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The perils and pitfalls of “patient-driven” clinical research

Dying of cancer can be a horrible way to go, but as a cancer specialist I sometimes forget that there are diseases that are equally, if not more, horrible. One that always comes to mind is amyotropic lateral sclerosis (ALS), more commonly known as Lou Gehrig’s disease. It is a motor neuron disease whose clinical course is characterized by progressive weakness, muscle atrophy and spasticity, with ultimate progression to respiratory muscles leading to difficulty breathing and speaking (dysarthria) and to the muscles controlling swallowing. The rate of clinical course is variable, often beginning with muscle twitching in an arm or a leg or slurring of speech. Ultimately, however, ALS progresses to the loss of ability to move, speak, eat, or breathe. The most common cause of death is from respiratory failure, usually within three to five years after diagnosis, although there is the occasional outlier with a less malignant form of the disease with a slower course of progression who can live a long time, such as Steven Hawking.

In other words, ALS is a lot like cancer in some ways. It is a progressive, fatal disease that usually kills within a few years at most. On the other hand, it is different from cancer in that, at least for many cancers we actually do have effective treatments that prolong life, in some cases indefinitely. In contrast the most effective treatment we currently have for ALS is a drug (riluzole) that is not particularly effective—it prolongs life by months—and can be best described as better than nothing, but not by a whole lot. So it is not surprising that ALS patients, like cancer patients, become desperate and willing to try anything. This is completely understandable, but sometimes this desperation leads to activities that are far more likely to do harm than good. I was reminded of this when I came across a post in the antivaccine propaganda blog, Age of Autism, referring to an article in The Scientist entitled Medical Mavericks. The fortuitous posting of this story, which was apparently designed to try to show that it’s not as crazy as critics have said to be treating autistic children with “Miracle Mineral Solution” (MMS) (which is a bleach) given that the introduction explicitly mentioned Kerri Rivera and the patient described in the article used sodium chlorite to treat his ALS, provided me the opening to discuss a group whose existence and advocacy brings up a complex tangle of issues that boil down to questions of how far patient autonomy should be allowed to go. I’m referring to a company, PatientsLikeMe, which describes itself thusly:
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Posted in: Cancer, Clinical Trials, Neuroscience/Mental Health

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Meet the new drugs, same as the old drugs?

“Targeted therapy.” It’s the holy grail of cancer research these days. If you listen to its most vocal proponents, it’s the path towards “personalized medicine” that improves survival with much lower toxicity. With the advent of the revolution in genomics that has transformed cancer research over the last decade, including the petabytes of sequence and gene expression data that pour out of universities and research institutes, the promise of one day being able to a patient’s tumor, determining the specific derangements in genome and gene expression that drive its uncontrolled proliferation, and finding drugs to target these abnormalities seems more tantalizingly close than ever. Indeed, it seems so close that even dubious practitioners, such as Stanislaw Burzynski, have jumped on the bandwagon, co-opting the terms used by real oncologists and real cancer researchers to sell “personalized gene-targeted cancer therapy,” which in their hands are really no more than a parody of efforts to synthesize the enormous quantity of genomic data each patient’s tumor possesses and figure out how best to take advantage of it, a “personalized genomic therapy for dummies,” if you will.

That’s not to say that there aren’t roadblocks to realizing this vision. The problems to be overcome are substantial, and I’ve discussed them multiple times before. For example, just a couple of weeks ago I discussed an example of just what it takes to apply these new genomic techniques to an individual patient. The resources required are staggering, and, more problematic, there often aren’t any single “magic bullet” molecular pathways identified that can be targeted with existing drugs. The case I discussed was a fortunate man indeed in that such a pathway was identified, but most tumors are driven by many derangements in growth control, metabolism, migration, and the other hallmarks of malignancy described by Robert Weinberg. Worse, in many cases we don’t even have drugs that can attack many of the abnormalities that drive cancer progression. Then there’s the issue of tumor heterogeneity, which comes about because cancer is as good example of a disease as I can think of in which evolution due to natural selection results in incredible differences in the cancer cells in one part of the tumor compared to other parts of the tumor or in the tumor metastases. A “targeted” therapy that targets the genetic abnormalities in one part of the cancer might well fail to target the genetic abnormalities driving another part of the tumor.

