Stunning Comments on the Risk of Breast Implants, and Cancer

The FDA recently identified a link between breast implants and a rare form of lymphoma. From today’s report in the New York Times:

When talking to patients about a rare type of cancer linked to breast implants, plastic surgeons should call it “a condition” and avoid using the words cancer, tumor, disease or malignancy, the president of the American Society of Plastic Surgeons advised members during an online seminar on Feb. 3.

This is how doctors spoke to patients 50 and 100 years ago, and in some cultures still do, by not mentioning scary words – especially to women, and not calling a cancer what it is.

Cosmetic verbage?

Most cancers aren’t lethal* is one message for 2011: the “big  C” turns out to be a spectrum of hundreds of diseases, each with distinct subtypes, and patients shouldn’t panic when they hear the word. Some are benign in behavior although technically malignant; others behave live chronic illnesses; some, unfortunately, grow fast and can kill.

Oncologists can have a hard time persuading patients that a slow-growing tumor doesn’t need much treatment. It would help if other doctors don’t shy away from the term – keeping it taboo and, ultimately, promoting fear.

shhhhh

*NCI – cancer incidence and mortality summary data, accessed 2/18/11

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Quote of the Day, on Health and Discrimination in Hiring

From an article in today’s New York Times on hiring discrimination against people who smoke:

“There is nothing unique about smoking,” said Lewis Maltby, president of the Workrights Institute, who has lobbied vigorously against the practice. “The number of things that we all do privately that have negative impact on our health is endless. If it’s not smoking, it’s beer. If it’s not beer, it’s cheeseburgers. And what about your sex life?”

I think he’s right, more or less, in a slippery-slope sort of way, seriously –

Lots to think about this weekend!

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Sad Stats for Science Knowledge in U.S. Schools

Today’s Times reports on our nation’s students’ poor science test results. The results are bleak: only 34% of fourth graders scored at a “proficient” level or higher; just 30% of eight graders scored at a proficient level or higher; 21% of twelfth graders scored at a proficient or higher level in science.

The mega-analysis, prepared by the National Center for Education Statistics, derives from 2009 testing of 156,500 fourth-graders and 151,100 eighth-graders, with state-by-state and nationwide metrics of those, and of 11,100 twelfth-graders. Student scores were ranked at one of three science knowledge levels for each peer group: advanced, proficient and basic, as defined by the Department of Education. Only a tiny fraction – as few as 1 or 2% of students – attained “advanced” scores on the science exams.

The complete report card analyzes the data by race, sex, urban vs. rural districts, private vs. public schools and other factors, and includes interactive state maps.

These numbers don’t bode well for our future-docs, or for empowered patients. With 70-80% of high school seniors lacking proficiency in science, informed consent and meaningful participation in health decisions are just theoretical concepts for most U.S. citizens.

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On a Velázquez Portrait, and the Value of Expertise

This is an unusual entry into a discussion on the limits of patient empowerment.

In late December the Times ran a story, beginning on its front page, about a portrait in the Metropolitan Museum of Art by Diego Velázquez, the 17th Century Spanish painter. The news was that the tall representation of the teenage Prince Philip IV would be back on display in the European paintings galleries after a 16-month cleaning, restoration and re-evaluation of the work. And, in case you weren’t up on your art history news – the painting really is a Velázquez.

label (ikonic's Flickr)

I learned this morning that the museum received the painting in 1913. It was a gift of Benjamin Altman (that would be B. Altman, as in the department store of my childhood…). The 7-foot portrait was considered a true masterpiece for hundreds of years, its authenticity supported by a receipt signed by Velázquez and dated Dec. 4, 1624. According to the Times now, in 1973 experts at the museum formally revised their opinion of the painting; they down-rated it, saying it’s a product of Velázquez’s studio, rather than of the artist himself.

Velazquez' Portrait of Philip IV, at the Metropolitan Museum

Evidently Michael Gallagher, the chief paintings conservator at the Met, recently became concerned about the painting’s “workshop” label based on his experience upon cleaning another, later Velázquez portrait at the Frick. “Its true condition was obfuscated by the decades of varnish and the liberal repainting,” he said of the Met portrait. According to the Times, Philip’s left eye was missing, possibly from flaking or vandalism. Ultimately, x-ray analyses and careful examination of the cleaned portrait convinced Gallagher and his colleagues of the portrait’s legitimacy.

