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Skyping Medicine

Yesterday, Dr. Pauline Chen reported in the New York Times on virtual visits, a little-used approach for providing care to patients hundreds or thousands of miles apart from their physicians.

Telemedicine depends on satellite technology and data transfer. It’s a theoretical and possibly real health benefit of the World Wide Web, that giant, not-new-anymore health resource that’s transforming medicine in more ways than we know.  Chen writes:

Telemedicine has the potential to improve quality of care by allowing clinicians in one “control center” to monitor, consult and even care for and perform procedures on patients in multiple locations. A rural primary care practitioner who sees a patient with a rare skin lesion, for example, can get expert consultation from a dermatologist at a center hundreds of miles away. A hospital unable to staff its intensive care unit with a single critical care specialist can have several experts monitoring their patients remotely 24 hours a day.

I’m reminded of three things:

First, my recent visit to my internist’s office on East 72nd Street, a short walk from my home. When I see my doctor she smiles warmly, shakes my hand firmly and examines me from head to toe. She takes my blood pressure with an old-fashioned sphygmomanometer, looks at my eyes and into my throat, applies a stethoscope to my scarred chest as she listens to my heart and lungs, and palpates – “feels” in doctorspeak – my lymph nodes, liver and spleen. All that along with a neurological exam; she sees how I stand, walk and balance my head over my torso.

Second, my husband’s conversation with his mom yesterday evening, via Skype, transmitted between his laptop in our living room and her computer in a Buenos Aires apartment.

Third, some history from the 1950s – on how early computer scientists envisioned the future of medicine. From my master’s thesis at Columbia University’s Graduate School of Journalism, on how the “How the Internet is Changing the Practice of Oncology”:

When Vladimir Kozmich Zworykin addressed the 1956 assembly on “Electrical Techniques in Medicine and Biology,” he marveled at the technological feats of computers, and envisioned how these new instruments might be applied in health care. Zworykin, an inventor of television …was privy to the newest developments in applied science.

…He’d seen closed-circuit “Telecolor Clinics” that transmitted the latest cancer research news to physicians in cities along the eastern Seaboard and Great Lakes Region. A color, television microscope linking monitors in Philadelphia, Washington and Baltimore enabled doctors in one city to identify cancer in another…

We’re back in the future! My take on telemedicine includes three components; each corresponds to one association above.

1. Telemedicine is not the same as real medicine. I like seeing my doctor in real life and am reassured by her true presence in the room.

Besides, a hands-on exam has some tangible benefits. A good doctor, who knows how breathing sounds should sound, confident in her examination skills, might skip an x-ray she’d otherwise order. A competent hematologist, skilled in palpating her patients’ lymph nodes, liver and spleen, could spare us the costs and risks of some CT scans and MRIs.

Of course, the doctor’s hands should be clean… (a topic unto itself)

2. Virtual visits might help. The reality of medicine requires innovation and compromise – making the best of a sometimes difficult situation.

As Pauline Chen points out in her column, there’s a shortage of doctors affecting some, particularly rural, parts of the U.S. Policy experts anticipate the problem won’t go away with current health care reform measures, and some business reports warn the situation will get worse. Telemedicine, while not ideal, might ameliorate this effect and make a positive difference in the health of people living far from major medical centers. The technology could, indeed, connect patients with specialists who would otherwise be out of reach.

3. The future of medicine will embrace some elements of telemedicine. We just need to fine-tune the process.

As I see it, Internet or satellite-directed medical examinations are most promising for image and data-centric fields like radiology and pathology. It’s telling that Pauline Chen’s first example pertains to dermatology (skin diseases). Sure, I think a far-away expert’s view of a skin lesion could be helpful – it might reassure some that a mole or a rash is nothing to worry about, or inform them that indeed, they should hop on a train to Memphis. For patients with benign-appearing lesions, telemedicine could save costs and time in travel and unnecessary appointments, besides biopsies.

But I’m wary of implementing this tool in primary care areas and interventional fields like surgery and obstetrics. The prospect of delivering babies upon real-time instruction by doctors in cities far away is not what I’m hoping for, at least not for my kids’ kids.

I guess we’ll have to wait and see.

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Looking Ahead: 7 Cancer Topics for the Future

Here’s my short list, culled from newsworthy developments that might improve health, reduce costs of care and better patients’ lives between now and 2020, starting this year:

1. “Real” Alternative Medicine. By this I don’t mean infinitely-diluted homeopathic solutions sold in fancy bottles at high prices, but real remedies extracted from nature and sometimes ancient practices.

A good example is curcumin, a curry ingredient from the root of the turmeric plant. We’re just starting to uncover this compound’s anti-cancer effects in humans. Another natural antidote that’s gaining ground is green tea; scientists are sifting through its components to see how it reduces cell growth in some forms of leukemia and other tumors.

2. Chemotherapy Pills. Why get treatment through an intravenous catheter if you can pop some pills instead? To be clear, some of the best and most effective cancer therapies require infusion. And just because a medication can be taken by mouth doesn’t mean the side effects are trivial.

But quite a few targeted therapies, like Gleevec or Tarceva, besides some old-fashioned drugs like Leukeran and new forms of old agents, like Xeloda, work just fine in pill or capsule form. Many patients, especially those with limited life expectancies, would gladly choose an oral combination therapy, the sort of medication cocktail taken by AIDS patients only for cancer, instead.

