PSA testing: will science finally trump politics?

Maybe the third time will finally be the charm.

In early November 2009, the U.S. Preventive Services Task Force voted unanimously to update its 15-month old recommendations on screening for prostate cancer in men younger than 75, changing its previous rating of "I" (insufficient evidence) to "D" (recommends against). But after a shocking political firestorm erupted over the Task Force's new recommendations making mammography optional for women in their 40s, it decided to postpone finalizing the new statement pending a more precise estimate of the harms inflicted by indiscriminate PSA testing. As a medical officer at the Agency for Healthcare Research and Quality, I personally wrote the evidence review upon which the USPSTF based its initial recommendations and helped to commission and oversee an independent report of the harms of prostate cancer treatments authored by one of AHRQ's Evidence-Based Practice Centers.

The USPSTF scheduled its "re-vote" on prostate cancer screening for its November 2010 meeting. As reported in the Wall Street Journal and on this blog, the Task Force was forced to cancel that meeting due to the unfortunate "scheduling conflict" with the critical midterm Congressional elections. The flagrant interference by White House officials in the work of this independent expert panel reflected not only a one-time political calculation, but the culmination of nearly a year of meddling with the timing of release of other potentially controversial scientific statements, as I've documented here, here, and here.

In the meantime, a virtual mountain of evidence was accumulating against PSA testing to detect prostate cancer. Two independent meta-analyses of randomized trials of population-based screening published last year in BMJ and the Cochrane Library concluded that routine screening had little to no health benefits and could not be recommended. Dr. Richard Ablin, who invented the PSA test in 1970, wrote an Op-Ed in the New York Times that labeled PSA testing a "profit-driven public health disaster" and called on the medical community to "confront reality" and stop using the test routinely. And just last week, a rigorous analysis published in the Journal of the National Cancer Institute convincingly dismantled the commonly held belief that PSA velocity, or the rate of rise in PSA in successive tests, could be used as an indication for prostate biopsy in men with normal PSA levels.

On March 10 and 11, the Task Force will meet in person for the first time in eight months to once again take up prostate cancer and several other topics that were unable to be addressed due to its previous meeting's cancellation. I no longer work for AHRQ and have had no involvement in planning this meeting. It is my sincere hope, however, that neither the USPSTF nor the federal government will be cowed by the prospect of triggering another political firestorm into soft-pedaling the scientific evidence that PSA testing does more harm than good.

Guest Blog: Avoiding "excess deaths"

Dr. Ed Pullen is a family physician who practices at Sound Family Medicine in Puyallup, WA. The following piece is excerpted from a previously published post on his blog, DrPullen.com.

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"Excess death" or excess mortality is defined by the free medical dictionary as “a premature death, or one that occurs before the average life expectancy for a person of a particular demographic category.” Smoking is one of the major causes of excess death. There is lots of debate about smokers rights, government intrusion into private lives, and reduction of government spending these days. Here are some thoughts on government-backed efforts to encourage and help citizens quit smoking. This is on my mind today because my Mom died this week of a smoking-related illness, throat cancer, and I was looking for any good news about smoking cessation programs or population-based success stories.

I found one success story in a press release from the MMWR outlining a program in Minnesota from 1999 through 2010. Over that time, Minnesota instituted state-wide smoking cessation programs, a comprehensive smoke-free law, increased tobacco taxes, and mass media campaigns. As a result, Minnesota outperformed the rest of the U.S. by having the prevalence of tobacco use in adults drop by 27 percent, from 22.1 percent in 1999 to 16.1 percent in 2010, compared to very modest reductions nationwide.

Minnesota is a fairly large state with a population of 5.27 million, and an estimated 3.87 million adults. This means that about 231,900 fewer Minnesota adults smoke now than smoked in 1999. If the smokers who quit reflect the demographics of the adult population in Minnesota, then using the excess death data from 2004 BMJ British physician study, a rough estimate would be that about 2,085,000 life years were extended to the citizens of Minnesota as a result of quitting smoking in this time frame.

