No Room For Emotion or Exceptions to the Rule (on Avastin)

My cousin testified before the FDA oncology advisory board on Tuesday about her experience taking Avastin. This is a tragedy, to deny the only drug that is keeping a 51 year old woman alive.

image from p.3 of today’s NYTimes business section

You have to wonder, are the advisory panel members so rational in all their behavior and choices? Are they always so razor-like in their oncology decisions?


These experts have an agenda, here: It’s to be perceived as scientists, even when their knowledge is imperfect and exceptions to the rule stand right in front of their eyes. But clinical medicine calls for flexibility, and tailoring of treatment to each case, and caring about each person, including those who fall at the tail, or in this case better end, of any Kaplan-Meier survival curve.

What would Larry Kramer do about this, I’ve been thinking: He’d scream, really loud, so loud he might break his eardrums. He’d wonder why others, affected and near, aren’t doing the same. And he’d understand why this picture is on page 3 of the business section, and not on the front cover; it’s because people don’t want to look or see or know or think about it too much, because it hurts.

That is the normal heart, and this is a normal response to what’s happening to women with metastatic breast cancer.


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Cathy Wants a New Doctor and a Second Opinion

Last night the Big C returned, not surprisingly with an opening dream sequence. Laura Linney, portraying Cathy Jamison in the Showtime series, is running. The scene turns out to be a nightmare, and she awakens with a headache and her husband by her side.

Laura Linney portrays Cathy, hugging her son in Showtime's "The Big C"

OK so far.

Within a few minutes, Cathy’s young oncologist informs her that the interleukin 2 hasn’t worked; after two rounds of “chemo” the melanoma hasn’t budged. Sitting at his desk in the consultation room, he suggests she roll some joints for relief of headaches. She says she wants another opinion. It’s about time.

The main problem Cathy faces in this episode is that she can’t get an appointment with her oncologist of choice, Dr. Atticus Sherman despite calling, calling and calling. So finally she thinks out of the box: “That would be a coffin,” intimates her deceased, elderly neighbor Marlene who visits, spiritually, from Season 1.

So Cathy dons a suit and heels, and pulls a small suitcase with wheels – in the style of a drug sales rep – to work her way into the famed oncologist’s office. This desperate strategy, reminiscent of that suggested by journalist Elizabeth Cohen in the Empowered Patient book, and tried at least once by Samantha in Sex in the City when she had breast cancer, seven years ago or so on HBO, nearly backfires. But in a stroke of changed fate, the same doctor’s office calls Cathy to let her know she’s got an appointment for next week.

Such drama, just to get an appointment didn’t move me. But perhaps I’m too removed from this sort of painfully real situation for the countless, frustrated patients who can’t get appointments with appropriate specialists.

I was disappointed with the episode for other reasons. It wasn’t rich with ideas. There was no meaningful discussion of Cathy’s cancer, and only a shallow exploration of her feelings.

Like other TV comedies, this show was about everyday junk and family life: her son’s farting habit, her friend’s active sex life and pregnancy, her brother’s insanity, her dog’s seeming to be dead and then turning out to be alive. This (non) focus is fair enough, I suppose; when a person has cancer, they’re indeed surrounded by people in their family and friends who have their own needs and issues.

A particular beef is this: Clearly Cathy needed a second opinion; that’s been the case all along. But the script-writers made it too easy by having the young oncologist be utterly clueless and behaving inappropriately. The value of a second opinion would be clarified if Cathy had chosen to seek another doctor’s input even if she were receiving seemingly expert care from a solid, more experienced physician.

And where is the Internet in all of this? Her friend Rebecca (Cynthia Nixon) might be looking some stuff up. Or her brother, for that matter, who’s now said to be manic depressive, could be maxing out on free and potentially useful information. His anger at his sister would be more credible if it were less extreme and if he were less bizarre; his is not a fair or typical depiction of his stated mental illness.

How will Cathy’s appointment with Dr. Sherman go next week? We’ll see.


