Wednesday, September 14, 2011

A Million Hearts or A Million Dreams?

Yesterday, Thomas R. Frieden, M.D., M.P.H., and Donald M. Berwick, M.D., M.P.P. used the bulliest of scientific pulpits, the New England Journal of Medicine, to announce their "Million Hearts" initiative aimed at "preventing" heart attacks and strokes.

Now I do not hold a Masters in public health or public policy, but I do know a thing or two about evidenced-based medicine and cardiology. So it seems only appropriate that a cardiologist should comment on the proclamations made by an infectious disease specialist and pediatrician who promise to "save a million hearts," especially when we consider the billions of taxpayer dollars that have been or will be allocated to their programs.

I suspect neither of these highly accomplished men from public policy circles knows if, or exactly how, they will save a million lives nor how they should appropriately measure the effect of their initiative. That is not the point. Sexy program names are the point and making sure those names appear in a scientific journal within reach of treating cardiologists is especially the point.

We should acknowledge that the authors have been very good at dangling statistics of death and destruction caused by heart attacks and stroke to drive their policies. After all, while cardiovascular disease has remained the number one killer of Americans year after year, it is also the biggest driver of health care costs in America. I have no doubt these two non-cardiovascular specialists are proposing their initiative as a straw dog in an effort to gain the public's favor while simultaneously working around the clock to reduce cardiovascular spending. This is, after all, about a money shift, not just about more good ideas for improving cardiovascular outcomes.

How do I know?

I know because you will not hear from these men about the changes underway to limit access to cardiologists by forcing their consolidation with larger health care systems. I know because doctors are scrambling to these systems in an effort per preserve their income in a system intent on cost cutting. I know because government regulators are also working to restrict access to technologies have proven efficacy at saving lives and prolonging life for our older seniors, like wearable defibrillators whose use is being "reconsidered" and percutaneous aortic valves that still wait to gain approval (likely with significant restrictions to their use) here in the US. I also know because even with all the waste, fraud, and abuse measures underway to the cost of health care delivery in America, there will still be a need to cut America's health care system payments by at least 10-20% over the next ten years to maintain the program's fiscal solvency.

So given these overriding needs to cut costs, Americans should expect there are rock-hard data upon which the authors have based their need to start such a "million heart" initiative. Sadly, there are not. In fact, when we dig deeper we find the health care dollars spent on many of the cornerstone programs that serve as the foundations to their theories have lacked sufficient data to even justify their continuation. Yet, they ignore these data.

Let's look closer at the six cornerstone "principles" upon which their "million hearts" initiatives rest:
  • Principle 1: Focus - The authors claim that "communication, clinical measurements, reporting by physicians and health care facilities, and health care systems will emphasize improving ABCS (Aspirin therapy administration, Blood pressure management, Cholesterol lowering, and Smoking cessation)." Few data support this claim. In fact, clinical measurement programs, like pay-for-performance measures, have failed to affect outcomes in smaller pilot programs here in the US and in a larger population studies overseas. Despite this, additional money for these programs continues to be promoted by these authors. We should really ask why.
  • Principle 2: Health Information Technology (HIT) - The authors claim that "HIT enables providers and facilities to provide cardiovascular care and target intervention to patients in need of intensified care through registries and EHR (electronic health records) functions used at the point of care." While this sounds great, the data so far do not support this assumption when outcomes are actually measured:
    In fact, EMRs (electronic medical records) were associated with significantly improved performance in only one measure — giving diet advice to high-risk adults. They didn’t improve performance in things including giving aspirin for coronary artery disease, depression treatment or blood-pressure measurement.
  • Principle #3 - Clinical innovations - The authors claim: Innovations such as team-based care, patient-centered medical homes and interventions to promote adherence will be supported, evaluated, and disseminated rapidly to increase the effective use of ABCS practices." In other words, they haven't figured out if any of these "innovations" actually work. Truth be known, patient-centered medical home pilot projects have been a bit of a disappointment so far. Still, our authors press on absolutely convinced, (convinced I tell you!) that these measures will work despite data to the contrary.
  • Principle #4: Policies and programs to reduce smoking and effects of second-hand smoke - This program is likely to be cost-effective. But we should temper our enthusiasm for these efforts now that the anti-smoking message is firmly established in our schools and public consciousness.
  • Principle #5: Policies for reducing sodium content of food - While it is one thing to project the number of lives saved from modest sodium restriction in the diet, its an entirely different thing to suggest public policy will change people's individual lifestyle decisions. Good luck getting Americans to restrict sodium to 3 grams per day, especially when people can buy a salt shaker. If Drs. Frieden and Berwick could also impact the farm subsidies for corn that have been criticised as a significant contributor to our current obesity epidemic, they might gain favor with cardiologists, but politics are not likely to permit such a move.
  • Principle #6: Policies at eliminating artificial trans fats in the diet - The authors expect to "further reduce the level of trans fats that increase LDL cholesterol levels, lower HDL cholesterol levels that increases the risk of heart attacks." This principle requires the authors to accept the cholesterol theory of reducing heart attacks, but recent studies are debunking that theory. Take the recent high-profile NIH-sponsored AIM-HIGH trial comparing statin to statin plus niacin therapy in patients with cardiovascular disease and low HDL levels. (This study was designed to show that increasing HDL levels with niacin would improve heart attack and stroke outcomes.) This study was stopped 18 months ahead of schedule not only because it was determined to be extremely unlikely that the increase in HDL produced by niacin would improve outcomes, but also because of an unexpected increase in strokes among the patients receiving niacin, a drug known to increase HDL. Support for the results of this study come from earlier trials on non-statin cholesterol lowering medications that lowered cholesterol but never reduced the outcomes of heart attack and stroke. Only statins as a class of drugs have shown such a benefit. So what gives? Doctors are not sure, but it's more about the statins than it is about the cholesterols. Still, such analyses are unimportant to our policy-makers intent on moving their agenda forward. You see it is far better to espouse non-factual takes in the New England Journal of Medicine unencumbered by critical discussion. Worse, given what we now know about elevating HDL levels from the AIM-HIGH trial, their programs could even have a deleterious effect to public health.
Most of the best ideas for improving the public's health will come from those on the front lines of specialized medical care and not those who dictate unproven policy initiatives from a place of theories, inexperience, and assumptions. Like the 90-minute door to balloon time, an idea stemming from the professionals in the field with hard data to suggest its benefit to our patients, these are the initiatives that save real lives.

