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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, Politics and Regulation, Science and the Media

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Dr. Oz revisited

We here at SBM have been very critical of Dr. Mehmet Oz, who through his relentless self-promotion (and with more than a little help from his patron Oprah Winfrey) has somehow become known as “America’s doctor.” Back in the early days, when he was the regular medical expert on The Oprah Winfrey Show, Dr. Oz was at least tolerable. Much of what he discussed was reasonably science-based and even sensible, mainly advice to eat better and get more exercise, which is what most primary care doctors tell their patients every day. True, he did “integrate” some non-evidence-based therapies in with the evidence-based therapies, which was not good given how a typical viewer wouldn’t be able to tell where the science-based advice ended and the magical thinking began, but for the most part, even on Oprah’s show, he kept his woo somewhat in check. At least, there were boundaries beyond which he wouldn’t pass, even though Dr. Oz’s wife is a reiki master and he has been a fan of reiki (gaining fame for inviting reiki masters into his operating room during cardiac surgery) since at least the 1990s. More recently, Dr. Oz has testified in front of NCCAM patron Senator Tom Harkin’s committee to promote “complementary and alternative medicine” (CAM) or, as its advocates like to call it now, “integrative medicine.” He’s also been the Medical Director for the Integrative Medicine Program at New York-Presbyterian Hospital/Columbia University Medical Center since 2001. (How he does his TV show, holds a job as a professor of surgery at Columbia University, and holds positions as Clinical Trials of New Surgical Technology, Attending Surgeon, and Director, Clinical Perfusion Services at the same hospital, I’ll never know. He must have the most understanding partners ever.)

Be that as it may, even after Dr. Oz landed The Doctor Oz Show, for the first half of his first season he kept it fairly straight and science-based. However, two years ago the mask began to slip when Dr. Oz first aired a credulous feature about reiki under the title Dr. Oz’s Ultimate Alternative Medicine Secrets. Not long after that, Dr. Oz featured a man who is in my opinion arguably the foremost promoter of quackery on the Internet, Dr. Joe Mercola, along with the master of quantum quackery, Dr. Deepak Chopra. It was at that point that one could rightly say that Dr. Oz had “crossed the Woobicon.” Since then, it’s been one thing after another, beginning in earnest about a year ago. For instance, in January 2011, Dr. Oz featured Dr. Mercola again in a completely credulous portrait that painted him a “brave maverick doctor,” only without a hint of irony. A couple of weeks later, he featured a yogi who advocated “detoxing” and a faith healer from my old stomping grounds in Cleveland. Then, just when I thought Oz couldn’t go any lower, he featured psychic scammer John Edward.

Finally, back in April 2011, Dr. Oz’s producers apparently figured out that there was a problem with Dr. Oz’s image, except that they saw it as an opportunity to gin up a little controversy on the show. They invited our very own Dr. Steve Novella on the show as the “skeptic” who criticizes Dr. Oz. I very much admire Steve for going into the lion’s den, where, he knew in advance, he would be the underdog and the audience would be against him. Steve acquitted himself well, and after his appearance, I have to admit, I pretty much stopped paying attention to Dr. Oz for several months. He basically faded into the background of quackery, a prominent voice “integrating” quackery with medicine, pseudoscience with science, in the apparent belief that mixing fantasy with reality somehow improves medicine. Personally, I prefer Mark Crislip’s take and will steal his statement about “integrative medicine”:

If you integrate fantasy with reality, you do not instantiate reality. If you mix cow pie with apple pie, it does not make the cow pie taste better; it makes the apple pie worse.

I just learned last week that Dr. Oz, while trying to make the cow pie taste better, is only continuing to succeed in making the apple pie taste worse. Witness an episode from last week featuring a long segment entitled Dr. Mercola’s Most Radical Alternative Cures, or, as the banner on the segment calls it, “Radical Cures Your Doctor Thinks Are Crazy.” Not surprisingly, Dr. Mercola has been bragging about his fourth appearance on Dr. Oz’s show yet again. (Video: Part 1 and Part 2).
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Posted in: Cancer, Energy Medicine, Science and the Media

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Reassessing whether low energy electromagnetic fields can have clinically relevant biological effects

It is with some trepidation that I write this, given that I realize this post might lead to charges that I’ve allowed myself to become so open-minded that my brains fell out, but I think the issues raised by what I’m about to discuss will make our readers think a bit—and perhaps spark some conversation. Because I’m in a bit of a contrarian mood, I’ll take that risk, although it’s possible I might end up with the proverbial egg on my face. As our regular readers know, the issue of the health effects of radiation from mobile phones has been a frequent topic of this blog. The reasons are obvious because fear mongering claims not based in science are frequently made in the lay press and in books (for example, Disconnect by Devra Davis) and, unfortunately, also by some physicians and scientists. Moreover, like homeopathy, the issue demands a discussion of prior probability and plausibility based on basic science alone, but the issues are a bit less clear-cut. Whereas the tenets of homeopathy clearly violate multiple laws of physics and chemistry, it is possible, albeit very unlikely, that radio waves might produce significant biological changes.

