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Do clinical trials work? It depends on what you mean by “work”

Introduction

(Skip to the next section if you want to miss the self-referential blather about TAM.)

As I write this, I’m winging my way home from TAM, crammed uncomfortably—very uncomfortably—in a window seat in steerage—I mean, coach). I had been thinking of just rerunning a post and having done with it, sleeping the flight away, to arrive tanned, rested, and ready to continue the battle against pseudoscience and quackery at home, but this seat is just too damned uncomfortable. So I might as well use the three and a half hours or so left on this flight to write something. If this post ends abruptly, it will be because I’ve run out of time and a flight attendant is telling me to shut down my computer in those cloyingly polite but simultaneously imperious voices that they all seem to have.

I had thought of simply recounting the adventures of the SBM crew who did make it out to TAM to give talks at workshops and the main stage and to be on panels, but that seems too easy. Even easier, I could simply post my slides online. But, no, how on earth can I reasonably expect Mark Crislip to post while he’s at TAM if I’m too frikkin’ lazy to follow suit? I’m supposed to lead by example, right, even if what comes out is nearly as riddled with spelling and grammar errors (not to mention the occasional incoherent sentence) as a Mark Crislip post? Example or not, lazy or not, I would be remiss if, before delving into the topic of today’s post, I didn’t praise my fellow SBM bloggers who were with me, namely Steve Novella, Harriet Hall, and Mark Crislip, for their excellent talks and insightful analysis. Ditto Bob Blaskiewicz, with whom I tag-teamed a talk on everybody’s favorite cancer “researcher” and doctor, Stanislaw Burzynski. It’ll be fun to see the reaction of Eric Merola and all the other Burzynski sycophants, toadies, and lackeys when Bob’s and my talks finally hit YouTube. Sadly, we’ll have to wait several weeks for that. (Hmmm. Maybe I will post those slides later this week.)
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Posted in: Cancer, Clinical Trials

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Angelina Jolie, radical strategies for cancer prevention, and genetics denialism

I had been debating whether to blog about Angelina Jolie’s announcement last week in a New York Times editorial entitled My Medical Choice that she had undergone bilateral prophylactic mastectomy because she had been discovered to have a mutation in the BRCA1 gene that is associated with a very high risk of breast cancer. On the one hand, it is my area of expertise and was a big news story. On the other hand, it’s been nearly a week since she announced her decision, and the news story is no longer as topical as it was. Also, I’ve already written about it a couple of times on my not-so-super-secret other blog, making the division of blogging…problematic. So, if some of this is a bit repetitive to those who are also fans of my more—shall we say?—insolent persona, I apologize, but try to be patient. I will be doing more than just rehashing a couple of posts from last week (although there will unavoidably be at least a little of that), because there have been even more examples of reactions to Jolie’s announcement that provide what I like to consider “teachable moments.” I will start by asserting quite bluntly that in my medical opinion, from the information I have available, Angelina Jolie made a rational, science-based decision. How she went about the actual mechanics might have had some less than scientific glitches along the way (more about that later), but the basic decision to remove both of her breasts to prevent breast cancer associated with a BRCA1 mutation that she carried was quite reasonable and very defensible from a scientific standpoint.

One advantage of waiting nearly a week to write about this story is that it provided me with the opportunity to sit back and observe the reactions that Jolie’s decision provoked. One thing that I really didn’t expect (although in retrospect maybe I should have) is the pure denialism on display that genes have any effect whatsoever on cancer. I say “in retrospect I should have” because I’ve written at least a couple of times before about how quacks use and abuse the term “epigenetics” in the same way that they abuse the word “quantum” and how they seem to believe that wishing makes it so (through epigenetics, of course!) to the point where they believe that genetics is irrelevant to cancer. Indeed, they go far beyond that, asserting that, in essence, environment is all. From what I’ve been reading thus far, the second strongest strain of reaction to Jolie’s announcement (after revulsion at the “mutilation” of women that it represented to certain quacks) is pure denial that mutations in BRCA1 and BRCA2 genes portend such a high risk of ultimately developing breast cancer. This denial is often accompanied by conspiracy mongering about BRCA1 and BRCA2 mutations being a “conspiracy” on the part of the “cancer industry” and Myriad Genetics & Laboratories, the company that holds the patents on BRCA1 and BRCA2, to increase genetic testing and preventative mastectomies. Myriad happens to have a complete monopoly on BRCA1 and BRCA2 testing because of this patent and has been criticized for its high prices and stifling of competition. There is currently a case before the U.S. Supreme Court regarding whether human genes are patentable under the law. I’m not a big fan of Myriad, and I’ll tell you why later. (Not that it matters; I’m stuck with them for now.) My personal distaste for Myriad Genetics aside, this sort of conspiracy mongering is part and parcel of the quack approach to denying the significance of BRCA1 mutations.

