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.
We are puzzled, then, by the tidiness of lowering the therapeutic bar for adults without disease from 10% risk to 7.5% risk in one fell swoop, because we know of no clinical trial or meta-analysis that would produce such a clean and clear dividing line. Like water prospectors of yore, the writing panels seem to have waved a divining rod at their industry-supported data sets and simply decided to split the difference between the current risk threshold and promoting treatment at a 5% risk threshold, which would have had them laughed out of the room.
The best result from this change, however, is that the guidelines will create significant problems for wellness vendors. The wellness industry has built its preventive medicine strategy, communicated to employees via health risk appraisals and biometrics, around the pursuit of hard targets, typically called “know your numbers” campaigns. The shift to a risk constellation strategy from a hard target strategy will flummox vendors who may soon realize that getting all the factors aligned to estimate employees’ risks will entail asking them questions that they won’t know the answer to (what’s your HDL?), may not want to answer truthfully (do you smoke?), or are privileged medical information that the vendor has no business knowing (are you currently being treated for high blood pressure?).
The final element of CVD risk estimation, which the calculator does not capture but a qualified adult medical care provider would, is family history. It is illegal for employers and wellness vendors to inquire about it.
Indeed, we encourage employees to refuse to answer those queries or to enter bogus data. Instead, we encourage everyone to download the risk calculator here and use it in privacy and then take the results to his or her primary care provider for discussion and, if safe, vigorously pursue a low-cost lifestyle change strategy before pharmacotherapy.
Sadly, the guidelines reflect a growing trend toward the medicalization of life so that it seems the very act of living is itself a pathology that requires intervention. This not only undermines claims of long-term cost-effectiveness, it perpetuates the myth that the pursuit of good health begins in the clinic. It is particularly disturbing because there is no shortage of data about the impact of exercise as a tool for either primary or secondary prevention of CVD. Too bad that the medical establishment isn’t as concerned about expanding the market share of sneaker companies as it is drug companies.
Vik Khanna is a St. Louis-based independent health consultant with extensive experience in managed care and wellness. An iconoclast to the core, he is the author of the Khanna On Health Blog. He is also the Wellness Editor-At-Large for THCB.
Tom Emerick is the President of Emerick Consulting and co-founder of Edison Health. Prior to consulting, Tom spent a number of years working in leadership positions for large corporations: Walmart Stores, Burger King, and British Petroleum.
Al Lewis is the author of Why Nobody Believes the Numbers, co-author of Cracking Health Costs: How to Cut Your Company’s Health Costs and Provide Employees Better Care, and president of the Disease Management Purchasing Consortium.