There’s also sometimes a maddening dogmatism on the part of some physicists that it’s “impossible” that long term exposure to radio waves could possibly cause cancer because such electromagnetic waves do not have anywhere near enough energy to cause ionization and thereby break chemical bonds. While it is certainly true that such radio waves can’t break chemical bonds and the likelihood that the radio waves from cell phones can cause cancer appears very low based solely on physics considerations, all too often the arguments made based on physics considerations alone use a simplistic understanding of cancer and carcinogenesis as their basis. It’s not for nothing that I have referred to such arguments as being based on a high school or freshman level of understanding about cancer—or just an outmoded understanding that prevailed a decade or two ago but today no longer does. Bernard Leikind, for instance, argued and famed skeptic Michael Shermer accepted that, because the radio waves used in cellular communications are too low energy to break chemical bonds and do not produce significant heating compared to other sources, “cell phones cannot damage living tissue or cause cancer.” Note the implicit assumption: That it is somehow necessary to “damage” living tissue in order to cause cancer. That’s an assumption that is arguably quite simplistic and ignores knowledge we’ve gained about epigenetics and how potential metabolic influences might cause cancer. Cancer is associated with characteristic cellular metabolic abnormalities, and determining which is responsible for the formation of cancer, metabolic abnormalities or gene mutations, has become a “chicken or the egg”-type of question.

I do not in any way believe that cell phone radiation actually is a cause of cancer because, unlike the case in homeopathy, where multiple well-established laws of physics would have to be overturned for homeopathy to work, I find the argument that a causation is “utterly impossible” far less persuasive than some physicists do when it comes to cell phone radiation and cancer. Even dismissing the “impossibility” argument, however, clearly such a link is at the very least incredibly implausible on physics considerations alone, as I have pointed out time and time again. Add to that the nearly completely negative epidemiological data in which only one group of researchers has been able to produce apparently “positive” studies, and my personal conclusion is that we probably already have enough data to reject a connection between radio waves and cancer and don’t need any more new large epidemiological studies; following up long term results on the ones already under way should be sufficient. That is not the same thing as arguing that radio waves have no significant biological effect, which is what, in essence, the argument from physics is based on. In fact, the inspiration for the rest of this post came from a meeting I had last week with a scientist and that scientist’s talk for our cancer center’s weekly Grand Rounds. What I learned did not demonstrate that cell phones cause cancer or even that they might cause cancer. Not even this scientist claimed his results were consistent with cell phone radiation causing cancer; in fact, he quite clearly stated they were not. However, what I learned from him cast some doubt (to me, at least) on the assumption that radio waves cannot have profound biological effects. In fact, ironically enough, this scientist is proposing the use of amplitude-modulated (AM) radio waves to treat cancer. I’m not yet convinced by any stretch of the imagination that this researcher is on to something, but his findings made me think about the perils and pitfalls of declaring something “impossible” solely on basic science considerations, because he has some very intriguing results that I can’t find a compelling reason to dismiss.

And, at least as of now, there’s no known physical mechanism that can explain his findings. Leaving aside the possibility of fraud or some sort of systematic bias that is not apparent in the methods sections of the papers I’m about to summarize, either he’s found something new and potentially promising, or he’s somehow very, very wrong.
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Posted in: Basic Science, Cancer, Clinical Trials

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Dr. Stanislaw Burzynski, antineoplastons, and the selling of an orphan drug as a cancer cure

Over the last couple of weeks, I’ve been spending a lot of time (and, characteristically, verbiage) analyzing the phenomenon known as Dr. Stanislaw Burzynski and his “cancer cure” known as antineoplastons. In part I of this series, Stanislaw Burzynski: Bad medicine, a bad movie, and bad P.R., I used the legal threats against bloggers criticizing the credulous promotion by the British press of fundraising campaigns to send children with terminal cancer to the Burzynski Clinic and the promotion of the medical propaganda movie Burzynski The Movie: Cancer Is Serious Business to review the movie’s claims and look into Burzynski’s claims for antineoplastons. Not surprisingly, I found the evidence for extravagant claims for their anticancer effects unconvincing. In part II, Dr. Stanislaw Burzynski’s “personalized gene-targeted cancer therapy”: Can he do what he claims for cancer?, I looked into Dr. Burzynski’s recent efforts to “diversify his portfolio, in which he has apparently decided to ride the new wave of genomic medicine to claim he can do “personalized, gene-targeted cancer therapy.” I concluded that he does appear to do that, only very badly, in essence “making it up as he goes along.”