If the entire U.S. replicated this program, and had smoking cessation rates that matched those in Minnesota, then by extrapolation we could add about 122 million years to the lives of Americans over a 10-year period if 6 percent less Americans smoked after the program.

When I think if the dollars spent to add a year of life of many medical interventions, this type of program seems like a bargain. In fact, one study suggests that for every dollar spent on tobacco cessation, a state saves $1.26 in lost revenue from work missed and tax revenue. If that’s true, then states can actually improve their bottom line while they improve the health of their citizens. Sounds pretty good to me.

- Ed Pullen

Who needs intensive primary care?

In almost every large hospital in this country, there are at least two types of patient beds: regular and intensive care. Intensive care beds are designed for the sickest of the sick - patients who require continuous monitoring, specialized respiratory or cardiovascular support, the most knowledgable consultants, the most powerful drugs. Intensive care units (ICUs) have long been accepted as a necessary innovation in inpatient care, leading to better outcomes for patients than would have otherwise occurred if they were treated with a hospital's "ordinary" resources.

In his recent New Yorker article, "The Hot Spotters," Harvard surgeon Atul Gawande reviewed medical outreach programs to the sickest, costliest five percent of outpatients, programs that he termed "intensive outpatient care." It was the first time I had seen this term, and it got me thinking. While hospital ICUs have primarily become the domains of subspecialist critical care physicians (often called "intensivists"), intensive outpatient care's natural leaders are primary care clinicians. So when Gawande described family physician Jeffrey Brenner's innovative program to improve care coordination and reduce hospitalizations in Camden, New Jersey, what he was describing was really intensive primary care:

If he [Dr. Brenner] could find the people whose use of medical care was highest, he figured, he could do something to help them. If he helped them, he would also be lowering their health-care costs. And, if the stats approach to crime was right, targeting those with the highest health-care costs would help lower the entire city’s health-care costs. His calculations revealed that just one per cent of the hundred thousand people who made use of Camden’s medical facilities accounted for thirty per cent of its costs. That’s only a thousand people—about half the size of a typical family physician’s panel of patients.

As Josh Freeman pointed out on his blog Medicine and Social Justice, the reason that attempts to constrain health care spending by increasing co-payments for drugs and other services (described by supporters as giving patients more "skin in the game") inevitably fail is that these interventions target the 90 percent of patients who hardly utilize the health care system at all. Meanwhile, the 5 to 10 percent whose illnesses drive health care expenditures - the sickest of the sick - cut back on essential care, their conditions spiral rapidly out of control, and hospitalizations and costs keep rising.

The programs described in Gawande's New Yorker article aren't the only models of intensive primary care out there. Some have been around for quite a few years, mostly targeting elderly patients with multiple chronic conditions and funded through Medicare. These include the national Program for All-Inclusive Care for Elderly (PACE), covering more than 23,000 people in 29 states; Johns Hopkins University's Guided Care nurse-coordinator program; and old-fashioned house calls, which family physician Steven Landers has dubbed "The Other Medical Home" and believes are key to revitalizing the specialty of family medicine.

Intensive primary care isn't for everyone, of course. For one thing, it costs too much. And for most patients with acute or simple health conditions, the 15-minute office visit model still works just fine. Intensive primary care should be reserved for the sickest of the sick - patients who require frequent monitoring, specialized social support, the most knowledgable consultants, the most complicated drugs. So how can we design criteria to identify patients who should be transferred from regular to intensive primary care - criteria that will improve the health of the sickest patients, be acceptable to payers, and result in lower health care costs?

Dietary Guidelines for Americans disappoint

Quick: How many milligrams of sodium did you eat during the Super Bowl?

If your big game buffet was anything like mine (hot dogs, buffalo wings, fries, and cole slaw), you probably blew through your day’s allowance of sodium in a single meal, according to the most recent edition of the federal government's Dietary Guidelines for Americans. These comprehensive guidelines for healthy eating, which are updated every five years to reflect the latest scientific data, advise that healthy adults and children ages 2 and older consume less than 2,300 mg of sodium per day. Adults over 50, or those with high blood pressure, diabetes, or kidney disease, should consume less than 1,500 mg. Unfortunately, only 1 in 7 of us currently meets those targets; the average American consumes 3,400 mg of sodium per day.

