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The Great American Hypertension Epidemic of 2017

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By MICHEL ACCAD, MD

On November 15, 2017, an epidemic of hypertension broke out and could rapidly affect tens of millions of Americans.  The epicenter of the outbreak was traced back to the meeting of the American Heart Association in Anaheim, CA.

The pathogen was released in a special 488-page document labeled “Hypertension Guidelines.”  The document’s suspicious content was apparently noted by meeting personnel, but initial attempts to contain it with an embargo failed and the virus was leaked to the press.  Within minutes, the entire healthcare ecosystem was contaminated.

At this point, strong measures are necessary to stem the epidemic.  Everyone is advised not to click on any document or any link connected to this virus.  Instead, we are offering the following code that will serve both as a decoy and as an antidote for the virulent trojan horse.

Only a strong dose of common sense packed in a few lines of text can possibly save us from an otherwise lethal epidemic of nonsense.  Please save the following text on your EHR cloud or hard-drive, commit it to memory or to a dot phrase, and copy and paste it on all relevant quality and pay-for-performance reports you are asked to submit.

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Expect big things from YOUR AHA Scientific Events. You Ask. We Listen. We Deliver.

By ELLIOTT ANTMAN, MD

Screen Shot 2014-10-27 at 3.03.00 PMThe American Heart Association is constantly looking for new ways to improve upon our scientific conferences. So, we are proud to announce the new AHA Scientific Meeting tagline: Expect big things from YOUR AHA Scientific Events. You Ask. We Listen. We Deliver.

What does this new tagline mean to the thousands of healthcare professionals who attend our AHA scientific events? It is our promise to the global cardiovascular healthcare community that we are listening to what you have to say. We promise to deliver enhancements that will make our scientific meetings convenient and mobile-friendly, while offering what the American Heart Association has always been known for: presentation and discussion of the very best in cardiovascular science.

So I encourage you to comment on our scientific meetings and we will continue to deliver results. I look forward to seeing you all at Scientific Sessions 2014 in Chicago, from November 15th-19th.

Learn more and register at scientificsessions.org.

Big Data gets a Big Spotlight at AHA Scientific Sessions

By AHA SCIENTIFIC SESSIONS in MARKETPLACE

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Big data is a big deal for healthcare providers and research scientists in 2014. At this  year’s Scientific Sessions, our Global Congress is focused on how Big Data is changing  the cardiology landscape.

From understanding the importance of data collection and analysis to discussing the  challenges cardiology professionals face when it comes to big data science, we’ll  explore the impact of big data on disease mechanisms and prevention.

The American Heart Association’s Scientific Sessions is the leading cardiovascular conference for basic, translational, clinical and population science in the United States, attracting more than 17,000 attendees from more than 100 countries. It’s five days of unmatched education designed to improve patient care by communicating the most timely and significant advances in basic, clinical, translational and population health

Learn more and register at scientificsessions.org.

A Challenge to Control Blood Pressure Using HIT

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By KAREN DeSALVO, MD and JANET WRIGHT, MD

Screen Shot 2014-07-30 at 2.13.16 PMHeart disease and stroke are two of the leading causes of death in the United States. To combat these threats, the Department of Health and Human Services (co-led by Centers for Disease Control and Prevention [CDC] and the Centers for Medicare & Medicaid Services [CMS]) has joined with private and non-profit organizations such as the American Heart Association, American Pharmacists Association and the YMCA, to launch Million Hearts®, a national initiative to prevent one million heart attacks and strokes by 2017. The initiative is working to encourage clinicians nationwide to improve the quality of care through use of the ABCS strategies – Aspirin when appropriate,Blood pressure control, Cholesterol management and Smoking cessation.

On July 7th, as we marked the halfway point in this ambitious drive to improve America’s health, the Office of the National Coordinator for Health Information Technology (ONC), in collaboration with the CDC, launched the EHR Innovations for Improving Hypertension Challenge to accelerate improvement on the Million Hearts® “B” strategy – Blood Pressure Control. The goal is to show how professionals are using health IT to improve patients’ cardiovascular health. Evidence-based treatment protocols are an essential tool for providers to use in improving blood pressure control.

What makes this ONC challenge unique?  First, it taps the expertise of clinicians who care for patients with hypertension and are using health IT to improve their control. Second, the challenge is designed to promote the scalability of critical tools for maximum impact and reach.Continue reading…

Circulation: The Nineties Called. They Want Their Wellness Policy Back

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By AL LEWIS and VIK KHANNA 

flying cadeuciiLast year, we soundly criticized the American Heart Association (AHA) on this blog for its proposal to lower the thresholds for treating cholesterol and getting larger numbers of Americans to swallow statins. We also exposed wellness vendor StayWell, for its mathematically impossible claims of success in British Petroleum’s wellness program. Proving that great minds aren’t the only ones that think alike, StayWell and the AHA have now joined forces.  Specifically, the AHA invited the CEO of StayWell, Paul Terry, Ph.D., to help write its workplace wellness policy statement, sort of like Enron inviting Bernie Madoff to help design its financial plan. You don’t learn of this fox-in-the-henhouse conflict of interest unless you read the table on the penultimate page of text.

