Counterfeit Drugs, A New Concern for Patients

This week the FDA issued an alert about fake Avastin. The real drug is a Genentech-manufactured monoclonal antibody prescribed to some cancer patients. Counterfeit vials were sold and distributed to more than a dozen offices and medical treatment facilities in the U.S. This event, which seems to have affected a small number of patients and practices, should sound a big alarm.

Even the most empowered patient – one who’s read up on his drug regimen, and engaged with his physician about what and how much he wants to receive, and visited several doctors for second opinions and went on-line to discuss treatment options with other patients and possibly some experts – can’t know, for sure, exactly what’s in the bag attached to his IV pole.

Counterfeit Avastin (images from FDA)

Scary because patients are so vulnerable –

The problem is this. If you’re sick and really need care, at some point you have to trust that what you’re getting, whether it’s a dose of an antibiotic, or a hit of radiation to a bone met, or a drug thinner, is what it’s supposed to be. If vials are mislabeled, or machines wrongly calibrated, the error might be impossible to detect until side effects appear. If you’re getting a hoax of a cancer drug in combination with other chemo, and it might or might not work in your case, and its side effects – typically affecting just a small percent of recipients – are in a black box, it could be really hard to know you’re not getting the right stuff.

What this means for providers is that your patients are counting on you to dot the i’s. Be careful. Know your sources. Triple-check everything.

The bigger picture – and this falls into a pattern of a profit motive interfering with good care – is that pharmacists and doctors and nurses need time to do their work carefully. They need to get rest, so that they’re not working robotically, and so that they don’t assume that someone else has already checked what they haven’t. And whoever is buying medications or supplies for a medical center, let’s hope they’re not cutting shady deals.

This issue may be broader than is known, now. The ongoing chemo shortage might make a practice “hungry” for drugs. And with so many uninsured, some patients may seek treatments from less-than-reputable infusion givers. The black market, presumably, includes drugs besides Avastin.

If I were receiving an infusion today, like chemo or anesthesia or an infusion of an antibody for Crohn’s disease, I’d worry a little bit extra. I mean, who will check every single vial and label and box? Think of the average hospital patient, and how much stuff they receive in an ordinary day – including IV fluids that might be contaminated with bacteria.

It’s scary because of the loss of control. This circumstance might be inherent to being a patient – in being a true patient and not a “consumer.”

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Oh, No Methotrexate!

structure of MTX (PubChem; NCBI)

I was astonished to learn that methotrexate supplies are running short. This chemotherapy may soon be unavailable to patients who need it. And it’s not just kids with leukemia, as the Times story highlights effectively.

Methotrexate is an old, bread-and-butter cancer kind of drug, a basic ingredient in standard regimens for many tumor types. I’ve personally administered this medication to patients with breast cancer, lymphoma, leukemia, head and neck tumors, ovarian cancer, colon cancer and people whose tumor cells spread to the brain. Doctors prescribe this drug, also, in a few non-malignant conditions, like rheumatoid arthritis.

Methotrexate has been used in cancer wards for over 50 years. And like other beyond-patent meds, it’s become less profitable to manufacture MTX compared to much costlier new agents. Hard to perceive this shortage as anything but a tragedy – that the business of health care renders valuable, inexpensive drugs out of reach.

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Do Adults Need Physicians to Tell Them to Exercise?

According to a new CDC report, only 1 in 3 doctors advise their adult patients to exercise. The survey-based findings are limited, in part, because they rely on people’s recollection of whether they’d visited a physician in the previous year and what they were told. Nonetheless, the study revealed some clear trends:

1. In 2010, 32.4% of adults who’d seen a health care professional were advised to begin or continue with exercise or other physical activity. That fraction’s up significantly from 2000, when a slim 22.6% of patients recalled their doctors telling them to get a move on.

2. Among folks over 85 years, nearly 29% say they were told to exercise. That number’s nearly doubled since 2000, when only 15.3% of elderly patients reportedly received this kind of advice.