A gradual shift from intravenous to oral therapies for cancer would transform the practice, and economics, of oncology as it’s practiced in North America.

3. Environmental Hazards. Where we live, what we carry and ingest surely affect our bodies and our cells. We’ve learned about Bisphenol A (BPA), an estrogen-like molecule that leaches from plastic food containers into the foods we eat.

Now, we should expect and demand more information on what’s really in the water, so to speak. And in our sunscreens, and in so many chemicals we use routinely and without hesitation.

4. Health Informatics. The Pew Research Center reports that two thirds of American adults are going on-line for health information.

But that’s only part of the story. Sure, the internet makes it easier for people to learn about medical conditions, but the same applies to physicians. In principle, the internet should help doctors stay current, make sound decisions and provide better care.

Electronic health records (EHRs) will, in the long run, reduce costs from duplicate testing, faxing and re-faxing of reports and, more importantly, lessen errors from illegible or incomplete medical files that are too-often inaccessible. Over the next decade, we’ll see how patients find value in their own records (or don’t), how privacy issues play out, and if electronic documentation of millions of health reports provides, in itself, new information on disease trends and treatment effects.

5. Better Cancer Monitoring. The costs and risks of repeated CT scans are very real.

For a cancer patient undergoing therapy, the current standard involves multiple scans at intervals of months or even weeks, to see how a tumor is responding, or not, to a particular treatment regimen. Once in remission, some people undergo additional periodic studies just to be sure there’s no evidence for the tumor’s recurrence.

The news is that easier, more accurate and less dangerous methods for monitoring tumors are forthcoming. Using microchip-based detectors doctors can, using just a few drops of blood, measure the extent of a colon or lung cancer and examine how tumor cell genetics change during treatment. Over time, this and similar technologies will improve and, with standardization in manufacturing, come down in price.

6. Palliative Care. Not everyone wants to spend the last days of his or her life in an ICU hooked up to a ventilator with tubes and intravenous lines. But few people prepare for the end of life when it happens in a hospital, and doctors don’t generally talk about it in advance.

Palliative care, the kind of medicine aimed at treating symptoms, rather than achieving cure, is underused in the United States. Over the next decade, we should see better education of doctors in this essential field in cancer medicine, and of the public, too.

7. Cancer Vaccines. These work by immunizing a person against a tumor just as one might, instead, inoculate a person with a modified virus or bacterium to stave off infection.

Cancer vaccines would stimulate and harness the body’s normal immune cells to confront and eradicate cancer cells. This year, the FDA will take another look at Provenge, a vaccine that’s designed to treat men with prostate cancer. Similar biological agents are in the works for most other tumor types.

We’ll be hearing more on these innovative drugs that, so far in clinical trials, appear to have few side effects. Whether the vaccines are effective – if they can shrink tumors – we’ll have to wait and see.

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Why Medical Lessons?

One of the things I liked best about practicing medicine is that I was constantly learning.

Making rounds at seven in the morning on an oncology floor would be a chore if you didn’t get to examine and think and figure out what’s happening to a man with leukemia whose platelets are dangerously low, or whose lymphoma is responding to treatment but can’t take anymore medicine because of an intense, burn-like rash. You’d have to look stuff up, sort among clues and discuss the case with the team and other physicians.

And then you’d get to talk to the patients and their families. In the teaching hospital where I worked as a clinical oncologist, you’d encounter a mix of folks from my east side neighborhood, Russian and Chinese and Spanish-speaking immigrants with homes in all parts of New York City, and a spectrum of visitors from countries like Cambodia, Pakistan and Ecuador. Each case offered a window into another family’s values and concerns.

Being a patient is an entirely different sort of experience except that, like being a doctor, it involves learning about medicine, problem-solving and meeting all kinds of individuals.

As a child with scoliosis – a curved spine – I discovered early that some therapies don’t work as you might hope or expect. I wore a back brace for 4 years, 23 hours each day, and it didn’t do the job. Then, my parents took me to consult with most of a dozen male orthopedists. Their crassness, frankness and sometimes kindness impressed me. I realized that like any other humans – whether they’re dictators or shopkeepers – doctors vary in their personalities.

Today I recall one young doctor who helped me, a resident at the Hospital for Joint Diseases. He came by my room early in the evening of December 31, 1974 because I needed a new intravenous (IV) catheter. By then I’d been in the hospital for weeks after spine surgery; there was hardly a vein left for heparin, a blood-thinner. It turned out the resident came from a town on Long Island not far from where I lived. He spoke openly, about his experiences in high school, as he calmly and patiently patted down my arms and hands and legs and feet until he found a spot for the IV. He got the line in, and I got my medication.

Just before midnight, Dick Clark was on TV for a “New Year’s Rockin’ Eve.” The resident, whose name I don’t recall, came by to see how I was doing. He stayed for perhaps 15 minutes, for what seemed like no reason other than to keep me company. We counted the seconds and watched the ball drop on a small black-and-white TV suspended by a hinged-metal arm over my hospital bed.

He was compassionate, and that made me feel better. What a difference he, one essentially unnamable young physician, made in my experience of that New Year’s eve in the hospital, and in my life and work.

