New Directions

Dear Readers,

Your author is en route to Chicago to attend the annual meeting of the American Society of Clinical Oncology. It’s the first time in years I’ll be there, and I’m looking forward to it – the next phase of my career, a blend of academics and new writing.

So it seems a fitting time to put this blog on hiatus. Not to worry, as always, I’ll pay attention to the conference proceedings. I’ll take extensive notes on cancer science and drugs. And I’ll see some old friends in the Windy City.

You will hear from me again soon!

To all of my readers, and especially those who have commented here or otherwise connected through Medical Lessons over the years, I say thank you. I’ve learned a lot, and not just about medicine.

Moving forward,

ES

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By |May 30th, 2014|from the author, Life as a writer, Medical Education, Oncology (cancer)|0 Comments|
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Get Cancer. Lose Your Job?

 

Let’s start with this fact: If you are employed and get a breast cancer diagnosis, it’s less likely you’ll be working at your job four years later. A newly-published study of women in Los Angeles and Detroit found that among women less than 65 years with limited-stage breast cancer, 76 percent had a paying job at the time of their diagnosis. Based on follow-up surveys of the same women four years later, the number employed was reduced by 30 percent. That’s a huge drop.

The study was just published on-line in the Cancer Journal. The authors, including a corresponding and lead author in a department of radiation oncology at the University of Michigan, make a point in the paper’s title, Impact of Adjuvant Chemotherapy on Long-Term Employment of Survivors of Early-Stage Breast Cancer, that chemotherapy may be to blame. And there’s some truth in this. Chemotherapy causes fatigue and, occasionally lasting problems such as neuropathy, heart weakness and chemobrain that might limit or impair a person’s capacity to work effectively.

On the other hand, the likelihood of developing many of those chemo-related effects depend on the dose and regimen selected. Radiation, often, causes fatigue, and – when administered to the chest, can cause premature heart disease (atherosclerosis) and lung problems, besides secondary tumors as a late consequence of treatment. It happens, though, that hormonal treatments, like Tamoxifen, can cause chemobrain too.

As someone trained to give chemotherapy, I’ll point out that none of these options for adjuvant treatment (what’s given to patients with limited disease to lessen the likelihood of recurrence) is a walk in the park. Each bears the potential for short and long-term toxicity. So I don’t blame chemotherapy in particular, although the study authors emphasized that as a culprit based on a low-level statistical correlation.

More broadly –

This news comes as no surprise. I know too well how women at work may be treated after a breast cancer diagnosis. I am privy to the stories of dozens of women who say they were unduly turned down for promotions or good assignments, opportunities…Upon returning to work, if they took time off (which some didn’t, such as your author, during her BC treatment), they  – if they take pride in their work – find themselves missing their own doctors’ appointments, exercise and other aspects of survivorship care, just to “prove” that they’re still valuable to their office, team, business.

The harsh reality is that people who have had cancer treatment are sometimes perceived as a burden on a working group: a consultant who can’t travel quite so much, a sales rep who looks less beautiful, a nurse who has to take an occasional half-day off for a check-up. Some bosses worry, although you’d be hard-pressed to find this in writing, that an employee who had cancer treatment may suffer a recurrence, and so she can’t be counted on – no matter how capable and motivated she may be – to lead a fellowship program, or to complete an ambitious project.

What would help is for doctors to guide patients with more nuanced advice, to avoid over-treatment. And patients should ask their physicians, based on their circumstances, for the least therapy that makes sense based on the size and molecular details of their tumor, to avoid long-term toxicity. And for employers to treat their workers who have illness – and not just breast cancer – as potentially valuable workers, contributors, over the long haul.

 

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By |April 28th, 2014|Breast Cancer, cancer survival, cancer treatment, Essential Lessons, health care costs, Life, Life as a Patient, Medical News, Women's Health|3 Comments|
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Palbociclib Appears to Prolong Progression Free Survival in Women with Metastatic Breast Cancer

Yesterday researchers at the annual AACR meeting announced the results of a clinical trial of a new drug with activity in some forms of breast cancer. Palbociclib (PD-0332991), a pill developed by Pfizer, was tested in women with metastatic breast cancer cells with estrogen receptors and lacking Her2. These ER+/Her2- tumors represent the most common breast cancer subtype, which is one reason so many people are eying the results of this relatively small, randomized study.