3. Adults with diabetes were told to increase their activity more often than those with high blood pressure, cardiovascular disease and cancer. Compared with healthy weight adults, obese people were twice as likely to have been told to exercise by a physician or other health professional.

An underlying message is that doctors should be prodding their patients to exercise. From the report:

Research points to the benefits of physical activity for reducing the risk of chronic health conditions (1–4). Engaging in regular physical activity can reduce medication dependence, help maintain functional independence, and improve the quality of life for older adults (5,6). Physicians and other health professionals can be influential sources of health information, and exercise counseling by primary care physicians has been shown to increase patients’ participation in physical activity (6–9).

There was discussion about this yesterday on Twitter, stemming in part from a USA Today article on the report. And here’s the essence of the short-form debate:

Some suggested that doctors don’t tell patients to exercise because they, themselves, are overweight. Or it’s because they don’t feel comfortable recommending for others what they don’t do themselves. While this might explain some physicians’ behavior or discomfort with the topic, it can’t explain that of the majority.

So why don’t more doctors prescribe exercise for their patients?

Reasons I wonder about include a lack of time for “non-essential” communication, especially in clinics. In specialists’ offices, the omission of exercise could have to do with the visit’s purpose. A gastroenterologist or internist who evaluates a patient for a problem like diarrhea, say, might not think to ask about exercise. For some doctors it might be, problematically, an attitude issue – that they just don’t care that much, or think it would be a waste of time to discuss the matter of exercise.

Whatever the reasons are that most doctors don’t bring up the issue, one might ask this: Why do adults need doctors to tell them about the health benefits of regular exercise? After all, it’s common knowledge – the kind of thing taught in elementary school, like nutrition should be – that regular exercise is good for most people. As we age, being out of condition makes every task in life, like walking a few blocks, harder.

In an ideal world, we’d have most adults exercising regularly, and doctors who’d occasionally intervene and counsel patients about what they shouldn’t do because of a particular medical condition, like arthritis or heart limitation. I guess we’re not there yet –

All for this week,

ES

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Thank You, Rachel and Susan

Yesterday morning, two women who were active in the on-line breast cancer community died.

Rachel Cheetham Moro (1970 – 2012) was a critical thinker who vigorously supported BCAction and the NBCC’s 2020 deadline. She was a generous and thoughtful on-line friend to many women in the metastatic and more general BC community, where she used the handle @ccchronicles. Her blog provided a running, witty commentary on breast cancer news and trends. Interspersed, she detailed occasional and lately, more frequent visits to the hospital, a Florida vacation, and reflections on her earlier years. In a recent post, she included this wonderful high school photo.

high school photo, from the Cancer Culture Chronicles

Dr. Susan Niebur was a mother in her late 30s, an astrophysicist and blogger who generously shared her experiences at her Toddler Planet blog and elsewhere, including on Twitter as @whymommy. She dealt with inflammatory breast cancer starting in April, 2007. In recent months she wrote less frequently, but  positively somehow, while taking radiation treatments for painful bone mets, going in and out of the hospital and, most recently, receiving hospice care at home.

Susan Niebur in 2011, Toddler Planet

Each of these women inspired many people I know. They were brave and open, and helped others to understand what it’s like to face progressive, metastatic disease. Their words didn’t only affect people with breast cancer, but influenced also their loved ones, and individuals who face all sorts of limiting illness.

Thank you, both, for what you’ve taught me about life.

ES

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Study Finds Wide Variation in Reoperation Rates after Lumpectomy for Breast Cancer

The Feb 1 issue of JAMA includes a major report on the practice of lumpectomy in the U.S. The study examined what happened to 2,206 women at four medical centers who opted for breast-conserving surgery at the time of breast cancer diagnosis. The main finding was that after lumpectomy, nearly one in four women had another operation to remove cancerous cells in the breast. Among all the breast cancer patients who began with a lumpectomy, 8.5% wound up with a mastectomy.

These are staggeringly high rates of re-operation in women who opted for small procedures to begin with. 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%.

