European Heart Guidelines Based On Disgraced Research May Have Caused Thousands Of Deaths 2

Despite a 2-year-old scandal discrediting key evidence, current guidelines relying on this evidence have not been revised. As a result of physicians following these guidelines, some researchers say, it is possible that thousands of patients may have died each year in the UK alone. It is unlikely that a true understanding of the damage will ever be known.

Current European Society of Cardiology guidelines recommend that beta-blockers be given to many patients having surgery for noncardiac reasons to protect the heart during surgery. (US guidelines are somewhat less aggressive in their endorsement of perioperative beta-blockade.) The guidelines, which were published in 2009, were based on analyses of the available trials. The strongest evidence came from the DECREASE family of trials, which appeared to strongly support perioperative beta-blockade, and one other large trial, POISE, which raised concerns that beta-blockers might lead to an increase in deaths. When the ESC committee combined all the data they found a neutral effect on mortality but a strong benefit due to significant reductions in non-fatal MI and stroke with beta blocker use. This was the basis for the strong recommendation in the ESC guidelines.

In 2011, however, faith in the reliability of the DECREASE trials was shattered as a result of a scientific misconduct scandal centering on the principal investigator of the studies, the now disgraced Dutch researcher Don Poldermans. The issue was further complicated because, in addition to his key role in the trials, Poldermans was the chairman of the committee that drafted the guidelines.

Now, a group of UK researchers, led by Darrel Francis, have published in the journal Heart the results of a meta-analysis of the remaining non-DECREASE trials that tested perioperative beta-blockade. With the removal of the DECREASE trials the findings were strikingly different from the earlier analyses. In a combined population of 10,529 patients taken from 9 trials there was a statistically significant increase in the risk of death in the group of patients randomized to beta-blockers…

Click here to read the full story on Forbes.

Don Poldermans
Darrel Francis
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More Bad News For Novartis Blood Pressure Drug Reply

In the last few days more bad news about valsartan (Diovan, Novartis) has emerged in Japan. Another major study conducted in Japan– the Jikei Heart Study– will be retracted and Japanese health authorities said they were investigating severe skin reactions associated with use of the drug.

The new events are only the latest problems for the drug and Novartis…

Click here to read the full story on Forbes.

 

Sex And The Cardiac Patient Should Not Be A Taboo Subject 3

It’s not an easy conversation to have. After a heart attack or other major cardiac event, talking about sex is awkward, and often avoided by patients, their partners, and physicians. But a new consensus statement from several major cardiology organizations urges physicians to get over their reluctance or embarrassment and counsel their cardiac patients about this important, but often neglected, aspect of their lives.

After a patient has a heart attack, stroke, cardiac surgery, cardiac device implantation, or is newly diagnosed with a cardiovascular condition, physicians and other healthcare professionals should provide individually tailored information and advice about a wide variety of issues relating to sexual activity, according to the consensus document developed by the American Heart Association (AHA) and the European Society of Cardiology and published in Circulation and the European Heart Journal. The advice “should address topics such as when to resume sex, specific methods and recommended positions, and the role of intimacy without sex,” said the American Heart Association in a press release.

The statement cites numerous concerns, both psychological and physiological, that patients may have after a coronary event, including “general anxiety, fear of having another MI, feeling unwanted by their partner or not good enough, changes in self-perceptions, inadequate knowledge regarding the impact of heart medications, and finally, partner concerns.”

Click here to read the full story on Forbes.

 

 

Possible Cognitive Benefits Found In Dementia Patients Taking Centrally Acting ACE Inhibitors Reply

An observational study from Ireland raises the intriguing possibility that certain blood pressure lowering drugs, centrally acting ACE inhibitors, may help slow the cognitive decline that is a hallmark of people with Alzheimer’s disease and other forms of dementia.

The study, published in BMJ Open, followed the rates of cognitive decline in 3 groups of patients: dementia patients being treated with centrally acting ACE inhibitors, dementia patients being treated with non-centrally acting ACE inhibitors, and dementia patients newly treated with centrally acting ACE inhibitors.

Click here to read the entire post on Forbes.