I was in the neighborhood, so I thought I’d check out the work for myself, in light of this new information. I spent a while staring at it, studying the prince’s hand and other features about which I’d recently updated my knowledge. Still, I realized, there was no way in the world I could tell, on my own and even if my life depended on it, if it were a Velázquez, or not a Velázquez.

Sometimes you have to rely on experts. I don’t have a Ph.D. in art history. Or anything approaching sufficient knowledge of Velázquez and his workshop, Prince Philip IV of Spain, x-ray analyses of oil paintings, varnish and resins, 17th Century receipts and signatures, or similar “cases” – like the related portrait that turns out to be in the Prado, and other works by the same painter – to know the difference.

That’s the thing – in medicine, if you have an unusual health condition, like a rare form of T cell lymphoma or an obscure infection, you may find that you depend on a doctor’s expertise. Recommending the right treatment (which might be no treatment) requires knowing and understanding the correct diagnosis. Figuring out what’s the correct diagnosis requires a lot of knowledge, and experience.

detail of hand, in Velazquez' painting

As for patient empowerment, I think what patients with rare or puzzling conditions can do is to make sure they’re comfortable with their physicians, that their doctors know what about what they’re treating and will admit when they’re unsure of a diagnosis or need more expert, specialist advice. The problem, then, is for doctors to admit what they don’t know, which in the end requires that they be well-educated and able to discern unusual cases and outliers, and take the time to notice – and not dismiss – details about their patients’ stories that warrant further examination and thought.

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A Reversal on End-of-Life Planning

The Obama administration will cut a new Medicare provision to compensate providers for discussing end-of-life care, according to the New York Times. This is an unfortunate reversal.

Too-often, doctors fail to have these discussions with their patients. This happens for many reasons including some physicians’ discomfort with the topic, their not wanting to diminish patients’ confidence in their healing powers, conflicts of interest (infusing chemotherapy is profitable; prescribing palliative home care is barely so, if at all) or simply being too busy to get around to the subject before a patient becomes critically ill and approaches death in an ICU setting. Most physicians need incentives to discuss palliative care options and end-of-life planning with patients in a thoughtful, not-rushed way.

The Medicare provision, which would have provided a small amount of compensation for doctors to spend time communicating with their patients about their preferences – whether they’d want to be kept alive on a ventilator with metastatic, refractory cancer, for example, or whether they’d want to be kept alive in a comatose state with a feeding tube for weeks or months or even years after suffering brain damage from low oxygen, might have helped some people get the kind of end-of-life care they’d choose, instead of what their doctors might give unthinkingly.

Again, I recommend that patients should be pro-active about their wishes. If your doctor doesn’t mention the topic, tell her what you want and document your wishes. Here’s a partial list of sites that provide related information on this subject:

Med­line­Plus on Advanced Direc­tives;

New York State: infor­ma­tion on Health Care Proxy forms and DNR orders

Medicare on Preparing for Your Future Health Care Needs

Fam­ily Care­giver Alliance on End-of-Life Choices

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Informed Consent on Paper, but Not in Reality

Over the long weekend I caught up on some reading. One article* stands out. It’s on informed consent, and the stunning disconnect between physicians’ and patients’ understanding of a procedure’s value.

The study, published in the Sept 7 Annals of Internal Medicine, used survey methods to evaluate 153 cardiology patients’ understanding of the potential benefit of percutaneous coronary intervention (PCI, or angioplasty). The investigators, at Baystate Medical Center in Massachusetts, compared patients’ responses to those of cardiologists who obtained consent and who performed the procedure. As outlined in the article’s introduction, PCI reduces heart attacks in patients with acute coronary syndrome – a more unstable situation than is chronic stable angina, in which case PCI relieves pain and improves quality of life but has no benefit in terms of recurrent myocardial infarction (MI) or survival.

