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Some Notes after Grand Rounds, and Questions for Medical Blogs and the Internet

Earlier this week I had the opportunity to host med-blog Grand Rounds. This honor – or assignment, depending on your perspective – came just in time for the new academic year.

(That would be today, July 10, 2010 – welcome new students! and interns! and “mature” doctors without supervision!)

Coincidentally, or not, over the past year I’ve made it my business to study what some might call on-line medicine. Since completing my J-School (that would be J for journalism, just to be clear) degree, I’ve spent much of my time reading, clicking and otherwise navigating through the medical blogosphere and greater Web.

So far I’ve tried to examine what’s out there – websites, on-line newspapers, magazines, blogs, advertisements, academic medical journals, Twitter, videos and more – as best I can, to understand how people find and share information having to do with health. What I’ve learned, largely confirming what I thought previously, is that the Internet as a source of medical information is a complex, evolving, powerful and largely unregulated instrument.

Some key questions for the future:

1. What is a blog and how might that be distinguished from, say, a website with ads and text, or from a newspaper or multimedia conglomerate with an engaging on-line section?

2. How might a reader identify a medical blog or health-related website? Is there a reason to separate these kinds of Internet domains from those concentrating on wellness, health care delivery, science, ethics or policy issues?

3. How much value, if any, should we assign to articles for which the author is unknown?

4. The issue of conflict of interest (COI) is slowly working its way into academic medical journals and continuing medical education programs for physicians. But on-line there’s essentially no regulation and it would be hard to implement any disclosure requirements even if there were. How the public might be informed of COI regarding on-line content – whether that’s provided by individual bloggers, newspaper-employed journalists, med-tech companies or pharmaceutical corporations – seems a critical issue for the future.

Any thoughts?

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Medical Blog Grand Rounds – June 29, 2010 Edition

(Vol. 6, No. 40)

Learning about medicine is a lifelong endeavor whether you’re a patient, a doctor, a caregiver, a hospital administrator or, perhaps, even an insurance company executive. In today’s Grand Rounds, we’ve an array of eleven perspectives that, directly or indirectly, bear on the suggested theme of education.

If there’s a motif that emerged unsolicited this week, it’s empathy, a term highlighted in the titles of two submitted posts:

In Glass Hospital, Dr. John Schumann considers what motivates health care workers in a thoughtful post, Finding Empathy. Schumann, an internist and medical educator at the University of Chicago, suggests that doctors and nurses need to re-encounter and re-engage with empathy to continually find meaning in their work.

Bedside Manner, a blog out of Boston’s Kenneth B. Schwartz Center, offers an article on ‘Boosting’ Empathy through Continuing Medical Education. Here, director Julie Rosen writes on newly-published data on the value of post-graduate, interdisciplinary sessions where clinicians discuss psychosocial and emotional aspects of patient care.

Near empathy lies the concept of interpersonal connectedness. In that vein, several of this week’s essays consider the essential and sometimes close (or not-so-close) relationships that form between patients and their doctors, between physician-educators and doctors-in-training, and between scientists who study particular disorders and the public that depends on their work:

In How Can I Explain it to You? The Life of a Grad Student With Lupus, a young woman (20-something, as self-described) blogs anonymously about her experiences as a person with systemic lupus erythematosus. Her latest post, it’s supposed to be a ‘doctor-patient’ not ‘doctor-disease’ relationship bemoans the lack of attention given to empathy (yes, it’s here too!) and patients’ lives in medical education. “Don’t test only the science,” she recommends.

Dr. Kimberly Manning is a medical educator at Atlanta’s Grady Memorial Hospital. In the ACP Hospitalist she considers the transience of some relationships, and permanence of others, formed between faculty and junior doctors passing through that public hospital’s residency training program. Her post, “Life at Grady: A clinician-educator reflects” included some lovely verse. After reading those lines, I couldn’t resist trying to find out more on Aleksandra Lachut, a poet previously unfamiliar to me.

A recent Health Business Blog offering weighs in on the emotional and healing value of connectedness among patients. In a transcript of his Podcast interview with LaChance Publishing President Victor Starsia, HBB author David E. Williams reveals why Debra LaChance founded the Healing Project. This non-profit organization provides support and education for people with breast cancer and other chronic or life-threatening diseases. It encourages patients’ sharing of stories through a book series, Voices Of.

In his wrenching Medicine vs. Religion: My Brother’s Keeper Revisited, Dr. Alan Dappen considers the predicament of a severely anemic woman who refused treatment for many years based on her firmly-held religious views. Drawing on his own, personal experiences with a brother whose faith-based ideals led him to decline care, Dr. Dappen persuaded the patient to accept medical help. This and related posts by can be found on Better Health.

A scientific sort of connection is espoused by Walter Jessen, Ph.D., who edits and writes at Highlight Health. In his early-June post on The 2010 NF Conference – Connecting the Public with the Research, he anticipated the research presentations at a meeting on neurofibromatosis (NF) sponsored by the Children’s Tumor Foundation. Although conference attendance was restricted to researchers, the foundation decided to provide information and updates to the public through a video and blog. What I liked best was the video, in which Dr. Kim Hunter-Schaedle explains the significance of the NF conference theme: “Back to the Future.”

Moving on, toward a most practical aspect of medical education, the ever-anonymous and Happy Hospitalist tells us in Difficult Foley Catheter Insertion. I Got To Watch The Cath Man In Action how glad he was to absorb, first-hand, details on the intricacies of placing a Foley the right way. (As someone who’s, um, had quite a few surgeries and subsequent catheters, I cannot exaggerate the significance I assign to this type of specialized knowledge.)

Going further in a pragmatic direction, Louise Norris advises patients and doctors to “think twice” before CT scans in her post Radiation Exposure from Medical Testing. She and her husband own Insurance Shoppers Inc., provider of the Colorado Health Insurance Insider blog. Of interest, Norris advocates a radiation medical record that would track a patient’s total exposure to imaging radiation over a lifetime. Health insurance companies could help patients, she suggests, by reducing their risk through the approval review process for imaging studies. “If an ultrasound could be used instead of an x-ray, or an x-ray instead of a CT scan, we could be saving money as well as preventing future cancers,” she writes.

My favorite title of the week comes from InsureBlogs Bob Vineyard, CLU (that’s Chartered Life Underwriter, just in case you’re wondering as I was). In his Mission Accomplished! post, Vineyard rails on the consequences of Romneycare including a primary care physician shortage. One lesson from the Massachusetts experience is that there will be an even greater demand for primary care physicians under Obamacare. As he sees it, the question for today’s aspiring physicians is whether or not to take advantage of that opportunity.

Finally, and coming full circle, the ACP Internist submitted a post authored by none other than Glass Hospital’s Dr. Schumann. This one’s called Cholesterol: validation of the self. Here, he questions the merit of an established and perhaps over-valued concept in medicine, that of lowering cholesterol.

It seems to me, the notion of challenging old assumptions is a terrific lesson with which to end any catalog of essays on education.

Lots to think about –

Many thanks to all who contributed to this week’s Grand Rounds!

ES

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Follow-up on the Harlem Heart Tests

Last month I examined the serious case of the overlooked heart tests at Harlem Hospital, as told initially in the New York Times. Since then, Times journalist Anemona Hartocollis has followed-up on the disorder at the medical center.

The problem is older and wider in scope than first indicated. Another 1,000 echocardiograms, beyond the first 4,000 told, went without review by a cardiologist.  The situation dates back to 2005, rather than 2007.  An additional 2,000 exams were reviewed by doctors who didn’t complete or sign reports on those studies, taking the total number of missing reports to the range of 7,000.

Concern persists that the errors arose due to administrative decisions and a shortage of cardiologists at the hospital. According to the paper:

…After the backlog was discovered, some doctors at Harlem Hospital said they had complained of understaffing to the administration but had been ignored. At one point, they said, the hospital was down to one cardiologist, who could not possibly review all of the echocardiograms.

Last week the hospital finished an internal investigation. Approximately 200 of the patients who had echocardiograms died before their tests were analyzed. According to the Times, a hospital spokeswoman stated that 14 patients received an incorrect diagnosis because the tests were mishandled.

Upon further contemplation, I’ve upped my lessons learned from 2 to 3:

1. For hospital administrators:

When doctors complain that they’re overworked, so much so they can’t meet their clinical responsibilities, don’t dismiss their concerns. A stressed system – with fewer clerks, escort workers, nurses, phlebotomists, aides and other workers – is a setup for rushed or frankly skipped work. These kinds of errors (delayed reports) might apply to how physicians interpret other kinds of complex medical tests including CT and MRI scans, pathology reports, bone marrow findings and other specialized evaluations.

Most physicians I know work long days, weekends and nights. Many work putting out one fire and then the next; it seems unlikely that this problem is isolated to a single department in one hospital. Rather, it’s a flag.

With so much new emphasis by law on restricting resident physicians’ hours, perhaps there’s insufficient attention to the workload of senior (“attending”) physicians. Their responsibilities should be limited, too, such that they can accomplish their work in a careful manner in a reasonable number of hours per week.

2. For doctors:

If neither you nor the patient has sufficient reason or even the inclination to check a test result, don’t order it. As I’ve suggested previously, we might save a lot (billions?) of dollars, besides precious medical resources – personnel, transport workers, clerks, machines and patients’ valuable time – which are limited whether we acknowledge that or not, by thinking more carefully about the tests we order.

This is not just about heart tests. I’m thinking of urine examinations, routine chest x-rays, nerve conduction studies, pulmonary function tests, swallowing tests, etc.

3. For patients:

What happened at Harlem Hospital is, among other things, a lapse in communication between patients and their physicians. The responsibility is shared. So if you don’t understand the reason for a test, ask for a better explanation. If you need a translator, ask for one. Ask for results. Be persistent.

Aspire to be pro-active, not passive in the health care system which, otherwise, may treat you like an object. “Own” yourself!

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On People Who Receive Care From Physicians

This week’s medical blog Grand Rounds will focus on posts having to do with “customer service” in health care. A problematic concept, it seems to me.

As a physician I never considered my patients as buyers or consumers. People came to me as their doctor, or I visited them in the hospital, and I thought my job was to identify if something was wrong and, if so, to identify the exact nature of the problem and then take care of the person as best I could. I didn’t contemplate the situation with a business mind-set.

