Newly Elected European Society Of Cardiology President Co-Authored Hundreds Of Papers With Don Poldermans Reply

The ESC today announced that Jeroen Bax, a Dutch cardiologist, will serve as the group’s President Elect for the next two years before becoming President starting in 2016. Bax is a professor of cardiology at Leiden University Medical Center.

Bax is also known for his very close collaboration with Don Poldermans, the disgraced Dutch researcher who has been accused of significant and multiple examples of scientific misconduct.

Click here to read the full post on Forbes.

 

 

 

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Early Hint At Cardiovascular Outcomes With Sanofi’s and Regeneron’s Rapidly Advancing Cholesterol Drug Reply

Amid a slew of new data demonstrating yet again that PCSK9 inhibitors lower LDL cholesterol– drastically and in a wide variety of different patient populations– data from one trial offers the first suggestion that the drugs may in fact improve cardiovascular outcomes. But the analysis, the authors cautioned, is a post-hoc analysis of a trial neither designed nor powered to study outcomes, so should be considered preliminary and speculative at best.

Four phase 3 trials with the Sanofi and Regeneron PCSK9 inhibitor alirocumab (pronounced “allee rock you mab” by Chris Cannon at a news conference) were presented today at the European Society of Cardiology meeting in Barcelona.

Click here to read the full post on Forbes.

 

SIGNIFY Trial Provokes Sound And Fury Over Controversial Servier and Amgen Drug Reply

The controversial drug ivabradine just got a little more controversial. The drug, which is marketed by Servier under the brand names of Corlentor and Procoralan, is available in Europe and elsewhere and is used for the treatment of heart failure and stable angina. The drug is not available in the US, but it is under development by Amgen for a heart failure indication.

Now a very large new study presented at the European Society of Cardiology meeting in Barcelona and published simultaneously in the New England Journal of Medicine has found no evidence of benefit in a stable angina population and found more adverse events associated with the drug and even suggested the likelihood of harm in a very large and important trial subgroup. The findings have resulted in an investigation by the European Medicines Agency, placing a cloud over the future status of the drug.

Click here to read the full post on Forbes.

 

Silencio! Claiming Pressure From European Regulators, Trial Leaders Cancel Press Conference Reply

Investigators of the much-anticipated and controversial SIGNIFY trial have told the European Society of Cardiology leadership that they will not participate in a previously scheduled press conference on Sunday at the society’s main meeting in Barcelona. But they say they will present the main results of their trial at a Hot Line session later in the afternoon.

According to the ESC, the SIGNIFY investigators, who include Kim Fox, Ian Ford, Philippe Gabriel Steg, Jean-Claude Tardif, Michal Tendera, and Roberto Ferrari, told the ESC leadership that regulators at the European Medicines Authority (EMA) had told the investigators that because they (the investigators) were scheduled to appear before the EMA they should not discuss or comment on their trial outside the official presentation at the ESC conference.

Click here to read the full post on Forbes.

 

 

 

PARADIGM-HF Establishes a New Paradigm for Heart Failure Treatment Reply

So far as I can tell the only problem with PARADIGM-HF is that the results are so good that it’s boring. Anyone interested can reasonably assume that what they hear or read about PARADIGM-HF — and cardiologists will be seeing and hearing an awful lot about it —  will be overwhelmingly positive.

Briefly, the trial did everything its sponsor (Novartis) and its investigators (led by Milton Packer and John McMurray) hoped. It met all its major endpoints in all the subgroups without raising any sort of a safety signal. If the findings are confirmed after a rigorous FDA review, then Novartis will likely have a blockbuster on its hand.

All the excitement is over a new drug still known only by its number, LCZ696.

Click here to read the full post on Forbes, including a detailed interview with Milton Packer.

 

Predicting PARADIGM-HF, Or What To Expect When You’re Expecting Reply

The wait is almost over. For the last 5 months the most eagerly awaited trial in the cardiovascular universe has been PARADIGM-HF, the large (8,500 patient) trial of a new and novel heart failure drug from Novartis. If reality lives up to the early hope and hype, the drug, LCZ696, could completely reshape the heart failure landscape and give Novartis that rarest of gems, a new and genuine blockbuster cardiovascular drug.