But we should realize what these feel-good perspective pieces are really about: they're about the money. More specifically, this perspective piece serves as a distraction to the money cuts and a money shifts from real-life proven therapies to mostly unproven, costly initiatives based on dreamy projections of public good rather than actual patient outcomes. As a result, we are now seeing the modus operandi of our government health care leaders of the future: placing feel-good happy-face programs in place based upon mostly unproven, theoretical data in favor of funding more expensive, better-proven therapies that really do save lives.


Addendum: John Mandrola, MD offers his more heart-healthy take.


Steve Parker, M.D. said...

Right on, brother.

Tim Hulsey, MD said...

There are liars. There are damned liars, and there are the pointy -headed, pseudo-intellectual, public health/public policy elite, who can't tell a patient from a spreadsheet!! Somehow, the masters degree programs these idiots go through wipes out all memory of the doctor- patient relationship, compassion, and humanity! They might as well be Watson, the IBM supercomputer. I'll bet they would do well on Jeopardy! Has anyone checked the base of their necks for USB ports?
I call "b__ls__t" on their whole process! They aren't man enough to tell the truth and use the "R" word- RATIONING. They don't know how to treat patients, only populations. These twits with MPH/MPPs should've had their heads pinched off as babies!
And no! I won't apologize for calling them what they are!

Keith said...

But Wes, we are still putting thousands of stents in patients even though the data suggests little efect on mrobidity or mortality over standard medical regimens contoling BP and cholesterol and using ASA.

There is plenty of unproven standard medical care on both sides of the technological divide. I think that those with a much higher price tag need to justify their benefits to a higher degree before we unleash them in our medical industrial complex to eat away and cause more of these large federal dificits that everyone seems to be concerned about (and rightly so!). In other wordsour ability to absorb these costs are not limitless and we must pick and choose treatments that are most cost effective; not the ones that generate the most porfit for hospitals and doctors.

Anonymous said...

Magnificent post, Dr. Wes.

Hope you send it, in some form, to the NEJM.

Anonymous said...

I'm only a patient that has had heart valve replacement so I don't know from studies. But I do know from advertising and marketing and I do know cigarette smoking is increasing in kids. And our memories are notoriously short in this country. The anti-smoking campaigns worked and as long as there are new batches of 16 year olds, we will continue to need anti-smoking campaigns. As to salt, I THOUGHT I had reduced my use considerably. HA! The amount they put in processed food is outrageous. Sounds like a very good idea to get industry to reduce the salt. And I'll support you on withdrawing corn supports. But you may be surprised that the complaints will come from both sides of the political arena. With regard to rationing, have you or any of your colleagues ever had to battle with an insurance company over a proposed procedure or care? Should that have ever occured, might you call that rationing or is it only rationing when it occurs under health reform? And I do think I've heard calls from the GOP that Medicare will need to be resturctured. What do you call that? Yes, you guys are doctors and know how to save lives. Now just pull out your economics degree, and tell me how we are going to pay for all this life-saving? The cost of medical care in this country is unsustainable.

Tim Hulsey, MD said...

Has there not been discussion in the literature about the lack of benefit from reduction of dietary salt? How many times has the "food pyramid" been turned on its head? It's almost like they spin it like a wheel of fortune! Professional statisticians don't have good things to say about the conclusions drawn from some medical research, and point out that real statisticians are usually not included in those studies.
Anonymous said, "....have you or any of your colleagues ever had to battle with an insurance company over a proposed procedure or care?"
I have fights weekly with insurance companies to get approval for scans, tests, or operations patients need. Frequently, this relates only to a set of rules read by a clerk. It usually costs more to jump through the hoops the insurance company requires than to do what I know needs to be done. I'm not sure if this is rationing or just an attempt to be in control.
Anonymous also said, ...just pull out your economics degree..."
Sorry, Anonymous. No economics degree, here. Just a BS in BS, er... I mean, Chemistry and Biology and an MD degree. I know how to treat cleft lip and palate, but I can't tell you if it is cost effective for "society." I only know what is good for patients, one at a time.
Anonymous also said, "... how we are going to pay for all this life-saving?" Do you mean, like heart valve replacement?

Anonymous said...

@Tim Hulsey, MD

Damn right, heart valve replacement! I was only 66, so I guess it made some sense. But I will never do it again and have made sure my living will is clear about no feeding tubes, vents, stents, etc.

Tim Hulsey, MD said...

I saw a man in my office in 1999, Mr. Green. When he was 66 y.o., he had another 54 years to live. He would have thought you were a young whipper-snapper. It's different for each patient. If we treat populations instead of individuals, rationing will be built in.
Well, I'm only 63 y.o. I've learned a lot, experienced a lot, played a lot of good music with friends, and eaten a lot of good food. I've stayed away from rice cakes and tofu. I've made some money, lost a little money, and had the privilege to afford to give away some medical care. If I die tonight, rest assured that I will die a happy man!