OP-ED

The Statinization of America

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 CostsHow to Cut Your Company’s Health Costs and Provide Employees Better Care, and president of the Disease Management Purchasing Consortium.

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flooded basement water on carpet cleanupGafas De Sol Carolina HerreraGafas Carolina HerreraCarolina Herrera Bolsosalan t falkoff, md, faafp Recent comment authors
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flooded basement water on carpet cleanup
Guest

constantly i used to read smaller articles or reviews which as well clear
their motive, and that iis also happening with this post which I am reading at this place.

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Gafas Carolina Herrera
Guest

attorney. Tim. What happened was after I introduced the censure resolution there was a lot of talk that didn’t mean anything? That’s a tough moral issue, Right.MR. But in the midst of this investigation, OK. South Carolina.MR. Yet it was on his radar screen enough to call someone from the Democratic side of the ledger and unequal to him to ask him for help to back off and again.

Gafas De Sol Carolina Herrera
Guest

many important breakthroughs were made in the understanding of scientific processes and physical phenomena. And I think there was a chance…GREGORY:? What more stands out to you this morning?(End videotape)MR.REP.SEN. WOODWARD:?REP. stadium box seats or the discounted use of private jets. that put these sanctions in place.

Gafas Carolina Herrera
Guest

a social worker at the Alzheimer’s Association, who was fading away into advanced dementia. This is what you wrote in your column about Barack Obama having some fun with his status. “Up until now The Chosen One’s [Obama’s] speeches had seemed to them less like stretches of words and more like soul sensations that transcended time and space? CLINTON:? Constriction of the walls of the arterties, The Taliban come to their villages cut off people’s limbs and paint graffiti with their gushing blood while they laugh and their victims die horrendously. It’s a simple question. PEROT:Now, Ted Cruz of Texas?… Read more »

Carolina Herrera Bolsos
Guest

shootings in the city are actually down 28 percent compared to 2012 and 18 percent compared to 2011, when eleven people were killed and more than 40 were hurt over a four-day period. you know,The boy is thought to have brought the Ruger 9mm from home,S. The oversight panel, You are either ruled or rule in a state.Anarchism is NOT mafias running the world. For months, Was he a change agent or a populist?

alan t falkoff, md, faafp
Guest

How much has been forgotten or ignored in the natural history and pathogenesis of cholesterol / lipid plaques. Are we just going to be looking at numbers and ignoring individual risk and pathology? Plaque buildup begins in the late teens ans early twenties. At what point and in who a plaque ruptures is ignored and not addressed in the numbers game.

Joel Hassman, MD
Guest
Joel Hassman, MD

Hope you don’t mind, I linked this post to my blog today regarding the role of Big Pharma to the overmedication of America.

Keep up the good work and attention to lack of concern for the well being of the public at large!

Alice Ceacareanu
Guest
Alice Ceacareanu

Love the title – nice pick! As a clinical pharmacist, I find the new statins’ utilization guidelines being of enormous benefit for the US population which is INDEED a population with pre-diabetes/diabetes, pre-hypertension/HTN, hypercholesterolemic and on the edge of wide-spreading metabolic syndrome. These facts not only warrant lower population survival, increased comorbidity and societal cost but they also constitute an exceptional environment for cancer development. US has a concerning shortage of oncology trained professionals and no financial security to address the forecast-ed cancer incidence in the coming two decades. Statins are dramatically underused even when referring to old guidelines. We… Read more »

B. Helton
Guest

This change is as the authors write clearly a contrivance, but not necessarily a bad-intentioned one. In healthcare we have learned to “not” follow the money rather to follow the definitions. So how might a layperson distinguish between the prior numeric-based approach and this new statinization effort? I suggest we begin with a single question: “Is this ‘healthcaring’?” Like gauging our satisfaction, a beautiful thing about “healthcaring” is we each know it when we have it, and we know it when either we or someone else doesn’t. This almost always works, however, can we actually figure out whether a definitional… Read more »

Alan Cassels
Guest

Al, you’re absolutely right. Don’t know what it’s like in the US but in Canada we estimate 80% of statin use is by people without existing heart disease and hence unlikely to see any benefit whatsoever. O the waste…

Charles Smith
Guest
Charles Smith

I disagree with the premise that big pharma held sway here. Over 90% of statin use is now generic. The guidelines are also essentially a death knell for lucrative drugs like zetia which have never proven effective.

Alan Cassels
Guest

These numbers from Thennt.com give some sense of the magnitude of effect. Obviously in people without established heart disease the benefits would be much smaller. (But the harms would likely be the same) Statins Given for 5 Years for Heart Disease Prevention (With Known Heart Disease) http://www.thennt.com/nnt/statins-for-heart-disease-prevention-with-known-heart-disease/ Benefits in Percentage 96% saw no benefit 1.2% were helped by being saved from death 2.6% were helped by preventing a repeat heart attack 0.8% were helped by preventing a stroke Harms in Percentage 2% were harmed by developing diabetes** 10% were harmed by muscle damage In Summary, for those who took the… Read more »

Al Lewis
Guest
Al Lewis

remember, these stats are for KNOWN heart disease. My issue is that when you draw the line at a much lower threshold, these statistics become far more skewed in the wrong direction.