This denial is usually coupled with confident blather that Angelina Jolie didn’t need to undergo “disfiguring” surgery to prevent BRCA1-associated breast cancer but instead could have achieved the same—or even better!—risk reduction if only she had used this magic herb or that miracle supplement and making certain “lifestyle” changes. It’s utter nonsense, of course, but it’s everywhere.

Before I get to the reactions to Jolie’s announcement, let’s first take a look at what she did, why, and the science behind it.
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Posted in: Basic Science, Cancer, Medical Ethics, Science and the Media

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Once more into the screening breach: The New York Times did not kill your patient

One of the more depressing things about getting much more interested in the debate over how we should screen for common cancers, particularly breast and prostate cancer, is my increasing realization of just how little physicians themselves understand about the complexities involved in weighing the value of such tests. It’s become increasingly apparent to me that most physicians believe that early detection is always good and that it always saves lives, having little or no conception of lead time or length bias. Sadly, just last week, I saw another example of just this phenomenon in the form of an article written by Dr. George Lombardi entitled My Patient, Killed By The New York Times. The depth of Dr. Lombardi’s misunderstanding of screening tests permeates the entire article, which begins with his recounting a story about a patient of his, whose death he blames on The New York Times. After describing the funeral of this 73-year-old man who died of prostate cancer, Dr. Lombardi then makes an accusation:

This one filled me with a special discomfort as I knew a secret: He didn’t have to die. I knew it and he had known it. Had he told?

About 5 years ago he had just retired and had a lot more time on his hands. He was a careful man, lived alone, considered himself well informed. He got into the habit of clipping articles on medical issues and either mailing them to me or bringing them in. They came from a variety of sources and were on a variety of topics. He wasn’t trying to show me up. He was genuinely curious. I kidded him that maybe he’d like to go to medical school in his retirement. ‘No’ he laughed, ‘I just like to be in the know.’

When he came in for his physical in 2008 he told me he’d agree to the DRE but not the PSA (his medical sophistication extended to the use of acronyms: DRE stands for digital rectal exam where I feel the prostate with my gloved finger for any abnormality and PSA for prostatic [sic] specific antigen which is a blood protein unique to the prostate and often elevated in prostate cancer). He had read that the use of PSA as a screening test was controversial. This was the year that the United States Preventive Services Task Force, a government panel that issues screening guidelines, recommended against routine PSA screens for older men. It was often a false positive (the PSA was elevated but there was no cancer), led to unnecessary biopsies, and besides most prostate cancers at his age were indolent and didn’t need to be treated. I countered that prostate cancer was the second leading cause of cancer deaths in men and that it was better to know than not to know. This way it would be our decision. The patient with his doctor deciding what was best. But no, he wanted to stick to his guns and since the DRE was normal no PSA blood test was sent.

After describing a conversation with the man’s daughter, who said, “My father was killed by The New York Times,” Dr. Lombardi then goes on to anecdotal evidence and a cherry-picked publication to support his view, quoting an oncologist who says he’s “seeing more men presenting with advanced prostate cancer” and then referring to a single paper in the current Annals of Internal Medicine about PSA screening. Before I look at the article and a recently published paper on screening mammography that made the news, I can’t help but point out that I (mostly) agree with Dr. Lombardi when he says:

Public health doctors, policy experts and journalists tend to look at the population as a whole. It is a better story if it is one story. It makes a better headline. Their statistics are people I sit across from everyday trying to figure out what the future holds. We each have our job to do.

