Tonight 11/20: Heart disease and inflammation explained to you, not in a lecture hall but in an Irish pub

From the Science by the Pint website. Full schedule below

Dr. Peter Libby
of Harvard Medical School

Fanning the Flames: New Links Between Inflammation and Heart Disease

Monday, November 20th, 6:30-8:30 at The Burren (247 Elm St, Somerville, MA 02144) (directions)

Half of all heart attacks occur in people with normal cholesterol levels. For decades, scientists and physicians have postulated that inflammation might be another critical, if not necessary, factor for driving heart disease. Dr. Peter Libby’s research group at Brigham and Women’s Hospital is dedicated to examining the link between inflammation and atherosclerosis, a condition which often precedes heart attack, and how we can use this knowledge to prevent heart disease. In the clinic, Dr. Libby and his colleagues, in association with Novartis, recently completed a landmark study (CANTOS) that showed that lowering inflammation independently of cholesterol can reduce the risk of heart attack, offering the first direct evidence that inflammation directly contributes to heart disease.

SbtP_winter2017-1

Advertisements

A round-up: The new and maybe-not-improved statin guidelines

See NYTimes to catch up on the debate over new guidelines from the American Heart Association that would vastly expand the use of cholesterol-lowering statins.  Here’s a Nov. 25 update. 

It was supposed to be a moment of triumph. An august committee had for the first time relied only on the most rigorous scientific evidence to formulate guidelines to prevent heart attacks and strokes, which kill one out of every three Americans. The group had worked for five years, unpaid, to develop them. Then, at the annual meeting of the American Heart Association, it all went horribly awry.

Many leading cardiologists now say the credibility of the guidelines, released Nov. 14, is shattered. And the troubled effort to devise them has raised broader questions about what kind of evidence should be used to direct medical practice, how changes should be introduced and even which guidelines to believe.

The critics of guidelines are Brigham researchers. The initial coverage by Todd Neale at MedPage Today talks about Dr. Ridker’s background conducting clinical trial on one statins and researching the biomarker C-reactive protein as a “marker of subclinical atherosclerosis.”

https://twitter.com/ToddNealeMPT/status/403554561748926464

The NYTimes

Less than a week after the American Heart Assn. and the nation’s cardiologists issued guidelines that would greatly expand the number of Americans taking a statin medication, the guidelines have been faulted for overestimating patients’ risk of heart attack or stroke.

Few authors of the new recommendations had even returned to their clinical practices before learning that an influential Harvard cardiologist and his biostatistician collaborator had taken the guidelines to task, arguing they use unreliable data on Americans’ health to calculate which patients would benefit from taking the medication. 

Dr. Paul Ridker and Dr. Nancy Cook, both professors at Harvard Medical School, estimate that between 13 and 16 million of the 33 million middle-aged adults targeted by the new guidelines for statin therapy do not have sufficiently high odds of having a heart attack or stroke over the next decade to warrant statins’ use.

Gary Schwitzer offers a  round-up within a round-up. His looks at conflicts of interest and link to a very funny cartoon from the Daily Kos, which also ran in the NYTimes week in review.

Some more coverage:

LA Times

In the summer of 2012, two Brigham and Women’s Hospital researchers were asked to review a draft of a major cholesterol treatment guideline. They sent back a pointed critique, declaring that the authors should abandon a proposed heart-disease risk calculator because it overestimated patients’ chances of getting sick.

So they were shocked when they saw the final guideline, which was issued last week by two leading heart groups. The risk calculator remained an integral part of the document and would be responsible for millions more Americans being put on cholesterol-lowering statin drugs to prevent heart attacks and strokes.

“I’m a strong advocate for statin therapy,” said Brigham cardiologist Dr. Paul Ridker. “I just want to see the right patients get treated.”

More from:

Medpage Today

The Lancet

Medscape

Don’t have a hot attack: Framingham Heart Study carries on

fhsWhat is up with the Framingham Heart Study? That long-running research project has been tracking the cardiac health of hundreds of local folk for decades.  (The algorithm used to estimate the 10-year risk of heart disease is called the “The Framingham Risk Score.”)

A story and a blog post recently reported woefully about a 40 percent sequester cut to the study’s National Institutes of Health funding.  Neither quoted anyone from NIH.