Eating too much sodium leads to high blood pressure, which increases risk of a heart attack, stroke, and kidney problems. Two studies published last year in the New England Journal of Medicine and the Annals of Internal Medicine estimated that reducing average sodium intake by 1,200 mg per day could prevent up to 92,000 deaths each year and save more than $30 billion in medical costs by 2050.

As a family doctor, I've observed that more and more of my practice is devoted to preventing and treating nutrition-related disorders such as high blood pressure, obesity, and diabetes. So I had hoped that the new dietary guidelines would provide me with concrete strategies for helping change my patients' eating habits for the better. Instead, the guidelines merely advise that folks "compare sodium in foods like soup, bread, and frozen meals—and choose the foods with lower numbers." That’s reasonable advice, but since up to 75 percent of dietary sodium comes from processed foods and restaurant meals, we should also be cooking more and eating out less—a simple message that I could not find in the guidelines.

"Enjoy your food, but eat less," the guidelines say. This empty statement is analogous to giving the Surgeon General's recent Call to Action to Support Breastfeeding a new title: "Dietary Guidelines for Infants," with the key message being: "Drink breast milk for as long as you can." Just as infants have little control over the milk they drink, your sodium intake is mostly determined by outside factors such as where you live, where the closest grocery stores and restaurants are, and what sorts of foods they offer. Recognizing this reality, the Institute of Medicine concluded last year that “the current focus on instructing consumers to select lower-sodium foods…cannot result in intakes consistent with public health recommendations.” But that’s exactly what the dietary guidelines do.

Although I can advise my patients to ignore the salt shakers in restaurants, to use spices in lieu of salt at home, and, yes, to choose foods with the lower sodium numbers, there is nothing they can do about sodium that is already in their food. It’s reassuring that Wal-Mart has announced plans to reduce the sodium content in its packaged food items by 25 percent and to make healthier choices such as fruits and vegetables more affordable. Hopefully, others in the food industry will follow suit.

The fact is that for most people, relying on willpower and personal choices to lower sodium intake to healthy levels is unrealistic and a recipe for failure. That doesn’t mean we should stop trying, but we need a lot more help to reach recommended nutritional goals—help that the Dietary Guidelines for Americans don’t offer.

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The above post was first published on my Healthcare Headaches blog at USNews.com.

Don Berwick on patient-centered health care

I'm a big fan of Don Berwick, the current administrator of the Centers for Medicare and Medicaid Services who last week was on Capitol Hill being grilled by a congressional committee on his views. Although Dr. Berwick (a pediatrician by training) made his reputation in the area of improving patient safety and quality, his views on patient-centered care are what I admire most.

Some may think that the concept of health care being "patient centered" is so obvious that it shouldn't need to be stated. Yet the term "patient centered" is a surprisingly recent idea in a health system that has long focused on treating discrete diseases and organ systems (e.g. the heart, the lungs, the kidneys, etc.) rather than whole patients. In prestigious academic hospitals, there has traditionally been a distinct pecking order: attending physicians at the top, followed by fellows, residents, nurses, students and other trainees, and finally, at the very bottom, the patients themselves.

Patient safety advocate Sorrel King, whose one-year old daughter died in Johns Hopkins Children's Center due to preventable medical errors, wrote in her poignant 2009 memoir Josie's Story that being in awe of the technical skills of her daughter's physicians made her reluctant to challenge questionable medical decisions until it was too late. She and her foundation have subsequently encouraged hospitals to create rapid response teams that could be triggered by anyone in the medical hierarchy who had concerns about a patient's condition, including - and especially - patients and family members.

In an article in the journal Health Affairs, Dr. Berwick related an episode during which a close friend who was having chest pain requested that he accompany her to the cardiac catheterization lab for emotional support and to help explain the procedure's results afterwards. The nurse and cardiologist both rejected his friend's request, giving no explanation other than "it's just not possible." (And I remember, with dismay, hearing these exact words from a physician when I wanted to accompany my newborn daughter to the hospital nursery for her first bath.)