What further clouds the story is that among 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 study, funded by the NIH, was sufficiently large 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.

Lumpectomy 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.

The authors discuss: “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.

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Komen Update – Future Plans?

As many ML readers are aware, late this morning, the Susan G. Komen Foundation announced it will not cut current grants or funding to Planned Parenthood. This reversal comes as welcome news to those who support the agency and its work. The New York City branch issued this statement.

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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A Note on the Komen Fiasco

When I first heard the Susan G. Komen Foundation is nixing its financial support of Planned Parenthood, I thought it might be a mistake. Maybe a rogue affiliate or anti-choice officer had acted independently of the group’s core and mission, and the press got the early story wrong. I waited for Nancy G. Brinker, Komen’s surviving sister, to step in and deny the BC agency’s change of plans. That didn’t happen.

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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Cyberchondria Rising – What is the Term’s Meaning and History?

Yesterday the AMA news informed me that cyberchondria is on the rise. So it’s a good moment to consider the term’s meaning and history.

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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The Iron Lady, a Film About an Aging Woman

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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Notes on Wendell Potter, and Why Companies Support the Individual Mandate

The current debate about the individual mandate reminded me to post this –

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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NEJM Reports on 2 New Drugs for Hepatitis C

Last week’s NEJM delivered an intriguing, imperfect article on a new approach to treating hepatitis C (HCV). The paper’s careful title, Preliminary Study of Two Antiviral Agents for Hepatitis C Genotype 1, seems right. The analysis, with 17 authors listed, traces the response of 21 people with hepatitis C (HCV) who got two new anti-viral agents, with or without older drugs, in a clinical trial sponsored by Bristol-Meyers Squibb.

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 NEJMDaclatasvir (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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What is the Disease Control Rate in Oncology?

Last week I came upon a new term in the cancer literature: the Disease Control Rate. The DCR refers to the total proportion of patients who demonstrate a response to treatment.

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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Regorafenib, an Experimental Pill Tested in Colon and Rectal Cancer Patients, on Conference Agenda

Tomorrow the American Society of Clinical Oncology* will host its 9th annual GI Cancers Symposium. Bloomberg and the LA Times have already reported findings of a paper, still in abstract form, to be presented on Saturday.

The drug of interest is regorafenib, a pill that loosely inhibits quite a few kinases – enzymes critical in cell signals that control growth of normal cells, tumors and blood vessels. The experimental med, manufactured by Bayer, is also known as BAY 73-4506. The new data emerge from an international, randomized Phase III trial that goes by a loaded acronym: CORRECT.

The study included 760 patients with advanced colon or rectal cancer whose tumor progressed after receiving standard treatments. Participants received either the study drug or BSC (best supportive care) and a placebo. According to the paper, BSC includes antibiotics, pain meds, radiation for bone mets, steroids and some other treatments. The median survival in patients who received the Regorafenib was 6.4 months, compared with 5.0 months in patients who got the placebo. This difference, of 1.4 months in the median, was statistically significant. The “disease control rate” – a term that warrants separate explanation – was 44% in the regorafenib group c/w 15% in the placebo group.

The most frequent high-grade toxicities reported so far include a skin reaction affecting patients’ hands and feet, fatigue, diarrhea, elevated bilirubin in the blood, and high blood pressure. (Question to ask the oncologist who’s presenting these data at the meeting – was the elevated bilirubin from liver damage or hemolysis? With all the $millions spent on this trial, surely someone’s followed up on that detail.)

The language of the report and investigators’ comments are reminiscent of some regarding Avastin for advanced breast cancer. According to a media release: “…a subset of patients in the trial have responded particularly well to regorafenib, continuing to have stable disease for a relatively long time; research is ongoing to find ways to identify these individuals.” There are no biomarkers known to check for Regorafenib responsiveness.