As a patient I don’t think in shopping terms when I visit my doctors or my physical therapist, although I do sometimes pay significant bills. Even for lab services, such as at Quest Diagnostics, I don’t feel as if I’m making a purchase. Sure, I’m annoyed when there’s a long wait or my results are inexplicably delayed. And I sometimes prefer one technician to another. I might mind the costs, and if there’s an error in my bill I’ll challenge that. Still, I don’t perceive myself as a health care customer.

In medical journals a patient typically is called a person, an individual, a subject in a clinical trial or (unfortunately) a case. But in some blogs and other sources I’ve been reading lately, most often having to do with health care delivery or IT, consumers pop up constantly. A good example occurs in a recent article in the journal Health Affairs, “Evidence That Consumers Are Skeptical About Evidence-Based Health Care.” This study generated a small brouhaha (in my opinion undeserved) about the public’s alleged blind faith in their personal physicians’ advice.

In reviewing that story, what most surprised me most about the paper was not so much the study’s findings (limited) or sponsorship (by the National Business Group on Health), but its language. The term “consumer” or “consumers” appears in the article’s title, no fewer than 5 times in the 125-word abstract and a noteworthy 39 times in the main paper excluding captions, tables, and references.

My point, which is really a question, is whether people who seek out or need health care should be referred to as consumers or customers. My gut feeling is that neither term is appropriate. But then again, I don’t believe that medicine can be or should be run as a business. Here’s why:

If physicians are in a position that they might be influenced by a profit motive, they’re less likely to make decisions based in evidence and are more likely to make recommendations that include income-generating procedures and treatments.

If people receive medical care from physicians who might generate greater income by recommending particular treatments, procedures or referrals, they may not receive the most appropriate care. What’s more, they are less likely to trust that their physicians are providing sound advice. The upshot is that when expensive medical care is needed – say, for the sake of this discussion, in the case of a young person with a curable leukemia – some individuals may be less trusting of physicians if they think they are motivated by money and may decline helpful and even life-saving treatments. So the profit motive, or even the appearance of a possible profit motive, has the potential to lessen the patient-doctor relationship and undermine good care.

What’s worse, though, and even more off-putting, is that in a financial transaction for medical care – in which a person with or without an illness is referred to as a “consumer” in a business called the health care industry – what’s really happening is that the illness, and maybe even the patient who has an illness, is rendered a commodity.

Ultimately this is the greatest downside of medicine as a business. No. I don’t think patients should be considered as customers or clients by any other name.

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Mind over Matter? Don’t Kid Yourself (on Stress and BC)

I learned of a new study implicating stress in reduced breast cancer survival by Twitter. Three days ago, a line in my feed alerted me that CNN’s health blog, “Paging Dr. Gupta,” broke embargo on the soon-to-be-published paper in the journal Clinical Cancer Research. It seems the story – that women who undergo a stress relief program live longer after breast cancer recurrence – couldn’t wait.

“Less stress helps breast cancer patients” is the title of the rushed post. What the researchers, based at Ohio State’s Comprehensive Cancer Center, report is that psychological intervention helps to increase the quality of life and survival among women with recurrent breast cancer.

The intervention at issue is this: weekly, small-group meetings of BC patients for 4 months after their initial surgery and diagnosis. Led by clinical psychologists, the women met 18 times and discussed strategies to reduce stress, improve mood, strengthen social networks, eat better, exercise and adhere to medical treatments.

The current report is an extension of previous findings among an initially larger group of women at the time of BC diagnosis. Then, the researchers randomized 227 patients after surgery, all with stage II or III disease, either to receive the intervention, or not, after an initial psychological assessment and blood tests to check their immune function. The women were overwhelmingly Caucasian, mostly with stage II tumors, well-educated and, for the most part, had ER/PR+ tumors. What the researchers noted was that:

…As predicted, patients receiving the intervention showed significantlowering of anxiety, improvements in perceived social support,improved dietary habits, and reduction in smoking…

In 2008, the same Stress and Immunity Cancer Project investigators reported in the journal Cancer that the psychological intervention reduces BC recurrence and prolongs survival. Here’s where the results become both exciting and suspicious. In 2007, with a median follow-up of 11 years, 62 women (29%) in the initial study had recurrent disease. The proportion among those who’d received the intervention was indeed lower, confirming the authors’ hypothesis that the intervention would help prevent BC from coming back. But the p-value for this difference was 0.034, barely meeting the threshold for statistical significance. Similar results were observed for overall survival among the women who’d attended the group sessions: they had a reduced risk from death with a minimally-significant p-value (0.028) for the difference.

Now, the Ohio group reports on the 62 patients who relapsed. Before going further, I should say that it’s a bummer of a result from a medical perspective and from mine as a BC survivor out at seven years. Group support aside, 44 (71%, yikes!) of the patients with recurrent disease have died with a median time until death (after recurrence) of 2.8 years (range: 0.9 – 11.8 years).

What the authors conclude is that the psychological intervention improved survival after BC recurrence. How the data flowed is this: among the recurrences, there were 33 women who’d been randomized to the assessment only, “A” arm of the original trial and 29 who’d been randomized to the intervention, “I” arm. These numbers were whittled down to 18 patients who could be followed for continued study on the “A” arm and 23 women on the “I” arm. So the total number of women evaluated in this new report is small: just 41 women.

Among those, the women who received the psychological intervention were more likely to survive, with what’s called a hazards ratio of 0.41. Here again the p-value is valid but marginal (p= 0.014). The authors show a very limited amount of data regarding test-tube based studies of natural killer (NK) and T lymphocytes in the different patient groups, and suggest in the paper’s abstract that “immune indices were significantly higher for the intervention arm.”

What would have killed this paper (pardon the verb) had I been a reviewer is this: among the 41 women with recurrent disease, there was a major difference in the treatments they received. According to the “Patients and Methods” section of the paper, in the section on “adherence, chemotherapy dose intensity,” the authors indicate that just 6 of the “A” patients received chemo in the 12 months following the recurrence, while 13 of the “I” patients got chemo in the same period.

My math: only 6 of the 18, or 33 percent of the “A” group (assessment-only) patients received chemo, while 13 of the 23 (56 percent) of the “I” (intervention) patients got chemo in the year after recurrence. That’s a huge difference in medical treatment among a very small number of patients.

My point: the small difference in survival after recurrence among those women who received structured psychological support, years earlier, may be attributable to the prompt chemotherapy they received upon relapse of the cancer. This seems a more plausible explanation than that group therapy-type sessions make a difference in tumor biology or treatment resistance. (Neither outcome is proved by this study.) The difference may also derive from better overall health in the women who initially received the intervention that included advice and support regarding diet, exercise, smoking cessation and medication compliance.

My opinion:

I think there can be tremendous value in psychological support for people with illness of any kind, whether that’s provided casually by supportive families and friends, one-on-one psychotherapy, medication and/or group meetings. And it’s easy to envision that meetings in which women with similar disease situations and concerns get together and discuss coping mechanisms, how to stay healthy, eat better and exercise could have positive effects on overall survival.

But the immune benefits of stress relief, like those presented in David Servan-Schreiber’s like-minded Anti-Cancer, are bogus. There’s no scientific evidence that the sort of NK or T cell changes tested in this study help or hurt breast cancer growth. It’s possible that a revved-up, stress and steroid-driven immune system might help kill cancer cells, or might favor their expansion. It could go either way. The effects of stress steroids on tumors vary and are complex. Prednisone and similar steroids, for example, which resemble the body’s natural stress steroid cortisol, are well-established and effective components of most lymphoma treatment regimens and once were a mainstay of breast cancer treatment. My point is not that the immune system doesn’t affect tumor growth. (I think it can and does.) But the effects are complicated and differ among individuals and according to the specific tumor type.

On linking stress and breast cancer: this argument, which is all that it is in the absence of better data, is patronizing and demeaning to women. It’s the kind of advice we offer children, that if they think and do the right things the outcome will be favorable. Oncology doesn’t work that way. If a woman’s breast cancer comes back, it’s not because she didn’t go to support groups or relax sufficiently. Tumors grow due to inherent, malignant properties of the cancerous cells and other biological factors in the body, such as other illnesses that may, indeed, weaken the immune system or limit a person’s capacity to receive effective treatment.

I’m all for stress reduction, as an aim in itself. But it’s not a cure for cancer.

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A Tapestry, and Double-Dose of Magic (on Carole King and James Taylor, Troubadour and Breaking Addiction)

My plan for today was to write on evidence-based medicine. But that can wait, at least until the morning comes.

I came upon the most wonderful recording of a concert by Carole King and James Taylor played in November, 2007 at LA’s Troubadour Club, a place I’ve never been. PBS aired the video, about an hour long in its fuller form, for its June fund-raising drive. I have tickets to see the pair at Madison Square Garden in a few weeks, and had seen yesterday morning a heartening review of the old friends’ joint concert tour.

Sweet Baby James (1970)

Even within the limits of our old TV and nothing approaching a Dolby sound system in our living room, the images – the sounds and smiles generated by Taylor and King, fixtures of my childhood – made me tremble with joy. It was lovely beyond verbal expression and I felt, among other things, glad.

Here’s the medical lesson – a surprise for me was Taylor’s astonishingly well appearance, in a born-in-1948-and-still-strumming sort of way. I’m speaking as a doctor now, as someone who’s used to eying people for signs of ill health. He looked fit, comfortable and happy in jeans and a button-down blue collared shirt. He grinned broadly while he sang, surely taking none of this for granted.

I couldn’t help but reflect on his past. He seems to have made it out of the woods. And how dark those were – to a teenager listening and watching him from afar, circa 1973, it seemed like he might not pull through. For purposes of this post, I’ll stick with the parts of Taylor’s health history that fell into the public domain long before the Internet entered our homes and minds.

Taylor, the son of a Harvard-trained physician, struggled with depression and serious drug use, including heroin addiction, for years. In 1969 a motorcycle accident broke his hands and feet.  In the same decade as he offered fabulous ballads – anthems like “Fire and Rain” and King’s “You’ve Got a Friend,” familiar even to my parents’ generation – he ravaged his body and then his marriage.

Tapestry (1971)

King’s personal story is less known to me, but the lyrics to Tapestry are deeply ingrained. I know them as I know the red carpet, flowered wallpaper and stodgy furniture of my old bedroom. She looks beautiful now. Older and gray, for sure, but natural, lovely, lively and playing strong.