In a speech delivered to last year's graduating class at Yale Medical School, Dr. Berwick made a passionate argument for physicians to override our tendency to allow mindless regulations to override a patient’s reasonable preferences:

Of course, it isn’t really "someone" at all. We don’t even know who, or what it is. Its voice sounds rational. Its words are these: "It is our policy," "It’s against the rule," "It would be a problem," and even, incredibly, "It is in your own best interest." What is irrational is not those phrases; they seem to make sense. What is irrational is what follows those phrases, in ellipsis, unsaid: "It is our policy … that you cannot hold your husband’s hand." "It is against the rules … to let you see this or to let you know this." "It would be a problem … if we treated you on your own terms, not ours." "It is in your own best interest … to miss your daughter’s moment of birth." This is the voice of power; and power does not always think the whole thing through.

Thus far, Dr. Berwick’s confirmation hearings have focused on his views about health care rationing and his exaggerated “love” for the United Kingdom’s National Health Service. His inquisitors are missing all the important questions. They should be asking, “What are your views on patient-centered health care?” “What have been your experiences with making patients feel respected and listened to?” "How do we make health care more responsive to the needs and wishes of patients and their families?" But they aren't doing that. So it is unlikely that Dr. Berwick will be permanently confirmed as CMS administrator, and once again, our country will get exactly the health care that it deserves.

Guest Video/Poem: Reference Range

Veneta Masson is a registered nurse and poet living in Washington, DC. She has written three books of essays and poems, drawing on her experiences over twenty years as a family nurse practitioner and director of an inner-city clinic. Her poetry collection Clinician's Guide to the Soul, including the following poem about the ambiguities of laboratory testing, "Reference Range," is available at sagefemmepress.com.

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- Veneta Masson

Guest Blog: Medical decision making: more signal less noise, please!

Marya Zilberberg, MD, MPH is a health services researcher with a specific interest in healthcare-associated complications and a broad interest in the state of the U.S. healthcare system. She is the president and CEO of EvidMed Research Group, LLC and an adjunct associate professor of epidemiology at the University of Massachusetts, Amherst. The following post is excerpted from a previous post on her blog, Healthcare, etc.

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It's official, I'm a country bumpkin! Driving in Boston last week I was distracted, annoyed, made anxious and confused by the constant traffic, billboards and signs. Despite the fact that I know the geography of Boston like the back of my hand, I nearly went down the wrong streets multiple times, including driving the wrong way on some one-way roads. But it seems that over the years of my living away, there has been a sharp increase in the information thrown at me from all directions. And while the value of this information is at best questionable, the sum total of this overstimulation is clearly confusion, wrong road choices and possibly a reduction in the safety of my driving. This whole experience reminded me of Thomas Goetz's distaste for how medical results are reported. Here is his excellent TED talk on the subject.



It is ironic that during this overwhelming city visit I also had the chance to speak to a doctor about "routine" preoperative testing and its value. Before surgery, it is recommended that a patient get a screening evaluation. Yet the components of this evaluation vary widely, and may include blood work, urinalysis, electrocardiogram, a chest X-ray and the like. Although evidence suggests that most of the points of this evaluation are useless at best, many institutions continue to order a "shotgun" panel of preoperative testing for everyone. This one-size-fits-all medicine results in reams of useless and distracting information, a high frequency of abnormal findings of questionable significance, a potential for harm, worry and needless healthcare spending.

In my conversation, I asked the anesthesiologist what the pre-test probability for someone with my characteristics was for a useful chest X-ray result, for example, and whether the fancy electronic medical record used by the hospital could help her determine this. While the answer to the former question was "probably exceedingly low," the answer to the latter was a definitive "no." It became clear that a patient like me should not in fact be subjected to a chest X-ray, since any pathology found on one would likely represent a false positive finding, which would nevertheless require potentially invasive follow-up. And guess what? By focusing on the particular individual in the office, rather than all comers, we could have gone through the entire menu of the possible preoperative tests "routinely" ordered and eliminated most, if not all of them. But my bet is that not all patients, not even all e-patients, either know or are able to initiate this type of a critical discussion. And yet what tests to obtain, if any, should always be a thoughtful and individualized decision. To approach testing in any other way is to risk generating noise, distraction and harm.

