Conservative, Liberal, or Relevant Blood Pressure? We need studies that are really relevant...

The following is a guest post from Robert Bowman, MD

One set of guidelines says to loosen up blood pressure control to prevent consequences such as falls. Almost in reaction there appears a new study that indicates a need to, perhaps, tighten up control to reduce the potential for stroke or heart disease. When British GPs were paid more to address BP there did not seem to be gains, other than better pay for participating GPs. Time after time we seem to have cutting edge studies that are pro-intervention. They remain until longer and bigger studies come out years later indicating problems or limitations involving the once “cutting edge” pro-intervention studies.

The lives of millions of people can be impacted by hypertension guidelines. How can we best deal with blood pressure issues?

The answer is not likely to be found in guidelines, quality measures, reports, or the latest studies.

The answer is more about process and less about print.

The problem with guidelines that are too liberal or too conservative is the same – they are too distant from the real world. The real problem remains the failure to include many of those most important to the process.

The real world in health care is what is happening at home. What is the real world for elderly patients? What happens when you get up at night to go to the bathroom? Do you get up at night more because of your medications or because of how you take them? Do your physicians coordinate the addition and subtraction of medications – including drugs that impact blood pressure or fluid volumes? With more and more medications there are more potential interactions. What happens when you get up from a chair or sofa? When you lose 10 or 15 pounds, do your medications drop your blood pressure to dangerous levels? Do you even have contact with a health care professional to help look out for the problem of weight loss and medications that are suddenly too effective?

We know about the benefits of blood pressure control, but do we know about the consequences of too much control?

Sadly we know less about the risk of blood pressure that is kept too low, the risk that a fall that may belife or lifestyle ending will occur.For example, should our blood pressure goals be more aggressive in men or in those with proven bone stability while being less aggressive with those likely to suffer greater consequences becaue they have osteopenia, osteoporosis, or other conditions? We often assume linear increase in risk, but this may not be the case.

What Is Missing from “Guidelines?”

With control of BP or coagulation or other treatments that defeat how the body adjusts to change, the patient and family must have the best understanding regarding what the drugs do and how the drugs impact their particular body and situations.

Large scale studies can be helpful, but the studies need to be relevant. Studies should reflect the real world. After three hundred recent home visits, observations indicated a few with perhaps lax control that may, just may have problems in 1, 5, or 10 years. There are also a different few of the 300 who are having falls or symptoms that suggest the potential for falls - with the potential of immediate consequences. Many large studies examine only the outcome of interest to the researchers – such as the rate of strokes in people with uncontrolled blood pressure – rather than the overall rate of harm or death to the people involved. In addition, many studies exclude from participation people who have the risk factors most likely to cause them harm. Studies that do examine all outcomes (“all-cause morbidity and mortality”) are of more value, and we need to be sure that the people we are treating in the “real world” are similar to those studied.

And then there is the problem of getting reliable BP measurements at the office or at home. How many people do we overtreat based on office-only measurements when lower home BP measurements are more relevant? How do we best use ambulatory measurements? Are these accessed and priced in ways that can make a difference?

A final reflection may be more relevant. In the 5 or 6 minutes of face-to-face time that is often all that exists, given current payment design, how do we get to know our patients well enough in our office environment to optimize BP control while minimizing the consequences to them as they live in their world? How do we teach them enough to loosen up medication when necessary to help prevent falls?

Addressing Problems and Solutions

One thing is certain. As long as research is distant and irrelevant, guidelines will contribute to too much negative consequence and not enough gain.

Practice-based research could contribute. But the real potential involves home-based research. The irrelevance of the academic setting and even the office was suggested by the founders of family medicine. What matters most is far away from university hospitals and NIH researchers. Lest we forget, the home – and the community -- is where it all happens.

Follow up to come:

Why the Home is the Best Unit of Analysis for Research

Simple treatments: bad doctors or a bad health system?

The New York Times editorial on September 9, 2012, “Simple treatments ignored”, is a commentary on a report in the September 7 issue of the Centers for Disease Control and Prevention (CDC) publication Morbidity and Mortality Weekly Report (MMWR)  that many Americans with hypertension (high blood pressure) were not being adequately treated. The Times notes that the study “found that 67 million Americans had high blood pressure and that 31 million of them were being treated with medicines that reduced their blood pressure to a safe level. The remaining 36 million fell into three groups: people who were not aware of their hypertension, people who were aware but were not taking medication, and those who were aware and were treated with medication but still had hypertension.”

This is definitely not a good thing; hypertension is a serious disease that can have devastating results – most obviously in stroke, but also in increasing the risk of heart attack and kidney failure. Also, as the article states, treatment is relatively easy – that is to say, there are drugs that are available for effectively keeping hypertension under control. In fact, so many people are receiving effective treatment that the incidence of bad outcomes, such as stroke, has greatly decreased. The Times editorial, however, creates the impression that much or most of the fault of for lack of treatment is the result of ignorant, incompetent, uncareful (or uncaring) physicians; the reason, they write, is “…mostly because overburdened doctors did not give hypertension high priority.” This is a highly dubious assumption.

