Paper Raises Hundreds Of Questions About The Integrity Of Stem Cell Research Group

Serious questions have been raised about the integrity and validity of research performed by a well-established German stem cell research group. A paper published in the International Journal of Cardiology exhaustively details a multitude of discrepancies and contradictions in papers from the researcher’s group. Further, the revelation of such widespread misconduct may lead to broader disturbing questions about…

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New Anticoagulant Found Safe And Effective In Acute Venous Thromboembolism

In a large clinical trial the new oral anticoagulant apixaban (Eliquis, Pfizer and Bristol-Myers Squibb) was at least as effective as standard therapy and caused fewer bleeding complications in patients with acute venous thromboembolism. The results of the AMPLIFY (Apixaban for the Initial Management of Pulmonary Embolism and Deep-Vein Thrombosis as First-Line Therapy) trial are being presented on Monday at…

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FDA Turns Back New Indication For Rivaroxaban To Prevent Stent Thrombosis In ACS Patients

Johnson & Johnson said today that it had received a complete response letter from the FDA for the supplemental new drug application for rivaroxaban (Xarrelto) for the prevention of stent thrombosis in patients with acute coronary syndromes (ACS). Earlier this year the FDA turned down for the second time the sNDA for the  general use of rivaroxaban to…

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Novel Heart Failure Drug From Novartis Gains ‘Breakthrough Therapy’ Designation From FDA

Serelaxin, the novel therapy under development for the treatment of acute heart failure, has received a “breakthrough therapy” designation from the FDA, according to Novartis, the company developing the drug. The designation, the FDA explains, “is intended to expedite the development and review of drugs for serious or life-threatening conditions” and requires “preliminary clinical evidence that demonstrates the…

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Roller Coaster Path To Approval For Eliquis Uncovered By FDA Documents

After the presentation and publication of the pivotal ARISTOTLE trial,  the novel anticoagulant apixaban (Eliquis, Pfizer and BristolMyers Squibb) was widely expected to be  a blockbuster. But then it got bogged down at the FDA where initial hopes for a speedy approval were dashed after highly critical reviews. Ultimately approval of the drug was delayed for 9…

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FDA Raises Concerns About The Cybersecurity Of Medical Devices

The FDA has raised concerns about the vulnerability of medical devices to cyberattack. In one dramatic instance, reported by the Wall Street Journal, a VA catheterization laboratory in New Jersey was temporarily closed after malware infected the lab’s computer devices.   … Halamka offered some additional perspective on the problem to the Washington Post: “There’s almost no medical…

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Hot Line Trials For European Society Of Cardiology Congress Announced

The European Society of Cardiology has published the full program for the 2013 Congress taking place in Amsterdam from August 31 through September 4. There will be 4 Hot Line Sessions. Here is the schedule for Hot Line trials: … Click here to read the full post on Forbes.      …

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New Trend? Free Tablet Computers For All Registrants At TCT Meeting

Cardiologists and others who attend this year’s TCT meeting in San Francisco will receive a free tablet computer. TCT is the highly influential interventional cardiology meeting run by the Cardiovascular Research Foundation. This year it will take place in San Francisco from October 27 through November 1. Heavily promoted in emails and on the site’s webpage, TCT is promising that…

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With One Big Exception FDA Reviewers Back More Benign View Of Avandia Trial

  The FDA today released a 538-page briefing document for an advisory panel meeting on Wednesday and Thursday that will reassess a key clinical trial and reconsider the fate of the now-tarnished former blockbuster diabetes drug rosiglitazone (Avandia, GlaxoSmithKline). (Click here for the FDA documents.) As reported last week, the re-adjudication of the RECORD safety trial performed…

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A CME Program Begs The Question: Promotion Or Education?

In recent years defenders of commercially-supported continuing medical education (CME) have claimed that the industry has cleaned up its act and that CME programs today are largely free of the abuses that were so common not so long ago. Perhaps. But there are still plenty of examples of programs that violate the fundamental principle that…

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Two FDA Officials Quarrel Over Safety Of Angiotensin Receptor Blockers

Two FDA officials are quarreling in public about their different views about the safety of angiotensin-receptor blockers (ARBs), according to a story by Thomas Burton in Friday’s Wall Street Journal. One official, Thomas Marciniak, contends that ARBs may increase the risk of cancer. Marciniak has been a vocal critic of FDA’s efforts to assess drug  safety. In…

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Independent Re-Adjudication Of RECORD Confirms Safety Of Rosiglitazone

An independent re-adjudication of the RECORD trial has confirmed the original findings of the trial, that rosiglitazone d0es not increase cardiovascular risk. But critics of the trial and the drug are unlikely to be appeased by the new result. The re-adjudication of RECORD will be the subject of an extraordinary two-day FDA advisory committee meeting next…

