Many of the women who had additional procedures did so for concern over having “clean margins” – that upon removal of a tumor, the edges of the specimen don’t reveal malignant cells. Re-excision for patients with negative margins varied by hospital; at one medical center the re-excision rate was 1.7%, at another it was 20.9%. Analysis by surgeon revealed huge variation, with re-excision rates ranging between 0 and 70%. The incidence of positive margins was 14%. For those women who did have positive margins – meaning that cancerous cells were evident along the edge of the lump removed — nearly 15% didn’t have a second procedure.

The big picture is that there was little pattern – or reason evident, at least at the collective level – for the surgeries and decisions to re-operate after lumpectomy for breast cancer.

The NIH-funded study was large enough to merit concern. It involved careful chart and pathology review of the specimens through a consortium of four medical centers around the country: the University of Vermont, Kaiser Permanente Colorado, Group Health in Washington State and the Marshfield Clinic in Wisconsin. And it reflects current practice; the surgeries took place between 2003 and 2008.

This is a very common procedure, and a significant issue, in terms of costs, and risks, and decisions women make every day upon receiving a new BC diagnosis. An estimated 60–70% of newly-diagnosed breast cancer patients choose breast-conserving surgery. So we’re talking about 160,000 or so lumpectomies per year in the U.S. (very approximate, ES: 2/3 of 240,000 new BC cases).  The variable results affect cosmetic outcome – the very reason many women choose lumpectomy to begin with and, potentially, the rate of BC recurrence.

In the discussion, the authors write: “Our finding…suggests that patients under similar clinical conditions are likely to undergo reexcision based on the treating surgeon and not just the clinical characteristics.” They offer possible explanations, including differences in surgical training, surgeons’ confidence in their operative techniques, how tumors are assessed in the operating room, and variation in how pathologists review specimens and “call” the margins positive or negative.

All of this meshes with my experience – knowing women who’ve had breast-conserving surgery and then got mixed information about the results and what to do next. You’d think lumpectomy would be a standard procedure by now, and that decisions about what to do after the procedure, surgically speaking (let alone decisions about chemo, hormonal treatments and radiation) would be straightforward in most cases.

Still, many breast cancer advocates, activists and others question Komen’s priorities. This episode draws attention to debate within the BC community about the relative merits of spending charity dollars on screening, education, awareness, research and other concerns.

The long-term fallout from this week’s news and the agency’s reversal aren’t known. As I suggested earlier, Komen’s leadership might take this opportunity to reassess its mission and goals.

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Rather, in a stilted video released yesterday, Brinker defends her agency’s decision as part of a “strategic shift” having to do with funding for any organization under investigation. That’s a bogus excuse, as others have detailed.

Komen, the world’s largest BC agency, has been under scrutiny for some time. Through its early fundraising campaigns and walks, the group raised public awareness — and discussion — of the disease. Since its inception in 1982, the agency has invested over $1.9 billion in education, breast-cancer screening, research and other grants. The discourse has changed, though. Now, many are critical of Komen’s historic focus on BC education and screening, including mammography, and tire of seeing so much pink.

This week’s outcry over the agency’s political turn has been fierce. It’s not too late for Komen’s leadership to take note, change course and revise its agenda.

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The network includes an extensive and well-organized cancer blog directory. Dennis provides an annotated list of websites, books and other resources for people affected by cancer.

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Cyberchondria is an unfounded health concern that develops upon searching the Internet for information about symptoms or a disease. A cyberchondriac is someone who surfs the Web about a medical problem and worries about it unduly.

Through Wikipedia, I located what might be the first reference to cyberchondria in a medical journal: a 2003 article in the Journal of Neurology, Neurosurgery, and Psychiatry. A section on the new diagnosis starts like this: “Although not yet in the Oxford English Dictionary, the word ‘cyberchondria’ has been coined to describe the excessive use of internet health sites to fuel health anxiety.” That academic report links back to a 2001 story in the Independent, “Are you a Cyberchondriac?”

Two Microsoft researchers, Ryen White and Eric Horvitz, authored a “classic” paper: Cyberchondria: Studies of the Escalation of Medical Concerns in Web Search. This academic paper, published in 2009, reviews the history of cyberchondria and results of a survey on Internet searches and anxiety.

Interesting that the term — coined in a newspaper story and evaluated largely by IT experts — has entered the medical lexicon. I wonder how the American Psychiatry Association will handle cyberchondria in the upcoming DSM-5.

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image, “the Iron Lady”

Over the weekend I saw the Iron Lady, a movie about Margaret Thatcher, the former Prime Minister of England.  I expected a top-notch, accented and nuanced performance by Meryl Streep, and got that.

The film surprised me in several respects. It’s really about aging, and how a fiercely independent woman withers. The camera takes you within her elderly, blurry, husband-conjuring mind. She’s forgetful and rambling, but maintains an interest in current events, and ideas. She looks back on events in her life with pride and, seemingly, some regrets.

Well done, worth seeing!

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About a year ago, I had the opportunity to hear Wendell Potter, author of Deadly Spin - an insider’s sharp critique of the insurance industry, speak at a meeting of the New York Metropolitan Chapter of Physicians for a National Health Program. Despite the cold, dark winter night and midtown dreariness of the meeting location, the large lecture room was packed. I arrived well before Potter’s presentation but couldn’t get a copy of his book; they’d sold out.

The meeting was instructive: I got a sense of Potter’s personal story (he’s from Tennessee, and lived for a while in Appalachia), his previous career (he worked as a journalist, turned to marketing, eventually led PR for Cigna) and his perspective on how people in the health care industry use language to frame the debate on health care reform. Since 2009, when he left his position at Cigna, he writes and speaks critically about the insurance industry.