The problem is, of course, that Dr. Lombardi takes that observation and draws the wrong conclusion, namely that his patient died because of lack of screening. He attacks a straw man, sidestepping the true argument, namely that evidence shows that PSA screening probably causes more harm than good for men at average risk of prostate cancer. Unfortunately, Dr. Lombardi obviously does not understand some very basic concepts behind cancer screening, nor does he apparently recognize that doctors who deal with the population-level data that we have regarding screening tests and try to apply them to individual patients are actually looking in a very systematic way about what the benefits of screening are to the individual patient. More on that later. In the meantime, although I wouldn’t go quite as far as Dr. John Schumann did in criticizing Dr. Lombardi, I do view his lament as a jumping off point to look at some recent data on screening for the two most common cancers, breast and prostate.

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Posted in: Cancer, Diagnostic tests & procedures, Politics and Regulation, Public Health, Science and the Media

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A holiday round in the mammography debate

There are times when the best-laid blogging plans of mice and men often go awry, and this isn’t always a bad thing. As the day on which so many Americans indulge in mass consumption of tryptophan-laden meat in order to give thanks approached, I had tentatively planned on doing an update on Stanislaw Burzynski, given that he appears to have slithered away from justice yet again. Then what to my wondering eyes should appear in my e-mail in box but news of a study that practically grabbed me by my collars, shook me, and demanded that I blog about it. As if to emphasize the point, suddenly e-mails started appearing by people who had seen stories about the study and, for reasons that I still can’t figure out after all these years, were interested on my take on the study. Yes, I realize that I’m a breast cancer surgeon and therefore considered an expert on the topic of the study, mammography. I also realize that I’ve written about it a few times before. Even so, it never ceases to amaze me, even after all these years, that anyone gives a rodential posterior about what I think. Then I started getting a couple of e-mails from people at work, and I knew that Burzynski had to wait or that he would be relegated to my not-so-secret other blog (I haven’t decided yet).

As is my usual habit, I’ll set the study up by citing how it’s being spun in the press. My local home town paper seems as good a place to begin as any, even though the story was reprinted from USA Today. The title of its coverage was Many women receiving unnecessary breast cancer treatment, study shows, with the article released the day before the study came out in the New England Journal of Medicine:
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Posted in: Cancer, Diagnostic tests & procedures, Public Health

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Alternative medicine use and breast cancer (2012 update)

[Editor’s note: It’s a holiday here in the U.S.; consequently, here is a “rerun” from my other super not-so-secret other blog. It’s not a complete rerun. I’ve tweaked it a bit. If you don’t read my other blog, it’s new to you. If you do, it’s partially new to you. See you all next week with brand spankin’ new material. It also (Ih hope) complement’s Scott’s excellent post from Thursday discussing the same issue and the same paper, but from a different perspective.]

As a cancer surgeon specializing in breast cancer, I have a particularly intense dislike reserved for cancer quacks, which I have a hard time containing at times when I see instances of such quackery applied to women with breast cancer. I make no apologies. These women are, after all, the type of patients I spend all my clinical time taking care of and to whose disease my research has been directed for the last 13 years or so. That’s why I keep revisiting the topic time and time again. Unfortunately, over the years, when it comes to this topic there’s been a depressing amount of blogging material. Indeed, Scott Gavura took a bite out of this particularly rotten apple just a few days ago. Even though he handled the discussion quite well, I thought it would be worthwhile for a breast cancer clinician to take a look. Our perspectives are, after all, different, and this is an issue that, from my perpective, almost can’t be discussed too often.