Today, December 31, I think of him as I navigate my path as a patient and as a doctor. I’m still learning about medicine, every day in each new year.

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Looking Ahead on Breast Cancer Screening

My plan is to move on after this post – too much is happening in medicine to dwell on the mammography issue longer, or at least for the time being.

So I’ll close on the 2009 screening controversy with a few comments and considerations for the future.

Breast cancer, along with lymphoma and a few other tumors, is one of the few malignancies that oncologists can treat effectively in the majority of cases – well enough that most women with the disease now live for an essentially normal lifespan. About the risks and costs of breast cancer screening, I think they’re exaggerated and misrepresented in the recent news.

My concerns are chiefly three – as outlined elsewhere and previously here:

1. The Task Force analyzed data that are decades old;

2. The updated recommendations don’t apply to digital mammography (a fact rarely mentioned in the press coverage);

3. Radiologists vary in training and skill.

My conclusion is that rather than ditching a life-saving procedure that’s imperfect, we should make sure that all doctors and radiology facilities are up to snuff.
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On the reputed risks of mammography, harms and costs stemming false positive test results –

The risks of mammography should be minimal if the FDA does its job regulating the procedure. Among women in their forties and fifties, the number of false positives in Category I (as outlined in my proposed classification) can be reduced by digital technology supplemented with sonograms, an inexpensive and safe procedure.

Clerical-type errors shouldn’t happen, as in all of healthcare. Put simply, the system needs be scrupulous.

False positives due to misunderstanding of results, as in Category 2, can be resolved by better education and more effective communication.

Regarding the costs of follow-up testing by sonograms, MRIs, and biopsies – the medical risks and financial costs can be minimized through more careful, besides current, evaluation of each method. Just this month, an article in the Annals of Internal Medicine described the value of core needle biopsy (by any of several methods) in evaluating breast lesions. This technology, in widespread use over the ten years, renders open biopsy – a procedure done in an operating room – obsolete; there’s no reason to consider operating room costs in assessing breast biopsies in 2010.

As for the risk of over-treatment, I think doctors and patients have a lot learn and discuss, carefully. My take on the news of the past season is that somehow there’s been a blurring of facts for different cancer types.

For decades, oncologists including me have recommended a “watchful waiting” approach for some elderly men who have prostate cancer. This sort of treatment, while often appropriate for a 75 or 85-year old man with a small prostate tumor, is irrelevant to the decisions facing a 45 year old woman with breast cancer, another disease entirely.

Going back to my definition of a false positive in mammography screening –

We need to distinguish between errors in the measurement (cancer or not) and errors in decisions that we – patients and doctors – make after upon detecting a premalignant or early-stage malignancy in a woman’s breast.

A finding of either DCIS or LCIS upon biopsy does not constitute a false positive result. Rather, it’s good medicine to identify these conditions, especially for a middle-aged woman who anticipates a meaningful half-life ahead. What goes wrong after the diagnosis, such as a rushed or ill-informed decision to treat only subtle pathology, is not a mistake from mammography.

Errors in over-treating small tumors, and all the physical and financial costs associated, should be attributed instead to a lack of knowledge regarding DCIS and LCIS. Our understanding of these conditions – the molecular and cellular pathology, the course over time if left untreated, and the effects of medication, surgery and other therapies – lags far behind what we know about most forms of breast cancer.

What I hope we can learn, through clinical trials over the next decade, is how best to treat low-grade conditions such as DCIS and LCIS. That way, the costs of over-treating those will not, come 2020, cloud what should be straightforward decisions on the diagnosis and treatment of breast cancer in relatively young women.

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Proposed Model for Evaluating False Positives in Screening Mammography

First, a definition* –

False positives happen in screening mammography when the images suggest the presence of a malignancy in a woman who doesn’t have cancer in her breast.

Here’s my proposed model –

Categories of False Positives in Screening Mammograms

False positives can arise during any of three conceptual segments of the testing process:

1. False positives occur during the test itself.

This happens when a radiologist inspects a film or digital image and labels the result as abnormal, but no cancer is present. This sort of problem is interpretive.

A common scenario goes like this – a spot in a mammography image suggests the presence of a possible tumor and the radiologist correctly notes that abnormality; later on, a doctor determines by sonogram, biopsy or another method that there is no malignancy in the breast.

(Other, uncommon problems in this category would include faulty equipment that reduce image quality, mislabeling or accidental switching of films; in principle, these kinds of errors should be non-events.)

2. False positives stem from miscommunication or misunderstanding of test results.

If a clerk accidentally phones the wrong patient and tells her she needs another procedure because the results of her mammogram are abnormal, that call might instigate an untoward, false positive result. If the error is corrected early on, so that affected woman worries only for a period of hours and has difficulty sleeping for one night, she might experience some psychological and/or small financial cost from the matter. But if the mistake isn’t caught until after she’s had a sonogram or MRI, and consulted with a surgeon or another physician, the costs grow.

False positives also arise if a patient misunderstands a test result. An essentially normal mammography report, for example, might mention the appearance of benign calcifications. Upon reading that result, a woman or her husband might become upset, somehow thinking that “benign” means “malignant.” This type of false positive error, based in poor communication and lack of knowledge, can indeed generate extra doctors’ visits, additional imaging tests and, rarely, biopsies to relieve misguided fears.