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Gregg Allman Stars in Hepatitis C Awareness Campaign, with Merck

This weekend I learned that Gregg Allman, of the Allman Brothers, has hepatitis C. Not just that; he underwent a liver transplant last year for treatment of liver cancer. This information came my way via CNN, in a clip narrated by Dr. Sanjay Gupta. The cable TV crew filmed the old rocker in Macon, Georgia, at the band’s Big House.

Gregg Allman, performing in 2010 (Wikimedia Commons)

“He’s taping a public service announcement for the drug company Merck, about hepatitis C,” Gupta says 40 seconds or so into the clip (italics added, ES).

Hepatitis C stays silent in many carriers, meaning that most people with the virus are unaware of their infected state. The liver-infecting virus spreads most often by contaminated needles, sexual relations or transfusion of infected blood. Over time, the virus tends to cause liver damage and blood problems including anemia and, rarely, a condition called mixed cryoglobulinemia. In patients with long-standing hepatitis C, there’s a significantly elevated risk of developing liver cancer.

For two decades there have been a few, fairly effective anti-viral drugs available for hepatitis C. Treatment generally reduces patients’ anemia and liver disease, which leads them to feel better, and also reduces the risk of the long-term effects of infection, including liver cancer. Last month the FDA approved two new drugs for hep C: Victrelis (boceprevir), manufactured by Merck, and Incivek (telaprevir), by Vertex Pharmaceuticals.

While I have no formed opinion as to which of these new drugs is most effective or less toxic or more affordable in the long term for patients with hepatitis C, I do find it strange that Gregg Allman will be singing for Merck.

Eat a Peach (album cover)

The ethics of this are complicated: On the one hand, it might be a good thing for a music icon to raise public awareness about hepatitis C, so that more people at risk might get tested and then treated early before they develop severe liver disease and cancer, and would feel better. Gregg Allman is in a position to spread that message effectively: “If I have hep C, you might have hep C. Let me tell you about it…” (somewhat in the style of Magic Johnson, on HIV).

On the other hand, the notion of a post-transplant musician serving as the public’s primary source for information on hepatitis C seems preposterous, especially if he’s tied in with a pharmaceutical company with a stake in the matter. The situation is reminiscent of Sally Fields starring in commercials for Boniva, an osteoporosis drug.

You might ask yourself – and it’s not a trivial exercise – who can best, and objectively, inform the public about viral liver infections and the potential benefits of treatment: doctors? (we harbor biases; many have industry ties); patient peers? (Allman is a heightened example, but he’s hardly objective about this, either); newspapers? (or radio…

Will Allman’s be wasted words? (Hard to resist.) Really I’m not sure.

But I might go to Allman’s concert for the American Liver Foundation, at the Beacon Theater, scheduled for July 27.

All for now.




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Looking Back on ‘The Normal Heart,’ and Patients’ Activisim

A few weeks ago I saw The Normal Heart, a play about the early, unfolding AIDS epidemic in NYC and founding of the Gay Men’s Health Crisis. The semi-autobiographical and now essentially historical work by Larry Kramer first opened at the Public Theater in 1985.

Cover of the paperback, published by “Plume,” from Wikipedia

The story takes on the perspective of a young man who’s seeing the death of too many of his friends and neighbors from a strange and previously-unknown disease. As much as the situation is disturbing, and frightening, and shattering of the gay men’s barely decade-old freedom to behave as they choose, most of the protagonist’s associates just can’t deal with it. Nor can other, potentially sympathetic officials like Mayor Koch, health officials at the CDC and NIH.

Among the men who form GMHC, in this drama, there’s a mixed crew. Some say they’re  embarrassed by the attention the illness drew to some gay men’s behavior. Many stay fully or half-closeted, understandably insecure in their jobs. They worry about discrimination and rejection by families, landlords and even doctors, some who were reluctant to take on patients with this disease. Some of the affected men and their friends, straightforwardly, fear death; others are in plain denial about what’s going on in their community.