The phase 2 trial, called PALOMA-1 included 165 post-menopausal women with advanced ER+/Her2 negative disease. The research subjects were assigned to take either Letrazole (Femara, an aromatase inhibitor, a drug that inhibits estrogen synthesis) alone, or Letrazole and also the experimental drug, Palbociclib. The study found a highly significant difference in progression free survival (PFS), the intended endpoint: the mean time until disease progressed was 20.2 months among women who took Palbociclib, as opposed to 10.2 months for those assigned to Letrazole alone. The p-value for the difference between the arms (1-sided) was 0.0004. That’s a powerful  result.

But there was no statistically significant difference in overall survival between the two groups, a fact that was irksome to some observers, particularly in the biotech investment world, and to some who were reminded of the Avastin story and its fall-out. Most of the women lived for approximately 3 years after enrolling, with a trend of a few months favoring the Palbociclib arm. Another problem is that over half the patients were recruited to the study based on biomarker results, having to do with cyclin D1 amplification and/or loss of p16. So it could be the results are more relevant to breast cancer patients who have those particular changes. How those molecular features, enriched in the final study population, relate to Palbociclib’s usefulness in breast cancer and other tumor types warrants more evaluation, for sure.

My feeling is that this may prove to be a useful drug, not just in breast cancer. Any medication which interferes with cell growth by blocking cyclin-dependent kinases (enzymes) called CDK-4 and -6 could be useful in quite a few malignancies. The main side effect was suppression of the bone marrow (low blood cells). Some questions I’d like to ask the researchers, and which I hope they’ll address in the Phase III study, is if certain types of mets (e.g. lung vs. bone) or certain molecular subtypes are more tempered by this drug.

As for 10 months of PFS – if it pans out in a formal, published work, that’s valuable. Imagine that you’re 55 years old and living with metastatic breast cancer. A drug that is likely to delay, by most of 2 years, your tumor’s expansion into the lungs (causing shortness of breath), or bones (causing fractures and pain) or liver, and elsewhere can be worth a lot. It’s about the quality of life, whether or not it’s extended.

One final concern is that this study wasn’t blinded, so the doctors’ assessment of how the patients were doing, and the patients’ assessment of how they were feeling,  may have been influenced by their knowing which arm they were on. Also, because this new drug is a pill, some insurance may not cover it – a policy issue that applies to many new cancer drugs.

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By |April 7th, 2014|Breast Cancer, cancer survival, cancer treatment, Medical News, Oncology (cancer), Pharmacology|2 Comments|
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JAMA Review on Mammography Points to the Need for Better Ways to Advise Women and Detect Breast Cancer

It’s hard to argue with the findings and conclusions of a new paper in JAMA put forth by Drs. Lydia Pace and Nancy Keating, both physicians with public health degrees and appointments at Harvard-affiliated hospitals. The article, published on April 2, has generated a predictable round of headlines along the lines of “Large Study Finds Little Benefit in Mammography.”

You might, while reading or hearing about this news, wonder about the value of yet another study on breast cancer screening. And you might, if you are following this blog, wonder why I remain convinced that mammography – when done right – has the potential to save many women’s lives and, what’s more, to spare even more from the physical, financial and emotional toll of prolonged treatment for advanced-stage disease.

Why I still think that breast cancer screening is a good idea for most middle-aged women (selected, from a longer list):

1. Several valid studies, most notably that from Sweden, have shown a significant survival benefit of breast cancer screening over the long term. These findings, which demonstrated a benefit to women screened in their forties, received little attention in the news.

2. Mammography is not all the same. It’s not a simple, black-and-white or numeric readout. The “result” depends a lot on the radiologist who interprets the images. Some radiologists, by their training and expertise, deliver lower false positive rates and higher true positive (malignant) “pickup” rates. To say that mammography doesn’t work, based on studies over a population, discounts the potential (and likely) benefit of having the procedure done by experts.

3. Pathology methods have improved over the past three decades. Some doctors, including epidemiologists and PCPs, may not be aware of new tools for evaluating tumors that lessen the risk of over-treating early-stage and indolent tumors.