So, both pieces failed to note that the cut is to the study’s administrative grant from the National Heart Lung and Blood Institute, not its research grants.  According to BU, the study receives an estimated $5.4 million in NIH grants for research. This funding is not impacted by the 40 percent cut.

In other words, the cuts come from the money used to run the program – office staff, data collection and the management of study subjects, not the scientific research projects that fall under the program’s umbrella. The data collected from the locals helps researcher understand the mechanics and, more recently, the genetics of heart disease as it impacts the rest of us.

In total, NIH says it will spend $21 million this year contracts for the FHS study infrastructure – including a study looking for biomarkers for heart disease. In addition to funding the BU research, NIH says its grants cover 17 FHS related studies at eight different organizations and universities. In addition to the Heart Lung and Blood institute, that money comes from five other NIH institutes and centers, including the National Institute on Aging, The National Institute of Diabetes and Digestive and Kidney Diseases and the National Institute of Neurological Disorders and Stroke.

None of this was clear in this first, July 20 story from the Metro West Daily:

The Framingham Heart Study expects to lose $4 million in funding as part of the federal budget cuts known as sequestration, study officials confirmed Friday in a statement. The $4 million cut takes effect Aug. 1 and represents 40 percent of funding it receives from the National Heart, Lung and Blood Institute (NHLBI), a division of the National Institutes of Health, the statement said.

 The story quotes a spokeswoman from Boston University, which is home to the study.

The cut with “result in a reduction in workforce affecting 19 staff from a variety of clinical and administrative areas, as well as reductions in clinic exams and lab operations.”

Then it quotes from a statement about NIH cuts in general from new Sen. Ed Markey:

“Slashing critical federal investment in medical research jeopardizes the health of many Massachusetts residents, while putting at risk tens of thousands of jobs in the commonwealth’s innovation economy and the industries they support,” Markey said. 

Then it quotes from Karen LaChance, a Framingham resident and president of the Friends of the Framingham Heart Study.

“We just hate to see any cut. It delays hopefully finding whatever the magic bullet might be to prevent heart disease.

Then it doesn’t quote anyone from NIH.

In a post on the Metro West Daily story,  WBUR’s CommonHealth blog offers the headline “Famed Framingham Heart Study Faces Deep Cuts From Federal Sequester.”

It was a “Say it isn’t so” moment this morning when I saw this MetroWest Daily News headline: Framingham Heart Study Faces $4 Million Cut. “Heart disease is the country’s number 1 killer, and chances are whatever you do to prevent it or treat it was influenced by the Framingham Heart Study, a venerable epidemiological gem right here in our own Boston suburbia….”

But, you could argue that it ain’t so.

As far as the impact of the cuts, Metro West Daily quote  BU as noting that “This loss of funding will result in a reduction in workforce affecting 19 staff from a variety of clinical and administrative areas, as well as reductions in clinic exams and lab operations.”

BU tells us that approximately 80 people work at the FHS. “The affected staff will see a reduction in hours beginning Aug. 19; if alternative funding sources are not identified, a layoff would occur Nov. 1. “

The FHS site was a little clearer on all this, with note on its home page:

New Information for FHS Participants edited July 20 2013

Q. Is the FHS closing?
A. No. The current Offspring and Omni Group 1 exams are continuing to Oct. 31, 2013. Ancillary studies are continuing as planned. Medical history updates are being collected on the regular schedule. Please respond to calls for FHS participation as usual.

By Wednesday August 1, BU had posted its own story on the BU Today website with the headline: “Framingham Heart Study Carries on, Despite Budget Cuts: 65-year-old core contract loses 40 percent of funding.”

Mediterranean diet and heart disease: Spanish study finds reduction in stroke, cardiac death rates

From the Globe

Spanish researchers tracked thousands of participants over roughly five years and found a 30 percent reduction in the rate of heart disease, primarily strokes, among the Mediterranean diet eaters compared with those who consumed more traditional low-fat fare. That diet included more starch and grains, but fewer nuts and oils.

Earlier studies analyzed health outcomes based on participants’ recall of meals and concluded there likely were benefits from a Mediterranean diet.

