A New Jersey cardiologist will receive $2.4 million for his role in a whistleblower lawsuit against Cooper Health System and Cooper University Hospital. Following an investigation by the US Department of Justice and the New Jersey Attorney General’s Office, Cooper agreed last week to pay $12.6 million to settle Medicare and Medicaid fraud allegations. The federal qui tam lawsuit was originally filed by Delaware Valley cardiologist Nicholas L. DePace, who claimed that Cooper paid illegal kickbacks to physicians for patient referrals.
A small study published online in the Journal of the American College of Cardiology suggests that yoga may benefit people who have atrial fibrillation. The study, which the authors describe as “a small, proof-of-concept study,” is the first of its kind. The findings raise the possibility that yoga may reduce AF symptoms and arrhythmia burden. Other physiological and quality of life benefits were also observed. But, the authors caution, large randomized trials will be required to confirm the finding.
The FDA said today that it had granted approval to the novel cholesterol-lowering drug mipomersen sodium for use as an adjunct to diet and drug therapy in patients with homozygous hypercholesterolemia. The drug, which was developed by Isis Pharmaceuticals, will be marketed under the brand name of Kynamro by Genzyme.
Kynamro was approved as an orphan drug, which the FDA describes as meaning it was developed to treat a condition affecting less than 200,000 people. The standard of approval for orphan drugs is less rigorous than other drugs. There has been some confusion about the number of people who have homozygous familial hypercholesterolemia. The FDA and ISIS/Genzyme said the condition affects about one in every million people.
In August 2011 the FDA issued a safety communication recommending that the extremely popular antidepressant citalopram (Celexa) not be used at doses greater than 40 mg/day because of a potential increased risk for serious cardiac arrhythmias associated with prolongation of the QT interval. Now a study published in BMJ lends support to this warning and suggests that other antidepressants may also prolong the QT interval.
Radial access is now the preferred approach for percutaneous coronary interventions, according to a consensus document from the European Society of Cardiology and other European organizations and published online in EuroIntervention. However, at least one prominent US interventional cardiologist thinks the “hard benefits” of radial access “are more controversial,” though he supports increased use of the newer approach.
The enormous success of ACE inhibitors in hypertension and heart failure spurred hope that adding a second drug to block the renin-angiotensin system would yield improved outcomes. Although definitive evidence supporting dual blockade of the renin-angiotensin system has never been found, more than 200,000 patients in the US currently receive this therapy. Now a large new meta-analysis suggests that dual blockade results in no improvement in mortality but is associated with an increase in important adverse events.
In a paper published online in BMJ, Harikrishna Makani and colleagues at Columbia University and New York University performed a meta-analysis of more than 68,000 patients who were enrolled in clinical trials comparing dual blockade of the renin-angiotensin system with monotherapy. They found no significant difference between the groups for all cause mortality or cardiovascular mortality, although dual blockade was associated with a signifcant 18% reduction in hospital admission for heart failure:
Merck has invested a substantial amount of money on the CETP inhibitor anacetrapib. Chemist and veteran pharma blogger Derek Lowe suspects that the company might as well have plunked the money down in a casino.
In a provocative new post, Lowe wonders if big pharma, in its desperation, has abandoned rational research in favor of, essentially, gambling. He notes that CETP is “a drug target that has incinerated a lot of money over the years” and wonders whether any of the compounds will “ever make it as a drug?” The failure of past CETP inhibitors, torcetrapib (Pfizer) and dalceptrapib (Roche), along with the recent failure of Tredaptive (Merck), “illustrate how little we know about this area [HDL].”
Let me say it right away: the best blog written by a doctor, at least that I’ve ever read, is by a provincial South African general surgeon who calls himself Bongi. He doesn’t write about complex medical policy, and he doesn’t worry too much about appropriate use criteria or whether a patient who needs anticoagulation should get warfarin or Xarelto. Instead, he writes about his astonishing experiences as a front-line surgeon (and, for many years, as a medical trainee) in a country on the border between first and third world medicine.
His stories will blow your head off. One minute you’ll be laughing. The guy is seriously funny, possessing a keen sarcastic wit with an edgy South African accent. But then, suddenly, just when you’re enjoying the antics of his colleagues and countrymen,he’ll turn deadly serious, and leave you breathless or in tears.