The two together, even on TV, deliver a double-dose like magic. They’d performed together, in 1970, at the Troubadour and now were doing it once again, with grace. The genuineness of the friendship between them, manifest in King’s glances over the piano toward Taylor and what might have been a few tears, and his beaming toward her, could not have been staged. They’ve had some difficult times, for sure, but this was beautiful.

I’m afraid I’m gushing romantic, but as a doctor I’ve seen so many patients who’ve suffered through hard times alone, physical and mental illnesses without anyone to turn to. You have to wonder, to what extent did Taylor’s support system – his dad, who reportedly drove to retrieve him from some tough spots – and his enduring friendships and his family, old and new, help him to recover.

Not all drug abuse stories end like this one. Our government reports, based on a large 2003 survey (which may underestimate use of an illegal substance), that nearly 120,000 Americans said they used heroin in the month before the survey and 314,000 took it the year prior. From 1995 through 2002, there were approximately 150,000 new heroin uses per year in the U.S. Most were over 18, male and addicted. As for depression, the numbers are huge and deaths, very real.

What I’m thinking is this – how lucky Taylor is to have had the friends, family, financial resources and courage to get the help he needed. The message he conveys is that it is possible, at least for some, to get through it, to get better and to move on.

And for me, how lucky I am to have those tickets. I can’t wait to see them in concert later this month, in person, live.

—–
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About Those Skipped Heart Test Results

Harlem Hospital Center stands just three miles or so north of my home. I know the place from the outside glancing in, as you might upon exiting from the subway station just paces from its open doors. The structure seems like one chamber of its neighborhood’s heart; within a few long blocks’ radii you’ll find rhythms generated in the Abyssinian Baptist Church; readings at the Schomburg Center and artery-clogging cuisine at the West 135th Street IHOP.

So I was saddened to hear about the missed heart studies. Or should I say unmissed? No one noticed when nearly 4,000 cardiac tests went unchecked at the Harlem center, a public hospital managed by the city’s Health and Hospitals Corporation. The skipped beats began sometime in 2007.

According to the Times report, that’s when hospital administrators, hurting perhaps for doctors sufficiently skilled in reading echocardiograms, OK’d a process by which technicians scanning the images would alert the responsible physicians if they noticed abnormalities. Otherwise they stored the results – pictures of the heart’s contractions, wall thickness and size, valves and some large vessels – for review, later.

Usually when a person gets an echocardiogram there’s a reason. Mine, for example, was done before I received a chemotherapy drug, adriamycin that can affect the heart’s function and, another time, before I had a major operation – basically to make sure my heart was strong enough to handle the stress of surgery. Years earlier, I’d had an echo (as doctors sometimes call these tests) to evaluate shortness of breath I experienced while pregnant. I like echocardiograms, as cardiac imaging methods go, although I must admit I find the blobby representations cryptic if not frankly rorschachian. These tests rely on ultrasound, the same technology we routinely use to examine unborn fetuses by projecting and canvassing sound waves. There’s no radioisotope or x-rays. Not even a magnet’s involved.

Echocardiogram reveals 4 heart chambers - adapted from Wikimedia Commons

What generally happens is that after the procedure a doctor, usually a cardiologist, inspects the images and provides a written assessment. Ideally, the test report reflects the reason for doing the procedure. So if a teenage soccer player has an echo to evaluate an episode of fainting on the field, the physician-reviewer would focus on structural heart abnormalities associated with sudden death in some young athletes. Sometimes the studies reveal enlargement of the heart; this can occur in alcoholics, in people with chronic forms of severe anemia like sickle cell disease, and in other conditions. For patients with atrial fibrillation – a disorder in which the heart flutters irregularly – doctors might look to see if there’s clot inside the heart’s walls that might, unmitigated, migrate through the arteries to the brain. Echocardiogram can assess the heart’s condition after a heart attack or in congestive heart failure. They can visualize holes in the heart chamber walls of infants, lapsed valves and more.

The Times story indicates that doctors didn’t review images for over half of the echocardiograms performed at Harlem Hospital since 2007. The medical center, staffed by doctors from Columbia University, had six attending cardiologists and six fellows in 1999, according to the paper. Now the hospital has only three full-time cardiologists and lacks a fellowship program. The hospital runs approximately 2,500 echocardiograms each year. Among those 4,000 patients whose tests went unread, some 200 have died since the time of the procedure. Hospital officials say it’s unlikely that any deaths are attributable to the lapse.

Since the story emerged last week, a squad of doctors has been scrambling to review the images. Heads rolled at Harlem Hospital: the clinical director was fired and the medical director has been demoted. An investigation, led by Dr. John N. Morley of the State Health Department, is underway. The press, or at least my local newspaper, is all over the matter.

So what’s to be learned from this oversight? My take’s two, so far:

1. It appears that at least some physicians working at Harlem Hospital felt it was understaffed and that they were too overworked to meet their clinical responsibilities, and that the administration did not adequately address their concerns. And while Health and Hospitals Corporation has indicated this problem is unique to that particular department – the echo lab – at one hospital, I’m not convinced.

Having worked for years in hospitals where cardiologists, gastroenterologists, hematologists and even pathologists spend much of their time putting out fires, so to speak, it’s scarily easy for me to envision how non-urgent tests could pile up without review. When hospitals operate with money as a bottom line, the difficult work doctors do doesn’t get easier. So we might blame individual physicians for not signing those reports. But I’d take the system to task, and not just at one Harlem hospital.

2. No one’s mentioned the patients’ role in all of this, which seems strange to me. These days, we expect that most patients will enter into discussions with their physicians about what tests they need done. Maybe at a medical center like Harlem Hospital, which serves a relatively poor population, the expectations differ regarding patients’ involvement in medical decisions. But if that is the case, those separate standards reflect another problem – of poor communication between physicians and their patients – equally demanding of our attention.

Lastly, as I’ve said previously here and elsewhere, we waste a lot of medical resources by ordering procedures without thinking. If a person undergoes a medical test there should be a reason for it, sufficient that either the doctor or the patient cares enough to find out the results.

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DNA Comes Home, or Maybe Not

Earlier this month employees at most of 7500 Walgreens pharmacies geared up to stock a new item on their shelves: a saliva sampler for personal genetic testing. On May 11, officials at Pathway Genomics, a San Diego-based biotech firm, announced they’d sell over-the-counter spit kits for around $25 through an arrangement with the retailer. A curious consumer could follow the simple package instructions and send their stuff in a plastic tube, provided in a handy box with pre-paid postage, for DNA analysis.

DNA helix structure (Wikimedia Commons)

Once the sample’s in the lab, the cost of genomics testing depends on what, and how much, you want to know. Pathway offers a variety of options. A pre-pregnancy planning report would check to see if you carry mutations for each of 37 inherited diseases – conditions as varied as beta thalassemia, cystic fibrosis and familial Mediterranean fever – for $179. A profile of tests for genes involved in metabolizing specific drugs, such as Plavix and Coumadin, goes for $79. A vaguer, health conditions panel suggests a propensity to develop particular diseases including Type II diabetes and melanoma. This series runs $179 if purchased separately, but might be had for less through a discounted package rate. A genetics ancestry evaluation lists for $249.

Within two days, after some controversy and a receipt of a letter from the FDA Office of In Vitro Diagnostic Device Evaluation and Safety addressed to James Plante, Founder and CEO of Pathway (dated May 10), Walgreens nixed the plan. Now, Congress wants to know more about direct-to-consumer personal genomics testing. On May 19, the House Committee on Energy and Commerce sent letters to Plante and the CEOs of two major competitors – Navigenics and 23andMe. House Committee Chairman Henry Waxman and colleagues have some questions about how samples are processed and the accuracy of the results:

“The Committee is requesting information from the companies on several aspects of the tests:  How the companies analyze test results to determine consumers’ risk for any conditions, diseases, drug responses, and adverse reactions; the ability of the companies’ genetic testing products to accurately identify any genetic risks; and the companies’ policies for the collection, storage, and processing of individual genetic samples collected from consumers.

The Federal Trade Commission has cautioned consumers about genetic testing kits since 2006.  Still, personal genomics tests are readily through available on-line sales. You can get the 23andMe “DNA Test for Health and Ancestry Information” from the manufacturer or at Amazon.com for $499. Navigenics takes a distinct approach by marketing its genetic tests strictly as a laboratory service for medical practitioners and so, thus far, avoids some rules regarding in vitro diagnostic tools.

New York State, my home, is one region where Walgreens wouldn’t have sold the kits in stores. That’s because of stricter state laws regarding genetic testing.

Dan Vorhaus, writing for the Genomics Law Blog, provides a considered analysis:

At present, whether a genetic test is subject to FDA regulation largely depends on how it is developed and marketed. The literature, as well as current FDA regulatory policy, divides genetic tests into two primary categories:

(i) in vitro diagnostic test kits (also sometimes referred to as IVD kits or, simply, as genetic test kits), which may be sold by their manufacturers directly to consumers, testing laboratories, clinicians or other approved recipients, depending on the device; and

(ii) laboratory developed tests (or LDTs, also sometimes referred to as “home brew” assays), which are not sold directly to the general public or to physicians; rather, a testing service (as opposed to the actual test itself) is marketed, and samples (e.g., of saliva) are collected and submitted to the laboratory for evaluation.

The FDA regulates IVD kits as medical devices…

Up until now personal genomics testing companies have had few constraints, and little profit. What’s clear from the recent news is that we’ll be hearing more about these kits – their manufacture, distribution, accuracy and interpreting results. And that doctors, for our part, have some serious studying to do. Whether the test results go directly to patients, or not, they’re sure to raise many legitimate questions. We’ll need some solid answers about the testing process in itself, besides meaningful responses about what’s found in our DNA.

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Why Blog on OncotypeDx and BC Pathology?

A few days ago I wrote on a relatively new pathology tool called OncotypeDx. This device measures expression of 21 genes in tumor cells to establish the likelihood a cancer will recur. For women with early-stage, ER+ tumors that haven’t yet spread to the lymph nodes, the OncotypeDx results stratify patients into three groups – those having a low, intermediate or high risk for recurrence at 10 years.

As things stand, chemotherapy is routinely prescribed for most women with early-stage BC after initial treatment by mastectomy or lumpectomy and radiation. But the overall relapse rate is fairly low (around 15% at 5 years, higher over time depending on other factors) for women who take an anti-estrogen pill like tamoxifen. Chemo reduces the recurrence rate by approximately one third. The problem is that women and their doctors don’t know in advance who’s likely to benefit.