The editorial goes on to praise, specifically, the Kaiser Health System for doing a good job of controlling its patients’ blood pressure, and thus reducing the rate of strokes and heart attacks:  “The organization created a hypertension registry to track patients and the care they were getting; eased the burden on doctors by using pharmacists to initiate drug therapy and medical assistants to monitor patients’ progress; made it easy for patients to get free blood pressure checks; and showed doctors how their record on controlling blood pressure compared with others in the system.” This is great.

People should get treated effectively for treatable diseases, and hypertension is certainly one. There are, however, many reasons why they are not always treated, and this problem includes patient as well as provider issues. Hypertension is, on the whole, asymptomatic; it does not cause pain or weakness or even, usually, headaches; thus the sobriquet “silent killer”. The treatments, in addition to drugs, include things like “…weight loss, increased physical activity, lower sodium and alcohol consumption, and stress management,” which require significant effort and commitment on the part of the patient, and are not easy to do.

But, more important, the lessons of Kaiser are not easily translated into the rest of the health system. Kaiser is a very atypical in that it is a vertically-integrated, closed-panel health system. For starters, and it is a very important start, every patient in their panel is insured (though Kaiser) and every patient sees a Kaiser provider. Thus, they control both the coverage and direct care of this population, and they have a large enough scale to do outreach programs to encourage and support people in adopting and maintaining the behaviors listed above. This is, however, not the case for most of the community. Many people are not insured, and many others have insurance that does not cover drugs and other treatments. A variety of factors, some provider related (such as not being able to get an appointment) and others originating from patients’ own decisions (choosing to go to ERs and urgent care centers, and indeed “doctor shopping”), they see different providers. That the US has an uncoordinated health non-system is the key problem, not that "their doctors are asleep at the switch."

The article concludes: “The benefits of reducing high blood pressure — not to mention the cost savings — are obvious. The wonder is that the health care system has done such a bad job of delivering those benefits.” To me the wonder is that we have tolerated not actually having a health system for as long as we have, and that health policy continues to try to address issues of quality of care while ignoring the elephants in the room: that so many people have no coverage or poor coverage, and that reimbursement overwhelmingly rewards intervening once problems have arisen rather than preventing them. That a physician hired by a hospital to inject clot-busters into the brain’s arteries to try to reverse a stroke that has already occurred earns, literally, several times as much as (and works much less than) a primary care physician who treats hypertension (and many other diseases). The reimbursement system is completely inequitable and inappropriate, and the health system is a sick hodge-podge of half measures.

First, we need a health insurance system that covers everyone: Medicare for all. Then we need to reward systems-based and outcomes-based care. Then maybe all of us can see results like Kaiser's.

The real face of lack of access to health care

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I have often written about the fact that lack of health insurance is a major source of cost for the health system. People without insurance often cannot afford to pay doctors or buy medications, and so do not seek care for treatable illnesses until they are so far gone that they can no longer be ignored, and then show up in the Emergency Room and require admission and treatment for advanced disease (for example, in Does the nation need a clear policy on a right to basic health care?, April 10, 2009). The cost is not only enormous in human terms -- treatable diseases converted into much more serious conditions because they haven’t been treated -- although this is the most important. It is also much more costly in terms of actual health care dollars, as these advanced conditions are much more difficult and expensive to treat.

However, as in every area, what affects us most are not the data or the statistics, but the individual stories of individual people.  These are the stories that touch our hearts because they we can identify with them – they could be our stories, or those of our friends or neighbors or relatives. These are the stories that make the evening news, the stories that might persuade a legislator to become interested in a problem, the stories that motivate us to send a donation to a worthy cause.

This was brought home to me very starkly when I recently served as the attending physician on our inpatient service in the hospital. We take care of a lot of patients, and they are very sick. Their medical diagnoses varied: kidney failure, diabetic ketoacidosis, malignant hypertension, severe asthma exacerbation, infections in a variety of places, etc. But, really, the most common diagnosis was lack of access to health care, mainly because of lack of health insurance. While not all these people are poor, they, like most people, have limited incomes, and have many other basic needs (rent, food, caring for their children) that compete with health care for the dollars available. Asymptomatic diseases (or conditions with “tolerable” symptoms) often seem to be a lower priority.

I’d like to share some of their stories, although obviously I cannot share their names or present too many actual details about them; I’ll make up initials and change some details that do not affect the essential issues. These are real people, with real names and real problems.