The scenes unfold between 1981 and 1984, more or less the time when I moved to Manhattan, lived downtown, applied and matriculated at NYU’s medical school. Many of the first clinical cases, i.e. patients, I saw, were young men with HIV and Kaposi’s sarcoma, one of the first conditions associated with the outbreak and that’s featured in the play – the appearance of maroon or violet-colored, usually but not always flat, often elongate, spots on the skin. The AIDS patients tended to have anemia, either from immune blood disorders or, more often, infection in the bone marrow. As a hematologist-to-be, I was intrigued.

Then and now, looking back, it’s hard not to respect those men’s activism, especially those who, with Kramer, created the AIDS Coalition to Unleash Power (ACT UP). They were impatient with the pace of research and physicians’ protocols, and spoke out so emphatically about their needs: for more research; for prevention and treatment; for easier access to new drugs; and, simply, for good medical care.

The play closes soon in New York;  its producers are said to be planning a tour and a London production of the work. Patients and their advocates, of all backgrounds and particular concerns, might take notes.

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Taking Care of Yourself When Someone You Love is Ill

This week a close relative was hospitalized and turns out to have a serious condition.  He’s not a blog-lover, so I’ll keep this abstract:

When a loved one gets sick, you have to take care of yourself. It’s hard to do your work, and to be there 24/7 for the rest of your family, and to eat nutritious, non-hospital cafeteria-type meals, and to find time to run or swim or whatever it is you do to take care of the one life you have.

So I’ll go to the gym today, just for half an hour. I’ll gor for a swim tomorrow, even if it’s just for half my usual laps: 30 minutes is better than no time in the water; 20 minutes is OK too, far better than not going at all. My intention is to keep up my routine, albeit reduced and adjusted, through what will hopefully be a long haul.

And I’ll write when I can.


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What’s Next on the Big C? (Hopefully a Second Opinion)

(Hopefully a second opinion)

When I last wrote on The Big C, a Showtime series in which the actress Laura Linney portrays a woman in her forties with advanced melanoma, I considered some of the options she might choose when the series resumes next Monday night.

Laura Linney, in Showtime's 'Big C'

At the end of Season 1, she elected to try a course of IL-2 as was recommended by her young oncologist. Meanwhile, the FDA has approved Ipilimumab (Yervoy), an antibody treatment that revs up the immune system. And she’s in line, according to the script, for possible entry into a clinical trial that likely involves a targeted therapy, like vemu­rafenib for patients whose malignant cells have a genetic mutation in B-RAF.

What I expect Cathy will do, before anything else happens and she receives any additional non-urgent treatment for her advanced melanoma, is get a second opinion. She’s a smart, sensible sort; in retrospect it’s hard to believe she didn’t do this earlier on and before starting the IL-2 therapy.

I wonder, also, if one of her family members or friends will do some research about melanoma on the Internet. That would help her find a doctor with appropriate expertise, and better know what questions she should ask of the oncologist during the consultation.

That’s all on Cathy’s decision, until next week.


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Lowering Cancer Care Costs by Reducing Tests After Treatment

This is the second in a series of posts on Bending the Cost Curve in Cancer Care. We should consider the proposal, published in the NEJM, gradually over the course of this summer, starting with “suggested changes in oncologists’ behavior,” #1:

1. Target surveillance testing or imaging to situations in which a benefit has been shown. This point concerns the costs of doctors’ routinely ordering CTs, MRIs and other imaging exams, besides blood tests, for patients who’ve completed a course of cancer treatment and are thought to be in remission.

The NEJM authors consider that after a cancer diagnosis many patients, understandably, seek reassurance that any recurrence will be detected early, if it happens. Doctors, for their part, may not fully appreciate the lack of benefit of detecting a liver met when it’s 2 cm rather than, say, just 1 cm in size. What’s more, physicians may have a conflict of interest, if they earn ancillary income by ordering lab and imaging tests.

My take:

It’s clear that some and possibly most cancer patients get too many and too frequent post-treatment surveillance tests. Believe it or not, yours truly, whose life was saved by a screening digital mammogram, maintains a healthy fear of excess radiation exposure. I agree to x-rays, CT scans, myelograms and whatever else my doctors suggest only when I’m reasonably confident that the test result would influence a treatment decision.