These, and many other reasons, are why we haven’t “cured cancer” yet.
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Posted in: Cancer, Clinical Trials

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The future of cancer therapy?

I was contemplating writing a post along the same lines as Harriet’s post about evolutionary medicine last week, but then on Sunday morning I saw an article that piqued my interest. Sorry, Harriet, my response, if I get to it, might have to wait until next week, although we could always discuss the usefulness (versus the lack thereof) of evolutionary medicine over a beer or two at The Amazing Meeting in a few days. In the meantime, this week’s topic will revisit a topic near and dear to my heart, a topic that I tend to view (sort of) in a similar way as Harriet views evolutionary medicine, namely personalized medicine or the “individualization” of treatments. It’s a topic I’ve written about at least twice before and that Brennen McKenzie wrote about just last week. In essence, we both pointed out that when it comes to “complementary and alternative medicine” (CAM) or “integrative medicine” treatments for various conditions and diseases, what CAM practitioners claim to be able to do with respect to “individualized care” is nonsense based on fantasy. Science-based medicine already provides individualized care, but it’s individualized care based on science and clinical trials, not tooth fairy science.

Serendipitously, this point was driven home over the weekend in an article by Gina Kolata in the New York Times entitled In Treatment for Leukemia, Glimpses of the Future. While the story is basically one long anecdote that shows what can be done when new genomic technologies are applied to cancer, it also shows why we are a very long way from the true “individualization” of cancer care. It also turns out that I’ve discussed the same basic story before, but here I’ll try to discuss it in a bit more detail.
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Posted in: Cancer, Clinical Trials, Medical Ethics

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Cantron: A tale of false hope for cancer

A couple of months ago, a reader sent me an article that really disturbed me. In fact, I had originally been planning to write about it not long after I received it. It is, as you might imagine given my specialty and what disturbs me the most wehen I encounter quackery, a story of a cancer patient. Worse, it’s the story of a cancer patient in my neck of the woods. True, it’s not in the same country, but my cancer center is only around two or three miles from the Detroit River and the Canadian border; so it’s plenty close enough. Too close, in fact. Reading the story, in fact, I realized that it features a form of cancer quackery that, as far as my searches have been able to tell me, we haven’t covered before here at SBM, which alone makes it worth taking on, even though the story is two months old. The “cure” is called Cantron, and it is deeply rooted right here in my metropolitan area. Not only that, its siren song and false promises are attracting patients from across the boarder in Canada. Bernie Mulligan is one such patient:
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Posted in: Cancer, Health Fraud, Homeopathy, Science and the Media

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Luc Montagnier and the Nobel Disease

Few awards in anything have the cachet and respect the Nobel Prizes in various disciplines possess. In my specialty, medicine, the Nobel Prize in Physiology or Medicine is quite properly viewed as the height of achievement. In terms of prestige, particularly in the world of science, the Nobel Prize is without peer. To win the Nobel Prize in Medicine or another scientific field, a scientist must have made a discovery considered fundamentally important to the point that it changes the way we think about one aspect of science or medicine. Winning the Nobel Prize in a scientific field instantly elevates a scientist from whatever he or she was before to the upper echelons of world science.

So how, one might ask, is it that seemingly so frequently Nobel Laureates embrace crankery or pseudoscience in their later years? They call it the Nobel Disease, and, indeed, it’s a term listed in the Skeptics’ Dictionary (where the term is attributed to me based on this post about Linus Pauling from four years ago, but I can’t claim credit for coining the term; it existed before I wrote that post) and Rational Wiki, complete with examples. What inspired me to take on this topic, dusting off some old knowledge and writings, is that we apparently have a new victim of the Nobel Disease. Well, perhaps “new” is not the right word, but he is the most recent example. I’m referring to Luc Montagnier, who with Françoise Barré-Sinoussi was awarded the Nobel Prize in Medicine for the discovery of HIV in 2008.