And this brings me back to Thomas Goetz's idea of redesigning how test results are reported. I love his idea. But to me what needs to happen before making the data patient-friendly, is making the decision-making provider-friendly. So, great idea, Mr. Goetz, but let us move it upstream, to the office, where the decision to get chest X-rays, cholesterols and urinalyses is made, and help the doctor visualize her patient's risk for a disease being present, the characteristics of the test about to be ordered, the probability of a positive test result, and all the downstream probabilities that stem from this testing, so as to put a positive test result in the context of the individual's risk for having the disease. Because getting the results of tests that perhaps should never have been obtained in the first place is following the GIGO (Garbage In, Garbage Out) principle. It is generating noise, distraction and detours going the wrong way down one-way roads. And when applied to medicine, these are definitely unwelcome metaphors.

- Marya Zilberberg

"Preventive health screenings" that are hardly a Life Line

The following deceptive advertisement appeared in my church's bulletin yesterday: Life Line Screening, the nation's leading provider of preventive health screenings, will offer their affordable, non-invasive, painless health screenings [in the church cafeteria] on April 9th. Five screenings will be offered that scan for potential health problems related to: blocked arteries, which is a leading cause of stroke; abdominal aortic aneurysms, which can lead to a ruptured aorta; hardening of the arteries in the legs, which is a strong predictor of heart disease; atrial fibrillation or irregular heart beat, which is closely tied to stroke risk; and a bone density screening, for men and women, used to assess the risk of osteoporosis. Register for a Wellness Package with Heart Rhythm for $149. Add Disease Risk Assessment with blood testing & biometrics for $79 more.

Although all of these tests sound good, every one is either 1) scientifically unproven; 2) proven to be beneficial only in certain groups of patients (rather than all adults); or 3) likely harmful in the long run, by increasing rates of false positive tests, subsequent unnecessary diagnostic procedures, and the adverse effects of those procedures. As you know, until last November I worked for a federally-supported program that reviews the scientific evidence to support screening tests, and based on that experience, I would not offer most of these tests to my own patients, much less market them directly to a church congregation. Specifically:

1. "Blocked arteries" / stroke screening is most likely a carotid ultrasound scan, which doesn't help because most patients with asymptomatic carotid artery blockages will not suffer strokes. Although the screening test is "non-invasive and painless," the confirmatory test, angiography, is not (it actually causes a stroke in a small number of patients) and unnecessary carotid endarterectomy can lead to death.

2. Abdominal aortic aneurysm screening is only recommended in men ages 65 to 75 who have ever smoked, because aneurysms are much less common in younger, female, and non-smoking populations. Even in men who are eligible for the test, it's important to weigh the potential benefits against the potential harms of corrective surgery, which has a not insignificant mortality rate itself.

3. "Hardening of the arteries in the legs," or screening for peripheral vascular disease with an arterial-brachial index, hasn't been proven to prevent heart attacks but will certainly lead to many false positive results.

4. I've never even heard of atrial fibrillation (irregular heart beat) screening, which I presume is doing a screening EKG, which is also totally unproven. Absolutely no organizations recommend this.

5. Screening for osteoporosis with bone density testing is the only test on the list that's actually worthwhile for a large number of adults, especially women over 65. But it's not appropriate to do this test without a prior consultation with a clinician who can discuss the risks and benefits of undergoing this type of screening. And there are still questions about whether men benefit to the same degree as women, or at all.

In a nutshell, that's why companies like Life Line have no business portraying these services as "preventive health screenings," in my church or any other community setting. (I've sent an e-mail to my pastor recommending that they be dis-invited for the reasons I've outlined above.) It's one thing to draw blood for a cholesterol test and take someone's blood pressure (which will cost a whole lot less than $149), and quite another to offer these other procedures which are, at the very least, a waste of money and quite possibly harmful.