4. Longer survival is not the only benefit of mammography. Late detection involves risks, and costs. “Screening neglect,” as some researchers call it, adds intensity to needed treatment when patients first seek care for advanced disease. This was the focus of a recent paper in the American Journal of Roentgenology that got little press except for the Cleveland Plains Dealer. The investigators in that careful but retrospective analysis found that among women in their forties, breast cancers detected in routine mammograms were significantly smaller than those detected in women who waited until they felt a lump or had symptoms. That finding was no surprise. But what mattered is that the difference in size of invasive breast cancers found – between screened and unscreened women – translated to less chemotherapy for those screened. The point: finding breast cancer early can reduce the need for toxic and costly treatment.

In reading the new JAMA paper, “A Systematic Assessment…” it seems like the authors are giving a well-prepared talk. Essentially it’s a review of reviews on mammography. Yes, it’s that “meta.” They examined the literature on mammography, going back to 1960 – but with an appropriate emphasis on more recent studies, to address 4 (huge, complex) questions: 1) what is the benefit of mammography screening, and how does it vary by patient age and risk?; 2) what are the harms of mammography screening?; 3) what is known about personalizing screening recommendations?  4) how can patients be supported to make more informed decisions about screening?

This is an ambitious set of questions, to say the least. The tables provided, which are for the most part inconclusive, draw heavily on findings that vary in the era of data collected, methods of analysis, and reasonableness of authors’ assumptions, i.e. validity.

But there is no news on mammography here, except that these two thoughtful investigators carefully reviewed the literature. There are no original data in this ambitious analysis, i.e. there is no new information about mammography’s effectiveness, the false positive rate, the harms of screening, overdiagnosis, etc.

Unfortunately the article, at a glance, may add to the growing perception among journalists, primary care physicians who may not read below the paper’s title, and others – including many ordinary women – that mammography’s effectiveness has been, again, disproved.  And so if journalists cover this “story,” as they have and will, our collective memory will incorrectly recall another negative finding, which this is not.

The authors’ main conclusions are that decision aides may be helpful, and that developing better ways of screening for breast cancer would be even better than that. I agree.

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By |April 2nd, 2014|Breast Cancer, cancer screening, journalism, Oncology (cancer), Public Health, Women's Health|3 Comments|
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Shirley Temple Made It Easier to Talk About Having Breast Cancer

If a former film star held a press conference today about having breast cancer, she would hardly make history by doing so. Unless she were exceptionally young or famous for her gorgeous body, a celebrity’s cancer announcement might receive less attention, in itself, than scrutiny over her treatment decisions. Parade lists dozens of famous individuals who have “come out” with a breast cancer diagnosis.

Shirley Temple in 1944 (Wikimedia image)

Shirley Temple in 1944 (Wikimedia image)

Yesterday, Shirley Temple Black died at the age of 85 years. In the fall of 1972, the former actress had a mastectomy to remove a tumor from her left breast. She was 44 years old. Within days after surgery at Stanford Hospital in San Francisco, she spoke to the media about her condition. She advised other women not to be afraid to see a doctor if they noticed a breast lump. Newspapers around the country reported on her surgery, and advice. “There is almost certain recovery from this form of cancer if it is caught early enough,” she said. Her intention was to encourage other women to not be afraid of seeking care for breast cancer.

In that era, her message was one of empowerment. In the early 1970s, many women were terrified of having a malignancy. If they felt a breast lump, they might wait months or years, until it grew through to the skin, eroding it, or spread to other body parts, eventually causing pain or death. The message of early detection, which some experts now question, was considered an imperative by almost all authorities – surgeons, medical oncologists and public health experts.

I must admit, I’ve never been a fan of Shirley Temple’s “baby burlesk” style of cuteness, curls and twirls. I acknowledge what historians say, that as a girl she delivered smiles and good cheer when she appeared in Depression-era films. Some of her most famous scenes, like singing “On the Good Ship Lollipop” in Bright Eyes, or dancing with Mr. Bojangles (Bill Robinson) in The Little Colonel, do bear a certain charm, or interest, through time.

