a change of place

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ES

(what follows here at ML will be old posts, rotated occasionally):

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By |September 7th, 2014|Blogs, from the author, journalism|Comments Off on a change of place|

“The Dallas Buyers Club” Takes on AIDS, Peer Patients, and Not Taking “No” for An Answer

If you’re a doctor or nurse of a certain age, the Dallas Buyers Club will jog memories. If you’re among those who lost a loved one or friend to AIDS maybe 20 or 30 years ago, or not, this new film might wrench your heart. Anyone watching will be pushed to think hard about drug development today, the slow pace of progress for metastatic breast cancer and other young life-takers, and the FDA’s role in sanctioning, or blocking, treatments for adults with terminal illness.

Dallas Buyers Club image from FOCUS films copy

scene from “the Dallas Buyers Club” (Focus Films)

The movie draws loosely on the story of Ron Woodroof, a Texan rodeo rider who developed AIDS around 1985. A rail-thin Matthew McConaughey, who says he dropped nearly 50 pounds for this role, somehow nails the look of young, HIV-infected men who were filing into hospitals and clinics back then. After absorbing his diagnosis and said prognosis of 30 days to live, the cowboy teams up with Rayon, a (fictitious) transgender woman portrayed, memorably, by Jared Ledo. Together with an oddball group of sympathetic accomplices, the pair set up shop, to procure and distribute unapproved medications the doctors won’t prescribe. Jennifer Garner plays a sympathetic young physician, Dr. Eva Saks, who in the movie crosses lines a bit incredibly, too personally in the second half, to help the AIDS patients and commiserate. But otherwise the film is spot-on. It captures the desperation, determination and clinging together of people, then, affected by what was incurable disease.

One question that sticks with me, as a physician reflecting on the story, is how unclear it is which drugs, exactly, helped the protagonist. Woodroof, as depicted in the film, briefly takes AZT and then moves on to all kinds of substances including DDC (Zalcitabine) from Mexico, interferon of unknown purity or dose from Japan, protein supplements and more. Through a mix of stuff he lives until 1992, seven years beyond what the doctors first told him to expect. An old-school clinical trialist, almost any of my former teachers, and anyone who appreciates evidence-based medicine (as I do, for the record) would know and state and insist that you can’t draw any conclusions based on what happened to the movie’s protagonist, or Woodroof in real life.

On the other hand, clinical trials are painfully slow. Published trials can be flawed. Even if they’re randomized and well-analyzed, the findings can be hard to interpret when it comes to a single patient’s course and well-being. What’s a dying man to do?

Another relevant point, for people affected by almost any health problem, is the extent to which the patients took charge in the Dallas Buyers Club. They found and shared information about their disease independently of their physicians. The image of an AIDS patient using an old computer in a library, looking up articles about his condition, anticipates patient networks of which there are hundreds, on-line and in communities, today.

I came away from this movie feeling optimistic. Because when I was a student, 30 years ago, I wouldn’t have believed that a man afflicted by AIDS, as McConaughey portrays, could now, likely, live for a long time.

#hope, and happy Thanksgiving,

ES

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Radiologists’ Experience Matters in Mammography Outcomes

There’s a new study out on mammography with important implications for breast cancer screening. The main result is that when radiologists review more mammograms per year, the rate of false positives declines.

The stated purpose of the research,* published in the journal Radiology, was to see how radiologists’ interpretive volume – essentially the number of mammograms read per year – affects their performance in breast cancer screening.  The investigators collected data from six registries participating in the NCI’s Breast Cancer Surveillance Consortium, involving 120 radiologists who interpreted 783,965 screening mammograms from 2002 to 2006. So it was a big study, at least in terms of the number of images and outcomes assessed.

First – and before reaching any conclusions – the variance among seasoned radiologists’ everyday experience reading mammograms is striking. From the paper:

…We studied 120 radiologists with a median age of 54 years (range, 37–74 years); most worked full time (75%), had 20 or more years of experience (53%), and had no fellowship training in breast imaging (92%). Time spent in breast imaging varied, with 26% of radiologists working less than 20% and 33% working 80%–100% of their time in breast imaging. Most (61%) interpreted 1000–2999 mammograms annually, with 9% interpreting 5000 or more mammograms.

So they’re looking at a diverse bunch of radiologists reading mammograms, as young as 37 and as old as 74, most with no extra training in the subspecialty. The fraction of work effort spent on breast imaging –presumably mammography, sonos and MRIs – ranged from a quarter of the group (26%) who spend less than a fifth of their time on it and a third (33%) who spend almost all of their time on breast imaging studies.