One question that comes up again and again is, “What’s the harm?” Basically, this question boils down to asking what, specifically, is the downside of choosing quackery over science-based medicine. In the case of breast cancer, the answer is: plenty. The price of foregoing effective therapy can be death; that almost goes without saying. In fact, it can be a horrific and painful death. It is, after all, cancer that we’re talking about. Aside from that, however, the question frequently comes up just how much a woman decreases her odds of survival by avoiding conventional therapy and choosing quackery. It’s actually a pretty hard question to answer. The reason is simple. It’s a very difficult topic to study because we as physicians have ethics. We can’t do a randomized trial assigning women to treatment or no treatment, treatment or quacke treatment, and then see which group lives longer and by how much. If a person can’t see how unethical that would be without my having to explain it, that person is probably beyond explanations. (As an aside, I can’t help but point out that a randomized trial of not vaccinating versus vaccinating is unethical for exactly the same reason; physicians can’t knowingly assign subjects to a group where he knows they will suffer harm. There has to be clinical equipoise.) There’s no doubt that foregoing effective treatment causes great harm.
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Posted in: Cancer, Clinical Trials, Health Fraud

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Rejecting cancer treatment: What are the consequences?

One of the points I’ve tried to emphasize through my contributions to Science-Based Medicine is that every treatment decision requires an evaluation of risks and benefits. No treatment is without some sort of risk. And a decision to decline treatment has its own risks. One of the challenges that I confront regularly as a pharmacist is helping patients understand a medication’s expected long-term benefits against the risks and side effects of treatment. This dialogue is most challenging with symptomless conditions like high blood pressure, where patients face the prospect of immediate side effects against the potential for long-term benefit. One’s willingness to accept side effects is influenced, in part, by and understanding of, and belief in, the overall goals of therapy. Side effects from blood-pressure medications can be unpleasant. But weighed against the reduced risk of catastrophic events like strokes, drug therapy may be more acceptable. Willingness to accept these tradeoffs varies dramatically by disease, and are strongly influenced by patient-specific factors. In general, the more serious the illness, the greater the willingness to accept the risks of treatment.

As I’ve described before, consumers may have completely different risk perspectives when it comes to drug therapies and (so-called) complementary and alternative medicine (CAM). For some, there is a clear delineation between the two: drugs are artificial, harsh, and dangerous. Supplements, herbs and anything deemed “alternative”, however, are natural, safe, and effective. When we talk about drugs, we use scientific terms – discussing the probability of effectiveness or harm, and describing both. With CAM, no tentativeness or balance may be used. Specific treatment claims may not be backed up by any supporting evidence at all. On several occasions patients with serious medical conditions have told me that they are refusing all drug treatments, describing them as ineffective or too toxic. Many are attracted to the the simple promises of CAM, instead. Now I’m not arguing that drug treatment is always necessary for ever illness. For some conditions where lifestyle changes can obviate the need for drug treatments, declining treatment this may be a reasonable approach – it’s a kick in the pants to improve one’s lifestyle. Saying “no” may also be reasonable where the benefits from treatment are expected to be modest, yet the adverse effects from treatments are substantial. These scenarios are not uncommon in the palliative care setting. But in some circumstances, there’s a clear medical requirement for drug treatment – yet treatment is declined. This approach is particularly frustrating in situations where patients face very serious illnesses that are potentially curable.  This week is the World Cancer Congress in Montreal and on Monday there were calls for patients to beware of fake cancer cures, ranging from laetrile, to coffee enemas, to juicing, and mistletoe. What are the consequences of using alternative treatments, instead of science-based care, for cancer? There are several studies and a recent publication that can help answer that question. (more…)

Posted in: Cancer, Herbs & Supplements

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The mammography wars heat up again (2012 edition)

One issue that keeps coming up time and time again for me is the issue of screening for cancer. Because I’m primarily a breast cancer surgeon in my clinical life, that means mammography, although many of the same issues come up time and time again in discussions of using prostate-specific antigen (PSA) screening for prostate cancer. Over time, my position regarding how to screen and when to screen has vacillated—er, um, evolved, yeah, that’s it—in response to new evidence, although the core, including my conclusion that women should definitely be screened beginning at age 50 and that it’s probably also a good idea to begin at age 40 but less frequently during that decade, has never changed. What does change is how strongly I feel about screening before 50.