Here’s why this is important:

What happens now is that most women choose to undergo treatment even though it’s unlikely their cancer will come back. This – the problem of overtreatment – was one of the main concerns to emerge from the mammography screening debate.

The original OncotypeDx data, which have been considered here and elsewhere, support that most women with low recurrence scores are unlikely to benefit from chemo. So if women and their doctors could access the kind of information provided by OncotypeDx, at a cost of ~$3800 each, tens of thousands of women with BC and low risk scores might opt out of chemo treatments each year.

For example, if a woman’s recurrence score is less than 18, the likelihood of a relapse within 10 years is only 7%. Such a patient might happily and rationally choose not to take adjuvant chemotherapy.

I can’t even begin to think of how much money this might save, besides sparing so many women from the messy business of infusions, temporary or semi-permanent IV catheters, prophylactic or sometimes urgent antibiotics, Neulasta injections, anti-nausea drugs, cardiac tests and then some occasional deaths in treatment from infection, bleeding or, later on, from late effects on the heart or not-so-rare secondary malignancies like leukemia. And hairpieces; we could see a dramatic decline in women with scarves and wigs.

So why doesn’t every woman with eligible (ER+, node-negative) BC get an OncotypeDx readout, or some other modern pathology report, such as Mammaprint, that’s available and already FDA-approved? (OncotypeDx is just an example, really, of an advance in science that’s moving at a snail’s pace into the clinic.)

One issue, perhaps, is that it’s challenging for some doctors to learn about this test sufficiently that they’re comfortable with it. Quantitative RT-PCR, the method by which RNA is measured in the assay, wasn’t invented until around 1990, long after many practicing oncologists completed school. And as for the particular 21 genes measured – they’re unfamiliar to most physicians I know. Now, you might say that it doesn’t matter – if the device works, the doctor doesn’t have to understand the underlying technology. But a black box-like approach to clinical cancer decisions is far from ideal.

From the physician’s perspective, it may be easier, and perhaps legally safer, simply to prescribe the chemo – which she knows well and uses all the time – than to engage in a decision-making process using new methods and terms she doesn’t fully command.

Besides, there’s a conflict of interest: many oncologists, hospitals and infusion centers make money by giving infusions of chemotherapy. Identifying a large subset of patients who wouldn’t benefit from chemo may not be a priority for some clinicians. In a recent JCO paper, half of the oncologists’ initial recommendations for a combination of chemotherapy and hormonal treatments changed to hormonal treatment (without chemo) upon seeing the patients’ OncotypeDx scores.

An ongoing large, NIH-sponsored TailorRx trial involving 10,000 patients aims to clarify the potential benefit of this test. I’m concerned that by the time those results are available, with relapse rates and survival curves at 5 and 10-years, the technology in science and availability of new treatments may persuade doctors, then, to question the trial’s relevance. Meanwhile, hundreds of thousands of women will be treated off protocol, many without this sort of information, in a sort of blinded guessing game about the chances of recurrence and whether or not they should take chemo.

For now I hope that all women with newly-diagnosed BC, and their physicians, know about OncotypeDx and other tools, and their potential to inform decisions regarding chemotherapy.

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More News, and Considerations, on OncotypeDx

This week I’ve been reading about new developments in breast cancer (BC) pathology.

At one level, progress is remarkable. In the 20 years since I began my oncology fellowship, BC science has advanced to the point that doctors can distinguish among cancer subtypes and, in principle, stratify cases according to patterns of genes expressed within tumors. This sort of information – cancer cell profiling – might inform prognosis and influence treatment decisions that BC patients and their doctors, usually oncologists, make every day.

What disappoints is the slow pace by which this knowledge infiltrates the clinic. In practice, women and their physicians rarely have much more information on BC pathology than what was available two decades ago – the tumor size in its largest dimension (crudely measured in centimeters), whether it’s spread to the lymph nodes (and if so, how many nodes), the type of cancer (based on the cells’ appearance under a light microscope: infiltrating ductal, lobular carcinoma and other BC forms) and whether the cells express a few key molecules including estrogen receptors (ER).

In the past five years, more laboratories are offering data on Her2 in BC samples. This complex molecule, an epidermal growth factor receptor, normally transmits signals from a cell’s surface to the interior. Her2 expression dictates the BC subtype in some newer classifications of the disease and usually determines the cells’ responsiveness to Herceptin, a monoclonal antibody treatment. Still, there’s been some controversy, in part due to variation among lab facilities in the reproducibility of Her2 testing results.

The problem is this: if pathologists don’t provide accurate, valid results on Her2 expression in BC cells – which can be measured by various methods – it’s hard for women and their physicians to make sound decisions based on the molecule’s expression. And Her2 is just one of dozens of molecules that can be measured in BC. The reason it’s tested, for the most part, is to foster decisions on Herceptin treatment and also, perhaps to a lesser extent, to provide prognostic information.

What puzzles me is why so few use better, modern pathology and other decision tools. Technologies like Mammaprint, Adjuvant! and OncotypeDx have been available for years but aren’t used routinely in most clinical settings. So I thought I’d do some more research and, in future posts, will consider each of these and other, relevant technologies.

For today I’ll focus on OncotypeDx.  This test, manufactured by the Redwood City, California-based Genomics Health, assesses BC recurrence risk in cases that are ER+, node negative (see below). As cancer gene testing panels go, OncotypeDx is a baby, based on expression of just 21 genes by a two-decade old method called quantitative RT-PCR. The test intrigues me; I’ve posted on it once before.

No doubt, my interest in OncotypeDx is intensified by my personal history of BC. My case was exactly the sort of ER+, node-negative tumor for which OncotypeDx is intended; often I’ve wondered what would have been my tumor’s recurrence score (RS) and if knowing that would have affected my decision to undergo treatment with adjuvant chemotherapy.

Some background terms –

ER+ means that the cells express hormone receptors, for estrogen, at the surface;

Node negative means that the breast cancer has not spread to the lymph nodes, or glands, of the armpit. (Axilla is the medical term for armpit. Axillary lymph nodes are normal immune organs that drain fluid including potentially foreign particles from the breast, chests and nearby arm. The nodes can swell if there’s an infection to which the body reacts, if malignant cells infiltrate the gland and sometimes due to autoimmune diseases like lupus.)

So an ER+, node negative breast tumor is one in which the cancer cells are sufficiently differentiated, or mature, to produce and bear hormone receptors at their surfaces and in which the tumor cells haven’t yet migrated to the armpit (or at least haven’t done so at a level that can be detected by a pathologist).

Real-Time, Reverse Transcriptase (RT) – Polymerase Chain Reaction (PCR) is a standard method for amplifying tiny amounts of nucleic acids such that they can be measured and sequenced. Standard PCR usually amplifies DNA whereas in RT-PCR, RNA transcripts are converted to DNA before amplification in a machine. This method can assess the amount of RNA, or message for a particular gene, that’s expressed in a pathology sample.

Adjuvant therapy refers to additional, or extra, treatment that’s given after initial cancer surgery to reduce the chances of the tumor’s recurrence.

Back to OncotypeDx –

This pathology tool predicts the likelihood that ER+, node-negative BC tumors will come back within 10 years of a woman’s primary treatment (mastectomy, or lumpectomy with radiation) usually followed by tamoxifen. The assay measures each of 21 genes in a panel and, using those results, calculates a “recurrence score” (RS) between 1 and 100. The higher the RS, the more likely the cancer will re-emerge after treatment.

According to the Genomics Health website, the test measures RNA in BC tumor specimens for the following transcripts:

Groups of genes measured in OncotypeDx assay, according to the manufacturer
cell proliferation tumor invasiveness growth factor receptors hormone responsiveness other genes of interest reference** genes
Ki-67

STK15

Survivin*

Cyclin B1

MybL2

Stromelysin 3

Cathepsin L2

Grb7

Her2

ER

PR (progesterone receptor)

Bcl-2*

Scube2

GSTM1

CD68

BAG1

Beta actin

GAPDH

RPLPO

GUS

TFRC

*In my opinion, survivin and bcl-2 might be better classified distinctly; the products of these genes inhibit apoptosis (programmed cell death).

**These “housekeeping” genes are not of known significance in BC pathology. Rather, they serve as controls in the assay for the quality of the RNA sample, and for comparison to other measured genes.

The OncotypeDx results are reported by risk group, as follows:

Low risk (RS <18, the 10-year recurrence rate was 7% in NSABP study – see below)

Intermediate (RS 18 – 30, the 10-year recurrence rate was 14%, in same);

Higher risk (RS >31, the 10-year recurrence rate was 30%, in same).

The tool has been tested in multiple clinical trials for its capacity to predict BC recurrence after surgery and tamoxifen in women with ER+, node-negative tumors. The study most-cited, and from which the above statistics are drawn, was published in the New England Journal of Medicine in 2004, based on a retrospective analysis of 668 cases by Genomics Health in collaboration with investigators of the National Surgical Adjuvant Breast and Bowel Project (NSABP, a large, NIH-sponsored, multicenter cancer research effort).

OncotypeDx has been on the market since 2004. The cost of one assay runs near $3800, and most U.S. insurance plans including Medicare will cover it. Tumor samples, set in fixative, are sent to a single lab – a Genomic facility – that’s regulated according to the Clinical Laboratory Improvement Amendments of 1988 (CLIA). The whole process takes 10-14 days. Still, the FDA has not approved the test for use as a decision-making tool.

Meanwhile, an NCI-sponsored trial called TAILORx will recruit and evaluate 10,000 women with ER+, node negative disease. Those investigators will determine, prospectively, if decisions based on OncotypeDx results can safely spare women with low RS the side effects and toxicity of chemotherapy without compromising their survival.

Why Oncotype and other new BC pathology tools matter –

In the U.S., the number of women who learn they have an ER+, node-negative BC approximates 100,000 per year. The question of adjuvant therapy – whether a woman should take tamoxifen or another hormonal agent and/or chemotherapy after surgery to reduce the risk of recurrent disease – is crucial.

If patients and their doctors could access more detailed molecular information about each case, they’d have a better sense of whether adjuvant treatment is likely to help in their particular situation. This approach would, potentially, spare many individuals with early-stage BC the costs, toxicity and hassle of unneeded chemotherapy. At the same time, it would help patients with small but riskier tumors by informing them that they have a high RS and thereby would more likely benefit from added therapy. Fewer women would receive chemotherapy, driving down costs, and the risks of additional treatment would be assumed only by those with a high likelihood of recurrence.