What’s odd is that, according to the abstract, # LBA385, all patients entered the study between May, 2010 and March, 2011. This means some subjects were evaluated for less than a year, and the longest observation period for any patient on the trial is 20 months. Seems early to draw meaningful conclusions about the long-term toxicity and possible benefits of a cancer drug, especially for tumor types, like colorectal cancer, that don’t generally grow fast (c/w a condition like acute leukemia).

The list of investigators’ disclosures regarding ties to industry is too long to post here. You can find them at the tail end of the release. The FDA has assigned Fast Track status to this drug, according to Bayer.

*I am an ASCO member.

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Breast Cancer Stats: Notes from the 2012 ACS Report, and a Key Question

Earlier this month, the ACS released its annual report on Cancer Facts and Figures. The document, based largely on analyses of SEER data from the NCI, supports that approximately 229,000 adults in the U.S. will receive a diagnosis of invasive breast cancer (BC) this year. The disease affects just over 2,000 men annually; 99% of cases arise in women. Non-invasive, aka in situ or Stage 0 BC, including DCIS, will be found in approximately 63,000 individuals.

The slightly encouraging news is that BC mortality continues to decline. This year, the number of expected deaths from BC is just under 40,000. From the ACS document: “Steady declines in breast cancer mortality among women since 1990 have been attributed to a combination of early detection and improvements in treatment.”

Survival data, from the report:

For all women diagnosed with BC, the 5-year relative survival rate has risen from 63% in the 1960s to 90% today. At 10 years, for women of all stages combined, the relative survival is 82% and at 15 years, 77%. Traditional staging still matters: For women with localized BC (that has not spread to glands or elsewhere outside of the breast), the 5-year relative survival at 5 years is 99%. For women with lymph node involvement, 5-year relative survival is 84%.

For those with metastatic disease, 5-year relative survival is 23%. The report cautions: these “stats don’t reflect recent advances in detection and treatment. For example, 15-year relative survival is based on patients diagnosed as early as 1990.”

Since 1990, we’ve seen testing and widespread use of (no longer) new drugs like Herceptin, taxane-type chemotherapies, aromatase inhibitors and other meds in women with MBC. In addition, it’s possible that better palliative care and supportive strategies, along with more effective treatments for infectious and other complications, may have extended survival.

What we’ve got to ask, and about which data are remarkably elusive, is this: What is the median survival for women with metastatic BC (MBC) in 2012?

Your author has spoken with several leading, national authorities on the subject, and no one has provided a clear answer. The reason for this informational hole is that SEER data includes the incidence of new cases at each stage, and mortality from the disease, but does not include numbers on stage conversion – when a woman who had early-stage disease relapses with Stage IV (MBC). There’s astonishingly little current data about on how long women live, on average, after relapsing.

20 years ago, oncology fellows learned that the median survival of women with MBC was around 3 years. Now, that is pretty much still what doctors tell patients, but there’s a sense that the picture is no longer so bleak. Much of what we know about survival of women with MBC comes from clinical trials of patients with particular subtypes (e.g. Her2+ or negative disease). That information, on subtypes and responsiveness to particular drugs, is crucial. But we also need to know the big picture, i.e. exactly – give or take a few thousand women – how many are alive now with MBC?

This information might inform research funding, planning of medical and social services, besides understanding the course of the illness and extensiveness of this problem. And if survival has indeed improved, that measurement, straightforward as it should be, might offer hope to those living with the disease, today.

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ACS Issues Annual Report on Cancer Stats: Some Key Findings, and Notes on Survivorship

ACS (annual report header)

This week the ACS released its annual report on Cancer Facts and Figures in the U.S. The journal Cancer analyzes and considers the data in a helpful articleSome of the key and mainly positive findings have been covered elsewhere:

Between 1990 and 2008, death rates from cancer in the U.S. declined rather steadily, overall, by 22.9% in men and 15.3% in women. More recently, between 2004 and 2008, the incidence of cancer has declined slightly in men (0.6% per year) but it’s been stable in women. During this most recent period for which complete data are available, the overall death rates continued to drop – by 1.8% in men and by 1.6% per year in women.