 

 

Novel Pulmonary Hypertension Drug From Bayer Shows Modest Promise In Phase 3 Trials 1

A new drug appears to have promising– but not game-changing– effects in people with two forms of pulmonary hypertension. Riociguat, a soluble guanylate cyclase stimulator under development by Bayer, is thought to have vasodilating, antiproliferative and antifibrotic effects.

Results of two phase 3 placebo-controlled trials were published today in the New England Journal of Medicine. CHEST-1 studied the clinical impact of riociguat in 262 patients with chronic thromboembolic pulmonary hypertension; PATENT-1 studied the the drug in 443 patients with pulmonary arterial hypertension.

Click here to read the full story on Forbes, including a comment from pulmonary hypertension expert John Ryan.

 

Ball-and-stick model of the riociguat molecule...

 

Funding For Landmark Framingham Heart Study Slashed By $4 Million Reply

One of the most important studies in the history of medicine will be sharply curtailed as a result of the federal budget cuts.

The landmark Framingham Heart Study (FHS) has been told by the National Heart, Lung and Blood Institute (NHLBI) that it will lose  $4 million of its funding. The cut represents 40% of its NHLBI funding and is a direct consequence of the sequester, the automatic cuts in the federal budget.

Click here to read the full story on Forbes.

 

 

Cardiology Goes Better With Coke 3

Diet Coke - get cancer, not fat

At the bottom of this post I’ve reprinted an email cardiologists are receiving from the American College of Cardiology. See the bottom of the message for the disclosure that Coca Cola is paying for this educational program. I don’t have much to say about this though I wonder what the faculty of this program will say about the role of sugared soda and obesity. I also wonder what position the ACC will take on public health efforts to curb sugar consumption.

There’s no reason to be surprised about this. Last year the president of the ACC was one of 22 participants chosen by the Coca-Cola Company to carry the Olympic Flame. And the ACC is far from the only mainstream medical organization to take money from Big Sugar. Coke pays a lot of money to the National Heart Lung and Blood Institute to put a red dress logo on the Diet Coke label and the American Heart Association has struck deals with, among others, Cheetos and Subway.

See Yoni Freedhoff’s Weighty Matters blog for much more about Coca Cola’s efforts to influence medical organizations.

Here’s the ACC email:

The American College of Cardiology is teaming up with the Preventive Cardiovascular Nurses Association (PCNA) to offer Never Too Early, Never Too Late: Cardiovascular Health for Women Throughout the Lifespan, an educational webinar, on Wednesday, August 14th from 1:00 p.m. – 2:00 p.m. EDT. This complimentary webinaroffers a comprehensive view of women’s cardiovascular health as they age. Our expert faculty, Jo-Ann Eastwood, PhD, RN, CCNS, ANCP-BC and Martha Gulati, MD, MS, FACC, will provide perspectives on clinical encounters during the childbearing years, perimenopausal period and in later life, while presenting opportunities to focus on, when indicated, cardiovascular disease (CVD) risk reduction, and the session will be moderated by JoAnne Foody, MD, FACC. During this webinar, the educators will encourage clinicians to seek and seize opportunities to discuss optimal cardiovascular management with their women patients in clinical practice settings, and as equally important, to champion them with their colleagues in the primary care and women’s health fields.Webinar highlights include:

  • A look at how gestational diabetes, pregnancy-associated hypertension and preeclampsia predict future CVD risk
  • Exploration into the prevalence of hypertension in women vs. men throughout the lifespan
  • Why gender differences matter with regard to tobacco use and cessation
  • The impact of women’s physical activity level on cardiovascular risk
  • Examples of successful cardiovascular health improvement programs targeted to women in a variety of age cohorts
  • One hour of CME, CNE and RD credit

Click here for additional registration, accreditation and faculty information for this complimentary educational course, Never Too Early, Never Too Late: Cardiovascular Health for Women Throughout the Lifespan. We hope you will join us on August 14th from 1:00 p.m. – 2:00 p.m. EDT!