Over on CardioExchange, Murray Essler, the chief investigator of the Symplicity HTN-2 trial, answers questions from John Ryan about renal denervation:
Non-pharmacologic antihypertensive measures must remain the starting point for patients with hypertension, but will often not be enough. Renal denervation should be reserved for patients in whom behavior modification combined with adequate and skillful antihypertensive drug prescribing cannot achieve BP reduction to target. There are no clinical trial data to support renal denervation in hypertension outside of this setting. In countries where the “genie is out of the bottle”, and clinical use is authorized, prevention of overuse will be difficult. In some instances government regulations will confine the use of renal denervation to drug-resistant hypertension. Insurer or governmental reimbursement rules should be framed to prevent overuse.
Two big trials will highlight this year’s American College of Cardiology meeting in March in San Francisco. First is the PREVAIL trial testing Boston Scientific‘s long-anticipated Watchman left atrial appendage closure device for stroke prevention in patients with atrial fibrillation. Second is the detailed presentation of the controversial failed HPS2-THRIVE trial of extended-release niacin and laropiprant.
Lately there’s been a lot of talk about personalized medicine. There’s a bold idea going around that people should take control of their own healthcare and manage the flood of new data stemming from a whole bunch of new technologies, including, but hardly limited to, personal genomes, biomarkers, wireless sensors, and iPhone ECGs.
…boutique-style healthcare is a lot like organic food, which may taste better and may help a few privileged people feel better about themselves, and may possibly yield a small individual health benefit (though there is absolutely no evidence to show this). However, there is absolutely no chance that organic food can be used to actually feed the vast majority of the 7 billion or so people currently living on this planet.
Similarly, taking control of individual health data will almost certainly allow a few privileged and obsessed people to feel they’re better off than most. It may even improve their health. But, again, more importantly, there is no possibility in the foreseeable future that this self-management of extremely complex personal health data will improve the overall public health of the planet.
Don’t miss this very practical discussion about the new generation of anticoagulants and the short term loan costs to cover them over on CardioExchange. Here are a few excerpts.
Christian Thomas Ruff:
I believe the addition of the 3 currently approved novel anticoagulants (dabigatran, rivaroxaban, and apixaban) will eventually translate into a greater proportion of eligible patients being treated; it certainly has in my practice…
Although I think it is important to continue to develop reversal agents for the novel anticoagulants, I don’t think the lack of such an agent is sufficient reason to avoid using a novel anticoagulant.
I think that price is one of the most important factors that has hindered uptake of the novel agents. Although these drugs may well be “cost-effective” in complicated analyses that focused on the costs and benefits to society at large, it is the out of pocket expense for the drugs that really matters to patients…
Andrew E. Epstein:
It is highly unlikely that a direct comparison of the new anticoagulants will ever be done. Thus, we will have to choose between one or another based on pharmacokinetics, convenience, and perhaps formulary availability. Substudy analyses are also important…
I am concerned that although the elderly often have the most to gain from the new anticoagulants, they are also the patients at greatest risk for bleeding, especially if renal function is labile with drugs cleared by the kidneys. For such patients, warfarin should be considered.
The bad news continues for Aranesp (darbepoetin alfa), Amgen’s long-acting erythropoietin-stimulating agent. The drug is intended to stimulate red cell blood production in patients with anemia. Amgen today announced the top line results of a large phase 3 heart failure trial of the drug and said the trial had failed to meet its primary endpoint.
The RED-HF (Reduction of Events With Darbepoetin Alfa in Heart Failure) Trial, which started in 2006, had randomized 2,278 patients with heart failure and anemia to receive either Aranesp or placebo.
The FDA on Tuesday released the full text of a warning letter sent last week to St. Jude Medical. The company had previously disclosed the existence of the letter in an SEC filing but did not make clear the full extent of the FDA warning. The letter from the FDA is the latest in a series of setbacks, short term loans UK and challenges to the company’s Durata and Riata ICD leads.
No food has had more ups and downs over the last century or so than the common egg. Following a long period in which eggs were ubiquitous and highly regarded, eggs fell from favor with the rise of concerns over cholesterol. Currently the American Heart Association recommends that people restrict dietary cholesterol to 300 mg per day, which effectively limits people to 1 egg per day at most. However, the relationship of dietary cholesterol and serum cholesterol is, at best, tenuous, and a significant number of experts now believe that egg consumption poses no risk to cardiovascular health.