Some numbers here might help:

Overall, for women with ER+, node-negative tumors the chances of cancer recurring five years after primary treatment (mastectomy, or lumpectomy and radiation) followed by tamoxifen are around 15%. Over time that risk rises – BC can strike back after 10, 15 years or even later; the recurrence rate is said to approach 30% over time. In general, a basic chemotherapy regimen – something like CMF – cyclophosphamide (Cytoxan), methotrexate and 5-fluorouracil (5FU) reduces the probability of recurrence by about a third.

So if 100 women with node-negative tumors have to decide whether to take chemotherapy after surgery +/- radiation, or not, without a tool like OncotypeDx or another modern pathology test, they’re making those decisions based on very crude approximations of their odds. Because they don’t know whose tumors will recur, most if not all of their oncologists will recommend chemotherapy. And most women do choose to undergo the extra treatment because they’re afraid that, otherwise, there’s a greater chance the cancer will come back.

This is exactly the situation I faced in November, 2002, when I had an ER+, node negative, 1.5 cm tumor. Then, I reasoned that BC tends to be more aggressive in younger women. With hopefully more decades ahead in my life – more time, in effect, for the disease to recur – an 85% disease-free rate at 5 years wasn’t good enough. So I went for the chemo and upped my chances to the 90% range. Not a big difference in the stats, but I wanted to position myself on the upper branch of that Kaplan-Meier curve. Now, had I known my recurrence score based on the pattern of gene expression in the tumor cells, that information would have been useful. But it wasn’t an option then and, unfortunately, it’s still rarely available to most women who are undergoing treatment for BC in 2010.

The slow pace of progress, science in hand, is kind-of shocking.

So what’s new with OncotypeDx?

Two months ago, I reviewed a small study published in the ACS Cancer journal on the experiences of most of 100 women with newly-diagnosed breast cancer whose oncologists used the OncotypeDx assay to evaluate their cases. In that, two-thirds of the women reported they “understood a large amount or all” of what the doctors told them about the results and nearly all said they would undergo the test if they had to decide again.

In its April 1 issue the Journal of Clinical Oncology (JCO) published two relevant reports and an editorial. These papers support that OncotypeDx offers useful information to women with early-stage breast cancer and that it can assist patients and doctors in care decisions, in some cases providing support for them to choose a chemotherapy-free treatment regimen.

One study, a “Prospective Multicenter Study of the Impact of the 21-Gene Recurrence Score Assay on Medical Oncologist and Patient Adjuvant Breast Cancer Treatment Selection” by Dr. Shelly Lo and colleagues, followed the analysis and prescribing patterns of 17 medical oncologists at 3 diverse academic medical centers and one community hospital. Genomic Health, provided free OncotypeDx kits and testing at their central lab for all 93 patients with ER+, node-negative BC who enrolled in the trial.

The mean age of the women was 55 years (range 35 – 77). The oncologists were asked to state their treatment preferences (hormonal treatment with or without chemo) before and after receiving the OncotypeDx results for their patients. What happened was this:

Before seeing the OncotypeDx results, the oncologists recommended chemo and hormonal therapy (CHT) to 42 of the 89 women for whom the study was completed. In 20 of those 42 cases (22% of the total, and nearly half of those women who were to receive chemo) the doctors changed their recommendation from CHT to HT (hormones only) upon reviewing the OncotypeDx report. In 8 cases, the oncologists switched their recommendation to include chemotherapy. In total, the OncotypeDx results influenced the oncologists’ preferences in 31% of the cases – nearly a third.

As for the patients – 74 of the 89 (83%) said the OncotypeDx results influenced their treatment decision. The assay report persuaded 9 patients in the group to opt for a less aggressive (chemo-free) approach. The majority (78 women, 95% of those responding) said they were glad they used the OncotypeDx assay. According to the paper, many patients felt reassured by the assay findings and benefited from a diminished perceived risk of recurrence (less worry, in effect).

The upshot is that the OncotypeDx assay – which costs around $3800 per evaluation – led to significantly fewer women with early-stage breast tumors getting chemotherapy in this trial of 89 patients. The doctors were more confident in their decisions to not give chemotherapy in cases with low RS and, overwhelmingly, the women felt glad about the decision-making process.

In the second JCO study in the April 1 issue, the number of patients evaluated was much greater – over a thousand. But this was a more complicated analysis in which the investigators applied OncotypeDx to old tumor samples and then, upon reviewing those cases in some well-documented randomized trials, examined how the cases fared in relation to the RS. What they found was that OncotypeDx score predicted the likelihood of loco-regional recurrence (LRR) in women who had node-negative, ER+ disease.

Bottom line –

The OncotypeDx tool has been on the market for 6 years. It has, in multiple and well-done studies, identified patterns of BC gene expression that accurately predict the likelihood of recurrence in women with early-stage, ER+, node-negative tumors. This should, in principle, reduce administration of chemotherapy – along with its attendant risks, costs and side effects – to women whose tumors are unlikely to relapse. Recent trials show that doctors find the results useful and that patients find it helpful in their decisions.

I can’t know for sure why the tool’s not used more often. But I have some concerns:

1. It takes time for doctors – even knowledgeable oncologists – to learn about this device, to know how it differs from other BC pathology tests like Mammaprint and decision tools (like Adjuvant!) and then it takes even more time for those physicians to discuss the results with their patients.

From the perspective of a physician sitting behind her desk or at a table with a newly-diagnosed BC patient, saying “this is what I think, you need treatment X” may be a lot easier than “well, let’s go over these OncotypeDx results…”

2. If the OncotypeDx report does indeed identify large subgroups of early-stage breast cancer patients who don’t need chemotherapy, the use of this test would reduce the number of patients who get chemotherapy. Oncologists, infusion centers and others generate income by prescribing chemotherapy. So there’s a potential conflict of interest.

3. Perhaps some physicians fear lawsuits for not giving chemotherapy to women who, without the OncotypeDx results, would receive it.

4. Some doctors might not recommend OncotypeDx because they don’t really understand the test, its merits and limitations.

5. Maybe OncotypeDx isn’t the best of the new BC adjuvant therapy decision tools. For this reason, among others, I will consider some of the other methods available in future posts.

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The Checklist and Future Culture of Medicine

Like many New Yorkers, I learned about the checklist in a magazine. I remember thinking, in late 2007, that maybe I’d seen something on the subject in The New England Journal. Indeed, a year earlier Dr. Peter Pronovost and colleagues reported on a simple, inexpensive strategy to save lives in a now-landmark article, “An Intervention to Decrease Catheter-Related Bloodstream Infections in the ICU.” Still, I’d missed the paper. Or at least I’d overlooked the significance.

Fortunately I had the opportunity to hear Pronovost, a still-youngish Professor at Johns Hopkins and recent MacArthur award recipient, speak at the annual meeting of the Association of Health Care Journalists in Chicago. After hearing his talk, I couldn’t wait to read more.

The checklist refers to 5 steps doctors can take to reduce the likelihood of patients getting serious infections from catheters placed in the ICU. One problem with Pronovost’s quintet is that it’s, well, unexciting. In his book Safe Patients, Smart Hospitals he reveals what a person shouldn’t forget before inserting an intravenous (IV) tube through a vein to the heart’s entryway:

1. wash hands with something like soap before the procedure;

2. set up a clean work area by covering the patient with a sterile drape and donning a gown, cap, mask and sterile gloves;

3. insert the catheter in a place other than the patient’s groin, if possible;

4. wipe down the patient’s skin with antiseptic fluid, chlorhexidine;

5. remove catheters that are no longer needed.

Pronovost, an intensive care specialist who holds an MD and a PhD in Public Health, first tested the checklist on his home turf, the surgical ICU at the Johns Hopkins Hospital in Baltimore, MD, in 2001. At the start, he distributed the list and asked ICU staff nurses to mark physicians’ compliance. It turned out the doctors skipped at least one step in over a third of central catheter placements. Next, he upped the list’s power by talking to Hopkins administrators. Nurses, they said, could call out a physician if they didn’t stick to the rules.

“This was revolutionary,” said Atul Gawande in the New Yorker.

What’s the big deal, you may wonder. It’s this – first, in the usual culture of medical practice, doctors don’t follow orders but give orders. And second, what’s implicit in the checklist is that physicians – even at one of the world’s most renowned medical facilities – are fallible to such a degree that their work can improve, and measurably so, by using something as ordinary as a checklist. It’s humbling.

“We don’t use checklists in health care because we still have his myth of perfection,” Pronovost said at the journalism conference.

In the year after Pronovost’s team implemented the checklist at Hopkins, the rate of central catheter infections there dropped from eleven percent to zero. As for how much good this did – the estimate runs at 43 infections spared, 8 deaths avoided and $2 million saved in one year at that hospital alone. The work expanded, soon to cover ICUs in most hospitals in the state of Michigan. There, after a lot of fuss, administrative hurdles and number crunching of results for some 375,757 catheter-days’ worth of infection data, the incidence of central line-associated bacterial infections snapped from 2.7, on average, for every 1000 days a patient was in a Michigan ICU with at least one central line, down to 0 (zero!).

These numbers are supported by impressive stats, with p-values falling below 0.002 in the original study. Estimates for the Keystone Initiative render some 1000 lives saved and $175 million in hospital costs reduced in a single year in Michigan. What’s more, all of this was accomplished without the use of expensive technology or additional ICU staffing.

This is a win/win intervention with huge implications. Every day some 90,000 people receive care in ICUs in North America. The annual incidence of catheter-related blood infections is 80,000 per year in the U.S.; the cost of treating each line infection runs around $45,000. In the U.S., we might save over $3 billion in expenses per year.

So why aren’t more hospitals and states adopting these and other, similar measures? Gawande addresses this, to some extent, in the New Yorker piece and in his book, The Checklist Manifesto. “There are hundreds, perhaps thousands, of things doctors do that are at least as dangerous and prone to human failure as putting central lines into I.C.U. patients,” he writes. “All have steps that are worth putting on a checklist and testing in routine care. The question – still unanswered – is whether medical culture will embrace the opportunity.”

Poka-yoke, a Japanese term for rendering a repetitive process mistake-proof, may be familiar to business students and corporate executives.  This concept, that simple strategies can reduce errors in highly complex works, is not the kind of thing most doctors pick up in med school. Rather, it remains foreign.

