Embattled Stem Cell Researchers Sue Harvard And Brigham And Women’s Hospital Reply

Two embattled and highly controversial stem cell researchers are suing the Brigham and Women’s Hospital and Harvard Medical School for an ongoing investigation into their research. The investigation has already resulted in the retraction of one paper in Circulation and an expression of concern about another paper in the Lancet.

The suit was filed by Piero Anversa, the highly prominent stem cell researcher who is a Harvard professor and the head of a large lab at the Brigham, and his longtime colleague, Annarosa Leri, an associate professor of medicine at Harvard who has coauthored many papers with Anversa. The suit places the blame for any scientific misconduct relating to the two papers on a third colleague and coauthor, Jan Kajstura, their longtime collaborator.

Click here to read the full post on Forbes.

 

New Devices May Bring Improved Treatment To Stroke Patients Reply

A large new trial provides the first substantial evidence that new devices can improve the outcome of patients who have acute ischemic stroke. Earlier, less sophisticated versions of the devices had produced disappointing results in clinical trials. The previous trials may also have been hindered by long treatment delays and difficulties in recruiting suitable patients. The new devices are retrievable stents that extract blood clots from inside vessels.

MR CLEAN (The Multicenter Randomized Clinical Trial of Endovascular Treatment for Acute Ischemic Stroke in the Netherlands), published in the New England Journal of Medicine today,  was designed to address the limitations of these previous trials. 500 patients with ischemic stroke were randomized to usual care or the addition of intraarterial treatment within 6 hours of symptom onset.

Click here to read the full post on Forbes.

 

Continuing Medical Education Payments To Physicians Will Be Exposed To Sunshine Reply

After a long and complicated struggle it now appears highly likely that industry will be required to disclose payments to physicians for continuing medical education (CME). This decision from CMS, which I am told by reliable sources is final, follows a long period in which CMS appeared to waver in its approach to incorporating CME into the Sunshine Act.

Click here to read the full post on Forbes.

 

No Advantage For Low Glycemic Index Diet Reply

In recent years the glycemic index (GI), a measure of a carbohydrate’s impact on blood sugar, has assumed a major role in discussions about diets and nutrition. Now a new study suggests that by itself, within the context of an otherwise healthy diet, GI may not be an important factor in improving cardiovascular risk.

In a paper published in JAMA, Frank Sacks and colleagues report the results of a randomized, crossover-controlled 5-week feeding trial comparing 4 different diets in 163 overweight or obese adults. The diets were either low- or high-carb and either low- or high-GI. Importantly, all the diets were based on previously established healthy dietary patterns based on the DASH diet, which is low in saturated and total fat and includes substantial amounts of fruits, vegetables, and low-fat dairy foods.

Click here to read the full post on Forbes.

 

Get Rid of Sugar, Not Salt, Say Authors Reply

Too much negative attention has been focused on salt and not enough on sugar, write two authors in Open Heart. Reviewing the extensive literature on salt and sugar, they write that the adverse effects of salt are less than the adverse effects of sugar. The evidence supporting efforts to reduce salt in the diet is not convincing and we would be far better off reducing sugar instead of salt in the modern diet.

Click here to read the full post on Forbes.

 

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New Drug From Isis Breaks Important Ground But Unlikely To Dent The Market Reply

The first important results with a new drug under development by Isis Pharmaceuticals may well have an enormous long term impact on our understanding of how blood flows through the body and how that same blood forms clots in response to damage and disease. But it appears unlikely that the new drug– an anticoagulant unlike anything else now available–  will have a major impact on the large and important anticoagulant market.

FXI-ASO, under development by Isis, is an antisense oligonucleotide that reduces the level of factor XI, a key component of the intrinsic (contact) coagulation pathway. All the currently available anticoagulants target the extrinsic (tissue factor) coagulation pathway.

Click here to read the full post on Forbes, including detailed perspectives by Sanjay Kaul and Ethan Weiss.

 

Women: Don’t Use Aspirin For Routine Prevention Of Heart Attacks, Stroke, And Cancer Reply

Although once widely recommended, aspirin for the prevention of a first heart attack or stroke (primary prevention) has lost favor in recent years, as the large number of bleeding complications appeared to offset the reduction in cardiovascular events. But at the same time evidence has emerged demonstrating the long-term effect of aspirin in preventing colorectal cancer, leading some to think that the risk-to-benefit equation for aspirin should be reconsidered.

Investigators in the Women’s Health Study therefore analyzed long-term followup data from 27,939 women who were randomized to placebo or 100 mg aspirin every other day.

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No, The Mediterranean Diet Won’t Help You Live Forever Reply

A new study published today provides fresh evidence for the healthful effects of the Mediterranean Diet. It even suggests that people who follow the Mediterranean Diet may live longer than people on most other diets. And this is just the latest piece of good news about this diet to appear in the last few years. But I want to warn my readers not to go overboard with this study. It appears to be an excellent, well-performed study, but it has many inherent limitations and is by no means definitive. In the long run it may raise as many questions as it answers.