My impression is that, in general, oncologists’ habits of ordering routine, interval-based imaging for patients in remission after cancer treatment (such as a scan every 3 or 4 or 6 or 12 months) are arbitrary and unsupportable by any published data. These sorts of practices, which vary among communities, arise like this: A senior, smart and well-intentioned oncologist at a major teaching hospital, circa 1990, orders newfangled CT scans of the chest, abdomen and pelvis on his lymphoma patients every 4 months for two years, and then every 6 months for two years, and then every 12 months, for no reason other that he thinks it’s a good idea. The patients like it; they’re reassured, and he (the oncologist) feels good about having prescribed the drugs that caused their sustained remission.

Talk about a positive feedback loop! (We needn’t even invoke financial incentives as a motivating force.) And then that’s just how it’s done by all the fellows he’s taught over the years, who then branch out into other communities and even other countries, and teach…

Why not?

Now things may be changing a bit, as patients like me are starting to fear radiation exposure, and also are starting to question doctors’ recommendations more than they did even a few years ago. Younger doctors, too, have more requirements to continue their medical education in order to keep practicing at most hospitals and maintain their board certificates, and so they, too, may be more questioning of these archaic practices.

About post-treatment screening with scheduled blood work, I see this issue somewhat differently than do the NEJM authors, mainly in that I’m optimistic about simple blood tests, in the future, that may provide affordable and clinically relevant information to patients who’ve undergone treatment with tumors at high risk of recurrence.

As the authors point out, there are some old tests, such as CEA screening, that can be helpful in monitoring for recurrence in patients with a history of colon cancer. In general, blood tests are less dangerous and less expensive than imaging studies. Besides, in patients with aggressive tumors that might respond to new targeted drugs, tests that measure circulating tumor cells (CTCs) in small blood samples, and could assess cells for new mutations, at low costs in the future (not now), might render some blood tests useful and even cost-effective, in the future.

Finally, I’d like to throw in a concern I have about some clinical trials, in case any study designers or persuasive cancer IRB members happen to be reading this post:

Some of the clinical trials for new cancer drugs may require too many follow-up MRIs, CTs and other scans. Even if Pfizer or any other company foots the bill, by participating in the trials patients shouldn’t be subjected to excessive radiation or even just the unpleasantness and hassle of a said-to-be-safe test like an MRI. This pet peeve is especially concerning in some trials requiring multiple post-treatment PET scans, the most rad-intense of common imaging methods.

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Don Berwick, Head of CMS, on the Value of Patient-Centered Care

A few weeks ago I had the opportunity to hear Dr. Don Berwick speak at the annual meeting of the Association of Health Care Journalists.

Berwick now heads the Centers for Medicare & Medicaid Services. When he spoke in April, on transparency and how we might simultaneously cut costs and improve care, I thought his talk was pretty good. This morning, through Twitter, I came upon a short clip from a Berlin conference in 2009. Here, he tackles the meaning of patient-centered care. It’s near-perfect:

Don Berwick, on YouTube: What Patient-Centered Care Really Means

My favorite lines:

…The errors and unreliability of health care are not the main reason that I fear that inevitable day in which I will become a patient…I can use my own wit to stand guard against them…


…What chills my bones is indignity. It is the loss of influence on what happens to me. It is the image of myself in a hospital gown, homogenized, anonymous, powerless, no longer myself. It is the sound of young nurse calling me “Donald” which is a name I never use, ‘It’s “Don.’…

It is the voice of the doctor saying ‘we think,’ instead of ‘I think,’ and thereby placing that small verbal wedge, the pronoun ‘we,’ between himself as a person and myself as a person…


Why I like this clip so much is that Berwick gets the nuanced language of medicine in a way few doctors, in my experience, do. He’s not so much afraid of data and making decisions or even errors, which are in theory surmountable problems, through better information and education, and despite everything may not lead to a “cure” or even a person’s survival, per se. He most fears being perceived as an object, without respect for his concerns and preferences.