3. False positives derive from errors or misinterpretation of results upon follow-up testing.

This category of false positives in screening mammography is by far the biggest, hardest to define and most difficult to assess. It includes a range of errors and confusion that can arise after breast sonograms, MRIs and breast biopsies.

3a. false positives in subsequent breast imaging studies such as sonograms and MRIs:

Many women in their forties and early fifties are premenopausal; their estrogen-stimulated breasts tend to be denser than those of older women. Reading their mammograms may be less accurate than for postmenopausal women. For this reason, a doctor may recommend a sonogram or MRI to further evaluate or supplement the mammography images.

These two radiology procedures – sonograms and MRIs – differ and, for the most part, are beyond the scope of this discussion except that they, too, can generate false positive results. A sonogram, for instance, may reveal a worrisome lump that warrants biopsy. MRIs are more expensive and sensitive; these tend to pick up subtle breast irregularities including a relatively high proportion of benign breast lesions.

3b. false positives in breast biopsy:

A breast biopsy is an invasive procedure by which a piece of the gland is removed for examination under the microscope. Sometimes pathologists use newer instruments to evaluate the genetic, protein and other molecular features of cells in the biopsy specimen. Years ago, surgeons did the majority of breast biopsies. Now, skilled radiologists routinely do a smaller procedure, a core needle biopsy, using a local anesthetic and a small albeit sharp instrument that’s inserted through the skin into the breast. Some doctors do a simpler procedure, fine-needle aspiration, by which they remove cells or fluid from the breast using a small needle attached to a syringe.

In principle, a false positive biopsy result would occur only when a pathologist, a physician trained to examine tumors at the cellular and molecular levels, misreads a case, meaning that he or she reports that the cells appear cancerous when they’re not. Fortunately, this is not a frequent issue in breast cancer diagnosis and management.

The real issue about false positives – and what may be the heart of the issue in mammography screening – has to do with how pathologists describe and define some premalignant conditions and low-grade breast tumors. This concern extends well beyond the scope of this tentative outline, but a few key terms should facilitate future discussion:

Lobular Carcinoma in Situ (LCIS) is not considered a malignancy by most oncologists, but rather an abnormality of breast glands that can develop into breast cancer.

Ductal Carcinoma in Situ (DCIS) is a Stage 0 breast tumor – a tiny cancer of breast cells that have not penetrated through the cells lining the ducts of the breast gland.

Indolent or “slow” tumors – The idea is that some breast cancers grow so slowly there’s no need to find or treat these.**

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*This definition warrants some discussion, to follow in a separate post.

**As a physician and trained oncologist, I am uncomfortable with the published notion of some breast tumors being “so slow” that they needn’t be found or evaluated. I include these tumors only for the sake of completeness regarding theoretical types of false positive results upon screening mammography, as there’s been considerable discussion of these indolent tumors in recent news.

Slow-growing breast tumors are quite rare in young women. In my view, their consideration has no bearing on the screening controversy at it pertains to women in their forties and fifties.

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As outlined above, the first two categories of false positives seem relatively minor, in that they should be amenable to improvements in quality of mammography facilities and technology; the third category is huge and where lies the money, so to speak.

Clearly there’s more work ahead –

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A Bit More on False Positives, Dec 2009, Part 1

The question of false positives in breast cancer screening – why and how these happen, how often these occur, and how much these cost, in physical, psychological and financial terms – remains a puzzle.

A few weeks ago the New York Times Magazine featured a piece on “Mammogram Math” under the heading “The Way We Live Now.” The author, a mathematics professor, argues that the risks and costs of mammography, though incalculable, outweigh the benefits. The paper printed the article along with a subtitle, “Why evidence-based medicine is actually right and scary” and later published three letters including one truncated response by me.

After a hiatus, I’ve rescanned the literature – just to be sure the question hasn’t been resolved in the past few weeks by a much-needed interdisciplinary team of health care policy experts, economists,  statisticians, surgeons, radiologists, oncologists, nurses and for good measure, perhaps a few breast cancer patients and survivors.

There’s little published progress to report, aside from more hype and theoretical numbers such as I offered in a November essay. So I’ve decided to take the analysis a step further by outlining a tentative framework for thinking about false positives in breast cancer screening.

In a separate post, I will outline a proposed outline for categorizing false positives as they relate to mammography. Why bother, you might ask – wouldn’t it be easier to drop the subject?

Make it go away,” sang Sheryl Crow on her radiation sessions.

Instead, I’ll answer as might a physician and board-certified oncologist who happens to be a BC survivor in her 40s:

To determine the damage done to women by screening mammography (as some claim and refer as evidence) we need establish how often false positives lead, in current practice, to additional procedures such as sonograms (fairly often, but the costs are relatively small), MRIs (less standard and more expensive), breast biopsies (scarier, slightly risky and more valued – how else can a pathologist determine if a woman with a breast lesion has cancer and, in the future, what type of therapy is best) or frankly inappropriate treatments such as chemotherapy for a non-cancerous condition (very damaging and the most costly of all putative false positive outcomes).

These numbers matter. They’re essential to the claim that the risks of breast cancer screening outweigh the benefits.

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Information Overload

Americans are consuming unprecedented amounts of information. Some small fraction of that – what we read, hear and see on TV – relates to health and illness. Today’s sources might include a story on cell phones and cancer, an NPR feature on autism or a commercial in which Sally Fields recommends Boniva, a drug for osteoporosis.