This is generally good news. Still, the total number of people in the U.S. who will receive a new cancer diagnosis in 2012 is estimated at 1,638,910. Some 577,190 people will die of a malignancy, which approximates to 1,500 cancer deaths per day in the U.S. Cancer is second only to heart disease as the cause of death in North America. Most cancers, some 77%, arise in people aged 55 or older; conversely, approximately 23% arise in people under 55 years of age. The NIH estimates that in 2007, direct health expenditures for cancer in the U.S. totaled $103.8 billion.

Some notes on survivorship:

The latest estimate is that 12 million people are alive in the U.S. after a cancer diagnosis. This number includes people who are undergoing treatment and many who are in remission. Another encouraging detail: from 1975-77, the overall 5-year survival was just 49%. Now, between 2001 and 2007, overall 5-year survival stands at 67%. In other words, in 1975, just over half of cancer patients died within 5 years of their diagnosis; by 2007, two thirds of cancer patients were alive at 5 years.

The report includes a critical section on a few kinds of cancers for which the rates are increasing. These include cancer in the oropharynx (mouth and throat) associated with human papillomavirus (HPV); esophageal cancer (adenocarcinoma type), melanoma and tumors of the pancreas, liver, bile duct, thyroid, and some kinds of kidney cancer. The Cancer journal has a separate article on these.

The full and detailed document, at 68 printed pages, deserves close review in many particulars. Next week I’ll go over the new data for breast cancer.

All for now,

ES

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Blood and Hip Surgery: New Study Supports Fewer Transfusions

Under the radar, over the holiday week, the NEJM published a report on transfusion requirements in older adults who surgical hip repair. The main finding is that most patients, including the elderly and those at risk for cardiac complications of the procedure, don’t benefit from getting so many red blood cell transfusions as is commonly prescribed.

The study, funded by the NHLBI, involved more than 2000 adults over 50 years of age who underwent hip surgery. Overall the patients were quite elderly, with a mean age above 80 in each group. The trial included patients with heart disease and risk factors for cardiac complications. Participants were randomized to receive red blood cells if their hemoglobin fell to a level below one of either two thresholds: 10 or 8 gm/dl. What happened is that, at the time of discharge from the hospital and by 60 days after the procedure, the rates of death, coronary syndrome and other complications were the same.

An accompanying editorial weighs in on the study and conclusion, that a standard threshold for ordering transfusions in the context of major hip surgery might be lowered. Reducing transfusions would lower demands on the blood supply, lessen the costs of administering these infusions, and reduce complications from infected or otherwise-damaging pints.

The study is important because it bolsters the evidence that too many units of blood are administered routinely.  Sometimes with good reason, busy surgeons recommend a threshold for what’s almost an automatic order that blood to be given. If there is such a threshold in a SICU (surgical ICU), operating room or elsewhere, this report suggests it’s often too high.

It would be better, for sure, if transfusions were ordered on a case-by-case basis, with input by a doctor who would assess each patient’s baseline level of hemoglobin and other relevant factors. For example, a patient who’s been anemic for years may tolerate a lower hemoglobin level than someone who’s never been anemic before, or whose lung function is marginal.

Still, the main take is that many patients undergoing surgery need less blood than their doctors realize, and that we can safely, overall, reduce the number of transfusions ordered for many patients, even in those who are older and with risk of heart disease.

What patients might do: if you’re going to have major surgery, talk with your doctor about whether you might need blood and how the surgeon will decide if you need blood or not, and how much. If you have a strong preference to avoid transfusion, let your doctor know about that and discuss how you might avoid getting unnecessary pints.

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What Causes Breast Cancer? Reviewing the IOM Report on BC and the Environment

Earlier this month the IOM issued a big report on breast cancer and the environment. The thick analysis, commissioned and sponsored by the Susan G. Komen for the Cure®, was authored by an expert panel. Their task – to assess all available information on what causes BC, and make recommendations accordingly – was essentially impossible. Some immediately critiqued the work and, perhaps implicitly, the funding – for its failure to yield sharp or clearly-actionable insights into BC causes.