Shirley Jane Temple was born on April 23, 1928. She retired from acting at 22 years, around the time she married Charles Alden Black. In the 1950s she entered the political realm, raising money for the Republican Party. In the 1960s, she conveyed support for the war in Vietnam. While Nixon was President, she served as a delegate to the United Nations and ambassador to Ghana. She held positions in the administration of Gerald Ford and, later, under George H. W. Bush as ambassador to Czechoslovakia. She was, most certainly, a woman with whom I might have had some serious disagreements at a dinner table.

What I choose to remember about Shirley Temple is that she lived for 41 years after having a mastectomy for breast cancer in 1972. She spoke openly about her medical condition, and encouraged other women to seek medical care if they noticed a lump. In doing so, she may have saved more than a few lives. And she made it easier for us, today, to talk about breast cancer, options, and long-term effects of treatment.

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By |February 11th, 2014|Breast Cancer, cancer awareness, Communication, Public Illness, Women's Health|0 Comments|
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More on Mammography, Breast Cancer, Misleading Arguments, Emotion and Women’s Health

It’s a holiday week. But when this morning’s paper delivered yet another op-ed by Dr. H. Gilbert Welch, citing (and breaking an embargo on) yet another, misleading and manipulative two-author analysis of breast cancer screening by him and one other scientist, I thought it worth documenting some concerns.

I’ll start by mentioning that Dr. Welch and I seem to agree on one point – that women should have access to information so they might make reasoned decisions about breast cancer screening. He refers, also, to controversy among professionals about the relative benefits and harms of screening mammography. That there is debate is incontrovertible. No argument there.

The problem is that educated, middle-aged women are being nudged, and frightened, or even charmed into not going for mammography. Nudged, by papers like the one in JAMA today, which acknowledges controversy about statistics and then suggests a falsely low range for lives saved per number of women who get screened. Frightened, by headlines that highlight the risks of overdiagnosis, a statistical concept. If a woman finds out she has an early-stage breast tumor, she and her doctor can (and should) actively decide how much therapy she should have based on the molecular subtype of her tumor, stage and other factors. Just because you find a Stage 0 or small tumor by screening, doesn’t mean you have to over-treat it. If medical education were what it should be, there would be little or no overtreatment because doctors would discuss appropriate options with women and not advise them to have too much therapy. And charmed, yes – by the false notion that breast cancer is often nothing to worry about, that in many cases it can be let alone. That it might just disappear.

I am not aware of a single pathology-documented, published case of a breast tumor going away on its own. Yes, there are slow-growing tumors that may not do harm. But those tend to occur in older women. Those cases are, in general, irrelevant to discussions of breast cancer screening in women between the ages of 40 and 60 or so. What matters most in assessing screening benefits is the number of life-years saved, which is potentially huge for women in this age bracket, and quality of life changes due to the intervention, as assessed over decades.

Mammography (Wikimedia image)

Mammography (Wikimedia image)

For today, I’ll point to just a few issues in the JAMA paper. The authors state that among 1000 U.S. women age 50 years who are screened annually for a decade, “490 to 670 will have 1 false alarm.” But as detailed in Table 2 of their paper, it turns out the range for women who undergo false-positive biopsies is far lower: between approximately 50 and 100 per thousand women, depending on the age group and study from which the authors draw the “data.” What that means, according to the numbers they’ve culled from studies of non-specialized radiologists, is that only 1 in 10 women would undergo a breast biopsy, and not have cancer, per decade of screening. So the numbers of false positives involving biopsy are not so high.

Most of the false positives are callbacks for additional imaging. Welch and his colleague talk about frequency and anxiety produced by “false alarms.” They go as far as to cite studies documenting that “anxiety may persist for at least 3 years and produce psychological morbidity…” But if women appreciated the data to support that, in most cases – approximately 85 percent – breast cancer can be removed and metastatic disease avoided, over the long haul, by early detection, most of us, and certain anyone making decisions based on reason, wouldn’t mind the follow-up and worrying about irregularities noted on a screening test. Most of us can handle the emotional aspects, and uncertainty, of screening over the course of a few days. To suggest otherwise is patronizing.