Pronovost is unusual because he examines health care delivery, in itself, rather than attempting an innovative cure for cancer or surgical method. His work just isn’t sexy enough to sell. I suspect that’s the reason he came to the health care journalism conference in Chicago and gave such an impassioned talk about the checklist, so that a few of us might help get the word out.

Things change, after all, and sometimes they do get better.

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A Routine Visit

Yesterday I visited my internist. I had no particular complaint. My back hurt no more than usual. The numbness in my left foot was neither better nor worse than it was last month. I wasn’t suffering from vertigo or abdominal pain. I went because I had an appointment to see her, nothing more.

Until just a few years ago, I rarely visited a doctor unless I was pregnant or sick. I called when there was a problem, and my doctor would see me in whatever unusual circumstances I was in. She checked on me when I was in the hospital, reviewing my labs and x-rays and whatever else there was to take in. When I had cancer, or needed pre-operative evaluations for surgery, she would check my heart and lungs and write a note as needed. Sometimes I went to her office for a flu shot.

The idea of an adult woman seeing the doctor for regular, what some might call “well,” care might seem strange or even wasteful. Some might consider it a luxury, which I suppose it is.

But I think some of the most informative doctors’ appointments are routine. That’s because there’s value in a doctor’s getting to know a patient when she’s not particularly ill, when she’s not in pain or terrified, when she’s feeling just as usual.

I’ve had the same primary care physician since 1987. She knows my habits, my fears and my quirks. She, as much as anyone, has a sense of how I’m doing – emotionally and physically. In some years, I’ve taken better care of myself than in others, and she’s very much aware of that. She examines me carefully and makes suggestions regarding diet, physical therapy and other everyday, non-urgent matters in my life that affect my health.

The best thing about having a doctor know me so well is a matter of trust. I rely on her not to solve what’s unsolvable, which of course no one can do, but to do the best she can to take care of me. If ever I’m very sick again, in a circumstance when I can’t make decisions for myself, I know she’ll act according to my interests. She’ll be able do so because she knows me, my usual self.

Having a doctor who knows you shouldn’t be a privilege. Really I wish it for everyone. It helps.

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Uncertainty Rules (on Eyjafjallajokull, volatility and a patient’s prognosis)

(on Eyjafjallajokull, volatility and a patient’s prognosis)

Eyjafjallajökull, April 2010 (Wikimedia Commons, attr: David Karnå)

As pretty much anyone traveling in Europe this week can tell you, it’s sometimes hard to know what happens after an unusual, disruptive event. Volcanologists – the people most expert in this sort of matter – can’t say for sure what the spitfire at Eyjafjallajokull will do next.

It comes down to this: the volcano’s eruption could get better or it could get worse. Or it might fluctuate for a while. If the situation persists, there’s no telling if its course will stutter, like seizures of varying intensity in a person with untreated epilepsy, or if it will flare sporadically like disease exacerbations in patients with MS and then, with some luck, peter out.

Some wonder if the ash might spread westward over the ocean, affecting distant cities like New York and Chicago. Unlikely, it seems to me, but this is far afield from my area of expertise.

What I do know is oncology, and so how I’m thinking about Eyjafjallajokull in medical terms – I want to know the prognosis: how bad and extensive will be the damage, how much will it cost, and in a few weeks or (please, volcanologist, don’t say it could be months) from now, how we can know for sure when the situation has cleared.

Aside from a few pulmonologists who rushed in to say there’s not much to worry about the silica-laden aerosolized dust particles, most scientists who’ve been interviewed have been cautious. I admire their candidness about what they don’t know.

For example, yesterday NPR’s All Things Considered offered this assessment:

“The volcanic eruption that has grounded planes and closed airports throughout Europe appears to be slowing down. But before travelers start rejoicing, Icelandic scientists have a warning: The eruption could start up again any time.

The website of the American Geophysical Union offers some explanations provided by Dr. John Eichelberger, Volcano Hazards Program Coordinator at the U.S. Geological Survey who, it happens, was grounded in Europe after attending a scientific conference:

“Although we’re pretty good at saying when an eruption will start, we’re not so good at saying when it’s going to end. You go mainly on the basis of history, what the volcano has done before. In the case of this volcano, the last time it erupted it was active for over a year. The other factor is how the wind is blowing…

Today, the BBC published several scientists’ opinions including these differing views:

Dr John Murray, an Earth scientist from the Open University in Milton Keynes, said that the ash had “significantly diminished” and the ice over the crater itself had melted…”This is the stage we have been waiting for: the steam explosions due to water being trapped within the erupting lava will have virtually ceased, and the activity has changed to lava outpouring,” he said. …Ash may resume at any time, but it is likely to be less pronounced and prolonged than before.”

But Dr Sue Loughlin from the British Geological Survey pointed out that a decrease in the volcano’s activity might not mean the end of the eruption all together. “There’s seismic activity ongoing, which means the eruption is ongoing…

You get the idea, a volcano in Iceland exploded for the second time in two months, putting much of Europe at a stand-still. Business travelers, vacationers, and companies had to stop and make new arrangements and even compromises. Disappointment and frustration ensued, besides some anger toward those whose job it is to decide if it’s safe to fly.

Going back to medicine – I’m thinking of a patient I once cared for with a non-Hodgkin’s lymphoma. When her disease struck, she was a young mother like me who led a complicated life with lots of responsibilities.

The type of lymphoma she had was uncommon; she sought multiple expert opinions regarding her exact diagnosis and treatment. My colleagues and I didn’t all agree about chemotherapy and radiation, and she was uncertain of how to proceed. Ultimately she opted for surgery and six months of chemotherapy. At the end of all that, she wanted to know if the lymphoma would come back.

“We can never be sure,” I told her. There’s really no choice but to watch and wait.

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When ‘No’ Turns Positive in Medical Care and Education

The medical word of the month is a most definite “no.”

The word is featured, explicitly and/or conceptually, in recent opinions published in two of the world’s most established media platforms – the New York Times and the New England Journal of Medicine. The combined message relates to a previous point I’ve made here and elsewhere, that if doctors would or could take the time to provide full and unbiased information to their patients, people might choose less care of their own good sense and free will.

Let’s start with David Leonhardt’s April 7 column, In Medicine, The Power of No. In this excellent essay he defines the difficulty: “deep down, Americans tend to believe that more care is better care.” Then he details the problem:

…It’s not just CT scans. Caesarean births have become more common, with little benefit to babies and significant burden to mothers. Men who would never have died from prostate cancer have been treated for it and left incontinent or impotent. Cardiac stenting and bypasses, with all their side effects, have become popular partly because people believe they reduce heart attacks…

Advocates for less intensive medicine have been too timid about all this. They often come across as bean counters…

After outlining the situation – too much and sometimes harmful medical care, combined with a population reticent in limiting any form of consumption – he offers three steps by which we might “learn to say no.” Those would include:

1. Learning about when treatments work and when they don’t. (This is problematic, he admits, citing the Institute of Medicine which reports that too often data are “incomplete or unavailable.”)

2. Giving patients the available facts about treatments. (This doesn’t happen as it should, he explains, for reasons including doctors’ persistent paternalism.)

3. Changing the economics of medicine, to reward better care rather than simply more care.

So, as I understand Leonhardt’s proposal, he’s saying that if we knew more, we’d be less demanding and ultimately more satisfied with the medical care we receive. And because more care is sometimes harmful, besides expensive, the consequence of saying “no” would be a big plus – in terms of quality and costs.

Moving on –

On April 8 the New England Journal of Medicine published a perspective piece, Cost Consciousness in Patient Care – What is Medical Education’s Responsibility? by Dr. Molly Cooke. This essay parallels Leonhardt’s in that it first reviews our medical overconsumption problem and then suggests specific steps to ameliorate it.

A major distinction is that Cooke addresses physicians and her proposal applies, for the most part, to their medical education. She considers that, at least historically, doctors are not trained to consider costs in the process of rendering medical decisions. The primary concern, we’re taught, is doing what’s right for our patients. The second, it seems, is an ivory-tower sort of wisdom:

…Academia celebrates the “high knowledge” of medicine: pathophysiology, molecular biology, genomics. Even evidence-based medicine, although it deemphasizes fundamental mechanisms, is regarded as acceptably intellectual in comparison with “low,” real-world concerns such as cost…

After mentioning physicians’ conflicting financial incentives in practice and many doctors’ hesitation to speak about or even consciously consider costs, she proposes three changes in medical training. In her terms:

1. We must be honest about the choices that we make every day. (What she intends here, as I read it, is that because physicians do indeed ration our time and other resources, we should be up-front, i.e. conscious about such value-laden decisions.)

2. We must prepare every physician to asses not only the benefit or effectiveness of diagnostic tests, treatments, and strategies, but also their value.

3. We must broaden our programs so that all trainees receive a foundation of exposure to health care management and health services delivery. (That we can afford for doctors-in-training to spend more of their time on the business of health care, I’m not convinced, but her point is that at least they should have a clue about how the real world of health care works and how much things cost.)

What Cooke says, in sum, is that for physicians to effectively counter the unsustainable medical expenses in the U.S., we should adjust medical education to train doctors to think – actively and consciously – about the economics of health care.

Now it’s easy to tie these two pieces together. The points are that regular citizens and doctors, both, need to learn more about the value of tests, procedures, treatments and other health care commodities. Just piling it all on blindly doesn’t yield the most value.

I’m reminded, lately, of a simple fact about numbers I knew in high school, that when you put together two negative numbers by multiplying them, you get a positive. Maybe, in the real, messy, complicated world of medicine and health care delivery, we can entangle these two learned no’s – patients choosing less and doctors recommending less – and get a bona fide, positive outcome

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Nice Nerds Needed

In last weekend’s edition of NPR’s Wait Wait…Don’t Tell Me!, host Peter Sagal asked a panelist about a serious problem facing the Pentagon: There’s a shortage of nerds, a.k.a. geeks.

Space Shuttle Atlantis (NASA image, Wikimedia Commons)

Happily, Houston Chronicle deputy editor and blogger Kyrie O’Connor came to the right answer.

On the quiz show, Sagal reported that Regina Dugan, head of DARPA (the Pentagon’s research arm and developer of the early Internet), recently testified before the House Armed Services Committee about her concern for our country’s most famous five-sided structure’s looming intellectual deficit.

“The decline in science education in this country means fewer nerds are being produced, a fact which has serious national security implications,” Sagal said in summary.