This course is being presented by the American College of Cardiology and the Preventive Cardiovascular Nurses Association (PCNA) through an educational grant from

Studies Suggest Most Widely Used Cardiac Imaging Technique Is Overused Reply

Echocardiography is a safe, noninvasive tool to image the heart without the use of radiation. For this reason it has become the most frequently used method to look at the heart for a wide variety of medical indications. Now two new studies suggest that, despite its popularity, transthoracic echocardiography is often not beneficial. One study finds that in most cases echocardiography does not change the treatment of patients. A second study suggests that using echocardiography to screen low-risk people for heart disease is not warranted.

In the first study, published in JAMA Internal Medicine,  Susan Matulevicius and colleagues reviewed the patient records for 535 consecutive  standard echocardiograms performed at their hospital (the University of Texas Southwestern Medical Center) in one month. Although the vast majority of cases were indicated according to current appropriate use criteria (AUC) — 91.8% were deemed appropriate, only 4.3% were deemed inappropriate, and 3.9% were deemed uncertain — less than a third of cases resulted in an active change in care…

In the second paper, also published in JAMA Internal Medicine, Norwegian researchers studied nearly 7,000 people who were already participating in the Tromsø observational study. The patients were randomized to receive an echocardiography screening examination or to a control group and were then followed for 15 years. Of the screening group patients, 7.6% ultimately received a diagnosis of a cardiac or valvular disorder.

Click here to read the full story on Forbes.

 

A Glimpse Of The Future Of Cardiology, Including Star Wars Holograms Reply

Goodbye flat images. Hello holography. Sometime in the not-too-far-distant future cardiologists may work with projected 3D holograms of the heart instead of images on a flat screen. And this is just the beginning of a technology-driven transformation of cardiology.

That’s the vision of Mount Sinai’s Partho Sengupta, who delivered a widely praised technology-gone-wild lecture at the annual meeting of the American Society of Echocardiography last month. The Feigenbaum lecture featured holograms of projected 3D digital images and animation to demonstrate, according to a Mt. Sinai press release, “the latest technology and future applications of functional echocardiography to more precisely analyze the structure, function and flow patterns of the cardiovascular system.”

Sengupta’s talk even featured an interactive discussion between Sengupta and a holographic projection of his mentor, James Seward, the retired former director of echocardiography at the Mayo Clinic. The conversation with Seward brought to mind Princess Leia’s holographic plea for help from Obi Wan Kenobi in Star Wars.

Click here for the full post on Forbes.

 

Sengupta talking with a holographic image of James Seward

Take Your Blood Pressure Pills Or Increase Your Risk Of Stroke Reply

A large new observational study demonstrates that people who don’t take their antihypertensive medications are much more likely to have a stroke. The new study, published in the European Heart Journal, used nationwide prescription, hospital and mortality records from 73,527 hypertensive patients in Finland.

The Finnish investigators compared 26,704 patients who were hospitalized or died of stroke with 46,823 patients who did not have an event. The stroke patients were older, less educated, had lower income, and were more likely to have diabetes or cancer than controls.

After adjusting for baseline differences between the groups, patients who were non-adherent were two to four times more likely to die from stroke or be hospitalized for stroke than their adherent counterparts.

Click here to read the full story on Forbes.

 

Diovan Data Was Fabricated, Say Japanese Health Minister And University Officials Reply

Following a long series of accusations, retractions, and the resignation of a prominent professor, it now is clear that data from a large Japanese study of valsartan (Diovan, Novartis) was fabricated. On Thursday officials at Kyoto Prefectural University of Medicine said that “had patient records been used in their entirety,” the Kyoto Heart Study “would have had a different conclusion,” reported AFB.

In 2009 the Kyoto Heart Study investigators, including the chief investigator, Hiroaki Matsubara, reported that treatment with valsartan resulted in significant cardiovascular benefits independent of the drug’s blood-pressure lowering effect. Now officials at the university say the drug had no such effect.

On Friday Norihisa Tamura, Japan’s health minister, said data had been “fabricated and falsified.” Tamura said he would set up a committee to prevent episodes like this from happening again.

Click here to read the full story on Forbes.

 

Norihisa Tamura

Medtronic Faces Removal Of CoreValve Transcatheter Heart Valve From German Market Reply

In the wake of a major patent decision, Medtronic will be forced to remove its CoreValve transcatheter heart valve from the German market. Edwards Lifesciences said today that a German Court had found that Medtronic infringed a key patent, known as the Spenser patent, and granted an injunction prohibiting the sale of CoreValve and CoreValve Evolut systems in Germany.