In a new paper published in BMJ, a group of researchers from China and Boston performed a meta-analysis of 8 studies that included 263 938 participants for coronary heart disease (CHD) and 210 404 participants for stroke and followed them for 8 to 22 years. The authors found no evidence for an association between egg consumption and either coronary heart disease or stroke…
Use it or lose it. A UK politician is urging the National Health Service (NHS) to increase use of the antiplatelet drug ticagrelor (trade name Brilinta in the US, Brilique and Possia in the EU) in order to prevent the loss of British jobs.
Like nearly all the major pharmaceutical companies, AstraZeneca has been fighting a difficult cycle of patent expirations and unsuccessful new drugs, leading to repeated rounds of layoffs. But, according to the Manchester Evening News, the UK-based company, with the help of UK politicians, is seeking to turn lemons into lemonade. Science Minister David Willetts is lobbying the National Health Service (NHS) “to increase its use of an AstraZeneca heart medicine, amid mounting political concern about the drugs company’s commitment to British jobs.
The minister, according to the paper, “has urged health officials to accelerate the uptake of Brilique [ticagrelor], a blood thinner used to treat patients suffering from severe angina or heart attacks, which has sold poorly despite winning a green light from the NHS’s cost-effectiveness watchdog in 2011.
AstraZeneca said although it invests heavily in producing new drugs in this country, it’s difficult to persuade primary healthcare trusts to adopt new costly medicines.
The group added: “Despite this recommendation and the NHS target of reducing the mortality rate from cardiovascular disease, it is currently only routinely available to patients in some parts of England.
“We share the NHS and the Government’s objective of broadening patient access to innovative medicines and continue to engage in dialogue.”
Although atrial fibrillation (AF) is well known to be associated with an increase in the risk of stroke and coronary heart disease, a similar association with sudden cardiac death (SCD) has been suspected but not demonstrated in the past. Now a new study examing data from two large population studies offers evidence that AF is also an independent risk factor for SCD.
Adding a non-steroidal anti-inflammatory drug (NSAID) to dual antihypertensive therapy (a diuretic plus either an ACE inhibitor or an angiotensin receptor blocker) is associated with an increase in risk for kidney injury, according to a large new retrospective study published in BMJ.
In the wake of HPS2-THRIVE many have argued that there is no longer any reason to prescribe niacin. William Boden, the lead investigator of AIM-HIGH and COURAGE, thinks there were enough flaws in the design of the niacin trials to justify the cautious use of niacin in certain circumstances. Says Boden:
“There is evidence of clinical outcome improvement (i.e., CHD death/MI reduction) from VA-HIT for gemfibrozil; there is similar clinical outcome improvement for niacin from the Coronary Drug Project. Numerous studies show niacin’s benefit on surrogate outcome measures (i.e., quantitative coronary angiography, IVUS, cIMT, etc.). What more evidence do you need?”
” I have not given up on niacin.”
Harlan Krumholz disagrees:
“We have to face the facts about the trials. They have failed to be supportive, and despite concerns about their flaws, they were developed by some of the best minds in our profession (including yours) and had millions of dollars devoted to them. I just feel that we cannot justify millions of people being prescribed a drug that has failed in two recent, large, prominent trials, which actually had signals of harm…”
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….
The experimental antiplatelet drug cangrelor was superior to traditional clopidogrel in reducing ischemic events at 48 hours in PCI patients, according to the Medicines Company, which is developing the drug. The company today announced positive results from the phase 3 CHAMPION PHOENIX trial, a randomized, double-blind study comparing intravenous cangrelor to oral clopidogrel in PCI patients. The primary endpoint was the composite of death, MI, revascularization and stent thrombosis at 48 hours.
In the last week two cases highlighted, yet again, the continuing shift in standards regarding PCI. In his interventional cardiology blog on CardioExchange, Rick Lange asks cardiologists: Could You Be Accused of Doing Unnecessary PCI?
“Public confidence is eroding as the number of reports of physician suspensions and monetary penalties for unnecessary PCIs grow. Accordingly, patients are questioning use of PCI, even when it is indicated and advisable.”
“Have investigations into unnecessary stenting changed your interventional practice? How so?”
The editor of Circulation Journal, the official journal of the Japanese Circulation Society (and not to be confused with the American Heart Association’s better known Circulation) has announced the retraction of two substudies from the Kyoto Heart Study. The papers, according to the editor, “contain a number of serious errors in data analysis.”
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.”