risk for CV disease.

Eating

In the second paper, published  in BMJ, investigators performed a systematic review of studies examining the effect of dietary fiber on cardiovascular and coronary heart disease.

Click here to read the full post on Forbes.

 

Keep Moving 

 

European Air Pollution Standards May Need To Be Strengthened Reply

A large new analysis published in the Lancet has found a strong association between long-term exposure to air pollution and the risk of dying. The results suggest that European standards for air quality may need to be strengthened.

The European Study of Cohorts for Air Pollution Effects (ESCAPE) analyzed data from 22 European  studies, including 367,251 participants followed for an average of 13.9 years. Nearly 30,000 deaths from natural causes occurred during followup. ESCAPE is the first large multi center study to examine long-term exposure to air pollution and mortality across many different European settings….

Click here to read the full story on Forbes.

 

Red Desert

 

Lancet Formally Retracts Jikei Heart Study Of Valsartan Reply

The Lancet has formally retracted the Jikei Heart Study paper, originally published in 2007. The retraction had been widely anticipated for more than a month, after a series of news reports in Japan made it clear that the long-simmering controversy over scientific misconduct involving the Novartis blood pressure lowering drug valsartan (Diovan) had come to a full boil. (See our earlier story here.)

As reported previously, the current scandal first began to unfold in late 2011 when a Japanese blogger pointed to a number of apparent errors in publications authored by Hiroaki Matsubara. This ultimately led to a series of retractions of Matsubara’s papers and the retraction of the main paper of the Kyoto Heart Study itself by the European Heart Journal.

In the notice of retraction

Click here to read the full story on Forbes.

Can Inflating A Blood Pressure Cuff Improve Outcomes Following Bypass Surgery? Reply

http://www.forbes.com/sites/larryhusten/2013/08/15/can-inflating-a-blood-pressure-cuff-improve-outcomes-following-bypass-surgery/

 

For several decades cardiologists have been intrigued by the concept of ischemic preconditioning. A small body of research has consistently found that brief episodes of ischemia (in which reduced blood flow results in damage to tissue) appeared to somehow prepare the body to better handle a major episode of ischemia. Now a new study from Germany published in the Lancet holds out the promise that deliberate ischemic preconditioning prior to bypass surgery might prevent ischemic injury caused by the surgery and may even improve long-term survival. But the investigators themselves say that the results need to be confirmed in a larger study.

Click here to read the full post on Forbes.

 

Large Meta-Analysis Quantifies Risk Of NSAIDs And Coxibs Reply

Findings from a very large meta-analysis of clinical trials of NSAIDs may now allow physicians to quantify the cardiovascular and gastrointestinal risks associated with these drugs. The results of the Coxib and traditional NSAID Trialists’ (CNT) Collaboration, employing data from more than 350,000 randomized patients, have now been published in the Lancet.

Here are some of the key findings:

Click here to read the full post on Forbes.

English: Sintofarm

Japanese Research Scandal Expands To A Second Trial And A Novartis Employee Reply

A Japanese research scandal, which has so far centered on actions taken by the once-prominent cardiologist Hiroaki Matsubara, has now expanded. As has been previously reported, several papers authored by Matsubara have been retracted, including, most notably, the main publication of the Kyoto Heart Study in the European Heart Journal.

Now, however, questions have been raised about  another clinical trial, the Jikei Heart Trial, which was published in the Lancet in 2007.  (Matsubara was not involved in this trial.) Novartis, which manufactures valsartan (Diovan), the drug studied in both trials, has announced that it is investigating both trials in response to new allegations that a Novartis employee worked on the trials without any disclosure of his company affiliation.

Click here to read the full story on Forbes.

Are Most People With Complex Coronary Disease Getting The Best Treatment? 1

angiogram

The relative value of PCI (stents) and bypass surgery for the treatment of people with blocked coronary arteries has been a topic of intense interest and debate for more than a generation now. Over time, the less invasive and more patient-friendly (and less scary) PCI has become the more popular procedure, but the surgeons (who perform bypass surgery) and cardiologists (who perform the less invasive PCI) have argued furiously about which procedure is safest and will deliver the most benefit in specific patient populations. In general, the most complex cases require the more thorough revascularization provided by surgery, while the more simple cases do well with PCI and can therefore avoid the trauma of surgery. But the specific criteria have remained murky, and interventional cardiologists have aggressively sought to take on increasingly more complex cases.