The main result was that, after discussing the procedure with a cardiologist and signing the form, 88% of the patients, who almost all had chronic stable angina, believed that PCI would reduce their personal risk for having a heart attack. Only 17% of the cardiologists, who completed surveys about these particular patients and the potential benefit of PCI for patients facing similar scenarios, indicated that PCI would reduce the likelihood of MI.

This striking difference in patients’ and doctors’ perceptions is all the more significant because 96% of the patients “felt that they knew why they might undergo PCI, and more than half stated that they were actively involved in the decision-making.”

What we have, here, is a study of informed consent, set up in a way that the doctors knew the study was ongoing – because they and their patients were participating, all in one division of one hospital – and, presumably, spent if anything more time and not less than usual talking with patients and answering questions about the procedure. (Note: this particular point is an assumption on my part, supported by the reported fact that 83% of the patients reported that their questions had been answered.)

The central finding is a failure of communication between doctors and patients about the potential benefit of the procedure: 88% of the patients, who’d signed consent, thought that PCI would prevent heart attacks and only 17% of the cardiologists at the same medical center thought the same. This matters, first, because over a million people in the U.S. undergo angioplasty each year and, more broadly, because it represents an everyday outgrowth of the  phenomenon of therapeutic misconception – when patients think a procedure has a greater potential benefit than it does.

The concept of therapeutic misconception, as was initially defined narrowly in the context of clinical trials, applies to all areas of medicine. In cancer treatment it’s a big deal but, in my experience, under-addressed. A common misconception among breast cancer patients, for example, concerns the benefit of adjuvant chemotherapy, which generally reduces the odds of recurrence by about a third. So if you have a stage II tumor with good molecular features and the odds of recurrence are somewhere around 15%, that comes down to around 10% with the treatment, which does bear significant side effects and risks. Another fairly common misunderstanding in oncology is in the area of Phase I clinical trials, in which the drugs are tested for toxic effects in humans, and to see how much people can withstand, and not for therapeutic effect.

This topic is worthy of lots more discussion than I can afford here. I do recommend reading the full article, including the methods about how the survey was done, and the editorial* in the Annals, which accompanied the paper, which like so many other provocative and significant reports in the medical literature, didn’t get much attention in the lay press.

One point the editorial considers is that, perhaps, the PCI consent form used by the study authors and said to be at a 12th grade reading level, should instead be provided at an 8th grade level, as some institutions recommend and require. I’m not so sure about this, because I think a lot of medical ideas and decisions simply cannot be communicated at a lower level without loss of content, i.e. nuanced information.

I’m eager for readers’ views on this – how often is it that doctors effectively convey why a procedure should be done or a treatment be given, and what might be done to improve the process?

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*subscription required

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The Author Chooses Not to Go to the Emergency Room

Yesterday the author of ML wasn’t feeling too well. She had (and has) what’s probably a recurrent bout of diverticulitis, a condition when a little pouch stemming from the colon becomes inflamed and causes pain and fever. This can be serious if infection of the colon’s wall progresses, or catastrophic if the colon ruptures.

So I’m thankful, today, among other things that I’m feeling better with antibiotics, extra fluids by mouth and a good dose of rest. I’m glad, also, that I avoided the hospital for evaluation and treatment, as were de rigueur for this ailment 20 years ago. I’m lucky that, so far, I’m doing OK. And I’m reminded that illness is not a metaphor for anything.

Really it’s a crapshoot – hard to know sometimes when it’s worth going to the ER or staying home and enjoying Thanksgiving with your family, as I did.

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Engage with Grace: Talking About the Hard Stuff

When I practiced oncology, I relished time spent talking with patients and their loved ones about tough decisions – when an indolent condition accelerated and it seemed time to start treatment, or when a cancer stopped responding to therapy and it seemed right to shift gears and, perhaps, emphasize palliation instead of more chemo, and at every value-loaded decision checkpoint in between.

These conversations weren’t easy; speaking of levels of care, palliation and end-of-life wishes are discussions that many doctors, even oncologists, still avoid. But I, in what I hope was a healthy way, always enjoyed that part of my work. My thinking was that even if I couldn’t change the course of an aggressive tumor, I might make a difference in the quality of a person’s end of life.