In this third and final part, I want to come back to antineoplastons, because it has been pointed out to me that there is an aspect of this story that has received little attention. One reader in particular has helped enormously in my education about this aspect of the Burzynski saga. I wish I could credit this person by name, but, for reasons I fully understand, I can’t. However, this person’s input was essential, and I’ve even appropriated (with permission, of course) a little bit of text here and there from our e-mail exchanges to “integrate” into this post. Putting this together with information in my previous posts, I think we can come to some conclusions about what it is that Dr. Burzynski is really doing.

Burzynski and an orphan drug

In the first part of this series, I pointed out that back in the 1970s Dr. Burzynski claimed to have discovered cancer-fighting substances in human urine, which he dubbed “antineoplastons,” claiming that patients with cancer had lower levels of these substances in their blood and urine. However, I was pretty vague about just what these substances were, other than to point out that they were modified amino acids and that since 1980 Dr. Burzynski has been synthesizing them in a chemistry lab rather than isolating them from urine as he had done up until then. This vagueness came simply from my interest in moving straight to looking at Burzynski’s claims rather than what these substances were. In retrospect, that might have been a mistake. The reason is that understanding what two of Burzynski’s antineoplastons are is critical to understanding what he is doing with them and why he might occasionally appear to be observing an antitumor response.
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Posted in: Basic Science, Cancer, Legal, Medical Ethics, Pharmaceuticals, Politics and Regulation

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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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Stanislaw Burzynski: Bad medicine, a bad movie, and bad P.R.

And the Lord spake, saying, “First shalt thou take out the Holy Pin. Then shalt thou count to three, no more, no less. Three shall be the number thou shalt count, and the number of the counting shall be three. Four shalt thou not count, neither count thou two, excepting that thou then proceed to three. Five is right out. Once the number three, being the third number, be reached, then lobbest thou thy Holy Hand Grenade of Antioch towards thy foe, who, being naughty in my sight, shall snuff it.

Cleric from Monty Python and the Holy Grail

I’ve always wondered about the power of the number three. When it comes to quackery propaganda movies, certainly three seems to be the magic number. For example, The Greater Good, an anti-vaccine propaganda film, features three anecdotes, three children allegedly suffering from vaccine injury, and it interspersed its interviews with experts, both real (such as Dr. Paul Offit) and phony (such as Barbara Loe Fisher) with vignettes from these children’s stories interspersed between them in a highly biased manner. I have to wonder whether these cliches are taught in film school, given that they seem to be so common. Such were the thoughts running through my brain as I watched the latest medical propaganda film by writer/producer Eric Merola that’s floating around the blogosphere and the film circuit, Burzynski The Movie: Cancer Is Serious Business. In this movie, there are three testimonials, and, if anything, they are far more manipulative than even the testimonials featured in The Greater Good, because each of them are of the type that portrays doctors as sending a patient home to die; that is, until a “brave maverick doctor,” one Stanislaw R. Burzynski, MD, PhD, comes to the rescue with his unconventional and unproven therapy. The only difference is that this film counts testimonials up to the number three in the beginning as “proof” that Burzynski can cure cancer before lobbing the Holy Hand Grenade of Burzynski towards its foes in the hopes that, being naughty in the filmmaker’s sight, the FDA and Texas Medical Board will snuff it. Or, as a caption says right at very the beginning of the movie:

This is the story of a medical doctor and PhD biochemist who has discovered the genetic mechanism that can cure most human cancers. The opening 30 minutes of this film is designed to thoroughly establish this fact — so the viewer can fully appreciate the events that follow it.

It turns out that the grenade is a dud.
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Posted in: Basic Science, Cancer, Clinical Trials, Medical Ethics, Politics and Regulation, Science and the Media

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Chemotherapy doesn’t work? Not so fast…

“CHEMOTHERAPY DOESN’T WORK!!!!!”

“CHEMOTHERAPY IS POISON!!!!”

“CHEMOTHERAPY WILL KILL YOU!!!!”