Naturally, Mr. Terry parlayed this windfall to StayWell’s advantage. The statement: “currently available studies indicate that employers can achieve a positive ROI through wellness” is footnoted to two studies authored by:  Paul Terry, along with other Staywell executives.  One wonders how a StayWell executive writing policy for the AHA based partly on StayWell’s own articles passes the AHA’s own test of “making every effort to avoid actual or potential conflicts of interest that may arise as a result of an outside relationship.”

How did this conflict of interest get by the peer reviewers? Look at the list of peer reviewers. Prominent among them is Ron Goetzel. Readers of THCB may recall Mr. Goetzel not just from his central role in the Penn State debacle, but also from the ”The Strange Case of the C. Everett Koop Award,” in which it was documented that his committee gave the ironically named award to a sponsor of the award (without disclosing that conflict), even though that sponsor had admitted lying about saving the lives of 514 cancer victims, who, as luck would have it, didn’t have cancer. (The sponsor, Health Fitness Corporation, a division of the equally ironically named Trustmark, has won the Koop award several times, thus proving the cost-effectiveness of their sponsorship.)

If this litany were not enough to dismiss the policy statement forthwith, there is small matter of the actual policy itself, a full employment act for wellness vendors and cardiologists alike, advocating more screening of more employees more often, while ignoring more self-evident facts than Sergeant Schultz. Specifically, they cherry-picked the available literature, continuing to cite the old “Harvard study” whose lead author has now walked it back three times. Except that they didn’t call it the “old Harvard study,” but rather a “recent [italics ours] meta-analysis,” despite the fact it was submitted for publication in 2009, and the average year of the analyses in the study was 2004.  Some studies began in the 1990s and were able to use sleight-of-hand to “show savings” despite presumably — in accordance with the conventional wisdom of the era — getting people to eat more carbohydrates and less fat.  No wonder Soeren Mattke of RAND Corporation dismissed the Harvard data as archaic in his interview with CoHealth radio in February 2014.

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A New Era in Value-Driven Pharmaceuticals

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By Leonard Kish & Cyndy Nayer

flying cadeuciiAt the end of March the Amercian College of Cardiology (ACC) and the American Heart Association (AHA) issued a joint statement saying they “will begin to include value assessments when developing guidelines and performance measures (for pharmaceuticals), in recognition of accelerating health care costs and the need for care to be of value to patients.”

You may have heard of value-based medicine, but are we entering a new era of value-based medications or value-driven pharma?

Price transparency is great, but it has be combined with efficacy to get to value (price for the amount of benefit). Medical groups are catching on to how important value assessments are, because if patients can’t afford their medication, they won’t take their medication, and that obviously can turn into poor outcomes.

Twenty-seven percent of American patients didn’t fill a prescription last year according to a Kaiser Family Foundation Survey. This trend seems likely to continue as we move toward higher-deductible plans, where those with insurance can have great difficulty affording medications.

Included in the ACC/AMA statement was a quote from Paul Heidenreich, MD, FACC, writing committee co-chair and vice-chair for Quality, Clinical Affairs and Analytics in the Department of Medicine at Stanford University School of Medicine.

“There is growing recognition that a more explicit, transparent, and consistent evaluation of health care value is needed…These value assessments will provide a more complete examination of cardiovascular care, helping to generate the best possible outcomes within the context of finite resources.”

Spreading risk and payment to different members of the health care value chain is beginning to make it apparent to more people and organizations that resources are finite. Patients and their physicians are starting to ask which treatments are worth the cost and have best likelihood of adherence.

An outgrowth of the move toward digital health and accountable care is that we’re entering every patient into a potential personal clinical trial with their data followed as a longitudinal study, and we can look much more closely at efficacy and adherence and reasons why it happens and why it doesn’t.

It won’t be long before we start to see comparative effectiveness across a variety of treatments and across a variety of populations. When we can connect outcomes data, interventions and costs all in the same picture we begin to see where the value (price against results) is and where it isn’t.

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How Clinical Guidelines Can Fail Both Doctors and Patients

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By Robert McNutt, MD & Nortin Hadler, MD

Any confusion over the recent news of cholesterol guidelines in the U.S. is perfectly understandable. On the one hand, the guidelines suggest that nearly half the population should use statins to stave off heart attacks and strokes. On the other, use of the drugs is not with potential side effects and, to many, will offer no substantive benefits. The controversy highlights a problem mired in an outdated way of thinking about health care and the doctor-patient relationship.

Guidelines came about after generations of physicians wanted to bring something more than “opinion and experience” to the patient’s bedside. In the late 1960s legislation for the U.S. Food and Drug Administration was amended to call for a demonstration of efficacy and an assessment of benefits and risk as prerequisite to the licensing of any pharmaceutical. Modern clinical science resulted, first slowly and now with an avalanche of clinical trials, each pouring forth outcome data galore.