That is my greatest fear, too.

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FDA Approves New Assay for Her2 in Breast Cancer

This week the FDA approved a new assay for Her2 expression in breast cancer biopsies. The technology, Inform Dual ISH, is manufactured by Ventana Medical Systems, a Roche subsidiary.

From Ventana Medical: the HER2 and Chromosome 17 probes are detected using two color chromogenic in situ hybridization (ISH)

Inform Dual ISH works like this: technicians, typically working under the supervision of a pathologist, expose a tiny bit of a breast biopsy specimen, fixed on a microscope slide, to probes for Her2. This gene, normally found on human chromosome 17, is amplified in some breast cancer cells. The assay exploits an enzyme, linked to the genetic probe, which creates a color (in this case, red) upon exposure to a chemical. The system allows a pathologist, using a microscope, to “see” and measure the gene’s presence on chromosomes in cells of an ordinary biopsy sample.

What’s interesting about this in situ hybridization (ISH) kit is that it doesn’t require a fluorescent microscope for imaging. The Ventana probe generates a simpler, ordinary color signal that can be detected by a light microscope. Most commercial assays for Her2 use a method called immunohistochemistry (IHC); that technique relies on antibodies that bind Her2, a cell surface receptor that’s implicated in cancer cell signaling and growth. This and other ISH assays measure genes directly on the chromosomes; by contrast, IHC usually tests for protein.

Her2 is the molecular target for Herceptin, and there’s been considered discussion about how and where it might be accurately assessed. So the “readout” from this diagnostic test might inform a woman and her doctor in deciding whether or not she should receive treatment with Herceptin.

How pathologists evaluate breast biopsy specimens matters a lot, especially when you’re on the receiving end of a diagnosis and you’re choosing among treatments. In 2007, ASCO and the College of American Pathologists published guidelines on Her2 testing in the Journal of Clinical Oncology. These groups recently updated the recommendations. How this new assay will be received by these societies, I’m not sure.

A key question, in this author’s mind, is where the Her2 measurements take place, and whether women should rely on local labs’ assays – by whatever method – to determine the Her2-ness of their breast tumors.

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Running 2 Lists That Might Lessen the Costs of Oncology Care

Recently the NEJM ran a Sounding Board piece on Bending the Cost Curve in Cancer Care. The authors take on this problem:

Annual direct costs for cancer care are projected to rise — from $104 billion in 20061 to over $173 billion in 2020 and beyond.2…Medical oncologists directly or indirectly control or influence the majority of cancer care costs, including the use and choice of drugs, the types of supportive care, the frequency of imaging, and the number and extent of hospitalizations…

The article responds, in part, to Dr. Howard Brody’s 2010 proposal that each medical specialty society find five ways to reduce waste in health care. The authors, from the Divisions of Hematology-Oncology and Palliative Care at Virginia Commonwealth University in Richmond VA, offer two lists:

Suggested Changes in Oncologists’ Behavior (from the paper, verbatim – Table 1):

1. Target surveillance testing or imaging to situations in which a benefit has been shown.

2. Limit second-line and third-line treatment for metastatic cancer to sequential monotherapies for most solid tumors.

3. Limit chemotherapy to patients with good performance status, with an exception for highly responsive disease.

4. Replace the routine use of white-cell-stimulating factors with a reduction in the chemotherapy dose in metastatic solid cancer.

5. For patients who are not responding to three consecutive regimens, limit further chemotherapy to clinical trials.

Suggested Changes in Attitudes and Practice (same, Table 2):

1. Oncologists need to recognize that the costs of cancer care are driven by what we do and what we do not do.

2. Both doctors and patients need to have more realistic expectations.

3. Realign compensation to value cognitive services, rather than chemotherapy, more highly.

4. Better integrate palliative care into usual oncology care (concurrent care).

5. The need for cost-effectiveness analysis and for some limits on care must be accepted.


For today, I’ll leave this provocative list without comment except to say that it should engender some long and meaningful, even helpful discussion.

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