Unfortunately, it didn’t take Montagnier very long to devolve into crankery. Until 2009, to be precise. Since then, Montagnier has embraced concepts like DNA teleportation and ideas very much like homeopathy. And then, just last month, his journey to the dark side was complete. Yes, Luc Montagnier presented at the yearly quackfest I discussed last week, the one in which there was much enthusiasm among the attendees for a treatment that involves administering bleach enemas to autistic children. He presented at Autism One, a coup that caused much rejoicing in the antivaccine movement.

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Posted in: Cancer, Neuroscience/Mental Health, Science and the Media, Vaccines

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Another cancer tragedy in the making

I despise cancer quacks.

I know, I know. My saying that is probably akin to saying that the sun rises in the east, water is wet, and Donald Trump’s hair resembles nothing in nature. You know, brain-meltingly obvious statements. It’s true, though. I despise cancer quacks. It doesn’t much matter to me whether the quack is a true believer or a calculating con artist, the end result is the same: People with cancer throwing their one best chance to survive away chasing pixie dust and promises of “natural” cures without the toxicity that is the unfortunate byproduct of the surgery, radiation, and chemotherapy that are the mainstays of our current armamentarium against cancer. I’m a cancer surgeon. This I cannot abide, which is part of the reason I became active promoting science-based medicine, started my other blog, and then was so eager to join up when the opportunity to join this blog presented itself four years ago.

It’s hard to blame patients, too. After all, as I’ve described so many times before, curing cancer is hard. Very hard. Cancer is complicated. Incredibly complicated. Quacks make it sound easy and simple. They postulate One True Cause of Cancer, and, as a result, often what they represent as the One True Cure for All Cancer. Faced with a life-threatening disease and the possibility of chemotherapy, surgery, and/or radiation therapy, patients are understandably frightened and, if they don’t have a scientific background, susceptible to the blandishments of quacks. That’s what happened to a patient I wrote about long ago, and that’s what happened to Kim Tinkham.

It’s also what is happening right now to a woman named Danielle, and, worse, she’s falling victim to the same cancer quack. Worse still, from my point of view, she’s blogging it.
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Posted in: Cancer, Health Fraud, Science and Medicine

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Dental X-rays and Brain Tumors — Oh My!

Fear sells, and the media loves it. If it’s scary, no matter how tenuous the link or inconclusive the study, you are going to see it on the news. How many times over the years have you heard that your cell phone might give you brain cancer, even though it never turns out to be true? Once such a claim is made, however, it becomes lodged into the public’s psyche and is accepted as true, even after refutations and retractions are published (see Wakefield, Andrew).

And so it is with x-rays. The latest scare du jour, a recent study out of Yale that claims to show a correlation between dental x-rays and intracranial meningioma — the most common brain tumor and usually benign — has been enjoying widespread attention in newspapers and on the evening news. We don’t know if it will be on Dr. Oz, because we can’t bring ourselves to watch that show, but we feel the chances are good. Other alt-medders will no doubt have collective woogasms over the story and will further incite fear and mistrust into the doctor-patient relationship. In fact, the Mercola website wasted no time in weighing in:

While this study does not necessarily establish causation between dental X-rays and tumors, previous research has also implicated dental X-rays in the development of thyroid cancer, and research clearly shows this type of radiation is not harmless…

Typical alarmist fear-mongering. When has any health care professional claimed that radiation is harmless? This is not cutting edge research; Wilhelm Röntgen, the discoverer of x-rays in 1895 and winner of the Nobel Prize in 1901 for his research in the field, advocated the use of lead aprons for protection from the ionizing radiation way back when. Further, trying to lump one study linking dental x-rays to meningioma to another study linking them to thyroid cancer is taking quite the kitchen sink approach. But if there are multiple alleged possible potential theoretical adverse effects from our dental death rays, it must be true, right?