Now, long term results from a highly influential trial comparing the two procedures offer what is likely the most definitive solution we are likely to have for a very long time. Five year results from the SYNTAX trial have now been published in the Lancet.

Here’s some of the perspective on this study from two very savvy cardiologists, Rick Lange and L. David Hillis. (These comments are extracted from their original publication in CardioExchange. Note that I work on CardioExchange, which is published by the New England Journal of Medicine.)

…The “bottom line” conclusions are:

  1. CABG should remain the standard of care for patients with complex lesions…
  2. For patients with 3-vessel disease considered to be less complex… PCI is an acceptable alternative.
  3. All the data from patients with complex multivessel CAD should be reviewed and discussed by a cardiac surgeon and an interventional cardiologist, after which consensus on optimal treatment can be reached.

But Lange and Hillis, while they seem to largely agree with the study findings, also cast doubt on whether most physicians are likely to pay attention to the study details. They wonder whether most hospitals actually live up to the standards in the study, which requires, for each patient, a review of each patient by the multidisciplinary heart team, and the calculation of a complex SYNTAX score to establish the precise degree of risk.

Okay, let’s be honest….

  1. In your hospital, in what percentage of patients with left main or 3 vessel CAD are all the data systematically reviewed and discussed by a “Heart Team”?
  2. Do you calculate SYNTAX on all patients with left main or 3 vessel disease, or do you usually just “guestimate” lesion complexity?

If Lange and Hillis’s suspicions are correct, many people with complex coronary lesions are not receiving the best possible care. Hmmm.

‘Somebody has finally twigged that the heart and the lungs are joined up to each other and live in this space called the chest…’ 1

Here are a few gems from Richard Lehman’s weekly cardiovascular literature review. Read the whole thing on CardioExchange.

On a JAMA study showing that ramipril increases walking time in patients with intermittent claudication:

This is the kind of trial that makes nobody millions of dollars, but which we should all be doing in our fields of interest. It took just three interested hospitals in Southern Australia.

On a NEJM study studying rivaroxaban in acutely ill medical patients:

Rule One for selling reprints is that you make the conclusion of the Abstract as favourable as possible, because this is all that most clinicians read…

On Lancet study showing a close association between pneumonia and cardiovascular disease:

Golly, somebody has finally twigged that the heart and the lungs are joined up to each other and live in this space called the chest, or thorax. This could have major implications. We could start thinking of providing services for elderly breathless patients rather than making them wander from chest physicians to cardiologists and back again: we could tackle the problem of the post-hospital syndrome by attending to the cardiovascular risks of chest infections and the right ventricular contribution to heart failure; we could even ask patients what their main problems are and whether they are sufficiently addressed to make them feel safe at home. But all this requires a level of genius far beyond the reach of any known health service.

 

 

Richard Lehman On ICDs In Clinical Practice And Serelaxin For HF Reply

This week in CardioExchange Richard Lehman is not quite as funny as most weeks (perhaps he’s still recovering from New Years’ celebrations?), but he has some interesting and useful comments on a JAMA study comparing real world patients garcinia cambogia plant uses in registries to patients in clinical trials and an impressive Lancet study testing the role of the novel agent serelaxin in acute heart failure.

“So after much hard work and statistical legerdemain, the study shows that the mortality of real-life heart failure patients after ICD implantation for primary prevention is the same as that in the trials, and less than that of the control patients in the trials. Which I guess is a useful thing to know.”

….

 “I don’t think that by itself it changes practice in any way, but it does show that recombinant human relaxin 2, serelaxin, is an interesting new treatment that deserves further study in heart failure.”

Hypertension And Smoking Top List Of Global Risk Factors 1

Screen Shot 2012-12-13 at 2.57.27 PMWorldwide, hypertension and tobacco smoking are the single largest causes of death and disability, according to findings from the Global Burden of Disease Study 2010 (GBD 2010), the largest ever assessment and analysis of global health and disease. In an unprecedented move, the Lancet devoted an entire issue to the study, including seven separate articles and eight comments.