The investigators summarize their findings in the abstract:

The mean false-positive rate was 9.1% (95% CI: 8.1%, 10.1%), with rates significantly higher for radiologists who had the lowest total (P = .008) and screening (P = .015) volumes. Radiologists with low diagnostic volume (P = .004 and P = .008) and a greater screening focus (P = .003 and P = .002) had significantly lower false-positive and cancer detection rates, respectively. Median invasive tumor size and proportion of cancers detected at early stages did not vary by volume.

This means is that radiologists who review more mammograms are better at reading them correctly. The main difference is that they are less likely to call a false positive. Their work is otherwise comparable, mainly in terms of cancers identified.**

Why this matters is because the costs of false positives – emotional (which I have argued shouldn’t matter so much), physical (surgery, complications of surgery, scars) and financial (costs of biopsies and surgery) are said to be the main problem with breast cancer screening by mammography. If we can reduce the false positive rate, BC screening becomes more efficient and safer.

Time provides the only major press coverage I found on this study, and suggests the findings may be counter-intuitive. I guess the notion is that radiologists might tire of reading so many films, or that a higher volume of work is inherently detrimental.

But I wasn’t at all surprised, nor do I find the results counter-intuitive: the more time a medical specialist spends doing the same sort of work – say examining blood cells under the microscope, as I used to do, routinely – the more likely that doctor will know the difference between a benign variant and a likely sign of malignancy.

Finally, the authors point to the potential problem of inaccessibility of specialized radiologists – an argument against greater requirements, in terms of the number of mammograms a radiologist needs to read per year to be deemed qualified by the FDA and MQSA. The point is that in some rural areas, women wouldn’t have access to mammography if there’s more stringency on radiologists’ volume. But I don’t see this accessibility problem as a valid issue. If the images were all digital, the doctor’s location shouldn’t matter at all.

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*The work, put forth by the Group Health Research Institute and involving a broad range or investigators including biostatisticians, public health specialists, radiologists from institutions across the U.S., received significant funding from the ACS,  the Longaberger Company’s Horizon of Hope Campaign, the Breast Cancer Stamp Fund, the Agency for Healthcare Research and Quality (AHRQ) and the NCI.

**I recommend a read of the full paper and in particular the discussion section, if you can access it through a library or elsewhere. It’s fairly long, and includes some nuanced findings I could not fully cover here.

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Henrietta’s Cells Speak

“One of the ways that I gained the trust of the family is that I gave them information.”

(R. Skloot, a journalist, speaking about her interactions with Henrietta Lacks’ family, Columbia University, Feb 2, 2010)

This week I had the opportunity to hear a terrific talk by Rebecca Skloot, author of a new, flying-off-the-shelves book –The Immortal Life of Henrietta Lacks.

Mrs. Henrietta Lacks died of metastatic cervical cancer in the colored ward at Johns Hopkins Hospital in Baltimore, MD in September 1951. She lived no more than 31 years and left behind a husband, five children and an infinite supply of self-replicating cancer cells for research scientists to study in years to come.

HeLa cells with fluorescent nuclear stain (Wikimedia Commons)

Like many doctors, I first encountered HeLa cells in a research laboratory. Investigators use these famous cells to study how cancer cells grow, divide and respond to treatments. I learned about Mrs. Lacks, patient and mother, just the other day.

Skloot chronicles her short life in fascinating detail. She contrasts the long-lasting fate and productivity of her cells with that of the woman who bore them. She connects those, and her human descendants’ unfortunate financial disposition, to current controversies in bioethics.

In the years following their mother’s death, scientists repeatedly approached her husband and asked her young children for blood samples to check the genetic material, to see if their DNA matched that of cell batches, or clones, growing in research labs.

The issue is this: her husband had but a third-grade education. The children didn’t know what is a “cell,” “HLA-testing” or “clone.”

The family had essentially no idea what the doctors who’d taken, manipulated and cloned their mothers’ cells were talking about, Skloot recounts. They thought the doctors were testing them for cancer.

Years later, when they learned that their mother’s cells were bought, sold and used at research institutions throughout the world, they became angry and distrustful. The problem was essentially one of poor communication, she considered.

“Even a basic education in science would have helped,” Skloot said. “Patients, they want to be asked, and they want to be told what’s going on.”

Well said!

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