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At Thanksgiving, when family and old friends come together, we face similar choices in the topics we discuss: we can chat about the weather, or delve into relatively heated topics like global warming, politics or religion, but it’s rare that we get into the existential stuff, where my thoughts tend to wander, or into the most-avoided topics of all: what to do when our loved ones get really sick.

This weekend, Medical Lessons is participating in its first blog rally. I learned about this last year from Paul Levy, who’s Running a Hospital in Boston, and was reminded earlier today in an email from Dr. Christian Sinclair of Pallimed. The purpose of the rally is to draw attention to the Engage With Grace project, which is, ultimately, about communication in non-trivial health decisions.

From the Engage With Grace website:

  • 73% of Americans would prefer to die at home, but anywhere between 20-50% of Americans die in hospital settings.
  • More than 80% of Californians say their loved ones “know exactly” or have a “good idea” of what their wishes would be if they were in a persistent coma, but only 50% say they’ve talked to them about their preferences.
  • Eight out of ten people say it is “very” or “somewhat” important to write down EOL wishes, but only 36% actually have written instructions.

The project goal is to get the conversation started – to get families talking about values and medical decisions when they’re together over the Thanksgiving holiday, instead of waiting until there’s an emergency and they’re forced to make critical decisions under pressure and without clear directive.

I don’t mean to suggest that this is an ideal or even a good subject for conversation at the Thanksgiving table, or in a house filled with neighbors or casual acquaintances. (I don’t think it is.) But maybe when you’re washing dishes in the kitchen with your brother, or driving your mom to the airport, or sitting on the bus with your son…

There’s never a good time, or enough time, to talk about these kinds of things. But these matter a lot, especially if you or someone you love becomes really sick, which happens sooner or later to most mortals. PBS aired a special on this topic last night, on the kinds of tough decisions families face when someone is acutely ill, which is available on-line and I suggest to my readers.

For tomorrow, my recommendation is to enjoy the holiday, as I intend to do!, and to eat lots of fresh fruits and vegetables, and to connect with the people you care about and don’t see as often as you’d like or wish you could –

And maybe on Friday, or Saturday, some of you will begin that difficult conversation.

Happy Thanksgiving!

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Does Cathy Make the Right Cancer Treatment Decision in the Big C?

scene from season finale, The Big C

“I don’t want to get sicker trying to get better and then just end up dying anyway” – Cathy, the 42 year old protagonist with advanced melanoma, on the Big C.

ML’s incoming search data suggest that some people out there are very determined to know exactly what happens to Cathy in Showtime’s new series about a young-seeming, middle-aged woman with advanced, presumably stage IV, melanoma. In last week’s review I elected not to give it away. Now I’ve reconsidered. So here’s a spoiler alert: Don’t read this post if you don’t want to know what happens to Cathy at the end of the Big C‘s first season.

After months of unusual and comfort zone-breaking behavior, Cathy reconsiders her initial decision to forgo treatment. She, possibly influenced and clearly supported by her husband’s enthusiasm for her middle-aged life and continued existence, indicates that she’s willing and ready to try treatment with Interleukin-2. Cathy seems to know something about the FDA-approved drug, which is generally toxic and ineffective in most melanoma cases. At one point, she lists its putative side effects, according to the show: “burning scabs all over my body, constantly throwing up, fluid on the lungs, my veins could shut down, I could die on the table…”

Nonetheless she decides to accept treatment:

“I’m gonna hang on as long as I can. And I’m going out ugly,” says Cathy, played by the actress, Laura Linney.

“It will never be hard for me to look at you,” responds her supportive husband Paul, portrayed by the actor Oliver Platt.

At this point Cathy’s hoping the Interleukin-2 (“interlaken,” as her husband keeps calling it, perhaps metaphorically, subconsciously, or else just simply) will keep her alive for six months, when she might or might not be eligible for an experimental anti-melanoma drug in a clinical trial.

So she goes for it: in the final scene she’s in the hospital, her mind cloudy, and dreaming. You may wonder what I think of her decision.