Does knowing more help us lead better, healthier lives?

In Bits, a NY Times blog on business, innovation, technology and society, Nick Bilton recently described our voracious appetite for enlightenment: 34 Gigabytes or, depending on how you count, nearly 12 hours’ worth of data-gleaning per day from diverse channels like television, radio, the Web, text messages and video games.

The Bits piece links to the Global Information Industry Center‘s “How Much Information?” (HMI?) project that issued a December 2009 paper. The research center, based at the University of California in San Diego, dates to 1960, when the Internet was, if anything, theoretical, and the concept of sharing computer-based data a matter of defense.

As best I can tell, the topics of “health” and “cancer” don’t figure prominently in the recent analysis. Maybe we don’t want to know much more on these subjects than we find in our doctors’ offices. But long runs of TV shows like “Marcus Welby, M.D.,” “ER” and “Scrubs” suggest otherwise. Indeed, many tune in regularly for a peek into the medical world, at least when fed in bits and pieces by idealized or heart-throb fictitious physicians with complex, warm and sometimes hot personal lives.

Nearly two-thirds of U.S. adults seek health-related information on the Web, says Susannah Fox of the Pew Research Center’s Internet & American Life Project. The agency tracks how North Americans use the Internet for medical purposes and published an update, “The Social Life of Health Information” earlier this year.

Dr. Kevin Pho touched on the issue in a December 16 post on KevinMD:

To be sure, doctors and other health professionals don’t get everything right. But anyone can find information on the web, which can be of dubious accuracy.

Knowing what to do with that data can only come with experience and training.

Fox, of the Pew Research Center, commented:

…one of our key findings is that most people use on-line health resources to supplement advice they get from doctors and other health professionals. After 10 years of researching this field, we have no evidence that the internet is replacing traditional sources of medical advice. Yes, many people are gathering and sharing health information online, but they are also discussing it with friends, family, and health professionals.

I was considering the matter last week, it happens, when I received an email from a former patient. He has hemochromatosis, an inherited disposition to iron overload. His body is programmed to take in excessive amounts of iron, which then might deposit in the liver, glands, heart and skin. He offered holiday greetings and mentioned “some amazing videos on hematology and hemochromatosis and genetics” he’d discovered on YouTube.

This is the future of medicine, I realized. A patient accesses public databases, videos and other resources to learn about signs and symptoms of his illness, what foods to eat or best avoid, what medicines and treatments he might need and if his condition is likely to affect others in his family.

Whether physicians want their patients to search the Internet for medical advice is beside the point. We’re there already, whether or not it’s good for us and whether what we find there is true.

The current issue is not about limiting non-professionals’ access to facts or fiction. Rather, it’s about how we might sift through so much material – whether that’s a CNN segment we take in, passively, while running on a treadmill in the gym, or a detailed analysis of a new prostate cancer treatment provided straight from an oncologist – and digest it properly.

Perhaps information is a bit like iron, an essential nutrient that makes us stronger. To benefit from such a surplus, we’ve got to somehow identify, process and absorb what’s useful, what helps and doesn’t hurt.

Patients using internet health information without physician guidance

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Legitimate Concerns and Unfortunate Timing on Radiation from C.T. Scanning

This week’s cancer news features a study in the current issue of the Archives of Internal Medicine, first reported by Reuters:

CHICAGO (Reuters) – Radiation from CT scans done in 2007 will cause 29,000 cancers and kill nearly 15,000 Americans, researchers said on Monday:

…The findings, published in the Archives of Internal Medicine, add to mounting evidence that Americans are overexposed to radiation from diagnostic tests, especially from a specialized kind of X-ray called a computed tomography, or CT, scan.

The risks of radiation from CT scanning will almost certainly add to the current confusion and concerns about the risks of breast cancer screening.

Mammography differs from CT scanning in several important ways:

1. Mammograms involve much less radiation exposure than CT scans.

According to the American Cancer Society, a typical mammogram uses between 0.1 to 0.2 mSV per image. So even if multiple images are taken of each breast, the total dose remains under 1 mSV.

Another source, the Health Physics Society, estimates a dose of 0.7 mSV per mammogram. So if a woman were to have a screening mammogram every other year between the ages of 40 and 49, she’d receive approximately 3.5 mSV in total from those procedures.

By contrast, a single CT scan involves over a 10-fold greater amount of radiation (such as 8 mSV for a CT of the chest, 10 mSV for a CT of the abdomen) according to the Health Physics Society fact sheet.

2. Mammography is well-regulated by the Food and Drug Administration (FDA) and other agencies.

The Mammography Quality Standards Act (MQSA) requires mammography facilities across the nation to meet uniform quality standards. The law, first passed in October, 1992, requires all mammography facilities to 1) be accredited by an FDA-approved accreditation body, 2) be certified by FDA, or its State, as meeting the standards, 3) undergo an annual MQSA inspection, and 4) prominently display the certificate issued by the agency.

3. Women who undergo screening mammograms can control when and where they get this procedure.

Screening mammograms are elective by nature; a woman can choose an accredited screening facility and, in advance, learn something about its reputation and screening methods. Most women between the ages of 40 and 50 are capable of tracking their mammograms, whether they choose to have those annually, biennially, or less often.