Years ago, breast cancer screening was widely considered an act of empowerment, a way for women to take control of their bodies, and to avoid the disfiguring and sadly lethal effects of late-stage breast cancer, besides the potential need for treatment until the end of life. Now, mammography is more accurate and involves less radiation than ever before. Women might be demanding universal access to better, state-of-the-art facilities, rather than shying away from the test.

As for those women who do get called for needle breast biopsies, I say that’s not such an onerous prospect. What’s key is that the procedure be done under local anesthesia, under imaging (typically ultrasound) guidance in an office by a skilled radiologist. The sample should be reviewed by a well-trained breast pathologist, and molecular studies evaluated in a central lab that routinely runs those kinds of tests.

Finally, in the end of today’s op-ed, Welch suggests that the way to reduce uncertainties about breast cancer screening is to carry out costly and somehow randomized clinical trials to see how much and how often screening is needed to demonstrate a survival benefit. But, as his tone suggests, I suspect he doesn’t really favor investment in those clinical trials.

The fact is, I don’t either, at least not for mammography at this point in the U.S.  As I and others have pointed out, it takes 15 – 20 years of follow-up in a trial to demonstrate that screening and early detection reduce breast cancer deaths. In North America, the availability of mammography correlates with a reduction in mortality from breast cancer by over a third. He and others have attributed improvements in survival to better treatments. I and others would suggest that while therapy has improved quite a bit since 1985, the greatest benefit derives from most women avoiding the need for life-long treatment by having small tumors found and removed before they’ve spread. This applies in over 80 percent of invasive cases. The survival boost is from the combination, with early detection playing a significant (large) role in the equation.

Why I don’t support starting new randomized trials for mammography, besides that they’d be costly and hard to carry out, is that we can’t wait 20 years to know how best and often to screen women. Rather, it would be better to spend those theoretical research dollars in finding how to prevent the disease. If in 20 years breast cancer is less common, as we all hope will be the case, and true positives are rare, screening of the population won’t be needed. (If breast cancer rates do climb, Bayes’ theorem would support screening, because the positive predictive value of the test would, unfortunately, be higher.) Either way, by 2034 the technology would have improved, or we might have a valid alternative to mammography for screening, and so the studies would be, again, out of date.

It would be better to spend what resources we invest in mammography on improving the quality of screening facilities, now, so that women who decide to go for the procedure can, at least, know that it’s being performed with modern equipment and by doctors and technicians who are capable of state-of-the-art procedures involving the lowest level of radiation exposure possible, careful reading of the images, and application of sonography to further examine the appearance of women with dense breasts, when needed.

All for now.

I wish all my readers a happy and healthy 2014,

ES

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By |December 30th, 2013|Breast Cancer, cancer screening, clinical trials, Communication, Medical News, Oncology (cancer), Women's Health|0 Comments|
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Birth of the Metastatic Breast Cancer Alliance

This week marks 11 years since my breast cancer diagnosis. My feelings are mixed. On the one hand, I’m keenly aware, and constantly appreciative, of the fortune of being alive and, as far as I know (knock on virtual wood), free of the disease. That’s great, of course, but I’m lucky – so far at least, still vying not to be cast off by some strange turn of statistical, informed roulette. I can’t help but think, especially today, of my countless BC “sisters” with metastatic disease.

October 13 is Metastatic Breast Cancer Awareness Day. In 2009, the U.S. Congress voted to designate this day for attention to the particular needs of people with metastatic breast cancer (MBC). Although it’s been unofficial since that year, the day has been adopted by several breast cancer agencies as a time to rally in support the cause – and needed research – for people affected by MBC.  For people who are living with MBC, the immediate goals are not so much to prevent breast cancer, or necessarily to cure it, but to find better treatments so they can live longer and fuller lives.National Metastatic Breast Cancer Awarness Day avatar 180 by 180 px

The number of women living with metastatic breast cancer is unknown. Almost all deaths from the disease occur in people who have advanced or metastatic (Stage 4) cases. This year, some 40,000 women and 400 men will die from breast cancer in the United States. According to the Centers for Disease Control, cancer is the number 1 cause of death in women between the ages of 35 and 64 years. Only lung cancer accounts for more cancer deaths among women. Almost all deaths from breast cancer occur in women with Stage 4 disease. The World Health Organization reports that approximately 458,000 will die from breast cancer this year, around the globe.