I’ve lost count of how many times I’ve come across statements like the ones above, often in all caps, quite frequently with more than one exclamation point, on the websites of “natural healers,” purveyors of “alternative medicine.” In fact, if you Google “chemotherapy doesn’t work,” “chemotherapy is poison,” or “chemotherapy kills,” you’ll get thousands upon thousands of hits. In the case of “chemotherapy kills,” Google will even start autofilling it to read “chemotherapy kills more than it saves.” The vast majority of the hits from these searches usually come from websites hostile to science-based medicine. Examples include Mercola.com, the website of “alternative medicine entrepreneur” Dr. Joe Mercola and NaturalNews.com, the website of Mike Adams, where you will find cartoons like this one, which likens the administration of chemotherapy to a Nazi death camp:

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Posted in: Cancer, Science and Medicine

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Dummy Medicines, Dummy Doctors, and a Dummy Degree, Part 1: a Curious Editorial Choice for the New England Journal of Medicine

Background

This post concerns the recent article in the New England Journal of Medicine (NEJM) titled “Active Albuterol or Placebo, Sham Acupuncture, or No Intervention in Asthma.” It was ably reviewed by Dr. Gorski on Monday, so I will merely summarize its findings: of the three interventions used—inhaled albuterol (a bronchodilator), a placebo inhaler designed to mimic albuterol, or ‘sham acupuncture’—only albuterol resulted in a clinically important improvement of bronchial airflow; for that outcome the two sham treatments were equivalent to “no intervention.” For all three interventions, however, self-reported improvements were substantial and were much greater than self-reported improvements after “no intervention.” In other words, dummy treatments made the subjects (report that they) feel better, whereas real medicine not only made them feel better but actually made them better.

Before proceeding, let me offer a couple of caveats. First, the word ”doctors” in the flippant title of this post refers mainly to two individuals: Daniel Moerman, PhD, the anthropologist who wrote the accompanying editorial, and Ted Kaptchuk, the Senior Author of the trial report. It does not refer to any of the other authors of the report. Second, I have no quarrel with the trial itself, which was quite good, or with the NEJM having published it, or even with most of the language in the article, save for the “spin” that Dr. Gorski has already discussed.

My quarrels are the same as those expressed by Drs. Gorski and Novella, and by all of us on the Placebo Panel at TAM. This post and the next will develop some of those points by considering the roles and opinions of Moerman and Kaptchuk, respectively.

A True Story

Late one night during the 1960s a friend and I, already in a cannabis-induced fog, wandered into a house that had been rented by one of his friends. There were about 8-10 ‘freaks’ there (the term was laudatory at the time); I didn’t know any of them. The air was thick with smoke of at least two varieties. After an uncertain interval I became aware of a guy who was having trouble breathing. He was sitting bolt upright in a chair, his hands on his knees, his mouth open, making wheezing sounds. He took short noisy breaths in, followed by what seemed to be very long breaths out, as though he was breathing through a straw. You could hear the wheezing in both directions. Others had also noticed that he was in distress; they tried to be helpful (“hey, man, ya want some water or somethin’?”), but he just shook his head. He couldn’t talk. My friend, who had asthma himself, announced that this guy was having an asthma attack and asked if he or anyone else had any asthma medicine. No one did.

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Posted in: Acupuncture, Cancer, Clinical Trials, Energy Medicine, Faith Healing & Spirituality, Health Fraud, Homeopathy, Medical Academia, Medical Ethics, Naturopathy, Pharmaceuticals, Public Health, Science and Medicine, Science and the Media

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Hash Oil for Gliomas? What Would You Do?

A friend asked me to look at the evidence for hash oil as a treatment for glioma. His teenage daughter was recently diagnosed with brain cancer: a grade 3 anaplastic ependymoma. It recurred very rapidly after surgery and radiotherapy and the latest tissue diagnosis shows an aggressive grade IV glioma. Her prognosis is not good. No further attempts at curative therapy are indicated; the oncologist prescribed only palliative therapy with temozolomide. Her father, who had recently lost his wife to cancer (breast cancer metastatic to lungs and brain), was understandably devastated. As he puts it, he remains “focused on the belief that just maybe a cure can be found.” He stumbled on what he calls “earth-shattering news” regarding hash oil. He and his friends established a private wiki website which they are constantly updating with information about THC (tetrahydrocannabinol, the active ingredient in marijuana and hash) and other possible cancer cures: everything from curcumin to diet. He asked me to look at the information he has accumulated. He said

I hope to convince you in the same way I have done with my daughter’s GPs and her neuro-oncologist at BC Children’s Hospital.

The oncologist was not exactly convinced. He didn’t say he thought hash oil was likely to work; he only said it would be reasonable to try it as a complementary therapy. He said

the data published so far appears very preliminary, most of its potential effectiveness in vivo so far appears in colonic disease, having said that there doesn’t appear to be any obvious down side as a complementary therapy and may have synergistic effect, so may be reasonable as add on to temodal if she tolerates it

I wasn’t convinced either.

I will discuss two issues here:

  1. What does the evidence say about gliomas and hash oil?
  2. When is it reasonable to try an unproven treatment as a last resort?

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Posted in: Cancer, Herbs & Supplements

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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, Politics and Regulation

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