The best recent posts you may have missed

Every other month or so, I post a list of my top 5 favorite posts since the preceding "best of" list on this blog, for those of you who have only recently started reading Common Sense Family Doctor or don't read it regularly. Here are my favorites from December and January:

1) 4 reasons not to be screened for lung cancer (1/13/11)

2) Healthy lifestyle counseling challenges (12/15/10)

3) Will small primary care practices survive health reform? (1/5/11)

4) Why screening for colorectal cancer shouldn't be a hard sell (12/20/10)

5) Primary care remains a prominent topic (1/26/11)

If you have a personal favorite that isn't on this list, please let me know. As always, thank you for reading!

Healthy habits are hard to maintain - even if you know what lies ahead

"It's about that time of the month," a physician colleague of mine said to me a few days ago, "when our patients start to let go of their New Year's resolutions." That is, all those well-intentioned promises we make to ourselves year after year to eat more fresh fruits and vegetables, to spend 30 minutes in the gym each day, or to start a walking program. Breaking unhealthy habits and starting healthy ones is hard, and most people require several attempts to succeed. As I discussed in a previous blog post, there's good evidence that even multiple intensive lifestyle counseling sessions led by trained professionals are only mildly helpful.

Compounding matters is the fact that every individual is different. You probably know people who’ve lived to ripe old ages in perfect health despite having eaten eggs every day of their lives or not exercising. My great-grandfather smoked cigarettes for 80 years, but died peacefully in his sleep in his late 90s. (Maybe he would have made it to the century mark if he'd quit.) Some researchers have suggested that a more effective way to motivate patients to change their lifestyles could be to give them personalized information about their risk for common chronic conditions such as cancer and heart disease. Others, though, have worried that this knowledge could encourage complacency among those who learn they’re at below-average risk. Why quit smoking, for example, if you think your genes will protect you from lung cancer?

Two recent studies have investigated. The first study, published in the January issue of the Annals of Family Medicine, randomly assigned about 4,000 primary care patients ages 35 to 65 to either a Web-based tool that used patient-provided health and family history information to give tailored lifestyle recommendations, or a generic prevention message. After six months, those who received the personalized messages were more likely than the generic-prevention group to consume five or more servings of fruits and vegetables daily and exercise for 30 minutes at least five times per week. Perplexingly, the personalized intervention actually made patients less likely to get their cholesterol level checked, and it had no impact on whether they quit smoking or got their blood pressure or blood sugar levels measured.

The second study, published in the New England Journal of Medicine, took a more high-tech approach to understanding whether giving patients a glimpse of what may lie ahead could help quash bad habits and inspire healthy ones. About 2,000 adults were offered the chance to purchase a genome-wide health risk profile of a saliva sample at a significantly discounted price ($150 as compared to a typical retail cost of $500 to $2,000). So they provided their DNA and completed standard assessments of anxiety symptoms, dietary fat intake, and exercise at the time of study enrollment and again three months later. The researchers found no changes in their anxiety levels, lifestyle behaviors, or their use of screening tests between the two periods. And only 25 percent of participants said they shared their test results with their physician.

For me, as a family physician, the take-home message of these two studies is that providing personalized health information to my patients based on the “old fashioned” collection of family history data is likely to be at least as good, if not better, than sequencing their genomes. A potential reason for why participants in the New England Journal study weren’t able to change their health habits is that high-tech genetic profiles can’t substitute for personal contact. Much of the training primary care physicians receive is geared toward learning how to help people make good decisions about their health. So if you fear that your New Year’s resolution may be falling by the wayside, I encourage you to make an appointment to see your family doctor to discuss small, realistic steps that you can take to get back on track. Obviously, your doctor can only do so much by outlining your personal health risks and suggesting ways you can reduce them. The rest is up to you.

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The above post was first published on my Healthcare Headaches blog at USNews.com.