As an oncologist I’m half-relieved. The patient will, undoubtedly, die too soon – within months or a year or, if she’s lucky, maybe two years or even longer – because you never really know for sure about these things, if she doesn’t take any treatment. Deaths from metastatic cancer can be unpleasant and painful. On the other hand, conventional therapy for stage IV melanoma rarely leads to complete remissions and, essentially, never cures the disease.

I admired that the patient, until this last episode, maintained such a no-nonsense approach to her condition. Her perspective seemed more mature than her oncologist’s. Despite her weird and nearly unraveling behavior, she’s clearer in her priorities than many patients I’ve known; she seems to understand that a treatment might give her a few additional months but is very unlikely to help her get well and, likely, would make her sick for the duration of her life.

Sometimes oncologists get carried away with hope. What I liked best about the story is that she, the patient, was realistic in this. She didn’t want to take toxic medications in desperation, without reason.

As a patient, my feelings are mixed, too. I respected Cathy lack of passivity in her decision. Accepting treatment initially would have been the easier, “normal” thing in our culture. In effect, so far, Cathy’s taken control of what happens to her body. At the same time, I couldn’t help wonder – what if she tried it? Maybe there is a cure in the pipeline, and she’d be eligible for an experimental agent in a few months, and that drug would help her, and she’d live beyond middle age, or at least until she’s 45 or 46.

Today is Monday, but there’s no new Big C episode because the season’s over. We won’t know how Cathy fares with the Interleukin-2 for a while. Even though she is just a cable TV character, she’s in a position to teach us about oncology and living with cancer.

Hopefully the show’s producers will provide insights into immune treatments, targeted agents, clinical trials, informed consent and palliative care. (I will consider Interleukin 2 and melanoma in a separate post, to follow.) But given the TV scenario, do you think Cathy’s made a sound decision?

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On Patient Empowerment and Autonomy

Yesterday a Tweet crossed my screen that got me thinking. The source of was Gilles Frydman, founder of ACOR (Association of Cancer Online Resources) and a pioneer in the e-patient community:

@gfry: Participatory Medicine evangelists say “Engaged, empowered patients are better, healthier patients.” Where is the evidence?

What makes this question so ripe, in my oncologist-patient-teacher-blogger’s way of thinking, is that we may never, even if formal studies do provide data on this issue 10 years ahead, reach an objective conclusion on this matter.

The problem is this: To prove that empowered patients are “better and healthier,” how would we design a trial? If we were to compare those engaged – who almost by definition are more educated or at least have Internet access, or who are one way or another are linked to people who can help them find needed information – they’d likely do better than the disconnected patients. But the outcome might be a function of confounding variables: their education, economic status, on-line connectivity, etc.

I think the answer is inherent in the goal of being engaged, and this has to do with the concept of patient autonomy – what’s essentially the capacity of a person to live and make decisions according to one’s own set of knowledge, goals and values.

Autonomy in medicine, which borders on the empowerment idea, can be an aim in itself, and therefore valuable regardless of any measured outcome. For autonomy, or patient empowerment, to be meaningful and maybe even “better” in the strictly medical sense, as measured by outcomes like survival or quality of life, there needs be stronger public education in the U.S. and everywhere.

You can read all you want on stem cells, gene therapy or rare forms of chronic leukemia that are driven by a turned-on oncogene, but if you don’t know the basics of science and math, or don’t have sufficient language skills to read and absorb new knowledge or at least ask pertinent questions, it’s easy to get lost in that information, overwhelmed or – worse – suckered by those who’d try to persuade you of something that’s not true, cloaked in pseudoscience, that’s abundant and available on-line and, occasionally, in some doctors’ offices.

This is why public education matters, so much.

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Another Take On An Ordinary Day

A few weeks ago, on August 1, I threw out the concept of living life every day as if it’s Shark Week. The line, delivered by 30 Rock‘s Tracy Morgan in that show’s first season, has stuck with and puzzled me for years.