The new study, published in The BMJfinds that women who more closely followed a Mediterranean diet had longer telomeres on the end of their chromosomes…

Click here to read the full post on Forbes.

 

Study Suggests Epinephrine for Cardiac Arrest May Be Harmful Reply

Epinephrine has been a cornerstone of therapy during cardiac resuscitation after cardiac arrest because of its well-established ability to stimulate the heart and increase the probability of a return of spontaneous circulation (ROSC). In recent years, however, concerns have been raised that people treated with epinephrine may have worse neurological outcomes following their resuscitation.

In a study published in the Journal of the American College of Cardiology, French researchers analyzed data from more than 1,500 patients who were successfully resuscitated after an out-of-hospital cardiac arrest and were subsequently treated at a large hospital in Paris….

Click here to read the full post on Forbes.

 

European Review Confirms Increased Risk with Ivabradine Reply

Following a review provoked by troubling findings that emerged from a large clinical trial, the European Medicines Agency (EMA) is making several recommendations intended to lower the risk of heart problems linked to the heart-rate-lowering drug ivabradine. The drug is marketed by Servier in Europe under the brand names of Corlentor and Procoralan and is indicated for the treatment of heart failure and stable angina. The drug is not available in the U.S. but is under development by Amgen for the indication of heart failure.

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Intent To Tweet And A Failure Of Communication Reply

For more than 15 years I’ve been trying to figure out how physicians can get involved with social media without devolving into Beliebers. It’s not easy. I often joke that the job is a bit like being the social director on a cruise for people with Asperger’s. But here’s the twist: it’s easy to be the social director on a cruise for sorority sisters and fraternity brothers, but you’re not really going to bring anything to the party that they won’t bring themselves. By contrast, those Asperger’s cruisers, just like many doctors, really need help making good use of social media.

A new study published in the venerable medical journal Circulation is a great example of the problems traditional medicine is having trying to figure out social media….

Click here to read the entire post on Forbes.

 

Losartan No Better Than Atenolol in Marfan’s Syndrome Reply

Beta-blockers have been the standard treatment for people with Marfan’s syndrome, a rare inherited connective tissue disorder that affects about 1 in 5000 people. The goal of treatment is to prevent or slow down the dilation of the aorta and avoid aortic dissection, the main cause of death. In recent years, studies have raised the hope that losartan, an angiotensin receptor blocker, might be more effective than beta-blockers in slowing aortic enlargement.

The Pediatric Heart Network Investigators randomized 608 children and young adults with Marfan’s syndrome to the beta-blocker atenolol or losartan….

Click here to read the full post on Forbes.

 

 

HDL Raising Drugs Probably Won’t Work But This Might 1

A new study offers important new insights into the protective role of HDL cholesterol (the “good” cholesterol) against cardiovascular disease. Earlier studies with drugs that increase HDL levels, including niacin and CETP inhibitors, have not shown benefit. The new study suggests that simply increasing HDL levels isn’t the way to go. Instead, cholesterol efflux, the ability of HDL to remove cholesterol from cells, part of the process called reverse cholesterol transport, appears to be the key. The results were presented today by Anand Rohatgi at the American Heart Association meeting in Chicago and published simultaneously in the New England Journal of Medicine.

The investigators followed 2,416 people participating in the Dallas Heart Study who were free of cardiovascular disease at the start for 9.4 years….

Click here to read the full post on Forbes.

 

Large Japanese Trial Casts Further Doubt On Aspirin To Prevent A First Heart Attack Reply

Although once quite popular, the use of aspirin to prevent a first heart attack has grown less popular in recent years as evidence has accumulated that the small benefits are outweighed by the increased risk of bleeding. Now a large trial from Japan has once again failed to provide any evidence to support the use of routine aspirin in high risk elderly people to prevent a first cardiovascular event.

The Japanese Primary Prevention Project (JPPP),  presented at the American Heart Association meeting in Chicago and published simultaneously in JAMA, enrolled  patients between 60 and 85 years of age with  hypertension, dyslipidemia, or diabetes. The open label study randomized 14,464 patients to aspirin 100 mg once daily or no aspirin in addition to conventional therapy. Patients were followed for up to 6.5 years for the primary combined endpoint of cardiovascular death, nonfatal stroke, or nonfatal MI….

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IMPROVE-IT Meets Endpoint And Demonstrates Real But Modest Clinical Benefit For Ezetimibe Reply

After all the waiting and all the controversy it turned out to be pretty simple. The IMPROVE-IT trial did what it set out to do and reached its primary endpoint. The benefit wasn’t very big or impressive but it will be enough to put to rest concerns that ezetimibe might have been an expensive placebo or that LDL might not be a reliable surrogate endpoint. The IMPROVE-IT results will also provide comfort to companies developing the next generation of cholesterol drugs, since their approval may have depended on validation of LDL as a surrogate endpoint.