From the New England Journal of Medicine

OW_MedPyramid_612x792

A total of 7447 persons were enrolled (age range, 55 to 80 years); 57% were women. The two Mediterranean-diet groups had good adherence to the intervention, according to self-reported intake and biomarker analyses. A primary end-point event occurred in 288 participants. The multivariable-adjusted hazard ratios were 0.70 (95% confidence interval [CI], 0.54 to 0.92) and 0.72 (95% CI, 0.54 to 0.96) for the group assigned to a Mediterranean diet with extra-virgin olive oil (96 events) and the group assigned to a Mediterranean diet with nuts (83 events), respectively, versus the control group (109 events). No diet-related adverse effects were reported.

The folks at the Harvard School of Public Health have been touting the diet for years. More here from them:

The key to this longevity is a diet that successfully resisted the last 50 years of “modernizing” foods and drinks in industrialized countries. These modern trends led to more meat (mostly beef) and other animal products, fewer fresh fruits and vegetables, and more processed convenience foods. Ironically, this diet of “prosperity” was responsible for burgeoning rates of heart disease, obesity, diabetes, and other chronic diseases.

The “poor” diet of the people of the southern Mediterranean, consisting mainly of fruits and vegetables, beans and nuts, healthy grains, fish, olive oil, small amounts of dairy, and red wine, proved to be much more likely to lead to lifelong good health.

 Other vital elements of the Mediterranean Diet are daily exercise, sharing meals with others, and fostering a deep appreciation for the pleasures of eating healthy and delicious foods.

UCSF v. Beth Israel on FDA on heart device safety

Docs from BI, working with the Food and Drug Administration, released a study this week suggesting that medical device makers are providing weak evidence to support the efficacy and safety of products, in particular cardiovascular devices like stents and implanted defibrillators.

The study was release earlier to counter a similar study in the Journal of the American Medical Association that faulted the agency for approving devices based on limited and potentially biased data.

Just prior to the release of the new study, FDA officials announced that they would strengthen the device review process.

The New York Times reported that the BIDMC “study found that more than 40 percent of the studies used to approve cardiovascular devices had lacked high-quality data about either the treatment or safety goals of the study.”Researchers also concluded that 25 percent of trials had failed to adequately follow patients enrolled in studies.”

Dr. William H. Maisel, a cardiologist at the Beth Israel Deaconess Medical Center who was involved in the study, said the review did not find a correlation between lower-quality data and problems related to the devices. However, he said he thought the potential for such links existed.

But, the JAMA study out of the University of California faulted the FDA review process and “concluded that the F.D.A. had approved cardiovascular devices based on data that ‘lacked adequate strength.’”

Their conclusion Premarket approval of cardiovascular devices by the FDA is often based on studies that lack adequate strength and may be prone to bias.

According to AP: The new studies, published in separate medical journals, cap a year of scrutiny and criticism for the FDA’s medical devices division. In August, the head of that division resigned, months after scientists under his leadership alleged they were pressured to approve certain products. The year began with congressional investigators saying the FDA should take immediate steps to make sure the riskiest devices are approved through the most stringent process.

Docs from BI, working with the Food and Drug Administration, released a study this week suggesting that medical device makers are providing weak evidence to support the efficacy and safety of products, in particular cardiovascular devices like stents and implanted defibrillators.

The study was release earlier to counter a similar study in the Journal of the American Medical Association that faulted the agency for approving devices based on limited and potentially biased data.

Just prior to the release of the new study, FDA officials announced that they would strengthen the device review process.

The New York Times reported that the BIDMC “study found that more than 40 percent of the studies used to approve cardiovascular devices had lacked high-quality data about either the treatment or safety goals of the study.”Researchers also concluded that 25 percent of trials had failed to adequately follow patients enrolled in studies.”

Dr. William H. Maisel, a cardiologist at the Beth Israel Deaconess Medical Center who was involved in the study, said the review did not find a correlation between lower-quality data and problems related to the devices. However, he said he thought the potential for such links existed.

But, the JAMA study out of the University of California faulted the FDA review process and “concluded that the F.D.A. had approved cardiovascular devices based on data that ‘lacked adequate strength.’”

Their conclusion Premarket approval of cardiovascular devices by the FDA is often based on studies that lack adequate strength and may be prone to bias.

According to AP: The new studies, published in separate medical journals, cap a year of scrutiny and criticism for the FDA’s medical devices division. In August, the head of that division resigned, months after scientists under his leadership alleged they were pressured to approve certain products. The year began with congressional investigators saying the FDA should take immediate steps to make sure the riskiest devices are approved through the most stringent process.