GBD 2010 was led by the Institute for Health Metrics and Evaluation (IHME) at the University of Washington. In a press release, IHME director Chris Murray said, “For decision-makers, health-sector leaders, researchers, and informed citizens, the global burden of disease approach provides an opportunity to see the big picture, to compare diseases, injuries, and risk factors, and to understand in a given place, time, and age-sex group, what are the most important contributors to health loss.”

Despite significant reductions in the rate of ischemic heart disease and stroke since 1990, overall these retained their position as the #1 and #2 worldwide causes of death. Among men 15-49 years of age, CV disease was the single largest cause of death, accounting for 12.8% of all deaths. For women of the same age CV disease was the third largest cause of death, following HIV/AIDS and other non-communicable diseases, accounting for 10.7% of all deaths.

Ischemic heart disease in 2010 now ranks as the largest single cause of global years of life lost. In 1990 it had ranked fourth, behind lower respiratory infections, diarrhea, and preterm birth complications. Stroke moved from fifth place to third place.

High blood pressure emerged as the single most important risk factor for death and disability, followed by tobacco smoking. In 1990 the top two risk factors were childhood underweight (#8 in 2010) and household pollution (#4 in 2010).

Lancet Editor Richard Horton Tweets Dark View of Contemporary Medicine 1

One brief message at a time, Lancet editor Richard Horton is tweeting his dark view of the contemporary medical establishment. If you have any interest at all in peeking behind the curtain to see what really goes on behind the scenes of top medical organizations then you need to follow Richard Horton’s Twitter feed. In sudden bursts of candor, humor, and cynicism, Horton has been tweeting thoughts that don’t often see the light of day.

Here’s his unvarnished opinion of the World Health Organization, for instance:

WHO is no longer a science-based organisation. WHO believes that scientists within the agency should be anonymous bureaucrats.

Science in WHO is seen as a dangerously subversive activity. Publication in journals brings the threat of disciplinary

And here’s a glimpse of the British side of the medical elite that we don’t normally see:

England is run by strange clubs. The Athenaeum is the one for high-ranking doctors. You can feel death oozing from the wood panels.

If you enter, you find cabals of Presidents/Professors plotting/sleeping in corners: an up-market rest home for the medical establishment.

And here’s the thread of tweets that prompted this post. It started a few weeks ago, and it’s about an ongoing editorial battle with authors and another highly respected journal. I can’t remember these sort of statements ever being made in public before, though these sort of stories are often discussed privately and always, to a journalist, off the record. The significance of these remarks is considerable. As Horton remarks at the end, the episode appears to lend evidence to the manipulation of journals by industry. (I’ve placed the tweets in chronological order to make them easier to read.)

When papers get salami sliced and divided between NEJM and us, it gets complicated. And sometimes nasty. And today, even threatening.

Now put to rest a terrible authorship dispute that has blocked an accepted paper for months. Crucial lesson: agree authors before starting.

The mother of all authorship disputes has broken out.

When papers get salami sliced and divided between NEJM and us, it gets complicated. And sometimes nasty. And today, even threatening.

In the saga of our salami sliced paper at NEJM and Lancet, both journals are now saying, it’s us or no go. This is getting silly.

NEJM/Lancet salami story, Part 164: US author writes to report “significant disagreement” among authors. We are told to suspend review…

Authors on both versions of what seems to be largely the same paper with our two journals to gather and resolve their dispute. We wait…

Lancet/NEJM salami latest. From Principal Investigator. “Approval [of the drug in question] has already occurred in the US, yet…

…private insurers are slow to place it on their formulary. A major publication is typically how this occurs in the US, and it is…

important to be in a journal typically recognised by US-based companies. This would include NEJM…Therefore, this publication is critical..

…to [company A’s] ability to “market” their product. Lancet, on the other hand, will aid [company Y] quite nicely.”

Is this first-hand evidence of journals being manipulated by pharma-sponsored authors for commercial goals?