Well, not so fast. We’re dentists, and unlike many knee-jerkers, we’ve actually read the study and would like to offer a little bit of insight into this before everyone panics. In fact, with respect to Letterman, we’d like to offer our Top Three Reasons Not To Panic:
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Posted in: Cancer, Dentistry, Epidemiology, Medical Academia, Science and the Media

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Supplements and cancer prevention

The bloggers here have been very critical of a law passed nearly 20 years ago, commonly referred to as the DSHEA of 1994. The abbreviation DSHEA stands for about as Orwellian a name for a law as I can imagine: the Dietary Supplement Health and Education Act. Of course, as we’ve pointed out time and time again, the DSHEA is not about health, and it’s certainly not about education. Indeed, perhaps my favorite description of this law comes from our very own Peter Lipson, who refers to it as a “travesty of a mockery of a sham.” Rather, it’s about allowing supplement manufacturers and promoters of so-called “complementary and alternative medicine” (CAM, with or without a preceding “s,” depending on your taste) who do not want pesky things like government laws and regulations to interfere with their selling of pseudoscience to market various compounds as “dietary supplements” with near-impunity. As Harriet Hall put it so accurately, the DSHEA is “a stealth weapon that allows the sale of unproven medicines just as long as you pretend they are not medicines.”

The DSHEA accomplishes this by making a seemingly reasonable distinction between food and medicine and twisting it in such a way that allows manufacturers to label all sorts of botanicals and various other compounds, many of which have substances in them with pharmacological activity, and sell them as “supplements” without prior approval by the FDA before marketing. As long as the manufacturer is careful enough not to make health claims that are too specific, namely that the supplement can diagnose or treat any specific disease, and sticks to “structure-function” statements (“it boosts the immune system!”), almost anything goes, particularly if a Quack Miranda Warning is included.

Not surprisingly, given what a big business supplements have become in this country largely due to the DSHEA, manufacturers and CAM advocates fight tooth and nail against any attempt to update the DSHEA to correct some of its more unfortunate consequences. Led by Utah Senator Orrin Hatch and Iowa Senator Tom Harkin, who together make up a bipartisan tag-team in defense of the supplement industry and do their best to block any effort to increase its regulation by the FDA. We saw that most recently when Arizona Senator John McCain, of all people, introduced a bill in 2010 to try to tighten up the DSHEA and was thoroughly slapped down by Orrin Hatch. More recently, not satisfied with how good things are for the supplement industry, another Utah Representative Jason Chaffetz reached across the aisle to Jared Polis, teaming up to introduce the Free Speech About Science Act, which basically seeks to allow the supplement industry to make more liberal claims about its products. All it will need is a “peer-reviewed” paper to support it (Mark and David Geier would do!), and you can claim almost anything. Anything to grow the supplement industry, which is currently around $30 billion a year.

That’s why it’s critical, from time to time, to look at actual evidence, and just last week Maria Elena Martinez, PhD, of the University of California San Diego, and co-authors did in a commentary published online in the Journal of the National Cancer Institute entitled Dietary Supplements and Cancer Prevention: Balancing Potential Benefits Against Proven Harms.
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Posted in: Cancer, Herbs & Supplements, Politics and Regulation

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The problem with preclinical research? Or: A former pharma exec discovers the nature of science

If there’s one thing about quacks, it’s that they are profoundly hostile to science. Actually, they have a seriously mixed up view of science in that they hate it because it doesn’t support what they believe. Yet at the same time they very much crave the imprimatur that science provides. When science tells them they are wrong, they therefore often try to attack the scientific method itself or claim that they are the true scientists. We see this behavior not just in quackery but any time scientific findings collide with entrenched belief systems, for example, medicine, evolution, anthropogenic global warming, and many others. So it was not surprising that a rant I saw a few weeks ago by a well-known supporter of pseudoscience who blogs under the pseudonym of Vox Day caught my interest. Basically, he saw a news report about an article in Nature condemning the quality of current preclinical research. From it, he draws exactly the wrong conclusions about what this article means for medical science:

Fascinating. That’s an 88.6 percent unreliability rate for landmark, gold-standard science. Imagine how bad it is in the stuff that is only peer-reviewed and isn’t even theoretically replicable, like evolutionary biology. Keep that figure in mind the next time some secularist is claiming that we should structure society around scientific technocracy; they are arguing for the foundation of society upon something that has a reliability rate of 11 percent.