Then I came upon a striking post called Live Each Day Like There’s a Lot of Them Left, dated August 2. Jen Singer, a blogger with two sons and a history of lymphoma, expresses the considered notion that maybe the best thing to do after cancer is to live, essentially, as you would do otherwise, except with a bit of added balance.

She writes:

… I — the one who has been so close to the end of life – am supposed to tell you to treat each day as though it’s your last. Except, if it were my last, I certainly wouldn’t be tanking up my mini-van for the rest of the week’s carpools…

Rather, I suggest that you treat every day as though you’ve got a whole lot of them left, precisely because you don’t really know if you do. Go about the everyday, do the drop-offs, get out the knots. Clean the house. Go ahead and get through the stuff that fills your To-Do list…Slog, if you must, because that’s perfectly okay…

Still, every now and then, don’t forget to turn up the radio and listen…

Her point, I think, is that we all have to move on with our lives if we can. It’s the nitty-gritty, mundane activities that keep families on track may also keep us sane, safe and sound. Cancer can be liberating, but that doesn’t necessarily mean we should exploit that as license to escape from responsibilities.

The pressure to “treasure each moment” can be counterproductive. To live life as usual is a challenge of another sort, important for the normal development of our kids and ourselves.

I like this perspective.

Like Jen, I take pleasure in the ordinary stuff – cooking, helping my family and yes, checking off items on the list of things I’ve been meaning to do for years. It’s a long list, and I’ve lots to take care of.

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New NY State Law on Information for Women Undergoing Mastectomy

A few days ago, NY State Governor Paterson quietly signed a new public health law* on information and access to breast reconstructive surgery. From the details provided on my state’s Open Legislation website, it seems this took place on August 13.

The purpose of the new law is to assure that all women undergoing mastectomy in NY are told about reconstructive surgery options and that insurance will cover those additional procedures.

What’s curious are two things – first, why so little coverage of this event? It is end-of-summer, I suppose.

But maybe editors and people like me who are educated in medicine and read newspapers are out-of-touch with the fact that many women who have breast cancer – over 200,000 each year in the U.S. – still don’t really know about breast reconstruction during or after cancer treatment. In my community, people read books and ask multiple doctors in second and third opinion before deciding whether to undergo a trans-flap or have implants inserted and then, once electing for implants, attempt a careful review the not-so-current literature on silicone vs. saline…

The reality is that many women, particularly poor women without newspapers or internet access in their homes, don’t know about any of this. They don’t know their insurance covers pretty much all of these options, by law. Now they will, or should as of Jan 1, 2011. Good.

The other curiosity is that a Montefiore Medical Center-affiliated plastic and reconstructive surgeon is said to have authored this bill, which was sponsored by State Senator Ruth Hassell-Thompson. The doctor’s intentions were surely good; he advocated its passage based on the sad case of a single mom who, after undergoing mastectomy and seeing several physicians, still wasn’t aware that she might undergo breast reconstruction. Nonetheless, it’s not surprising that a plastic surgeon in the Bronx cares about this legislation.

There is a dark side to this, unfortunately. Even among the women with good insurance and purportedly top docs, the results of reconstructive breast surgery are sometimes devastating to the women who undergo these procedures. These are no boob-jobs, and there’s widespread misconception about that. So I hope the law, also, might eventually protect women from botched attempts at reconstruction, an under-reported problem that might also be newsworthy.

*addendum – first link above adjusted because the previous url, http://www.cnbc.com/id/38743477 is no longer available, ES 2/14/11

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Living Like It’s Shark Week!

Today is the start of this year’s Shark Week on the Discovery Channel.

shark (adapted image from Wikimedia Commons)

Dialog from NBC’s 30 Rock, Season 1, Episode 4 “Jack the Writer” (2006)*:

Tracy Jordan: But I want you to know something… You and me, it’s not gonna be a one-way street. Cos I don’t believe in one-way streets. Not between people, and not while I’m driving.

Kenneth: Oh, okay.

Tracy Jordan: So here’s some advice I wish I would have got when I was your age… Live every week, like it’s shark week.

(No further explanation is given. In the next scene the comedy writers take a one-minute dance break and then Jack provides an intro to GE’s six sigma program.)

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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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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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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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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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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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