The main results of the trial will first be presented at a press conference in Barcelona, Spain this Saturday in connection with the annual meeting of the European College of Cardiology.

Click here to read the full post on Forbes.

 

Rise In Popularity Of E-Cigarettes Sparks Concerns And Recommendations Reply

The recent dramatic rise in popularity of e-cigarettes threatens to reverse hard-fought progress in the war against smoking, according to a new policy statement from the American Heart Association. “E-cigarettes have caused a major shift in the tobacco-control landscape,” said the lead author of the statement, Aruni Bhatnagar, chair of cardiovascular medicine at the University of Louisville.

But the AHA did not completely reject the use of e-cigarettes as an aid to stop smoking.

Click here to read the full post on Forbes.

 

Why Guidelines Should Be Waged Like War 1

Here’s a modest proposal: we need fewer and shorter guidelines. In fact, I’d like to propose that guidelines, like war, should be waged only when there is absolute consensus and overwhelming evidence.

Anyone interested in the subject is aware that guidelines are in a complete mess.

Click here to read the full post on Forbes.

United Nations Security Council Resolution 707

United Nations Security Council Resolution 707 (Photo credit: Wikipedia)

 

US Department Of Justice Ends Investigation Of AstraZenca Trial Reply

AstraZeneca announced today that the US Department of Justice has ended its investigation into alleged misconduct associated with the pivotal PLATO trial. The company said it had fully cooperated with the investigation, which began in October of 2013.

Click here to read the full post on Forbes.

 

An Old Study Fuels Debate Over Blood Pressure Guidelines Reply

In the last year new guidelines relating to cardiovascular disease have been the subject of intense criticism and debate. The status of the blood pressure guidelines has been particularly contentious, since several different groups have published contradictory guidelines, while several authors of the most prominent group, the Eighth Joint National Committee, published an impassioned dissent from their own published guideline. Many hypertension experts have taken aim at the change in therapeutic target for systolic blood pressure in patients age 60 or older, from 140 mm Hg to 150 mm Hg.

In an attempt to determine the optimal blood pressure for patients age 60 or older, Sripal Bangalore and colleagues performed a post-hoc analysis of 8,354 patients who participated in the INVEST trial, who were age 60 or older, and who had a baseline systolic blood pressure greater than 150 mm Hg…

Click here to read the full post on Forbes, including comments from Sripal Bangalore and Harlan Krumholz.

 

An Expert’s Perspective: Why Salt Is Not Like Tobacco And Why Guidelines Are Tricky Reply

At the center of this week’s renewed debate on salt was Salim Yusuf, the long influential and often controversial cardiology researcher and clinical trialist based at McMaster University in Hamilton, Ontario. I spoke with Yusuf before the publication of the New England Journal of Medicine papers, which include his own two papers from the PURE study.

Yusuf was troubled by the tone of the salt debate. He’s no stranger to scientific controversies and intense disagreement, but “scientific criticism is one thing, personal attack is another,” he said. Because he has presented data that suggests that moderately high levels of sodium may not be as bad as some had thought, and that very low levels of sodium may actually be harmful, “we’ve come under huge attack.”

Click here to read the full post on Forbes.

 

New Studies Fuel The Debate Over Sodium Reply

Three papers and an editorial in the New England Journal of Medicine are sure to throw fresh fuel on the ongoing fiery debate over sodium recommendations. Current guidelines recommend that people should limit their intake of sodium to 1.5  to 2.4 grams per day, but these recommendations are based on projections and have never been tested in clinical trials or other large studies.

Two papers from the  ongoing Prospective Urban Rural Epidemiology (PURE) study offer fresh evidence against the low sodium recommendations.

Click here to read the full post on Forbes.

 

The Complicated Story Behind Yet Another Disappeared Article At A Top Heart Journal Reply

Once again the European Heart Journal has “unpublished” an article without any notice of retraction or explanation. Strangely, the article– Russian science through the prism of intelligence: is fraud still possible?– can still be viewed (at least for now) with a vestigial URL , but it can not be found through the usual channels on the journal site. The pages for the story on PubMed and the EHJ site now state: “This article has been temporarily removed.”