These are the kinds of numbers that can be hard for some people to face, or think about too much. Deaths from breast cancer amount to 110 people each day in the U.S., or 1,255 each day, around the globe. I’m thinking of a lecture room of women every day in the U.S., or a train’s worth.., every single day, on average. Hard to envision. But it’s almost impossible not to get the message if just one woman, perhaps at the table over a lunch meeting, tells you about her daily life with relapsed or otherwise metastatic disease, and no end of treatment in sight.

If you break the deaths down by age group, as does the American Cancer Society in its most recent report on Breast Cancer Facts & Figures, you’ll find these numbers in Table 1: over 1,000 women die of breast cancer each year under the age of 40 years; an additional 4,780 die under the age of 50; almost 12,000 die between the ages of 50 and 64; the remainder of BC deaths (nearly  23,000) occur in people age 65 and older. The overwhelming proportion of cases arises in women, although there’s a trend of more cases in men. The median age of a breast cancer diagnosis is 61 years; this is largely a disease of middle-aged women.

Some encouraging news on the research front, besides new drugs in the pipeline and ongoing trials, is the formation of a new, cooperative coalition of breast cancer charities that will work together to address the problem MBC. The new Metastatic Breast Cancer Alliance includes a spectrum of pink and gray agencies, young and old, working together. The main thing is to promote knowledge and research about breast cancer metastases – to reduce formation and growth of metastases, and to treat those affected with better, less toxic meds.

I’m delighted to see an example of BC agencies working together, constructively. Sure, each group has its particular priorities and “personality,” if you will. But we all want to end misunderstanding, and we all hope to improve the lives of people living with Stage 4 disease. Breast cancer is not “easy.” It’s serious and life-destroying. The more research and scientific attention that we devote to men and women with metastatic breast cancer, the more likely will be an extension of their survival, and improved quality of what lives they’ve living, now and hopefully in the future.

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By |October 13th, 2013|Breast Cancer, cancer awareness, cancer survival, Oncology (cancer), Women's Health|0 Comments|
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Good News from SCOTUS on Gene Patents, But Questions Remain

Today the U.S. Supreme Court issued a unanimous decision on the Myriad Patent case, having to do with the company’s ownership of BRCA-1 and BRCA-2 gene sequences. The main opinion, authored by Justice Thomas, says this:

“A naturally occurring DNA segment is a product of nature and not patent eligible merely because it has been isolated, but cDNA is patent eligible because it is not naturally occurring.

At first glance, this is terrific news for patients world-wide. It means is that no company, university, other entity or individual can patent human genes.

Keep in mind – the case doesn’t just apply to BRCA and evaluating a person’s risk for breast and ovarian cancers. Rather, there are hundreds of human genes implicated in cancer that are potential targets for treatment, that might be evaluated, and thousands linked to other diseases. The decision continues:

“Myriad did not create or alter either the genetic information encoded in the BCRA1 and BCRA2 genes or the genetic structure of the DNA. It found an important and useful gene, but groundbreaking, innovative, or even brilliant discovery does not by itself satisfy the… <patent law>

West façade of U.S. Supreme Court Building. (Franz Jantzen)

West façade, U.S. Supreme Court (Franz Jantzen), gov’t image

What’s clear is that gene sequences, as they occur in human cells, can’t be owned just because they’re found, no matter how important they are. This circumstance should allow other researchers and firms to create cDNA from the natural sequences to develop new (competing and potentially less costly) assays and, even better – do their own work – tantamount to providing “second” and “third” opinions (etc. & n.b. IMO more is better!) research to understand how the genes lead cause disease in some people and might targeted for therapy. Great –

But the decision suggests that many lab-generated complementary DNA (cDNA) strands remain patentable, or up for grabs once created – which may be the reason some biotech stocks have rising values today. I’m neither a lawyer nor an analyst, but I do know from my experience as a researcher that it’s essentially trivial to generate cDNA from a short DNA segment, potentially with a mutation of interest. So how might the cDNA be patented, if anyone who has access to the original genetic sequence might form the cDNA by routine lab methods?