“Nerds molt into tech geeks. Tech geeks grow into scientists and scientists maintain the United States technical superiority,” he explained. No worries, though –

Sagal suggests the current nerd shortage will self-correct based on the predictable laws of high-school ecosystems. (To listen to his short description of this evolutionary process, check the track for Panel Round 2, after minute 4:48.)

Wired covered, earlier, the same story on DARPA’s looming technogeek shortage and Dugan’s forward-thinking statement on the matter:

…outlined her vision for the future of the Pentagon’s blue-sky research arm, with everything from plant-based vaccines to biomimetics making the short list. But none of it’s possible, she told the panel, without more investment in American universities and industry to cultivate the techies of the future…

So we lack sufficient math and science education to support the Pentagon’s needs for cutting-edge technology. And we all know that American businesses are losing out for the same reasons.

My concern is health, that some turned-on science and math-oriented kids should grow up and become physician-scientists or even plain-old, well-trained doctors who are good at interpreting graphs and applying detailed, technical information to patients with complex medical conditions. Last week I wrote that better education would improve health and medical care delivery in the U.S. This seems like an obvious point, but the more common discussion strikes on the need for math and science education to support hard technology in industry.

We’re facing a shortage of primary care physicians, oncologists and other doctor-types. Lots of clever and curious young people are turning away from medicine. The hours are too long, the pay’s too low, and the pressure is too great. If we want doctors who know what they’re doing, we should invest in their education and training, starting early on and pushing well past their graduation from med school.

Sure, we like physicians who are kind and honest people and can talk to them in ways they understand. This is crucial, but only to a point – we still depend on doctors to know their stuff.

I like doctors who are nice nerds. We need more of those, too.

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9 + 1 Ways to Reduce Health Care Costs

Recently in the Times‘ “Patient Money” column, Lesley Alderman shared nine physicians’ views on how we might reduce our country’s health care mega-bill.

Here, I’ll review those comments, add my two cents to each, and then offer my suggestion (#10, last but not least)  regarding how I think we might reduce health medical costs in North America without compromising the quality of care doctors might provide.

The “answers” from the Times piece*:

1. Insure Catastrophes Only

I don’t see this as a solution, first because it would reduce insurance costs without reducing routine health care costs. This sort of system would discourage people from seeking preventive or routine care. And it might effectively punish those with non-catastrophic illnesses.

2. Change Malpractice Law

Yes, fear of malpractice triggers some extra medical testing, driving up costs, hassle and occasional risks. But I doubt the costs of malpractice fear-inspired medical testing amount to more than two percent of our health care budget, if that much.

This point is valid but is way over-emphasized by the AMA and others.

3. Counsel Nutrition

It’s hard to argue with your mom. (Eat your fruits and vegetables.)

This falls into the category of preventive care and better public education and is obviously a good idea. But given the anticipated physician shortage, I’m not sure we can afford for many doctors to spend a lot of time on this topic. Ultimately, this agenda may be best served by nutritionists who collaborate with physicians, schools, public health programs and other agencies.

4. Rely on Evidence…

I agree. But the evidence has to be fair, current and free of bias, including academic bias.

5. But Allow for Expertise

Yes.

6. Use ‘Integrative Medicine’

I’m open to acupuncture, herbs and other “alternative” remedies if people find them to be helpful, and even more so if there’s evidence to support their use. At the same time, I’m wary – there’s a huge amount for sale in this market.

As far as reducing health care costs, I doubt that more integrative medicine would be effective. I’m not persuaded by the evidence supporting hypnosis before surgery, as is mentioned in the Times piece. (And just in case it comes up, somewhere else  – I don’t think the purchase or use of candles has anything to do with health care in the absence of an electric black-out.)

7. Pay to Treat Child Obesity

Sure, someone should intervene to help heavy kids slim down before they become heavier adults. But it’s better to reduce obesity before it happens. (Back to the garden, suggestion #3, above).

8. Stop Over-treating

This huge idea, articulated by Dr. H. Gilbert Welch, is essential to reducing health care costs.

The problem is in establishing a consensus on what’s worth screening for, what’s worth treating, and what’s best left alone.

More on this later –

9. Restore the Humanity

“…There are doctors in training now who do not want to do a physical exam; they just want the lab tests and the echo-cardiogram on a heart patient, for example. But the laying on of hands is a powerful tool in establishing trust and in healing…”

The idea here, provided by Dr. Edward Hallowell, is that doctors order tests rather than knowing and examining their patients.

I couldn’t agree more completely.

*For the names of the physicians who were quoted in the New York Times, please check that column directly. (As I’ve excerpted from their comments, that were already condensed, I don’t think it appropriate to use their names out of context here.)

So, here’s my entry – if I’d been asked by the Times columnist what I think should be done to reduce health care costs, I’d say something like this:

(10) Think More, Do Less

For a swamped, chronically-running late physician (know a few?) it’s easy to order a standard set of tests (such as blood work, an electrocardiogram, a urine analysis and sometimes even a CT scan or MRI) before meeting a patient. So a doctor working in a hospital might wait for the labs before evaluating a patient in the emergency room. In an office, a consulting doctor might “lab” a person (yes, it’s been used as a verb) before thinking about the case.

Lately, patients are speaking up a bit in this regard, partly afraid of x-rays and partly afraid of the costs of so much testing. But, especially for hospitalized patients who are sometimes quite sick and may not be able to say no, or “doctor, do I really need that test?” most rely on their physicians to weigh the costs and potential benefits of what tests they order and treatments they prescribe. (This ties in with point #8, above.)

Stabs at efficiency like admission “order sets” for hospitalized patients can be useful in busy hospitals and may, indeed, render it less likely that a needed test is left out when blood is drawn. But for patients who are hospitalized for, say, two or three weeks at a time, with multiple tubes of blood removed each day, the tests add up. (Note:  some very sick patients do indeed need lots of blood tests, sometimes as often as every few hours.)

What I’m suggesting is that doctors shouldn’t order tests by default, in a routine sort of way. Excessive, daily blood work in hospitalized patients is just one example of this phenomenon. I’m aware of other, costlier examples.

Ultimately, what I think would help patients most, and would save lots of money, are smart and well-educated doctors who have the time to know their patients (#9, above) and think really hard. The more familiar a doctor is with a person and his or her disease, the more readily she’ll pick up on a change in the patient’s condition, and the more likely she’ll prescribe therapy that meshes with the patient’s values and that works, too. When a physician stays up-to-date, she’s more likely to establish a correct diagnosis and implement appropriate, effective treatment if needed.

So I think better medical education should be added to the list, along with greater compensation for physicians’ time in terms or thinking, reading and communicating with their patients.

minor rev 4/7/10, ES

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An Ordinary Day

If there’s one obvious thing I didn’t learn until I was well into my forties it’s this:

Don’t let a day go by without doing something you feel good about.

This message is not unusual, cryptic or even interesting. It’s simple, really so trite you could find it in most any “how having cancer changed my life” book available in bookstores and on-line.

Why say it again? Everyone knows we should relax and enjoy sunny weekend days like this.

Because it’s a reminder to myself, as much as for some readers and maybe a few fledgling doctors out there. One of my biggest regrets, during and after so many medical hurdles, is that I was overly ambitious. I am, probably still, one of those people who’s hard-wired to achieve. At work, when I was a young physician-hematologist-oncologist-cancer researcher-pregnant wife, I worked long, long hours. After dinner in our apartment, I’d stay up late, reading, and get up early enough to read the paper and have some breakfast before morning rounds. Later, as my career matured, I used extra hours for research, presentations, grant proposals and, of course, more reading. I loved my work as much as anyone I’ve ever known, wishing I could put more time into it, not less.

Illness places real limits on people’s capabilities. I refused to accept this. I just kept pushing. No excuses.

Looking back, I see that I should have slowed down earlier in my career and made more time for my family and for myself. I needed physical therapy and an occasional day off. Even while I had breast cancer, undergoing treatments, I worked in the clinic, took on administrative responsibilities at the hospital (in lieu of being on-call), and continued to write and review manuscripts, besides teach. After my back operation, a huge, painful and bloody affair, I returned to work and took call like everyone else. It took me too long to realize that I should pull back.

So I think it’s a lesson, or at least it’s one for me. It has to do with the Passover story of Exodus. Making sure to enjoy life, taking some time of each day and week to focus on what you choose, is the privilege of not being a slave.

An unfortunate reality is that many people work long hours because they must, due to financial necessity or because they have no choice. But for those who aren’t so strapped that they must work 16 hour days, who do it for pleasure as much as for wages or for riches, maybe it’s a reminder to take care. Sometimes it takes discipline to know when to shut out the light, or even call it quits. Less is more, sometimes even better.

It shouldn’t take a catastrophic illness to get this message through. Maybe just a good night’s sleep, or another sunny day tomorrow.

Take it easy.

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News, Information, Facts and Fiction

This morning I was in the gym, half-watching CNN as I did my usual exercises. Mathew Chance, a senior international correspondent based in Moscow, recapped the horrific scene involving explosions at two metro stations at the peak of rush hour. Chance reported that the bombers were both women. Most of the other facts surrounding the tragedy remain uncertain, he said. John Roberts, one of the CNN hosts, asked about any claims of responsibility for the terrorist attacks.

“Well, in fact, we had some information earlier today,” Chance responded. “…there had been a claim of responsibility…But that information appears to be incorrect.”

Wow!  Now, there’s an AM Fix.

Can information be wrong? Of course it can, we all know. There’s good evidence for this in my medical textbooks, among other reliable sources.

Lately, and especially since I started this blog, I’ve been thinking a lot about the nature of information – how we define it, how and if it might be distinguished from data, and what separates information and opinion.

“Information is the lifeblood of modern medicine,” wrote Dr. David Blumenthal in a carefully-designated “perspective” piece in the February 4 issue of the New England Journal of Medicine. He continued:

Health information technology (HIT) is destined to be its circulatory system. Without that system, neither individual physicians nor health care institutions can perform at their best or deliver the highest-quality care, any more than an Olympian could excel with a failing heart…

OK, so information needs to get around. It’s kind-of like blood; we can’t thrive without it. We won’t win any gold medals in health-care delivery before implementing the Health Information Technology for Economic and Clinical Health (HITECH) Act.

I agree on the essentialness of information in medical practice and decision-making. But that brings us back to the crucial issue of its nature – how people, doctors, scientists, news reporters or anyone, literate or otherwise, can tell if something’s true or untrue.