·     AG has diabetes and high blood pressure. (These two conditions, diabetes and high blood pressure, are going to be a recurrent theme; they are the mainstay, most-common, diseases of any general adult medicine practice. They are treatable, but when not well controlled their complications -- strokes or kidney failure or heart attacks or amputations – are also major contributors to the work of many subspecialists: cardiologists and endocrinologists and nephrologists and neurologists and surgeons and orthopedists, just to name a few.) AG had lost his job, and while unemployed and without health insurance he hadn’t been going to the doctor. Luckily, his chronic diseases weren’t bothering him much, except for a small sore on the bottom of his foot. High blood pressure often causes no symptoms, until the stroke or heart attack; foot sores in diabetes are a big threat, because the disease both diminishes the sensation of pain, so it doesn’t hurt much, and the circulation of blood so it doesn’t heal well, but the lack of pain makes it seem not so bad. He finally found a job, a reasonably good job with the promise of health insurance after a while. Unfortunately, it involved walking almost 20 miles per day, not a good thing for his foot. The foot developed a severe infection, requiring expensive hospitalization for intravenous antibiotics, and might still need to be amputated.

·     PS also has diabetes, which, especially when untreated, makes one susceptible to infections, and he has had several of them. Now, in late middle age, he presents with a very serious infection, requiring not only intravenous antibiotics, but surgery to clean out the pus, resulting in an open wound. A machine attached to drain out the residual infection and keep it clean will need to be regularly replaced, for many weeks as he continues the intravenous antibiotics. Fortunately (should you ever be in a similar situation), home health can be arranged to provide these services. Provided you have health insurance coverage. Oh yes, and a home. PS has neither. Makes follow-up care a little more difficult.

·    DR is a good deal younger but also had a severe infection requiring long-term antibiotics for a foot infection, after an unsuccessful attempt at outpatient treatment. And, yes, his diabetes is uncontrolled because he hasn’t had insurance and so hasn’t gone to the doctor or taken his medicine in quite a while. He also had lost over 80% of his kidney function, so he’ll be on dialysis soon. There is a “silver lining” (!); thanks to a law passed early in the 1970s, anyone with end-stage kidney disease requiring dialysis is eligible for Medicare, so he will be insured. Of course, the cost to Medicare will be far, far more than would have been the treatment of his diabetes, had he had coverage before the “end stage”.

·     MT will also become insured through this wonderful program, although her kidney failure is due mainly to untreated high blood pressure rather than diabetes. As I noted above, high blood pressure is often asymptomatic (thus the sobriquet “silent killer”); she didn’t have insurance or money so didn’t go to the doctor to find out how uncontrolled it was, as it slowly destroyed her kidneys.

Not all of our patients’ problems came from diabetes or infections, and not everyone who is uninsured is poor.

·     KF has asthma, pretty severe asthma, for which he was taking an inhaler to be able to breathe. It is a bronchodilator (airway-opener), the right drug for an acute attack, but KF’s attack never went away and he was taking far more of it than was safe. And spending an awful lot of money on it. It is available for a much lower cost at some pharmacies that provide certain generic medications for $4, but he didn’t know that. He does now, after being in the hospital for a week getting expensive breathing treatments. It’s a good thing, too, because the other inhalers that he needs to prevent (or at least decrease the frequency and severity of) these attacks, steroids and sustained-release bronchodilators, cost a lot, well over $100 per inhaler. They have been around for a long time, so one would expect that by now at least some of them would be available generically and cheaper. But there’s a great story here. The propellant in these inhalers used to be fluorocarbons, but these, as we know, destroy the ozone layer and contribute to a lot of bad environmental effects. So they were made illegal, and the pharmaceutical manufacturers had to replace them with environmentally safe propellants. Good for the environment. Unfortunately, bad for KF and millions of other people with asthma; using a different propellant meant that the drug was a “new formulation”, which allowed the drug makers to extend their patents for many years. So low-cost inhaled steroids are still not available. This is a cruel joke, but it is not a joke. The pharmaceutical companies will not suffer; only patients will.

AG, PS, DR, MT, and KF were all people we cared for in one week, and they were not the only ones with a primary diagnosis of lack of health insurance coverage. Of course, we also took care of lots of sick people with health insurance; I don’t work in a “safety net” hospital. People with insurance, even with good insurance (and certainly not all insurance is “good”, not all insurance covers necessary medications and tests) also get serious diseases and need to be hospitalized. But the people whose stories I have told, and others I have not discussed, stand out because they didn’t have to be as sick as they were and require the costly services that they did. That they were, and did, is not only immoral and bad medicine, it is bad economics. It is inexcusable.

Maybe DR and MT would not have had kidney failure and need dialysis if they had Medicare or any other kind of coverage before needing it. Maybe everybody should have Medicare. In a future blog, I’ll discuss the proposals to “save Medicare” that are currently being floated, but now I’d just like to have some thought given to saving these actual people. Got any ideas?

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