The document starts, blandly, with some straightforward stuff. The recommendations for lifestyle changes seem paternalistic when not obvious. Where the report gets interesting, and offers value, is in considering a few specific environmental toxins that might be causative in the current breast cancer epidemic. While proving that any one (or several) of the chemicals listed below causes  BC will be difficult, developing a clear, working list of likely compounds that merit research attention is an important step.

Some background:

Each year, over 230,000 women in the U.S. develop a breast tumor. The problem, in terms of preventing breast cancer, is that most established risk factors – like being older, later age at menopause, being young at the time of first menstruation and some genetic traits – aren’t amenable to intervention.

For this project, the IOM committee interpreted the term “environment” broadly – it considered all possible causes of BC that aren’t directly inherited through DNA, including factors that might influence a genetic disposition. They looked at a wide range of exposures: “how a woman grows and develops during her lifetime; what she eats and drinks; the physical, chemical, and microbial agents she encounters; how much physical activity she engages in; medical treatments and interventions she undergoes; and social and cultural practices…”

What they found, with my comments interspersed and conclusions:

The most convincing evidence linked BC to hormone therapy with estrogen and progesterins, ionizing radiation (as might occur in medical procedures like CT scans; the amount of radiation in mammography is too low for concern, the committee emphasizes), excess weight (i.e. being fat, or more-than-fat) in postmenopausal women, and alcohol (addressed here, previously).

Where they found no clear link: smoking (surprise! the evidence is limited, they say), personal use of hair dyes, non-ionizing radiation (like that emitted by microwaves and other electrical devices).

On the up side: Physical activity appears to lessen a woman’s breast cancer risk.

Quite a few factors fell into a gray zone, for which “the evidence is less persuasive but suggests a possible association with increased risk.” These are: exposure to secondhand smoke (this might be a cause, but smoking isn’t? seems unlikely, ES), nighttime shift work (steroids/stress effect? Or just too much junk food).

Finally, they name some chemicals: benzene, ethylene oxide, or 1,3-butadiene (these may be present in some workplaces; one might be exposed from breathing auto exhaust, pumping gas, or inhaling tobacco smoke, they indicate) and bipsphenol A (BPA) – one of the “biologically plausible hazards in the environment.” As they indicate, animal data provide clear evidence for a mechanism by which BPA, which is widely-used in plastic containers and food packaging, might cause breast cancer. “But studies to assess the risk in humans are lacking or inadequate.”

The IOM committee study authors consider the difficulties in testing environmental hazards. Of course, as they point out, it wouldn’t be ethical to deliberately expose women to potentially harmful substances in a clinical trial. For this reason, they advocate more research in animals and in vitro systems. But those kinds of experiments are limited, in their words: “they can provide indications that a chemical or other agent may cause harm, but these models are approximations of human experience.”

So we’re stuck with a lot of inconclusive data, and an obvious moral imperative not to systematically test the effects of possible environmental toxins on women who might develop BC. There’s a table posted, with strategies to reduce risk, but it recommends for the most part obvious things, and an annoyingly-toned paragraph:

These actions include avoiding unnecessary medical radiation throughout life, avoiding use of postmenopausal hormone therapy that combines estrogen and progestin, avoiding smoking, limiting alcohol consumption, increasing physical activity, and, particularly for postmenopausal breast cancer, minimizing weight gain. Some of these actions may have additional health benefits beyond their potential contribution to reducing breast cancer risk. In many cases, women can be aided by the actions of others, including their families and health care providers.

(Why don’t they just say: “be a good girl, get rest, and stay slim?”)

The segment on the future and needed research emphasizes the need for research on early-life exposure to chemicals, pre-menopausal obesity, and other factors that may influence development of BC later on in a woman’s life. This makes sense to me.