Near the end of the opinion, the justice writes:

“…but the lab technician unquestionably creates something new when cDNA is made. cDNA retains the naturally occurring exons of DNA, but it is distinct from the DNA from which it was derived. As a result, cDNA is not a ‘product of nature’ and is patent eligible under <patent law §101>, except insofar as very short series of DNA may have no intervening introns to remove when creating cDNA. In that situation, a short strand of cDNA may be indistinguishable from natural DNA.

The document clarifies the cDNA issue just slightly:

“It is important to note what is not implicated by this decision. First, there are no method claims before this Court… the processes used by Myriad to isolate DNA were well understood by geneticists at the time of Myriad’s patents ‘were well understood, widely used, and fairly uniform insofar as any scientist engaged in the search for a gene would likely have utilized a similar approach’…

Nor do we consider the patentability of DNA in which the order of the naturally occurring nucleotides has been altered. Scientific alteration of the genetic code presents a different inquiry, and we express no opinion about the application of <patent law §101> to such endeavors.

How I interpret this is that if a researcher generates a short cDNA segment based on a gene, that’s not patentable, but if it’s a long strand involving lots of clipped introns, that might be patentable.

Taking in all this, which is far from simple, I have a question and a wider point:

What goes unaddressed by the justices is the patentability of cDNA based on common genetic variants in cancer. Those are “naturally occurring” mutations, inasmuch as they arise in humans. But the cDNA generated from those sequences might remain patentable. There are loads of examples in this regard: Consider, for example, the genetic mutations in EGFR, and ALK, that are used in lung cancer diagnosis, treatment decisions and development of new targeted drugs. In the current issue of the New England Journal of Medicine, doctors report on SALL4, a gene that occurs in some liver cancers and might be a good, useful target for therapy in that disease.

The point is that the Supremes – and those would be lawyers – need to know about biology. Justice Scalia, sadly in my view, wrote his own opinion not because he disagreed with the others, but because he felt there was too much science in the decision. From the Scotus Blog today:

“Many readers no doubt will share the view of Justice Antonin Scalia, in a short, separate opinion refusing to join in a section “going into the fine details of molecular biology,” of which he said he had neither knowledge nor belief.  Scalia said he did understand enough …

This scares me, that one of the Justices, our most accomplished lawyers who might make decisions on cloning, and stem cells and who knows what in the future, copped out because he lacks science education – what should be required high school biology in  U.S. schools, public and private – to form an opinion that matters so much.

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By |June 13th, 2013|Genetics, Medical News, Oncology (cancer), Science|0 Comments|
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On Friends Affected by Cancer, and Environment Oncology

Dear Readers,

Yesterday I learned that a woman I know slightly, a journalist, has Stage 4 lung cancer. Debra Sherman is a reporter for Reuters and began a blog, Cancer in Context.  It’s a moving start of what I hope is a long journey.

What struck me is how Debra describes crossing a line, a bit the way I felt when I found out I had breast cancer. She writes:

I have been writing about medical technology and healthcare for more than a decade. I’ve covered the major medical meetings, including the big one on cancer. I’ve written stories about new cancer drugs and treatments…I wrote those stories objectively and never imagined any would ever apply to me.

She’s shifted from what you might call a “straight” reporter to an i-reporter journalist. And although it’s true that Debra may be less objective than some other writers on the subject, she’s already knowledgeable – through her prior work – on many of the relevant terms and issues. Much of what she knows already, vocabulary included, may allow her to make more informed decisions. It’s possible it may enable her to write in a way that helps readers more than ever.

Earth, from space (NASA image, Wiki-commons)

Earth, from space (NASA image, Wiki-commons

I wish her the best with her column, and with her health ahead.

The bigger issue, of which the story reminds me, is that we’re living among too many young and middle-aged people who have cancer. Every day I read or hear of another case among my neighbors, a friend, a blog. Each reminds me of the need for research, better drugs, and greater knowledge of why so many tumor types – including lung cancer in women who haven’t smoked much, and breast cancer in young women – are on the rise.

The ASCO meeting, where believe me I wish I could be but can’t now, offers a bright picture for targeted drugs, genomics, novel immunotherapy and better data access and analyses through a huge new platform called CancerLinQ, All good. Great, really.