…a more careful examination of the original article leads to the suspicion that this story is a bit more complicated and raises questions both about the internal peer review process at the EHJ and about the original paper.

Click here to read the full post on Forbes.

 

IMPROVE-IT Trial Scheduled For Presentation In November Reply

Results of the eagerly-awaited and highly controversial IMPROVE-IT trial are finally going to be revealed. The American Heart Association has announced that the  trial will be presented by Chris Cannon on November 17 at 11:51 AM (central time) in Chicago at the group’s annual scientific sessions . IMPROVE-IT compared the effect on cardiovascular outcomes of the statin simvastatin with Vytorin (the combination of simvastatin and ezetimibe, manufactured by Merck) in more than 18,000 patients with acute coronary syndromes.

Both Vytorin and IMPROVE-IT have been the subject of considerable controversy.

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Principal Investigator Of Suspended Cytori Stem Cell Trials Remains Hopeful Reply

Shares of Cytori Therapeutics took a big bit hit today after the company disclosed in a press release that it had suspended enrollment in its ATHENA and ATHENA II trials. This kind of news is never a good sign, but the   principal investigator of the trial tells me that he believes the current problems are surmountable and that the trials are still viable.

Click here to read the full post on Forbes.

 

No Retraction For You! Review Panel Exonerates Medical Journal In Statin Kerfuffle Reply

An independent review panel has rejected a demand by a prominent researcher that TheBMJ retract two controversial articles. The report largely exonerates the journal’s editors from any wrongdoing.

As previously reported, Rory Collins, a prominent researcher and head of the Cholesterol Treatment Trialists’ (CTT) Collaboration, had demanded that TheBMJ retract two articles that were highly critical of statins. Although TheBMJ issued a correction for both papers for inaccurately citing an earlier publication and therefore overstating the incidence of adverse effects of statins, this response did not satisfy Collins. He repeatedly demanded that the journal issue a full retraction of the articles, prompting TheBMJ’s editor-in-chief, Fiona Godlee, to convene an outside panel of experts to review the problem.

The report of the independent statins review panel exonerates TheBMJ from wrongdoing and said the controversial articles should not be retracted:

Click here to read the full post on Forbes.

 

Guideline Critics Shift Attacks From Beta Blockers To Statins Reply

With the release today of updated European and US guidelines the ongoing controversy regarding beta-blockers appears to be resolved. But that doesn’t necessarily mean there will be an outbreak of guideline peace and harmony. The critics who helped ignite the controversy over beta blockers now say new statin recommendations contained in the guidelines are based on deeply flawed evidence.

Both the new European and US guidelines say that preoperative initiation of statin therapy may be considered in patients undergoing vascular surgery and that people already taking statins should continue taking them. Now some of the same critics who attacked the reliability of the beta blocker guideline say that this recommendation is not supported by the evidence.

Click here to read the full post on Forbes.

 

 

 

Dutch Investigation Finds Serious Flaws In Influential New England Journal Of Medicine Study Reply

Erasmus Medical Center says it has wrapped up its investigation of Don Poldermans, the disgraced cardiology researcher who was fired for research misconduct. The full extent of the misconduct has never been known, and from an examination of the Erasmus report it appears likely that it never will be known.

One major finding– though downplayed in the medical center’s press release– is that the most prestigious and influential publication from the Poldermans’ group, the 1999 publication of the DECREASE 1 study in the New England Journal of Medicine– appears to be riddled with serious problems.

Click here to read the full post on Forbes.

 

 

Medicine faculty of the Erasmus MC, taken in t...

Medicine faculty of the Erasmus MC, taken in the afternoon (Photo credit: Wikipedia)

 

More Questions Raised About Boehringer Ingelheim’s Pradaxa 1

Once again dabigatran (Pradaxa) has raised the wrath of the critics. Several articles and an editorial published today in The BMJ raise more questions and concerns about the drug, which is the first of the new oral anticoagulants. Relying on new evidence along with previously disclosed data, Deborah Cohen, the  investigations editor for The BMJ, casts doubt on the reliability of the data supporting the drug as well as the behavior and decisions of regulatory authorities, trial investigators, and employees  of Boehringer Ingelheim, the drug’s manufacturer.