The most troubling findings have to do with the chemicals. Carcinogens like benzene are hard to put a finger on, when it comes to causing cancer in a population where cars are abundant and oil leaks often, and occasionally abundantly, into large gulfs of water. The BPA issue is a genuine concern, with little clear data in humans. Until those data are evident (which, if it takes decades to show the effects on youngsters exposed who develop BC in, say, their 40s), will not be for a while – you have to wonder if doctors should recommend more drastic steps to avoid routine exposure to and ingestion of potentially toxic chemicals.

If you’d like to read about this report and some of the concerns about chemicals that might cause BC, I recommend this post by Julia Brody, of the Silent Spring Institute.

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Noting the Death of Christopher Hitchens from Esophageal Cancer

The author is saddened to learn that Christopher Hitchens died late yesterday evening at the age of 62, roughly a year and a half after receiving a diagnosis of esophageal cancer. He was a prolific and articulate man; I respected him for his words.

His essays on the language and cancer might be of particular interest to some readers of this blog.

The NCI reports there are some 17,000 new cases of esophageal cancer in North American each year; it’s not a common tumor, and most cases arise in men. The annual number of deaths from esophageal cancer approaches 15,000 in the U.S. These numbers are telling: it’s not an easy disease to have, or to treat.

——

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Quote of the Day: On Death Panels and the Insurance Industry, From Dr. Donald Berwick

Dr. Donald Berwick left his position last week as head of CMS. He said this, as quoted in the WSJ’s Washington Wire, yesterday:

“Maybe a real death panel is a group of people who tell health care insurers that is it OK to take insurance away from people because they are sick or are at risk for becoming sick.”

I couldn’t agree with him more.

All for this week,

ES

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Learning From the San Antonio Breast Cancer Symposium, At a Distance

There’s a ton of BC and women’s health news this week. But yours truly is, among other things, not in San Antonio where is the 34th annual San Antonio Breast Cancer Symposium.

NTW, quite a few major news outlets are covering this business closely and carefully, as are some bloggers I know. Upon reading the news, I was simultaneously impressed by the number of new drugs for metastatic breast cancer that are being tried, and daunted upon realizing how difficult (read: IMPOSSIBLE) besides costly it’ll be to sort out these drugs used in so many combinations. Rather than recapitulating the data, some of which was published on-line this week in the NEJM, and most of which are still preliminary, I thought I’d just list some of the drugs being tested, and add a bit about how they’re administered and might work:

Entinostat is an oral histone deacetyalase (HDAC) inhibitor that’s not yet available in the US by any prescription off protocol.

Everolimus is a tablet (i.e. a pill) designed to inhibit an enzyme called mTOR. It’s sold for use in some cancers under the brand name Afinitor.

Exemestane is a tablet that reduces estrogen production. It’s an aromatase inhibitor sold as Aromasin. (This drug was approved by the FDA in 2005; it’s not quite so new, but is being tested in distinct settings, mainly in women with early-stage BC.)

Pertuzumab is a monoclonal antibody that binds Her2, in a distinct way from Herceptin.

Obviously this is but a partial list of drugs discussed at the meeting. Still, it’s heartening to this one oncologist to review even a short list of diverse new agents that might arrest the disease.

The history of the SABCS is interesting.  From the organization’s website:  the first meeting was held in November 11, 1978 during what’s said to have been “Breast Cancer Awareness Week.” The original conference’s sponsors included the Cancer Therapy and Research Center (CTRC, at UT San Antonio), the Texas Division of the ACS, the University of Texas Health Science Center at San Antonio (UTHSCSA) and the Bexar County Medical Society. Some 141 physicians and surgeons attended what’s described as one-day course.

It grew…

Now, the SABCS hosts a 5-day program with physicians, scientists, patients, advocates, reporters…from around the world. It’s jointly-sponsored by the CTRC and American Association for Cancer Research (AACR) and the Baylor College of Medicine.

The Alamo (WC image)

Next year, maybe I’ll go to the 35th annual event, and see what’s really happening in San Antonio.

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