In thinking about each new case in my “world” – if I could pick a field for future investigation that might lead to insight on cancer’s causes and, ultimately, reduce the cancer burden 30 and 50 years from now, I might choose the tiny, under-funded area of environmental oncology

That’s a tough field. Most oncologists want to work with patients. Researchers want to publish papers. Cause-and-effect is hard to demonstrate, especially when most of the data is untenable and you’re up against businesses, politics and people who, understandably, don’t recall precisely what they ingested years ago. But to stop cancer from happening so much, that’s where the money is. IMO, nothing more.

All for this week,

ES

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By |June 3rd, 2013|Blogs, cancer causes, Environmental Health, journalism, Life, Life as a Patient, Life as a writer, Oncology (cancer)|1 Comment|
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Questions for ASCO – on Tamoxifen, ATLAS and aTTom

On Sunday in Chicago, oncologists and others at the plenary session of the annual ASCO meeting will be talking about an abstract that matters a lot to women with breast cancer. It’s a study on Tamoxifen that bears on how long women with estrogen-receptor positive (ER+) tumors should take adjuvant hormonal therapy after initial treatment for early-stage BC.

tamoxifen binding an ER receptor (Wikimedia Commons)

tamoxifen binding an ER receptor (Wiki-Commons)

Why this matters so much is that ER+ tumors account for most BC cases. So if you’re a pre-menopausal woman who’s had a tumor removed by surgery, there’s a good chance your doctor will recommend adjuvant (“extra”) treatment with Tamoxifen for 5 or (probably) 10 years. The reasoning behind this recommendation is that the recently-published ATLAS study demonstrated a clear lengthening of life among women with ER+ tumors who took the longer course.

The usual dose of Tamoxifen (Nolvadex) is 20 milligrams per day. The bargain-rate cost is around $9 for a month’s supply GoodRx.com  – so we’re talking just over $110/year x 5 or 10 years. That’s small change as oncology drugs go, although the numbers add up over so many patients affected…

Tamoxifen carries a small but real risk for what most doctors consider side effects, like blood clots and occasional, typically low-grade uterine cancers. The problem with Tamoxifen – which is not so much a risk as a definite consequence of taking this medication – is that it has anti-estrogen effects that many young (and older) women consider undesirable. Already our breasts have been cut. Feeling “feminine” is not trivial. Many don’t want it!

(Mental exercise: imagine hundreds of thousands of men ages 35-55 agreeably accepting a prescription for partial chemical castration to reduce the chances of a tumor recurring, after they’ve already had significant treatment to reduce those odds)

Your author has been in rooms filled with doctors where the overwhelming consensus expressed was that hormonal treatments in women with BC are terrific. Indeed, they extend life and, in some cases – such as those with low Oncotype scores – afford women the option of skipping chemo. But how are they so sure we’d rather take an anti-estrogen for 5-10 years rather than 3-6 months of chemo? Answer: I don’t think anyone knows.

One limitation of the ATLAS study (and as best I can tell the same for aTTom) is that the trial doesn’t distinguish between women who got adjuvant chemo and those who didn’t get chemo. So it’s unclear whether Tamoxifen helps prevent recurrence, or extend life, in women who’ve also received chemotherapy for the disease.

Here are 2 questions for aTTom:

1. How do we know that women with small, node-negative (low risk) tumors who receive chemotherapy, as is standard in many communities, get additional benefit from Tamoxifen after chemo?

2. Should pre-menopausal women with small, ER+ tumors be given a choice between taking chemo or Tamoxifen?

In other words, is there evidence to support the combination – chemo followed by hormonal Rx – as the standard, adjuvant care for women with early-stage, ER+ tumors? or that women prefer hormonal pills over a short course, like 4 cycles, of chemo?

I’m eager to hear about the updated aTTom (adjuvant Tamoxifen Treatment offers more?) findings, to be published and presented on Sunday. I hope my colleagues – doctors, patients, advocates and journalists will ask good questions!

All for now,

ES

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By |May 31st, 2013|Breast Cancer, cancer treatment, clinical trials, Medical News, Oncology (cancer), Women's Health|3 Comments|
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