My changes in emphasis and conclusions regarding screening mammography derive from my reading of the latest scientific and clinical evidence, but it’s more than just evidence that is in play here. Mammography, perhaps more than screening for any disease, is affected by more than just science. Policies regarding mammographic screening are also based on value judgments, politics, and awareness and advocacy campaigns going back decades. To some extent, this is true of many common diseases (i.e., that whether and how to screen for them are about more than just science), but in breast cancer arguably these issues are more intense. Add to that the seemingly eternal conflict between science and medicine communication, in which a simple message, repeated over and over, is required to get through, versus the messy science that tells us that the benefits of mammography are confounded by issues such as lead time and length bias that make it difficult indeed to tell if mammography—or any screening test for cancer, for that matter—saves lives and, if it does, how many. Part of the problem is that mammography tends to detect preferentially the very tumors that are less likely to be deadly, and it’s not surprising that periodically what I like to call the “mammography wars” heat up. This is not a new issue, but rather a controversy that flares up periodically. Usually this is a good thing.

And these wars just just heated up a little bit again late last week.
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Posted in: Cancer, Diagnostic tests & procedures, Politics and Regulation, Public Health

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Dr. Stanislaw Burzynski’s “personalized gene-targeted cancer therapy”: Can he do what he claims for cancer?

Last week, I wrote a magnum opus of a movie review of a movie about a physician and “researcher” named Stanislaw Burzynski, MD, PhD, founder of the Burzynski Clinic and Burzynski Research Institute in Houston. I refer you to my original post for details, but in brief Dr. Burzynski claimed in the 1970s to have made a major breakthrough in cancer therapy through his discovery of anticancer substances in the urine that he dubbed “antineoplastons,” which turned out to be mainly modified amino acids and peptides. Since the late 1970s, when he founded his clinic, Dr. Burzynski has been using antineoplastons to treat cancer. Over the last 25 years or so, he has opened a large number of phase I and phase II clinical trials with little or nothing to show for it in terms of convincing evidence of efficacy. Worse, as has been noted in a number of places, high doses of antineoplastons as sodium salts are required, doses so high that severe hypernatremia is a concern.

Although antineoplastons are the dubious cancer therapy upon which Dr. Burzynski built his fame, they aren’t the only thing he does. Despite the promotion of the Burzynski Clinic as using “nontoxic” therapies that “aren’t chemotherapy” by “natural medicine” cranks such as Joe Mercola and Mike Adams, Dr. Burzynski’s dirty little secrets, at least as far as the “alternative medicine” crowd goes, are that (1) despite all of the attempts of Dr. Burzynski and supporters to portray them otherwise antineoplastons are chemotherapy and (2) Dr. Burzynski uses a lot of conventional chemotherapy. In fact, from my perspective, it appears to me as though over the last few years Dr. Burzynski has pivoted. No longer are antineoplastons the center of attention at his clinic. Rather, these days, he appears to be selling something that he calls “personalized gene-targeted cancer therapy.” In fact, it’s right there in the first bullet point on his clinic’s webpage, underlined, even! Antineoplastons aren’t even listed until the third bullet point.

But what is “personalized gene-targeted cancer therapy,” according to Dr. Burzynski? Here is how it is described:
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Posted in: Basic Science, Cancer, Clinical Trials, Pharmaceuticals

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Hope and hype in genomics and “personalized medicine”

“Personalized medicine.” You’ve probably heard the term. It’s a bit of a buzzword these days and refers to a vision of future medicine in which therapies are much more tightly tailored to individual patients than they currently are. That’s not to say that as physicians we haven’t practiced personalized medicine before; certainly we have. However it has only been in the last decade or so that our understanding of genomics, systems biology, and cell signaling have evolved to the point where the vision of personalized medicine based on each patient’s genome and biology might be achievable within my lifetime.