Rob
Guest

It’s interesting that your numbers are so different from the ones I read and my own clinical experience. Only 4% saw benefit at all? People with known CAD or risk-equivalent? 2% develop diabetes? 10% are “harmed” by muscle damage? First off, here’s a summary statement from uptodate.com on the risk of diabetes: “It appears likely that statin therapy confers a small increased risk of developing diabetes, and that the risk is slightly greater with intensive statin therapy than moderate statin therapy. As would be expected, given the evidence from clinical trials that statins reduce CV events in patient with diabetes… Read more »

Rob
Guest

“So, let me get this straight. We give statins so we can eat sugar.” What? I never mentioned sugar; I simply said that knowing risk is a good thing, and that treating that risk (sometimes using statins) is better than treating a proxy marker like LDL. I agree that lowering sugars consumption is highly likely to be a good thing, but am confused as to why I was put as someone who didn’t think that. But blanket statements demonizing one thing (sugar) as the cause of all wrong sound quite similar to those demonizing another (LDL). We focus on risk… Read more »

Jordan Shlain MD
Guest
Jordan Shlain MD

Sorry, Rob – I didn’t mean to reply to you. Meant to further make the sugar point. While there are many things that are involved in risk, for sure, a very important one is not weighted apporpriately in risk reduction strategies.

I appreciate that the references are not news to you, but guess what, if they were news to the general public and policymakers, we’d be having the dialogue at a national level, not on a comment section of a blog.

Al Lewis
Guest
Al Lewis

not that there is anything wrong with it…

One concern would be that people think if they are on statins that they have carte blanche or close to it in lifestyle choices such as sugar consumption, just the way people with high-efficiency light bulbs are less vigilant about turning them off

Rob
Guest

So should we not talk about seat belts because they encourage people to drive recklessly?

Vikram Khanna
Guest

There is zero evidence that seat belts promote high risk driving.

Matthew Holt
Guest

Hey Jordan, the comments section of THCB IS a national dialogue!

Rob
Guest

Is there a question that statins, when used in populations at high risk for heart disease, lower that risk? I would say there is little question, even when one accepts the challenges to the idea that the culprit is actually the LDL cholesterol. So it would seem to me that we need the most powerful tools available to identify CVD risk accurately so we can decide whether or not to use the treatments we know work in high risk populations. I applaud the attempt to take the focus off of the hard numbers and onto the idea of risk-reduction. Recommendations… Read more »

Jordan Shlain MD
Guest
Jordan Shlain MD

There is growing evidence that sugar consumption in excess (the average american eats 22 tsp of sugar and the recommendation is 7tsp) leads to increase risk for heart disease. Futhremore, there is mounting correlation that sugar consumption leads to Type II diabetes (which is yet another risk factor for CVD). So, let me get this straight. We give statins so we can eat sugar. Seems like we’re solving a second order problem here. Basu S, Yoffe P, Hills N, Lustig RH. The relationship of sugar to population-level diabetes prevalence: an econometric analysis of repeated cross-sectional data. PLoS ONE. 2013;8:e57873. Malik… Read more »

Vik Khanna
Guest

As I noted for another commenter, the long-term benefit for phrama is the opening of the door to a much larger population to which it can sell new products. While many new patients will use generics in the short term, there are expensive new “blockbuster” statins in the pipeline, and, despite all the best efforts to limit access to those drugs, there will be intense pressure to prescribe them. Further, given that the generics business is a volume business, those manufacturers are no doubt pleased with the effective overnight doubling of their market. Even when you make only pennies on… Read more »

Rob
Guest

OK, so the question then comes down to this: 1. Do statins save lives? 2. If so, then are the folks recommending this in these in the pocket of pharma or are they interested in saving lives? 3. Why not educate doctors that “blockbuster” drugs (of which I have no knowledge) must prove significant endpoints (i.e. Not the lowering of cholesterol, but the reduction of heart events and prolongation of life) before we use them in the place of drugs with strong evidence that supports that. You use a straw-man argument here. Just because someone is going to make a… Read more »

Vikram Khanna
Guest

No one is objecting to statins for high risk populations.

The point of our objection and that of many, many others is that the new guidelines expand the definition of who’s at risk in an arbitrary manner by shifting the threshold for use in adults without disease.

Al Lewis
Guest
Al Lewis

Tim, thanks for asking the question and I wonder why no one else has. I’ll bet on evolution over pharmaceutical company data any day