Medtronic said it would appeal the decision and said the action “will limit options for physicians and their patients who need transcatheter aortic valve procedures, which Medtronic believes is contrary to sound health policy.”

Click here to read the full post on Forbes.

I

Link To Prostate Cancer Brings More Bad News For Fish Oil Story Reply

Adding more confusion to an already fishy story, a new study has found a significant association between omega-3 fatty acids and the risk of prostate cancer. Although the linkage had been previously observed, the finding surprised the investigators, who wrote that “these findings contradict the expectation that high consumption of long-chain omega-3 fatty acids and low consumption of omega-6 fatty acids would reduce the risk of prostate cancer.”

In a report published in JNCI, investigators analyzed data from men who had participated in the SELECT (Selenium and Vitamin E Cancer Prevention Trial) trial. They compared 834 men who developed prostate cancer with 1,393 matched controls. When compared with men who had the lowest levels of omega-3 fatty acids, men in the highest quartile of omega-3 fatty acids were at significantly increased risk for low-grade, high-grade, and total prostate cancer:

Click here to read the full story on Forbes.

 

Daily Fish

‘A Plane Just Crashed At SFO!’ 1

A young cardiology fellow was on duty last Saturday at San Francisco General Hospital when the director of the cath lab came running into the room:  “A plane just crashed at SFO!” Payal Kohli tells her story about that day, and reflects on its meaning, on CardioExchange (a cardiology website published by the New England Journal of Medicine). Here are a few excerpts:

No one really knew what to expect at SFGH, the main trauma center in SF and the closest hospital to the airport.  But, within a matter of minutes, we were already functioning in full “crisis mode” with updates from the hospital’s command center coming to us every few minutes on the overhead PA system.  Within the next hour, every member of the hospital’s team prepared seamlessly to receive mass casualties and care for the victims.  Magically, everything was working like clockwork. There was a lot less chaos than I expected.

As the dozens of victims started streaming in, they were more than just numbers.  I was most struck by their young faces.  There were a large number of patients under the age of 18 years and SFGH doesn’t have a pediatric service.  Should I just treat them as adults without atherosclerosis, I wondered?

We faced the entire spectrum of injuries, from broken bones and bruises to severe traumatic brain injury, inhalation injuries, burns, blunt abdominal trauma, rhabdomyolysis from crush injuries, and spine fractures.  As cardiologists, we were largely consulted for arrhythmias (atrial and His-Purkinje blocks) as well as the obvious “rule out cardiac contusion.”  We were able to discharge a large majority very quickly but a handful have remained critically ill, including some very young patients.

Sadly, in our society acts of terrorism have become so increasingly common that I have started to wonder if every physician should now have a “core competency” that involves dealing with mass casualties and disasters.  I hardly felt prepared for the day I had and I think I would have benefitted from some formal training on the clinical and non-clinical consequences of major disasters as part of my training. Instead, last Saturday I received a crash course in disaster medicine.

Read the entire post on CardioExchange.

SFGH

Low Rate Of Problems With Statins In Study Of Quarter Million Patients 1

A very large analysis of previously published studies finds that statins are generally safe and well tolerated, but helps confirm previous links to a small increased risk for diabetes and elevation of liver enzymes. Some statins were better tolerated than other statins and lower-dose statins were better tolerated than high dose statins.

In a paper published in Circulation: Cardiovascular Quality and OutcomesHuseyin Naci and colleagues report their findings from a systematic review of clinical trials with statins for both primary and secondary prevention. The data from 55 placebo controlled trials and 80 trials included nearly 250,000 subjects comparing statins to placebo or to other statins. Previous analyses of available data have generally confirmed the overall benign profile of statins, but have not explored in depth the differences between statins and the effect of different doses of individual statins.

The new study found no differences between statins and placebos in the rate of discontinuations due to myalgia, CK elevation and cancer, but statins were associated with a higher risk for diabetes (OR 1.09, CI 1.02-1.16) and transaminase elevations (OR 1.51, CI 1.24-1.84).

Click here to read the full post on Forbes.