Potter made several points that clarified my understanding of the insurance companies’ support of the Patient Protection and Affordable Care Act, and why many business-minded sorts are adamant about the individual mandate component in the law.

Insurance companies can’t make a profit without the individual mandate unless they deny coverage to people with pre-existing conditions, he explained. ”Think about it,” he said. “If young and healthy people aren’t going to buy insurance, and insurance companies can’t refuse to cover those with pre-existing conditions, the companies would be responsible only for providing health care to people who choose insurance, including everyone who is sick.”

“Most Republicans who say they favor repeal are disingenuous in that,” he said. “They’re using a smoke screen tactic to persuade the public that they’re against the legislation, but really they support it,” he told. “The insurance companies need it to stay in business,” he added.

The new legislation will also serve most large providers of health care services. That’s because without reform,  more and more Americans will go without any insurance. “If you keep shifting the costs of health care to consumers, they won’t buy it,” he said. And without insurance, most people can’t afford all but the most essential medical services — if those.

So the individual mandate assures that the insurance industry can remain profitable. And it serves the health care industry by maximizing the number of healthy people who will participate in health care spending.

In other words (ES): The health care industry needs health care to be affordable to many “consumers.”

All for now -
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The 21 study participants all had chronic infection by HCV genotype 1, a strain that’s common in North America and relatively resistant to standard treatment. All subjects were between 18 and 70 years old, with a measurable level of HCV RNA in the blood, no evidence of cirrhosis, and no response to prior HCV treatment (according to criteria detailed in the paper). In the trial, 11 patients received a combination regimen of daclatasvir (60 mg once daily, by mouth) and asunaprevir (600 mg, twice daily by mouth) alone; the other 10 patients took the experimental drugs along with 2 older meds for HCV - Peginterferon (Pegasys, an injectible drug by Roche) and Ribavirin (Copegus, a pill, by Roche).

The main finding is that the 10 patients assigned to take 4 drugs all did strikingly well in terms of reducing detectable HCV in their blood over the course of 24 weeks. There was a dramatic response, also, in 4 of the 11 patients assigned to the new drugs only. An accompanying editorial highlighted the work as a Watershed Moment in the Treatment of Hepatitis C. The medical significance is that they’ve demonstrated proof of principle: by “hitting” a resistant HCV strain with multiple anti-viral drugs simultaneously, they could reduce it to undetectable levels.

The first question you have to ask about this report is why the NEJM – the most selective of medical journals — would publish findings of an exploratory analysis of two new pills paired with two older drugs for HCV. The best answer, probably, is that the virus infects some 4 million people in the U.S. and approximately 180 million people worldwide, according to the study authors. HCV can cause liver damage, cirrhosis, liver cancer (which is usually fatal) and, occasionally blood disorders.

The new drugs derive from some interesting science. This, maybe, also is a factor in why the article was published in the NEJM. Daclatasvir (BMS-790052) blocks a viral protein, NS5A, that’s essential for HCV replication. The second new drug, asunaprevir (BMS-650032) inhibits a viral protease, NS3.

I have several concerns about this report. One is that the researchers screened 56 patients for possible registration but enrolled only 21 on the trial; according to a supplementary Figure 1, 35 potential subjects (over half) didn’t meet criteria for eligibility. This disparity makes any once-researcher wonder about bias in selecting patients for enrollment. If you’re a pharmaceutical company and want to show a new drug or combo is safe, you’re going to pick patients for a trial who are least likely to experience or display significant toxicity.

Toxicity seems like it could be problematic. Diarrhea, fatigue and headaches were common among the study subjects. Worrisome is that 6 patients (of 21, that would be 28.5% of those on the trial) had liver problems manifest by at least one enzyme (the ALT) rising over 3 times the normal limit.

Further complicating the picture is there’s no indication of how these new drugs mesh with the two drugs approved for HCV in 2011: Vic­trelis (boceprevir) and Incivek (telaprevir).

Given all these limitations, you might wonder about BMS’s influence at the Journal or, more likely, the manuscript’s peer reviewers. The 17 study authors, and the editorialist, separately, disclose a host of industry ties.

What I’m thinking, as much as I’m critical of this research work, is that this is probably the way of the future – smaller, pharma-funded studies of targeted new drugs in complicated combinations. Many will be authored by academics with ties to industry, if not put forth directly by company-employed researchers. These quick-and-promising studies in select patient groups will be routine. And while advocates push for rapid publication of new clinical research in patients with resistant, disabling diseases, it’ll be hard for physicians and patients to interpret these kinds of data.

So these particular findings may turn out to be true and life-saving, or not. The bigger concern is this: It would be helpful if the journals would take a really tough stance on full disclosure of authors and editors ties to industry. As Merrill Goozner has emphasized, the Physician Payment Sunshine Act – a small component of the 2010 HCR legislation — has important implications for academic medicine and reporting of clinical research studies.

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There are 4 parts:

Health Tips

True Stories

Myth-busters and Controversies

Health Care Costs

Congratulations, and thanks, to Val for pulling together so much thoughtful work!

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In oncology terms: The DCR is the sum of complete responses (CR) + partial responses (PR) + stable disease (SD).

Another way of explaining it: Some people with cancer have measurable, growing tumors. For example, a man might have a sarcoma with multiple metastases in the lung that are evidently progressing. If the patient starts a new treatment and the lung mets don’t shrink but stop getting bigger, that might be considered a stabilizing effect from the therapy, and his response would be included in the DCR.
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