Many CT scans are ordered for patients who are in the hospital – a very different sort of circumstance. Many hospitalized patients don’t feel well, don’t understand what’s happening to them and/or lack the needed assertiveness or language skills to ask about a scan before it’s done.

Summary:

Mammography is a relatively safe and highly-regulated procedure in the U.S.  The recent news on risks from radiation in CT scanning should not confound the discussion of breast cancer screening.

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How Well Do You Really Want to Know the “Red Devil?”

I know what it’s like to get the “red devil” in the veins.

You can learn about Adriamycin, a name brand chemotherapy, on WebMD. Or, if you prefer, you can check on doxorubicin, the generic term, using MedlinePlus, a comprehensive and relatively reliable public venture put forth by the National Library of Medicine and National Institutes of Health. If you’re into organic chemistry, you might want to review the structure of 14-hydroxydaunomycin, an antibiotic and cancer therapy first described 40 years ago in the journal Biotechnology and Bioengineering.

from the National Center for Biotechnology Information (NCBI) database, http://pubchem.ncbi.nlm.nih.gov, accessed 12/11/09.

from the National Center for Biotechnology Information (NCBI) database, http://pubchem.ncbi.nlm.nih.gov, accessed 12/11/09.

When I was a medical student, I studied some facts about doxorubicin hydrochloride, enough at least to answer a few questions during pharmacology exams. Later, as a resident in internal medicine, I knew the drug to be an anthracycline, a chemotherapy that intercalates into DNA, wreaking havoc in cells’ genetic material and reducing the replication potential.

As an oncology fellow, I prescribed and administered the clear, intense red fluid to patients with lymphoma and breast cancer. I learned to be careful: if the medicine slips from the intravenous catheter and enters the nearby, tender tissue below the skin, it can harm. The drug commonly causes hair loss and stomatitis; mouth sores can be so painful it hurts to eat, even when the nausea doesn’t squelch your hunger, or talk. Adriamycin affects the bone marrow, where blood cells are produced, and heart.

It’s not an easy drug; my patients knew this and so did I.

This month marks seven years since my first dose of Adriamycin, part of the “A/C” regimen that’s sometimes given to breast cancer patients. Was it worth going bald, getting anemia, sluggishness, mouth sores, chemo brain and all else that I experienced? Yes; I have no doubts. But I was lucky; my tumor was small and I needed only a few cycles.

I never knew Adriamycin as the red devil until a few years ago when a friend’s stepmother, undergoing treatment, used the term in an email.  She’s a woman who read lots of blogs and shared her experiences with other breast cancer patients online. I realized that despite working in an academic medical center and regularly communicating with physician-friends and oncologists at meetings, I still had a few things to learn.

Now that I’m writing about cancer, I wonder what sorts of information people really want or need to make informed decisions. I suppose some would like to know the chemical structure of doxorubicin before receiving such a potentially poisonous, possibly life-saving drug. Maybe a patient’s husband, or daughter, would seek details about the half-life, metabolism in the liver, side effects and more.

When I received my chemotherapy, I didn’t want to read about breast cancer or treatments. Rather, I chose an oncologist I trusted and liked. Then, for the most part, I followed her advice. But this sort of strategy’s not for everyone, particularly for patients who don’t know their doctors as I knew mine. Besides, most cancer patients aren’t already board-certified oncologists.

With so much available data at our fingertips, some patients will amass many resources about their condition. Others will be more passive, mainly listening to their physicians or perhaps, to friends and family members who do the research on their behalf. To a large extent, it’s a matter of personality –

Ultimately, you can’t know everything about Adriamycin until you’ve had it in your veins. Whether being familiar with the chemical structure makes a difference, is less certain.

What’s clear is this: with so much information at our disposal, there’s an opportunity for patients to help doctors make better decisions.

(all links accessed 12/11/09)

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On Juno and Screening Test Stats

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“Well, well” says the convenience store clerk. “Back for another test?”

“I think the first one was defective. The plus sign looks more like a division symbol, so I remain unconvinced,” states Juno the pregnant teenager.

“Third test today, mama-bear,” notes the clerk.

Juno recluses herself and uses a do-it-yourself pregnancy test in the restroom, on film.

“What’s the prognosis … minus or plus?” asks the clerk.

…”There it is. The little pink plus sign is so unholy,” Juno responds.

She’s pregnant, clearly, and she knows she is.

(from Juno the movie*)
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Juno\’s pregnancy test
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Think of how a statistician might consider Juno’s predicament – when a testing device is useful but sometimes gives an unclear or wrong signal.

Scientists use two terms – sensitivity and specificity – among others, to assess the accuracy of diagnostic tests. In general, these terms work best for tests that provide binary sorts of outcomes – “yes” or “no” type situations. Sensitivity refers to how well a screening tool detects a condition that’s really present (pregnancy, in the teenager’s case). Specificity, by contrast, measures how well a test reports results that are truly negative.**

Juno’s readout is relatively straightforward – a pink plus sign or, not; the possibilities regarding her true condition are few.

Still, even the simplest of diagnostic tests can go wrong. Errors can arise from mistakes in the procedure (a cluttered, dirty store is hardly an ideal lab environment), from flawed reagents (the package might be old, with paper that doesn’t turn vividly pink in case of pregnancy) or from misreading results (perhaps Juno needs glasses).