Click here to read the full post on Forbes.

 

Cleveland Clinic Once Again Tops Heart Hospital Rankings Reply

For the twentieth year in a row the Cleveland Clinic made the #1 spot on the US News & World Report‘s annual ranking of heart hospitals. The Cleveland Clinic was 4th in the overall category. For the first time the Mayo Clinic was the top hospital overall, beating long-time rivals Massachusetts General and Johns Hopkins.

As I’ve stated before, I am not a big fan of these sort of ratings. But irrational as they may be they often have enormous practical significance.

Here’s the top 20:

Click here to read the full post on Forbes.

 

FDA Once Again Reaches Conclusions At Odds With Its Own Staff Reply

Once again the FDA has reached a conclusion that is directly opposed by some of its own scientists.  Last month the FDA affirmed the safety of olmesartan, a popular blood pressure lowering drug (sold as Benicar and other names). But that reassuring view is not shared by the  FDA scientists who performed the study that provided the basis for the review. And now outside experts are also raising concerns about the drug.

Back in 2010 the FDA said that it was initiating a safety review of olmesartan due to troubling findings from 2 clinical trials that raised the possibility that patients with type 2 diabetes taking olmesartan might have an increased risk of cardiovascular death. Four years later the FDA announced  that it had completed that review.

Click here to read the full post on Forbes, including comments from Sanjay Kaul and Franz Messerli and Sripal Bangalore.

FDA Places Clinical Hold On Phase 3 Trial Of Novel Anticoagulant Reply

A highly promising novel anticoagulant system now appears to be in serious difficulty. Regado Biosciences announced today that the FDA had placed a “clinical hold” on patient enrollment and dosing in the REGULATE-PCI trial, which is testing the Revolixys anticoagulation system. Revolixys consists of the Factor IX inhibitor pegnivacogin and an agent, anivamersen, which reverses its anticoagulant effect.

REGULATE-PCI is a phase 3 trial comparing Revolixys to bivalirudin (Angiomax, The Medicines Company) in 13,000 patients undergoing PCI.

Click here to read the full post on Forbes.

 

 

 

Controversial Trial Finds No Benefit For Expensive Medicines Company Drug Reply

Although there is broad consensus in the medical community that primary PCI is the best treatment for heart attack patients when it can be delivered promptly, there is no agreement about the best accompanying drug regimen, which usually entails a combination of antiplatelet and antithrombotic drugs. The role of one antithrombotic, bivalirudin (Angiomax, The Medicines Company) has been particularly uncertain because it is far more expensive than its alternative, unfractionated heparin.

HEAT-PPCI was designed to help settle this problem.

Click here to read the full post on Forbes.

 

Merck Uses Legal Threats To Stifle Negative Advice About Zetia And Vytorin In Italy Reply

In response to repeated legal threats, a public health doctor in Italy has withdrawn advice to curtail use of a controversial drug. The drug, ezetimibe, is a key ingredient in Zetia and Vytorin, which is manufactured by Merck. The cholesterol-lowering drug has been the subject of fierce controversy because it has never been shown to improve clinical outcomes. Despite the controversy, in 2013 the drugs had combined sales of more than $2.6 billion.

MSD Italy, the Italian arm of the company, sent two “cease and desist” letters to Alberto Donzelli, who is “the head of education, appropriateness, and evidence based medicine at the public health authority of Milan (Milan Healthcare),” according to The  BMJwhich published a news report of the affair.

Click here to read the full post on Forbes.

 

More Sunshine: CMS Wants Companies To Report Payments To Physicians For Medical Education Reply

In a major reversal of policy, CMS wants industry to report payments to physicians for continuing medical education. The move would eliminate from the Physician Payment Sunshine Act the current exemption for CME.

Initially CMS’s  proposal for implementation of the Sunshine Act required industry to report payments to physicians for CME programs. But after considerable debate and lobbying from industry, the final rule included an exemption. As a result, companies are not now required to report payments to speakers at accredited CME events as long as the companies don’t select the speakers or directly pay them.

CMS now appears to have changed its mind. Near the end of its list of proposed changes for next year, CMS is proposing to eliminate the exemption:

Click here to read the full post on Forbes.