Last year in journalism school at Columbia University I took a course called “Evidence and Inference.” We went as far back as Plato’s cave, and as far forward as the New York Times’ 2002 reporting on possible evidence for weapons of mass destruction in Iraq. The point of the exercise, in sum, was that it’s sometimes hard, even for inquisitive journalists, scholars and scientists, to tell fact from fiction.

(Rest assured, I didn’t need a graduate course at Columbia to learn that much, although I did enjoy going back to school.)

Last week’s cover story in the Economist, on “Spin, Science and Climate Change,” drew my attention to some parallels between the Climategate controversy and distrust regarding other areas of scientific and medical knowledge. In a briefing within, the author or authors write:

…In any complex scientific picture of the world there will be gaps, misperceptions and mistakes. Whether your impression is dominated by the whole or the holes will depend on your attitude to the project at hand. You might say that some see a jigsaw where others see a house of cards. Jigsaw types have in mind an overall picture and are open to bits being taken out, moved around or abandoned should they not fit. Those who see houses of cards think that if any piece is removed, the whole lot falls down. When it comes to climate, academic scientists are jigsaw types, dissenters from their view house-of-cards-ists.

The authors go on to consider some ramifications of a consensus effect. (There’s an interesting discussion on this, which relates to a herding effect, in a recent post by Respectful Insolence).  Meanwhile, house-of-card-ists, dubbed doubters, emphasize errors from confirmational bias, or the tendency of some people to select evidence that agrees with their outlook.

There’s far more to consider on this subject – how we perceive and represent information – than I might possibly include in today’s post. So let’s just call this the start of a long conversation.

Getting back to medical lessons – the problem is that most of us can’t possibly know what’s really right. (Yes, I mean doctors too.) Few know enough of the relevant and current facts, or even the necessary terms, to make decisions about, say, which therapy is best for Ewing’s sarcoma in a four-year-old child or whether a new drug for Parkinson’s is worth a try in your dad’s case. Even for those of us who know something about statistics, it’s tricky.

Ultimately, I think it comes down to a matter of trust in the people who provide us information. It’s about knowing your source, whether that’s Deep Throat, a person reporting from the street in Moscow early this morning, or your personal physician.

Well, it’s a holiday for me over the next few days. I’ll read some history first, and then some fiction.

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Another Erroneous Report on Breast Cancer Screening by Mammography

This week delivered another piece on the non-value of breast cancer screening by mammography. The report, published in the British Medical Journal (BMJ), would be minor except that it may add to the growing heap of erroneous data on the topic.

Disclosure: I’m a board-certified oncologist, I’ve had breast cancer and this issue matters to me more than it otherwise might. I’m biased, yes for sure. It’s also true that my position is particularly informed.

The new study is limited and confusing. My initial take was that it wasn’t post-worthy. But since it’s out there, mentioned and even deemed important by some friends and colleagues, I thought I should explain why I think it’s wrong:

What the authors tried to do was analyze trends in breast cancer mortality in relation to mammography’s availability in distinct regions of Denmark over several decades. Using Poisson regression, a form of statistical analysis, they looked for a correlation and found none. They concluded that they couldn’t detect a benefit of screening mammograms among Danish women who might benefit (see below).

Map of Denmark, CIA World Factbook (Wikimedia Commons)

Here’s what I think are the two most serious flaws in this observational study:

1. The investigators divided Denmark into two groups for analysis: one defined as the “screened area” comprises Copenhagen, where mammography’s been available since 1991, and Funen County, where it’s been available since 1993; and the “non-screened” area representing approximately 80% of the population – “the rest of the country.”

The problem is that Copenhagen is Denmark’s capital and Funen, the other main “screened” region, contains Odense, the country’s third largest city. It’s not reasonable to compare changes in breast cancer survival, with or without screening, between women living in mainly urban and mainly rural areas, as these regions can differ at baseline in education, diet, alcohol use, cigarette use, pollution levels and other potentially confounding variables. Also, the quality of medical care in itself can vary between urban and rural districts. Differences in availability of primary care, surgical and other supportive services can influence survival trends independently of breast cancer screening.

2. For purposes of their study, the authors split the Danish women into three age brackets: aged 35-54, “women who were too young to benefit from screening”; aged 55- 74, “women who could benefit from screening”; and 75 – 84, “older age groups.” This assumption, that women under the age of 55 can’t benefit from mammography, introduces circular reasoning into the study, right from the start.

—-

I’m not sure why the BMJ published this paper. I’m concerned, really, that it’s agenda-driven work. The authors state, up front, that their findings contradict those of 2005 report drawn from a distinct but overlapping data set, that mammography was associated with a 25% reduction in breast cancer deaths in Denmark.

What’s curious is that the researchers do in the end identify a possible small cancer mortality reduction among the younger women. In their words:

…We also note that in the age group too young to have benefited from screening, women experienced proportionately larger reductions in breast cancer mortality after screening was introduced than did those that could have benefited from screening.

This non-logic reflects the investigators’ erroneous presumption that there cannot be an advantage in women aged 35 – 55.

You can go ahead and examine this paper directly if you like. A true advantage of the BMJ is its open-access; it provides full text freely upon registration.

My take-home message: this flawed publication should not be used to support the contention that breast cancer screening by mammography is ineffective. Nor does it elucidate much about what’s happening with mammograms and breast cancer survival trends in Denmark.

What it does reveal, if anything, is how different researchers using similar but non-identical data sets can come up with conflicting results if they want to.

Finally, I’ll remind my readers that the mortality rate among women with breast cancer has declined dramatically in the U.S. since 1990 and in Copenhagen, when mammography became prevalent in those places. The studies published in November, 2009 in the Annals of Internal Medicine, on which the new U.S. Preventive Services Task Force recommendations were based, are limited by reasons I’ve outlined here and elsewhere.

Addendum (3/28/08) : typo correction, some links and map added on March 28 by ES.

Regret: I wish I could find a better public domain map source.

Request: if any readers happen to know something about Danish epidemiology, and how Copenhagen and Funen counties do or don’t differ from the rest of Denmark, please chime in!

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A Small Study Offers Insight On Breast Cancer Patients’ Capacity and Eagerness to Participate in Medical Decisions

Last week the journal Cancer published a small but noteworthy report on women’s experiences with a relatively new breast cancer decision tool called Oncotype DX. This lab-based technology, which has not received FDA approval, takes a piece of a woman’s tumor and, by measuring expression of 21 genes within, estimates the likelihood, or risk, that her tumor will recur.

As things stand, women who receive a breast cancer diagnosis face difficult decisions regarding the extent of surgery they should undergo (see the New York Timesarticle of last week, with over 200 people weighing in on this ultra-sensitive matter). Once the surgeon has removed the tumor, choices about chemotherapy, hormone modifiers, radiation and other possible treatments challenge even the most informed patients among us.

Oncotype DX and similar techniques, like the FDA-approved Mammaprint, provide a more detailed molecular profile of a malignancy than what’s provided by conventional pathology labs. For women who have early-stage (non-metastatic), estrogen-receptor positive (ER+) breast cancer, this test provides risk-assessment that’s personalized, based on gene expression in the individual’s tumor.

Oncotype DX has been commercially available since 2004. The test “reads” three levels of risk for breast cancer recurrence at 10 years: “low” if the predicted recurrence rate is 11% or less, “intermediate” if the estimated rate falls between 12% and 21%, and high if the risk for recurrence is greater than 21%.

The investigators, based at the University of North Carolina, Chapel Hill, identified women eligible for the study who had an ER+, Stage I or II breast cancer removed and tested with the Oncotype Dx tool between 2004 and 2009. The researchers sent surveys to 104 women, of whom 78 completed the questionnaires and 77 could be evaluated for the study. They distributed the surveys between December, 2008 and May, 2009.

Several factors limit the study results including the small number of participants and  that the women were treated at just one medical center (where the oncologists were, presumably, familiar with Oncotype Dx). The patients were predominantly Caucasian, the majority had a college degree and most were financially secure (over 60% had a household income of greater than $60,000). Nonetheless, the report is interesting and, if confirmed by additional and larger studies involving other complex test results  in cancer treatment decisions, has potentially broad implications for communication between cancer patients and their oncologists.

Some highlights of the findings:

1. The overwhelming majority of women (97% of the survey respondents) recalled receiving information about the Oncotype Dx test from their oncologists. Two-thirds (67%) of those women reported they “understood a large amount or all” of what the doctors told them about their recurrence risk based on the test results.

2. Nearly all of the respondents (96%) said they would undergo the test if they had to decide again, and 95% would recommend the test to other women in the same situation.

3. Over three-quarters, 76% “found the test useful” because it determined whether there was a high chance their cancer would come back.

4. The majority of respondents (71%) accurately recalled their recurrence risk, indicating a number within 4% of that indicated by their personal test results.

Taken together, these findings support that a majority of women with breast cancer whose oncologists shared with them these genomic testing results, and who filled out the surveys, had good or excellent recall of the Oncotype Dx reports and felt that the test was helpful.

As an aside, the women were asked to rate their preferences regarding their personal input in medical decisions. Among the 77 respondents, 38% indicated they prefer to have an active role in medical decisions (meaning that they prefer to make their own decisions regardless of the doctor’s opinion or after “seriously considering” the doctor’s opinion) and 49% indicated they like a shared role, together with their doctors, in medical decisions. Only 13% of the women said they “prefer to leave the decision to <the> doctor.”

What’s striking is that among these women with early-stage breast cancer, 85% said they like to be involved in medical decisions. And 96% said they’d undergo the test again. Most of the women, despite imperfect if not frankly limited numeracy and literacy (as detailed in the publication) felt they understood the gist of what their doctors had told them, and indeed correctly answered questions about the likelihood of their tumor’s recurrence.

The results are encouraging, overall, about women’s eagerness to participate in medical decisions, and their capacity to benefit from information derived from complex, molecular tests.

*The capacity of Oncotype Dx to accurately assess the risk of breast cancer recurrence has been evaluated in previous, published studies including a 2004 publication in The New England Journal of Medicine and a 2006 paper in the Journal of Clinical Oncology. The test is manufactured, run and marketed by Genomic Health, based in Redwood City, California.

The National Cancer Institute lists an ongoing trial for women with hormone receptor-positive, node-positive breast cancer that includes evaluation with the Oncotype Dx tool.

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