 

Recent €23 Million Biotech IPO Relied Heavily On Questionable Research 2

A successful €23 million initial public offering  (IPO) last week was based on highly questionable research, according to a group of UK physicians who have scrutinized the available data. In addition, one of the researchers, a prominent European cardiologist, failed to disclose in a key paper that he helped to start, and held a significant interest in, the company, Cardio3 BioSciences.

On July 4 Cardio3 BioSciences, a biotechnology company focusing on cardiac stem cell therapy, said that it had raised €23 million in an IPO on the NYSE Euronext Brussels and NYSE Euronext Paris. The company’s main product is called C-Cure, which it defines as “a unique cell therapy aimed at repairing damaged tissue and improving heart function, clinical outcomes and quality of life.” C-Cure uses uses pre-programmed cardiac progenitor cells to treat heart failure. As described by the company, “the supporting science is the result of Mayo Clinic innovation leading to advanced product development, manufacturing scale-up, and clinical trial execution by Cardio3 BioSciences catalyzed by ongoing collaboration facilitated through Mayo Clinic Ventures.”

The company plans to use the IPO money for a Phase III trial, following what the company describes as “positive Phase II results, recently published in the Journal of the American College of Cardiology.”

But the phase II results are a bit more complicated, according to Darrel Francis and colleagues (who last week published a paper highly critical of a different stem cell group). Francis et al have identified numerous errors in the paper which raise serious questions about the validity of the data and whether any useful conclusions can be drawn from the paper.

One striking finding– obvious once it has been pointed out– is that the authors report at different times different number of patients enrolled in the trial. The text of the paper says 48 patients were randomized, Figure 1 lists 47, and Table 1 lists 45 (42 men and 3 women).

Click here to read the full story on Forbes.

 

 

FDA Warns That Popular Blood Pressure Drug Can Cause Severe Diarrhea Reply

The FDA is warning that the widely-used antihypertensive agent olmesartan (marketed as Benicar, Benicar HCT, Azor, Tribenzor, and generics) may cause severe diarrhea. According to an FDA safety announcement, olmesartan “can cause intestinal problems known as sprue-like enteropathy. Symptoms of sprue-like enteropathy include severe, chronic diarrhea with substantial weight loss.” The warning is being added to the label of drug products containing olmesartan. Olmesartan is a member of the class of drugs known as angiotensin II receptor blockers (ARBs).

The FDA said that it has found no evidence that other angiotensin II receptor blockers increase the risk for sprue-like enteropathy.

The FDA recommends that physicians tell their patients taking olmesartan to contact them if they develop severe, chronic diarrhea with substantial weight loss. Symptoms may take months or years to develop after initiation of olmesartan therapy. The FDA advises physicians to look for other causes of the symptoms, including celiac disease. Olmesartan should be replaced with another antihypertensive agent if no other cause is found.

Paper Raises Hundreds Of Questions About The Integrity Of Stem Cell Research Group 2

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 the reliability of scientific publications and the ability of the clinical research system to police itself.

In “Autologous bone marrow-derived stem cell therapy in heart disease: Discrepancies and contradictions,” Darrel Francis and colleagues scrutinize 48 papers from the research group of Bodo-Eckehard Strauer. According to Francis et al, the 48 papers from Strauer’s group contained reports on only 5 actual clinical studies, or “families” of reports, and that duplicate or overlapping reports were common. The paper contains details about more than 200 errors in the papers, including contradictory descriptions of the design, protocol and results of the trials. Francis et al write:

“Readers cannot always tell whether a study is randomised versus not, open-controlled or blinded placebo-controlled, or lacking a control group. There were conflicts in recruitment dates, criteria, sample sizes, million-fold differences in cell counts, sex reclassification, fractional numbers of patients and conflation of competitors’ studies with authors’ own.

Contradictory results were also common. These included arithmetical miscalculations, statistical errors, suppression of significant changes, exaggerated description of own findings, possible silent patient deletions, fractional numbers of coronary arteries, identical results with contradictory sample sizes, contradictory results with identical sample sizes, misrepresented survival graphs and a patient with a negative NYHA class.”

Click here to read the full post on Forbes.

Bodo-Eckehard Strauer