The Burden of Clinical Data

Clinicians are expected to stay current with this wealth of information. The modern medical curriculum instructs all budding physicians on how to evaluate the quality and the clinical relevance of all such contributions to the body of clinical science. Because some (or perhaps many) find this exercise overwhelming, there are organizations—many academic and some without any discernible relationships with purveyors that could pose a conflict of interest—that attempt to bundle the information in a fashion that might be relevant to particular physicians or physicians in particular specialties. Some of this bundling is quite systematic, some quite helter-skelter.

Occasionally there is a contribution to the literature that offers an unequivocal advantage for a particular patient group. More often, the bundlers are faced with a heterogeneous literature that often demonstrates little, if any, efficacy. Faced with these circumstances, biostatistics has offered up many a method to impute more value to the literature than is apparent at first blush. The result is that all this bundling adds to an enormous and ever-expanding secondary literature.

What is the clinician to do?

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The Cholesterol Gulag

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By Vik Khanna, Tom Emerick & Al Lewis

Last week, we were amongst the very first opinion leaders to speak out against the new cholesterol guidelines from the American Heart Association (AHA) and the American College of Cardiology (ACC).

Our error was not going far enough.

Monday’s New York Times carried a devastating portrait of the development of the guidelines, leaving readers with the unmistakable impression that this absurd attempt to make people into patients was not just poor policy it was a hubristic, avoidable policy folly, sort of like the bridge to nowhere and federal housing policy pre-2008.

Trust is an interesting thing; once broken it almost resists reconstruction.  Public trust in the AHA and ACC is crumbling as we write and deservedly so, as what should have been clear becomes more confusing and conflicted by the minute.

Instead of giving generally healthy middle aged American adults (like the three of us) the safe haven of a cardiovascular disease (CVD) prevention framework that is understandable, sensible and actionable, we got a cholesterol gulag.  Only here in the land of the free, it’s not a government gulag imprisoning the political opposition.

No, in a phenomenon unique to the US, it’s a health gulag intended to take people who need advice, support, and guidance and give them a pill, which is the first step in an intentional ensnarement in the medical care system.  It’s the Hospital California…on steroids, and you can’t even checkout because that would be against this addled medical advice.

To clarify: we have zero objection to providing statins, especially low-cost generic ones, to people under age 75 with current CVD, diabetes, or extremely high cholesterol levels.  The drugs may very well save their lives.

Our beef is with the cockamamie reduction in the ‘risk-to-treat’ threshold from 10% risk of heart attack or stroke in the next 10 years to 7.5% for people with none of the above noted problems.

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The Statinization of America

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By Vik Khanna, Tom Emerick & Al Lewis

On November 12, 2013, the American Heart Association (AHA) and the American College of Cardiology (ACC) disrupted the cardiovascular disease (CVD) universe by issuing four new guidelines.  The guidelines depart from past efforts because the relevant federal agency, the National Heart, Lung, and Blood Institute (NHBLI), did not lead development.  NHBLI now ‘sponsors’ guideline development, but has deferred actual writing and publication to private groups.

No word on when long-awaited companion blood pressure guidelines will emerge.  If the blood pressure guidelines look anything like these cholesterol guidelines, then all rational arguments about cost containment will effectively come unhinged.

The guideline release was well orchestrated, not unexpected in organizations so well-funded by the pharmaceutical companies.  They are the population that stands to benefit the most from what Alan Cassels, author of Selling Sickness and Seeking Sickness, which both seemed to anticipate moves like this, calls “statinization.” Fortunately, not everyone was drinking the “treatment today, treatment tomorrow, treatment forever” Kool-Aid; contrarian physicians believe that the guidelines simply lowered the therapeutic bar without clear evidence that doing so will improve outcomes, an ironic observation given that this is supposed to be about primary prevention.

The contrivance of simply altering a definition and having the subsequent area under the curve of healthy people who require treatment expand to include, oh, say 30 million more Americans is a merger-and-acquisition coup for pharma that would make Gordon Gekko blush.

Lowering the therapeutic bar will increase health care spending as physicians write more prescriptions and see more patients more often, certainly to monitor liver health, and probably for the side effects that cause double digit percentages of patients to stop and are routinely underreported in studies sponsored by the industry.

It also gives patients false security by promoting the belief that the heartily recommended drugs – statins – will provide a “cure,” a clinical get-out-of-jail-free card, which will surely diminish enthusiasm for lifestyle-based approaches to prevention that are free but unfortunately not reimbursable.  And, as Abramson and Redberg note in their New York Times essay, the enunciated strategy will require perpetual treatment of 140 people to forestall 1 heart attack.  Many of these people will now live long enough to experience “disease substitution,” allowing them to die of cancer or dementia.

The most important element of the new guidelines, however, is the shift away from pursuit of hard targets (get total cholesterol below 240 and LDL below 180) to a risk-based approach (for people without clinically evident disease), in which the therapeutic goal is to medicate non-diseased adults aged 40 to 75 who have an estimated 10 year risk of developing heart disease greater than 7.5% (down from 10% risk over 10 years).  Overall, this necessary and overdue shift properly emphasizes CVD risk as a constellation and exposes our cultural tendency to seek or initiate treatment because of a single adverse attribute, which has led us to waste a fortune chasing clinical ghosts.

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