Now, I’ve noted previously that atheists often attempt to compare ideal science with real theology and noted that in a fair comparison, ideal theology trumps ideal science. But as we gather more evidence about the true reliability of science, it is becoming increasingly obvious that real theology also trumps real science. The selling point of science is supposed to be its replicability… so what is the value of science that cannot be repeated?

No, a problem with science as it is carried out by scientists in the real world doesn’t mean that religion is true or that a crank like Vox is somehow the “real” intellectual defender of science. Later, Vox doubles down on his misunderstanding by trying to argue that the problem in this article means that science is not, in fact, “self-correcting.” This is, of course, nonsense in that the very article Vox is touting is an example of science trying to correct itself. Be that at it may, none of this is surprising, given that Vox has demonstrated considerable crank magnetism, being antivaccine, anti-evolution, an anthropogenic global warming denialist, and just in general anti-science, but he’s not alone. Quackery supporters of all stripes are jumping on the bandwagon to imply that this study somehow “proves” that the scientific basis of medicine is invalid. A writer at Mike Adams’ wretched hive of scum and quackery, NaturalNews.com, crows:

Begley says he cannot publish the names of the studies whose findings are false. But since it is now apparent that the vast majority of them are invalid, it only follows that the vast majority of modern approaches to cancer treatment are also invalid.

But does this study show this? I must admit that it was a topic of conversation at the recent AACR meeting, given that the article was published shortly before the meeting. It’s also been a topic of e-mail conversations and debates at my very own institution. But do the findings reported in this article mean that the scientific basis of cancer treatment is so off-base that quackery of the sort championed by Mike Adams is a viable alternative or that science-based medicine is irrevocably broken?

Not so fast there, pardner…
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Posted in: Basic Science, Cancer, Clinical Trials

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Cancer care in the U.S. versus Europe: Is more necessarily better?

The U.S. is widely known to have the highest health care expenditures per capita in the world, and not just by a little, but by a lot. I’m not going to go into the reasons for this so much, other than to point out that how to rein in these costs has long been a flashpoint for debate. Indeed, most of the resistance to the Patient Protection and Affordable Care Act (PPACA), otherwise known in popular parlance as “Obamacare,” has been fueled by two things: (1) resistance to the mandate that everyone has to buy health insurance, and (2) the parts of the law designed to control the rise in health care costs. This later aspect of the PPACA has inspired cries of “Rationing!” and “Death panels!” Whenever science-based recommendations are made that suggest ways to decrease costs by reevaluating screening tests or decreasing various tests and interventions in situations where their use is not supported by scientific and clinical evidence, whether by the government or professional societies, you can count on it not being long before these cries go up, often from doctors themselves.

My perspective on this issue is that we already “ration” care. It’s just that government-controlled single payer plans and hybrid private-public universal health care plans use different criteria to ration care than our current system does. In the case of government-run health care systems, what will and will not be reimbursed is generally chosen based on evidence, politics, and cost, while in a system like the U.S. system what will and will not be reimbursed tends to be decided by insurance companies based on evidence leavened heavily with business considerations that involve appealing to the largest number of employers (who, let’s face it, are the primary customers of health insurance companies, not individuals insured by their health insurance plans). So what the debate is really about is, when boiled down to its essence, how to ration care and by how much, not whether care will be rationed. Ideally, how funding allocations are decided would be based on the best scientific evidence in a transparent fashion.

The study I’m about to discuss is anything but the best scientific evidence.
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Posted in: Cancer, Diagnostic tests & procedures, Politics and Regulation, Science and the Media

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