The  Improved Reduction of Outcomes: Vytorin Efficacy International Trial, presented Monday morning at the American Heart Association meeting in Chicago, randomized 18,144 high-risk patients within 10 days of an acute coronary event to either ezetimibe or placebo on top of a statin….

Click here to read the full post on Forbes.

Cannon

Big Study Looks At Length of Drug Treatment After Stent Implantation Reply

The advent of drug-eluting stents dramatically reduced the restenosis (reclogging) rate associated with bare-metal stents but prompted new concerns about the rare but potentially lethal complication of stent thrombosis (ST). Cardiologists have relied upon dual antiplatelet therapy to prevent ST but there has been considerable uncertainty and controversy about the ideal duration of therapy.

The Dual Antiplatelet Therapy (DAPT) trial was coordinated by the Harvard Clinical Research Institute as part of a large-scale collaboration with the FDA, stent manufacturers, and pharmaceutical companies…. The main results of the trial were presented on Sunday at the American Heart Association meeting in Chicago and published simultaneously in the New England Journal of Medicine.

Click here to read the full post on Forbes.

 

At the American Heart Association Meeting You Really Can’t Escape The New Cholesterol Drugs 1

There’s no escaping them. At the American Heart Association in Chicago going on right now Amgen and Sanofi/Regeneron, which are developing competing cholesterol lowering drugs known as PCSK9 inhibitors, have mounted a full scale attack to capture the eyeballs and the brains of cardiologists and any other innocent bystanders who happen to be at the McCormick convention center.

Click here to read the full post on Forbes.

Amgen Door Hanger

 

IMPROVE-IT Trial Paper Won’t Be Published Right Away In The New England Journal Of Medicine 1

The presentation of the eagerly awaited IMPROVE-IT trial, scheduled for Monday at the American Heart Association meeting, won’t be accompanied by a simultaneous publication in the New England Journal of Medicine. Although no one except for a small group of insiders knows for sure, this news may have important implications.

Click here to read the full post on Forbes.

 

Newly Identified Mutations Act Like a Lifetime of Treatment with Ezetimibe Reply

A very large genetic study published in the New England Journal of Medicine offers compelling evidence in support of a central role for LDL cholesterol in coronary heart disease.

In a series of studies analyzing blood samples from nearly 100,000 people, Sekar Kathiresan and colleagues identified 15 rare mutations that block the activity of a single gene — called Niemann-Pick C1-Like 1 (NPC1L1). The mean LDL level was 12 mg/dL lower in mutation carriers than noncarriers. There were just 11 carriers of the mutations among 29,954 people with CHD versus 71 carriers among 83,140 people without known CHD (carrier frequency: 0.04% vs. 0.09%).  This worked out to a 53% reduction in CHD risk for mutation carriers.

Click here to read the full post on Forbes, including comments from James Stein, Sekar Kathiresan, and Harlan Krumholz.

Popular Diets Achieve Only Modest Long-Term Weight Loss Reply

Four of the most popular current weight loss diets produce at best only modest long-term benefits, a new study published in Circulation: Cardiovascular Quality and Outcomes shows. The study also found few significant differences across the four diets, offering little hope that any one diet can produce a serious dent in the obesity epidemic.

Mark Eisenberg and colleagues systematically searched the literature for studies evaluating the effects of the Atkins, South Beach, Zone, and Weight Watchers diets. They identified 12 randomized, controlled studies with follow-up of at least 1 year. Ten studies compared one of the diets with usual care. In these trials, Weight Watchers was the only diet to consistently outperform usual care in achieving weight loss, but this difference was modest at best, yielding a 1-year weight loss range of 3.5 to 6 kg with Weight Watchers compared with 0.8 to 5.4 kg with usual care. In the two head-to-head trials, Atkins and Zone resulted in a similar but modest weight loss. Longer-term data out to 2 years — available only for the Weight Watchers and Atkins diets– showed that some of the original weight loss was regained over time. Only one small trial studied the South Beach diet.

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What You Need To Know About IMPROVE-IT Reply

The IMPROVE-IT trial will be big news when its results are finally presented on November 17 during the annual meeting of the American Heart Association. The results of the trial–underway for nearly a decade– have been long and eagerly awaited by everyone interested in cardiovascular medicine.  The trial could impact the future sales of a key Merck drug, ezetimibe, though because it is nearing the end of its patent life the commercial significance is somewhat limited. However, IMPROVE-IT will also have very important implications beyond its specific effect on one drug franchise and could influence the fate of several new drugs now being investigated and may even alter the entire drug development and evaluation process.

Here’s some background information and links to useful resources.

Click here to read the full post on Forbes.

 

Nonobstructive Coronary Artery Disease Linked to Elevated Risk Reply

A large number of people who undergo elective coronary angiography are found to have nonobstructive coronary artery disease, and these patients have significantly increased risk for myocardial infarction and death, according to a retrospective study published in JAMA.

Click here to read the full post on Forbes.