Why does this matter, now?

The medical and political news are dense with statistics on mammograms; getting a handle on the costs of cancer screening requires more information than most of us have at our disposal.

Of course, breast cancer is not like pregnancy. Among other distinguishing features, it’s not a binary condition; you can’t be a little bit pregnant.  (Both are complicated, I know.)

To get to the bottom of the screening issue, we’ll have to delve deeper, still.

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*Thanks Juno, Dwight and everyone else involved in the 2007 film; details listed on IMBD.

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**I was surprised to find few accessible on-line resources on stats. For those who’d like to understand more on the matter of sensitivity and specificity, I recommend starting with a 2003 article by Tze-Wey Loong in the British Medical Journal. This journal, with a stated mission to “help doctors to make better decisions” provides open, free access to anyone who registers on-line.

I’ll offer an example here, too:

To measure the accuracy of Juno’s kit, a statistician might visit a community of 100 possibly pregnant women who used the same type of device. If 20 of the women are indeed pregnant (as confirmed by another test, like a sonogram), but only 16 of those see the pink plus sign, the sensitivity of the test would be 16/20, or 80 percent. And if, among the 80 women who aren’t due, 76 get negative results, the specificity would be 76/80, or 95 percent.

False negatives: among the 20 pregnant women 4 find negative results; the false negative rate (FN) is 4/20, or 20 percent.

False positives: among the 80 women who aren’t pregnant 4 see misleading traces of pink; the false positive (FP) rate is 4/80, or 5 percent.

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Stats in the News!

False positives have hit the headlines.

Check the New York Times, Wall Street Journal, CNN – they’re everywhere. Even the Ladies’ Home Journal skirts the subject.

The discussion on mammography runs something like this: studies show that cancer screening save few lives. Among women younger than 50 years, there’s a high rate of false positive results. Those misleading tests lead to more imaging procedures such as sonograms and MRIs, additional biopsies and, necessarily, higher screening costs.

Women are ignoring the numbers, choosing reassurance over hard facts. Some say members of the pro-mammogram camp are irrational, even addicted.

The best response is to look carefully at the research findings.

Two recent publications sparked the current controversy: one, a single paper in the Journal of the American Medical Association and the other, a cluster of articles in the most recent Annals of Internal Medicine. Using a variety of research tools, the authors in both journals examine the effectiveness of cancer screening. Here, the investigators consider the risks and benefits of mammography from a medical perspective; they don’t focus on monetary aspects of the issue.

The problem of false positives in mammography is most-fully addressed in the AnnalsScreening for Breast Cancer: An Update for the U.S. Preventive Services Task Force. The authors assess, among other newsworthy subjects (such as the value of breast self-examination) the potential risks and benefits of mammography. In the Results section, they delineate five sorts of mammography-associated harms (see “key question 2a”):

1. Radiation exposure – not a big deal, the exposure level’s low;

2. Pain during procedures – women don’t mind this, at least not too much;

3. Anxiety, distress and other psychological responses – the patronizing terms tell all;

4. False-positive and false-negative mammography results, additional imaging, and biopsies – the subject of this and tomorrow’s posts;

5. Over-diagnosis – this interesting and, in my view, exaggerated issue warrants further discussion.

For now, let’s approach the problem of false positives in mammography (as in #4, above).

What is a false positive?

False positives happen in mammography when the images suggest the presence of a malignancy in a woman who doesn’t have cancer in her breast.

How often do these occur?

To their credit, the Annals authors state clearly: “published data on false-positive and false-negative mammography results, additional imaging, and biopsies that reflect current practices in the United States are limited…”

Before we can establish or even estimate the costs of false positives in screening mammography, medical or economic, we need to better define those and, then, establish the frequency with which they occur.

Turns out, the calculation’s not so simple as you might think.

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Another Take on Mammography

In my latest piece, Mammography: a Not-So-Fatalistic View, I outline reasons why the recent task force findings on mammography don’t hold.

Three key issues have escaped the headlines:

1. The expert panel carried out a careful analysis using data that are, necessarily, old;

2. The recommendations don’t apply to digital mammography;

3. Mammograms are not all the same – the quality varies by the methods used and skills of the radiologists who read them.

We need to set the bar higher for mammography. If everyone could have a state-of-the-art mammogram, as I did some years ago, followed by a sonogram to better analyze the tiny abnormalities the radiologist noted (before rushing to biopsy), the stats on cancer screening would be incontrovertible; there would be no debate.

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Getting the Math on Mammograms

The latest news’ focus on the breast cancer screening madness is about money.

So let’s do the math:

First, for argument’s sake, let’s say the U.S. Preventive Services Task Force is right – that to save the life of one woman between the ages of 40 and 49, on average, you’d have to screen some 1903 additional women every year or so for a period of 10 years.

This is, admittedly, a huge assumption; the panel analyzed two decades’ worth of data, some unpublished, involving complex models applied to millions of data points (humans) amassed in imperfectly-collected data sets that vary in size, scope and accuracy.

Next, let’s say the cost of a mammogram is $150, around what Medicare pays (yet another assumption, but we need to keep this simple or we’ll never get a sense of what’s really at stake here).