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Candidate Therapeutic Target For Pulmonary Arterial Hypertension Identified

I don’t normally write about pre-clinical research but my friend and CardioExchange colleague John Ryan has been on a tear lately (he even won a Young Investigator award from the AHA last year) with some fascinating and potentially important research. Briefly, and, I hope, not too simply, Ryan’s research may have uncovered a key mechanism underlying the…

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Rivaroxaban Gains Approval In Europe For ACS Indication

Rivaroxaban (Xarelto, Bayer) has been approved in Europe for the prevention of atherothrombotic events (cardiovascular death, myocardial infarction or stroke) following an acute coronary syndrome (ACS). The drug was approved at a dose of 2.5 mg twice-daily and should be used in combination with standard antiplatelet therapy. Rivaroxaban is now the only oral anticoagulant to receive an…

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Spinning RECORD: Battle Over Rosiglitazone Heats Up Two Weeks Before Crucial FDA Meeting

Battle lines are being drawn two weeks before a highly unusual two-day FDA advisory committee meeting to discuss the contentious diabetes drug rosiglitazone (Avandia, GlaxoSmithKline). This will be the second time an FDA panel has wrestled with the fate of the drug and expectations have been that the discussion will once again be heated. But at…

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Novartis Acknowledges Employees Participated In ‘Independent’ Trials

Novartis has acknowledged that employees of the company participated in five “independent” investigator-initiated post-registration trials without disclosing their relationship to the company. The company said that a broader “comprehensive investigation with independent third party experts is ongoing” but that it has “provided an update” to Japanese medical societies and to the principal investigators of the five…

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European Medicines Agency Starts Review of Combined Use Of Drugs That Block The Renin-Angiotensin System

The European Medicines Agency said last week that it was initiating a review of the combined use of agents that block the renin-angiotensin system (RAS). The three classes of RAS-blocking drugs (ACE inhibitors, ARBs, and direct renin inhibitors) are used to treat hypertension and congestive heart failure. The EMA said that the review was being performed to…

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Instagram for Heart Attacks: iPhone App Speeds ECG Transmission To Hospital

In the crucial early stages of a possible heart attack, EMTs on the scene now rely on slow and unreliable proprietary technology to transmit vital ECG data to physicians at a hospital for evaluation. But a new iPhone app using standard cell phone networks may help speed the process and, ultimately,  cut delays in treatment…

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Salt Report From IOM Sparks Much Heat, Only A Little Light

An Institute of Medicine report on salt earlier this week sparked a lot of controversy. The report concludes that there’s no evidence to support current efforts to lower salt consumption to less than 2,300 mg/day. Unfortunately, the press coverage offered little insight into the science behind the issue. On the Knight Science Journalism Tracker blog,…

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Suspicions Raised About Another Japanese Cardiovascular Researcher

Significant questions about research misconduct have been raised about a prominent Japanese cardiovascular researcher, Issei Komuro. Last year a Nature paper on which Komuro served as a co-author was corrected because “several images were mistakenly switched or duplicated during preparation of the artwork.” The Nature correction states that the “corrections do not alter any of…

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Burton Sobel, Towering Cardiologist, Dead At 75

Burton Sobel, a towering scientist and cardiologist, died at home on May 3 at the age of 75. Sobel had been treated in the past for prostate cancer and had suffered a recurrence, but it is not known if this was the immediate cause of his death. Sobel was among the most powerful and influential…

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FDA Approves Combination Of Ezetimibe And Atorvastatin

The FDA has approved a new combination drug from Merck for lowering cholesterol. The drug, which will carry the brand name of Liptruzet, is a combination of two previously approved cholesterol-lowering drugs, ezetimibe and atorvastatin. Merck said the new drug (pronounced “LIP-true-zett”) would be commercially available starting next week. Liptruzet will be available as a…

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Scrutiny Of Sodium Meta-Analysis In Heart Uncovers Duplicated And Missing Data

A meta-analysis published in the journal Heart has been retracted. As Adam Marcus writes in Retraction Watch, the retraction occurred when the journal editors learned “that two of the six studies included in the review contained duplicated data.  Those studies, it so happens, were conducted by one of the co-authors [of the meta-analysis].” The article,…

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

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…

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Danish Study Finds No Increased CV Risk With Azithromycin In General Population

A large observational study found no increased risk for cardiovascular events associated with azithromycin (Zithromax, Pfizer) in a general population of young and middle-age adults. In a paper published  in the New England Journal of Medicine, Danish investigators report the results of a large national observational study comparing people who took azithromycin with matched controls…

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