I was thinking about personalized medicine recently because of the confluence of several events. First, I remembered a post I wrote late last year about integrating patient values and experience into the decision process regarding treatment plans. Second, a couple of months ago, Skeptical Inquirer published an execrably nihilistic article by Dr. Reynold Spector in Skeptical Inquirer in which he declared personalized medicine to be one of his “seven deadly medical hypotheses,” even though he never actually demonstrated why it is deadly or that it’s even really a hypothesis. Come to think of it, with maybe–and I’m being very generous here–one exception, that pretty much describes all of Dr. Spector’s “seven deadly medical hypotheses”: Each is either not a hypothesis, not deadly, or is neither of the two. Third, this time last week I was attending the American Association for Cancer Research (AACR) meeting in Orlando. I don’t really like Orlando much (if you’re not into Disney and tourist traps, it’s not the greatest town to hang out in for four days), but I do love me some good cancer science. One thing that was immediately apparent to me from the first sessions on Sunday and perusing the educational sessions on Saturday was that currently the primary wave in cancer research is all about harnessing the advances in genomics, proteomics, metabolomics, and systems and computational biology, as well as the technologies such as next generation sequencing (NGS) techniques to understand the biology of each cancer and thereby target therapies more closely to what biological abnormalities drive each cancer. You can get an idea of this from the promotional video the AACR played between its plenary sessions:

Which is actually a fairly good short, optimistic version of my post Why haven’t we cured cancer yet? As I mentioned before, with this year being the 40th anniversary of the National Cancer Act, as December approaches expect a lot of articles and press stories asking that very question, and I’m sure this won’t be the last time I write about this this year.
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Posted in: Basic Science, Cancer, Clinical Trials, Diagnostic tests & procedures, Politics and Regulation

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Death by “alternative” medicine: Who’s to blame? (Revisited)

(NOTE: There is now an addendum to this post.)

(NOTE #2: The videos of Robert O. Young’s interview with Kim Tinkham have been removed, as I predicted in this post that they would be. Fortunately, I downloaded copies before he managed to do that. Part 6 appears to be still there–for now.)

(NOTE #3: It was announced on the Facebook page Caring for Kim that the subject of this post, Kim Tinkham, passed away on December 7, 2010 in the late afternoon. Although it was not revealed what kind of cancer she died of, Tinkham almost certainly died from metastatic breast cancer. Quackery appears to have claimed another victim.)

I hate stories like this. I really do. I hate them with a burning passion that makes it hard for me to see straight when I first find out about them.

In fact, you might even say that stories like this are a major part of the reason why I do what I do, both here and elsewhere. They’re a major part of the reason why I’ve recently branched out into public speaking, something that used to terrify me beyond belief but that lately I’ve become at least competent at–sometimes even not bad at all. Sadly, the story I’m about to tell is one I’ve told before, most recently at the Lorne Trottier Science Symposium, where I gave a talk on cancer cure “testimonials,” although at the time I gave the talk the story’s outcome, although predictable, was not yet known.

Now it is.

The woman to whom I refer is named Kim Tinkham, who was diagnosed with breast cancer over three and a half years ago. Regular readers may recall that Kim Tinkham achieved fame not long after that when she was featured on The Oprah Winfrey Show in an episode about The Secret, an episode I discussed posts entitled The Oprah-fication of Medicine and On the nature of “alternative” medicine cancer cure testimonials. I don’t want to discuss the utter nonsense that is The Secret in any detail here. However, for those unfamiliar with this particular bit of New Age woo, it’s important to point out that The Secret’s “Law of Attraction” takes the germ of a reasonable idea (namely that one’s attitudes and wishes influence whether one gets what one wants in life, something that’s been known for millennia) and goes off the deep end of woo by proclaiming that, in essence, you can get anything you want by wanting it badly enough and thinking positive thoughts. Basically “The Secret” is that you have the power to “attract” good to yourself by thinking happy thoughts (hence “the law of attraction,” which, according to Secret adherents always works). It’s an idea that resonates in so much of “alternative medicine,” such as German New Medicine or Biologie Totale. Of course, the implication of “Secret” thinking is that, if you don’t get what you want, it’s your fault, an idea that also resonates with so much “alternative” medicine, where a frequent excuse for failure is that the patient either didn’t follow the regimen closely enough or didn’t want it badly enough.

Basically, The Secret is what inspired Kim Tinkham to eschew all conventional therapy for her breast cancer and pursue “alternative” therapies, which is what she has done since 2007. Before I discuss her case in more detail, I’m going to cut to the chase, though.

This weekend, I learned that Kim Tinkham’s cancer has recurred and that she is dying. On Saturday, a reader of my other blog sent me an e-mail that informed me:
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Posted in: Cancer, Faith Healing & Spirituality, Health Fraud, Science and the Media

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