So if 2000 women (I’m rounding up) undergo annual screening for 10 years, the bill would come to $300 thousand per year, for a total cost of $3 million over a decade.  If those same middle-aged women were to get their mammograms biannually (every other year), the cost would be roughly $1.5 million per life saved.

This, the so-called cost of screening mammography for women between the ages of 40 and 49 (let’s call it “X”), is all over the news in various calculations, some that get closer to the right answer than others.

But what’s the cost of caring for one 45 year old woman with metastatic breast cancer?

Let’s call that amount “Y.”

Even the heartless among us would admit that we need to subtract, X-Y, to determine the financial cost of breast cancer screening to save one middle-aged woman’s life.

An insurance executive might say it’s in the range of $400 thousand, or a million dollars, or maybe even two million, if the woman lives long enough to go in and out of the hospital over the course of five years, undergo multiple surgical procedures, have semi-permanent intravenous catheters inserted and removed, suffer infections from those requiring at-home multi-week courses of intravenous antibiotics, all of this besides, of course, receiving chemotherapy, radiation, hormone treatments, incalculably expensive antibody infusions and newer, targeted therapies, followed by hospice (hopefully) or ICU care in the end.

Quick answer: maybe it’s cost-effective, or nearly so, to do screening mammograms on asymptomatic women in their forties.

But consider –  if the expert panel’s numbers are off just a bit, by as little as one or two more lives saved per 1904 women screened, the insurers could make a profit!

By my calculation, if one additional woman at a cost of, say, $1 million, is saved among the screening group, the provider might break even.  And if three women in the group are saved by the procedure, the decision gets easier…

Now, imagine the technology has advanced, ever so slightly, that another four or five women are saved among the screening lot.

How could anyone, even with a profit motive, elect not to screen those 2000 women?

The truest answer, of course, is that the value of any one person’s life is inconceivably huge.  And that doesn’t even enter into the equation.

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To Screen is Human

Smack in the midst of October-is-breast-cancer-awareness-month, the Journal of the American Medical Association published a provocative article with a low-key title:  “Rethinking Screening for Breast Cancer and Prostate Cancer.”  The authors examined trends in screening, diagnosis and deaths from cancer over two decades, applied theoretical models to the data and found a seemingly disappointing result.

It turns out that standard cancer screening is imperfect.

The subject matters, especially to me.  I’m a medical oncologist and a breast cancer survivor, spared seven years ago from a small, infiltrating ductal carcinoma by one radiologist, an expert physician who noted an abnormality on my first screening mammogram.

The New York Times featured the new findings in a front-page article that elicited over 200 readers’ comments.  Quite a few cheered the frank, non-party line that mammography‘s not all it’s cracked up to be.  Same goes for measuring the prostate specific antigen in men’s blood, a test that sometimes marks for prostate cancer.

Some readers connected the dots between cancer screening, the pharmaceutical industry and physicians’ income.  Because doctors make money by interpreting scans, doing biopsies and giving chemotherapy, perhaps they can’t be trusted to make unbiased recommendations.  Like an aggressive tumor, the story spread everywhere – cable news, NPR, a host of blogs.

Fear, hassle, insurance forms (if you’re lucky), blood tests, anxiety, CAT scans, possibly a cancer diagnosis with attendant surgery, radiation, chemotherapy, nausea and who knows what else ensues.  Yuck.  The toll is huge, even apart from the finances.

The Food and Drug Administration estimates that radiologists perform some 37 million mammograms each year in the United States.  Women undergo 70 percent of those scans for routine screening purposes.  (Doctors order the other 30 percent to evaluate lumps or other signs of cancer that’s already evident.)  My math:  that’s 26 million screening mammograms at, roughly, $100 per scan, for a total cost of $2.6 billion annually.

Compounding the confusion, a few days later the Times ran a related piece highlighting reports that some tumors shrink or even disappear without treatment.  That’s wonderful news, if it’s true.  Perhaps you can skip the mammogram, not find the cancer, and it’ll just go away.

This represents a form of wishful thinking.  Reality check in three points:

1. Prostate cancer is not the same as breast cancer.  You can’t simply lump these together in a study and draw conclusions about testing or treatment for either condition.

2.  Breast cancer is a common and very real cause of death in North America, where each year there are nearly 200,000 new cases and more than 40,000 associated deaths.

3. Mammograms save lives by uncovering tumors when they’re still small enough for surgical removal.

In 2009, there is no known cure for metastatic breast cancer.  A woman’s chances of surviving for five years after she’s found to have a small, localized tumor lie in the 98 percent range; if she’s noted with metastatic disease, those odds hover around 25 percent.

So what’s a woman to do?

Sure, it’s discomfiting to know that screening doesn’t always work.  And for some, it’s disheartening that doctors, insurance companies and x-ray machine makers generate profits by detecting, evaluating and treating cancer.  In case you haven’t been following the health care reform debate, health care’s an imperfect business.

Many will continue to go for annual mammograms, especially in October, and their doctors will, emphatically, recommend that they get those.  And many men will request of their internists, or urologists, or whoever’s taking care of them, that they get a blood test for prostate cancer, “just to be sure.”  Likely, a few more skeptics will opt out of the screening process.

Screening for breast and prostate cancer could be better.  The same applies to pretty much everything in health care, as in any human enterprise.  But it’s the best that we’ve got, for the time being.

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