Over-treatment? There’s an app for that

ss accCritics have knocked the recently updated guidelines  on statins for patients at risk of heart disease. While some heart specialist spent years putting together advice for the high risk, others said the guidelines will result in massive overtreament.

Still, health monitoring apps are hot,. The American College of Cardiology is now offering an iPhone/ iPad risk calculator,  the Globe’s Daily Dose reports. This paragraph from the Boston.com post was cut off the print version of the story.

The app does instruct doctors to have a discussion about the risks and benefits of statins and to consider patient preferences; whether busy primary care providers will make the time to have that discussion, rather than simply prescribing the drugs, remains to be seen. 

The headlines were different as well. 

Print: App Calculates Heart Disease

Boston.com: Heart disease risk app may increase statin prescriptions

Don’t like the ACC app? There are already a handful of others.

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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.”

Boston docs on debate over cholesterol screening for kids

A couple of Boston-area docs weigh in on charges of industry influence in the debate over whether to test kids for cholesterol.  From the Globe:

CHICAGO — Should all US children be tested for high cholesterol? Doctors are still debating that question months after a government-appointed panel recommended widespread screening that would lead to prescribing medicine for some kids.

Fresh criticism was published online Monday in the journal Pediatrics by researchers who say the guidelines are too aggressive and were influenced by panel members’ financial ties to drug makers.

Other criticism was published earlier this year in the Journal of the American Medical Association. …JAMA included additional criticism from a dissenting member of the panel that produced the kids’ cholesterol guidelines, Dr. Matthew Gillman of Harvard Medical School. He recommends more narrow screening based on family history of cholesterol problems.

… Dr. Sarah De Ferranti, an American Academy of Pediatrics spokeswoman and director of preventive cardiology at Boston Children’s Hospital, said the question should be part of a conversation parents should have with their pediatrician about heart disease risks, including weight, blood pressure, and lifestyle. She said she would have her children tested.

Most of the Peds articles are behind the pay wall. But, UCSF put out a press release on the latest comments. And the NIH guidelines are online.

From NIH: Integrated Guidelines for Cardiovascular Health and Risk Reduction in Children and Adolescents

From UCSF: New lipid screening guidelines for children overly aggressive, UCSF researchers say recommendations fail to weigh benefits against potential harms

Recent guidelines recommending cholesterol tests for children fail to weigh health benefits against potential harms and costs, according to a new commentary authored by three physician-researchers at UCSF.

Moreover, the recommendations are based on expert opinion, rather than solid evidence, the researchers said, which is especially problematic since the guidelines’ authors disclosed extensive potential conflicts of interest.

The guidelines were written by a panel assembled by the National Heart, Lung and Blood Institute (NHLBI) and published in Pediatrics, in November 2011. They also were endorsed by the American Academy of Pediatrics. The guidelines call for universal screening of all 9 to 11-year-old children with a non-fasting lipid panel, and targeted screening of 30 to 40 percent of 2 to 8-year-old and 12 to 16-year old children with two fasting lipid profiles. Previous recommendations called only for children considered at high risk of elevated levels to be screened with a simple non-fasting total cholesterol test.

The call for a dramatic increase in lipid screening has the potential to transform millions of healthy children into patients labeled with so-called dyslipidemia, or bad lipid levels in the blood, according to the commentary by Thomas Newman, MD, MPH, Mark Pletcher, MD, MPH and Stephen Hulley, MD, MPH, of the UCSF Department of Epidemiology and Biostatistics and e-published on July 23 in Pediatrics.

“The panel made no attempt to estimate the magnitude of the health benefits or harms of attaching this diagnosis at this young age,” said Newman. “They acknowledged that costs are important, but then went ahead and made their recommendations without estimating what the cost would be. And it could be billions of dollars.”

Some of the push to do more screening comes from concern about the obesity epidemic in U.S. children. But this concern should not lead to more laboratory testing, said Newman.

“You don’t need a blood test to tell who needs to lose weight. And recommending a healthier diet and exercise is something doctors can do for everybody, not just overweight kids,” he said

The requirement of two fasting lipid panels in 30 to 40 percent of all 2 to 8-year olds and 12 to 16 –year- olds represents a particular burden to families, he said.

“Because these blood tests must be done while fasting, they can’t be done at the time of regularly scheduled ‘well child’ visits like vaccinations can,” said Newman. “This requires getting hungry young children to the doctor’s office to be poked with needles on two additional occasions, generally weekday mornings. Families are going to ask their doctors, ‘Is this really necessary?’ The guidelines provide no strong evidence that it is.”

The authors note that the panel chair and all members who drafted the lipid screening recommendations disclosed an “extensive assortment of financial relationships with companies making lipid lowering drugs and lipid testing instruments.” Some of those relevant relationships include paid consultancies or advisory board memberships with pharmaceuticals that produce cholesterol-lowering drugs such as Merck, Pfizer, Astra Zeneca, Bristol-Myers Squibb, Roche and Sankyo.

“The panel states that they reviewed and graded the evidence objectively,” said Newman. “But a recent Institute of Medicine report recommends that experts with conflicts of interest either be excluded from guideline panels, or, if their expertise is considered essential, should have non-voting, non-leadership, minority roles.”

Evidence is needed to estimate health benefits, risks and costs of these proposed interventions, and experts without conflicts of interest are needed to help synthesize it, according to Newman. He said that “these recommendations fall so far short of this ideal that we hope they will trigger a re-examination of the process by which they were produced.”

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Newman and Hulley have no disclosures. Pletcher has NIH funding to support research on targeting of cholesterol-lowering medications to prevent cardiovascular disease.

Caution or stubbornness? Boston docs shun new heart procedure

longwood mapBoston-area docs are known for their reluctance to adopt new procedures. The Washington Post reports that holds true for a new approach to angioplasty. Instead of steering the catheter into the coronary arteries through the groin, some docs go through the wrist.

Questions about the best method of performing cardiac catheterizations, one of the most common procedures in medicine and among the most profitable for hospitals — Medicare reimburses (George Washington University) GWU about $10,600 for an angioplasty involving one stent — reflect some of the issues in the roiling health-care debate. Is the radial approach, which has a steep learning curve, actually superior or largely a fad? Can it cut costs by reducing hospital stays? And if patients are given a choice of catheterization sites, what factors should they consider? …

In Boston, a city brimming with teaching hospitals and interventional cardiologists — heart specialists with advanced training who perform procedures — only a handful of physicians specialize in radial catheterization, said Pinak B. Shah, director of interventional cardiology training at Brigham and Women’s Hospital.

“There’s no data out there to suggest it is worse and growing evidence that it may be better,” said Shah, an assistant professor of medicine at Harvard Medical School, who performs 60 to 70 percent of procedures through the wrist.

Shah said he believes a combination of financial self-interest, the relative paucity of medical devices designed for radial access, resistance by older physicians and the general tendency of doctors to regard patient discomfort as secondary have contributed to under-use of the approach.